Legal Case Summary

This is our number of 2011, 14, 13, and 14, 14 in Rage Evochloro-Medical products. Just to be able to combine these cases, we leave it here to figure out how to present it. Okay, thank you, Ray honor. I'm Mark Levy and I'm representing Devacore products with me at Council's table. It's Jerry Grassel, the Associate General Counsel. We are appealing from two rejections that arose in re-examination proceedings in the US patent office. The unusual situation here is that a forester is the primary reference against one patent, and then in the second case, forester is on trial. In essence, that's close although the forester is a related patent, it's not the identical reference, but the disclosure is identical. So the reference is Forester O55 and the... Does that mean Forester disclosed everything but the swellable material? Well, the answer is not technically no. Forester teaches that the marker can be made of a metal or it could be made of a polymer, and that polymer is selected so that it can be imaged or capable of being imaged. But that's the extent of the forester disclosure. The forester disclosure does not go into that way to make that polymer imageable as to incorporate a radial pipe material into it. It leaves that aspect of that aspect of the thing dangling. Okay, so we have got the two appeals. We've got 1413, which is the Fulton Patent. In both cases, we're dealing with marking the location at which a breath biopsy has been taken. And in the Fulton Patent, that marker is a polymer composition that has three properties. It is swellable, it is radial pate, and it is biopsy-absorbable. In the 14th, Fort... In the biopsy-absorbable

. In terms of swellable. Your Honor, we would say no, absolutely not for several reasons. The bi is using a swellable material in a punch-like apparatus in order to take a skin biopsy. And the function of that swellable material... The biopsy-absorbable is one of two reference to talking about, obviously, see. Is that a method for marking a biopsy site providing a swellable body, removing a specimen and serving the body? There's a lot to it, except after you look at four, forster, and then you've got the swellable body. Well, I guess the other point that you've got though is you do have a swellable body in the bi. But you really don't have any motivation, you don't have any real teaching that says that within the context of a breast biopsy, you need a swellable material. Obviously, when you're taking a biopsy from the ability to see the outer skin and the like, I mean, we all know how we bleed when we're cut. Hemostasis is very critical, and the objective of the bi is let's take this biopsy without using a suture, and in order to do that, we're going to put this swellable material in there. But now how do we get to the point where we say, okay, now we're doing a breast biopsy. Now we're in the classic situation, we're doing a needle biopsy of a breast. And we've got the same problems, and we're going to solve those same problems the same way. That leaf is missing from the record, that's missing from the prior art, and that is where the devochor invention comes in. In other words, the other thing to keep in mind is... So the invention here is this idea that you've got the idea to do it. It's not how you do it. The materials to do it with are in the public domain, so to speak, and in other words, swellable polymers are known. We don't deny that. But this port has on many occasions pointed out that merely having the materials available is not enough to render an invention obvious

. Yeah, but these are all the same fields biopsy. You say they're all in the same field, but we're talking about a breast biopsy here, which is taken under very, very unique, carefully controlled from a number of different aspects. And with minimal invasion, versus the secondary reference is a punch. But you have to be able to find any cases and analogous circumstances. This is pretty close. If you look at our cases, I think, and the ones where we've said it's analogous, sorry, it's analogous field, I don't know that I can think of any that would support your viewing terms, the details of death, being a different field. Can you come up with anything? You think this is close to some other case that we said it was a completely different field? Well, you're on our other side. No, but it's hard to find cases that match up like this. That would match in this type of situation. I guess I have to come back again to the point that again we're talking about a breast biopsy, which conventionally is a very minimally invasive needle biopsy. And in fact, there's no evidence in the record that swelling hemostasis is even an issue. In fact, if you look at the forest or pad, the principal examples of the principal examples that forest puts forth for the marker are metals. And those metals clearly are metal elements. Those metal elements clearly don't have any hemostatic properties, but according to forestry they're perfectly fine. And if you look at the forest or pattern in column one of the patterns, forestry makes a statement about the problems that accompany bleeding, the problems that accompany a biopsy and versus tissue removal. In forestry states, when you remove it, tumor, you have pleating problems. But forestry completely leaves out, so to speak, the... I can direct you to that disclosure. But when forestry is talking about the biopsy, forestry does not get into any issue of hemostasis. I'm going to refer specifically to A267 in the record of the 1413 P.O. But the biopsy

... the biopsy is working on the open skin and is a different tissue, a different location, external versus internal. It's a problem of a different nature. And again, going back to forestry, he's using these metal elements and has no hemostasis problem in those situations. He also proposes to use a polymer that a polymer could be used as a marker, but he certainly doesn't telegraph that we've got a need here to absorb the blood that we've got problems that are flowing out of this and hence we need to make this type of modification in this. And that's the word flowing out, traditionally. But yeah, and did you catch, anyway, my reference to forestry and the absence of any indication that bleeding is a problem is that it's a-260, it's column 1, lines 44 to 50 of the forestry reference. Since what's combining these cases and we're talking about forestry, why doesn't Anderson pretty much take care of forestry? Because the forestry, which as we recognize forestry doesn't have the swellable limitation. Right, it doesn't, and Anderson doesn't either. Anderson doesn't either, so that's not neither here nor there. But Anderson, even though it talks about administering interloken, it does so. And it goes into a tumor site and takes a biopsy. Yeah, well, in Anderson, yes, and one of the things that I find intuitively difficult to understand is how when we're dealing with biopsy, and we have tissues that we don't know whether they're cancerous or not, you would go and use an anti-cancer agent like interloken 2, which is highly toxic. But apart from that, and probably even more importantly than that intuitive question, is that the Anderson process, the composition that Anderson developed, is never positioned in a biopsy site. What Anderson does is he goes in, and they use the example of brain surgery, but it could be surgery on any organ of the body. You're going to remove the tumor. You go in, your tissue is in the surgeon's eye. He needs to verify that he's got the right tissue before he goes and takes the entire tissue out. So he takes a small, what they call core localization biopsy. He grabs a little tissue, runs it down to the lab, they put it under the scope, they verify that he's got the right tissue, and he comes back in and he would completely remove the tumor. At that point in time, the surgery is being completed, the tumor is totally eradicated. The biopsy site doesn't even exist because to the extent it was in that tumor initially, and he's that little site where he verified that he had the right stuff. It's completely gone

. And now he inject a chemo therapeutic agent into that. Now, that set of circumstances is so totally in my mind, just so totally far removed from the marking a biopsy. He said, I have that for instance, it's essentially a biopsy site. And leaving out the, I mean, anacinth is a reference for everything it discloses, but everything that it discloses isn't the only thing that's disclosed. In other words, it goes in. I mean, this is not, right, nothing. But being the skill of, no, of serogen, but this doesn't seem revolutionary. Well, to go into a biopsy site and to market with a bio degradable radio-paked polymer. Well, I think you also have to remember that these patents are going back a very long time. I mean, the Fulton patent, where this was on its third re-examination, and these patents go back to the mid-90s. So I don't think you can apply today. You've got to be careful when you're dealing with patents that are this old to jump to conclusions in terms of how simple something may appear today versus, you know, as of the date these patents were filed. But again, I do think it's, I think that, you know, to hold out that a reference that has nothing to do with marking a bio. And really has nothing to do with marking anything. And to say that a person of ordinary skill in the art would have been, with all these things available in front of him, or would have picked up on that reference and said, oh, there here's a problem in marking breast biopsy. And we're going to fix that problem using this as a spin-off of this inter-luchin-2 composition. I find to be a stretch. Plus, now buy. Plus, now buy, which is... Which doesn't have the inter-luchin. And which doesn't have the inter-luchin, but is also merely a hemostat, which there's no indication in the record of any importance in a criticality. I mean, there's nothing in the primary references that get that show any criticality to controlling human stasis within the confines of a breast biopsy

. And indeed, as I say, we can't ignore the fact that Forester is just putting little pieces of metal in there and not having any problems. So, I think it's a large... I think also we have to... I also have to ask the question again, though, whether this person of ordinary skill in this art would reasonably consider this subject matter within the context of marking a breast biopsy. And these claims are specifically directed to marking breast biopsies and specifically to taking a biopsy... A breast biopsy sample. And that brings into them all of the dimensions and considerations that go with that type of a surgical procedure. Okay, let's get here from the government. We'll say we'll read metal times. I have a little bit more time, correct? You do. You will fair amount of more times. Do you want to talk about the other parts of the field or the field? I guess what I want... Well, we've really talked about both the fields... I don't know if I can explain it

. ...to already do some extent. And I think we need to touch upon in the 14-14 appeal the board's decision. And in that appeal, and there are two procedural issues which we feel, which I think is pretty clear, were in violation of the rules and of 35 U.S.C.6 B. And that is that the first issue that I would get to is that in rendering the decision in the 14-14 case, the board developed its own rejection. A rejection that was promised entirely upon the Anderson reference in one in which the board concluded that Anderson was broad enough that applicants could be construed as being broad enough to read on Anderson. That statement, that fact, that finding never appeared during the course of the prosecution of the application. Furthermore, early on in the prosecution of the re-examination of the Forrester patent, the examiner had was confronted with a rejection over... The examiner was made a rejection over Anderson and the applicant responded to that rejection and the examiner agreed that applicant had overcome that rejection and withdrew it. So we've got the board adopting a... we've got the board rendering a decision in which the board sets forth a construction of the claims of the Anderson patent. As reading on... construction of the claims of the Forrester patent, as reading on Anderson, when in fact that very issue had been addressed earlier in the prosecution of the case and had specifically abandoned

. So clearly, for it to come up in the board's decision here is a new issue. Secondly, the rejection that was actually in front of the board were two 103 rejections. One was a 103 rejection of the majority of the claims in the case over Nebai and view of Anderson and Lee and the second rejection was a rejection of claims eight and twelve over the combined teachings of Lee, Nebai and Anderson. Now, when the board rendered its decision, it abandoned these two rejections. That abandoned both... the whole 103 analysis kind of went to the side and the board justified everything that it did on the premise that... And in fact, it concluded that... well, we're affirming the rejections because Anderson can be... Anderson... the claim one can be construed as reading on Anderson. So, in essence... they went on to say

... they sued Nebai in there. They did throw Nebai in there, but the analysis was a 102 analysis based on Anderson. So, I think... and we never had a chance... we had no chance whatsoever. Furthermore, in the examiners' answer, she specifically indicated that she was only relying upon Anderson to teach the radio-pake material. So, here we go from a situation where in the final rejection and in the examiners' answer, Anderson... the Anderson has been relied upon solely as teaching a radio-pake material to a decision by the board in which Anderson now re-zoned... or the... Anderson has now held to teach every limitation in the claim. And that issue.

.. I think that issue was totally new. The second error that the board made was... we always had two rejections in this case. There was all of the rejection of claims one and a number of the other claims. And then there was a second rejection of claims eight and twelve over Lee and Duof Nebai and Anderson. Those claims were... they were separately... they appeared separately in the final rejection. They appeared separately in the examiners' answer. They appeared separately in the brief. And yet in the board's opinion, and yet the board decided that applicant had not... had not separately argued with Anderson. And therefore, the board on its own initiative combined them for consideration and selected claim one as being a representative of this group. Well, that action of the board was.

.. was... all premise... was premise under 31... let's see here... what is it? It's 31 CFR... I've got it here someplace. That was all premise under 31 CFR... 47... sorry... 41.37 C17. And 41.37 C17 only permits the board to group claims and to select a representative claim. And it specifically says for each ground of rejection applying two or more claims, the claims may be argued separately or a group. That's for each ground of rejection. The next sentence in 41.37 C17 says, when multiple claims subject to the same ground of rejection are argued as a group by the appellant, the board may select a single claim from that group. Well, that is not what we had here. What we had here is two separate rejections, both under 103. In one case, the references were treated differently in both rejections and applied differently in both rejections. And the board, as I say, suicide pay on its own initiative and without any authority of this rule, combined the consideration of claim one, and rejected everything. And that appears to be clearly a violation. And as much we should have an opportunity to go back and review this case should have been remanded. Considered by the board separately. If the board had considered those limitations separately, claim a specifically calls for a procedure that is a percutaneous procedure. And the Anderson reference does not have anything with regard to percutaneous. I'm sorry, I interrupt. But the problem I have with that particular argument is I thought you conceded in your briefs that you didn't even reference the term percutaneous in your petition for review before the end. Well, I'll tell you, throughout the prosecution's case that we remanded the claims. Well, am I right about that? I mean, I understood it. It did not appear in the brief

... 41.37 C17. And 41.37 C17 only permits the board to group claims and to select a representative claim. And it specifically says for each ground of rejection applying two or more claims, the claims may be argued separately or a group. That's for each ground of rejection. The next sentence in 41.37 C17 says, when multiple claims subject to the same ground of rejection are argued as a group by the appellant, the board may select a single claim from that group. Well, that is not what we had here. What we had here is two separate rejections, both under 103. In one case, the references were treated differently in both rejections and applied differently in both rejections. And the board, as I say, suicide pay on its own initiative and without any authority of this rule, combined the consideration of claim one, and rejected everything. And that appears to be clearly a violation. And as much we should have an opportunity to go back and review this case should have been remanded. Considered by the board separately. If the board had considered those limitations separately, claim a specifically calls for a procedure that is a percutaneous procedure. And the Anderson reference does not have anything with regard to percutaneous. I'm sorry, I interrupt. But the problem I have with that particular argument is I thought you conceded in your briefs that you didn't even reference the term percutaneous in your petition for review before the end. Well, I'll tell you, throughout the prosecution's case that we remanded the claims. Well, am I right about that? I mean, I understood it. It did not appear in the brief. It was raised at the oral hearing. It was raised at the oral hearing. And one reason it didn't appear at the brief was at the brief. Because in the original 103 rejections, the examiner had taken the position that the use of interleukin 2 in those compositions was optional. And we jumped all over that. And the examiner with regard to the by, the examiner had taken the position that the by, that the claims could be construed as reading on a biopsy of the skin on the breast. And we pointed out a biopsy of the skin on the breast is a skin biopsy. It's not a breast biopsy. We jumped on that issue. So with the playing field one way, we responded to these 103 rejections and hit what we consider to be very, you know, some critical weakness. But it's kind of hard to press on a field to be arguing that we ought to send something back to the board because they didn't deal with a particular limitation or at least in your written presentation, you didn't cover that to the board. Well, if they, I think that if we, well, I think that if they had, if the board had, we also didn't concede that claim eight and claim one should be grouped together. And that's a limit that claim eight should not be considered considered on its own merits and claim eight clearly calls for, you know, a percutaneous procedure. So, you know, so we are, so we were really, we were really thrown a curve here by the board. We went from these 103 rejections to this 102 analysis. And the 102 analysis is only feasible if you ignore claim eight, which the board conveniently did by grouping it with claim one. These types of maneuvers, I think, need to be discouraged. You know, we can only address the rejections as they're presented to us. And then to be confronted with this 102 analysis and to have a claim that was specifically amended to include the percutaneous limitation during prosecution. And to have that just completely ignored and dropped out for everybody's convenience is an injustice. Okay. Thank you. Thank you, Mrs. Lee

. It was raised at the oral hearing. It was raised at the oral hearing. And one reason it didn't appear at the brief was at the brief. Because in the original 103 rejections, the examiner had taken the position that the use of interleukin 2 in those compositions was optional. And we jumped all over that. And the examiner with regard to the by, the examiner had taken the position that the by, that the claims could be construed as reading on a biopsy of the skin on the breast. And we pointed out a biopsy of the skin on the breast is a skin biopsy. It's not a breast biopsy. We jumped on that issue. So with the playing field one way, we responded to these 103 rejections and hit what we consider to be very, you know, some critical weakness. But it's kind of hard to press on a field to be arguing that we ought to send something back to the board because they didn't deal with a particular limitation or at least in your written presentation, you didn't cover that to the board. Well, if they, I think that if we, well, I think that if they had, if the board had, we also didn't concede that claim eight and claim one should be grouped together. And that's a limit that claim eight should not be considered considered on its own merits and claim eight clearly calls for, you know, a percutaneous procedure. So, you know, so we are, so we were really, we were really thrown a curve here by the board. We went from these 103 rejections to this 102 analysis. And the 102 analysis is only feasible if you ignore claim eight, which the board conveniently did by grouping it with claim one. These types of maneuvers, I think, need to be discouraged. You know, we can only address the rejections as they're presented to us. And then to be confronted with this 102 analysis and to have a claim that was specifically amended to include the percutaneous limitation during prosecution. And to have that just completely ignored and dropped out for everybody's convenience is an injustice. Okay. Thank you. Thank you, Mrs. Lee. We have your rebuttal time, say it. Mr. Johnson. May I please the court. Opposing council is wrong when he says that a person of ordinary skill and yard would not have known to conduct a breast biopsy in the 13 appeal. The forester teaches that particular aspect of claim one. And this court is completely correct that forester teaches everything that's in claim one except for the sullable limitation. Anderson is the bridge that gets us to the buy that teaches the sullable limitation. Anderson teaches a biodegradable composition. And forester says that a biodegradable polymer can be used as a marker. Well, when you look at Anderson, which mentions the biodegradable composition, Anderson says that the composition can include a hemostatic agent. The bi teaches a hemostatic agent. And it teaches that the benefit of having this hemostatic agent is that it controls bleeding. So one ordinary skill and yard seeing the clear teachings of Anderson would want to rely upon the sullable materials that's in the bi and combined that with forester. Once those references are all combined, then the claim would be rendered obvious based upon those three teachings. Of course, Mr. Lee, he says what tells you to combine with the motivation. The motivation comes from Anderson itself, your honor. Forester teaches that the biodegradable marker can be actually that the marker can be a biodegradable composition. Anderson teaches a biodegradable composition. And Anderson says that that biodegradable composition can include things like hemostatic agents and radiopact markers. The bi teaches a biodegradable agent, which is hemostatic. It's a sullable material. So the person of ordinary skill and yard would be motivated to rely upon the bi's sullable materials because of the teachings in Anderson

. We have your rebuttal time, say it. Mr. Johnson. May I please the court. Opposing council is wrong when he says that a person of ordinary skill and yard would not have known to conduct a breast biopsy in the 13 appeal. The forester teaches that particular aspect of claim one. And this court is completely correct that forester teaches everything that's in claim one except for the sullable limitation. Anderson is the bridge that gets us to the buy that teaches the sullable limitation. Anderson teaches a biodegradable composition. And forester says that a biodegradable polymer can be used as a marker. Well, when you look at Anderson, which mentions the biodegradable composition, Anderson says that the composition can include a hemostatic agent. The bi teaches a hemostatic agent. And it teaches that the benefit of having this hemostatic agent is that it controls bleeding. So one ordinary skill and yard seeing the clear teachings of Anderson would want to rely upon the sullable materials that's in the bi and combined that with forester. Once those references are all combined, then the claim would be rendered obvious based upon those three teachings. Of course, Mr. Lee, he says what tells you to combine with the motivation. The motivation comes from Anderson itself, your honor. Forester teaches that the biodegradable marker can be actually that the marker can be a biodegradable composition. Anderson teaches a biodegradable composition. And Anderson says that that biodegradable composition can include things like hemostatic agents and radiopact markers. The bi teaches a biodegradable agent, which is hemostatic. It's a sullable material. So the person of ordinary skill and yard would be motivated to rely upon the bi's sullable materials because of the teachings in Anderson. Anderson is that bridge that gets us from forester to the bi. A opposing counsel has argued that the bi is not analogous to heart and neither is Anderson. However, they are both in the same field of invention. Both of those references deal with hemostatic agents. And that is exactly what the 205 patent was getting at. Anderson teaches that what you want to do is control bleeding after you cut into an individual because there could be hemorrhaging. The bi also teaches that you want to control bleeding after a biopsy. One of ordinary skill and yard was a doctor would also know these things based upon his practice in the field. So both of those references are analogous because they are in the same field of invention. And not only for that reason, but also because they also dealt with the problem that the inventor was dealing with. The 205 patent expressly states that it deals with biopsies and localizing that area. Well, a biopsy is simply removing tissues. And that is exactly what Anderson is dealing with, removing tissue that is cancerous. And that is also what the device is dealing with, removing tissue that is cancerous. So because the bi and Anderson deal with the same problem that the 205 patent was getting at, then they are also analogous for that reason as well. So there are two separate reasons why the references for this court are analogous art. And when you look at analogous art, KSR is also very broad in its discussion as to what can be analogous art. And here clearly those two references Anderson and the bi are analogous for the reasons I just mentioned a moment ago. How about the second appeal? Anderson looks a little off the track talking about injection of interleukin tube. Hasn't really deal with biopsies. Well, while you're on a biopsy is merely the removal of tissue and you want to make some determination as to what it was that you removed. With respect to the IL-2, Anderson teaches that a number of different embodiments in its specification and explains with respect to one embodiment that you want to start with this biodegradable polymer. And then you add the IL-2, but you can also add other stuff. You can add hemostatic agents and you can also add a radiopath marker

. Anderson is that bridge that gets us from forester to the bi. A opposing counsel has argued that the bi is not analogous to heart and neither is Anderson. However, they are both in the same field of invention. Both of those references deal with hemostatic agents. And that is exactly what the 205 patent was getting at. Anderson teaches that what you want to do is control bleeding after you cut into an individual because there could be hemorrhaging. The bi also teaches that you want to control bleeding after a biopsy. One of ordinary skill and yard was a doctor would also know these things based upon his practice in the field. So both of those references are analogous because they are in the same field of invention. And not only for that reason, but also because they also dealt with the problem that the inventor was dealing with. The 205 patent expressly states that it deals with biopsies and localizing that area. Well, a biopsy is simply removing tissues. And that is exactly what Anderson is dealing with, removing tissue that is cancerous. And that is also what the device is dealing with, removing tissue that is cancerous. So because the bi and Anderson deal with the same problem that the 205 patent was getting at, then they are also analogous for that reason as well. So there are two separate reasons why the references for this court are analogous art. And when you look at analogous art, KSR is also very broad in its discussion as to what can be analogous art. And here clearly those two references Anderson and the bi are analogous for the reasons I just mentioned a moment ago. How about the second appeal? Anderson looks a little off the track talking about injection of interleukin tube. Hasn't really deal with biopsies. Well, while you're on a biopsy is merely the removal of tissue and you want to make some determination as to what it was that you removed. With respect to the IL-2, Anderson teaches that a number of different embodiments in its specification and explains with respect to one embodiment that you want to start with this biodegradable polymer. And then you add the IL-2, but you can also add other stuff. You can add hemostatic agents and you can also add a radiopath marker. One of one of the skills in the art who's merely conducting a biopsy would know that he shouldn't add IL-2 right off the bat. You can add the other ingredients that Anderson is talking about, the hemostatic agents and even the radiopath markers. With respect to the location of conducting a biopsy in the breast, Anderson is the reference that teaches it in the 14 reference, in the 14 appeal. Because with respect to claim one, the examiner relied upon the bi, Anderson, and Lee. Well, Anderson clearly teaches that its biodegradable compositions can be implanted into any section of the body, including the breast. What about the procedural aspects? New rejection? Yes, Your Honor. It's our position that there is no new rejection here by the pool. You just mentioned that the examiner relied on Lee, Navai, and Anderson. The board as I understand it with respect to one and eight. We like, well, predominantly with on Anderson, but at least in combination with Navai, no reference to Lee, right? Well, Your Honor, the board clearly understood what the rejection was. And in its decision on rehearing, it specifically noted that the examiner relied on three different references. So it might not have identified the names of the three different references, but it clearly noted that the examiner, and I can point the court to that. The question is, what the board relied on, and how did the examiner relied on, right? That's the problem. Yes, Your Honor. And here, at 814, at the very top in the first paragraph, the board states, in this case, the examiner relied upon the combined teachings of the three prior references, including Anderson. So it specifically identified the fact that the examiner relied upon three different references. The examiner was very specific as to why Anderson must be relied on for 10 and the concern that's been raised has been added to board wishes to find a different rationale for the combination that the applicant should have an opportunity to respond before the board or before the office. Through one of the procedures, when new grounds are raised, rather than having to raise it before the court for the first time. That's correct, Your Honor. But I was merely pointing out the fact that the board clearly understood what the examiner's rejection was. I'll just ask my question. What the board understood, the question is what the board states, it relies upon, particularly in this case, is quite conspicuous. The examiner said she was relying on Anderson only for one aspect. I'll first start with that because the examiner made a number of different findings

. One of one of the skills in the art who's merely conducting a biopsy would know that he shouldn't add IL-2 right off the bat. You can add the other ingredients that Anderson is talking about, the hemostatic agents and even the radiopath markers. With respect to the location of conducting a biopsy in the breast, Anderson is the reference that teaches it in the 14 reference, in the 14 appeal. Because with respect to claim one, the examiner relied upon the bi, Anderson, and Lee. Well, Anderson clearly teaches that its biodegradable compositions can be implanted into any section of the body, including the breast. What about the procedural aspects? New rejection? Yes, Your Honor. It's our position that there is no new rejection here by the pool. You just mentioned that the examiner relied on Lee, Navai, and Anderson. The board as I understand it with respect to one and eight. We like, well, predominantly with on Anderson, but at least in combination with Navai, no reference to Lee, right? Well, Your Honor, the board clearly understood what the rejection was. And in its decision on rehearing, it specifically noted that the examiner relied on three different references. So it might not have identified the names of the three different references, but it clearly noted that the examiner, and I can point the court to that. The question is, what the board relied on, and how did the examiner relied on, right? That's the problem. Yes, Your Honor. And here, at 814, at the very top in the first paragraph, the board states, in this case, the examiner relied upon the combined teachings of the three prior references, including Anderson. So it specifically identified the fact that the examiner relied upon three different references. The examiner was very specific as to why Anderson must be relied on for 10 and the concern that's been raised has been added to board wishes to find a different rationale for the combination that the applicant should have an opportunity to respond before the board or before the office. Through one of the procedures, when new grounds are raised, rather than having to raise it before the court for the first time. That's correct, Your Honor. But I was merely pointing out the fact that the board clearly understood what the examiner's rejection was. I'll just ask my question. What the board understood, the question is what the board states, it relies upon, particularly in this case, is quite conspicuous. The examiner said she was relying on Anderson only for one aspect. I'll first start with that because the examiner made a number of different findings. And one of the findings was that, and I can direct this court to the examiner's answer, and that's found at 836, where the examiner said that Anderson teaches a method of removing malignant tissue prior to implanting. That's one finding that it made and it also indicated that the material may be injected into any desired site, and such as the breadth. That's another finding that it made Anderson. You were saying that the examiner's answer can raise new grounds of rejection? No, I'm not saying that at all. What I'm merely pointing out is that the examiner made a number of different findings. What Devacore's pointing to is merely one of the findings. Yes, they're complaining that they didn't have an adequate chance to respond to the grounds on which the board relied. Yes, you're right. What I see, they have a good point. Well, that would not be accurate, Your Honor, because they had an opportunity to address all of the examiner's findings with respect to Anderson when they received their final rejection. But I thought we were talking about Lee. I thought we would talk about the absence, but maybe I'm not positive with a judge in Newman and I reference the same thing. But my concern was the examiner rejected it based on Anderson, Dubai, and Lee. And then the board comes up and rejects, Dubai and Anderson. Why isn't that a new ground for rejection? In this case, Your Honor, what the board was doing was merely relying to the arguments that were made in the brief to it. And in their brief to the board, most of their arguments were with respect to Anderson. Their focus was on addressing Anderson. And what they said, and the board was quite good in outlining each of the different points that the, that Devakor raised, A4, they pointed out each of the different arguments that Devakor raised in their briefs to the board. One of them dealt with Anderson is in a different field of invention. Anderson is not suitable for being a biopsy marker. And Anderson is not enabled. So they made a strategic decision to focus their brief just on Anderson. And it was the board's responsibility to respond to those arguments. And that's just what they did

. And one of the findings was that, and I can direct this court to the examiner's answer, and that's found at 836, where the examiner said that Anderson teaches a method of removing malignant tissue prior to implanting. That's one finding that it made and it also indicated that the material may be injected into any desired site, and such as the breadth. That's another finding that it made Anderson. You were saying that the examiner's answer can raise new grounds of rejection? No, I'm not saying that at all. What I'm merely pointing out is that the examiner made a number of different findings. What Devacore's pointing to is merely one of the findings. Yes, they're complaining that they didn't have an adequate chance to respond to the grounds on which the board relied. Yes, you're right. What I see, they have a good point. Well, that would not be accurate, Your Honor, because they had an opportunity to address all of the examiner's findings with respect to Anderson when they received their final rejection. But I thought we were talking about Lee. I thought we would talk about the absence, but maybe I'm not positive with a judge in Newman and I reference the same thing. But my concern was the examiner rejected it based on Anderson, Dubai, and Lee. And then the board comes up and rejects, Dubai and Anderson. Why isn't that a new ground for rejection? In this case, Your Honor, what the board was doing was merely relying to the arguments that were made in the brief to it. And in their brief to the board, most of their arguments were with respect to Anderson. Their focus was on addressing Anderson. And what they said, and the board was quite good in outlining each of the different points that the, that Devakor raised, A4, they pointed out each of the different arguments that Devakor raised in their briefs to the board. One of them dealt with Anderson is in a different field of invention. Anderson is not suitable for being a biopsy marker. And Anderson is not enabled. So they made a strategic decision to focus their brief just on Anderson. And it was the board's responsibility to respond to those arguments. And that's just what they did. They responded to each one of the arguments raised. And because they found that Anderson, the teachings in Anderson, addressed each of the arguments, that's why their decision was limited to Anderson itself. But they also made findings, as this court has already noted, with respect to Dubai as well. And in their decision on request for re-hearing, they pointed out that the examiner addressed three different references. And that was the decision that they were referring. With respect to whether or not the claims were separately argued, your Honor, it's the board correctly found that claims eight and twelve were not separately argued. When you look at what they actually argued in their appeal to the board, they argued claim one and they did so properly. With respect to claim eight, what they did was they came up with two different paragraphs. And in the first paragraph, that first paragraph listed out different elements for their argument under the heading of claim eight and claim twelve. But nowhere in that first paragraph did they identify the precutaneous limitation, which they alleged to be the patentable limitation over claim one. And then in their second paragraph, they argued for the same reason that we argued with respect to claim one, we believe that there's no motivation to combine the different references. However, at no point at all did they argue in their first paragraph or their second paragraph, the patentable limitation with respect to claim eight. They argued all of the arguments with respect to claim one. So the board probably found that because they didn't create any arguments with respect to the separate patentability of claim eight, that they had not separately argued claim eight with respect to claim eight. All the board needed to do in actuality is simply point out what they could have done rather is simply say for the same reasons that we said claim one isn't patentable neither is claim eight and twelve. They decided not to go that route though. Well, it seems to have been an unfortunate omission at the time we get up here, right? Well, you're out of that was one possibility, but what they also did was proper because because the record did not separately argue the patentability for claims eight and twelve. This case is closely aligned with loving and in loving they created a separate heading for some of the claims. However, they did not specifically argue the patentability of those particular claims and this court found that because they did not separately argue the patentability with respect to those particular claims that the board properly decided in that case. Just hypothetically, if an examiner relies on three references and has a rejection of one or three rejection based on a combination of those three references. And a case goes up to the board and the board reevaluate and it starts and it uses just two of those three references, not the third. Isn't that hypothetically typosetically viewed as a new ground for rejection? I think that it would depend because there could be a number of situations like the one we have here where the board merely addresses the arguments that were made in the brief. And in doing so, if they determine that they only need to address two of the three references, then that would be satisfactory. Opposing council has pointed to our rule but we believe that he has not actually accurately discussed our rules because the rule, although he pointed to basically half of the rule, the most important part for our purposes here, is the part that was not discussed

. They responded to each one of the arguments raised. And because they found that Anderson, the teachings in Anderson, addressed each of the arguments, that's why their decision was limited to Anderson itself. But they also made findings, as this court has already noted, with respect to Dubai as well. And in their decision on request for re-hearing, they pointed out that the examiner addressed three different references. And that was the decision that they were referring. With respect to whether or not the claims were separately argued, your Honor, it's the board correctly found that claims eight and twelve were not separately argued. When you look at what they actually argued in their appeal to the board, they argued claim one and they did so properly. With respect to claim eight, what they did was they came up with two different paragraphs. And in the first paragraph, that first paragraph listed out different elements for their argument under the heading of claim eight and claim twelve. But nowhere in that first paragraph did they identify the precutaneous limitation, which they alleged to be the patentable limitation over claim one. And then in their second paragraph, they argued for the same reason that we argued with respect to claim one, we believe that there's no motivation to combine the different references. However, at no point at all did they argue in their first paragraph or their second paragraph, the patentable limitation with respect to claim eight. They argued all of the arguments with respect to claim one. So the board probably found that because they didn't create any arguments with respect to the separate patentability of claim eight, that they had not separately argued claim eight with respect to claim eight. All the board needed to do in actuality is simply point out what they could have done rather is simply say for the same reasons that we said claim one isn't patentable neither is claim eight and twelve. They decided not to go that route though. Well, it seems to have been an unfortunate omission at the time we get up here, right? Well, you're out of that was one possibility, but what they also did was proper because because the record did not separately argue the patentability for claims eight and twelve. This case is closely aligned with loving and in loving they created a separate heading for some of the claims. However, they did not specifically argue the patentability of those particular claims and this court found that because they did not separately argue the patentability with respect to those particular claims that the board properly decided in that case. Just hypothetically, if an examiner relies on three references and has a rejection of one or three rejection based on a combination of those three references. And a case goes up to the board and the board reevaluate and it starts and it uses just two of those three references, not the third. Isn't that hypothetically typosetically viewed as a new ground for rejection? I think that it would depend because there could be a number of situations like the one we have here where the board merely addresses the arguments that were made in the brief. And in doing so, if they determine that they only need to address two of the three references, then that would be satisfactory. Opposing council has pointed to our rule but we believe that he has not actually accurately discussed our rules because the rule, although he pointed to basically half of the rule, the most important part for our purposes here, is the part that was not discussed. And that begins with the sentence which states, notwithstanding any other provision of this paragraph, the failure of a pellant to separately argue claims which pellant has grouped together, shall constitute a waiver of any argument that the board must consider the patentability of any ground claims separately. And any claim argued separately should be placed under separate heading and claims argued as a group should be placed under a separate heading identifying the claims by number, a statement which merely points out that the claimer's sites, what the claimer's sites will not be considered an argument for separate patentability of the claim. Can that just give us the site that you're reading from just the purposes of clarity of the record? Yes, Toronto. That's 37 CFR, section 41.37, C sub 7. Thank you. And the problem that Devrick or has here is that they did not argue the separate patentability of claims eight and 12. So for that reason, they have not satisfied what they required to do as far as the rule is concerned in arguing claims eight and 12. And our rules are established to ensure that there's an orderly process before the agency by violating that rule, it just creates confusion as to the briefing process. And even if this court were to find that the board and properly separately argued and properly decided the separate argument raised by Devrick or Devrick or still has the problem in that they failed to argue the percutaneous limitation in their brief to the board. They had a number of opportunities to do so. The final rejection from the examiner wanted to lead as the reference which teaches that particular limitation. They did not address that particular argument by the examiner and their brief to the board. They only raised it for the first time in their brief to the board. They did not address, sorry, for the first time in their oral hearing and their argument at the oral hearing. But they did not do so properly. What they said as the oral hearing was that we will address claim eight and 12 and I pointed this out in a footnote, but they never came back to discuss it. So although they might have had an intent to do so, they failed to do so. But even if they had done so, it still would have been late at that time because they're supposed to raise all of their arguments in their brief to the board and they fail to do so with respect to that particular limitation. Thank you. Thank you. I think this court's precedent in Ray McDaniel is clearly pertinent to the issues that we have here today. McDaniel makes it very clear that the board cannot just do away with the examiner's rejections in spite of its obligations under 35 USC Section 6D. So regardless of whether percutaneous was argued separately or not, the fact remains that the final rejection included two, there were two 103 rejections

. And that begins with the sentence which states, notwithstanding any other provision of this paragraph, the failure of a pellant to separately argue claims which pellant has grouped together, shall constitute a waiver of any argument that the board must consider the patentability of any ground claims separately. And any claim argued separately should be placed under separate heading and claims argued as a group should be placed under a separate heading identifying the claims by number, a statement which merely points out that the claimer's sites, what the claimer's sites will not be considered an argument for separate patentability of the claim. Can that just give us the site that you're reading from just the purposes of clarity of the record? Yes, Toronto. That's 37 CFR, section 41.37, C sub 7. Thank you. And the problem that Devrick or has here is that they did not argue the separate patentability of claims eight and 12. So for that reason, they have not satisfied what they required to do as far as the rule is concerned in arguing claims eight and 12. And our rules are established to ensure that there's an orderly process before the agency by violating that rule, it just creates confusion as to the briefing process. And even if this court were to find that the board and properly separately argued and properly decided the separate argument raised by Devrick or Devrick or still has the problem in that they failed to argue the percutaneous limitation in their brief to the board. They had a number of opportunities to do so. The final rejection from the examiner wanted to lead as the reference which teaches that particular limitation. They did not address that particular argument by the examiner and their brief to the board. They only raised it for the first time in their brief to the board. They did not address, sorry, for the first time in their oral hearing and their argument at the oral hearing. But they did not do so properly. What they said as the oral hearing was that we will address claim eight and 12 and I pointed this out in a footnote, but they never came back to discuss it. So although they might have had an intent to do so, they failed to do so. But even if they had done so, it still would have been late at that time because they're supposed to raise all of their arguments in their brief to the board and they fail to do so with respect to that particular limitation. Thank you. Thank you. I think this court's precedent in Ray McDaniel is clearly pertinent to the issues that we have here today. McDaniel makes it very clear that the board cannot just do away with the examiner's rejections in spite of its obligations under 35 USC Section 6D. So regardless of whether percutaneous was argued separately or not, the fact remains that the final rejection included two, there were two 103 rejections. The second claim eight was moved and grouped with claim one improperly and under McDaniel's debacle is entitled to consideration of the rejection of claim eight under 35 USC Section 6D. The other point I would like to make is that we've had a lot of discussion today with regard to the Forester O55 reference as contrasted with the Lee reference in the 1414 appeal. The Lee reference only shows using a little air bubble to mark the biopsy site. So while Forester may teach, well Forester teaches metallic elements and the possibility of using polymers, in the 1414 case, the Lee reference is the only reference that relates to biopsy markers. And that marker is nothing more than a little bubble of air and to make this transition to make this leap from replacing a bubble of air to a polymer composition whether it's described by a nearby or Anderson seems to be a real stretch. Secondly, Anderson, I think it is an insult to the language to say that Anderson teaches a biopsy. Anderson does not teach a method for marking biopsies. Anderson mentions that he uses a tumor core localization biopsy, something that is conventionally used by surgeons all the time to make sure they've got the right tissue. But the Anderson patent is not directed to marking biopsies. Anderson is a chemotherapy that's designed to treat cancers using interleukin 2. The biopsy, the patents that teach marking biopsies are Forester O55 with its elements and Lee with its little bubble of air. And particularly in the case of the rejection over Lee and 1414, you've got an enormous jump there to say, it's obvious to replace this bubble of air with Anderson's interleukin 2 or the bi-swellable polymer that's being used in a punch for a skin biopsy. So I think on those bases, at a minimum, a remand of these 14-14 cases is appropriate.

This is our number of 2011, 14, 13, and 14, 14 in Rage Evochloro-Medical products. Just to be able to combine these cases, we leave it here to figure out how to present it. Okay, thank you, Ray honor. I'm Mark Levy and I'm representing Devacore products with me at Council's table. It's Jerry Grassel, the Associate General Counsel. We are appealing from two rejections that arose in re-examination proceedings in the US patent office. The unusual situation here is that a forester is the primary reference against one patent, and then in the second case, forester is on trial. In essence, that's close although the forester is a related patent, it's not the identical reference, but the disclosure is identical. So the reference is Forester O55 and the... Does that mean Forester disclosed everything but the swellable material? Well, the answer is not technically no. Forester teaches that the marker can be made of a metal or it could be made of a polymer, and that polymer is selected so that it can be imaged or capable of being imaged. But that's the extent of the forester disclosure. The forester disclosure does not go into that way to make that polymer imageable as to incorporate a radial pipe material into it. It leaves that aspect of that aspect of the thing dangling. Okay, so we have got the two appeals. We've got 1413, which is the Fulton Patent. In both cases, we're dealing with marking the location at which a breath biopsy has been taken. And in the Fulton Patent, that marker is a polymer composition that has three properties. It is swellable, it is radial pate, and it is biopsy-absorbable. In the 14th, Fort... In the biopsy-absorbable. In terms of swellable. Your Honor, we would say no, absolutely not for several reasons. The bi is using a swellable material in a punch-like apparatus in order to take a skin biopsy. And the function of that swellable material... The biopsy-absorbable is one of two reference to talking about, obviously, see. Is that a method for marking a biopsy site providing a swellable body, removing a specimen and serving the body? There's a lot to it, except after you look at four, forster, and then you've got the swellable body. Well, I guess the other point that you've got though is you do have a swellable body in the bi. But you really don't have any motivation, you don't have any real teaching that says that within the context of a breast biopsy, you need a swellable material. Obviously, when you're taking a biopsy from the ability to see the outer skin and the like, I mean, we all know how we bleed when we're cut. Hemostasis is very critical, and the objective of the bi is let's take this biopsy without using a suture, and in order to do that, we're going to put this swellable material in there. But now how do we get to the point where we say, okay, now we're doing a breast biopsy. Now we're in the classic situation, we're doing a needle biopsy of a breast. And we've got the same problems, and we're going to solve those same problems the same way. That leaf is missing from the record, that's missing from the prior art, and that is where the devochor invention comes in. In other words, the other thing to keep in mind is... So the invention here is this idea that you've got the idea to do it. It's not how you do it. The materials to do it with are in the public domain, so to speak, and in other words, swellable polymers are known. We don't deny that. But this port has on many occasions pointed out that merely having the materials available is not enough to render an invention obvious. Yeah, but these are all the same fields biopsy. You say they're all in the same field, but we're talking about a breast biopsy here, which is taken under very, very unique, carefully controlled from a number of different aspects. And with minimal invasion, versus the secondary reference is a punch. But you have to be able to find any cases and analogous circumstances. This is pretty close. If you look at our cases, I think, and the ones where we've said it's analogous, sorry, it's analogous field, I don't know that I can think of any that would support your viewing terms, the details of death, being a different field. Can you come up with anything? You think this is close to some other case that we said it was a completely different field? Well, you're on our other side. No, but it's hard to find cases that match up like this. That would match in this type of situation. I guess I have to come back again to the point that again we're talking about a breast biopsy, which conventionally is a very minimally invasive needle biopsy. And in fact, there's no evidence in the record that swelling hemostasis is even an issue. In fact, if you look at the forest or pad, the principal examples of the principal examples that forest puts forth for the marker are metals. And those metals clearly are metal elements. Those metal elements clearly don't have any hemostatic properties, but according to forestry they're perfectly fine. And if you look at the forest or pattern in column one of the patterns, forestry makes a statement about the problems that accompany bleeding, the problems that accompany a biopsy and versus tissue removal. In forestry states, when you remove it, tumor, you have pleating problems. But forestry completely leaves out, so to speak, the... I can direct you to that disclosure. But when forestry is talking about the biopsy, forestry does not get into any issue of hemostasis. I'm going to refer specifically to A267 in the record of the 1413 P.O. But the biopsy... the biopsy is working on the open skin and is a different tissue, a different location, external versus internal. It's a problem of a different nature. And again, going back to forestry, he's using these metal elements and has no hemostasis problem in those situations. He also proposes to use a polymer that a polymer could be used as a marker, but he certainly doesn't telegraph that we've got a need here to absorb the blood that we've got problems that are flowing out of this and hence we need to make this type of modification in this. And that's the word flowing out, traditionally. But yeah, and did you catch, anyway, my reference to forestry and the absence of any indication that bleeding is a problem is that it's a-260, it's column 1, lines 44 to 50 of the forestry reference. Since what's combining these cases and we're talking about forestry, why doesn't Anderson pretty much take care of forestry? Because the forestry, which as we recognize forestry doesn't have the swellable limitation. Right, it doesn't, and Anderson doesn't either. Anderson doesn't either, so that's not neither here nor there. But Anderson, even though it talks about administering interloken, it does so. And it goes into a tumor site and takes a biopsy. Yeah, well, in Anderson, yes, and one of the things that I find intuitively difficult to understand is how when we're dealing with biopsy, and we have tissues that we don't know whether they're cancerous or not, you would go and use an anti-cancer agent like interloken 2, which is highly toxic. But apart from that, and probably even more importantly than that intuitive question, is that the Anderson process, the composition that Anderson developed, is never positioned in a biopsy site. What Anderson does is he goes in, and they use the example of brain surgery, but it could be surgery on any organ of the body. You're going to remove the tumor. You go in, your tissue is in the surgeon's eye. He needs to verify that he's got the right tissue before he goes and takes the entire tissue out. So he takes a small, what they call core localization biopsy. He grabs a little tissue, runs it down to the lab, they put it under the scope, they verify that he's got the right tissue, and he comes back in and he would completely remove the tumor. At that point in time, the surgery is being completed, the tumor is totally eradicated. The biopsy site doesn't even exist because to the extent it was in that tumor initially, and he's that little site where he verified that he had the right stuff. It's completely gone. And now he inject a chemo therapeutic agent into that. Now, that set of circumstances is so totally in my mind, just so totally far removed from the marking a biopsy. He said, I have that for instance, it's essentially a biopsy site. And leaving out the, I mean, anacinth is a reference for everything it discloses, but everything that it discloses isn't the only thing that's disclosed. In other words, it goes in. I mean, this is not, right, nothing. But being the skill of, no, of serogen, but this doesn't seem revolutionary. Well, to go into a biopsy site and to market with a bio degradable radio-paked polymer. Well, I think you also have to remember that these patents are going back a very long time. I mean, the Fulton patent, where this was on its third re-examination, and these patents go back to the mid-90s. So I don't think you can apply today. You've got to be careful when you're dealing with patents that are this old to jump to conclusions in terms of how simple something may appear today versus, you know, as of the date these patents were filed. But again, I do think it's, I think that, you know, to hold out that a reference that has nothing to do with marking a bio. And really has nothing to do with marking anything. And to say that a person of ordinary skill in the art would have been, with all these things available in front of him, or would have picked up on that reference and said, oh, there here's a problem in marking breast biopsy. And we're going to fix that problem using this as a spin-off of this inter-luchin-2 composition. I find to be a stretch. Plus, now buy. Plus, now buy, which is... Which doesn't have the inter-luchin. And which doesn't have the inter-luchin, but is also merely a hemostat, which there's no indication in the record of any importance in a criticality. I mean, there's nothing in the primary references that get that show any criticality to controlling human stasis within the confines of a breast biopsy. And indeed, as I say, we can't ignore the fact that Forester is just putting little pieces of metal in there and not having any problems. So, I think it's a large... I think also we have to... I also have to ask the question again, though, whether this person of ordinary skill in this art would reasonably consider this subject matter within the context of marking a breast biopsy. And these claims are specifically directed to marking breast biopsies and specifically to taking a biopsy... A breast biopsy sample. And that brings into them all of the dimensions and considerations that go with that type of a surgical procedure. Okay, let's get here from the government. We'll say we'll read metal times. I have a little bit more time, correct? You do. You will fair amount of more times. Do you want to talk about the other parts of the field or the field? I guess what I want... Well, we've really talked about both the fields... I don't know if I can explain it. ...to already do some extent. And I think we need to touch upon in the 14-14 appeal the board's decision. And in that appeal, and there are two procedural issues which we feel, which I think is pretty clear, were in violation of the rules and of 35 U.S.C.6 B. And that is that the first issue that I would get to is that in rendering the decision in the 14-14 case, the board developed its own rejection. A rejection that was promised entirely upon the Anderson reference in one in which the board concluded that Anderson was broad enough that applicants could be construed as being broad enough to read on Anderson. That statement, that fact, that finding never appeared during the course of the prosecution of the application. Furthermore, early on in the prosecution of the re-examination of the Forrester patent, the examiner had was confronted with a rejection over... The examiner was made a rejection over Anderson and the applicant responded to that rejection and the examiner agreed that applicant had overcome that rejection and withdrew it. So we've got the board adopting a... we've got the board rendering a decision in which the board sets forth a construction of the claims of the Anderson patent. As reading on... construction of the claims of the Forrester patent, as reading on Anderson, when in fact that very issue had been addressed earlier in the prosecution of the case and had specifically abandoned. So clearly, for it to come up in the board's decision here is a new issue. Secondly, the rejection that was actually in front of the board were two 103 rejections. One was a 103 rejection of the majority of the claims in the case over Nebai and view of Anderson and Lee and the second rejection was a rejection of claims eight and twelve over the combined teachings of Lee, Nebai and Anderson. Now, when the board rendered its decision, it abandoned these two rejections. That abandoned both... the whole 103 analysis kind of went to the side and the board justified everything that it did on the premise that... And in fact, it concluded that... well, we're affirming the rejections because Anderson can be... Anderson... the claim one can be construed as reading on Anderson. So, in essence... they went on to say... they sued Nebai in there. They did throw Nebai in there, but the analysis was a 102 analysis based on Anderson. So, I think... and we never had a chance... we had no chance whatsoever. Furthermore, in the examiners' answer, she specifically indicated that she was only relying upon Anderson to teach the radio-pake material. So, here we go from a situation where in the final rejection and in the examiners' answer, Anderson... the Anderson has been relied upon solely as teaching a radio-pake material to a decision by the board in which Anderson now re-zoned... or the... Anderson has now held to teach every limitation in the claim. And that issue... I think that issue was totally new. The second error that the board made was... we always had two rejections in this case. There was all of the rejection of claims one and a number of the other claims. And then there was a second rejection of claims eight and twelve over Lee and Duof Nebai and Anderson. Those claims were... they were separately... they appeared separately in the final rejection. They appeared separately in the examiners' answer. They appeared separately in the brief. And yet in the board's opinion, and yet the board decided that applicant had not... had not separately argued with Anderson. And therefore, the board on its own initiative combined them for consideration and selected claim one as being a representative of this group. Well, that action of the board was... was... all premise... was premise under 31... let's see here... what is it? It's 31 CFR... I've got it here someplace. That was all premise under 31 CFR... 47... sorry... 41.37 C17. And 41.37 C17 only permits the board to group claims and to select a representative claim. And it specifically says for each ground of rejection applying two or more claims, the claims may be argued separately or a group. That's for each ground of rejection. The next sentence in 41.37 C17 says, when multiple claims subject to the same ground of rejection are argued as a group by the appellant, the board may select a single claim from that group. Well, that is not what we had here. What we had here is two separate rejections, both under 103. In one case, the references were treated differently in both rejections and applied differently in both rejections. And the board, as I say, suicide pay on its own initiative and without any authority of this rule, combined the consideration of claim one, and rejected everything. And that appears to be clearly a violation. And as much we should have an opportunity to go back and review this case should have been remanded. Considered by the board separately. If the board had considered those limitations separately, claim a specifically calls for a procedure that is a percutaneous procedure. And the Anderson reference does not have anything with regard to percutaneous. I'm sorry, I interrupt. But the problem I have with that particular argument is I thought you conceded in your briefs that you didn't even reference the term percutaneous in your petition for review before the end. Well, I'll tell you, throughout the prosecution's case that we remanded the claims. Well, am I right about that? I mean, I understood it. It did not appear in the brief. It was raised at the oral hearing. It was raised at the oral hearing. And one reason it didn't appear at the brief was at the brief. Because in the original 103 rejections, the examiner had taken the position that the use of interleukin 2 in those compositions was optional. And we jumped all over that. And the examiner with regard to the by, the examiner had taken the position that the by, that the claims could be construed as reading on a biopsy of the skin on the breast. And we pointed out a biopsy of the skin on the breast is a skin biopsy. It's not a breast biopsy. We jumped on that issue. So with the playing field one way, we responded to these 103 rejections and hit what we consider to be very, you know, some critical weakness. But it's kind of hard to press on a field to be arguing that we ought to send something back to the board because they didn't deal with a particular limitation or at least in your written presentation, you didn't cover that to the board. Well, if they, I think that if we, well, I think that if they had, if the board had, we also didn't concede that claim eight and claim one should be grouped together. And that's a limit that claim eight should not be considered considered on its own merits and claim eight clearly calls for, you know, a percutaneous procedure. So, you know, so we are, so we were really, we were really thrown a curve here by the board. We went from these 103 rejections to this 102 analysis. And the 102 analysis is only feasible if you ignore claim eight, which the board conveniently did by grouping it with claim one. These types of maneuvers, I think, need to be discouraged. You know, we can only address the rejections as they're presented to us. And then to be confronted with this 102 analysis and to have a claim that was specifically amended to include the percutaneous limitation during prosecution. And to have that just completely ignored and dropped out for everybody's convenience is an injustice. Okay. Thank you. Thank you, Mrs. Lee. We have your rebuttal time, say it. Mr. Johnson. May I please the court. Opposing council is wrong when he says that a person of ordinary skill and yard would not have known to conduct a breast biopsy in the 13 appeal. The forester teaches that particular aspect of claim one. And this court is completely correct that forester teaches everything that's in claim one except for the sullable limitation. Anderson is the bridge that gets us to the buy that teaches the sullable limitation. Anderson teaches a biodegradable composition. And forester says that a biodegradable polymer can be used as a marker. Well, when you look at Anderson, which mentions the biodegradable composition, Anderson says that the composition can include a hemostatic agent. The bi teaches a hemostatic agent. And it teaches that the benefit of having this hemostatic agent is that it controls bleeding. So one ordinary skill and yard seeing the clear teachings of Anderson would want to rely upon the sullable materials that's in the bi and combined that with forester. Once those references are all combined, then the claim would be rendered obvious based upon those three teachings. Of course, Mr. Lee, he says what tells you to combine with the motivation. The motivation comes from Anderson itself, your honor. Forester teaches that the biodegradable marker can be actually that the marker can be a biodegradable composition. Anderson teaches a biodegradable composition. And Anderson says that that biodegradable composition can include things like hemostatic agents and radiopact markers. The bi teaches a biodegradable agent, which is hemostatic. It's a sullable material. So the person of ordinary skill and yard would be motivated to rely upon the bi's sullable materials because of the teachings in Anderson. Anderson is that bridge that gets us from forester to the bi. A opposing counsel has argued that the bi is not analogous to heart and neither is Anderson. However, they are both in the same field of invention. Both of those references deal with hemostatic agents. And that is exactly what the 205 patent was getting at. Anderson teaches that what you want to do is control bleeding after you cut into an individual because there could be hemorrhaging. The bi also teaches that you want to control bleeding after a biopsy. One of ordinary skill and yard was a doctor would also know these things based upon his practice in the field. So both of those references are analogous because they are in the same field of invention. And not only for that reason, but also because they also dealt with the problem that the inventor was dealing with. The 205 patent expressly states that it deals with biopsies and localizing that area. Well, a biopsy is simply removing tissues. And that is exactly what Anderson is dealing with, removing tissue that is cancerous. And that is also what the device is dealing with, removing tissue that is cancerous. So because the bi and Anderson deal with the same problem that the 205 patent was getting at, then they are also analogous for that reason as well. So there are two separate reasons why the references for this court are analogous art. And when you look at analogous art, KSR is also very broad in its discussion as to what can be analogous art. And here clearly those two references Anderson and the bi are analogous for the reasons I just mentioned a moment ago. How about the second appeal? Anderson looks a little off the track talking about injection of interleukin tube. Hasn't really deal with biopsies. Well, while you're on a biopsy is merely the removal of tissue and you want to make some determination as to what it was that you removed. With respect to the IL-2, Anderson teaches that a number of different embodiments in its specification and explains with respect to one embodiment that you want to start with this biodegradable polymer. And then you add the IL-2, but you can also add other stuff. You can add hemostatic agents and you can also add a radiopath marker. One of one of the skills in the art who's merely conducting a biopsy would know that he shouldn't add IL-2 right off the bat. You can add the other ingredients that Anderson is talking about, the hemostatic agents and even the radiopath markers. With respect to the location of conducting a biopsy in the breast, Anderson is the reference that teaches it in the 14 reference, in the 14 appeal. Because with respect to claim one, the examiner relied upon the bi, Anderson, and Lee. Well, Anderson clearly teaches that its biodegradable compositions can be implanted into any section of the body, including the breast. What about the procedural aspects? New rejection? Yes, Your Honor. It's our position that there is no new rejection here by the pool. You just mentioned that the examiner relied on Lee, Navai, and Anderson. The board as I understand it with respect to one and eight. We like, well, predominantly with on Anderson, but at least in combination with Navai, no reference to Lee, right? Well, Your Honor, the board clearly understood what the rejection was. And in its decision on rehearing, it specifically noted that the examiner relied on three different references. So it might not have identified the names of the three different references, but it clearly noted that the examiner, and I can point the court to that. The question is, what the board relied on, and how did the examiner relied on, right? That's the problem. Yes, Your Honor. And here, at 814, at the very top in the first paragraph, the board states, in this case, the examiner relied upon the combined teachings of the three prior references, including Anderson. So it specifically identified the fact that the examiner relied upon three different references. The examiner was very specific as to why Anderson must be relied on for 10 and the concern that's been raised has been added to board wishes to find a different rationale for the combination that the applicant should have an opportunity to respond before the board or before the office. Through one of the procedures, when new grounds are raised, rather than having to raise it before the court for the first time. That's correct, Your Honor. But I was merely pointing out the fact that the board clearly understood what the examiner's rejection was. I'll just ask my question. What the board understood, the question is what the board states, it relies upon, particularly in this case, is quite conspicuous. The examiner said she was relying on Anderson only for one aspect. I'll first start with that because the examiner made a number of different findings. And one of the findings was that, and I can direct this court to the examiner's answer, and that's found at 836, where the examiner said that Anderson teaches a method of removing malignant tissue prior to implanting. That's one finding that it made and it also indicated that the material may be injected into any desired site, and such as the breadth. That's another finding that it made Anderson. You were saying that the examiner's answer can raise new grounds of rejection? No, I'm not saying that at all. What I'm merely pointing out is that the examiner made a number of different findings. What Devacore's pointing to is merely one of the findings. Yes, they're complaining that they didn't have an adequate chance to respond to the grounds on which the board relied. Yes, you're right. What I see, they have a good point. Well, that would not be accurate, Your Honor, because they had an opportunity to address all of the examiner's findings with respect to Anderson when they received their final rejection. But I thought we were talking about Lee. I thought we would talk about the absence, but maybe I'm not positive with a judge in Newman and I reference the same thing. But my concern was the examiner rejected it based on Anderson, Dubai, and Lee. And then the board comes up and rejects, Dubai and Anderson. Why isn't that a new ground for rejection? In this case, Your Honor, what the board was doing was merely relying to the arguments that were made in the brief to it. And in their brief to the board, most of their arguments were with respect to Anderson. Their focus was on addressing Anderson. And what they said, and the board was quite good in outlining each of the different points that the, that Devakor raised, A4, they pointed out each of the different arguments that Devakor raised in their briefs to the board. One of them dealt with Anderson is in a different field of invention. Anderson is not suitable for being a biopsy marker. And Anderson is not enabled. So they made a strategic decision to focus their brief just on Anderson. And it was the board's responsibility to respond to those arguments. And that's just what they did. They responded to each one of the arguments raised. And because they found that Anderson, the teachings in Anderson, addressed each of the arguments, that's why their decision was limited to Anderson itself. But they also made findings, as this court has already noted, with respect to Dubai as well. And in their decision on request for re-hearing, they pointed out that the examiner addressed three different references. And that was the decision that they were referring. With respect to whether or not the claims were separately argued, your Honor, it's the board correctly found that claims eight and twelve were not separately argued. When you look at what they actually argued in their appeal to the board, they argued claim one and they did so properly. With respect to claim eight, what they did was they came up with two different paragraphs. And in the first paragraph, that first paragraph listed out different elements for their argument under the heading of claim eight and claim twelve. But nowhere in that first paragraph did they identify the precutaneous limitation, which they alleged to be the patentable limitation over claim one. And then in their second paragraph, they argued for the same reason that we argued with respect to claim one, we believe that there's no motivation to combine the different references. However, at no point at all did they argue in their first paragraph or their second paragraph, the patentable limitation with respect to claim eight. They argued all of the arguments with respect to claim one. So the board probably found that because they didn't create any arguments with respect to the separate patentability of claim eight, that they had not separately argued claim eight with respect to claim eight. All the board needed to do in actuality is simply point out what they could have done rather is simply say for the same reasons that we said claim one isn't patentable neither is claim eight and twelve. They decided not to go that route though. Well, it seems to have been an unfortunate omission at the time we get up here, right? Well, you're out of that was one possibility, but what they also did was proper because because the record did not separately argue the patentability for claims eight and twelve. This case is closely aligned with loving and in loving they created a separate heading for some of the claims. However, they did not specifically argue the patentability of those particular claims and this court found that because they did not separately argue the patentability with respect to those particular claims that the board properly decided in that case. Just hypothetically, if an examiner relies on three references and has a rejection of one or three rejection based on a combination of those three references. And a case goes up to the board and the board reevaluate and it starts and it uses just two of those three references, not the third. Isn't that hypothetically typosetically viewed as a new ground for rejection? I think that it would depend because there could be a number of situations like the one we have here where the board merely addresses the arguments that were made in the brief. And in doing so, if they determine that they only need to address two of the three references, then that would be satisfactory. Opposing council has pointed to our rule but we believe that he has not actually accurately discussed our rules because the rule, although he pointed to basically half of the rule, the most important part for our purposes here, is the part that was not discussed. And that begins with the sentence which states, notwithstanding any other provision of this paragraph, the failure of a pellant to separately argue claims which pellant has grouped together, shall constitute a waiver of any argument that the board must consider the patentability of any ground claims separately. And any claim argued separately should be placed under separate heading and claims argued as a group should be placed under a separate heading identifying the claims by number, a statement which merely points out that the claimer's sites, what the claimer's sites will not be considered an argument for separate patentability of the claim. Can that just give us the site that you're reading from just the purposes of clarity of the record? Yes, Toronto. That's 37 CFR, section 41.37, C sub 7. Thank you. And the problem that Devrick or has here is that they did not argue the separate patentability of claims eight and 12. So for that reason, they have not satisfied what they required to do as far as the rule is concerned in arguing claims eight and 12. And our rules are established to ensure that there's an orderly process before the agency by violating that rule, it just creates confusion as to the briefing process. And even if this court were to find that the board and properly separately argued and properly decided the separate argument raised by Devrick or Devrick or still has the problem in that they failed to argue the percutaneous limitation in their brief to the board. They had a number of opportunities to do so. The final rejection from the examiner wanted to lead as the reference which teaches that particular limitation. They did not address that particular argument by the examiner and their brief to the board. They only raised it for the first time in their brief to the board. They did not address, sorry, for the first time in their oral hearing and their argument at the oral hearing. But they did not do so properly. What they said as the oral hearing was that we will address claim eight and 12 and I pointed this out in a footnote, but they never came back to discuss it. So although they might have had an intent to do so, they failed to do so. But even if they had done so, it still would have been late at that time because they're supposed to raise all of their arguments in their brief to the board and they fail to do so with respect to that particular limitation. Thank you. Thank you. I think this court's precedent in Ray McDaniel is clearly pertinent to the issues that we have here today. McDaniel makes it very clear that the board cannot just do away with the examiner's rejections in spite of its obligations under 35 USC Section 6D. So regardless of whether percutaneous was argued separately or not, the fact remains that the final rejection included two, there were two 103 rejections. The second claim eight was moved and grouped with claim one improperly and under McDaniel's debacle is entitled to consideration of the rejection of claim eight under 35 USC Section 6D. The other point I would like to make is that we've had a lot of discussion today with regard to the Forester O55 reference as contrasted with the Lee reference in the 1414 appeal. The Lee reference only shows using a little air bubble to mark the biopsy site. So while Forester may teach, well Forester teaches metallic elements and the possibility of using polymers, in the 1414 case, the Lee reference is the only reference that relates to biopsy markers. And that marker is nothing more than a little bubble of air and to make this transition to make this leap from replacing a bubble of air to a polymer composition whether it's described by a nearby or Anderson seems to be a real stretch. Secondly, Anderson, I think it is an insult to the language to say that Anderson teaches a biopsy. Anderson does not teach a method for marking biopsies. Anderson mentions that he uses a tumor core localization biopsy, something that is conventionally used by surgeons all the time to make sure they've got the right tissue. But the Anderson patent is not directed to marking biopsies. Anderson is a chemotherapy that's designed to treat cancers using interleukin 2. The biopsy, the patents that teach marking biopsies are Forester O55 with its elements and Lee with its little bubble of air. And particularly in the case of the rejection over Lee and 1414, you've got an enormous jump there to say, it's obvious to replace this bubble of air with Anderson's interleukin 2 or the bi-swellable polymer that's being used in a punch for a skin biopsy. So I think on those bases, at a minimum, a remand of these 14-14 cases is appropriate