[00:00:00] Speaker 01: is 16 1487 in Ray Chudok. [00:00:04] Speaker 03: Good morning, Your Honor. [00:00:22] Speaker 01: Good morning. [00:00:23] Speaker 01: Let's make sure everybody has a chance to say a few things. [00:00:29] Speaker 01: OK, why don't you proceed, Mr. Leary. [00:00:31] Speaker 03: May it please the court. [00:00:35] Speaker 03: This case is about a scalpel. [00:00:40] Speaker 03: The picture of the Chudik scalpel is on page six of the opening brief. [00:00:49] Speaker 03: And the picture of the alleged anticipation is on page eight. [00:00:57] Speaker 03: I'd like to talk about this. [00:00:58] Speaker 03: Just a couple of things. [00:01:00] Speaker 03: One of them is the evidence in the case, or lacking thereof. [00:01:08] Speaker 03: And then I would like to turn to the in-range Freiburg case, which seems to me to be the case that the solicitor relies on most heavily. [00:01:24] Speaker 03: Just a very brief review, the claim [00:01:29] Speaker 03: involved has a phrase right at the beginning describing the blade of the Chudik scalpel configured for creating a passageway through skin and soft tissue to a target site on a bone. [00:01:54] Speaker 03: In the opening brief I [00:01:57] Speaker 03: asserted that there is no evidence to support the examiner's conclusions that the blade in the anticipation in the Samuels pattern is capable of doing what this claim calls for. [00:02:15] Speaker 03: And I'm going to repeat that now so that my colleague can mention any evidence that they found since the briefing schedule. [00:02:25] Speaker 04: Let me ask you a question that [00:02:28] Speaker 04: I didn't find an answer to it, and maybe I can be held by counsel for both parties. [00:02:35] Speaker 04: And is there a situation in the human body where you have skin and then bone? [00:02:42] Speaker 04: Or is it the case that there's always at least some amount of soft tissue or some sort of layer other than skin that's always found between the bone [00:02:55] Speaker 03: Your Honor, I'm a lawyer, so I'm going to repeat hearsay. [00:03:00] Speaker 03: My client is an orthopedic surgeon, and I asked him that very question. [00:03:04] Speaker 03: He says there is always soft tissue beneath the skin before you get down to the bone. [00:03:15] Speaker 03: That's the best I can answer you, and that's my understanding. [00:03:19] Speaker 01: Did you have an opportunity to amend your claim? [00:03:22] Speaker 01: I mean, some question arises here why, if you heard the board came up with this construction, even if you disagree with it, why you just didn't narrow the claim language to account for it. [00:03:34] Speaker 03: Yes, Your Honor. [00:03:35] Speaker 03: I did have an opportunity to amend the claim, and we elected not to. [00:03:40] Speaker 03: We don't need to. [00:03:42] Speaker 03: The anticipation that there is no evidence anywhere that we can find that the [00:03:52] Speaker 03: Samuel's patent is capable of doing what the claim calls for already. [00:03:57] Speaker 03: So that's why we didn't have to amend it. [00:04:00] Speaker 04: And that's because the Samuel's patent is designed to only pierce skin. [00:04:09] Speaker 03: It's not only designed that way, Your Honor. [00:04:11] Speaker 03: It's limited to that. [00:04:13] Speaker 03: And excuse me, it doesn't pierce the skin. [00:04:15] Speaker 03: It makes a nick in the skin. [00:04:16] Speaker 03: And they repeat that word nick several times. [00:04:21] Speaker 03: And actually, the Samuel's Patent has a blocker and has a blade down below the blocker. [00:04:29] Speaker 03: And that distance from the base of the blocker to the point of the blade down here is always the same. [00:04:38] Speaker 03: It doesn't change. [00:04:41] Speaker 05: Are you saying that the anticipatory reference is not analogous art? [00:04:47] Speaker 03: No, Your Honor. [00:04:47] Speaker 03: I'm saying it is. [00:04:51] Speaker 03: incapable of being an anticipation. [00:04:54] Speaker 03: It's not a matter of non-analogous argument. [00:04:58] Speaker 05: The examiner said there are certain bones in your body that lie very, very close to your skin. [00:05:06] Speaker 05: Although there's going to be some soft tissue under the surface layer of the skin of the bone, the bone is very, very close. [00:05:16] Speaker 05: I broke my wrist two weeks ago today, and the bones are very close to the skin. [00:05:25] Speaker 03: I understand that. [00:05:26] Speaker 05: Exactly. [00:05:27] Speaker 05: And I thought that the rationale of the board, as well as the examiner, was that the anticipatory reference was capable of puncturing the skin to a target site on a bone, the bone lying very, very close to the skin. [00:05:46] Speaker 03: The answer to your question, first of all, is it's not capable of doing that. [00:05:51] Speaker 03: And as I was just explaining, is if that blocker rides on the surface of the skin and the tip of the blade makes a nick in the skin, that's all it's ever going to make. [00:06:05] Speaker 03: it doesn't go through to the soft tissue, and it never gets down to the bone. [00:06:10] Speaker 05: And what you just... Right, but if you look at the drawing of the anticipatory reference, right, it shows a blade, which is like a triangle, and it shows a considerable distance between the apex of the triangle, which is where the annulated hole is. [00:06:32] Speaker 05: And you see quite a little distance [00:06:34] Speaker 05: down to where the blocking device is. [00:06:40] Speaker 05: So it certainly looked to me that the Samuels teaches a device that might have been designed simply to barely touch [00:06:51] Speaker 05: the skin, right, to make a little prick, to make a little bigger hole so something else could go in. [00:06:57] Speaker 05: But if you simply look at the structure, right, if you pushed the Samuel's device against my leg up to where it would stop as a result of the blocking device, you would be well under the skin. [00:07:14] Speaker 03: No, Your Honor, you don't. [00:07:16] Speaker 05: Why not? [00:07:17] Speaker 03: First of all, if you look at column four, [00:07:21] Speaker 03: That's Appendix Page 418. [00:07:28] Speaker 03: Look at the top of Column 4. [00:07:30] Speaker 03: Position between Blade 10 and Handle 20 is Blocker 22. [00:07:35] Speaker 03: As may be seen in Fig 1, Blocker 22 has a width greater than that of Blade 10. [00:07:41] Speaker 03: As will be discussed below, this is necessary so that the depth of the blade travel into the patient's skin [00:07:50] Speaker 05: Well, of course it's limited. [00:07:54] Speaker 03: Well, that says it doesn't go through to the bone. [00:07:57] Speaker 05: Well, it's not asking whether it goes through the bone. [00:08:00] Speaker 03: I thought that was your question. [00:08:01] Speaker 05: It's not asking where the bone lies, sir, but it's admitting right there that the depth to which 32, i.e. [00:08:09] Speaker 05: the apex, the depth to which it can fall [00:08:14] Speaker 05: is as great as the distance between 32 and the level of 22. [00:08:20] Speaker 05: Correct? [00:08:22] Speaker 03: No. [00:08:23] Speaker 03: Not correct. [00:08:25] Speaker 03: It's not greater than that. [00:08:27] Speaker 03: It's limited to the depth that the point of the blade can penetrate. [00:08:31] Speaker 05: Yes. [00:08:32] Speaker 03: And it can't go any further than that. [00:08:35] Speaker 05: Samuel blade can't go any deeper than where 22 touches the skin. [00:08:42] Speaker 03: That's all this ambulance thing can do, is get down to the skin and nick it. [00:08:48] Speaker 03: Is that what you're asking? [00:08:50] Speaker 05: No, no, no. [00:08:51] Speaker 05: I'm looking at drawing. [00:08:54] Speaker 05: That's on page 414, isn't it? [00:08:57] Speaker 05: Of figure one. [00:08:58] Speaker 05: And figure one is showing a triangular blade that has a, what do you call it? [00:09:07] Speaker 03: Let's call it a blocker. [00:09:08] Speaker 03: A blocker, okay. [00:09:09] Speaker 05: And the blocker is some considerable distance below the point of the sticking where you nick. [00:09:16] Speaker 03: But that distance is defined, Your Honor. [00:09:18] Speaker 05: Where? [00:09:19] Speaker 03: When in the passage I just read. [00:09:22] Speaker 05: The distance is to say that it is, you will go no deeper than the blocker will allow you to go. [00:09:30] Speaker 03: That's correct. [00:09:31] Speaker 05: Right. [00:09:31] Speaker 05: And I'm saying all you have to do is look at the device to see that it's designed to go more than just a tiny little prick through the skin. [00:09:41] Speaker 03: But so that passage also says so that the depth of the blade travel into the patient's skin is limited. [00:09:51] Speaker 03: That's right. [00:09:52] Speaker 01: Limit doesn't mean not existing. [00:09:54] Speaker 05: And you may or may not hit a bump. [00:09:57] Speaker 05: If you're going for my rear end bone coming through my cheek, you're never going to find it with Samuels. [00:10:06] Speaker 05: But if you're looking for a bone in the back of my wrist, you're going to find it because it's wise with almost right at the skin. [00:10:15] Speaker 03: Let me say two things, Your Honor. [00:10:18] Speaker 03: First of all, [00:10:20] Speaker 03: I think the passage I just read is a controlling passage. [00:10:23] Speaker 03: There's another one close to the bottom of the page I could also read. [00:10:27] Speaker 03: But secondly, there is no evidence in the case anywhere. [00:10:34] Speaker 03: The board never conducted any tests, never tried anything. [00:10:41] Speaker 03: The examiner never tried anything. [00:10:44] Speaker 03: There is no evidence to support the argument that [00:10:49] Speaker 03: the point of the Samuel's blade goes on down to the bone. [00:10:53] Speaker 03: There's no evidence to prove that at all. [00:10:56] Speaker 03: You can make your supposition, Your Honor, and look at the drawing, but there's no evidence to support that. [00:11:02] Speaker 03: And you know we can't do anything without evidence. [00:11:07] Speaker 05: But if you have a bone, isn't the device capable of reaching a shallow bone? [00:11:12] Speaker 03: No, Your Honor, it's not. [00:11:14] Speaker 03: Why not? [00:11:16] Speaker 03: Because the distance between the blocker [00:11:19] Speaker 03: and the point of the blade holds the point of the blade above the bone, above the soft tissue. [00:11:28] Speaker 03: It only nicks the skin, and that's what this patent says it does. [00:11:32] Speaker 03: And this patent is the only evidence to that subject in the case. [00:11:39] Speaker 01: Well, the reference you've been talking about on the same column four, it talks about you advance [00:11:46] Speaker 01: the blade into the patient's skin until blocker 22 impedes further travel. [00:11:51] Speaker 01: So doesn't that suggest what Judge Clevender has been describing? [00:11:55] Speaker 01: It's the blocker. [00:11:56] Speaker 01: This goes as far as the blocker will take it. [00:11:59] Speaker 03: Yes. [00:12:00] Speaker 03: And the blocker is always resting on the dirt surface of the skin. [00:12:04] Speaker 03: And the blocker is there to only allow you to produce a nick. [00:12:09] Speaker 03: That's all the possible. [00:12:12] Speaker 05: Assume that the examiner had gone to a medical record and put in evidence a bone in the body that is so close to the skin that there is virtually nothing between the skin and the body. [00:12:32] Speaker 03: You've just supplied evidence, Your Honor. [00:12:34] Speaker 05: So assume that evidence was in the record. [00:12:37] Speaker 05: Then you lose, right? [00:12:40] Speaker 03: If there was such evidence, I would have to rely on this patent. [00:12:46] Speaker 03: I don't think I'd lose, Your Honor, but that makes a closer case if there was such evidence. [00:12:50] Speaker 03: I'd have to somehow... I would have had to somehow combat that, and at that point, the burden would have shifted to me to disprove it. [00:13:05] Speaker 03: There was no reason for any burden to be [00:13:10] Speaker 03: shifted to me, the board didn't have anything more than its agreement with the examiner's findings, which I say are unsupported, but if they had had reason to think that the point of the Samuel's blade went deeper. [00:13:26] Speaker 03: For some evidence in the record, I would have had to do something, but I didn't have to. [00:13:33] Speaker 05: The board can't take judicial notice of the existence of a bone in the body that lies so close to the skin as to having no real difference between the amount of soft tissue under the skin from a dermatology point of view as opposed to the top of your brain or back of your hand. [00:14:01] Speaker 05: It's not possible to take judicial notice of anatomy. [00:14:05] Speaker 03: You wouldn't permit judicial notice of what you've just hypothesized. [00:14:12] Speaker 03: You wouldn't permit that. [00:14:13] Speaker 03: There's no evidence to suggest that. [00:14:19] Speaker 03: In fact, it's contrary to the patent. [00:14:22] Speaker 03: What you're looking at, I believe, is the drawing of the scalpel which is out in the open, the Samuel scalpel. [00:14:30] Speaker 03: And I'm saying that that's probably an accurate drawing if you blow up the size of the scalpel and look at it as a picture without anything else around. [00:14:41] Speaker 04: Counselor, there's also the drawings in the pan, like 3A and 3B, that show skin, the human hair. [00:14:51] Speaker 04: I think I put into perspective a little bit more, perhaps, the size of the blade. [00:14:56] Speaker 03: My understanding... Excuse me, your honor, I would have, but I was limited to the question. [00:15:01] Speaker 04: Okay, yeah. [00:15:04] Speaker 04: I'm pointing out that there are other figures in the patent that also indicate, one could say indicate the size of the blade, but as far as I know, none of these figures provide the distance between the blocker and the tip of that blade. [00:15:26] Speaker 03: They only show you that the blade is going into the skin. [00:15:31] Speaker 03: They do not show you anything below the skin, even the soft tissue or the bone. [00:15:37] Speaker 03: Oh, my. [00:15:39] Speaker 03: I have five minutes, I believe. [00:15:41] Speaker 01: Well, actually, your time has expired. [00:15:43] Speaker 01: But we'll restore three minutes for rebuttal. [00:15:45] Speaker 01: Why don't we turn to the other side? [00:15:47] Speaker 01: Thank you. [00:16:07] Speaker 00: May it please the court. [00:16:10] Speaker 00: Chuck spends a lot of time focusing on Samuels and the use of the term Nick. [00:16:17] Speaker 00: But I want to explain I guess a little background of what Samuels teaches and why one understands that the blade would actually penetrate the skin and be capable of reaching bone. [00:16:31] Speaker 00: First off, [00:16:32] Speaker 00: At column one, a skin neck is defined as a skin incision, so it's not just simply sort of just touching the surface. [00:16:39] Speaker 00: And a dermatotomy, which is what's discussed in Samuels, is a skin incision of the skin. [00:16:48] Speaker 00: But more generally, if you look to column one and two, which explains the background of the invention and the purpose of the blocker, I think it becomes clear [00:17:02] Speaker 00: that the blades in Samuel's would reach bones that are close to the skin surface. [00:17:10] Speaker 01: But it never says that. [00:17:11] Speaker 01: It never explicitly talks about anything than nicking the skin, right? [00:17:16] Speaker 05: Specifically in the background, you have a line reference, Ms. [00:17:19] Speaker 05: Nelson? [00:17:20] Speaker 00: At the beginning of column one, Samuel's discusses the field of the invention, which is basically interventional radiology and surgical [00:17:32] Speaker 00: procedures that are performed percutaneously. [00:17:35] Speaker 00: Percutaneous means through the skin. [00:17:39] Speaker 00: And in particular they're talking about being able to access particular tubular structures like the drainage system of the kidneys, the bile ducts and vascular system, through the skin. [00:17:51] Speaker 00: to allow entry of a catheter or some kind of other surgical instrument. [00:17:57] Speaker 00: And it explains in the next paragraph that the way it works is that a guide wire is first inserted, and then these surgical blades allow it to be enlarged, bigger than the guide wire, to allow passage of something like a catheter or other devices. [00:18:13] Speaker 00: And in column two, the corth pattern, they describe passing [00:18:19] Speaker 00: or making a cut through a patient through the skin and the subcutaneous tissue to allow passage of an endoscopic instrument. [00:18:29] Speaker 00: So those are the background, that's the background art. [00:18:32] Speaker 00: Then in column one at line 55, it describes the purpose of the blocker. [00:18:40] Speaker 00: And that purpose is to basically prevent the problem where if [00:18:47] Speaker 00: the tubular structure is somewhere near. [00:18:51] Speaker 00: Yes, column one, line 55. [00:18:56] Speaker 00: Further Disadvantage. [00:18:58] Speaker 00: It talks about the scalpels in the art, and it talks about the problem of the scalpels [00:19:08] Speaker 05: Potentially damage going too far you whatever canal they built in there that they ran the wire through You can you can adversely affect that structure is that the idea the idea is that the tubular structure that you're tending to access if you go too far you could actually damage it so if you're trying to get to the somehow in the beginning they managed to make a hole and you go down and drill some holes in your bones right and then put a canal through that the string is going to go through and [00:19:33] Speaker 00: They're describing catheters and endoscopes, but the idea is, yes, you make a big enough hole that you can get whatever it is in through the skin and to the tubular structure you're trying to access, whether it be the bile ducts or vascular, like the veins of the blood veins or blood arteries. [00:19:52] Speaker 00: But it talks about the problem that sometimes when these structures are closer to the skin surface, that inadvertently a surgeon could go too far and actually [00:20:03] Speaker 00: the blade would puncture the actual target tubular structure. [00:20:10] Speaker 05: It's meaning that the blocker is designed to make sure you don't go in that deep. [00:20:16] Speaker 05: Right. [00:20:17] Speaker 05: So I suppose your adversary's argument would be, well, if you were worried about going in far enough that you might hit the tubular structure, so you want to make sure you don't do that, you're not going in very far. [00:20:28] Speaker 05: And so you're not likely to be going in far enough to hit a bone. [00:20:33] Speaker 05: Is the tubular structure going to be in the bone down there somewhere? [00:20:38] Speaker 00: The tubular structure could be, based on the description, would be things like blood vessels or blood arteries or some kind of vascular tissue or bile ducts or whatever. [00:20:49] Speaker 00: A fair reading by one of skill in the art of Samuels would mean that you could place the blocker as appropriate so that you could actually get the catheter. [00:21:00] Speaker 04: Where did we get that? [00:21:02] Speaker 04: So where do you get that fair reading? [00:21:05] Speaker 00: Because of the background and the fact that it describes in column one what the whole point of the blocker is. [00:21:13] Speaker 00: It describes the purpose of the blocker. [00:21:15] Speaker 04: In column one, I'm just looking at that. [00:21:17] Speaker 04: It's still referring to the limitation of a skin neck. [00:21:27] Speaker 04: I don't see what you're... I don't see your argument. [00:21:34] Speaker 00: A skin neck, which it defines as an incision, and the whole point of the invention is to allow passage of a catheter or other device. [00:21:43] Speaker 00: Talking about Samuels? [00:21:44] Speaker 00: Samuels, yes. [00:21:46] Speaker 00: And just that they've [00:21:49] Speaker 05: is to make a big enough hole in the skin to be able to stick into it, the thing that's going to go down there and do the work in the surgery. [00:21:56] Speaker 00: Right, but without going so far. [00:21:58] Speaker 00: So you need to get far enough to get it into where it needs to go, but not, you don't want the blade to go so far. [00:22:04] Speaker 04: To make sure it doesn't go too far, you need to padute the skin level. [00:22:08] Speaker 04: It's got a blocker that prevents the blade from going beyond the skin. [00:22:15] Speaker 00: It's got to get through the skin to get to wherever the catheter needs to go or whatever. [00:22:20] Speaker 04: Yeah, it nicks the skin. [00:22:21] Speaker 04: You have a blade. [00:22:22] Speaker 04: It nicks the skin, but only the skin. [00:22:26] Speaker 04: Because there's a blocker there that prevents it from going any further. [00:22:32] Speaker 04: Now, the examiner one time said, well, what you can do is you can sit there and nick and nick and nick and nick until you get to bone. [00:22:39] Speaker 04: But the board rejected that interpretation correctly. [00:22:44] Speaker 00: focused that the examiner had made two different arguments. [00:22:46] Speaker 04: One was that and the other was simply that there are plenty of... And then the board rejected the nick, nick, nick argument. [00:22:53] Speaker 00: It didn't reject it, but it focused on the other argument by the examiner, which was that there are plenty of bones that are close to the skin surface, just like tubular structures. [00:23:02] Speaker 05: Maybe the question around the board accepted it. [00:23:04] Speaker 05: The board said we accept the examiner's findings, lock, stock, and rural. [00:23:09] Speaker 05: They did they did adopt the examiner's finance adopted each never adopted the whole thing Yes, I guess they're inferior adopting the Nick Nick Nick rationale as well as the bone close to the skin correctional Correct, but they focused they focused the only one they mentioned in supporting their decision was the fact that there are bones in the body that lie close to the skin What do you do with your adversaries argument that that is? [00:23:39] Speaker 05: Evidence is made up out of a whole cloth. [00:23:43] Speaker 05: Where in the record is there a document that describes a bone that lies in a body so close to the skin that there is virtually no difference between that situation and the situations described in the antispore reference? [00:24:04] Speaker 00: I think the evidence is Samuels itself and [00:24:07] Speaker 00: the knowledge of one's skill in the art. [00:24:09] Speaker 05: One's skill in the art would know about the bone in the body in this class? [00:24:14] Speaker 00: I think even a lay person would know that there are bones that are very close to the skin surface, like your knuckles or your knees or your forehead. [00:24:21] Speaker 04: Let's say I'm a lay person. [00:24:23] Speaker 04: Obviously, I'm a lay person on this. [00:24:25] Speaker 04: But if you penetrate the skin, there's always something, it seems to me, between the bone and the skin. [00:24:33] Speaker 04: I mean, I've seen some injuries even to my own hand [00:24:37] Speaker 04: and where the board's decision talks about, the temple. [00:24:42] Speaker 04: There's a place here in the head, right around in here, where the bone lies very close to the skin, places of the hand, maybe the knee. [00:24:55] Speaker 04: But is there a layer of tissue underneath the skin, between bone and skin? [00:25:02] Speaker 04: You're saying there's no tissue? [00:25:06] Speaker 00: Well, first off, I think soft tissue is a broad term that's used medically to mean anything that's not hard tissue like bones. [00:25:13] Speaker 00: So soft tissue encompasses the skin. [00:25:15] Speaker 00: But that aside, yes, I think that in most circumstances, there is probably something beneath the skin that's very minimal. [00:25:22] Speaker 04: So if Samuels is designed to prevent you from getting to that? [00:25:27] Speaker 00: I don't think that there's anything in Samuels that indicates that. [00:25:29] Speaker 00: In fact, quite to the contrary, the purpose of Samuels is, again, [00:25:33] Speaker 00: to introduce a catheter or an endoscopic instrument. [00:25:35] Speaker 00: Well, that's different. [00:25:36] Speaker 04: That's different. [00:25:37] Speaker 04: What you do after you make the neck and the skin is separate from what the blade is designed to do. [00:25:42] Speaker 04: The blade is designed only to neck, and it seems to me that the pen is full of that reference. [00:25:49] Speaker 04: That reference is clear to the pen, that Samuelson, the blade only penetrates the skin. [00:25:58] Speaker 04: I don't see anything else that says [00:26:01] Speaker 04: It's supposed to go to the bone. [00:26:03] Speaker 04: You can get the blocker and alter it. [00:26:09] Speaker 04: So I'm having a hard time following your reasoning. [00:26:14] Speaker 00: The description here in Samuel's, it's clear that the whole point is to get things in. [00:26:20] Speaker 00: That the reason that you use the knife, as explained here and in the prior art, [00:26:24] Speaker 00: is to actually make a larger hole so that you can pass whatever you want. [00:26:28] Speaker 04: The question here isn't whether the catheter or maybe even the wire that you insert in the channel of the blade, that that goes beyond the skin. [00:26:38] Speaker 04: What we're looking at here is whether the blade does. [00:26:41] Speaker 00: Well, the blade has to make the cut in order for the catheter to go through. [00:26:45] Speaker 04: Right. [00:26:45] Speaker 04: And the blade has a channel that the wire, guiding wire and the catheter flow through. [00:26:51] Speaker 04: But we're looking only at the blade and the depth of the cut that the blade makes, not the wire. [00:26:57] Speaker 00: Correct. [00:26:58] Speaker 00: The wire goes through first, and then the blade cuts around it. [00:27:01] Speaker 00: So the wire makes a very narrow point to whatever it's trying to access. [00:27:06] Speaker 04: And then- And do you say that Samuel's cuts beyond the blade? [00:27:10] Speaker 04: Forget about the wire. [00:27:12] Speaker 04: That the blade cuts beyond the depth of the skin? [00:27:15] Speaker 00: Yes, it has to, because it has to get through the skin to allow the catheter to get through. [00:27:19] Speaker 04: As it describes at the bottom of four, it talks about- So you're saying in the process of penetrating the skin that [00:27:28] Speaker 04: Any of the underlying tissue has to also somehow be touched or implicated. [00:27:38] Speaker 04: Because there's nothing here that shows me that the blade also cuts beneath the skin. [00:27:47] Speaker 00: Well, the prior art, like Porth and so forth, talks specifically about Porth [00:27:52] Speaker 00: talks about going through the skin and subcutaneous tissue to access the kidney to allow an endoscopic instrument to go through. [00:28:01] Speaker 00: The blade has to go so far as to make the cut [00:28:04] Speaker 00: as far as it needs to go in order to allow the passage of the instrument. [00:28:08] Speaker 05: What happens if your tubular structure that you're worried about is an artery? [00:28:14] Speaker 05: It's on the back of my hand. [00:28:16] Speaker 05: So you've got skin, right? [00:28:19] Speaker 05: And then there's the artery. [00:28:20] Speaker 05: Maybe there's something between the skin and the artery. [00:28:23] Speaker 05: Correct. [00:28:24] Speaker 05: But clearly we don't want to go deep enough to hit the artery. [00:28:27] Speaker 05: Correct. [00:28:28] Speaker 05: Because the priority teaches away from that. [00:28:30] Speaker 05: I mean, Patton teaches away from that. [00:28:32] Speaker 05: Patton wants to make sure we don't go deep enough to get to the artery. [00:28:36] Speaker 05: Right. [00:28:37] Speaker 05: So how do we know we're going to get to the bone in my hand? [00:28:42] Speaker 05: Because we know we don't want to go deep enough to get to the artery. [00:28:46] Speaker 00: Correct, but Samuels encompasses multiple blades and one of skill in the art would know to place the blocker as appropriate depending on the structure you're trying to reach. [00:28:56] Speaker 00: But to the same extent that one could, using Samuels blade, reach an artery that is below the surface of the skin and some tissue. [00:29:06] Speaker 05: So where do we teach the differing blades and all that stuff that you just mentioned? [00:29:12] Speaker 00: Well, there's no limitation on the length of the blade or on the position of the blocker, so... Well, the limitation is just cutting the skin. [00:29:19] Speaker 04: I mean, that's pretty clear. [00:29:21] Speaker 00: I disagree that it's clear that it is limited to just cutting and certainly not just going partway, as my counsel on the other side would suggest, and just going partially through the skin. [00:29:33] Speaker 00: I think it's quite clear that the only way you're going to get a catheter through, which is what it describes at the bottom of column four, [00:29:40] Speaker 00: Line 58 to 60 is to get through whatever tissue you need to skin subcutaneous tissue to get the catheter to where you need to get it. [00:29:57] Speaker 04: Is that really Samuelson? [00:30:00] Speaker 00: That is Samuelson, yes. [00:30:02] Speaker 00: Samuelson talks about a catheter at the bottom of the board. [00:30:05] Speaker 04: We're talking about the blade. [00:30:09] Speaker 04: You're talking about the depth of the cut in the blade. [00:30:12] Speaker 00: Right, and the depth of the cut of the blade has to be deep enough to get through whatever tissue you need to to get to the tubular structure you're trying to access. [00:30:23] Speaker 00: If the blade isn't long enough, you're not going to be able to make that hole that you need. [00:30:29] Speaker 04: So if I had to get to the bone on my thigh, are you saying that the Samuelson blade would help me do that? [00:30:38] Speaker 00: depends on where exactly which bone. [00:30:40] Speaker 04: I mean, I... No, my thigh, my thigh bone. [00:30:42] Speaker 04: Anywhere on my thigh. [00:30:43] Speaker 04: I got a big thigh. [00:30:46] Speaker 04: Anywhere on my thigh. [00:30:47] Speaker 00: Well, it might not access that, you know, I think that might not be a reasonable interpretation of Samuelson, but I think Samuelson fairly understood in the context of placing this blocker, it's simply to access things that are close to the skin. [00:31:01] Speaker 00: surface below the skin. [00:31:02] Speaker 00: But I think any blade that one would construct in keeping with Samuelson, one would also be able to reach bone. [00:31:09] Speaker 00: And I also submit along the lines of what Judge Clevenger was saying. [00:31:15] Speaker 00: I'm sorry. [00:31:15] Speaker 00: I'm at the end of my time. [00:31:16] Speaker 05: No, please go ahead. [00:31:17] Speaker 05: I wanted to come back to my question to you about where's the evidence in the record that there's a bone in the body that's close enough to the surface that by nicking the skin, and Judge Breena's hypothetical, you'll actually get to the bone. [00:31:33] Speaker 05: And you said, well, a common sense. [00:31:38] Speaker 05: Everybody knows, but that's not evidence. [00:31:42] Speaker 05: And your adversary, I thought, very candidly said, well, if there was evidence in the record that there's a bone in the body that can be reached by essentially a neck, he knew he'd have a much harder case. [00:31:55] Speaker 05: But there's no evidence like that in the record. [00:31:58] Speaker 00: Well, I disagree there's no evidence. [00:32:00] Speaker 00: Because again, I think the sandwich is fairly betrays. [00:32:03] Speaker 05: But we have to be able to get, this thing has to be capable of getting at a bone. [00:32:09] Speaker 05: That's the claim limitation, right? [00:32:12] Speaker 00: Correct. [00:32:13] Speaker 05: So the anticipatory reference has to show you're going to be able to get out of bone. [00:32:17] Speaker 05: Judge Brin has just pointed out that the anticipatory device isn't going to get to the bone in his thigh. [00:32:24] Speaker 05: The blocker is going to stop the short point from getting to that bone, whereas it could probably get to the bone in the back of my thumb, or in my head, or where's the other? [00:32:39] Speaker 00: In addition to what I've just laid out, I also would submit that at column three, it describes that the handle is of a length that a physician... What line on columns three? [00:32:50] Speaker 00: Lines two to three, and then again at lines 58 to 60, it describes the handle as being something that is held between the fingers of the surgeon. [00:33:02] Speaker 00: And looking to column at figure four, assuming that's drawn to scale, [00:33:09] Speaker 00: your fingers are used to grasp the handle. [00:33:13] Speaker 00: The blade is about half as long. [00:33:14] Speaker 00: It doesn't matter. [00:33:15] Speaker 04: I mean, you've got to hold the knife. [00:33:18] Speaker 04: If the surgeon doesn't hold it between his or her fingers, how's he going to hold the knife? [00:33:26] Speaker 00: That gives you an idea of the scale, because [00:33:29] Speaker 00: on figure four. [00:33:30] Speaker 00: If you can have a long handle. [00:33:32] Speaker 04: The handle is not in dispute here. [00:33:34] Speaker 04: The length of the handle doesn't matter. [00:33:36] Speaker 04: Even if he's got a hole with two hands. [00:33:40] Speaker 04: The question is the blade. [00:33:43] Speaker 00: Right, but figure four describes pictures of the blade and the handle. [00:33:48] Speaker 00: And the blade is about half as long as the handle. [00:33:51] Speaker 00: And column three describes the handle as being [00:33:58] Speaker 00: something that they could easily hold between their fingers. [00:34:01] Speaker 00: And so if the fingers can hold that blade, even at the smallest estimate of how long that blade. [00:34:07] Speaker 04: Look at figure 3A and 3B. [00:34:12] Speaker 04: There you have human hairs, I guess, on skin. [00:34:16] Speaker 04: And the hairs are longer than the blade. [00:34:19] Speaker 04: And obviously, the handle is way, way longer than both the blade and the human hairs. [00:34:25] Speaker 00: I think the blade is longer than the hairs. [00:34:28] Speaker 00: and hairs are quite long. [00:34:31] Speaker 04: But I'm just pointing that out to you. [00:34:34] Speaker 00: But I think there's certainly evidence in four that if it's something that's grasped between the fingers, fingers are perhaps, at a minimum, an inch. [00:34:44] Speaker 00: The handle could be longer. [00:34:47] Speaker 00: Then that blade is at least a half inch, and that is certainly enough. [00:34:51] Speaker 04: I mean, really, we're not saying that this is going to skip. [00:34:59] Speaker 00: One would expect that the blade and the handle would be drawn to scale. [00:35:05] Speaker 04: Where does it say that? [00:35:07] Speaker 04: You're saying that this is the size of the blade between the sandwich things? [00:35:13] Speaker 00: I mean, with respect to the blade, between the blade and the handle that there is, that they're drawn proportionally. [00:35:20] Speaker 00: The blade size and the handle size. [00:35:22] Speaker 05: Where is it saying that? [00:35:23] Speaker 00: One would just expect that they would draw them to size. [00:35:28] Speaker 04: Certainly the the instrument that is that really the view that we take in in figures and if they're drawn to That this is the life-size image of a Device for that it's drawn to size. [00:35:46] Speaker 04: I mean I see tractors drawn on here certainly I wouldn't be able to argue that The wheels got to be bigger than depicted on the tractor [00:35:57] Speaker 00: No, I'm not saying that it's drawn to size, but it's drawn proportionally so that the hand, the size of the handle and the size of the blade are drawn so that one gets, and it's probably much smaller than that and you still have a triangular shape right there. [00:36:10] Speaker 05: It's a conical blade. [00:36:14] Speaker 05: I can't really tell. [00:36:15] Speaker 05: Can you tell from the... It's a little bit wider. [00:36:17] Speaker 00: The blade's a little wider in the middle if you look at figure two and then it's narrower at the edges. [00:36:22] Speaker 00: Okay. [00:36:28] Speaker 05: Well, I still, I mean, I don't hear you. [00:36:30] Speaker 05: I haven't heard you to point to any evidence in the reference to prove that there is a bone in the body that is shallow enough that could be reached by the anticipated reference. [00:36:42] Speaker 00: I think the evidence is simply that one of skill and the art would appreciate from Samuels that the blocker could be placed at whatever distance [00:36:51] Speaker 00: would be appropriate to access whatever tubular structure you're trying to access below the span. [00:36:56] Speaker 04: Show me what independence is that, that the blocker is adjustable like that. [00:37:05] Speaker 05: Well, you're drawing an inference from what you quoted earlier in column one at lines 56, 7, 8, 9. [00:37:14] Speaker 05: Correct. [00:37:15] Speaker 05: You're saying that if the purpose of this particular invention is to make certain you never go deep enough, [00:37:21] Speaker 05: to damage structure. [00:37:23] Speaker 05: Correct. [00:37:24] Speaker 05: And so the operating surgeon, and you claim that this device is capable of being adjusted in different depths and sizes, if a surgeon is operating in a particular area, he knows he doesn't want to go any deeper than X because it hits structure. [00:37:38] Speaker 05: Correct. [00:37:39] Speaker 05: But he knows he can go to whatever depth he needs to go to so long as he hasn't hit structure. [00:37:44] Speaker 05: And so if he's in a situation where there is a bone, if there is one in your body that's very close, [00:37:49] Speaker 05: and he needs to nick the skin to get the catheter in, he can use this device because he can be assured that he isn't going to go deep enough to hit the structure. [00:37:59] Speaker 05: Correct. [00:37:59] Speaker 05: That's what you draw out of one. [00:38:03] Speaker 05: But still, it doesn't tell you anything about where the bone is. [00:38:07] Speaker 00: Samuels doesn't, but I think the examiner's view [00:38:12] Speaker 00: is that that's something that one of skill in the art would appreciate, and one lay person even, that in certain places like here, they're very close. [00:38:19] Speaker 05: And to the extent your... Is the examiner's credibility in any way impaired by the prick, prick, prick example that he used, which I think we all agree is wrong? [00:38:29] Speaker 04: Nick, Nick, Nick. [00:38:30] Speaker 05: Nick, Nick, Nick. [00:38:33] Speaker 05: That was... Do you have an examiner who's wrong half the time? [00:38:37] Speaker 05: means we should validate what the examiner says on the other hand? [00:38:41] Speaker 00: I mean, I don't think the nick-nick-nick procedure is totally crazy because it's understood in the art that, and if you look to even Samuel's, but that when you insert the blade, the skin falls apart. [00:38:55] Speaker 04: Why would a surgeon use a different scalpel? [00:38:58] Speaker 04: Instead of nick-nick-nicking, sitting there nicking away [00:39:02] Speaker 04: to get to the bone of a little bitty blade. [00:39:04] Speaker 04: I mean, even when I cut steaks, I know where to use a little blade and a big one. [00:39:11] Speaker 00: But this is to a device, to a product. [00:39:14] Speaker 00: And the issue is, and this court's case law is always held, that simply a new use for an old device does not make it patentable. [00:39:28] Speaker 01: Thank you. [00:39:41] Speaker 03: Thank you, your honor. [00:39:42] Speaker 03: I'll just make a couple of brief points here. [00:39:47] Speaker 03: I thought I heard counsel say something about losing the device in Samuels to make a deep enough nick to install a catheter. [00:40:00] Speaker 03: That's not Samuels. [00:40:04] Speaker 03: The catheter, the handle in Samuels and the blade [00:40:10] Speaker 03: have a cannulation down the middle. [00:40:13] Speaker 03: And the tool follows the cannulation down to the skin. [00:40:18] Speaker 03: That's what's happening here. [00:40:20] Speaker 05: But the idea is to make a big enough hole in the skin to allow whatever it is you're passing through to get through. [00:40:25] Speaker 03: Whatever you use, Your Honor, it ain't Samuels. [00:40:30] Speaker 03: To make that hole. [00:40:32] Speaker 05: That's what Samuels talks about concerning the catheter. [00:40:35] Speaker 03: But Samuels doesn't say he uses that device that he's using. [00:40:40] Speaker 03: in order to make the hole to install the guide wire. [00:40:44] Speaker 03: That's what I'm saying. [00:40:48] Speaker 05: Well the guide wire went in early. [00:40:50] Speaker 03: Exactly, exactly. [00:40:52] Speaker 05: How do you do that? [00:40:55] Speaker 05: They show a picture here of a knee and the knee has a hole in both of the knee bones, pre-existing hole, and a wire is threaded through [00:41:08] Speaker 05: the bone and the wire comes out through the skin and then they use that guide wire to know where to make the prep. [00:41:14] Speaker 05: It seems to me like they've got that cart in front of the horse. [00:41:17] Speaker 03: If I can borrow from other things I've done for this orthopedic surgeon, you usually have some kind of suture pin or [00:41:32] Speaker 03: or guide wire leading pin, and you install it with a tool that sends the guide wire to the place you want it to be fastened or where, even if you want to make it go through the skin. [00:41:47] Speaker 05: I was trying to make a hole in the skin to get it there. [00:41:50] Speaker 03: But you have another tool to use it. [00:41:52] Speaker 03: You're not using this dermatology instrument to install the guide wire. [00:41:57] Speaker 05: That's what I couldn't understand, because I figured you had to make a pretty big hole in the skin [00:42:01] Speaker 05: to get on there and drill holes in the bone to have the wire go through the holes. [00:42:05] Speaker 05: So why are you worrying about making a tiny little crack after you've opened the skin up big enough to do the drilling? [00:42:12] Speaker 03: I sure agree with you, Your Honor. [00:42:14] Speaker 03: You've got to use something big enough to get that guide wire fastened in place. [00:42:20] Speaker 03: The other thing I wanted to just quickly mention is in the Schreiber case, the majority [00:42:31] Speaker 03: points out to the minority. [00:42:35] Speaker 03: I think Judge Newman was the one who wrote the dissent. [00:42:38] Speaker 03: And I've forgotten who wrote the opinion of the court. [00:42:45] Speaker 03: In Schreiber, the devices were a cone to shake popcorn out of a few kernels at a time. [00:42:54] Speaker 03: And in the Hart's pet, which was the prior art alleged anticipation, it was a spout. [00:43:00] Speaker 03: that went on an oil can. [00:43:03] Speaker 03: And they were the same size and same shape and same everything. [00:43:06] Speaker 03: And that's why Schreiber says it's not patentable to try to cover a new use for an old structure. [00:43:16] Speaker 03: That's not this case. [00:43:18] Speaker 03: You've got to get rid of that blocker. [00:43:19] Speaker 03: You've got to make the blade longer. [00:43:23] Speaker 03: You've got to do all kinds of things with the tool. [00:43:27] Speaker 03: And so Schreiber [00:43:29] Speaker 03: Well, the court has said many times that you can't base an anticipation on hypotheses or conjectures, and you don't. [00:43:43] Speaker 03: And so the Schreiber case, I agree with the Schreiber case. [00:43:50] Speaker 03: I'd rather like it, but in its context, it doesn't apply here. [00:43:55] Speaker 03: Thank you. [00:43:56] Speaker 01: We thank both sides, and the case is submitted.