[00:00:00] Speaker 02: Our next case for argument is 21-1149, Blefax v. Myco Industries. [00:00:06] Speaker 02: Mr. Lurie, please proceed. [00:00:10] Speaker 03: Good morning, Your Honors. [00:00:11] Speaker 03: This is Tom Lurie on behalf of Myco and John Choate. [00:00:16] Speaker 03: Today, we're here asking the Court to vacate an improvidently issued preliminary injunction. [00:00:24] Speaker 03: In our brief, we've raised three issues. [00:00:27] Speaker 03: Today, I want to focus primarily on the issue of validity. [00:00:33] Speaker 03: Lefax did not meet its burden to show that MICO's validity challenge lacks substantial merit, which is the standard it had to meet. [00:00:43] Speaker 03: There's one reference. [00:00:44] Speaker 01: Counsel, can I just interrupt you for a second? [00:00:46] Speaker 01: I'm sorry, but I want to make sure, as a threshold matter, you raised three issues [00:00:51] Speaker 01: None of which relate to the other three factors for preliminary injunction analysis, right? [00:00:58] Speaker 01: Likelihood of success on infringement, public interest balancing of interest. [00:01:05] Speaker 01: You really just are putting most of your eggs in this basket as well as the fact that you claim there was an upsetting of the status quo. [00:01:17] Speaker 03: Yeah, and an over-broad injunction. [00:01:19] Speaker 03: Yes, Your Honor, that is correct. [00:01:21] Speaker 01: Okay. [00:01:21] Speaker 03: Okay. [00:01:22] Speaker 01: And the law is... Make sure where our focus is. [00:01:25] Speaker 03: Yes, thank you. [00:01:26] Speaker 03: And the law is, and it's not disputed, that if the validity of the patent is in question, the preliminary injunction should not issue. [00:01:35] Speaker 01: So the other fact is... I don't think that's a fair statement of the law. [00:01:38] Speaker 01: I mean, it's pretty clear it has to be more than just in question, right? [00:01:42] Speaker 03: I'm sorry. [00:01:43] Speaker 03: I didn't mean to suggest that [00:01:46] Speaker 03: That just a mere question was enough. [00:01:49] Speaker 03: My point was that if there's a substantial question on the issue of validity, that defeats the preliminary injunction request, is what I was trying to say. [00:02:00] Speaker 01: Okay. [00:02:00] Speaker 01: On this question, you agree, I assume, that what a prior AHRQ reference shows is a question of fact, right? [00:02:12] Speaker 03: Correct. [00:02:13] Speaker 01: So to the extent that the [00:02:15] Speaker 01: the court analyzed, uh, what the prior art, uh, showed what I don't even know how to pronounce this Nishamon. [00:02:24] Speaker 01: Is that how you pronounce that? [00:02:26] Speaker 01: I pronounce it Nickamon, but Nickamon showed the prior, the district court's conclusions about what it showed. [00:02:35] Speaker 01: We would have to find to be clearly erroneous to disagree with the district court's conclusions on that point. [00:02:43] Speaker 01: Right. [00:02:45] Speaker 03: Yes, to the extent that there would be fact issues that are disputed such as that, that would be true. [00:02:54] Speaker 03: But here, the district court's fact findings in terms of the key fact findings are really fact findings that favor a resolution in Michael's favor. [00:03:07] Speaker 03: It's his legal conclusion or his [00:03:12] Speaker 03: is failure to apply the right legal test for anticipation and obviousness that we take up as the primary issue. [00:03:25] Speaker 01: So you don't dispute the district court's characterization of Figure 3 in Neekman? [00:03:37] Speaker 03: I guess that's a broad question, but his characterization, let me be specific, his characterization of Figure 3 is that it's an electromechanical device that dispenses, and this is from Appendix 26, dispenses the micro abrasive and oil to any appropriate material such as an applicator slash device slash wand. [00:04:00] Speaker 03: We agree with that. [00:04:01] Speaker 03: That's exactly what figure three shows. [00:04:04] Speaker 01: Well, here's the issue. [00:04:06] Speaker 01: You don't really address paragraph 83, and yet you have to go back to paragraph 66 that states that the composition may be dispensed in any way, and then it refers to the dispensing or the applicator in two different ways. [00:04:30] Speaker 01: Paragraph 83 actually then refers back to that. [00:04:38] Speaker 01: So in order for there to be anticipation, one would have to conclude that what was being shown in Figure 3 is not what was being [00:04:54] Speaker 01: dispensed, but what it was being dispensed by, not where it was being dispensed to, in other words. [00:05:02] Speaker 03: Well, excuse me, paragraph 83 is a relevant paragraph, but it's not the primary focus of our analysis or argument. [00:05:14] Speaker 03: It's paragraph 65 and 66. [00:05:17] Speaker 01: The district court focused on paragraph 83. [00:05:20] Speaker 03: It did. [00:05:21] Speaker 03: It did. [00:05:22] Speaker 01: And there's nothing wrong with that focus. [00:05:25] Speaker 01: The applicator referred to in paragraph 83 would have to be the thing dispensing the composition, not the thing to which the composition is being dispensed. [00:05:33] Speaker 01: And the district court found, as a matter of fact, that paragraph 83 didn't satisfy. [00:05:40] Speaker 01: I mean, that figure three didn't show what you thought it did. [00:05:45] Speaker 03: Well, figure three doesn't show a swab on the end of the [00:05:52] Speaker 03: of the applicator, if that's the question you're asking. [00:05:56] Speaker 03: And we don't disagree with that. [00:06:01] Speaker 03: We're not saying that Figure 3 shows that. [00:06:02] Speaker 03: What we're saying is the description of Figure 3 in conjunction with Figure 2 and the other paragraphs that relate to those figures disclosed to one of ordinary skill in the art who's a medical doctor or doctor of autometry with some years of experience in treating these things. [00:06:22] Speaker 03: that the figure three device can be used with a figure two wand. [00:06:30] Speaker 03: Figure two is called a wand, and it's undisputed that it has a swab. [00:06:34] Speaker 03: And the district court found that figure three shows the handheld device dispensing the micro abrasive in oil to any appropriate material such as an applicator slash device slash wand. [00:06:49] Speaker 03: And our position is, [00:06:52] Speaker 03: that when you read Nickerman's express disclosures, that a wand is one of the things that figure three's handheld device can dispense onto. [00:07:04] Speaker 03: And the only description of wands in Nickerman is with respect to figures one and two, both showing wands with thwabs. [00:07:15] Speaker 03: But that is an express disclosure and anticipatory disclosure. [00:07:21] Speaker 01: of using the... So you are expressly disagreeing with the factual conclusion that the applicator referred to in paragraph 33 would have to be the thing dispensing the composition, not the thing to which the composition was being dispensed, right? [00:07:39] Speaker 01: I mean, we'd have to find that that conclusion by the district court is clearly erroneous for the reasons that you're saying. [00:07:48] Speaker 03: Well, to the extent that [00:07:50] Speaker 03: So, paragraph 83 is talking about a kit that is sold. [00:07:59] Speaker 03: And it's explaining that among the things that can be sold in the kit is an applicator and it gives and it says that applicator EG pad or swab. [00:08:11] Speaker 03: It's not specifically referring to paragraph 65 or figure 3 or even figure 2 necessarily. [00:08:20] Speaker 03: Um, but so it's, it's not clear to me that that is a relevant, I agree that, you know, he said that, but it's not particularly relevant to the question before the court because whether or not the kit has an applicator that's a swab doesn't address the disclosures in Nickaman that [00:08:46] Speaker 03: that I talked about in paragraph 65 and 66 in the district court's findings regarding those. [00:08:52] Speaker 01: Well, you would agree that paragraph 66 states that the composition can be dispensed in different ways, and it refers to it in two different forms, is from an applicator or to an appropriate material such as an applicator, right? [00:09:09] Speaker 03: Right. [00:09:09] Speaker 03: So it says the material may be dispensed in any way and to any appropriate material. [00:09:16] Speaker 03: So in both sentences, say a wand is one of those ways or materials. [00:09:26] Speaker 03: So again, we're back to the point that a wand is something that may be used to dispense and is also a material that can be used to dispense. [00:09:40] Speaker 03: And that's what the district court found and we agree with that. [00:09:43] Speaker 03: And again, going back to figures one and two, the description of the wand has a swab on it. [00:09:52] Speaker 03: And there's also paragraph 79 that says any of these methods. [00:09:56] Speaker 01: Council, if figure three dispenses onto a wand, how would that possibly anticipate? [00:10:06] Speaker 03: If it dispenses onto a wand, how would it anticipate? [00:10:09] Speaker 03: Because then you have the combination that's [00:10:11] Speaker 03: that Bluff-X says is missing. [00:10:13] Speaker 03: You have an electromechanical device with an operably attached swab. [00:10:23] Speaker 03: I see my time is up and I'm in my rebuttal time. [00:10:26] Speaker 03: I'm happy to answer further questions. [00:10:29] Speaker 02: Thank you, counsel. [00:10:30] Speaker 02: Let's hear from Mr. Armenio, please. [00:10:34] Speaker 00: Thank you, Chief Judge Moore. [00:10:36] Speaker 00: And may it please the court here [00:10:38] Speaker 00: The district court had full briefing, full hearing for the preliminary injunction and then had a motion for reconsideration, a motion to adjust the preliminary injunction and a further hearing. [00:10:52] Speaker 00: The district court gave Michael every opportunity and came out with the findings that each of the four preliminary injunction factors all strongly favored full effects. [00:11:03] Speaker 00: We respectfully submit that the preliminary injunction should be affirmed. [00:11:08] Speaker 00: With respect to the particular issue that counsel has focused on in this argument, I think Judge O'Malley's question is the light to the heart of the matter. [00:11:19] Speaker 00: Michael would need to show a clearly erroneous finding of fact to succeed on their current argument. [00:11:27] Speaker 00: They have not done so and they cannot do so. [00:11:31] Speaker 00: Judge O'Malley has pointed out there is a big difference between what the abrasive [00:11:38] Speaker 00: composition is dispensed by versus what it is dispensed to. [00:11:43] Speaker 00: And we know from Michael's own brief that they say the micro abrasive composition is the essence of the nicotine invention. [00:11:52] Speaker 00: They say that in their own brief. [00:11:54] Speaker 00: And so even if we look at what is dispensed by or what it is dispensed on to, there is no [00:12:03] Speaker 00: suggestion of combining the figure two swab and the figure three handheld applicator. [00:12:12] Speaker 01: What's your response? [00:12:14] Speaker 01: Your friend on the other side just at the end there said that figure three dispenses onto a wand, and so therefore it anticipates. [00:12:24] Speaker 01: So he says the opposite of what you're just saying. [00:12:30] Speaker 00: Right. [00:12:31] Speaker 00: What I would respectfully suggest is that there would be no reason to have a double dispenser, right? [00:12:39] Speaker 00: There's nothing in the Nickerman reference that says you would need to dispense it from a handheld applicator, then dispense it onto another applicator, a swab of some kind, and then, as a third step, touch the eye. [00:12:55] Speaker 00: Would there be no reason for a handheld dispenser [00:12:58] Speaker 00: to just then dispense it onto a swab and then the swab dispenses it onto the eye. [00:13:04] Speaker 00: Moreover, that does not even get close to discussing the actual method of Claim 16, where the swab has to be moved [00:13:15] Speaker 00: relative to the electromechanical device in claim 16, and then the swab has to contact the eyelid margin to contact and impact the removable debris to clear the eyelid margin. [00:13:29] Speaker 00: There are multiple parts of the claim that even if there were a mere combination, would still not be reached in this method of treatment claim. [00:13:42] Speaker 00: So when we look at [00:13:44] Speaker 00: The NICOMIN, I think one thing I would also note from NICOMIN is NICOMIN itself points out, for example, in paragraph 60, that Appendix 1447, that you need to, quote, be minimizing unnecessary abrasion, damage, or irritation to the eye region or sensitive periocular region, close quote. [00:14:10] Speaker 00: So even NICOMIN, [00:14:11] Speaker 00: in the reference itself is saying be careful. [00:14:15] Speaker 00: Your eyelid margin is sensitive. [00:14:17] Speaker 00: Don't irritate it. [00:14:18] Speaker 00: Don't unnecessarily abrade it. [00:14:21] Speaker 00: Michael has admitted that this micro abrasive composition is the essence of nicotine, but they're trying to combine nicotine in a way [00:14:31] Speaker 00: that the examiner in issuing the 087 found would not apply for algebra and swab because of the danger, safety danger to the eye region and pointed to the pink point IPR decision in the related 718 application, excuse me, patent where the PTAB reached the same conclusion that there are serious safety concerns about having moving [00:15:00] Speaker 00: swab or moving anything near the aisle. [00:15:04] Speaker 00: And Nicomene itself acknowledges that. [00:15:07] Speaker 00: So even if counsel for Michael could convince this court that there was a clearly erroneous finding of fact by the district court, which Blackfax would respectfully submit it cannot do, there are still other aspects of the claim that cannot be reached, that are not reached by Michael's argument. [00:15:26] Speaker 00: And there is the overriding concern about safety near the island margin that Michael has never addressed, that Nickerman acknowledges, that the examiner acknowledged in granting the 087, that the PTAB acknowledged in the 718 patent in the same family, and that the district court noted... [00:15:49] Speaker 02: Judge Moore, I'm just confused. [00:15:51] Speaker 02: I'm not following your argument. [00:15:53] Speaker 02: It doesn't track with the briefing that I read. [00:15:55] Speaker 02: Where is all this coming from? [00:15:56] Speaker 00: I apologize, Judge Moore. [00:16:03] Speaker 00: I was trying to respond to what I thought was the question. [00:16:07] Speaker 00: And it was, is this combinable? [00:16:10] Speaker 00: And my answer was no. [00:16:13] Speaker 00: And then I was asked, well, what if it could be combined? [00:16:15] Speaker 00: Is there anything more in the patent? [00:16:18] Speaker 00: And I was pointing to the remainder of claim 16, which is what we point to on page 23 of our brief. [00:16:28] Speaker 00: For example, we show that, [00:16:31] Speaker 02: Council, are you focusing on obviousness? [00:16:34] Speaker 02: I mean, I'm sorry. [00:16:36] Speaker 02: I thought that we were focusing on anticipation. [00:16:38] Speaker 00: Yes, I'm trying to focus on anticipation, Your Honor. [00:16:47] Speaker 00: And what I'm saying is, in connection with anticipation for MICO, even if they could combine the two pieces, as they suggest, which we dispute, [00:16:58] Speaker 00: it would still not anticipate the method of treatment claim 16. [00:17:17] Speaker 00: So moving forward, Michael has not been able to identify any clearly alonious finding of fact by the district court. [00:17:29] Speaker 00: They don't make any other argument. [00:17:33] Speaker 00: The only last thing I would point out is that the argument by Michael in its briefing about at once envisioning certain features is an argument they did not present. [00:17:49] Speaker 00: in the district court and an argument they did not make in their opening appellate brief. [00:17:56] Speaker 00: And so we believe that is an argument that comes too late. [00:18:01] Speaker 00: And it's certainly also an argument that is rebutted by both the Nickerman reference itself and the Parabat 87 generalities that they point to and also the examiners [00:18:18] Speaker 00: use of nicotine in searching, consideration of nicotine, and no finding that nicotine disclosed the claims method of treatment. [00:18:28] Speaker 01: Counsel, you referred to a sign or a stopple in your brief, but isn't there a problem with the fact that the district court never made any findings on that? [00:18:38] Speaker 01: And what we're supposed to be reviewing now is the district court's weighing of the preliminary injunction factors. [00:18:46] Speaker 01: So I don't see how we could [00:18:49] Speaker 01: put that into the mix at this point, could we? [00:18:52] Speaker 01: I'm putting it inside the expert suit. [00:18:58] Speaker 00: Understood. [00:18:58] Speaker 00: Thank you, Your Honor. [00:19:00] Speaker 00: Your Honor is 100% correct that district court did not reach that issue at all. [00:19:04] Speaker 00: It's an argument that we made below. [00:19:06] Speaker 00: We have stated it merely in the alternative, but Your Honor is 100% correct that the judge only made one factual finding that's relevant and [00:19:22] Speaker 00: is related to the 275 application that is the subject of the assignment. [00:19:30] Speaker 00: So the district court did make that factual finding, but there was no further discussion by the district court of the assigner estoppel doctrine. [00:19:39] Speaker 00: That factual finding that the 087 patent is related to the 275 application that was assigned [00:19:48] Speaker 00: would be reviewable by the court. [00:19:50] Speaker 00: But again, I 100% agree that's the only finding that the district court made relevant to a sign or stopple. [00:19:58] Speaker 02: Council, when it comes to anticipation, do you agree there would be a substantial question if Figure 3 rather than having what looks like a straw actually had a swab on the end of it? [00:20:17] Speaker 00: It would depend, Your Honor, in my view, on what the swab was doing, right, because it isn't just buffering, if you will, or padding the end of the applicator so you don't hit. [00:20:34] Speaker 02: What if it was vibrating, rotating, rubbing, or otherwise moving? [00:20:44] Speaker 00: If there was a disclosure of a swab that was spinning and the swab itself was designed to impact the debris on the eye and remove it, then that would be much different than what we have before us here. [00:20:59] Speaker 00: And that would be closer, certainly. [00:21:03] Speaker 00: But what we found here, [00:21:05] Speaker 00: is the examiner and the district court and the PTAP and the related 718 patent IPR all found that you wouldn't combine that and things and the reason you wouldn't combine it is for safety concerns and I would respectfully suggest that when there's safety concerns the person of ordinary skill in the art does not envisage [00:21:28] Speaker 00: things that are unsafe, and this would be a subject for which if Michael wanted to really press this argument, there needed to be some kind of... Council, you keep referring to this other IPR and safety concerns. [00:21:43] Speaker 02: Was the Niekomen reference the reference at issue here that maybe anticipates part of that IPR? [00:21:50] Speaker 00: Nickerman was not the subject of the discussion in the IPR. [00:21:54] Speaker 00: What was the discussion in the IPR was an electromechanical drive, the algebra brush, and a swab as well. [00:22:03] Speaker 00: So when we look at the swab as disclosed in, for example, Stevens, and so what we have is not Nickerman in the pink point IPR, but what we have is the concept of a swab [00:22:17] Speaker 00: which in one reference in the IPR was held in a person's hand and gently applied to the eyelid versus an electromechanical drive like the Alger brush. [00:22:28] Speaker 00: And what the PTAP discussed and what the examiner in issuing the 087 patent referenced in their Notice of Allowance, which we see at Appendix 294, the examiner in this patent, the 087, referencing [00:22:43] Speaker 00: the lack of motivation and rationale from that pain point IPR, what we see is that didn't make sense to the examiner, and they said a person of ordinary skill and the art would not do it. [00:23:01] Speaker 02: Okay, counsel, let's hear from the opposing side. [00:23:07] Speaker 02: You have some rebuttal time left, Mr. Lurie. [00:23:10] Speaker 03: Yes, thank you. [00:23:12] Speaker 03: Let me take up the first point that Mr. Arminio made, which is that there's no suggestion of combining in Nickaman. [00:23:21] Speaker 03: Paragraph 79 specifically says, any of these methods of applying the compound may be combined with any other method. [00:23:31] Speaker 03: And the only three figures that come before that are figures one, two, and three, which specifically show figures one, figure one shows [00:23:41] Speaker 03: a hand holding a wand that on its tip has a swab. [00:23:48] Speaker 03: And Nickerman says that's chafing the eyelid margin. [00:23:52] Speaker 03: Figure two shows a wand with a swab on the tip as well. [00:24:00] Speaker 03: It doesn't indicate what's holding it or what's moving it, but it also says it's moving it and chafing. [00:24:07] Speaker 03: And then figure three shows the handheld device [00:24:10] Speaker 03: that Nickerman says is chafing the eyelid margin the same way. [00:24:15] Speaker 03: So the chafing method, and each of them is applying the compound, are combinable. [00:24:22] Speaker 03: And Nickerman expressly says that in paragraph 79. [00:24:25] Speaker 03: Mr. Arminio said there'd have to be a double dispenser. [00:24:30] Speaker 03: I don't understand that statement because if figure two is attached to [00:24:37] Speaker 03: the handheld device of Figure 3, which it very well could be. [00:24:41] Speaker 03: There is no double device that's necessary. [00:24:45] Speaker 01: Well, very well could be. [00:24:47] Speaker 01: Very well could be. [00:24:48] Speaker 01: Is it the standard for anticipation? [00:24:49] Speaker 01: I mean, it has to disclose every single element. [00:24:54] Speaker 03: It does. [00:24:54] Speaker 03: It does. [00:24:55] Speaker 03: But again, we don't have to prove invalidity here. [00:24:58] Speaker 03: We just need to raise a substantial question. [00:25:01] Speaker 01: I know. [00:25:01] Speaker 01: You have to prove the [00:25:03] Speaker 01: The patentee has to prove by a preponderance of the evidence that you're not likely to win by clear and convincing evidence. [00:25:14] Speaker 01: So I mean, Tight and Tire makes it very clear that it's not just a question of you saying we're asserting invalidity. [00:25:21] Speaker 02: Okay, hold on. [00:25:21] Speaker 02: Can I just correct Judge O'Malley? [00:25:23] Speaker 02: Because this is fun and I never get to correct her. [00:25:25] Speaker 02: Actually, what you have to approve since this is on appeal is the district court clearly erred in finding the contrary. [00:25:32] Speaker 01: Better yet. [00:25:33] Speaker 01: Better, even better. [00:25:36] Speaker 03: Well, and I hate to weigh into this too, but in Amazon, for example, the test was stated as [00:25:46] Speaker 03: The patent owner has to prove that invalidity lacks substantial merit. [00:25:51] Speaker 03: And that's the pages. [00:25:53] Speaker 01: Yeah, but the Titan Tire is the clearest description of the methodology that's to be employed and how the law works. [00:26:01] Speaker 01: And Titan Tire makes it clear that that's not enough. [00:26:06] Speaker 03: It's not enough. [00:26:08] Speaker 03: Well, we don't have to prove invalidity as a matter of law. [00:26:13] Speaker 01: We just have to show that there's a substantial question and that there's a... You have to raise a question and then the burden shifts to the patent holder to show by a preponderance of the evidence that you're not likely to prevail ultimately at trial where your burden would be clear and convincing evidence. [00:26:35] Speaker 01: And that's what the district courts found by a preponderance of the evidence was shown. [00:26:40] Speaker 03: It did. [00:26:40] Speaker 03: And that's the, that's the error we believe based on this undisputed record effectively, the record itself. [00:26:46] Speaker 03: I mean, if you read neck them in, it's, it's not unclear what it says. [00:26:49] Speaker 03: I mean, this is a case very much like blue Calypso where, um, the, the reference there was Paul P a U L and, and the court said the board then recognized that although Paul did not explicitly disclose an example of a particular campaign, it was about a piece of software. [00:27:08] Speaker 03: that uses campaigns and refer a friend campaign tools together, it did contemplate combining the disclosed functionalities, and it pointed to what Blefix calls the boilerplate. [00:27:20] Speaker 03: It was a much broader boilerplate than paragraph 79. [00:27:23] Speaker 03: It basically said, you know, if there's hardware or software, anybody could use it. [00:27:28] Speaker 03: And that was enough, and that is enough. [00:27:31] Speaker 03: Now, again, we're not saying we absolutely win on that, but that is good enough for a reasonable jury [00:27:38] Speaker 03: to find in our favor, and that's the standard at this stage. [00:27:43] Speaker 03: If you read Amazon, Blue Calypso, that's the standard we have to meet that could a reasonable jury find in our favor. [00:27:50] Speaker 03: And absolutely, under this law, a reasonable jury could find that Nickaman anticipates Claim 16. [00:27:59] Speaker 03: Now, the last thing I want to take up very briefly is the safety concept. [00:28:03] Speaker 03: Nickaman addresses safety, and it says his [00:28:07] Speaker 03: treatment is safe and even chafing is safe. [00:28:11] Speaker 03: I guess my time is up and I'll end there if there are no other questions. [00:28:15] Speaker 02: I thank both counsel for their argument. [00:28:16] Speaker 02: The case is taken. [00:28:17] Speaker 02: Thank you, Your Honor. [00:28:20] Speaker 02: The Honorable Court is adjourned until this afternoon at 2 p.m.