[00:00:00] Speaker 02: Our final case this morning is Idre Adami, 2024, 1218. [00:00:06] Speaker 02: Mr. Hyde. [00:00:09] Speaker 01: Good morning, Your Honors, and if it pleases the court. [00:00:15] Speaker 01: My name is Marty Hyde, and I represent the patent applicant in this case, Dr. F10 Adami. [00:00:21] Speaker 01: And I'm trying not to take it personally that I cleared out the courtroom. [00:00:27] Speaker 01: This case is about the patent bargain [00:00:30] Speaker 01: And that patent bargain says that any person skilled in the art should be able to make use and operate an invention that's in a patent. [00:00:42] Speaker 01: There's no dispute that that person skilled in the art, in this case, are medical doctors. [00:00:47] Speaker 02: Counsel, please listen to questions rather than keep your mouth shut. [00:00:52] Speaker 02: I focused on your brief. [00:00:56] Speaker 02: The law requires enablement, and it has an application. [00:00:59] Speaker 02: It does. [00:01:00] Speaker 02: And it requires enablement consistent with the scope of a claim. [00:01:05] Speaker 02: And here, we have a claim which encompasses a variety of alcohols, some of them toxic. [00:01:17] Speaker 02: One of them, ethylene glycol, is essentially antifreeze. [00:01:21] Speaker 02: And basically, your specific disclosure is one anecdotal instance of a person brought into an emergency room [00:01:31] Speaker 02: and treated and then two years later he's found to be free of HIV. [00:01:40] Speaker 02: That's not an enabling disclosure of a claim of this breadth. [00:01:45] Speaker 01: So thank you, Judge Laurie. [00:01:49] Speaker 01: Let me try to unpack your question. [00:01:51] Speaker 01: First of all, as far as toxicity goes, toxicity should not be a determination factor whether it's enabled or not. [00:01:59] Speaker 01: There are many materials that are used in medicinal cases that are highly toxic. [00:02:04] Speaker 01: For example, toxol is a medicine that's patented and has been on the market for over 20 years. [00:02:13] Speaker 01: It's highly toxic, but it's also used to treat breast cancer and other types of cancers. [00:02:21] Speaker 02: But there isn't a disclosure in the application of dosages for these various alcohols. [00:02:29] Speaker 01: Well, so again, [00:02:33] Speaker 01: The person having ordinary skill in the art is critical here. [00:02:36] Speaker 01: This is a patent written by a doctor for other doctors, for other medical professionals. [00:02:42] Speaker 01: And yes, the anecdotal example that you mentioned [00:02:46] Speaker 01: is just anecdotal. [00:02:47] Speaker 01: And it was placed in the specification merely as background, not as a working example of the application. [00:02:57] Speaker 02: It might have been better off without it. [00:02:59] Speaker 01: Yes, exactly, Your Honor. [00:03:01] Speaker 02: And limiting your claim to ethanol. [00:03:05] Speaker 01: Well, we could limit the claims to ethanol. [00:03:09] Speaker 01: But Dr. Adami, in his professional opinion, [00:03:12] Speaker 01: felt that some of the other alcohols that are in that same series would also be useful in treating HIV virus. [00:03:20] Speaker 02: Well, there's a big difference between ethanol and ethylene glycol and methanol. [00:03:27] Speaker 01: Actually, not really, your honor. [00:03:29] Speaker 02: Ethylene glycol has- You wouldn't drink methanol tonight. [00:03:33] Speaker 01: Well, methanol is toxic. [00:03:35] Speaker 01: So is taxol. [00:03:36] Speaker 01: Ethanol is toxic in high doses, and ethylene oxide is toxic in high doses. [00:03:45] Speaker 01: But all those materials are alcohols. [00:03:49] Speaker 00: But the board's conclusions, I thought, were driven by the fact that there's no guidance as to what the amount of which alcohol and for what duration to use. [00:04:01] Speaker 00: There's none of that information. [00:04:03] Speaker 00: Are they wrong about that? [00:04:06] Speaker 00: Are we missing something? [00:04:07] Speaker 01: I think that's where the person having an ordinary skill in the art here is extremely advanced. [00:04:17] Speaker 00: In order to go your way, we have to accept your assertion that a person skilled in the art would have known what amount of which alcohol and for what duration to use it. [00:04:30] Speaker 01: So Your Honor, you don't have to accept what I say. [00:04:35] Speaker 01: You just have to look at the claims. [00:04:37] Speaker 01: And the patent office, actually, their best argument is one raised by the examiner. [00:04:43] Speaker 01: And he said, well, I believe it was a he, that the claim doesn't say when to stop, right? [00:04:51] Speaker 01: When to stop the treatment. [00:04:53] Speaker 01: Well, I'm not the sharpest tack in the box, but if I had HIV, I'd want that viral load to be zero. [00:05:01] Speaker 01: And I'm sure a person having ordinary skill in the art, a medical doctor, would know when to stop the treatment at an acceptable HIV load. [00:05:11] Speaker 01: And the HIV load is easily measured. [00:05:15] Speaker 01: In fact, the [00:05:18] Speaker 01: The PTAB's reference SINAT uses PCR to determine viral loading. [00:05:24] Speaker 01: So even the patent office has agreed that it's easy, not easy, but it's part of the art to be able to understand what the viral load is. [00:05:37] Speaker 04: So your position is that someone skilled in the art would just know and they don't need working examples and they will just continue to try and the person [00:05:46] Speaker 01: I apologize. [00:05:51] Speaker 01: I'm hard of hearing. [00:05:52] Speaker 01: So if you could speak up. [00:05:54] Speaker 04: It seems to me that your position is, well, a person skilled in the arts would know when to stop with the doses, despite the fact that there are no working examples, even if knowing when to stop might be when the patient expires. [00:06:10] Speaker 04: That sounds kind of crazy to me. [00:06:13] Speaker 01: So that brings up two points. [00:06:15] Speaker 01: A patent does not have to guarantee results. [00:06:19] Speaker 01: Paxil is patented, but people still die from breast cancer. [00:06:24] Speaker 04: The other thing that the premises that a person having... They died from breast cancer because they weren't cured or because they took too much Paxil. [00:06:34] Speaker 01: because they were not cured. [00:06:36] Speaker 01: In this case, a patent does not have to guarantee results. [00:06:44] Speaker 01: It just sets out, as Judge Lurie mentioned, that it has to be enabled. [00:06:52] Speaker 01: A person that it's designed for has to be able to carry out the invention. [00:06:57] Speaker 01: And the Patent Office [00:06:59] Speaker 01: didn't point out a single step, a single step, that a person having ordinary skill in the art could not carry out. [00:07:09] Speaker 01: Their determination was conclusory. [00:07:13] Speaker 01: They looked at the whole invention and said, this doesn't work. [00:07:17] Speaker 01: And they cited five examples. [00:07:19] Speaker 01: They cited five studies. [00:07:21] Speaker 02: Counsel, it's a bit off the track with respect to an agent like, but I can't imagine this claim [00:07:29] Speaker 02: Patent gives, as you know, a right to exclude. [00:07:34] Speaker 02: I can't imagine who's going to be excluded here. [00:07:37] Speaker 02: Is someone going to treat HIV by putting someone under anesthesia and then intubation? [00:07:47] Speaker 01: Well, the alternative is to die from HIV. [00:07:53] Speaker 02: There are lots of treatments for HIV. [00:07:55] Speaker 02: I see them on television every night. [00:07:58] Speaker 01: I understand. [00:07:59] Speaker 01: But again, that's outside the scope of the claims. [00:08:03] Speaker 01: So we're trying to treat HIV with these claims. [00:08:11] Speaker 01: All these claims. [00:08:12] Speaker 01: And the patent office doesn't argue that any of these steps in the patent are unable to be carried out by the person having an ordinary spilling heart, the faceta. [00:08:27] Speaker 02: So I guess entering into an emergency room isn't in the claim. [00:08:33] Speaker 01: I'm sorry, Your Honor. [00:08:35] Speaker 02: Entry into an emergency room in treatment and waiting for two years isn't in the claim. [00:08:43] Speaker 02: So it doesn't exactly track your example. [00:08:46] Speaker 01: Well, that's correct. [00:08:49] Speaker 01: The anecdotal example was we would have been better off without that in there, because you don't have to have a working example to get a patent. [00:08:58] Speaker 01: It's constructive reduction to practice. [00:09:02] Speaker 01: That anecdotal example was put in there primarily just to show Dr. Adami's thought process in coming up with this invention. [00:09:13] Speaker 01: Now, the patent office spends a lot of time talking about that anecdotal example. [00:09:20] Speaker 01: So I would say, imagine that anecdotal example isn't in the patent. [00:09:25] Speaker 01: If it's not in the patent, it's not an issue. [00:09:27] Speaker 01: And a patent that reduces an invention to constructive use is patentable. [00:09:39] Speaker 01: So let me try to get back on track here with my arguments. [00:09:44] Speaker 01: I think the examples in Amgen versus Sanofi are really helpful to understand what the scope is of the enablement requirement. [00:10:00] Speaker 01: And in that case, [00:10:04] Speaker 01: went up to the Supreme Court. [00:10:06] Speaker 01: Judge Laurie's opinion was unanimously accepted by the Supreme Court. [00:10:11] Speaker 01: And the examples that are in Sam Gen and the Supreme Court case are, I think, instructive. [00:10:17] Speaker 01: You look at the Samuel Morse patent that's discussed in the Amgen case. [00:10:22] Speaker 01: And there you got seven claims that everyone agreed was allowable. [00:10:27] Speaker 01: The eighth claim, Samuel Morse tried to claim all means of achieving telegraphic communication, very, very broad, and didn't provide the details of how to enable that claim in the specification. [00:10:44] Speaker 01: Unlike Dr. Adami, [00:10:46] Speaker 01: His claims are self-enabling. [00:10:49] Speaker 01: A person having ordinary skill in the art, a medical doctor or a PhD, could read these steps and be able to practice the invention. [00:11:02] Speaker 02: Counsel, you are into your bottle. [00:11:04] Speaker 02: You can continue or save it as you wish. [00:11:07] Speaker 01: I'm sorry, Your Honor. [00:11:08] Speaker 01: Can you repeat that? [00:11:08] Speaker 02: You are into your bottle, Tom. [00:11:10] Speaker 02: You can continue to use it or save it. [00:11:13] Speaker 01: I'd like to reserve for rebuttal, Your Honor. [00:11:34] Speaker 02: Ms. [00:11:34] Speaker 02: Kelly, good morning. [00:11:36] Speaker 03: Good morning, Your Honors. [00:11:39] Speaker 03: May it please the court? [00:11:41] Speaker 03: The board correctly found that persons of ordinary skill in the arc, as Judge Proce recognized, would not know how much of at least three of the recited alcohols to give to a patient and for how long in order to reduce viral load. [00:11:58] Speaker 03: The board further found, and correctly so, as Judge Laurie recognized, [00:12:04] Speaker 03: that at least three of these alcohols are toxic to humans. [00:12:12] Speaker 03: And the fact that there is so much unpredictability in the art that it was very likely that this, given this unpredictability, that this method would not reduce viral load at best. [00:12:26] Speaker 03: And at worst, that it would kill a patient. [00:12:28] Speaker 02: And of course, dosages are usually a matter for the FDA. [00:12:33] Speaker 02: And it is standard with method of treatment claims to use to file before one has clinical data based on animal studies and have a range of dosage. [00:12:51] Speaker 02: If he had done that, if they had done that, one wouldn't necessarily need an actual example. [00:12:58] Speaker 03: Uh, correct, Your Honor, because in that case, the art would have been less unpredictable. [00:13:04] Speaker 03: If there were in vitro studies and in vivo studies in animals, this wouldn't be an unpredictable area. [00:13:12] Speaker 03: But as it were, the problem here is that we're dealing with something that is known to kill people. [00:13:21] Speaker 03: You know, people try to commit suicide, as the Kripkowski reference shows. [00:13:26] Speaker 03: People have tried to commit suicide using all four of the recited alcohols. [00:13:33] Speaker 03: that's how toxic those at least three of them can be and we're talking about very high levels so we're talking about a point four blood alcohol level for ethanol and there really isn't any guidance as to what we really want what is needed given the unpredictability of the art for the methanol, the ethylene glycol and the isopropanol so the board correctly found that there really isn't any [00:14:03] Speaker 03: likelihood that this invention will reduce HIV burden and there is a likelihood that it might kill somebody and as this court recognized in cases like [00:14:19] Speaker 03: 318 patent litigation, and I want to make sure I get this name right, press control group versus hydro claim, that the utility and the enablement requirement are very closely related. [00:14:36] Speaker 03: And then if the claim fails to be useful or operative in this case, then it also fails to meet the how to use component of the enablement requirement. [00:14:49] Speaker 03: And so for at least those two reasons that the board found, these claims are not enabled. [00:14:56] Speaker 03: Do your honors have any further questions? [00:15:02] Speaker 02: Apparently not, Ms. [00:15:03] Speaker 02: Kelly. [00:15:05] Speaker 03: Thank you. [00:15:06] Speaker 03: We'll cede our time. [00:15:12] Speaker 02: Ms. [00:15:12] Speaker 03: Sahar, you have some time. [00:15:21] Speaker 02: You have up to four minutes if you need it. [00:15:24] Speaker 01: Let me just summarize and bring up some points that were raised in the PTO's arguments. [00:15:32] Speaker 01: First of all, this idea of predictability. [00:15:35] Speaker 01: Again, a patent does not have to guarantee results. [00:15:40] Speaker 01: That's well established. [00:15:42] Speaker 01: The toxicity of the materials I don't think is an issue. [00:15:49] Speaker 01: a plethora of examples of toxic materials being used as medicine under the guidance of a person having ordinary skill in the art, a medical doctor, a PhD, or someone that has that knowledge to be able to apply the highly toxic materials. [00:16:06] Speaker 01: As far as the patent office making that determination, I think they're out of their jurisdiction. [00:16:19] Speaker 01: That's not what the patent statute requires. [00:16:22] Speaker 01: The patent statute requires that an inventor provide details of how to use the invention. [00:16:28] Speaker 01: Whether it should be acceptable or not is not part of the USPTO's mandate. [00:16:34] Speaker 01: That's the FDA or other medical associations or regulatory bodies to determine whether a [00:16:42] Speaker 01: treatment is practical or not, or effective, or should be used. [00:16:47] Speaker 01: That is not the Patent Office's bailiwick. [00:16:50] Speaker 02: Does this specification close specific doses for ethanol and different doses for ethylene glycol and different doses for methanol? [00:17:03] Speaker 01: I can't cite to the specification directly, but the specification does talk about the relative toxicity of those materials and how to treat it, how to use those in the claims. [00:17:18] Speaker 01: But again, the claims are self-enabling. [00:17:21] Speaker 01: You cannot look at these claims as a medical professional and say, well, I don't know how to do that step. [00:17:27] Speaker 01: And in fact, I don't think you even have to reach the in-wand factors in this case, because [00:17:34] Speaker 01: you know, and Ray Wans is all about undue experimentation, that there's no undue experimentation needed here. [00:17:45] Speaker 01: And even though [00:17:46] Speaker 01: And that's even given the fact that experimentation is allowed, reasonable experimentation is allowed by the person having ordinary skill in the art. [00:17:56] Speaker 01: The patent office never brought up any specific step in this claim. [00:18:01] Speaker 01: They used references that were in opposite. [00:18:04] Speaker 01: They used four references that talked about alcohol use over a long period of time. [00:18:10] Speaker 01: They were all longitudinal studies. [00:18:13] Speaker 01: The fifth reference said, [00:18:16] Speaker 01: You know, ethylene glycol could be toxic. [00:18:20] Speaker 01: Well, water is toxic in high concentrations. [00:18:24] Speaker 01: So it's up to the person having ordinary skill in the art to implement this invention. [00:18:31] Speaker 01: And Dr. Adami believes that he did so. [00:18:34] Speaker 01: So Your Honors, we just ask that this court reverse the PTAB's ruling. [00:18:45] Speaker 01: and remand for further processing as the court shall determine. [00:18:48] Speaker 01: So thank you very much. [00:18:50] Speaker 02: Thank you, counsel. [00:18:50] Speaker 02: Thank you to both counsel. [00:18:51] Speaker 02: The case is submitted. [00:18:53] Speaker 02: And that concludes today's arguments.