Publications – Oblon, McClelland, Maier & Neustadt, L.L.P. https://www.oblon.com/?r=publications/feed Intellectual Property Law Firm en-us 15 Sep 2021 00:00:00 -0800 firmwise http://blogs.law.harvard.edu/tech/rss Fed. Circ.'s PTAB Ruling Casts Spotlight On Arbitration Pacts https://www.oblon.com/https://www.law360.com/articles/1420391/fed-circ-s-ptab-ruling-casts-spotlight-on-arbitration-pacts&anc=995&format=xml <strong>Christopher Ricciuti</strong>&nbsp;is quoted in the <em>Law360</em> article &quot;Fed. Circ.'s PTAB Ruling Casts Spotlight On Arbitration Pacts.&quot;&nbsp;<br /> Article 14 Sep 2021 00:00:00 -0800 https://www.oblon.com/https://www.law360.com/articles/1420391/fed-circ-s-ptab-ruling-casts-spotlight-on-arbitration-pacts&anc=995&format=xml PTAB ADOPTS IDENDEX IN FINDING MARKUSH GROUP NOT ENABLED https://www.oblon.com/?t=40&an=118724&anc=995&format=xml <p>&nbsp;&nbsp;&nbsp;&nbsp;In Post Grant Reviews (PGR) the Patent Trial and Appeal Board (PTAB) may consider all statutory challenges to patent claims including those under 35 U.S.C. &sect; 112. One such challenge was brought in <i>Syngenta Crop Protection v. FMC Corp</i> in PGR2020-00028 (Syngenta), decided August 31, 2021, against U.S.P. 10,294,202 (&lsquo;202 patent). The PTAB found all challenged claims, 1-3, 9-13, and 21-30, unpatentable as lacking an enabling disclosure commensurate in scope with the claims and a subset, claims 9 &ndash; 13, as lacking written description, 35 U.S.C. &sect; 112(a).</p> <p>&nbsp;&nbsp;&nbsp;&nbsp;The &lsquo;202 patent is directed to pyrrolidinone herbicides:</p> <p>1. A compound selected from Formula I, N-oxides and salts thereof :<br /> <img src="data:image/png;base64,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" alt="" /></p> <p>Followed by Markush definitions of each variable covering almost 4 pages of the opinion. The Petitioner asserted, the PTAB agreed, and patentee did not deny that the claims cover over a billion compounds. The PTAB found on a largely undisputed record that the level of skill in the art was relatively high but the art unpredictable.&nbsp;The PTAB also found that Q<sup>1</sup>, Q<sup>2</sup>, R<sup>1</sup>, and R<sup>6</sup> groups alone each recite well over a thousand possible independent options. The issue was then the degree of guidance provided in the specification for practicing the full scope of the claims.</p> <p>&nbsp;&nbsp;&nbsp;&nbsp;The PTAB noted that the specification provides no disclosure of the compounds&rsquo; mode of action. The PTAB acknowledged that the patentee need disclose an invention&rsquo;s mode of action citing <i>Alcon Research Ltd. v. Barr Labs., Inc.</i>, 745 F.3d 1180, 1190 (Fed. Cir. 2014). The Patent Owner admitted that without this information to practice the full scope of the claims, ordinarily skilled artisans must engage in iterative QSAR modeling to develop a structure-activity relationship themselves. The evidence was that knowledge of the mode of action would have assisted in the QSAR modeling process.&nbsp;The Patent Owner&rsquo;s expert testimony to the contrary was rejected on this point because almost half of its expert&rsquo;s 150-plus publications provided a mode of action and only a few provided QSARs for herbicides.</p> <p>&nbsp;&nbsp;&nbsp;&nbsp;The &lsquo;202 patent specification had over 350 examples of synthesizing compounds and herbicidal activity for 335 of the compounds. The PTAB noted that the Patent Owner correctly argued there was no requirement either (1) the Specification to disclose testing of &ldquo;each&rdquo; claimed compound and modifying of &ldquo;each&rdquo; claimed variable, or (2) that an ordinarily skilled artisan know in advance precisely all the compounds that will show herbicidal activity. But that the law required that that &ldquo;the specification must contain sufficient disclosure to enable an ordinarily skilled artisan to make and use the <i>entire </i>scope of the claimed invention at the time of filing,&rdquo; citing <i>MagSil Corp. v. Hitachi Global Storage Techs., Inc.</i>, 687 F.3d 1377, 1382 (Fed. Cir. 2012) (emphasis added). The PTAB then framed the question as&nbsp;be whether the &lsquo;202 patent examples demonstrated variation sufficient to guide the selection and use of non-exemplified compounds within the scope of the claims.</p> <p>&nbsp;&nbsp;&nbsp;&nbsp;The examples were not the Patent Owner&rsquo;s friend. The examples demonstrated that some of compounds with a pyrazole group, a member of the Markush group, at Q<sup>1</sup> had little or no utility as herbicides. Only the compounds with Phenyl or substituted phenyl at these positions demonstrated herbicidal activity. PTAB noted that thousands of heterocyclic groups were possible at R<sup>1</sup> none of which were exemplified other than the pyrazoles some of which were inactive. One-third of the compounds where Q<sup>2 </sup>was not a phenyl group showed no activity. Similar issues existed for other variables on the claimed herbicides.</p> <p>&nbsp;&nbsp;&nbsp;&nbsp;The Patent Owner sought to justify the limited scope of the examples by arguing that early filing of an application with a disclosure of novel compounds is to be encouraged. The PTAB rejected the argument based on <i>In re Surrey</i>, 370 F.2d 349, 355 (CCPA 1966) that one is &ldquo;not entitled to a claim for a large group of compounds merely on the basis of showing that a selected few are useful and a general suggestion of a similar utility in the others.&rdquo; &nbsp;The PTAB also relied on <i>MagSil, </i>687 F.3d at 1381 for the proposition that enablement prevents &ldquo;overbroad claiming that might otherwise attempt to cover more than was actually invented.&rdquo;</p> <p>&nbsp;&nbsp;&nbsp;&nbsp;The takeaway is that one needs to reasonably assure that all members of Markush group have the recited utility whether claimed or not in the unpredictable arts. While actual experiments are not mandatory some method must be employed. Complicating the Patent Owner&rsquo;s challenge was that the patent claims asserted that the claimed compounds were herbicides. Based on the PTAB&rsquo;s reasoning, even had the claims been silent as to utility, the enablement requirement would still have been issue since the 35 U.S.C. &sect;112(a) requires &ldquo;. . . and of the manner making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same,&nbsp;. . ..&rdquo; When presenting Markush claims one should present claims of varying scope with at least some derived from compounds demonstrated to have the use recited. That is, the inventors can explain why the members of the reduced group would function similarly to the exemplified ones.</p> Article 07 Sep 2021 00:00:00 -0800 https://www.oblon.com/?t=40&an=118724&anc=995&format=xml Claims to a Spread-Spectrum Method For Sending Data Over a Communications Channel Are Patent Ineligible under Section 101 https://www.oblon.com/?t=40&an=118590&anc=995&format=xml <p>Plaintiff Zyrcuits IP LLC has sued Defendants Acuity Brands, Inc. and Universal Electronics Inc. for infringement of claim 4 of U.S. Patent No. 6,671,307 (the &lsquo;307 patent). Defendants argued that Zyrcuits&rsquo;s complaints should be dismissed because the &lsquo;307 patent is invalid under 35 U.S.C. &sect; 101 for failing to claim patentable subject matter. Applying the two-step framework from <i>Alice, </i>the court found that the &lsquo;307 patent was invalid under &sect; 101, as the claims of the &lsquo;307 patent are directed to the abstract idea of grouping data together with a single code and do not contain any inventive concept.</p> <p>&nbsp;</p> <p>The &lsquo;307 patent describes applying signal codes to blocks of interleaved data for spread-spectrum transmission. According to the written description, spread-spectrum transmission was previously accomplished using parallel codes. Zyrcuits alleged that Acuity and Universal Electronics infringe claim 4 of the &lsquo;307 patent.</p> <p style="margin-left: 40px;">Claim 4 recites a spread-spectrum method improvement for sending data over a communications channel, comprising the steps of:<br /> storing, at a transmitter, N bits of interleaved data as stored data, with N a number of bits in a symbol;<br /> selecting, at said transmitter in response to the N bits of stored data, a chip-sequence signal from a plurality of 2<sup>N</sup> chip-sequence signals, as an output chip-sequence signal; and<br /> transmitting, at said transmitter, the output chip-sequence signal as a radio wave, at a carrier frequency, over said communications channel, as a spread-spectrum signal.</p> <p>The court noted that claim 4 described grouping together data that may come from multiple sources, applying a single chip-sequence code to the grouped data, and then transmitting the code by radio wave. Under <i>Alice</i> Step One, whether the claims are drawn to patent ineligible subject matter, the court found that the &lsquo;307 patent was directed to the abstract idea of grouping spread-spectrum data together with a single code instead of with parallel codes. The court explained that the Federal Circuit had indicated repeatedly that claims directed to the manipulation of data are abstract absent additional features, because &ldquo;information as such is an intangible.&rdquo; <i>Elec. Power Grp., LLC v. Alstom S.A., </i>830 F.3d 1350, 1353 (Fed. Cir. 2016).</p> <p>The court pointed out that representative claim 4 was directed to the manipulation of information: &ldquo;It requires &lsquo;storing&rsquo; specified data, &lsquo;selecting&rsquo; a signal based on the stored data, and then &lsquo;transmitting&rsquo; the signal&rdquo; and that &ldquo;Zyrcuits repeatedly referred to the content of claim 4 as an &lsquo;algorithm.&rsquo;&rdquo; &ldquo;A process that start[s] with data, add[s] an algorithm, and end[s] with a new form of data [is] directed to an abstract idea.&rdquo; <i>RecogniCorp, LLC v. Nintendo Co., Ltd., </i>855 F.3d 1322, 1327 (Fed. Cir. 2017) (citing <i>Digitech Image Techs., LLC v. Elecs.for Imaging, Inc., </i>758 F.3d 1344 (Fed. Cir. 2014)). &ldquo;This is exactly what is recited in claim 4.&rdquo;</p> <p>Zyrcuits argued that claim 4 recited a technical solution to the problem of spread-spectrum signal transmission without using parallel codes. According to Zyrcuits, the &lsquo;307 patent teaches &ldquo;particular techniques-with limiting detail-to solve the problem of transmitting spread-spectrum signals without using parallel codes.&rdquo; The court pointed out that claims directed to forms of data collection and manipulation are not directed to an abstract idea if they offer technical improvements to computer technology. <i>Compare Smart Sys. Innovations, LLC v. Chi. Transit Auth., </i>873 F.3d 1364, 1372 (Fed. Cir. 2017) (&ldquo;We have determined that claims directed to the collection, storage, and recognition of data are directed to an abstract idea.&rdquo;);<i>Enfish, LLC v. Microsoft Corp.</i>, 822 F.3d 1327, 1336 (Fed. Cir. 2016) (finding claims subject-matter eligible when directed to the &ldquo;improvement to computer functionality itself&rdquo;). Zycruits relied on the <i>Enfish </i>line of cases to argue that the &lsquo;307 patent is subject-matter eligible since, according to Zyrcuits, it describes specific techniques with limiting detail.</p> <p>However, the court pointed out that claim 4 did not provide a technical solution to a technical problem and that Zyrcuits failed to identify in its briefing any particular technical solution disclosed in the &lsquo;307 patent. &nbsp;According to the court, Zyrcuits pointed to unexplained block quotes from the patent and the unsupported, conclusory statement in the complaints that claim 4 addressed the problem of interference and output signal distortion with a technical solution. The court noted that the step of storing &ldquo;&lsquo;N bits of interleaved data as stored data, with N a number of bits in a symbol&rsquo; could simply be summarized as &lsquo;storing data as stored data.&rsquo; The selection step teaches &lsquo;selecting ... a chip-sequence signal from a plurality of 2<sup>N</sup> chip-sequence signals,&rsquo; but provides no details about <i>how</i> this selection should be made.&rdquo; The court further noted that the third step required nothing more than &ldquo;transmitting ... the output chip-sequence signal as a radio wave, at a carrier frequency, over said communications channel, as a spread-spectrum signal, which is transmitting data in a known way.&rdquo; The &ldquo;how&rdquo; information Zyrcuits pointed to only confirms that the storing, selecting, and transmitting steps are exactly what they first appear to be, i.e., the abstract manipulation of information. &ldquo;Claim 4 may use technical jargon, but that does not mean it teaches a technical solution.&rdquo; &nbsp;The court noted that it might be true that the patent is directed to a useful idea, but a patent is still invalid for lack of subject-matter eligibility when it teaches a useful abstract idea. &ldquo;The fact that an [idea] can be used to make a process more efficient, however, does not necessarily render an abstract idea less abstract.&rdquo; <i>See Secured Mail Sols. LLC v. Universal Wilde, Inc., </i>873 F.3d 905, 910 (Fed. Cir. 2017).</p> <p>The court concluded that under Step One of <i>Alice</i>, &ldquo;representative claim 4 is directed to the idea of applying a signal code to a block of interleaved data (thereby avoiding parallel codes), and the claim does not provide any guidance on <i>how </i>to accomplish this idea. Therefore the &lsquo;307 patent is directed to an abstract idea.&rdquo;</p> <p>The court then proceeded to determine whether the claims contain an &ldquo;inventive concept&rdquo; &ldquo;sufficient to transform the claimed abstract idea into a patent-eligible application&rdquo; under <i>Alice</i> and <i>Mayo</i>. &nbsp;The court stated that it was insufficient for the patent to &ldquo;simply state the law of nature while adding the words &lsquo;apply it&rsquo;&rdquo; citing <i>Mayo v. Prometheus</i>, 566 U.S. 66, 72 (2012), &nbsp;and noted that a claim directed towards an abstract idea must include &ldquo;&lsquo;additional features&rsquo; to ensure &lsquo;that the [claim] is more than a drafting effort designed to monopolize the [abstract idea]&rsquo;&rdquo; citing <i>Alice Corp. Pty. v. CLS Bank Int'l, </i>573 U.S. 208, 216, 221 (2014). &ldquo;No such additional features exist here, and I find that, whether considered individually or as an ordered combination, the claim elements of the 307 patent do not &lsquo;transform&rsquo; the claimed abstract idea into patent-eligible subject matter.&rdquo; According to the court, claim 4 &ldquo;simply takes an abstract idea for transmitting data and implements it &lsquo;at a transmitter&rsquo; as a &lsquo;radio wave&rsquo; over a &lsquo;communications channel&rsquo;&rdquo; and the invocation of generic communication technology does not provide an inventive concept.</p> <p>Zyrcuits argued that there was a disputed factual issue about whether claim 4 recites &ldquo;well-understood, routine, and conventional activities.&rdquo; &nbsp;In response, the court explained that &ldquo;Zyrcuits cannot artificially create a dispute of fact by making the conclusory allegation that &lsquo;claim 4 embodies an inventive concept,&rsquo; . . . when the #307 patent itself resolves any possible factual issues.&rdquo; The court pointed to Figures 1 and 2 of the patent that show a prior art system that includes a generic transmitter and a communication channel. The patent also explains that the claimed process can be implemented on a &ldquo;general purpose processor.&rdquo; &nbsp;&ldquo;Implementing an abstract idea on a general purpose processor or a generic transmitter does not constitute an inventive step. <i>Alice, </i>573 U.S. at 222.&rdquo;</p> <p>Zyrcuits further asserted that the claimed process was unconventional. The court disagreed because &ldquo;the alleged unconventional process is the abstract idea to which claim 4 is directed, and the abstract idea itself cannot provide the inventive feature required at step two.&rdquo; The court noted that the expert declaration submitted by Zyrcuits in opposition to the pending motion confirms this conclusion. The inventive concept identified by the expert, the method for spread-spectrum data transmission without parallel codes, is the abstract idea to which claim 4 is directed. &ldquo;The patent lacks any additional features that would make the claims eligible under &sect; 101, because it simply applies an abstract idea using conventional technology.&rdquo;</p> <p>The court found find that the &lsquo;307 patent was invalid under &sect; 101 for lack of subject-matter eligibility and granted the defendants&rsquo; motion to dismiss.</p> <p><i>Zyrcuits IP LLC v. Acuity Brands, Inc., </i>No. CV 20-1306-CFC, 2021 WL 3287801, at *1 (D. Del. Aug. 2, 2021);</p> <p><a href="https://cases.justia.com/federal/district-courts/delaware/dedce/1:2020cv01306/73369/19/0.pdf">https://cases.justia.com/federal/district-courts/delaware/dedce/1:2020cv01306/73369/19/0.pdf</a></p> Article 23 Aug 2021 00:00:00 -0800 https://www.oblon.com/?t=40&an=118590&anc=995&format=xml The Week That Was In Skinny Labels https://www.oblon.com/?t=40&an=118398&anc=995&format=xml <p>This week saw two cases reported with possible implications for skinny labels. The first was a recommendation be Magistrate Judge Hall, District of Delaware, that Hikma Pharmaceuticals could not dodge Amarin&rsquo;s lawsuit claiming Hikma induced infringement of Amarin&rsquo;s patents on the use of its heart drug Vascepa&reg; . The patents in suit are U.S. Patent Nos. 9,700,537 (the &rsquo;537 patent), 8,642,077 (the &rsquo;077 patent), and 10,568,861 (the &rsquo;861 patent) under 35 U.S.C. &sect; 271(b). In an interesting twist, Amarin also sued Health Net, an insurance provider, for also inducing infringement of the same patents. The suit against Health Net appears to be a first where an insurance company was sued for inducing infringement of method of using a drug.</p> <p>Vascepa&reg; currently has two FDA-approved indications: (1) treatment of severe hypertriglyceridemia (the &ldquo;SH indication&rdquo;); and (2) cardiovascular risk reduction (the &ldquo;CV indication&rdquo;). Only the CV indication is protected by patents.</p> <p style="margin-left: 40px;">The &lsquo;537 patent claim 1 reads:</p> <p style="margin-left: 80px;">A method of reducing occurrence of a cardiovascular event in a hypercholesterolemia patient consisting of:</p> <p style="margin-left: 80px;">identifying a patient having triglycerides (TG) of at least 150 mg/DL and HDL-C of less than 40 mg/dL in a blood sample taken from the patient as a risk factor of a cardiovascular event, wherein the patient has not previously had a cardiovascular event, and administering ethyl icosapentate in combination with a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor,</p> <p style="margin-left: 80px;">wherein said 3-hydroxyl-3-methylglutaryl coenzyme A reductase inhibitor is administered to the patient at least one of before, during and after A method of reducing occurrence of a cardiovascular event in a hypercholesterolemia patient consisting of:</p> <p style="margin-left: 80px;">identifying a patient having triglycerides (TG) of at least 150 mg/DL and HDL-C of less than 40 mg/dL in a blood sample taken from the patient as a risk factor of a cardiovascular event, wherein the patient has not previously had a cardiovascular event, and administering ethyl icosapentate in combination with a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor,</p> <p style="margin-left: 80px;">wherein said 3-hydroxyl-3-methylglutaryl coenzyme A reductase inhibitor is administered to the patient at least one of before, during and after administering the ethyl icosapentate; and</p> <p style="margin-left: 80px;">wherein the 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor is selected from the group consisting of pravastatin, lovastatin, simvastatin, fluvastatin, atorvastatin, pitavastatin, rosuvastatin, and salts thereof, and wherein daily dose of the 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor are 5 to 60 mg for pravastatin, 2.5 to 60 mg for simvastatin, 10 to 180 mg for fluvastatin sodium, 5 to 120 mg for atorvastatin calcium hydrate, 0.5 to 12 mg for pitavastatin calcium, 1.25 to 60 mg for rosuvastatin calcium, 5 to 160 mg for lovastatin, and 0.075 to 0.9 mg for cerivastatin sodium.</p> <p style="margin-left: 40px;">The &lsquo;077 patent claims 1 and 8 recite:</p> <p style="margin-left: 80px;">1. A method of reducing triglycerides in a subject with mixed dyslipidemia on statin therapy comprising, administering to the subject a pharmaceutical composition comprising about 2500 mg to 5000 mg per day of ethyl eicosapentaenoate and not more than about 5%, by weight of all fatty acids, docosahexaenoic acid or its esters to effect a reduction in fasting triglyceride levels in the subject.</p> <p style="margin-left: 80px;">8. The method of claim 1 wherein the subject exhibits a reduction in hs-CRP compared to placebo control.</p> <p style="margin-left: 40px;">The &lsquo;861 patent claims 1 and 2 recite:</p> <p style="margin-left: 80px;">1. A method of reducing risk of cardiovascular death in a subject with established cardiovascular disease, the method comprising administering to said subject about 4 g of 5 ethyl icosapentate per day for a period effective to reduce risk of cardiovascular death in the subject.</p> <p style="margin-left: 80px;">2. The method of claim 1, wherein the subject has a fasting baseline triglyceride level of about 135 mg/dL to about 500 mg/dL and a fasting baseline LDL-C level of about 40 mg/dL to about 100 mg/dL.</p> <p>At the time Hikma filed its ANDA the the only approved use was the SH indication.&nbsp; The Vascepa&reg; &nbsp;label, copied by Hikma, provided that, and up until 2019, the Vascepa&reg; &nbsp;label contained the following &ldquo;limitation of use&rdquo; regarding the CV indication: &ldquo;The effect of VASCEPA&reg; &nbsp;on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.&rdquo; Upon FDA approval of the CV indication Amarin amended to the label to add the CV indication and removed the limitation on use and added the patents to the Orange Book. After Amarin received approval for the CV indication and listed the patents in the Orange Book, Hikma submitted Section viii statements for the listed patents. Hikma did not add the CV indication to its label keeping only the SH indication but did remove the CV limitation of use from the label it had originally proposed prior to approval of Vascepa&reg; &rsquo;s CV indication. After Amarin received approval for the CV indications, the majority of Vascepa&reg; &rsquo;s sales were for these uses, a fact known to Hikma. Hikma issued two press releases stating &ldquo;Vascepa&reg; &nbsp;is a prescription medicine that is indicated,&nbsp;<i>in part</i>, as an adjunct to diet to reduce triglyceride levels in adult patients with severe (&ge;500 mg/dL) hypertriglyceridemia&rdquo; (emphasis added) and stating the 2019 &ldquo;Vascepa&reg; sales were approximately $919 million&rdquo; which Hikma knew included sales for the CV indication.&nbsp; Both press releases were available on Hikma&rsquo;s website as of the filing of the litigation.</p> <p>The Magistrate in making her recommendation noted that she could not weigh the evidence but must take the allegations as true and determine &ldquo;whether a complaint plausibly alleges inducement in a pharmaceutical case is thus no different than the analysis in any other case. The court must determine whether the complaint plausibly alleges that the generic manufacturer &ldquo;offer[ed] a product with the object of promoting its use to infringe, as shown by clear expression or other affirmative steps taken to foster infringement.&rdquo;&nbsp;<i>DSU Med. Corp. v. JMS Co.</i>, 471 F.3d 1293, 1305-06 (Fed. Cir. 2006) (en banc in relevant part).&rdquo; She rejected Hikma&rsquo;s argument that it could not be liable for inducement absent the FDA approval for its product for the CV indications citing&nbsp;<i>AstraZeneca LP v. Apotex, Inc.</i>, 633 F.3d 1042, 1045-46 (Fed. Cir. 2010).</p> <p>Health Net was dragged in as a defendant because of its insurance scheme. Like most insurance companies it has various tiers for prescription drug compensation for insureds.&nbsp; In this case Health Net Placed generic Vascepa&reg; in Tier one which had the lowest copay and branded Vascepa&reg; in Tier 3 which had a higher copay. This might not have caused a problem except that some of Health Net&rsquo;s plans required &ldquo;Prior Authorization&rdquo; before it will cover and pay for either Vascepa or Hikma&rsquo;s generic version. To obtain the authorization the patient&rsquo;s medical dotor must submit documentation demonstrating that the prescription is being given for either the SH or the CV indication which maps to either the SH or CV use of Vascepa&reg;.&nbsp; Amarin had provided notice to Health Net that Vascepa&reg;&rsquo;s for CV would infringe its patents. Amarin in its complaint that the prior authorization and different tiers for the brand and generic provides encouragement to doctors to prescribe Hikma&rsquo;s product. This is a novel inducement theory at least in ANDA cases but the Magistrate recommended denying Health Net&rsquo;s motion to dismiss.</p> <p>The recommendation to deny the motions to dismiss was based on the Magistrate&rsquo;s conclusion that the complaint stated a plausible claim against both Hikma and Health Net</p> <p>The decision underscores the need for a generic to be careful in its press releases and in label carve outs. Also, that sometimes and insurer may request too much information before approving coverage especially where it has been advised of the existence of patent protection.</p> <p>The second case is the second round of&nbsp;<i>GlaxxoSmithKline LLC. v. Teva Pharm. USA, Inc.</i>, 2018-1976, 2018-2023.&nbsp; The first round is discussed here with a more complete recitation of the facts. [Click through the links here to read the past Skinny Label blog posts:&nbsp;<strong><a href="https://www.lifesciencesipblog.com/gsk-vs-teva-induced-infringement-skinny-labels-and-fat-damages">GSK vs. Teva: Induced Infringement, Skinny Labels and Fat Damages</a></strong>;&nbsp;<strong><a href="https://www.lifesciencesipblog.com/gsk-v-teva-the-federal-circuits-first-look-at-skinny-labels-and-35-usc-271b">GSK v Teva - The Federal Circuit's First Look at Skinny Labels and 35 U.S.C. 271(b)</a></strong>; and&nbsp;<strong><a href="https://www.lifesciencesipblog.com/glaxosmithkline-v-teva-not-a-skinny-label">GlaxoSmithKline v. Teva - Not a Skinny Label?</a></strong>] In this decision the majority cited to additional evidence that Teva had engaged marketing that touted its generic product&rsquo;s use for the patented indication of heart failure.&nbsp; One of the more important points is that the jury had found Teva&rsquo;s &ldquo;skinny label&rdquo; was not so skinny. GSK&rsquo;s Carvedilol was approved for three indications, hypertension, congestive heart failure (CHF) and reducing cardiovascular mortality in patients with left ventricular dysfunction following a myocardial infarction (&ldquo;post-MI LVD&rdquo;). Teva had carved out CHF indication but not the post-MI LVD indication. The jury found that Teva had induced infringement of the CHF claims with the label recitation of post-MI-LVD a decision Judge Stark overturned on JMOL. The Federal Circuit reversed the Judge Stark on this point because, according to the Court, Judge Stark had treated it as a question of law and not fact which it was.&nbsp; GSK had introduced evidence that the post-MI LVD indication would cause doctors to use the generic product for the CHF indication as well.</p> <p>The per curiam opinion reflects Judge Newman&rsquo;s often expressed belief that judges should not supplant the jury&rsquo;s function by re-weighing the evidence.&nbsp;</p> <p>The majority acknowledges that there is evidence supporting Teva&rsquo;s position that it did not induce infringement.&nbsp; However, it is the jury&rsquo;s function and not the court&rsquo;s to weigh the evidence.&nbsp; From the tenor of the opinion, it seems that if this had been a bench trial, Judge Stark&rsquo;s finding of no inducement would have been affirmed. For the branded drug companies this may counsel careful consideration of filing an infringement suit under 35 U.S.C. &sect; 271(e)(2) where a jury trial is not available when the question of inducement is a close one as here.&nbsp; While there is a significant advantage to the automatic 30 month stay that comes with a &sect; 271(e) suit, if the patent has significant life, a &sect; 271(b) suit may be better since it can be filed about 10 months before the earliest FDA approval date.</p> For generics, the Amarin and GSK litigations are a red flag that skinny labels are no guarantee of clear sailing. Further, that the skinny label ad press releases must be carefully considered from the viewpoint induced infringement. Article 09 Aug 2021 00:00:00 -0800 https://www.oblon.com/?t=40&an=118398&anc=995&format=xml B&B Hardware Revisited: Issue Preclusion and Claim Preclusion Based on TTAB Judgments https://www.oblon.com/A11960/assets/files/News/LES June_ BDarville_YOnoe_8.6.21.pdf&anc=995&format=xml <strong>Brian Darville</strong>&nbsp;and <strong>Yuki Onoe </strong>co-authored the article &quot;B&amp;B Hardware Revisited: Issue Preclusion and Claim Preclusion Based on TTAB Judgments,&quot; featured in the <em>LES Japan News</em> June 2021 edition. A Japanese version: &quot;B&amp;B Hardware 最高裁判決: TTAB 判決に基づく争点遮断効 (issue preclusion) および請求遮断効 (claim preclusion)&quot; was also featured in the June edition of&nbsp;<em>LES Japan News. </em>Both versions are in the PDF below. Article 06 Aug 2021 00:00:00 -0800 https://www.oblon.com/A11960/assets/files/News/LES June_ BDarville_YOnoe_8.6.21.pdf&anc=995&format=xml The Developing IPR-Appellate Landscape Following Thryv v. Click-to-Call https://www.oblon.com/A11960/assets/files/News/2021_08.02 Ricciuti_and_Onoe_JIPAarticle.pdf&anc=995&format=xml <strong>Christopher Ricciuti </strong>and<strong> Yuki Onoe</strong> co-authored the article&nbsp;[米国]Thryv最高裁判決およびIPRと上訴に関する判例の展開&nbsp; featured in the July edition of Intellectual Property Magazine (知財管理).&nbsp;<br /> <br /> ____________________________________________________________________________________________<br /> <p>知財管理Vol71.7(847)2021<br /> タイトル:[米国]Thryv最高裁判決およびIPRと上訴に関する判例の展開</p> Article 03 Aug 2021 00:00:00 -0800 https://www.oblon.com/A11960/assets/files/News/2021_08.02 Ricciuti_and_Onoe_JIPAarticle.pdf&anc=995&format=xml AlphaFold 2, Open Source AI for Protein Structure Prediction https://www.oblon.com/?t=40&an=118329&anc=995&format=xml <p>On July 15, a team of scientists published a <i>Nature</i>&nbsp;article, titled &ldquo;Highly accurate protein structure prediction with AlphaFold.&rdquo;<a href="file:///C:/Users/ProfileDisk/ssejas-castro/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/RK8JVMEI/AI%20patent%20blog%20post%20by%20Yuki%20on%20DeepMind%20protein%20structure%20prediction%202Aug2021.DOCX#_ftn1" name="_ftnref1" title="">[1]</a>&nbsp;The article describes how the neural network model developed by Google&rsquo;s DeepMind can predict protein structures &ldquo;with atomic accuracy even where no similar structure is known.&rdquo;<a href="file:///C:/Users/ProfileDisk/ssejas-castro/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/RK8JVMEI/AI%20patent%20blog%20post%20by%20Yuki%20on%20DeepMind%20protein%20structure%20prediction%202Aug2021.DOCX#_ftn2" name="_ftnref2" title="">[2]</a>&nbsp;In addition, DeepMind has now open-sourced the code for AlphaFold 2, allowing further collaborations for even more accurate protein structure prediction.</p> <p>A protein can have a highly complex 3D structure through a process called protein folding, and the task of predicting the structure has been &ldquo;an important open research problem for more than 50 years.&rdquo;<a href="file:///C:/Users/ProfileDisk/ssejas-castro/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/RK8JVMEI/AI%20patent%20blog%20post%20by%20Yuki%20on%20DeepMind%20protein%20structure%20prediction%202Aug2021.DOCX#_ftn3" name="_ftnref3" title="">[3]</a>&nbsp;Last year DeepMind entered the research competition CASP14 (14th Critical Assessment of protein Structure Prediction), won the competition, and redesigned AlphaFold to create AlphaFold 2 in December 2020. The CASP competitions, considered as &ldquo;the Olympics of protein folding,&rdquo;<a href="file:///C:/Users/ProfileDisk/ssejas-castro/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/RK8JVMEI/AI%20patent%20blog%20post%20by%20Yuki%20on%20DeepMind%20protein%20structure%20prediction%202Aug2021.DOCX#_ftn4" name="_ftnref4" title="">[4]</a>&nbsp;have been held biennially since 1994, and after the development of AlphaFold 2, some view that the protein folding problem has been essentially solved. DeepMind has successfully improved the prediction accuracy &ldquo;by incorporating novel neural network architectures and training procedures based on the evolutionary, physical, and geometric constraints of protein structure.&rdquo;<a href="file:///C:/Users/ProfileDisk/ssejas-castro/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/RK8JVMEI/AI%20patent%20blog%20post%20by%20Yuki%20on%20DeepMind%20protein%20structure%20prediction%202Aug2021.DOCX#_ftn5" name="_ftnref5" title="">[5]</a>&nbsp;&nbsp;</p> <p>AlphaFold inspired other research efforts, which led to the publication of another article on July 15, &ldquo;Accurate prediction of protein structures and interactions using a three-track neural network.&rdquo;<a href="file:///C:/Users/ProfileDisk/ssejas-castro/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/RK8JVMEI/AI%20patent%20blog%20post%20by%20Yuki%20on%20DeepMind%20protein%20structure%20prediction%202Aug2021.DOCX#_ftn6" name="_ftnref6" title="">[6]</a>&nbsp;The article by academic researchers describes how their RoseTTAFold model predicted protein structures at the accuracy level close to that of AlphaFold. The model features a three-track network where &ldquo;information at the 1D sequence level, the 2D distance map level, and the 3D coordinate level is successively transformed and integrated.&rdquo; With such technology &ldquo;RoseTTAFold enables solutions of challenging X-ray crystallography and cryo-EM modeling problems, provides insight into protein function in the absence of experimentally determined structures, and rapidly generates accurate models of protein-protein complexes.&rdquo;</p> <p>Protein misfolding could lead to various diseases and disorders, and thus the availability of computational tools that provide insight into protein folding is significant to drug discovery and development. The prediction models, together with experimental techniques, are expected to help better understand the causes of diseases and design compounds that could effectively treat the diseases.</p> <p>In terms of patent protection, London-based DeepMind filed three PCT International Applications with the same title &ldquo;Machine Learning for Determining Protein Structures&rdquo; on September 16, 2019, claiming priorities to the same three U.S. provisional applications filed in September and November 2018.</p> <p><img src="https://www.theaipatentblog.com/R3507S374/assets/images//chart%20_%208.2.21%20YOnoe%20blog.jpg" hspace="0" vspace="0" align="absmiddle" alt="" border="0" width="600" height="100" /></p> <p style="margin-left: 40px;">U.S. Provisional Applications:</p> <p style="margin-left: 80px;">No. 62/734,757 filed September 21, 2018<br /> No. 62/734,773 filed September 21, 2018<br /> No. 62/770,490 filed November 21, 2018</p> <p>WO2020/058174 includes claims to a prediction method, a system, and computer storage media. Claim 1 is as follows.</p> <p style="margin-left: 40px;">1. A method performed by one or more data processing apparatus for determining a final predicted structure of a given protein, wherein the given protein includes a sequence of amino acids, wherein a predicted structure of the given protein is defined by values of a plurality of structure parameters, the method comprising:<br /> generating a plurality of predicted structures of the given protein, wherein generating a predicted structure of the given protein comprises:<br /> obtaining initial values of the plurality of structure parameters defining the predicted structure;<br /> updating the initial values of the plurality of structure parameters, comprising, at each of a plurality of update iterations:<br /> determining a quality score characterizing a quality of the predicted structure defined by current values of the structure parameters, wherein the quality score is based on respective outputs of one or more scoring<br /> neural networks which are each configured to process: (i) the current values of the structure parameters, (ii) a representation of the sequence of amino acids of the given protein, or (iii) both; and<br /> for one or more of the plurality of structure parameters:<br /> determining a gradient of the quality score with respect to the current value of the structure parameter; and<br /> updating the current value of the structure parameter using the gradient of the quality score with respect to the current value of the structure parameter; and determining the predicted structure of the given protein to be defined by the current values of the plurality of structure parameters after a final update iteration of the plurality of update iterations; and<br /> selecting a particular predicted structure of the given protein as the final predicted structure of the given protein.</p> <p>The prediction method of Claim 1 generates multiple predicted structures of a given protein, conducts certain calculations, and at the end selects a particular predicted structure of the given protein as the final predicted structure.&nbsp;The calculations involve obtaining initial values of structural parameters defining the predicted structure and updating the values.&nbsp;The updating process includes the following determining process using neural networks (emphasis added):</p> <p style="margin-left: 40px;">&ldquo;determining a quality score characterizing a quality of the predicted structure defined by current values of the structure parameters, wherein the quality score is based on respective outputs of&nbsp;<u>one or more scoring neural networks which are each configured to process: (i) the current values of the structure parameters, (ii) a representation of the sequence of amino acids of the given protein, or (iii) both</u>&rdquo;</p> <p style="margin-left: 40px;">Claim 1 therefore recites the general functions of the neural networks, but does not recite any specific architectures of neural networks. Thus, similar to&nbsp;<a href="https://www.theaipatentblog.com/disclosing-ai-inventions-part-i-identifying-the-unique-disclosure-issues">Ed Garlepp&rsquo;s discussion</a>&nbsp;on unique disclosure issues with AI, the neural network is treated more like a &ldquo;black box&rdquo; in the claim, although DeepMind was presumably working to develop novel network architectures. This claim is a good example of the balance needed by patent practitioners when drafting claims that involve a neural network.</p> <p>We note the PCT application was filed well before DeepMind conducted more extensive studies in CASP14, facing the challenge to model various unknown protein structures provided in May-August 2020. During the pandemic the team worked on predicting the structure of SARS-CoV-2 Orf8, one of the coronavirus proteins. In view of the serious circumstances DeepMind was sharing the findings and publishing the results as they were obtained. The patent strategy at DeepMind might have shifted toward an open strategy through such work, which resulted in the recent publication of the details of their technology with the source code being made available under an open-source license.&nbsp;</p> <p>We look forward to tracking the prosecution of this patent as well as the general evolution of this technology.</p> <div><br clear="all" /> <hr align="left" size="1" width="33%" /> <div id="ftn1"> <p><a href="file:///C:/Users/ProfileDisk/ssejas-castro/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/RK8JVMEI/AI%20patent%20blog%20post%20by%20Yuki%20on%20DeepMind%20protein%20structure%20prediction%202Aug2021.DOCX#_ftnref1" name="_ftn1" title="">[1]</a>&nbsp;Jumper, J. et al. Highly accurate protein structure prediction with AlphaFold.&nbsp;<i>Nature&nbsp;</i>https://doi.org/10.1038/s41586-021-03819-2 (2021).</p> </div> <div id="ftn2"> <p><a href="file:///C:/Users/ProfileDisk/ssejas-castro/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/RK8JVMEI/AI%20patent%20blog%20post%20by%20Yuki%20on%20DeepMind%20protein%20structure%20prediction%202Aug2021.DOCX#_ftnref2" name="_ftn2" title="">[2]</a>&nbsp;<i>Id.</i>, Abstract.</p> </div> <div id="ftn3"> <p><a href="file:///C:/Users/ProfileDisk/ssejas-castro/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/RK8JVMEI/AI%20patent%20blog%20post%20by%20Yuki%20on%20DeepMind%20protein%20structure%20prediction%202Aug2021.DOCX#_ftnref3" name="_ftn3" title="">[3]</a>&nbsp;<i>Id.</i></p> </div> <div id="ftn4"> <p><a href="file:///C:/Users/ProfileDisk/ssejas-castro/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/RK8JVMEI/AI%20patent%20blog%20post%20by%20Yuki%20on%20DeepMind%20protein%20structure%20prediction%202Aug2021.DOCX#_ftnref4" name="_ftn4" title="">[4]</a>&nbsp;DeepMind (2020).&nbsp;<i>AlphaFold: The making of a scientific breakthrough</i>&nbsp;[Video]. YouTube. https://www.youtube.com/watch?v=gg7WjuFs8F4</p> </div> <div id="ftn5"> <p><a href="file:///C:/Users/ProfileDisk/ssejas-castro/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/RK8JVMEI/AI%20patent%20blog%20post%20by%20Yuki%20on%20DeepMind%20protein%20structure%20prediction%202Aug2021.DOCX#_ftnref5" name="_ftn5" title="">[5]</a>&nbsp;Jumper, J. et al. Highly accurate protein structure prediction with AlphaFold.&nbsp;<i>Nature&nbsp;</i>https://doi.org/10.1038/s41586-021-03819-2 (2021).</p> </div> <div id="ftn6"> <p><a href="file:///C:/Users/ProfileDisk/ssejas-castro/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/RK8JVMEI/AI%20patent%20blog%20post%20by%20Yuki%20on%20DeepMind%20protein%20structure%20prediction%202Aug2021.DOCX#_ftnref6" name="_ftn6" title="">[6]</a>&nbsp;M. Baek&nbsp;<i>et al.</i>,&nbsp;<i>Science&nbsp;</i>10.1126/science.abj8754 (2021).</p> </div> </div> Article 02 Aug 2021 00:00:00 -0800 https://www.oblon.com/?t=40&an=118329&anc=995&format=xml AlphaFold 2, Open Source AI for Protein Structure Prediction (Japanese) https://www.oblon.com/?t=40&an=118333&anc=995&format=xml <p>7月15日に興味深い<i>Nature</i>論文が発表された。タイトルは &ldquo;Highly accurate protein structure prediction with AlphaFold&rdquo;<a href="file:///C:/Users/ProfileDisk/ssejas-castro/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/RK8JVMEI/JP%20version_%20blog%20post%20by%20Yuki%20on%20DeepMind%20protein%20structure%20prediction%202Aug2021.DOCX#_ftn1" name="_ftnref1" title="">[1]</a> (AlphaFoldによる高精度タンパク質構造予測)で、Google傘下のDeepMind社によって開発されたニューラルネットワークに関する詳細が記載されている。同技術によれば、あるタンパク質について&ldquo;with atomic accuracy even where no similar structure is known&rdquo;<a href="file:///C:/Users/ProfileDisk/ssejas-castro/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/RK8JVMEI/JP%20version_%20blog%20post%20by%20Yuki%20on%20DeepMind%20protein%20structure%20prediction%202Aug2021.DOCX#_ftn2" name="_ftnref2" title="">[2]</a>(同様の構造が未知の場合でも原子レベルで)精度良くその構造を予測することができるとされている。DeepMind社は同時に AlphaFold 2のソースコードを開放しており、さらに高精度のタンパク質構造予測を目指してより一層活発な研究開発が期待される。</p> <p>タンパク質はフォールディング(折り畳み)により複雑な3D構造をとりうる。構造予測は「50年を超える長期に渡って、広く取り組まれてきた重要な研究課題」<a href="file:///C:/Users/ProfileDisk/ssejas-castro/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/RK8JVMEI/JP%20version_%20blog%20post%20by%20Yuki%20on%20DeepMind%20protein%20structure%20prediction%202Aug2021.DOCX#_ftn3" name="_ftnref3" title="">[3]</a>と言われている。昨年DeepMind社はCASP14 (14th Critical Assessment of protein Structure Prediction)と呼ばれる評価実験に参加し、他社技術を超える精度での予測に成功した後、AlphaFoldの改良版であるAlphaFold 2を12月に発表した。CASP 評価実験は「タンパク質フォールディングのオリンピック」<a href="file:///C:/Users/ProfileDisk/ssejas-castro/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/RK8JVMEI/JP%20version_%20blog%20post%20by%20Yuki%20on%20DeepMind%20protein%20structure%20prediction%202Aug2021.DOCX#_ftn4" name="_ftnref4" title="">[4]</a> とも言われ、1994年から2年ごとに行われてきた。AlphaFold 2の開発によりタンパク質フォールディングの問題はほぼ解決されたとの見方もある。DeepMind社は、「進化に関わるタンパク質構造への制約、物理的及び立体的制約をもとにした、新規のニューラルネットワーク構造やトレーニング方法を導入することによって」<a href="file:///C:/Users/ProfileDisk/ssejas-castro/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/RK8JVMEI/JP%20version_%20blog%20post%20by%20Yuki%20on%20DeepMind%20protein%20structure%20prediction%202Aug2021.DOCX#_ftn5" name="_ftnref5" title="">[5]</a>、構造予測の精度を大幅に改善することに成功した。</p> <p>AlphaFoldが刺激となり他の研究も進められ、7月15日同日に別の論文も発表されている。タイトルは &ldquo;Accurate prediction of protein structures and interactions using a three-track neural network&rdquo;<a href="file:///C:/Users/ProfileDisk/ssejas-castro/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/RK8JVMEI/JP%20version_%20blog%20post%20by%20Yuki%20on%20DeepMind%20protein%20structure%20prediction%202Aug2021.DOCX#_ftn6" name="_ftnref6" title="">[6]</a> (3トラックニューラルネットワークを用いた、タンパク質の構造及び相互作用の高精度予測)である。この論文は大学等の研究チームによるもので、RoseTTAFold モデルによってAlphaFoldに近い精度でタンパク質構造予測が可能になったと述べられている。このモデルは3トラックのネットワークを使用して「1D配列レベル、2D距離マップレベル、3D配位レベルの情報が次々と変換され組み入れられる」点が特徴的である。これにより 「RoseTTAFold は、X線結晶構造解析やクライオ電子顕微鏡によるモデリングでは困難とされた問題を解決でき、実験による構造決定を行わずともタンパク質の機能に関する知見を得ることができ、タンパク質複合体に対しても高精度のモデルを短時間で提供することができる」と説明されている。</p> <p>タンパク質の折り畳み異常が起こると様々な疾患や障害の原因となりうるため、折り畳みに関する知見をもたらす予測計算ツールの開発は医薬品の研究開発に非常に重要である。そのような予測モデルと実験手法とを用いれば、特定疾患の原因に対する理解を深めることができ、治療に効果を示す化合物設計にもつながることが期待される。</p> <p>特許保護に関しては、ロンドンを拠点とするDeepMind社は&ldquo;Machine Learning for Determining Protein Structures&rdquo;(タンパク質構造決定のための機械学習)というタイトルで2019年9月16日にPCT出願を3件行っている。優先出願は2018年9月と11月の米国仮出願である。</p> <img src="https://www.oblon.com/A11960/assets/images//chart _ 8.2.21 YOnoe blog.jpg" hspace="0" vspace="0" align="absmiddle" alt="" border="0" width="600" height="100" /><br /> <p>U.S. Provisional Applications:</p> <p style="margin-left: 40px;">No. 62/734,757 filed September 21, 2018<br /> No. 62/734,773 filed September 21, 2018<br /> No. 62/770,490 filed November 21, 2018</p> <p style="margin-left: 40px;">WO2020/058174公報では、予測方法、システム、コンピュータストレージメディアのクレームが公開されており、クレーム1は下記の通りである。</p> <p style="margin-left: 40px;">1. A method performed by one or more data processing apparatus for determining a final predicted structure of a given protein, wherein the given protein includes a sequence of amino acids, wherein a predicted structure of the given protein is defined by values of a plurality of structure parameters, the method comprising:<br /> generating a plurality of predicted structures of the given protein, wherein generating a predicted structure of the given protein comprises:<br /> obtaining initial values of the plurality of structure parameters defining the predicted structure;<br /> updating the initial values of the plurality of structure parameters, comprising, at each of a plurality of update iterations:<br /> determining a quality score characterizing a quality of the predicted structure defined by current values of the structure parameters, wherein the quality score is based on respective outputs of one or more scoring neural networks which are each configured to process: (i) the current values of the structure parameters, (ii) a representation of the sequence of amino acids of the given protein, or (iii) both; and<br /> or one or more of the plurality of structure parameters:<br /> determining a gradient of the quality score with respect to the current value of the structure parameter; and<br /> updating the current value of the structure parameter using the gradient of the quality score with respect to the current value of the structure parameter; and determining the predicted structure of the given protein to be defined by the current values of the plurality of structure parameters after a final update iteration of the plurality of update iterations; and<br /> selecting a particular predicted structure of the given protein as the final predicted structure of the given protein.</p> <p>クレーム1の予測方法は、あるタンパク質に対し複数の構造を予測し、それに基づいて特定の計算を行った後、1つの予測構造を最終的な予測構造として選ぶというものである。計算の内容は、予測構造を定義する構造的パラメータの初期値を求めそれをアップデートするものであり、アップデートの際に下記のようなニューラルネットワークを用いた決定を行う(下線は追加)、とクレーム1に記載されている:</p> <p style="margin-left: 40px;">&ldquo;determining a quality score characterizing a quality of the predicted structure defined by current values of the structure parameters, wherein the quality score is based on respective outputs of <u>one or more scoring neural networks which are each configured to process: (i) the current values of the structure parameters, (ii) a representation of the sequence of amino acids of the given protein, or (iii) both</u>&rdquo;</p> <p>上記の通り、クレーム1に書かれているのはニューラルネットワークの一般的な機能であって、特定のネットワーク構造ではない。DeepMind社は新規のネットワーク構造を開発していたとみられるが、このクレームの中では「ブラックボックス」のように扱われている。<a href="https://www.theaipatentblog.com/disclosing-ai-inventions-part-i-identifying-the-unique-disclosure-issues">Ed Garleppのブログ記事</a> でも取り上げているが、AI関連発明のクレームをどのように表現するかは検討課題である。ニューラルネットワークの関わるクレームにどの程度の詳細を記載すべきかそのバランスを考えるための良い例のように思われる。</p> <p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; PCT出願が行われた後、DeepMind社はCASP14において昨年5月から8月に課題として出された未知のタンパク質構造のモデリングに挑戦し、研究開発を重ねている。パンデミック下でコロナウィルスに関わるタンパク質の1つであるSARS-CoV-2 Orf8のモデリングにも取り組み、何らかの知見が得られた時点で速やかに結果を公表するということを進めてきた。そのような背景でDeepMind社の特許戦略もよりオープンな方向にシフトし、技術内容の公開とオープンソースライセンスに基づくソースコードの開放につながったのかもしれない。&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</p> <p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 今後も特許出願の動向と技術の発展に注目していきたい。</p> <div><br clear="all" /> <hr align="left" size="1" width="33%" /> <div id="ftn1"> <p><a href="file:///C:/Users/ProfileDisk/ssejas-castro/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/RK8JVMEI/JP%20version_%20blog%20post%20by%20Yuki%20on%20DeepMind%20protein%20structure%20prediction%202Aug2021.DOCX#_ftnref1" name="_ftn1" title="">[1]</a> Jumper, J. et al. Highly accurate protein structure prediction with AlphaFold. <i>Nature </i>https://doi.org/10.1038/s41586-021-03819-2 (2021).</p> </div> <div id="ftn2"> <p><a href="file:///C:/Users/ProfileDisk/ssejas-castro/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/RK8JVMEI/JP%20version_%20blog%20post%20by%20Yuki%20on%20DeepMind%20protein%20structure%20prediction%202Aug2021.DOCX#_ftnref2" name="_ftn2" title="">[2]</a> <i>Id.</i>, Abstract.</p> </div> <div id="ftn3"> <p><a href="file:///C:/Users/ProfileDisk/ssejas-castro/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/RK8JVMEI/JP%20version_%20blog%20post%20by%20Yuki%20on%20DeepMind%20protein%20structure%20prediction%202Aug2021.DOCX#_ftnref3" name="_ftn3" title="">[3]</a> <i>Id.</i></p> </div> <div id="ftn4"> <p><a href="file:///C:/Users/ProfileDisk/ssejas-castro/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/RK8JVMEI/JP%20version_%20blog%20post%20by%20Yuki%20on%20DeepMind%20protein%20structure%20prediction%202Aug2021.DOCX#_ftnref4" name="_ftn4" title="">[4]</a> DeepMind (2020). <i>AlphaFold: The making of a scientific breakthrough</i> [Video]. YouTube. https://www.youtube.com/watch?v=gg7WjuFs8F4</p> </div> <div id="ftn5"> <p><a href="file:///C:/Users/ProfileDisk/ssejas-castro/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/RK8JVMEI/JP%20version_%20blog%20post%20by%20Yuki%20on%20DeepMind%20protein%20structure%20prediction%202Aug2021.DOCX#_ftnref5" name="_ftn5" title="">[5]</a> Jumper, J. et al. Highly accurate protein structure prediction with AlphaFold. <i>Nature </i>https://doi.org/10.1038/s41586-021-03819-2 (2021).</p> </div> <div id="ftn6"> <p><a href="file:///C:/Users/ProfileDisk/ssejas-castro/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/RK8JVMEI/JP%20version_%20blog%20post%20by%20Yuki%20on%20DeepMind%20protein%20structure%20prediction%202Aug2021.DOCX#_ftnref6" name="_ftn6" title="">[6]</a> M. Baek <i>et al.</i>, <i>Science </i>10.1126/science.abj8754 (2021).</p> </div> </div> Article 02 Aug 2021 00:00:00 -0800 https://www.oblon.com/?t=40&an=118333&anc=995&format=xml USPTO Updates Its Guidance On Interim Director Review Process https://www.oblon.com/?t=40&an=118198&anc=995&format=xml <p>On July 20, 2021, and in response to the Office&rsquo;s request for feedback on the interim Director review process, the USPTO has updated and revised its <a href="https://protect-us.mimecast.com/s/O3miCW6jLyu5NnGkixpTW2?domain=lnks.gd" target="_blank"><i>Arthrex </i>Q&amp;As</a> to clarify certain aspects of the interim procedure.</p> <p>For example, and as discussed in my June 29, 2021 <a href="https://www.oblon.com/uspto-issues-guidance-on-an-interim-director-review-process-following-arthrex">post</a>,&nbsp;the Office&rsquo;s original guidance was unclear as to whether serial panel rehearing and then Director review petitions would be allowed. The Q&amp;A now makes clear that a party <i>cannot</i> request both Director review and panel rehearing after issuance of a final written decision:</p> <p style="margin-left: 40px;">[A]fter a panel issues a final written decision in an inter partes review or a post-grant review, a party may request either Director review or rehearing by the original PTAB panel, but may not request both. If a party requests Director review, and that review is not granted, the party may not then request PTAB panel rehearing. If a party requests rehearing by the original PTAB panel and the panel denies rehearing, the party may not request Director review of that decision. In the event a panel grants rehearing, however, a party may request Director review of that panel decision following the same procedure described above. If a party requests both Director review and panel rehearing (either together, or in the alternative) of a final written decision or a decision granting rehearing by a PTAB panel, the Office will treat such a request as a request for Director review.</p> <p><br /> The Office also provided the following guidance as to what happens to a Director review request when it is received by the USPTO:</p> <p style="margin-left: 40px;">Requests for Director review will be evaluated by an advisory committee established by the Director. That committee will advise the Director on whether decisions merit review. The advisory committee will include members from various business units within the Office, such as the Office of the Under Secretary, the PTAB, the Office of the Commissioner for Patents, the Office of the General Counsel, and the Office of Policy and International Affairs. The Director will determine whether review will be granted or denied.</p> <p>As to the criteria for evaluating whether to grant or deny a request for Director review, the Q&amp;A&rsquo;s state that &ldquo;[a]lthough there is no exclusive list of criteria, decisions may warrant review if they include, for example, material errors of fact or law, matters that the Board misapprehended or overlooked, novel issues of law or policy, issues on which Board panel decisions are split, issues of particular importance to the Office or patent community, or inconsistencies with Office procedures, guidance, or decisions.&rdquo;</p> <p>We will continue to monitor developments in this area and provide updates on our website.</p> Article 21 Jul 2021 00:00:00 -0800 https://www.oblon.com/?t=40&an=118198&anc=995&format=xml Judge Albright Grants Motion to Dismiss for Improper Venue: Holds That Leased Shelf Space Alone is Not Enough to Qualify as a "Regular and Established Place of Business" https://www.oblon.com/?t=40&an=118182&anc=995&format=xml <p>On June 22, 2021, Judge Albright granted Defendant PEAG, LLC&rsquo;s motion to dismiss for improper venue under Rule 12(b)(3), finding that venue in the Western District of Texas was improper.</p> <p>By way of background, Koss Corporation filed suit against PEAG, LLC in the Western District of Texas on July 22, 2020. PEAG is incorporated in the State of Delaware with its principal place of business located in Carlsbad, California. In its Complaint, Koss alleged direct and indirect infringement of four patents related to wireless and wearable headphone products, alleging that PEAG infringed each patent by selling wireless headphone products and that venue was proper in the Western District of Texas because PEAG has transacted business in the district.&nbsp; PEAG filed a motion to dismiss for improper venue or, in the alternative, to transfer venue based on the convenience of the parties.&nbsp; Specifically, PEAG argued that it neither resides in the Western District of Texas nor has a &ldquo;regular and established place of business&rdquo; in Texas.</p> <p>Where a patent case may be brought is governed by a specific patent-venue statue, 28 U.S.C. &sect; 1400(b).&nbsp; The statue allows an infringement action to be brought either (1) in a district where the defendant resides, which for a corporation is its state of incorporation; or (2) in a district &ldquo;where the defendant has committed acts of infringement and has a regular and established place of business.&rdquo;&nbsp; The Federal Circuit has clarified that a defendant&rsquo;s regular and established place of business must be (1) a physical place in the district; (2) a regular and established place of business; and (3) the &ldquo;place of the defendant.&rdquo;&nbsp; <i>In re Cray Inc.</i>, 871 F.3d 1355, 1360 (Fed. Cir. 2017).</p> <p>In opposition to PEAG&rsquo;s motion to dismiss, Koss argued that PEAG met the &ldquo;regular and established place of business&rdquo; requirement from &sect; 1400(b) by possessing or controlling a physical place of business in the district, specifically, by exercising control over leased shelf space in various retail stores in the District.</p> <p>Judge Albright in his June 22, 2021 order disagreed, stating that Koss had &ldquo;failed to prove that PEAG has a regular and established place of business in this District because (1) PEAG does not lease or own any real property in the Western District of Texas; and (2) PEAG does not possess or control any physical place in this district.&rdquo;</p> <p>Judge Albright noted that while PEAG leased the shelf space in retail stores, it did not have employees actually residing in the district and was not in charge of stocking the shelves or maintaining the shelf space.&nbsp; Here, PEAG would merely ship its products to third-party retail stores, and the retail store employees would ultimately be in charge of placing the product on the shelves.&nbsp; Judge Albright used this fact to distinguish the present case from <i>Tinnus Enters., LLC v. Telebrands Corp.</i>, 2018 U.S. Dist. LEXIS 78342 (E.D. Tex. May 2, 2018), where an Eastern District of Texas Court previously found that leased shelf space was an appropriate basis for venue in a patent case, because the defendant&rsquo;s agent was responsible for sales-related operations, such as restocking, affixing pricing stickers, and arranging lots.&nbsp; Ultimately, Judge Albright concluded that &ldquo;[l]eased shelf space can only serve as a &lsquo;regular and established place of business&rsquo; under the patent venue statute if the defendant also has an employee or agent conducting business in that district.&rdquo;</p> <p>Whether other district courts and the Federal Circuit will ultimately agree with Judge Albright&rsquo;s conclusion that leased shelf space alone is not enough to satisfy the &ldquo;regular and established place of business&rdquo; prong of the patent venue statute remains to be seen.&nbsp; But this decision may be an important and useful guide for any company that ships products into the Western District of Texas without an employee or agent in the district assisting with that process. The decision also represents one of a few recent decisions from Judge Albright where defendants have successfully avoiding litigating in the Western District of Texas.&nbsp; Stakeholders and practitioners can look to these cases for useful insights into the facts and arguments that work (or don&rsquo;t work) when arguing for a transfer out of Waco, and we plan to follow-up with a much more in-depth look at these decisions in the near future.</p> Article 20 Jul 2021 00:00:00 -0800 https://www.oblon.com/?t=40&an=118182&anc=995&format=xml