Publications – Oblon, McClelland, Maier & Neustadt, L.L.P. https://www.oblon.com/?r=publications/feed Intellectual Property Law Firm en-us 07 Dec 2022 00:00:00 -0800 firmwise http://blogs.law.harvard.edu/tech/rss Written Description is Not Always Your Friend https://www.oblon.com/?t=40&an=129681&anc=995&format=xml <p>While an adequate written description is essential for patentability, 35 U.S.C. &sect; 112(a), like everything else too much can have adverse consequences as uniQure biopharma recently learned in IPR2021-00926 (IPR) involving U.S.P. 9,982,248 (&lsquo;248).</p> <p>The &lsquo;248 patent specification defines many conventional terms in the polypeptide and pharmaceutical arts. A definition which ultimately sunk many of &lsquo;248 claims was &ldquo;treat&rdquo; or &ldquo;treatment.&rdquo; Treatment of a disease may have different meanings depending on the context. For example, it is well-known to treat Alzheimer&rsquo;s or Parkinson&rsquo;s disease with anti-psychotics to improve a patient&rsquo;s quality of life without curing the underlying disease. But treating a bacterial infection with an antibiotic normally does mean &ldquo;curing&rdquo; the disease by killing off the bacteria. While defining terms to avoid issues in prosecution, or litigation or licensing may be useful, it must be done with a view to the specific invention. If the disease is Parkinson&rsquo;s defining the term as a &ldquo;cure&rdquo; will create enablement issues absent proof that the disclosed treatment cures Parkinson&rsquo;s and not, simply ameliorates its symptoms. The &lsquo;248 patent was directed to treating acoagulopathy in humans which includes hemophilia B.</p> <p style="margin-left: 40px;">The &lsquo;248 patent defined the term &ldquo;treat&rdquo; or &ldquo;treatment&rdquo; as:</p> <p style="margin-left: 40px;">In the present text the term &ldquo;treat&rdquo; or &ldquo;treatment&rdquo; of a pathology means the prophylaxis and/or therapy and/or cure of this pathology. The term prophylaxis means advantageously to at least partially arrest the development of a potential disease and/or to prevent the worsening of symptoms or progression of a disease. Advantageously, the term therapy means a partial or total alleviation of the disease symptoms.</p> <p>In the IPR the definition became dispositive of the patentability of some claims at issue. The &lsquo;248 patent was directed to treating acoagulopathy with gene therapy.&nbsp; Acoagulopathy is caused by a body&rsquo;s inability to generate the vitamin K-dependent glycoprotein, FIX, synthesized in the liver, and playing a fundamental role in the coagulation cascade. With gene therapy the concept was to help the body synthesize&nbsp; FIX.&nbsp; Others had attempted this with varying degrees of success. One key to the success of the&rsquo;248 patent was the use of a specific adeno-associated virus (AVV) for inserting the FIX glycoprotein to provide for expression of FIX <i>in vivo.</i>&nbsp; The prior art to Manno taught the use of AVV to introduce FIX into a patient with&nbsp; hemophilia B where therapeutic levels of FIX were achieved and maintained for about 8 weeks and experienced an immune response which caused a short duration of efficacy. In contrast Manno reported that in dogs and nonhuman primates the expression was long lasting.</p> <p>Manno was combined with another reference, Stafford, where Manno was used to address the deficiencies in Stafford. The patentee argued that Manno failed at treating hemophilia B.&nbsp; This argument was dismissed by the PTAB because the PTAB had adopted as the definition the one proposed by the Petitioner taken from the specification.&nbsp; A definition which defined &ldquo;treating&rdquo; hemophilia which included partial alleviation of symptoms, for any duration of therapeutic efficacy.&nbsp; Here the evidence was that the Manno therapeutic efficacy lasted for 10 weeks.&nbsp; A declaration submitted by the patentee was dismissed because it assumed claim limitations related to the duration of treatment and efficacy that under the PTAB claim interpretation were not present in the claims.</p> <p>Here arguments that may have succeeded were negated by the Patentee&rsquo;s definition of &ldquo;treatment.&rdquo; Had the definition not been present the Patentee could have presented evidence as to how one skilled in the art would have interpreted &ldquo;treatment&rdquo; which could have included a long duration without an immune response, an argument precluded by the specification&rsquo;s definition. The patentee wanted broad protection which its definition provided but in doing so undercut the patentability of the invention.</p> <p>In defining terms in an application, one needs to first carefully consider whether defining the term will be advantageous or are there possible adverse consequences.&nbsp; Here the PTAB used the definition against the Patentee. Had the term not been defined then the Patentee could have provided testimony as to what how term would be understood by one of ordinary skill in the art.&nbsp; Absent a definition there would have been a battle of the experts where the Patentee&rsquo;s arguments might have been persuasive. Where the term is unusual or not well understood, then a definition may be required but then the definition should be carefully considered in view of the inventor&rsquo;s objective. Broad definitions do not necessarily lead to strong claims and may preclude patenting later developments.</p> Article 21 Nov 2022 00:00:00 -0800 https://www.oblon.com/?t=40&an=129681&anc=995&format=xml A Class of 957 Predicted Salts Is Insufficient To Meet the ‘At Once Envisage' Standard https://www.oblon.com/?t=40&an=129444&anc=995&format=xml <p>Mylan Pharmaceuticals, Inc. (&ldquo;Mylan&rdquo;) appealed from the final written decision of the USPTO Patent Trial and Appeal Board (the &ldquo;Board&rdquo;) holding that Mylan failed to show that claims 1&ndash;4, 17, 19, and 21&ndash;23 of U.S. Patent 7,326,708 (the &ldquo;&rsquo;708 patent&rdquo;) were anticipated or would have been obvious over the cited prior art.</p> <p>Merck Sharp &amp; Dohme Corp. (&ldquo;Merck&rdquo;) owns the &rsquo;708 patent, which describes sitagliptin dihydrogenphosphate (&ldquo;sitagliptin DHP&rdquo;). Sitagliptin DHP is a dihydrogenphosphate salt of 4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro [1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine. Sitagliptin DHP belongs to the class of dipeptidyl peptidase-IV inhibitors, which can be used for treating non-insulin-dependent (i.e., Type 2) diabetes. Independent claim 1 recites a sitagliptin DHP salt with a 1:1 stoichiometry.</p> <p>Mylan petitioned for <i>inter partes</i> review of claims 1&ndash;4, 17, 19, and 21&ndash;23 of the &rsquo;708 patent and argued that the claims were anticipated by WO 2003/004498, a Merck-owned publication (equivalent to U.S. Patent 6,699,871 (collectively &ldquo;Edmondson&rdquo;)). Edmondson is directed to compounds which are inhibitors of the dipeptidyl peptidase-IV enzyme and are useful in the treatment of diseases in which the dipeptidyl peptidase-IV enzyme is involved, e.g., type 2 diabetes. Edmondson discloses a genus of DP-IV inhibitors and 33 species, one of which is sitagliptin and further discloses that pharmaceutically acceptable salts can be formed using one of eight particularly preferred acids. The salts may exist in crystalline forms, including as hydrates. Mylan also argued that the claims would have been obvious over Edmondson and two additional publications by Brittain and Bastin.</p> <p>The Board determined that there was no express disclosure of all of the limitations of the 1:1 sitagliptin DHP salt in Edmondson, and that Mylan could not fill in the gaps by arguing that a skilled artisan would &ldquo;at once envisage&rdquo; what was missing. Also, Mylan had not proven an inherent disclosure of the 1:1 sitagliptin DHP salt in Edmondson, and experimental evidence and technical literature undeniably showed that 1:1 sitagliptin DHP did not form every time sitagliptin and DHP were reacted. The Board concluded that the claims were not expressly or inherently anticipated by Edmondson and would not have been obvious in view of Edmondson, Bastin, or Brittain.</p> <p>The Board considered the issue whether Merck could antedate Edmondson with evidence that it had reduced to practice the subject matter of claims 1, 2, 17, 19, and 21&ndash;23 before Edmondson was published on January 16, 2003. The Board concluded that Merck had reduced to practice &ldquo;at least as much, and in fact more, of the claimed subject matter than was shown in Edmondson. Thus, Merck could successfully antedate the subject matter of claims 1, 2, 17, 19, and 21&ndash;23, and thus Edmondson was not a 35 U.S.C. &sect; 102(a) reference,&rdquo; but was a 35 U.S.C. &sect; 102(e) (pre-AIA) reference. Because it was undisputed that the inventions claimed in the &rsquo;708 patent and the subject matter of Edmondson were commonly owned by Merck at the time of the invention, the Board determined that the 35 U.S.C. &sect; 103(c)(1) (pre-AIA) exception applied to the claims at issue.</p> <p>The Board further considered whether claim 3, which recites the (S)-configuration of sitagliptin DHP, and claim 4, which recites the crystalline monohydrate form of (R)-sitagliptin, would have been obvious in view of Edmondson, Bastin, and Brittain and found that the references did not disclose &ldquo;anything related to (S)-sitagliptin or even a racemic mixture of any sitagliptin salt.&rdquo; The Board concluded that Mylan did not show that claim 3 would have been obvious. The Board also found that Mylan provided no rationale to explain why a person of ordinary skill would have been motivated to make the claimed crystalline monohydrate form of 1:1 sitagliptin DHP of claim 4 and failed to show that a skilled artisan would have had a reasonable expectation of success in making the crystalline monohydrate form of the 1:1 sitagliptin DHP salt. Thus, the Board held that Mylan had not demonstrated that claims 1&ndash;4, 17, 19, and 21&ndash;23 were anticipated or would have been obvious. Mylan appealed.</p> <p>Mylan raised three challenges on appeal at the Court of Appeals for the Federal Circuit (&ldquo;the Court&rdquo;). First, Mylan contended that the Board erred in determining that a 1:1 stoichiometry of sitagliptin DHP was not anticipated by Edmondson. Second, Mylan contended that the Board erred in determining that the &rsquo;708 patent antedated Edmondson. Third, Mylan contended that the Board erred in determining that Mylan failed to prove obviousness of claims 3 and 4.</p> <p>On appeal, Mylan argued that Edmondson anticipated the claims because it disclosed sitagliptin in a list of 33 compounds and asserted that Edmondson disclosed acids forming &ldquo;pharmaceutically acceptable salts,&rdquo; including phosphoric acid in a list of eight &ldquo;particularly preferred&rdquo; acids. Mylan asserted that sitagliptin DHP was effectively disclosed in Edmondson, and Edmondson thus anticipated the challenged claims. Mylan further asserted that a skilled artisan would &ldquo;<i>at once envisage</i>&rdquo; a 1:1 stoichiometry of the sitagliptin DHP salt for two reasons. First, Example 7 of Edmondson disclosed a sitagliptin hydrochloride salt having a 1:1 stoichiometry. Second, the experimental data presented by Mylan&rsquo;s expert illustrated that under the conditions allegedly similar to those in Edmondson only a 1:1 sitagliptin DHP stoichiometry could be formed. Mylan contended that the Board thus erred in holding that a 1:1 stoichiometry was not anticipated by Edmondson.</p> <p>Merck argued that the combined list of 33 compounds and eight preferred salts, taking into account various stoichiometric possibilities, would result in 957 salts, some of which might not even form under experimental conditions. &ldquo;That, Merck asserts, does not meet the standard set by the &lsquo;at once envisage&rsquo; theory. Merck argues that Mylan seeks to expand the theory inappropriately, improperly focusing on whether skilled artisans could have envisaged 1:1 sitagliptin DHP among the members of the class instead of envisaging <i>each</i> member of the disclosed class.&rdquo; Merck asserted that Mylan used hindsight to single out one compound from the large class and further argued that Mylan&rsquo;s own expert conceded that Edmondson did not direct a skilled artisan to sitagliptin from among the 33 DP-IVs, and it did not disclose a phosphate salt of any DP-IV inhibitor.</p> <p>The Court agreed with Merck that the Board had not erred in determining that Edmondson did not expressly disclose a 1:1 sitagliptin DHP salt. The Court pointed out that the Board grounded its finding in the testimony from Mylan&rsquo;s own expert stating that nothing in Edmondson directed a skilled artisan to sitagliptin from among the 33 listed DP-IV inhibitors. Further, nothing in Edmondson singled out phosphoric acid or any phosphate salt of any DP-IV inhibitor, and the list of &ldquo;pharmaceutically preferred&rdquo; salts included 44 pages earlier in the specification. The Board reasonably concluded that Edmondson did not expressly disclose the 1:1 sitagliptin DHP salt. The Court also agreed with Merck that the Board had not erred in determining that Edmondson did not inherently disclose a 1:1 sitagliptin DHP salt.</p> <p><i>In re Petering</i> stands for the proposition that a skilled artisan may &ldquo;at once envisage each member of [a] <i>limited</i> class, even though the skilled person might not at once define in his mind the formal boundaries of the class.&rdquo; 301 F.2d 678, 681 (emphasis added). The key term here is &ldquo;limited.&rdquo; &nbsp;The list of 33 compounds, with no direction to select sitagliptin from among them, plus the eight &ldquo;pharmaceutically preferred&rdquo; acids and various stoichiometric possibilities, results in 957 salts, some of which may not exist. &ldquo;That is a far cry from the 20 compounds &lsquo;envisaged&rsquo; by the narrow genus in <i>Petering</i>.&rdquo; The Court noted that Mylan&rsquo;s own expert even stated that salt formation was an unpredictable art that required a &ldquo;trial and error process.&rdquo; A specific number defining a &ldquo;limited class&rdquo; depends on the &ldquo;class.&rdquo; &ldquo;But we agree with Merck and hold that the Board did not err in finding that a class of 957 predicted salts that may result from the 33 disclosed compounds and eight preferred acids, some of which may not even form under experimental conditions, is insufficient to meet the &lsquo;at once envisage&rsquo; standard set forth in <i>Petering</i>.&rdquo;</p> <p>Concerning Mylan&rsquo;s challenge to the Board&rsquo;s determination that Mylan failed to prove that claims 1&ndash;4, 17, 19, and 21&ndash;23 would have been obvious the obviousness, Mylan argued that the Board erred in finding that Merck&rsquo;s reduction to practice of the 1:1 (R)-sitagliptin DHP salt antedated Edmondson, because Edmondson disclosed sitagliptin hydrates, and Merck had not made hydrates of 1:1 sitagliptin DHP until March 2003, about two months after the January 16, 2003 Edmondson publication date. Mylan also argued that the Board erred in finding that Edmondson did not disclose hydrates of sitagliptin phosphate.</p> <p>Merck argued that Edmondson could not serve as an obviousness reference and the Court agreed with Merck. Merck showed that it developed a 1:1 sitagliptin DHP salt in December 2001 with experimental confirmation in early 2002. As Merck highlighted, Mylan did not argue that claim 4, directed to a crystalline monohydrate, was anticipated by Edmondson, &ldquo;which it could have done had it believed that Edmondson disclosed a crystalline monohydrate.&rdquo; The Board&rsquo;s finding that Edmondson did not disclose 1:1 sitagliptin DHP and did not disclose a hydrate of that salt was supported by substantial evidence. The Court agree with the Board that Merck reduced to practice &ldquo;more . . . than what is shown in [Edmondson] for the claimed subject matter.&rdquo;</p> <p>The Court also agreed with Merck that the Board&rsquo;s decision that Mylan failed to show obviousness of claims 3 and 4 of the &rsquo;708 patent was supported by substantial evidence. With respect to claim 3, the Board found that there was no motivation to combine Edmondson and Bastin to make sitagliptin DHP and that the two references did not provide motivation to make (S)-sitagliptin. The Board further highlighted that Mylan advanced no expected or theoretical benefit to making the (S)-enantiomer of 1:1 sitagliptin DHP, and that the general disclosure on diastereomers in Edmondson encompassed millions of potential compounds and salts with no motivation to make the (S)-enantiomer with a reasonable expectation of success, particularly in an unpredictable activity like salt formation. With respect to claim 4, the Board found that there was no motivation to combine the references and that a skilled artisan would have had no reasonable expectation of success in doing so. The Board credited Mylan&rsquo;s expert testimony that a skilled artisan &ldquo;couldn&rsquo;t predict with any degree of certainty&rdquo; hydrate formation. The Board further addressed the numerous downsides of hydrates reported in the literature, including those stating that a skilled artisan would have several reasons for avoiding hydrates. The Board also credited Merck&rsquo;s expert testimony who stated that a skilled artisan would have sought to avoid hydrates, and that forming crystalline salts, including hydrates, was highly unpredictable.</p> <p>The Court agreed with Merck that the Board&rsquo;s decision was supported by substantial evidence and affirmed the Board&rsquo;s decision that the claims of the &rsquo;708 patent were not anticipated and also would not have been obvious over the cited prior art.<br /> <br /> <em>Mylan Pharmaceuticals Inc. v. Merck Sharp &amp; Dohme Corp.,</em> Case No. 2021-2122 (Fed. Cir. Sep. 29, 2022)</p> Article 26 Oct 2022 00:00:00 -0800 https://www.oblon.com/?t=40&an=129444&anc=995&format=xml USPTO Extends Cancer Immunotherapy Pilot Program https://www.oblon.com/?t=40&an=129407&anc=995&format=xml <p>To accelerate innovation in the health and medical fields, the USPTO published a Federal Register Notice announcing a fifth extension of its Cancer Immunotherapy Pilot Program. Petitions requesting participation in the pilot program that are compliant with the program&rsquo;s requirements and are filed on or before January 31, 2023, will be accepted. The extension will also allow the USPTO to continue the program while it evaluates potential expansion opportunities. The USPTO first implemented the Cancer Immunotherapy Pilot Program in June 2016, in support of the White House&rsquo;s National Cancer Moonshot initiative, which sought to accelerate cancer research. It permits patent applications pertaining to cancer immunotherapy to be advanced out of turn for examination and reviewed earlier. The extension reflects the continued effectiveness of the pilot program. All parameters will remain the same as in the original pilot through the January 31, 2023, extension.</p> <p>Requirements</p> <ul> <li>Applications must contain one or more claims to a method of treating a cancer using immunotherapy.</li> <li>Applicants must file a grantable petition under this initiative using the USPTO patent electronic filing system (EFS-Web).</li> <li>Open to: <ul> <li>any application that has not received a first Office action,</li> <li>any application where the petition is filed with a Request for Continued Examination (RCE), or</li> <li>any application not under final rejection where the claimed cancer immunotherapy is the subject of an active&nbsp;Investigational New Drug (IND) application that has entered Phase II or Phase III (FDA) clinical trials.</li> <li>No additional fee is required to participate in the program.</li> </ul> </li> </ul> <p><a href="https://www.uspto.gov/patents/initiatives/patent-application-initiatives/patents-4-patients">https://www.uspto.gov/patents/initiatives/patent-application-initiatives/patents-4-patients</a></p> <p>&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</p> Article 24 Oct 2022 00:00:00 -0800 https://www.oblon.com/?t=40&an=129407&anc=995&format=xml Still Receiving Alice Rejections? Time to Revisit USPTO Guidance https://www.oblon.com/?t=40&an=129339&anc=995&format=xml <strong>Aldo Martinez </strong>is featured in <em>IP Watchdog</em> with the article: &quot;<a href="https://www.ipwatchdog.com/2022/10/17/still-receiving-alice-rejections-time-to-revisit-uspto-guidance/id=152173/">Still Receiving Alice Rejections? Time to Revisit USPTO Guidance</a>.&quot;<br /> <br /> <p><em><a href="https://www.supremecourt.gov/opinions/13pdf/13-298_7lh8.pdf" target="_blank">Alice Corp v. CLS Bank Int&rsquo;l</a>, </em>134 S. Ct. 2347 (2014) sent rejections under 35 U.S.C. &sect; 101 skyrocketing from under 10,000 per year prior to the&nbsp;<em>Alice</em>&nbsp;decision to nearly 35,000 the year the Supreme Court handed down its decision (2014). Peaking at just over 100,000 rejections in 2018, the USPTO&rsquo;s&nbsp;<a href="https://www.federalregister.gov/documents/2019/01/07/2018-28282/2019-revised-patent-subject-matter-eligibility-guidance" target="_blank">January 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG)</a>&nbsp;helped to stabilize and ultimately lower the number of rejections under Section 101 to just over 20,000 in 2021. Though this number may continue to drop &ndash; the data on Section 101 rejections for 2022 is not yet complete &ndash; one thing is for sure: The number of rejections under Section 101 post&nbsp;<em>Alice</em>&nbsp;still far outnumber the Section 101 rejections made prior to&nbsp;<em>Alice</em>&nbsp;by at least 10,000 per year. As illustrated in Fig. 1 (data gathered using&nbsp;<a href="https://www.juristat.com/" target="_blank">juristat.com</a>), the majority of rejections under Section 101 made since 2014 are still&nbsp;<em>Alice</em>&nbsp;rejections, which leaves room for this number to decrease further.</p> <p><img wp-image-152174="" aligncenter="" jetpack-lazy-image="" src="https://i0.wp.com/www.ipwatchdog.com/wp-content/uploads/2022/10/Alice-Article-Graph.jpg?resize=872%2C548&amp;ssl=1" alt="" width="550" height="300" data-recalc-dims="1" srcset="https://i0.wp.com/www.ipwatchdog.com/wp-content/uploads/2022/10/Alice-Article-Graph.jpg?w=872&amp;ssl=1 872w, https://i0.wp.com/www.ipwatchdog.com/wp-content/uploads/2022/10/Alice-Article-Graph.jpg?resize=300%2C189&amp;ssl=1 300w, https://i0.wp.com/www.ipwatchdog.com/wp-content/uploads/2022/10/Alice-Article-Graph.jpg?resize=768%2C483&amp;ssl=1 768w" data-lazy-loaded="1" sizes="(max-width: 872px) 100vw, 872px" loading="eager" align="absmiddle" border="" hspace="0" vspace="0" /></p> <p>Assuming not all of the 20,000&nbsp;<em>Alice</em>&nbsp;rejections under Section 101 are made in applications that truly describe and claim a judicial exception (i.e., law of nature, natural phenomenon, abstract idea) without significantly more, there is still hope for reducing the number of&nbsp;<em>Alice</em>&nbsp;rejections made per year. However, careful planning during the drafting of an application is necessary in order to minimize the need to make deeply narrowing claim amendments and estoppel-inducing arguments in reaction to an&nbsp;<em>Alice</em>&nbsp;rejection, or worse, discovering that no amount of amending and argumentation can save the application and its claims.</p> <p>The USPTO&rsquo;s guidance on subject matter eligibility, such as the 2019 PEG, and particularly the&nbsp;<a href="https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf" target="_blank">October 2019 Update</a>&nbsp;to the PEG (October 2019 PEG Update), can be an effective guide for writing an applications that can avoid and/or overcome&nbsp;<em>Alice</em>&nbsp;rejections without drastic amendments to the claims. For example, the 2019 PEG modified Step 2A of the patent eligibility claim analysis into two prongs: Prong one &ndash; does the claim recite a judicial exception? Prong two &ndash; does the claim recite additional elements that integrate the judicial exception into a practical application? &nbsp;If the answer to the prong one is &ldquo;no,&rdquo; or if the answers to both prongs are &ldquo;yes,&rdquo; the claim is deemed not directed to an abstract idea and patent-eligible under Section 101. Period, full stop. Thus, it&rsquo;s worth the effort to draft an application that leads the reader (i.e., patent examiner), step-by-step, to the conclusion that the claims are patent eligible by answering prongs one and two of Step 2A with a &ldquo;yes&rdquo; to each.</p> <p>Why focus on &ldquo;yes&rdquo; answers to prongs one and two of Step 2A? Anecdotally, once a patent examiner makes an&nbsp;<em>Alice</em>&nbsp;rejection, it is very difficult, i.e., nearly impossible, to persuade the examiner that the claims do not recite a judicial exception (i.e., that Step 2A, prong one can be answered &ldquo;no&rdquo;). Therefore, it may be easier and more effective to focus on obtaining a &ldquo;yes&rdquo; for both prongs one and two. One way to do so is to focus on the technological improvement achieved by the invention in order to demonstrate that the claims integrate whatever abstract idea upon which they touch into a practical application.</p> <h2><strong>Technology</strong></h2> <p>The October 2019 PEG Update states that integration into a practical application may be shown through &ldquo;an improvement in the functioning of a computer, or an improvement to another technology or technical field.&rdquo;&nbsp; Logically, this involves identifying the technology or technical field improved by the invention defined in the claims. While seemingly a trivial step,&nbsp;<em>Alice</em>&nbsp;rejections often assert that the claims fail to reflect a technical improvement because they recite &ldquo;generic&rdquo; computer elements. Implicit in the assertion is the view that the technology improved is &ldquo;computer technology.&rdquo;&nbsp; This makes sense to some extent since the only technology that is expressly identified in the October 2019 PEG Update is computer technology (&ldquo;an improvement in the functioning of a computer&rdquo;). The remaining technologies are lumped into the somewhat ambiguous &ldquo;another technology or technical field.&rdquo;&nbsp; Thus, if an application and its claims do not expressly define the relevant technology or technical field, and the invention involves software or computers, there is a good chance a patent examiner may deem the technology to be &ldquo;computer technology&rdquo; by default.</p> <p>Therefore, it is good practice to expressly state the technology or technical field in the specification of the application, whether the technology is computer/software related or not. This is more than a simple one-sentence declaration of the technology that is often included in the &ldquo;Field of the Invention&rdquo; section of the specification. Such sentences are typically quite broadly stated and not normally well tied to the invention described in the specification and/or claimed. Instead, the identification of the technology should include an explanation of the technology, how the disclosed invention fits within the technology, and any subcategories of the technology (i.e., if the technology is wireless communication, for example, subcategories may be cellular communication, WiFi communication, Bluetooth communication, etc.)&nbsp; The objective is to begin to establish a narrative of patent eligibility by (1) providing a description of the technology from which a person of ordinary skill would identify the technology as such, and (2) provide a context for the invention.<br /> Of course, some applicants may bristle at the idea of adding a description of the technology that is any longer than a single sentence for fear that the description may be considered as an admission by the USPTO and/or be somehow used to effectively narrow the scope of any resulting patent claims. However, if a patent examiner mistakenly identifies the technology and/or does not fully appreciate the significance of the improvement achieved by the invention reflected in the claims, the result may be a lingering&nbsp;<em>Alice</em>&nbsp;rejection that requires several rounds of amendments and arguments to overcome &ndash; if the rejection can be overcome at all. This may prove more damaging than a paragraph or two added to the specification to more clearly describe the technology and to lend some context to the claimed invention. At least doing so provides the applicant an opportunity to control the narrative and to be proactive with regard to potential&nbsp;<em>Alice</em>&nbsp;issues/rejections.</p> <h2><strong>The Improvement</strong></h2> <p>Once the technology or technological field is identified and described, the next step is to describe the improvement and how the disclosed invention achieves the improvement. The October 2019 PEG Update does not require an application to expressly describe the improvement but doing so helps build the patent-eligibility narrative started with the identification and description of the technology or technical field. The October 2019 PEG Update offers guidance for describing the improvement to the technology. For example, the October 2019 PEG Update regards, as an important first inquiry, whether the &ldquo;specification&hellip;provides sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement.&rdquo;&nbsp; Good news here: The identification and description of the technology or technical field lays the groundwork for a solid description of the improvement. More good news: most applications also describe the invention in good detail &ndash; at least enough to satisfy 35 U.S.C. 112. Thus, all that may be required is to explain how the features of the invention, individually and/or collectively, provide an improvement to the technology or technical field.</p> <p>The temptation may be to add a paragraph or two either at the beginning of the application&rsquo;s specification or at the end describing the improvement. However, care should be taken with this approach so that the features of the invention are clearly linked to the stated improvement. The October 2019 PEG Update makes it clear that setting forth the improvement &ldquo;in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art)&rdquo; is not sufficient. The more decoupled the features of the invention are from the description of the improvement, the less likely it is to be deemed to adequately tie a judicial exception to a practical application. It may be better to weave the description of the improvement into the description of the invention by, for example, explaining the significance and/or contribution of each feature of the invention to the improvement, explaining how the features collectively provide an improvement, or both. Use cases can also be helpful in this regard, and may serve to separate the description of the invention (important for claim drafting flexibility) from description of how the invention provides a technological improvement.</p> <p>It&rsquo;s important to note that weaving the description of the technological improvement into the detailed description of the invention and/or into use cases does carry some risks. Many applicants prefer not to extol the virtues of one inventive feature over another for fear that the inventive feature might be deemed critical and/or essential, or might otherwise be used to narrow resulting patent claims in some way. Adding descriptions of how the features of an invention achieve a technological improvement can do just that. However, the need for narrowing amendments and estoppel-creating arguments may result in very narrow claims anyway. Of course, this has to be taken case-by-case, but the risks of expressly tying features of the invention to the technological improvement may still be outweighed by the benefit of creating a narrative of patent-eligibility under Section 101, especially for computer implemented inventions and/or software-based inventions, that serves to limit the amount of claim amendments and arguments necessary during prosecution.</p> <h2><strong>The Claims</strong></h2> <p>The descriptions of the technology, the invention, and the technological improvement provide a good narrative for patent-eligible claims. To keep the narrative going, the claims should be drafted with terms directly from the specification and which are associated with the description of the technology and the technological improvement. While claims can, and should, be drafted with broader language than the application&rsquo;s specification, incorporating terms from the specification into the claims increases the chances that a reader will make the connection between the claims and the technological improvement. The aim is to connect the dots for the reader rather than to rely on the reader to make the connection on their own. &nbsp;A good approach is to recite the technology in the preamble, recite the feature(s) of the invention that directly lead to the improvement in the body of the claim(s), and expand upon these the features in the dependent claims. Of course, how broad or narrow to draft the claims will depend on a number of factors including the type of technology, the applicant&rsquo;s goals for the application, and an honest assessment on how likely the application is to incur an&nbsp;<em>Alice</em>&nbsp;rejection. However, the drafting strategy described herein will put the claims on a path towards patent eligibility under Section 101.</p> <h2><strong>Final Thoughts</strong></h2> <p>It is important to expressly identify the technology, the technological improvement, how the invention achieves the technological improvement, and to tie the three together in an application&rsquo;s specification. Otherwise, a reader may not connect these dots in a manner in which applicant intended. It is also important to tie the claim language to the technology and technical improvement described in the specification for much the same reasons. This way, an applicant can proactively address potential&nbsp;<em>Alice</em>&nbsp;Section 101 issues and reduce the need to make deeply narrowing amendments and present pages of estoppel-inducing arguments in reaction to an&nbsp;<em>Alice&nbsp;</em>rejection made in prosecution.</p> <p>It is, perhaps, impossible to fully safeguard an application against an&nbsp;<em>Alice</em>&nbsp;rejection under Section 101, especially if the subject matter of the application is software related. However, with some planning and some guidance from the 2019 PEG and October 2019 PEG Update, it is possible to draft an application that mitigates the risks of receiving an&nbsp;<em>Alice</em>&nbsp;rejection, and that provides an applicant with every opportunity to overcome an&nbsp;<em>Alice</em>&nbsp;rejection if received.</p> <div>&nbsp;</div> Article 17 Oct 2022 00:00:00 -0800 https://www.oblon.com/?t=40&an=129339&anc=995&format=xml Is the Supreme Court Poised to Consider the Federal Circuit's "Possession of the Invention" Definition of Written Description? https://www.oblon.com/?t=40&an=129234&anc=995&format=xml <p>The Supreme has relisted the petition for certiorari in <i>Juno Therapeutics, Inc. v. Kite Pharma, Inc</i>., 21-1566 where Juno petitioned for review of the Federal Circuit&rsquo;s decision reported at 10 F.4th 1330 (2021) reversing the decision of the lower court finding U.S.P. 7,446,190 to not be invalid for lack of written description or enablement and awarding damages of over $1.2 billion. While the relisting of a certiorari petition does not guarantee cert will be granted, statically since 2016 between about 30 and 40% of relisted petitions have been granted. The SCOTUS blog has detailed analysis <a href="https://www.scotusblog.com/2022/01/the-statistics-of-relists-over-the-past-five-terms-the-more-things-change-the-more-they-stay-the-same/">here</a>. Considering that the overall grant rate for petitions is only about 4% this indicates that the Juno petition has a much greater than normal possibility of being granted.</p> <p>This is particularly true since, as noted by Juno in its petition, the Supreme Court has requested the views of Solicitor General in <i>Amgen Inc. v. Sanofi </i>(No. 21-757) on the same section in 35 U.S.C. &sect; 112 with respect to the Federal Circuit&rsquo;s separate enablement requirement. Further Chief Justice Roberts this week stayed the Federal Circuit&rsquo;s mandate in <i>Novartis v. HEC Pharm Co., Ltd.</i> where the Federal Circuit controversially on rehearing had applied an enhanced written description requirement. Both Juno and Amgen in their petitions and Novartis in its motion for a stay of the mandate challenged the Federal Circuit&rsquo;s interpretation of 35 U.S.C. &sect; 112 as having a separate written description and enablement requirement with Novartis also challenging the &ldquo;enhanced&rdquo; requirement.</p> <p>It appears that the convergence of certiorari petitions has increased the probability of the Supreme Court reviewing the written description issue.</p> Article 05 Oct 2022 00:00:00 -0800 https://www.oblon.com/?t=40&an=129234&anc=995&format=xml Failure to Identify the Invention and to Explain How you Do It May Lead to Invalidity under Section 101 https://www.oblon.com/?t=40&an=129236&anc=995&format=xml <p>Integrated Technology Solutions, LLC (&ldquo;ITS&rdquo;) alleged that products manufactured and distributed by iRacing.com Motorsport Simulations, LLC (&quot;iRacing&quot;) infringed on U.S. Patent 10,046,241. iRacing moved to dismiss, arguing that the &lsquo;241 patent was invalid under 35 U.S.C Section 101, as construed by <a href="https://scholar.google.com/scholar_case?case=7784134755284986738&amp;hl=en&amp;as_sdt=6,47&amp;as_vis=1"><i>Alice Corp. Pty. Ltd. v. CLS Bank Int'l.,</i> 573 U.S. 208 (2014),</a>&nbsp;and its progeny, because the asserted claims were directed to an abstract idea and were patent-ineligible. The U.S. District Court, D. Massachusetts (&ldquo;the Court&rdquo;) found that the claims at issue were directed at patent-ineligible concepts, and that the elements of each claim did not transform the claim into patent-eligible application, and granted the motion to dismiss.&nbsp;</p> <p>The &lsquo;241 patent relates to systems, methods, and other embodiments associated with output production. It is described as an &ldquo;in-game modifier for racetrack videogames whereby evaluations of both simulated environmental conditions and player actions change the performance of the system during game play.&rdquo; The patented methods involve multiple systems comprised of identification, check, determination, and modification components. ITS asserted that iRacing&rsquo;s non-downloadable online competitive racing simulation software infringed on one or more claims of the &lsquo;241 patent, that iRacing&rsquo;s subscription service to use the non-downloadable online simulation software induced infringement.&nbsp; ITS further asserted a claim of contributory infringement based on iRacing&rsquo;s continued sale of the subscription service for the software.</p> <p>Analyzing the claims at issue, the Court first considered whether the claims were directed to a patent ineligible concept under <i>Alice</i> Step One. ITS argued that the claims were directed to more than just an abstract idea, because the &ldquo;patent describes improved rendering techniques for maps&rdquo; that &ldquo;provide greater accuracy in game mechanics and allow for indirect player interaction as the rendered maps are continually modified.&rdquo; ITS further asserted that the temperature and tire elements in racing games were &ldquo;only two of many elements in one of many invention embodiments&rdquo; described in the specifications, and that &ldquo;at least&rdquo; the modification component was not abstract, where &ldquo;one of the touchstones of abstraction is whether a person could perform the claimed steps in their head,&rdquo; and a human cannot modify a racetrack by determining to leave tire remnants.</p> <p>iRacing contended that &ldquo;the basic thrust of the independent claims is the abstract idea of simulating the impact of a racetrack surface on a vehicle&rsquo;s performance,&rdquo; and that &ldquo;[e]ach claim merely enumerates a series of generic steps that describe the raw concept of this simulation, not how to perform it.&rdquo; The claims do not &ldquo;recite any non-generic hardware that might change this result&rdquo; where the &ldquo;components are merely placeholders for any available generic hardware or software&rdquo; and a &ldquo;human could perform the claimed operations mentally without even using a pencil and paper.&rdquo;</p> <p>The Court found that ITS had failed to refute the generality of the claims and that the patent did not extend beyond an abstract concept where it did not specify <u>how</u> to perform the purported concepts and was overly broad in its attempt to specify numerous variations on the overarching idea. &ldquo;While the claims list &lsquo;identification component[s],&rsquo; &lsquo;check component[s],&rsquo; &lsquo;determination component[s],&rsquo; and &lsquo;modification component[s],&rsquo; &hellip; nowhere does the &lsquo;241 Patent sufficiently detail <u>how</u> these components will actually be performed or implemented. As the Federal Circuit has explained, &lsquo;[c]laims directed to generalized steps to be performed on a computer using conventional computer activity are not patent eligible.&rsquo;&nbsp;<a href="https://scholar.google.com/scholar_case?case=6966994416985363479&amp;hl=en&amp;as_sdt=6,47&amp;as_vis=1"><i>Two-Way Media Ltd. v. Comcast Cable Communs., LLC</i>, 874 F.3d 1329, 1337 (Fed. Cir. 2017)</a>.&rdquo; The Court pointed out that the components represented generalized steps and failed to specify <u>how</u> these steps were to be performed. &ldquo;Patent &lsquo;241 does not place limitations or specifics on how the claimed components will aim to identify, check, determine, and modify the racing area. The specifications only underscore the generalization of the claimed components.&rdquo;</p> <p>iRacing further argued that in <a href="https://scholar.google.com/scholar_case?case=17222566443023004602&amp;hl=en&amp;as_sdt=6,47&amp;as_vis=1"><i>Bot M8 LLC v. Sony Corp. of Am</i>., 465 F. Supp. 3d 1013 (N.D. Cal. 2020)</a>, &ldquo;the court invalidated a gaming patent claim that, like the &lsquo;241 Patent, recited a series of formless &lsquo;devices&rsquo; (no different from the claimed &lsquo;components&rsquo; here) for performing generic steps.&rdquo; ITS argued that the &lsquo;241 patent contrasted with that in <i>Bot M8</i>, because &ldquo;[a] driver cannot perform a mental step of modifying a discrete section of track, much less to what degree, when there is no stimulus with which to prompt [the] driver to do so, especially in the environment of an actively played game.&rdquo;&nbsp;ITS contended that the present case was different from <i>Bot M8</i> because in that case, the methodology that linked players to modify a slot-machine game could easily be performed by the human mind. In <i>Bot M8</i>, the Northern District of California analyzed the eligibility of a patent describing the process where &ldquo;a game result achieved by a game player and a game result achieved by another game player are totalized and the specification value is changed in accordance with the total result.&rdquo;&nbsp;<a href="https://scholar.google.com/scholar_case?case=17222566443023004602&amp;hl=en&amp;as_sdt=6,47&amp;as_vis=1"><i>Bot M8</i>, 465 F. Supp. 3d at 1017-18</a>.&nbsp;On summary judgment, the court found the patent ineligible under <i>Alice</i>, noting that while it described a function for modifying video games based on player interaction, &ldquo;the claim leaves open&nbsp;how&nbsp;to accomplish this, and the specification provides hardly any more direction.&rdquo; <i>Id.</i> at 1020. Further, the court noted that although the patent was limited to the field of gaming machines, it &ldquo;merely recites result-oriented uses of conventional computer devices,&rdquo; and &ldquo;neither the patent specification, patent owner, or patent owner&rsquo;s experts articulate a technological problem solved by the [] patent.&rdquo; <i>Id.</i> at 1020.</p> <p>Here, the Court noted that the &lsquo;241 patent similarly failed to describe the &ldquo;how&rdquo; regarding the identification, check, determination, and modification components. As in <i>Bot M8</i>, the &lsquo;241 patent specifications failed to alleviate any of the ambiguity in determining how to accomplish the patented claims. The specification provides numerous applications of the claimed process but fails to detail the &lsquo;how&rsquo;. ITS further attempted to distinguish <i>BotM8</i> on the ground that humans could not perform the &lsquo;241 patent function in their mind. However, the Court noted that &ldquo;the processes to be performed&mdash;identifying, checking, determining, and modifying&mdash;are all components of ordinary mental processes.&rdquo; &ldquo;While ITS asserts that a human-being cannot modify a racetrack by intentionally leaving a remnant &hellip; such racetrack modification is irrelevant. In <i>Electric Power</i>, the patent claims included complex descriptions of detection, display, accumulation, and derivation of voltages and frequencies from phasor measurements.&nbsp;<a href="https://scholar.google.com/scholar_case?case=9923382287048026820&amp;hl=en&amp;as_sdt=6,47&amp;as_vis=1">830 F.3d 1350, 1351-52</a>. However, the courts &lsquo;have treated analyzing information by steps people go through in their minds . . . as essentially mental processes within the abstract-idea category.&rsquo; <i>Id</i>. at 1354. &lsquo;[M]erely selecting information, by content or source, for collection, analysis, and display, does nothing significant to differentiate a process from ordinary mental processes.&rsquo; <i>Id.</i> at 1355. Similarly, the claims of the &lsquo;241 Patent describe processes performed in the human mind, and provide nothing more to remove themselves from abstraction, and the addition of the virtual racetrack does not change the analysis.&rdquo;</p> <p>ITS further argued that the '241 patent provided many advantages over the prior art by allowing &ldquo;indirect interaction between players,&rdquo; through racetrack modification, thereby presenting commercial value for various entities. iRacing contended that the claims, which only contain generic components, &ldquo;do not recite improvements&nbsp;to computer technology&nbsp;that would spare them from abstraction.&rdquo; &nbsp;The Court agreed that the '241 patent invoked &ldquo;the use of unspecified computer technology to run an abstract process of identifying, checking, determining, and modifying.&rdquo; ITS attempted to save this process from abstraction by describing its application as &ldquo;improved map rendering of the disclosed invention.&rdquo; However, &ldquo;where ITS fails to offer any technological means of effecting that concept,&nbsp;providing instead an amorphous set of varying processes accompanied by 22 figures, the claims of the &lsquo;241 patent fail to rise above abstraction under Alice step one.&rdquo; The Court relied on multiple cases and noted that&nbsp;&ldquo;the lack of clear instruction as to how these logical structures and processes are implemented to improve computer technology brings the &lsquo;241 Patent claims into the realm of abstract ideas.&rdquo; &ldquo;ITS contends that the &lsquo;241 Patent is similar to that in <i>McRO</i> because developing human-created rules that can be performed in the human mind &lsquo;is a particular way of programming or designing software&rsquo; that &lsquo;does provide an adequate description for those skilled in the art to accomplish the procedures set out in the claims.&rsquo;&rdquo; <i>See</i> <a href="https://scholar.google.com/scholar_case?case=16226248573370819841&amp;hl=en&amp;as_sdt=6,47&amp;as_vis=1"><i>McRO, Inc. v. Bandai Namco Games Am. Inc.,</i> 837 F.3d 1299 (Fed. Cir. 2016)</a>. The Court, however, noted that &ldquo;unlike in <i>McRO</i>, the claims here do not recite specific steps or processes to effectuate the claims. Indeed, the &lsquo;241 Patent reads like an invitation for someone to create the software that may or may not improve the technology associated with racing simulations.&rdquo; The Court concluded that, as written, the &lsquo;241 patent &ldquo;does not avoid abstraction where it provides no clear guidance on how the claims will be performed.&rdquo;</p> <p>The Court further reviewed the claims under <i>Alice</i> Step Two, i.e., does the inventiveness of the claim make it patent eligible? Concerning the inventiveness, ITS argued that the &lsquo;241 patent resolved technical problems related to computerized gaming simulations, particularly in systems providing a more realistic simulation by allowing for the indirect player interaction. According to ITS, the solution to this problem was to identify a racing area, determine the effect of the characteristic in the area, and then modify the area based upon the effect in a manner that modifies the game itself. &ldquo;This collection of steps is a particular and transformative one.&rdquo; iRacing argued that the &lsquo;241 patent did not recite an inventive concept that served to transform the abstract idea into a patent-eligible application. iRacing pointed out that the identification, determination, and modification functions of the claims in the &lsquo;241 patent were the ineligible abstract idea itself, and therefore could not supply the separate inventive concept. &ldquo;The specification does not limit the components to any specific arrangements or definition where they only state the potential incorporation into other components.<a name="r[5]">&rdquo;</a> Finally, iRacing argued that limiting the claims to the technological environment of the videogame did not save the &lsquo;241 patent from ineligibility.</p> <p>Based on the analysis under <i>Alice</i> and related cases, the Court stated that there was &ldquo;still nothing that removes the claims from patent-ineligible subject matter. Contrary to ITS's assertions, the &lsquo;241 Patent differs from the patent in <i>DRR Holdings</i> under <i>Alice</i> step two because the specifications at issue do not sufficiently bring the claim out of abstraction. In that case, the court held that the claims &lsquo;specify how interactions with the Internet are manipulated to yield a desired result&mdash;a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink.&rsquo; <i>DDR Holdings</i>, 773 F.3d at 1258.&rdquo; ITS argued that the modifications in its patent were similarly interdependent and &ldquo;override a routine and conventional sequence of events&rdquo; that was &ldquo;specific to problems in the realm of these gaming technologies.&rdquo; The Court, however, determined that the claims of the &lsquo;241 patent did not recite a specific way to automate the tire remnant and temperature changes sought and that the claims &ldquo;fail to recite &lsquo;additional features&rsquo; that bring the claims out of abstract ideas into the realm of cognizable programmatic solutions.&rdquo; The claims of the &lsquo;241 patent &ldquo;invoke alterations of virtual worlds and the components therein, and in the setting of a virtual world, none of these components are inventions of ITS.&rdquo; Furthermore, the claims of the &lsquo;241 patent fail to claim an &ldquo;ordered combination of claim limitations that transform the abstract idea of [modifiable virtual worlds] into a particular, practical application of [the] abstract idea.&rdquo; &nbsp;The Court granted iRacing&rsquo;s motion to dismiss.</p> <p>It is important to remember that the name of the game is still the Claim. Many Section 101 rejections are a result of how the claims are constructed. Many patent eligibility disputes arise because of lack of precision in the claims and failure to identify the invention and explain how it has been achieved. It is important to identify What the invention is and How you do it (steps, combinations, etc.) and therefore the key to success is quality claims. Reciting a result rather than how the result has been achieved may lead to patent ineligibility.&nbsp; When the specification clearly defines the problem being solved and how the solution improves upon previous approaches (and make sure this is reflected in the claims), rejections under Section 101 may be avoided. An invention that involves a technical solution to a technical problem is more likely to be eligible. Also, specific elements may make claims patent eligible. The claim&rsquo;s specificity and technical character should be connected to its advance over the prior art and a description of the invention with a high level of specificity, including specific components and how they communicate and work together, may save the claim.&nbsp;</p> Article 05 Oct 2022 00:00:00 -0800 https://www.oblon.com/?t=40&an=129236&anc=995&format=xml 4 Takeaways From OpenSky's PTAB Sanctions https://www.oblon.com/A11960/assets/files/News/OpenSky PTAB Sanction _ Law360.pdf&anc=995&format=xml <strong>Chris Ricciuti</strong> has been quoted in the <em>Law360</em> article &quot;<a href="https://www.law360.com/articles/1537143/4-takeaways-from-opensky-s-ptab-sanctions">4 Takeaways From OpenSky's PTAB Sanctions</a>.&quot;&nbsp; Article 04 Oct 2022 00:00:00 -0800 https://www.oblon.com/A11960/assets/files/News/OpenSky PTAB Sanction _ Law360.pdf&anc=995&format=xml Federal Circuit Trumped By Supreme Court On Stay Of Mandate In Gilenya https://www.oblon.com/?t=40&an=129197&anc=995&format=xml <p>Just two days after the Federal Circuit denied a stay of its mandate in <i>Novartis v. HEC Pharm Co., Ltd.,</i> the Supreme Court granted a stay of the mandate pending a further order of the Court and requiring HEC to file a response to the Novartis stay request.</p> <p>Novartis&rsquo; petition raises issues with the Federal Circuit which go beyond the issues in this case. One issue is the Federal Circuit&rsquo;s failure to follow it own precedent regarding written description. The Federal Circuit and its predecessor have a string decisions where written description is determined by what the application teaches one skilled in the art. An <i>haec verba </i>description is not required merely that one skilled in the art would understand from the written description that the inventor had possession of the invention. Instead, the Federal Circuit adopted a standard it was clarity to the court which mattered and refused to consider what was implicit in the disclosure at odds with <i>Marconi Wireless Tel. Co. of Am. v. United States</i>, 320 U.S. 1, 34 (1943) where the Court held that in prosecution before the patent office one could amend claims to make what was implicit explicit. &nbsp;The Federal Circuit ignored the language of 35 USC &sect;112 which requires both written description and enablement is determined by reference to &ldquo;any person skilled in the art.&rdquo;</p> <p>Novartis also pointed out that &ldquo;although the Federal Circuit is to achieve&ldquo;desirable uniformity&rdquo; in cases involving patent law, <i>Markman</i>, 517 U.S. at 390, the decision in this case only increases the substantial uncertainty that already existed regarding written description. As commentators have explained, &ldquo;[p]roper application of the written description doctrine is challenging&rdquo; because &ldquo;the Federal Circuit&rsquo;s development of the law surrounding the written-description requirement has been turbulent&rdquo; and &ldquo;the contours of the legal test for written description are ever-evolving.&rdquo; Aaron B. Rabinowitz, <i>Ending the Invalidity Shell Game: Stabilizing the Application of the Written Description Requirement in Patent Litigation</i>, 12 Minn. J.L. Sci. &amp; Tech. 127, 148 (2011). Because &ldquo;predictability and stability are of prime importance&rdquo; in matters affecting &ldquo;property rights,&rdquo; <i>Landgraf v. USI Film Prods.</i>, 511 U.S. 244, 271 (1994),<a href="file:///C:/Users/ProfileDisk/ssejas-castro/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/RK8JVMEI/Federal%20Circuit%20Trumped%20By%20Supreme%20Court%20On%20Stay%20Of%20Mandate%20In%20Gilenya%20(2).docx#_ftn1" name="_ftnref1" title="">[1]</a>&rdquo; coupled with <i>Marconi</i> the Court will grant <i>certiorari</i>.</p> <p>On the same day the Court granted the stay of the mandate it considered the <i>writ of certiorari</i> in <i>Juno Therapeutics, Inc. v. Kite Pharma, Inc.</i>, No. 21-1566 (filed June 13, 2022), where issue of the need to &ldquo;show possession of the invention&rdquo; is at issue as here. The difference is this case is one where the unrebutted evidence shows &ldquo;possession&rdquo; of the invention. It is possible that the Court could combine <i>Juno</i> and this case to resolve the mess the Federal Circuit has created.</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/Federal%20Circuit%20Trumped%20By%20Supreme%20Court%20On%20Stay%20Of%20Mandate%20In%20Gilenya%20(2).docx#_ftnref1" name="_ftn1" title="">[1]</a> Novartis petition at page 24.</p> </div> </div> Article 03 Oct 2022 00:00:00 -0800 https://www.oblon.com/?t=40&an=129197&anc=995&format=xml Longtime Copyright Office Leader Marybeth Peters Dead At 83 https://www.oblon.com/A11960/assets/files/News/MaryBeth Passing Away 9.30.22.pdf&anc=995&format=xml <strong>Eric Schweibenz</strong> has been quoted in the Law360 article &quot;<a href="https://www.law360.com/articles/1535802/longtime-copyright-office-leader-marybeth-peters-dead-at-83">Longtime Copyright Office Leader Marybeth Peters Dead At 83</a>.&quot;&nbsp;<br /> Article 30 Sep 2022 00:00:00 -0800 https://www.oblon.com/A11960/assets/files/News/MaryBeth Passing Away 9.30.22.pdf&anc=995&format=xml Vidal's Director Reviews Show Hands-On Approach With PTAB https://www.oblon.com/A11960/assets/files/News/Dir. Vidal Review - 9.29.22 Law360.pdf&anc=995&format=xml <strong>Chris Ricciuti</strong> is quoted in the <em>Law360</em> article &quot;<a href="https://www.law360.com/ip/articles/1535115/vidal-s-director-reviews-show-hands-on-approach-with-ptab?nl_pk=a7de7530-012f-44e5-a1b5-f0dea42553ea&amp;utm_source=newsletter&amp;utm_medium=email&amp;utm_campaign=ip&amp;utm_content=2022-09-29">Vidal's Director Reviews Show Hands-On Approach With PTAB</a>.&quot;&nbsp;<br /> Article 29 Sep 2022 00:00:00 -0800 https://www.oblon.com/A11960/assets/files/News/Dir. Vidal Review - 9.29.22 Law360.pdf&anc=995&format=xml