Nantomics

Patent Trials and Appeals Board

Jan 20, 2022

2022000877 (P.T.A.B. Jan. 20, 2022)

UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 16/859,826 04/27/2020 Patrick Soon-Shiong 102402.0008US2 7532 149345 7590 01/20/2022 Umberg Zipser, LLP 1920 Main Street, Suite 750 Irvine, CA 92614 EXAMINER SKIBINSKY, ANNA ART UNIT PAPER NUMBER 1631 NOTIFICATION DATE DELIVERY MODE 01/20/2022 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): ipsupport@umbergzipser.com patents@umbergzipser.com rdean@umbergzipser.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte PATRICK SOON-SHIONG, SHAHROOZ RABIZADEH, STEPHEN CHARLES BENZ, JOHN ZACHARY SANBORN, and CHARLES JOSEPH VASKE __________ Appeal 2022-000877 Application 16/859,826 Technology Center 1600 __________ Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and RACHEL H. TOWNSEND, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 involving claims to a method of reducing a false positive or a false negative diagnosis for a patient having diseased tissue using a high throughput computer-based genomic analysis. The Examiner rejected the claims under 35 U.S.C § 101 as directed to non- statutory subject matter and under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the Real Party in Interest as Nantomics, LLC (see Appeal Br. 2). Appeal 2022-000877 Application 16/859,826 2 Statement of the Case Background “With respect to molecular diagnostics, tests identifying gene mutations that may be relevant in signaling pathways have revealed hundreds of ‘actionable’ genes that may be subject to pharmaceutical intervention” (Spec. ¶ 5). “Moreover, genome sequencing data of a tumor per se may not necessarily provide the specific information that indicates that a mutation is in fact foundational to tumor development or growth” (id. ¶ 6). “[A] genome-only approach will be prone to substantial false positive rates and will therefore unnecessarily expose a patient to ineffective and often highly toxic treatment” (id. ¶ 7). “The inventors have discovered that to accurately predict the downstream effects of gene alterations, patient- and tumor- specific DNA information is needed, along with orthogonal technologies such as determination of RNA transcription levels, RNA sequencing, proteomics, and analysis of cell signaling pathways” (Spec. ¶ 9). The Claims Claims 15 and 19-25 are on appeal. Independent claim 15 is representative and reads as follows: 15. A method of reducing a false positive or a false negative diagnosis for a patient having diseased tissue using a high throughput computer-based genomic analysis system, the method comprising: obtaining sequence data of normal tissue and the diseased tissue from the patient using at least one multi-lane sequencing device comprising multiple flow cell lanes for sequencing the patient's normal tissue and diseased tissue in a common run; Appeal 2022-000877 Application 16/859,826 3 wherein the at least one sequencing device generates the sequence data comprising genome sequence data, exome sequence data, and RNA sequence data of each of the normal and diseased tissues by sequencing a genome, an exome, and RNA of the patient’s normal and diseased tissues; and wherein the exome sequence data and the RNA sequence data are enriched relative to the genome sequence data by at least a factor of five; and applying a sequence-based treatment model to the sequence data to form a patient-specific sequence report; classifying the diseased tissue based on the patient- specific sequence report, wherein classifying comprises: comparing the exome sequence data and the RNA sequence data of the normal tissue and the diseased tissue with the genome sequence data of the normal tissue and the diseased tissue for each gene in a gene panel comprising ALK, APC, BRAF, CDKN2A, CEBPA, DNMT3A, EGFR, ERBB2, EZH2, IDHI, IDH2, JAK2, KIT, KMT2A, KRAS, MET, MLHI, MSH2, MSH6, NOTCH1, NPMI, NRAS, PDGFRA, PDGFRB, PIK3CA, PMS2, POLDI, POLE, PTEN, RET, and STK11; wherein the patient-specific sequence report comprises an increase in the exome sequence data or the RNA sequence data of the diseased tissue relative to the normal tissue of one or more of the genes in the gene panel without a corresponding mutation in the genome sequence data of the diseased tissue of the one or more genes, thereby avoiding a false negative diagnosis based on genomic sequencing alone; the method further comprising: providing the patient having the diseased tissue with a therapy that targets an exome or a RNA product of Appeal 2022-000877 Application 16/859,826 4 the one or more genes having the increase in the exome sequence data or RNA sequence data of the diseased tissue; and wherein the diseased tissue is a tumor having an anatomical location in the patient selected from the group consisting of bladder, breast ductal, breast lobular, colon, glioblastoma, head and neck, kidney, lung adenocarcinoma, lung squamous, ovary, rectal, uterine, glioma, prostate, melanoma, and thyroid. The Issues A. The Examiner rejected claims 15, 19-21, 24, and 25 under 35 U.S.C. § 101 as being directed to non-statutory subject matter (Ans. 3-9). B. The Examiner rejected claims 15 and 19-25 under 35 U.S.C. § 112(a) as failing to comply with the written description requirement (Ans. 9-10). A. 35 U.S.C. § 101 The Examiner finds the claims apply “a sequence-based treatment model to . . . sequence data to form a patient specific report. This step reads on a mental process and is therefore an abstract idea” (Ans. 4). The Examiner also finds the claims “recite a natural correlation between a patient’s genetic information and disease state exhibited by an increase of exome or RNA sequence in the sample tissue” (id.). The Examiner finds the “judicial exceptions are not integrated into a practical application” and “do not include additional elements that are sufficient to amount to significantly more than the judicial exception because multi-lane or multi-channel sequencers are well known routine and conventional” (id. at 5-6). Appeal 2022-000877 Application 16/859,826 5 The Alice Test The Supreme Court has long interpreted 35 U.S.C. § 101 to include implicit exceptions: “[l]aws of nature, natural phenomena, and abstract ideas” are not patentable. See, e.g., Alice Corp. v. CLS Bank Int’l, 573 U.S. 208, 216 (2014). In determining whether a claim falls within an excluded category, we are guided by the Supreme Court’s two-step framework, described in Mayo and Alice. Id. at 217-18 (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 75-77 (2012)). In accordance with that framework, we first determine if there is a judicial exception. “If a claim is directed essentially to a method of calculating, using a mathematical formula, even if the solution is for a specific purpose, the claimed method is nonstatutory.” Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1351 (Fed. Cir. 2014). If the claim is “directed to” a judicial exception, we turn to the second step of the Alice and Mayo framework, where “we must examine the elements of the claim to determine whether it contains an ‘inventive concept’ sufficient to ‘transform’ the claimed abstract idea into a patent- eligible application.” Alice, 573 U.S. at 221 (quotation marks omitted). Guidance The United States Patent and Trademark Office published guidance on the application of 35 U.S.C. § 101. USPTO’s 2019 Revised Patent Subject Matter Eligibility Guidance (“Guidance”).2 Under the Guidance, in 2 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50-57 (January 7, 2019). Appeal 2022-000877 Application 16/859,826 6 determining what concept the claim is “directed to,” we first look to whether the claim recites: (1) any judicial exceptions, including “[l]aws of nature, natural phenomena, and abstract ideas,” (quoting Alice, 573 U.S. at 216) and/or including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes) (Guidance Step 2A, Prong 1); and (2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)- (c), (e)-(h)) (Guidance Step 2A, Prong 2). Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim: (3) adds a specific limitation beyond the judicial exception that are not “well-understood, routine and conventional in the field” (see MPEP § 2106.05(d)); or (4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. (Guidance Step 2B). See Guidance, 84 Fed. Reg. at 54-56. Guidance Step 1 First, under “Step 1,” we consider whether the claimed subject matter falls within the four statutory categories set forth in § 101, namely “[p]rocess, machine, manufacture, or composition of matter.” Guidance 53- 54; see 35 U.S.C. § 101. Claim 15 recites a “method” and, thus, falls within Appeal 2022-000877 Application 16/859,826 7 the “process” category. Consequently, we proceed to the next step of the analysis. Guidance Step 2A Prong 1 Second, under “Step 2A Prong 1,” we evaluate “whether the claim recites a judicial exception, i.e., an abstract idea, a law of nature, or a natural phenomenon.” Guidance 54. In this case, we agree with the Examiner that claim 15 recites at least two exceptions identified in the Guidance. Claim 15 recites a mental process because other than performing conventional nucleic acid sequencing reactions (see Ans. 7), the “applying a sequence-based treatment model” and “classifying the diseased tissue” may reasonably be performed in the human mind (Guidance 53). The Federal Circuit has explained that the courts “continue to ‘treat[] analyzing information by steps people [could] go through in their minds, or by mathematical algorithms, without more, as essentially mental processes within the abstract-idea category.’” Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1146-47 (Fed. Cir. 2016). In addition, claim 15 recites a natural correlation of genomic and exomic sequence data for “avoiding a false negative diagnosis based on genomic sequencing alone” (Claim 15). Claim 15 involves a comparison of genomic sequence from normal and diseased tissue with RNA and exome sequence data in order to determine if the mutations identified are disease associated or not, and this natural correlation is used to determine the accuracy of a diagnosis correlating a particular mutation with disease. The Specification explains “it should be recognized that precision cancer medicine will require reclassification of cancers based on their molecular profile and not on tissue type” (Spec. ¶ 70). This molecular profile is simply Appeal 2022-000877 Application 16/859,826 8 a classification of particular natural correlations between genes that impact cancer treatment and genes that do not. In claim 15, steps incorporating these judicial exceptions are combined with data gathering and analysis steps that may use a computer (see Spec. ¶¶ 17, 50), but claim 15 does not require that these data analysis steps are performed by a computer and is directly drawn to the judicial exception of mental processes. Indeed, while the Specification suggests that “the inventive subject matter enables construction or configuration of a computing system to operate on vast quantities of digital data, beyond the capabilities of a human” (Spec. ¶ 53), claim 15 does not include a limitation that requires analysis of an amount of data exceeding the amount capable of being analyzed in a human mind. Claim 15 obtains specific information, analyzes that information using particular natural correlations associated with diseased tissues, and then generally suggests generic uses of that data. Claim 15 may obtain useful information, but claim 15 does not improve the computer itself or any other device. See Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1355 (Fed. Cir. 2016) (“[M]erely selecting information, by content or source, for collection, analysis, and display does nothing significant to differentiate a process from ordinary mental processes.”). Appellant does not identify any teaching in the Specification that actually improves either the computer or the physical components of the system. In contrast, the Examiner provides evidence that these systems are entirely conventional (see Ans. 7). Appeal 2022-000877 Application 16/859,826 9 Appellant contends When all the elements of the instant claims are considered, it would be clear that the pending claims are not towards an abstract idea. For example, the limitation “wherein the exome sequence data and the RNA sequence data are enriched relative to the genome sequence data by at least a factor of five” is not abstract under Step 2A. (Appeal Br. 10). We find this argument unpersuasive because “it is not enough, however, to merely improve a fundamental practice or abstract process.” Customedia Techs., LLC v. Dish Network Corp., 951 F.3d 1359, 1364 (Fed. Cir. 2020). Customedia asserted “the claimed invention improves the data delivery system’s ability to store advertising data, transfer data at improved speeds and efficiencies, and prevent system inoperability.” Id. at 1363. But the Court did not find improving data sufficient, instead finding that to “be a patent-eligible improvement to computer functionality, we have required the claims to be directed to an improvement in the functionality of the computer or network platform itself.” Id. at 1364. For claim 15, “fundamentally, it is not enough, for patent-eligibility purposes, to improve an abstract process by invoking a computer merely as a tool for carrying out that process.’” In re Rosenberg, 813 Fed. Appx. 594, 597 (Fed. Cir. 2020). Therefore, we find that claim 15 recites the judicial exceptions drawn to abstract ideas including mental processes and to natural phenomena. 3. Guidance Step 2A Prong 2 Having determined that claim 15 recites judicial exceptions, we proceed to “Step 2A Prong 2” of the Guidance, which requires that we evaluate whether “the claim as a whole integrates the recited judicial exception into a practical application of the exception.” Id. at 54. “A claim Appeal 2022-000877 Application 16/859,826 10 that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.” Id.; see Mayo, 566 U.S. at 78. The Guidance specifies that this evaluation is conducted by first “[i]dentifying whether there are any additional elements recited in the claim beyond the judicial exception(s), [then] ‘evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application.’” Guidance 54-55. Appellant contends: Classifying the diseased tissue based on genome sequence data for each member of the recited list of genes cannot be an abstract idea under Step 2A, amounts to significantly more under Step 2B, and has not been shown to be a well-known, routine, and conventional practice. Accordingly, recitation of this exact list of list makes the instant claims, as a whole, patent eligible under § 101. (Appeal Br. 12). We recognize that the method uses nucleic acid and proteomic sequencing technologies but the method of claim 15 is not drawn to an improvement in any of these sequencing technologies, but rather to analysis of data obtained from sequencing by any method whatsoever (see Spec. ¶¶ 44, 46 (“There are numerous methods of partial and complete genome sequencing known in the art, and all of them are deemed suitable for use herein”; “with respect to RNA sequence information, it is contemplated that all manners of RNA sequencing are deemed suitable for use herein”; “suitable techniques for conducting such quantitative proteomic analysis on Appeal 2022-000877 Application 16/859,826 11 tissue samples are describe in U.S. patents”)). Indeed, claim 15 encompasses the use of any sequencing device, and even data already generated, and then performing the abstract idea analysis of the natural phenomena associating true mutations present in the patient with the abstract idea that therapies should target such mutations. Even if we agree that integration need not necessarily improve the operation of a computer, depending on the type and nature of the judicial exception and the technology at issue, “[a]n inventive concept that transforms the abstract idea into a patent-eligible invention must be significantly more than the abstract idea itself, and cannot simply be an instruction to implement or apply the abstract idea on a computer.” BASCOM Glob. Internet Servs., Inc. v. AT&T Mobility LLC, 827 F.3d 1341, 1349 (Fed. Cir. 2016). Here, claim 15 simply instructs the artisan to analyze data to obtain and analyze data to identify the natural phenomenon of mutations associated with diseases such as cancer with no specific treatment required. “[T]he combination amounts to nothing significantly more than an instruction to doctors to apply the applicable laws when treating their patients.” Mayo, 566 U.S. at 79. And claim 15 “does not recite a specific method of treating the disease using an improved set of specific doses in light of this discovery. Instead, the broad directive . . . collapses into a claim focused on the natural phenomenon.” INO Therapeutics LLC. v. Praxair Distribution Inc., 782 Fed. Appx. 1001, 1007 (Fed. Cir. 2019). Claim 15 does “not include additional elements that are sufficient to amount to significantly more than the judicial exception.” The Specification discloses that the claimed method expressly relies upon known prior art sequencing methods (see Spec. ¶¶ 44, 46; Ans. 7). The Specification teaches Appeal 2022-000877 Application 16/859,826 12 “to include any suitable combination of computing devices, including servers, interfaces, systems, databases, agents, peers, engines, controllers, modules, or other types of computing devices operating individually or collective” (Spec. ¶ 51). Claim 15 lacks any physical or structural component that integrates the judicial exceptions of the abstract idea or natural phenomena into any practical application that improves the computer system itself, the sequencer itself, or any particular device. The only improvement recited, if any, is to the judicial exceptions involving the abstract idea and natural phenomenon of associating particular data to more accurately identify genes that are correlated with disease and to generically apply that data to identify treatment. So “these clauses tell the relevant audience about the laws while trusting them to use those laws appropriately where they are relevant to their decision-making.” Mayo, 566 U.S. at 78. Step 2A Prong 2 requires that only “additional elements recited in the claim beyond the judicial exception(s)” be considered. Guidance 54-55 (emphasis added). As discussed above, the analysis of nucleic acid and protein mutations fall under the judicial exceptions to § 101. Appellant does not provide any rebuttal evidence, whether in the form of references, a declaration, or other disclosure, demonstrating that the ordinary artisan was unaware that nucleic acid or protein sequences could be analyzed to determine if the mutation was actually physiologically relevant in order to eliminate false positive or negative mutations. Moreover, “generally link[ing] the use of a judicial exception to a particular technological environment or field of use” is insufficient to integrate a judicial exception into a practical application. Guidance 55. See Parker, 437 U.S. at 595 (determining that limiting an ineligible alarm limit Appeal 2022-000877 Application 16/859,826 13 calculation to specific process variables in a chemical process was insufficient for patent eligibility). Thus, limiting the method of claim 15 by requiring preliminary known and routine sequencing processes does not integrate the judicial exception into a practical application. For the above reasons, Appellant has not shown that the Examiner erred in concluding that claim 15 does not integrate the recited judicial exceptions into a practical application. 4. Guidance Step 2B Having concluded that claim 15 recites judicial exceptions but does not integrate them into a practical application-i.e., that the claim is “directed to” those exceptions (Guidance 54)-we finally turn to whether the claim provides an “inventive concept,” i.e., whether the additional elements beyond the exceptions, individually and in combination, amount to “significantly more” than the exceptions themselves. Id. at 56. According to the Guidance, “[a]dd[ing] a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field” may indicate an inventive concept is present. Id. Conversely, “simply append[ing] well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality,” typically indicates an inventive concept is absent. Id. Appellant contends even if the claims recite only abstract idea and well known, routine, and conventional steps, which they do not, the pending claims should still be eligible under § 101 because of the non- conventional and non-generic arrangement that provides a technical improvement in the art. See BASCOM Global Appeal 2022-000877 Application 16/859,826 14 Internet Servs. v. AT&T Mobility LLC, 827 F.3d 1341, 1350-51 (2016). (Appeal Br. 12). We do not agree. As already discussed above, we note that the Specification itself demonstrates that “the risks and disadvantages of analyzing DNA from tumor samples alone without matched normal samples (i.e., sample from non-diseased healthy tissue of the same patient) was recently highlighted by Jones” (Spec. 6). Thus, the concern over verifying mutations as being physiologically relevant was already known, as were the various sequencing technologies (see Spec. ¶¶ 44, 46; Ans. 7). No element of the claims is non-conventional or non-generic. And unlike Bascom, which was drawn to a particular implementation of content filtering (see Bascom, 827 F.3d at 1350), claim 15 is drawn to simply comparing types of data to determine accuracy in the context of sequence data to determine whether a data correlation of the mutation is a false positive or false negative (see Claim 15). We agree with the Examiner there are no “additional” elements recited in claim 15, as the abstract idea and natural phenomena associated with verifying whether mutations in genes are associated with disease or no are not additional elements. And the use of generic sequencing technologies and a generic computer to perform generic functions that are “well-understood, routine, conventional activit[ies]” previously known in the industry are not enough to transform the abstract idea into a patent-eligible invention. See Alice, 573 U.S. at 225-26. Thus, for the reasons explained above, we agree with the Examiner that claim 15 “simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of Appeal 2022-000877 Application 16/859,826 15 generality,” and, thus, fails to present an “inventive concept” because the claim does not recite additional elements that provide “significantly more” than the recited judicial exceptions. See Guidance 56. Therefore, we sustain the Examiner’s rejection of claim 15 as ineligible subject matter under § 101. As a result, we also sustain the rejection of claims 19-21, 24, and 25 under § 101. See 37 C.F.R. § 41.37(c)(1)(iv). B. 35 U.S.C. § 112(a) The Examiner finds, regarding claims 15 and 22-25, that the “specification does not have written description support for these limitations of providing treatment to a patient targeting the hormone receptor for patients with any of the claimed disease tissues (i.e. types of tumors)” (Ans. 10). The Examiner finds “[t]here is never a step of treatment disclosed in the specification; the specification lacks support commensurate in scope with the step of providing a treatment” (id.). The Examiner finds “[d]isclosure of providing a patient with a treatment that targets the exome or RNA product of the listed genes or alternative to a therapy that targets the mutation in the genome sequence of the diseased tissue is not disclosed” (id.). Appellant contends the exome and RNA sequence analysis is disclosed to represent the relevant pathway model, which as discussed above, represents the various “baskets” and targeted treatment. Instant paragraph 0040, FIG. 4A, 4B, and 5. Accordingly, a therapy that targets the exome or the RNA product as recited in claim 15 is supported by the instant specification and drawings. (Appeal Br. 13). Appellant contends “the instant application supports the limitation of providing the patient with a therapy that targeting the hormone Appeal 2022-000877 Application 16/859,826 16 receptor, as recited in claim 22. Specifically, targeting of the hormone receptor ‘basket’ is disclosed at instant FIG. 4B and paragraph 0039” (id. at 13-14). Lastly, Appellant contends the instant application supports the limitation of providing the patient having the diseased tissue with an alternative to a therapy that targets the mutation in the genome sequence of the diseased tissue, as recited in claim 24. Specifically, identification of “false positives” and ineffective treatments to avoid based on a mutation in a genome sequence that does not have a corresponding RNA transcription level, and thus indicating whether or not the specific sequence should be targeted, is disclosed at instant paragraph 0047. (id. at 14). In Amgen, the Court explained that: An adequate written description must contain enough information about the actual makeup of the claimed products -“a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials,” which may be present in “functional” terminology “when the art has established a correlation between structure and function.” Amgen Inc. v. Sanofi, 872 F.3d 1367, 1378 (Fed. Cir. 2017). Applying the Amgen written description analysis to these facts, we agree with the Examiner that the Specification lacks any definition, structure, chemical name, physical or other properties of specific therapies that target “the exome or the RNA product” of claim 15, that target “the hormone receptor” of claim 22, or that target “the mutation in the genome sequence” of claim 24. Of particular note, when Appellant amended or added these claim recitations, Appellant not only failed to provide any specific therapies Appeal 2022-000877 Application 16/859,826 17 in the Specification but also did not provide any evidence that the prior art provided therapies for any gene in the gene panel comprising ALK, APC, BRAF, CDKN2A, CEBPA, DNMT3A, EGFR, ERBB2, EZH2, IDHI, IDH2, JAK2, KIT, KMT2A, KRAS, MET, MLHI, MSH2, MSH6, NOTCH1, NPMI, NRAS, PDGFRA, PDGFRB, PIK3CA, PMS2, POLDI, POLE, PTEN, RET, and STK11 as recited in claim 15 (see Appellant’s Response, filed Nov. 30, 2020). In the absence of such disclosure, claims to such therapeutic modalities lack descriptive support in the Specification and were properly identified as new matter by the Examiner. This is similar to Juno Therapeutics, Inc., v. Kite Pharma, Inc., 10 F.4th 1330, 1337 (Fed. Cir. 2021) where the Court explained “this patent provides nothing to indicate that the inventors possessed the full scope of the genus that they chose to claim.” As in Juno, Appellant does not provide meaningful guidance teaching which therapies, if any, will bind the identified targets. Therefore, we sustain the Examiner’s rejection of claim 15 as ineligible subject matter under § 112, first paragraph. As a result, we also sustain the rejection of claims 19-25 under § 112, first paragraph. See 37 C.F.R. § 41.37(c)(1)(iv). DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 15, 19-21, 24, 25 101 Eligibility 15, 19-21, 24, 25 15, 19-25 112(a) Written Description 15, 19-25 Appeal 2022-000877 Application 16/859,826 18 Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed Overall Outcome 15, 19-25 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED