Sunil Kumar et al.Download PDFPatent Trials and Appeals BoardMay 6, 20212020002806 (P.T.A.B. May. 6, 2021) Copy Citation 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. 14/124,261 12/06/2013 Sunil Kumar 2011P00518WOUS 5645 24737 7590 05/06/2021 PHILIPS INTELLECTUAL PROPERTY & STANDARDS 465 Columbus Avenue Suite 340 Valhalla, NY 10595 EXAMINER WHALEY, PABLO S ART UNIT PAPER NUMBER 3619 NOTIFICATION DATE DELIVERY MODE 05/06/2021 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): katelyn.mulroy@philips.com marianne.fox@philips.com patti.demichele@Philips.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte SUNIL KUMAR, RANDEEP SINGH, and NEVENKA DIMITROVA ____________________ Appeal 2020-002806 Application 14/124,2611 Technology Center 3600 ____________________ Before DEBORAH KATZ, JON M. JURGOVAN, and JOHN E. SCHNEIDER, Administrative Patent Judges. JURGOVAN, Administrative Patent Judge. DECISION ON APPEAL Appellant seeks review under 35 U.S.C. § 134(a) from a Final Rejection of claims 1–4 and 7–15, constituting all of the claims pending in the application.2 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM.3 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. According to Appellant, the real party in interest is Koninklijke Philips N.V. Appeal Br. 3. 2 Claims 5 and 6 were canceled and thus are not on appeal before us. 3 Our Decision refers to the Specification (“Spec.”) filed December 6, 2013; the Final Office Action (“Final Act.”) mailed April 10, 2019; the Response after Final Action (“Resp. after Final Act.”) filed June 10, 2019; the Advisory Action (“Advisory Act.”) mailed July 5, 2019; the Appeal Brief Appeal 2020-002806 Application 14/124,261 2 CLAIMED INVENTION The claims recite a method for assembly of nucleic acid sequence data, which comprises nucleic acid fragment reads, into contiguous nucleotide sequence segment(s) of a genome sequence. Spec. Abstract. The method aligns fragment reads to a reference sequence to detect gaps within the aligned sequence, and performs de novo sequence assembly for the gaps. Id. The method combines the aligned and de novo assembled fragments to obtain the contiguous nucleotide sequence segment(s) which is recorded in a machine-readable storage device. Id. Claim 1 is independent. The remaining claims depend from claim 1. Claim 1, reproduced below, is representative of the claimed subject matter. 1. A method for assembly of nucleic acid sequence data comprising nucleic acid fragment reads into a contiguous nucleotide sequence segment(s) of a genome sequence, comprising: accessing a file comprising one or more digital files comprising pluralities of nucleic acid sequence data from pluralities of nucleic acid fragment reads; selecting, by a computer system, a digital file comprising a plurality of nucleic acid sequence data from a plurality of nucleic acid fragment reads corresponding to the genome sequence, wherein said nucleic acid fragment reads are obtained from a sequencing device; selecting, by the computer system, a second digital file comprising a nucleic acid reference sequence, wherein said nucleic acid reference sequence is obtained from a nucleic acid sequence reference source; performing, by the computer system, a set of alignments of said nucleic acid sequence data to said nucleic acid reference (“Appeal Br.”) filed September 3, 2019; the Examiner’s Answer (“Ans.”) mailed December 30, 2019; and the Reply Brief (“Reply Br.”) filed February 27, 2020. Appeal 2020-002806 Application 14/124,261 3 sequence by comparing said nucleic acid fragment reads with genomic or sub-genomic reference sequences within said nucleic acid reference sequence, to generate a nucleic acid sequence alignment; identifying, by the computer system, one or more gaps within said nucleic acid sequence alignment by comparing said nucleic acid sequence data with said nucleic acid reference sequence to which said nucleic acid sequence data has been aligned, wherein each of the identified one or more gaps comprises a region within the nucleic acid sequence alignment which does not align with said nucleic acid reference sequence; applying, by computer system, a de novo contig sequence assembly technique to said identified one or more gaps using nucleic acid sequence data mapping to said identified one or more gaps, wherein said de novo contig assembly technique utilizes: (i) a first nucleic acid fragment read, selected from the plurality of nucleic acid sequence data, which partially overlaps with both a portion of the gap and a region of the nucleic acid sequence alignment directly abutting a first side of the gap; and (ii) a plurality of nucleic acid fragment reads in addition to the first nucleic acid fragment read, each of the plurality of nucleic acid fragment reads aligning with a portion of the growing de novo contig assembly; determining, by the computer system, a contiguous nucleotide sequence segment by combining the generated nucleic acid sequence alignment with the results of said de novo contig sequence assembly; and recording said contiguous nucleotide sequence segment in a rapidly retrievable form on a machine-readable storage device configured to receive nucleic acid sequence data. Appeal Br. 25–26 (Claims App.). REJECTION Claims 1–4 and 7–15 stand rejected under 35 U.S.C. § 101 as directed to a judicial exception to patent eligibility without significantly more. Final Act. 2–10. Appeal 2020-002806 Application 14/124,261 4 ANALYSIS Standard of Review We undertake a limited de novo review of the appealed rejection for error based upon the issues identified by Appellant, and in light of the arguments and evidence produced thereon. Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential). Legal Principles of Patent Eligibility Patentable subject matter is defined by 35 U.S.C. § 101, as follows: [w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. In interpreting this statute, the Supreme Court emphasizes that patent protection should not preempt “the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1972) (“Benson”); Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71 (2012) (“Mayo”); Alice Corp. v. CLS Bank Int’l, 573 U.S. 208, 217–18 (2014) (“Alice”). The rationale is that patents directed to basic building blocks of technology would not “promote the progress of science and the useful arts” under the U.S. Constitution, Article I, Section 8, Clause 8, but instead would impede it. Accordingly, laws of nature, natural phenomena, and abstract ideas, are not patent-eligible subject matter. Thales Visionix Inc. v. U.S., 850 F.3d 1343, 1346 (Fed. Cir. 2017) (citing Alice, 573 U.S. at 216–17). The Supreme Court set forth a two-part test for subject matter eligibility in Alice (573 U.S. at 217–19). The first step is to determine whether the claim is directed to a patent-ineligible concept. Id. (citing Mayo, 566 U.S. at 76–77). If so, then the eligibility analysis proceeds to the Appeal 2020-002806 Application 14/124,261 5 second step of the Alice/Mayo test in which we “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 (quoting Mayo, 566 U.S. at 72, 79). There is no need to proceed to the second step, however, if the first step of the Alice/Mayo test yields a determination that the claim is directed to patent eligible subject matter. The Patent Office has revised its guidance for how to apply the Alice/Mayo test in the 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50–57 (January 7, 2019) (“the Revised Guidance”). Under the Revised Guidance, the first step of Alice/Mayo is addressed in two prongs in which we determine whether the claim recites: (1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, mental processes, or certain methods of organizing human activity such as a fundamental economic practice or managing personal behavior or relationships or interactions between people); and (2) additional elements that integrate the judicial exception into a practical application (see Manual of Patent Examining Procedure (“MPEP”) § 2106.05(a)–(c), (e)–(h) (9th Ed., Rev. 10.2019, June 2020)). 84 Fed. Reg. at 51–52, 55. A claim that integrates a judicial exception into a practical application applies, relies on, or uses 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. 84 Fed. Reg. at 54. When the judicial exception is so integrated, then the claim is not directed to a judicial exception and is patent-eligible under § 101. 84 Fed. Reg. at 54. Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then evaluate Appeal 2020-002806 Application 14/124,261 6 whether the claim provides an inventive concept in step two of Alice/Mayo. 84 Fed. Reg. at 56; Alice, 573 U.S. at 217–19, 221. Evaluation of the inventive concept involves consideration of whether an additional element or combination of elements (1) adds a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; or (2) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present. The Examiner’s rejection follows the flowchart shown in MPEP § 2106. Claim 1 USPTO Step 1 – Does the claim recite a statutory category of invention? The Examiner finds the method for assembly of nucleic acid sequence data, as recited in claim 1, falls within one of the four statutory categories of invention. Final Act. 3. The method qualifies as a “process” under 35 U.S.C. § 101, so we agree with the Examiner that Step 1 of the patent eligibility analysis is satisfied. Final Act. 3. We proceed in our analysis to USPTO Step 2A, which is the first step of Alice/Mayo. USPTO Step 2A, Prong 1 – Does the claim recite a judicial exception to patentability? The Examiner finds that the “performing,” “identifying,” “applying,” and “determining” steps of claim 1 recite abstract ideas. Final Act. 3. Specifically, the Examiner finds that these steps are “mental processes Appeal 2020-002806 Application 14/124,261 7 because they can be reasonably performed by the human mind and include evaluation.” Id. at 4. The Examiner finds that “other than reciting these steps are performed on a computer system, nothing in the claim element precludes the step from practically being performed in the mind.” Id. Appellant argues that the claim is not focused on an abstract idea, but on an improvement. Appeal Br. 14–16; Reply Br. 3. However, USPTO Step 2A, Prong 1 focuses on whether the claim recites a judicial exception— improvements are addressed later in Step 2A, Prong 2. See Revised Guidance, 84 Fed. Reg. at 55. Accordingly, we do not address Appellant’s argument here, but subsequently under Step 2A, Prong 2. Appellant contends “[n]ext-generation sequencing (NGS) involving millions of reads and billions of base pairs is no longer performed using pen and paper or [in] one’s mind.” Appeal Br. 18; Reply Br. 2. As the Examiner notes, this argument assumes limitations which are not present in the claims. Ans. 9–10. Specifically, the claim does not recite “next generation sequencing.” Appellant appears to be arguing for patentability based on a limitation reciting a “next generation sequencing (NGS) device” in an Amendment after Final Office Action filed June 10, 2019. The Examiner refused entry of this amendment as requiring further search. See Advisory Act. 3. Accordingly, the amended claims are not considered in this appeal. Further, the claims do not recite sequencing involving millions of reads and billions of base pairs, so Appellant’s argument is not supported by corresponding language in the claim. Under broadest reasonable interpretation of the claim, there is no limit on how small the contiguous nucleotide sequence segment could be, including segment lengths that could Appeal 2020-002806 Application 14/124,261 8 be determined in one’s mind. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1369 (Fed. Cir. 2004) (“[T]he PTO is obligated to give claims their broadest reasonable interpretation during examination.”). As the claims do not recite the limitations that Appellant argues, we find Appellant’s argument unpersuasive. In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (stating that limitations not appearing in the claims cannot be relied upon for patentability). To the extent Appellant argues that the Examiner has “deconstructed [the claim] . . . to such a high level of abstraction that it ensures patent ineligibility” (Appeal Br. 17), we disagree. The Examiner’s finding is that “with the exception of using a computer system, there is nothing in the claims themselves that foreclose these steps from being performed by a human, mentally or with pen and paper.” Ans. 5 (emphasis added); see also Final Act. 4. The “performing,” “identifying,” “applying,” and “determining” steps of claim 1 lack specifics that would confine their performance only to a computer system. In other words, even though the claim recites performance with a computer system, the recited actions could be carried out in the human mind or with pen and paper. These steps are thus properly classified under the “mental processes” category of abstract ideas constituting judicial exceptions to patent eligibility. See CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1375 (Fed. Cir. 2011) (“That purely mental processes can be unpatentable, even when performed by a computer, was precisely the holding of the Supreme Court in Gottschalk v. Benson”). Appeal 2020-002806 Application 14/124,261 9 USPTO Step 2A, Prong 2 – Is the claim directed to a judicial exception? The Examiner finds that additional elements of claim 1 (other than the ones reciting judicial exceptions) are the “computer system” and the “storage device”4 and the steps of “accessing,” “selecting . . . a digital file,” “selecting . . . a second digital file,” and “recording.” Ans. 6; see also Final Act. 4–5. The Examiner finds “that the additionally recited elements do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception and, as such, does not integrate the abstract idea into a practical application.” Final Act. 4 (citing MPEP § 2106.05(a)–(h)). We agree with the Examiner. The claim merely recites that the steps are carried out by a “computer system” and “storage device.” As such, the claim amounts to nothing more than an instruction to apply the abstract ideas using a generic computer system and storage device, and this does not render abstract ideas patent-eligible. See Alice, 573 U.S. at 223; MPEP § 2106.05(f). In other words, the claim at issue here merely invokes the “computer system” and “storage device” as tools to carry out the recited abstract ideas recited in the claim. See Affinity Labs of Tex., LLC v. DirectTV, LLC, 838 F.3d 1253, 1262 (Fed. Cir. 2016); TLI Commc’ns LLC v. AV Auto, LLC, 823 F.3d 607, 613 (Fed. Cir. 2016). The Examiner further finds the additional elements “amount to insignificant extra-solution activity and are not indicative of integration into 4 The Examiner does not mention the “sequencer device” here, but does address it later under the USPTO Step 2B analysis. We view this as harmless error, however, because the claim does not recite use of the “sequencer device” in the performance of a step, but merely describes it as the device from which the nucleic acid fragment reads are obtained. Appeal 2020-002806 Application 14/124,261 10 a practical application, i.e. no amount of insignificant extra-solution activity can render the claims statutory.” Ans. 6; see also Final Act. 4–5. We agree with the Examiner. The “accessing” and the two “selecting” steps amount to data gathering and do not integrate the steps reciting judicial exceptions into a practical application. See CyberSource, 654 F.3d at 1375; MPEP § 2106.05(g). The “recording” step merely stores the result of the abstract mental processes, i.e., the contiguous nucleotide sequence segment, on a machine-readable storage medium capable of storing it. Such storing of data has been found insufficient to integrate a judicial exception into a practical application. See, e.g., Content Extraction & Transmission LLC v. Wells Fargo Bank, Nat’l Ass’n, 776 F.3d 1343, 1348 (Fed. Cir. 2014). The Examiner further finds that “[t]he claim essentially results in determining and storing a contiguous nucleic acid sequence inside of a computer by combining comparative and de novo assembly strategies, i.e. the claim as a whole generally links the use of the judicial exception to a particular technological environment (namely a computer system).” Final Act. 4. We agree. The claim provides little detail of how the computer system carries out the recited steps. As such, the claim generally links the use of the judicial exception to a computer system, which is insufficient to constitute a practical application. Appellant argues that “the claims are directed to a specific improvement in the functionality of the computerized NGS system, namely an improved ability to more quickly and accurately generate a contiguous nucleotide sequence segment.” Appeal Br. 20. As already noted, the Examiner did not allow entry of the amendment reciting the computerized NGS system, so Appellant improperly argues a limitation that is not present Appeal 2020-002806 Application 14/124,261 11 in the claim as presented on appeal. See Self, supra. For the same reason, the cases that Appellant cites are inapposite to the facts of this case. Likewise, Appellant argues that the claim “recites a specific structure (the visual report comprising the generated and stored contiguous nucleotide sequence segment, which is more accurate than prior art sequences).” Appeal Br. 21. No such feature is recited in the claim. Appellant further argues “[t]here are many practical applications with direct benefits listed in the application.” Appeal Br. 20 (citing Spec. ¶¶ 4–5, 54–55). Though these practical applications may be set forth in the Specification, none are recited in the claims, and it is improper to import limitations from the Specification into the claims. Phillips v. AWH Corp., 415 F.3d 1303, 1323 (Fed. Cir. 2005) (en banc). Appellant further contends “the claim as a whole integrates the alleged abstract idea into a practical application, with regard to the storage and display of the generated and stored contiguous nucleotide sequence segment, for review and/or use with other applications.” Appeal Br. 21; Reply Br. 3–4. As a whole, the claim recites steps that can be classified as either mental processes or extra-solution activity, and, contrary to Appellant’s assertions, the claim does not recite any display or use of the stored sequence segment with other applications. Ans. 4–7; see also Final Act. 4–5. We agree with the Examiner that the claims, considered as a whole, do not recite anything that amounts to a practical application. Step 2B – Does the claim recite an inventive concept sufficient to transform the judicial exception into patent-eligible subject matter? The Examiner finds that “[t]he claims do not recite any steps/elements appended to the judicial exception that amount to ‘significantly more’ than the judicial exception.” Final Act. 5. The Examiner takes official notice Appeal 2020-002806 Application 14/124,261 12 that the steps of “accessing” and “selecting” files are well-understood, routine, and conventional in the art and amount to nothing more than insignificant extra-solution activity, i.e., routine data collection. Id. The Examiner also lists numerous cases in which laboratory techniques in the life science arts were held to be well-understood, routine, and conventional when claimed in a generic manner or as insignificant extra- solution activity. Final Act. 5–6 (citing MPEP § 2016.05(d)). These cases include using polymerase chain reaction to amplify and detect DNA, Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377 (Fed. Cir. 2015); detecting DNA or enzymes in a sample, Ariosa, 788 F.3d at 1377–78; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362 (Fed. Cir. 2017); analyzing DNA to provide sequence information or detect allelic variants, Genetic Techs., 818 F.3d at 1377; amplifying and sequencing nucleic acid sequences, and hybridizing a gene probe, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 764 (Fed. Cir. 2014). See also In re Board of Trustees of Leland Stanford Junior Univ., 991 F.3d 1245, 1252 (Fed. Cir. 2021) (receiving and storing data in a computer memory and extracting a predicted haplotype are well-understood, routine and conventional). The subject matter of these cases bears similarity to the present one and lends support to the Examiner’s finding that the recited steps of claim 1 were well-understood, routine, and conventional. The Examiner finds the “recording” step “amounts to nothing more than mere instructions to implement an abstract idea or a computer as well as Appeal 2020-002806 Application 14/124,261 13 insignificant extra-solution activity, i.e., data output. Final Act. 6 (citing MPEP § 2016.05(d)). We agree with the Examiner’s assessment. The Examiner takes official notice that the claimed “computer system,” “storage device,” and “sequencer device” are well-understood, routine, and conventional in the art. Final Act. 6 (citing DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245 (Fed. Cir. 2014); Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716–717 (Fed. Cir. 2014)); see also Alice, 573 U.S. at 225. We agree with the Examiner’s finding at least as to the “computer system” and “storage device.” The Specification describes the “sequencer device” as one of a few different commercial models or “any other suitable sequencer device.” Spec. 28. As generically described in the Specification, it is not apparent how the “sequencer device” would constitute or contribute to an “inventive concept.” Furthermore, as the claim is recited, the “sequencer device” is merely a device from which nucleic acid fragment reads are obtained, and it is not used to perform any of the recited steps. The Examiner further finds that “determining and storing a contiguous nucleic acid sequence inside of a computer by combining comparative and de novo assembly strategies” is well known to one of ordinary skill in the art.” Final Act. 6. For this proposition, the Examiner cites Pop et al., BRIEFINGS IN BIOINFORMATICS, 2009, vol. 10, no. 4, pp. 354–366 (“Pop”). Id. Appellant argues “the claimed method comprises a complex series of components and processes that results in a nonconventional method and system,” and lists several claim features. Appeal Br. 22–23; see also Reply Br. 4–5. These features include the claimed files comprising nucleic acid sequence data and reference data; nucleic acid sequence alignment; gaps Appeal 2020-002806 Application 14/124,261 14 found by comparing nucleic acid sequence data with a reference; de novo sequence assembly; a contiguous nucleotide sequence segment from the aligned sequence and de novo sequence assembly; and a machine-readable storage device to receive and store the nucleic acid sequence data in a rapidly retrievable form. Appellant does not address, however, the Examiner’s finding that combining comparative and de novo assembly strategies was well known, as evidenced by Pop. Appellant further argues the claimed computerized NGS system is both novel and non-obvious, and so is not a generic system that would preempt the field. Appeal Br. 23; Reply Br. 4–5. The claim does not recite a computerized NGS system, and Appellant’s mere assertion, without evidence, that the claim is novel and non-obvious is insufficient, particularly when the Examiner cites Pop as evidence it is not. We further note that “the absence of complete preemption does not demonstrate patent eligibility.” Ariosa, 788 F.3d at 1379. Appellant contends the Examiner “incorrectly imports a new requirement for Step 2B of the Alice Analysis, that an applicant provide ‘objective evidence of an improvement to the technology.’” Reply Br. 5 (citing Ans. 10). We do not agree that the Examiner imported such a requirement. The Examiner cited Pop for the proposition that combining comparative and de novo strategies was known in the art. Appellant presented no argument or evidence to counter the Examiner’s evidence. Conclusion for claim 1 In conclusion, Appellant shows in USPTO Step 1 of the patent eligibility analysis that claim 1 is a statutory process. The Examiner, however, shows in USPTO Step 2A, Prong 1 that the claim recites judicial Appeal 2020-002806 Application 14/124,261 15 exceptions, namely, mental processes that are abstract ideas. The Examiner also shows in USPTO Step 2A, Prong 2 that the claim does not recite additional elements that integrate those judicial exceptions into a practical application. The Examiner further demonstrates in USPTO Step 2B that the additional elements do not set forth an inventive concept. Accordingly, we sustain the Examiner’s § 101 rejection. A. Remaining Claims No arguments were presented for the remaining dependent claims. See generally, Appeal Br. and Reply Br. Accordingly, we sustain the Examiner’s § 101 rejection of these dependent claims for the same reasons stated for claim 1. CONCLUSION The Examiner’s rejection of claims 1–4 and 7–15 under 35 U.S.C. § 101 is affirmed. In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–4, 7–15 101 Eligibility 1–4, 7–15 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). See 37 C.F.R. § 41.50(f) (2019). AFFIRMED Copy with citationCopy as parenthetical citation