U.S. Serial No. 15/603,013
`Response to Non-Final Office Action dated June 26, 2019
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`Attorney Docket No. 44854-701402
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`REMARKS
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`Claims 1-7, 9-10, 12-13, 17-20, and 22-28 are currently pending in this application. With
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`this amendment, claims 1, 9, 10, 22-26, and 28 are currently amended. Support for the
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`amendments to the claims can be found throughout the as-flled application, including paragraph
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`390. No new matter is believed to be introduced.
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`Upon entry ofthis amendment, claims 1-7, 9-10, 12-13, 17-20, and 22-28 are pending in
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`this application. Allowance of the application is respectfully requested.
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`1)
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`Claim Rejections — 35 USC § 101
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`The Office Action maintains its rejection of claims 1-7, 9, 10, 12, 13, 17-20, and 22-28
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`under 35 USC. § 101 because the claimed invention is allegedly directed to a judicial exception
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`(i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
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`Applicant respectfully traverses for at least the following reasons.
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`Under Step 1 of the AliceMayo test, one asks whether the claimed subject matter falls
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`within one of the categories of patentable subject matter: process, machine, manufacture, or
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`composition of matter. See 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed.
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`Reg. at 53—54. Under Step 2, there are two parts. First, under Step 2A Prong One, one evaluates
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`whether the claims recite a judicial exception. See October 2019 Patent Eligibility Guidance
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`Update published October 17, 2019, at 10. Under Step 2A Prong Two, one evaluates if the claim
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`is “directed to” that judicial exception. Id.
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`With regard to Step 2A Prong Two, recent USPTO Guidance states: “a claim that recites
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`a judicial exception is not directed to that judicial exception if the claim as a whole ‘integrates
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`the recited judicial exception into a practical application of that exception.’ [ ] Prong Two thus
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`distinguishes claims that ‘directed to’ the recited judicial exception form claims that are not
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`‘directed to’ the recited judicial exception.” Id. (citing: 2019 Revised Patent Subject Matter
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`Eligibility Guidance (2019 PEG) published on January 7, 2019 (84 Fed. Reg. 50, 53)(emphasis
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`added).
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`In performing Step 2A, the “markedly different” test applies. Where the claim is to a
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`nature-based product produced by combining multiple components (e.g., a claim to “a probiotic
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`composition comprising a mixture of Lactobacillus and milk”), the markedly different
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`U.S. Serial No. 15/603,013
`Response to Non-Final Office Action dated June 26, 2019
`
`Attorney Docket No. 44854-701402
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`characteristics analysis should be applied to the resultant nature-based combination, rather than
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`its component parts. For instance, for the probiotic composition example, the mixture of
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`Lactobacillus and milk should be analyzed for markedly different characteristics, rather than the
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`Lactobacillus separately and the milk separately. MPEP 2106.04. Moreover, “[t]he additional
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`limitations should not be evaluated in a vacuum, completely separate from the recited judicial
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`exception. Instead, the analysis should take into consideration all the claim limitations and how
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`those limitations interact and impact each other when evaluating whether the exception is
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`integrated into a practical application.” October 2019 Patent Eligibility Guidance Update at 12
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`(emphasis added).
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`“[I]n order to be markedly different, an applicant must have caused the claimed product
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`to possess at least one characteristic that is difi’erentfrom that of the counterpart.” MPEP §
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`2106.04(c)(II)(B) (emphasis added). In the case of cDNA, the Supreme Court has squarely
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`stated that cDNA is patent eligible subject matter: “we hold that a naturally occurring DNA
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`segment is a product of nature and not patent eligible merely because it has been isolated, but
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`that cDNA is patent eligible because it is not naturally occurring.” Ass ’nfor Molecular
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`Pathology v. Myriad Genetics, Inc, 569 US. 576 (2013).
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`A) The claims integrate the judicial exception into a practical application at Step 2A
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`Prong 2
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`Independent claims 1 and 28, the each recite a nucleic acid cDNA library, which is a
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`composition of matter and thus within one of the categories of patentable subject matter under
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`Step 1.
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`Claims 1 and 28 each recite “subsets of nucleic acids,” wherein each of the subsets of
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`nucleic acids comprises gene fragment nucleic acids that, inter alia, collectively encode cDNA
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`sequence for one of the at least 1000 genes, wherein at least one of the gene fragment nucleic
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`acids in each of the subsets of nucleic acids encodes cDNA sequence lacking the at least one
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`intron. As such, the libraries of claims 1 and 28 include, in part, gene fragment nucleic acids
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`which may span only a corresponding exon and not an intron sequence. Thus, under Step 2A
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`Prong One, claims 1 and 28 recite a judicial exception: gene fragment nucleic acids
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`corresponding to genomic sequence.
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`However, claims 1 and 28 are not “directed to” the corresponding genomic sequence.
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`Rather, they are directed to subsets of gene fragment nucleic acids which collectively encode
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`U.S. Serial No. 15/603,013
`Response to Non-Final Office Action dated June 26, 2019
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`Attorney Docket No. 44854-701402
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`cDNA sequence for at least 1000 genes, wherein at least one of the gene fragment nucleic acids
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`in each of the subsets ofnucleic acids encodes cDNA sequence lacking the at least one intron.
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`The resulting nucleic acid cDNA library is one clearly not present in nature. Such a conclusion
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`is consistent the Supreme Court’s conclusions: “cDNA is patent eligible because it is not
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`naturally occurring.” Ass ’nfor Molecular Pathology v. Myriad Genetics, Inc., 569 US. 576
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`(2013). In sum, claims 1 and 28 recite additional elements that integrate the judicial exception
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`into a practical application.
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`Accordingly, Applicants submit that claim 1 and claim 28, and dependent claims from
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`each of those claims, are not “directed to” a judicial exception under Step 2A, and qualify as
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`patent eligible subject matter. (Step 2A Prong Two: N0). For at least these reasons, Applicant
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`respectfully requests withdrawal of the rejection to claims 1-7, 9, 10, 12, 13, 17-20, and 22-28
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`under 35 USC. § 101.
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`II) Claim Rejections — 35 USC § 112
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`A) Claims 1-7, 9, 10, 12, 13, 17-20, and 22-28 are rejected under 35 USC. § 112(b) or
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`35 USC. 112 (pre-AIA), second paragraph, as allegedly being indefinite for failing to
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`particularly point out and distinctly claim the subject matter which the inventor or a joint
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`inventor, or for pre-AIA the applicant regards as the invention. Applicant respectfully
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`disagrees.
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`Solely to expedite prosecution, (i) the language of “varying within a range of lengths” is
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`no longer present in claim 1 and claim 28, (ii) greater delineation between “nucleic acids” and
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`“gene fragment nucleic acids” is provided in claim 1 and claim 28, and (iii) amended claim 25
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`recites “bases” instead of “base pairs.” As such, because the language forming the basis of the
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`rejection to the claims is no longer present in the amended claims, withdrawal of the rejection to
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`the claims under 35 USC. § 112(b) is respectfully requested.
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`B) Claims 1-7, 9, 10, 12, 13, 17-20, and 22-28 are rejected under 35 USC. 112(a) or 35
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`USC. 112 (pre-AIA), first paragraph, as failing to comply with the written description
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`requirement, specifically for the term “genomic sequence.” Applicant respectfully disagrees.
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`Solely to expedite prosecution, the term “genomic sequence” in claim 1 and claim 26 has
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`been amended to recite “genomic DNA sequence.” Support for such language can be found in at
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`U.S. Serial No. 15/603,013
`Response to Non-Final Office Action dated June 26, 2019
`
`Attorney Docket No. 44854-701402
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`least paragraph 390 of the application as filed. As such, withdrawal of the rejection to the claims
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`under 35 USC. § 112(a) is respectfully requested is respectfully requested.
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`III) Claim Rejections — 35 USC § 103
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`A)
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`Claims 1-7, 12, 13, 17-20, and 22-28 are rejected under 35 USC. § 103 as
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`allegedly being obvious over US 2008/0287320 (hereinafter “Baynes”) in view of (2002) PNAS,
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`99(20): 12612-12616) (hereinafter “Gao”), as evidenced by Cruse (Cruse et al. “Atlas of
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`Immunology, Third Edition,” Boca Raton: CRC Press, 2010. Pages 261-265, 282-283). This
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`rejection is respectfully traversed for at least the following reasons.
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`To render a claim obvious, the cited reference(s) must be shown to teach or suggest each
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`and every claim feature. See In re Royka, 490 F.2d 981, 985 (CCPA 1974) (to establish prima
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`facie obviousness of a claimed invention, all the claim features must be taught or suggested by
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`the prior art), see also CFMT, Inc. v. YieldUp Int ’1 Corp, 349 F.3d 1333, 1342 (Fed. Cir. 2003).
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`“In determining whether obviousness is established by combining the teachings of the prior art,
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`the test is what the combined teachings of the references would have suggested to those of
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`ordinary skill in the art.” In re GPACInc., 57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal
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`quotations omitted, citation omitted).
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`Independent claim 1 and claim 28 both recite a nucleic acid cDNA library comprising,
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`inter alia, “gene fragment nucleic acids” that “collectively encode cDNA sequence for one of the
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`at least 1000 genes” and “wherein each of the at least 1000 genes is a different genomic DNA
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`sequence.”
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`Applicant submits that neither Baynes nor Gao disclose the technical features quoted
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`above. Baynes discloses generation of “variant” gene libraries. To generate variant gene
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`libraries, Baynes discloses methods for combining variant nucleic acids (assembled
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`oligonucleotides that are gene fragments) for variant gene assembly. See, e.g., Baynes at
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`Abstract (stating: “[a]spects of the invention relate to the design and synthesis of nucleic acid
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`libraries containing non-random mutations or variants)” As such, Baynes is silent as to libraries
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`comprising “gene fragment nucleic acids” that “collectively encode cDNA sequence for one of
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`the at least 1000 genes” and wherein each of the at least 1000 genes is a different genomic DNA
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`sequence as recited in each of independent claims 1 and 28.
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`Gao fails to cure this deficiency of Baynes. For example, Gao discloses libraries of
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`assembled genes which are subsequently subjected to a process for gene shuffling. The
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`U.S. Serial No. 15/603,013
`Response to Non-Final Office Action dated June 26, 2019
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`Attorney Docket No. 44854-701402
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`disclosed product of Gao is a library of genes in various combinations. See Gao at 12613, left
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`column. Thus, Gao is silent as to libraries comprising “genefragment nucleic acids” as recited
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`in each of independent claims 1 and 28.
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`Evan assuming, arguendo, that Baynes and Gao could be properly be combined as
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`hypothesized by the Office Action, which Applicants strenuously refute, such a combination
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`would not arrive at the presently claimed invention. As stated above, Baynes is directed to
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`variant nucleic acid libraries. The proposed modification by the Office Action is to incorporate
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`the combinatorial shuffling method of assembled genes described in Gao to the gene variants
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`described in Baynes. As such, the resulting product would be a combinatorial library of variant
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`gene fragments. This combination would still be missing “wherein each of the at least 1000
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`genes is a different genomic DNA ” for reasons described above.
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`For at least these reasons, Applicant respectfully requests that the rejection to claims 1-7,
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`12, 13, 17-20, and 22-28 under 35 U.S.C. § 103 be withdrawn.
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`B)
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`Claims 9 and 10 are rejected under 35 U.S.C. § 103 as allegedly being obvious S
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`2008/0287320 (hereinafter “Baynes”) in view of Gao, as applied to claim 17, and in further view
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`of Mazor (Mazor et al.) (2009) “Isolation of Full-Length IgG Antibodies from Combinational
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`Libraries Expressed in Escherichia coli”, from Therapeutic Antibodies: Methods and Protocols,
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`Methods in Molecular Biology, vol. 525, Edited by Antony S. Dimitrov, Humana Press Inc.,
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`New York, NY, pages 217-23 9) and Cruse. This rejection is respectfully traversed for at least the
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`following reasons.
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`The deficiencies of the combination of Baynes ’320 in view of Gao in rendering amended
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`independent claim 1 obvious are addressed above. Applicant submits that Mazor is cited by the
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`Office Action merely for disclosure of length of sequence spanned by nucleic acid sequence and
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`fails to cure the deficiencies of Baynes ’320 and Gao addressed above. For at least these
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`reasons, Applicant respectfully requests that the rejection to claims 9 and 10 under 35 U.S.C. §
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`103 be withdrawn.
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`C)
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`Claim 20 is rejected under 35 U.S.C. 103 as allegedly being obvious over US
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`Baynes in view of Gao, as applied to claim 17, and in further view of Pirrung, MC. (2002)
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`Angewandte Chemie International Edition, 41 : 1276-1289) (hereinafter “Pirrung”) This rejection
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`is respectfully traversed for at least the following reasons.
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`U.S. Serial No. 15/603,013
`Response to Non-Final Office Action dated June 26, 2019
`
`Attorney Docket No. 44854-701402
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`The deficiencies of the combination of Baynes ’320 in view of Gao in rendering amended
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`independent claim 1 obvious are addressed above. Pirrung is cited by the Office Action merely
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`for disclosure of surface elements of a DNA chip and fails to cure the deficiencies of Baynes
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`’320 and Gao addressed above. For at least these reasons, Applicant respectfully requests that
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`the rejection to claim 20 under 35 U.S.C. § 103 be withdrawn.
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`D)
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`Claim 22-24 is rejected under 35 U.S.C. 103 as allegedly being obvious over US
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`Baynes in view of Gao, as applied to claim 1, and in further view of US 2010/0099103)
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`(hereinafter “Hsieh”). This rejection is respectfully traversed for at least the following reasons.
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`The deficiencies of the combination of Baynes ’320 in view of Gao in rendering amended
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`independent claim 1 obvious are addressed above. Hsieh is cited by the Office Action merely for
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`disclosure of barcode sequence and fails to cure the deficiencies of Baynes ’320 and Gao
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`addressed above. Moreover, like Gao, Hsieh is directed to generation of diversity in antibody
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`libraries by shuffling assembled genes. See Hsieh at [0086] describing gene sources. For at least
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`these reasons, Applicant respectfully requests that the rejection to claim 22-24 under 35 U.S.C. §
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`103 be withdrawn.
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`U.S. Serial No. 15/603,013
`Response to Non-Final Office Action dated June 26, 2019
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`Attorney Docket No. 44854-701402
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`CONCLUSION
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`Applicant respectfully solicits the Examiner to expedite examination of this application to
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`issuance. Should the Examiner have any questions, Applicant requests that the Examiner contact
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`the undersigned at 617-598-7824. The Commissioner is hereby authorized to charge any fees that
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`may be required, or credit any overpayment to Deposit Account No. 23-2415, referencing
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`Attorney Docket No. 44854-701402.
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`Respectfully submitted,
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`WILSON SONSINI GOODRICH & ROSATI
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`A Professional Corporation
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`Date: October 24 2019
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`By:
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`/DaVid S. Harburger/
`David S. Harburger
`Registration No. 65,159
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`650 Page Mill Road
`Palo Alto, CA 94304
`Direct Dial: (617) 598-7824
`Customer No. 021971
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`-11-
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