U.S. Serial No. 15/603,013
`Notice of Non-Compliant Amendment dated April 1, 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, and 17-23 are currently pending in this application. With this
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`amendment, claims 1, 2, 5-7, 9, 10, 12, 22 and 23 are currently amended, claim 21 is cancelled
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`without prejudice or disclaimer, and claims 24-28 are new. Support for the amendments to the
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`claims can be found throughout the as-filed application and original claims, including paragraphs
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`[00357], [00390], [00474], and [00504]. 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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`I) Applicant Initiated Telephonic Interview Summary
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`Applicant thanks Examiner Hammell for the courteous telephonic interview on April 11,
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`2019, with Applicant’s representative David Harburger. During the interview, the claim set filed
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`by Applicant on October 9, 2018 was discussed. Examiner Hammell proposed deletion of the
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`phrase “without correcting errors in the nucleic acids” from the claim 1 to overcome the written
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`description rejection. See also Applicant-Initiated Interview Summary mailed April 16, 2019.
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`Examiner Hammell also proposed incorporation of the language “wherein each of the at least
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`1000 genes comprises at least one intron” into claim 1 to overcome the 101 rejection.
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`II) Claim Rejections — 35 USC § 101
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`The Office Action dated November 7, 2018, rejects claims 1-7, 9, 10, 12, 13, 17-20, 22
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`and 23 under 35 USC. § 101 because the claimed invention is allegedly directed to a judicial
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`exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly
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`more. This rejection is respectfully traversed for at least the following reasons.
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`During the Telephonic Interview on April 11, 2019, Examiner Hammell acknowledged
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`that incorporation of the language of previously pending claim 21 (now cancelled) regarding
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`each gene comprising “at least one intron” into claim 1 would overcome the § 101 rejection.
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`Such language is now reflected in amended independent claim 1. It is also noted that claim 21
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`was not rejected under 35 USC. § 101 in the Office Action.
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`Accordingly, withdrawal of the rejection to independent claim 1 and dependent claims 2-
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`7, 9, 10, 12, 13, 17-20, 22, and 23 under 35 USC. § 101 is respectfully requested.
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`U.S. Serial No. 15/603,013
`Notice of Non-Compliant Amendment dated April 1, 2019
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`Attorney Docket No. 44854-701402
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`III) Claim Rejections — 35 USC § 112
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`The Office Action rejects claims 1-7, 9, 10, 12, 13, and 17-23 under 35 USC. § 112(a)
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`as allegedly failing to comply with the written description requirement. This rejection is
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`respectfully traversed for at least the following reasons.
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`During the Telephonic Interview on April 11, 2019, Examiner Hammell acknowledged
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`that deletion of the phrase “without correcting errors in the nucleic acids” from claim 1 would
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`overcome the written description rejection. Such language is no longer reflected in amended
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`independent claim 1.
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`Accordingly, withdrawal of the rejection to independent claim 1 and dependent claims 2-
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`7, 9, 10, 12, 13, 17-20, 22, and 23 under 35 USC. § 112(a) is respectfully requested.
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`IV) Claim Rejections — 35 USC § 103
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`A)
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`Claims 1-7, 9, 10, and 17-23 are rejected under 35 USC. § 103 as allegedly being
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`obvious over Gao (Gao et al. (2002) PNAS, 99(20): 12612-12616) (hereinafter “Gao”) in view
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`of Hsieh (US 2010/0099103) (hereinafter “Hsieh”) as evidenced by Janda (US 6,472,147)
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`(hereinafter “Janda”). This 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 Inl’l 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 GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal
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`quotations omitted, citation omitted).
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`Amended independent claim 1 recites, a nucleic acid cDNA library comprising nucleic
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`acids, inter alia, “wherein the nucleic acids comprise subsets of nucleic acids, and wherein each
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`of the subsets of nucleic acids comprises nucleic acids: (i) varying within a range of lengths, (ii)
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`collectively spanning at least 0.5 kb in length, and (iii) collectively encoding cDNA sequence for
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`one of the at least [000 genes.”
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`Applicant submits that neither Gao nor Hsieh, alone or in combination, disclose a library
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`of nucleic acids having subsets of nucleic acids “collectively encoding cDNA sequence for one
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`of the at least 1000 genes,” as recited in claim 1. As such, claim 1 is directed to a nucleic acid
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`-6-
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`U.S. Serial No. 15/603,013
`Notice of Non-Compliant Amendment dated April 1, 2019
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`Attorney Docket No. 44854-701402
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`cDNA library comprising gene fragments. In contrast to the gene fragment cDNA library of
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`claim 1, Gao is directed to generation of combinatorial antibody libraries generated by starting
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`with assembled genes and shuffling the assembled genes to generate diversity. See Gao at 12613,
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`left column. As such, the nucleic acid libraries of Gao are of a very different from the “subsets
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`of nucleic acids
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`collectively encoding cDNA sequence for one of the at least 1000 genes” as
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`recited in claim 1.
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`Applicant respectfully submits that Hsieh does not cure the deficiency of Gao. Like Gao,
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`Hsieh is directed to generation of diversity in antibody libraries by shuffling assembled genes.
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`See Hsieh at [0086] describing gene sources.
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`Moreover, Gao and Hsieh are silent as to any suggestion of a nucleic acid library
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`comprising subsets of nucleic acids collectively encoding cDNA sequence for a gene. As such,
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`the cited disclosures provide no motivation to a person having ordinary skill in the art to modify
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`the disclosure of Gao to arrive at the nucleic acid library of claim 1.
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`For at least these reasons, Applicant respectfully requests that the rejection to
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`independent claim 1 and dependent claims therefrom under 35 U.S.C. § 103 be withdrawn.
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`B)
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`Claims l-7, 9, 10, l7, l9, and 21-23 are rejected under 35 U.S.C. § 103 as allegedly
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`being obvious over Baynes (US 2008/0287320) (hereinafter “Baynes ‘320”) in view of Gao and
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`Hsieh. This rejection is respectfully traversed for at least the following reasons.
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`Applicant submits that neither Baynes ’320, Gao nor Hsieh, alone or in combination,
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`disclose subsets of nucleic acids “collectively encoding cDNA sequence for one of the at least
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`1000 genes wherein each of the at least 1000 genes is a different genomic sequence” as recited
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`in claim 1.
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`Baynes ’320 teaches methods for combining variant sequences for variant gene
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`assembly. See, e.g., Baynes ’320 at Abstract (stating: “[a]spects of the invention relate to the
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`design and synthesis of nucleic acid libraries containing non-random mutations or variants)”.
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`As such, the combinatorial nucleic acid libraries of Baynes do not encode cDNA sequences
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`collectively encoding for a gene that corresponds to genomic sequence as presently claimed.
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`Gao and Hsieh are addressed above and fail to cure the deficiencies of Baynes ’320.
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`Moreover, to modify Baynes ’320 to be applied for synthesis of a large library of non-
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`variant genomic sequence would impermissibly frustrate the intended purpose of Baynes ’320.
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`U.S. Serial No. 15/603,013
`Notice of Non-Compliant Amendment dated April 1, 2019
`
`Attorney Docket No. 44854-701402
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`For at least these reasons, Applicant respectfully requests that the rejection to
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`independent claim 1 and dependent claims therefrom under 35 U.S.C. § 103 be withdrawn.
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`C)
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`Claims 12 and 13 are rejected under 35 U.S.C. § 103 as being obvious over Baynes ’320
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`in view of Gao, and Hsieh, as applied to claim 17, and in further view of Baynes (WO
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`2008/054543) (hereinafter “Baynes ’543”). This rejection is respectfully traversed for at least
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`the following reasons.
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`Applicant respectfully submits that the deficiencies of the combination of Baynes ’320 in
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`view of Gao and Hsieh in rendering amended independent claim 1 obvious are addressed above.
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`Applicant submits that the addition of Baynes ’ 543 fails to cure these deficiencies. When
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`properly considering the disclosure of Baynes ’543 as a whole, the disclosure expressly provides
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`for limitations on the structure of the oligonucleotides described therein to arrive at a product
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`very different than what is described in claim 1.
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`Specifically, Baynes ’543 discloses a pool-based method of nucleic acid assembly
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`utilizing oligonucleotides capable of assembly to each other, where the oligonucleotides are of
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`the same length. Baynes ’543 explains that “since all the oligonucleotides being amplified will
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`be of the same length, all oligonucleotides should be amplified to the same extent, barring any
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`sequence-specific effects.” Id. at page15, lines 25-27 (emphasis added). Moreover, in the
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`section entitled “oligonucleotide embodiments,” the disclosure states: “[t]he total length of the
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`oligonucleotides generally will not vary, except for those oligonucleotides comprising target
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`sequences with deletions.” Id. at page 19, lines 17-18 (emphasis added).
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`Moreover, Baynes ’543 expressly teaches for removal of any sequences which
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`erroneously do not have the same length:
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`The spacer sequence is designed to increase the length of the oligonucleotide with
`the desired result that all oligonucleotides synthesized on, for example, a chip will
`be of the same length. As a result, when the oligonucleotides are harvested from
`the chip and pooled, the majority will have the same length. Oligonucleotides that
`include a deletion however will be shorter than the majority of oligonucleotides,
`and it is possible to identify and thus remove those shorter oligonucleotides from
`the pool.
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`Baynes ’543 at page 9, lines 12-18.
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`As such, a person of ordinary skill in the art considering Baynes ’543 would be motivated
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`to generate a library consisting of oligonucleotides having the same sequence length and not the
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`U.S. Serial No. 15/603,013
`Notice of Non-Compliant Amendment dated April 1, 2019
`
`Attorney Docket No. 44854-701402
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`nucleic acid cDNA library of amended independent claim 1 comprising subsets of nucleic acids
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`“varying within a range oflengths” that collectively encode for cDNA sequence for a gene.
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`Therefore, any modification to the primary reference based on the express teachings of Baynes
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`’543 would necessarily provide guidance to one of skill in the art away from arriving at the
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`nucleic acid cDNA library recited in claim 1. Moreover, Applicant submits that it would be
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`improper to disregard these strong design preferences of Baynes ’543. See Polaris Indus. v.
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`Arctic Cat, 882 F.3d 1056, 1069 (Fed. Cir. 2018) (stating: “[b]ut even if a reference is not found
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`to teach away, its statements regarding preferences are relevant to a finding regarding whether a
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`skilled artisan would be motivated to combine that reference with another reference”).
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`For at least these reasons, Applicant respectfully requests that the rejection to claims 12
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`and 13, which depend from independent claim 1, under 35 U.S.C. § 103 be withdrawn.
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`D)
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`Claims 18 and 20 are rejected under 35 U.S.C. § 103 as being obvious over Baynes ’320
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`in view of Gao, and Hsieh, as applied to claim 17, and in further view of Pirrung (Pirrung, MC.
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`(2002) Angewandte Chemie International Edition, 41 : 1276-1289). This rejection is respectfully
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`traversed for at least the following reasons.
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`The deficiencies of the combination of Baynes ’320 in view of Gao, and Hsieh in
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`rendering amended independent claim 1 obvious are addressed above. Applicant submits that
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`Pirrung is cited by the Office Action merely for disclosure of surface elements of a DNA chip
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`and fails to cure the deficiencies of Baynes ’320, Gao, and Hsieh as addressed above.
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`For at least these reasons, Applicant respectfully requests that the rejection to claims 18
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`and 20 under 35 U.S.C. § 103 be withdrawn.
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`U.S. Serial No. 15/603,013
`Notice of Non-Compliant Amendment dated April 1, 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
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`that 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: May 9, 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
`(617) 598-7824 (direct)
`Customer No. 021971
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`-10-
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