U.S. Serial No. 15/603,013
`Response to Non-Final Office Action dated July 10, 2018
`
`Attorney Docket No. 44854-701.402
`
`REMARKS
`
`Claims 1-7, 9-10, 12-13, and 17-21 are currently pendingin this application. With this
`
`amendment, claim 1 is currently amended and claims 22 and 23 are new. Support for the
`
`amendments to the claims can be found throughoutthe as-filed application, including paragraph
`
`536. No new matteris believed to be introduced.
`
`Upon entry of this amendment, claims 1-7, 9-10, 12-13 and 17-23 are pending in this
`
`application. Allowance of the application is respectfully requested.
`
`QD
`
`Claim Rejections — 35 USC § 101
`
`The Office Action maintainsits rejection of claims 1-7, 9, 10, 12, 13 and 17-20 under 35
`
`U.S.C. § 101 because the claimed invention is allegedly directed to a judicial exception (1.¢., a
`
`law of nature, a natural phenomenon,or an abstract idea) without significantly more. Applicant
`
`respectfully disagrees.
`
`Amended independentclaim 1 recites a nucleic acid cDNAlibrary, “wherein each ofthe
`
`nucleic acids comprises at least one barcode sequencefor identification of said nucleic acid.”
`
`Applicant submits that a library of nucleic acids comprising such barcode sequencesare
`
`structurally different than those found in nature. As such, these structurally different nucleic
`
`acids rise to the level of a “marked difference” from what is found in nature, and accordingly the
`
`nucleic acid cDNAlibrary of claim 1 is not as a whole directed to a “product of nature”judicial
`
`exception to patent eligibility. As such, Applicant submits that claim 1 and dependent claims
`
`therefrom are not directed to a judicial exception (Step 2A: NO), and qualifies as eligible subject
`
`matter. See MPEP § 2106.04.
`
`Forat least these reasons, Applicant respectfully requests withdrawal of the rejection to
`
`claim 1 and dependent claims 2-7, 9, 10, 12, 13 and 17-20 under 35 U.S.C. § 101.
`
`II) Claim Rejections — 35 USC § 112
`
`The Office Action rejects claims 1-7, 9, 10, 12, 13 and 17-21 under 35 U.S.C. § 112(a) or
`
`35 U.S.C. 112 (pre-AIA), first paragraph, as allegedly failing to comply with the written
`
`-A.
`
`

`

`U.S. Serial No. 15/603,013
`Response to Non-Final Office Action dated July 10, 2018
`
`Attorney Docket No. 44854-701.402
`
`description requirement. This rejection is respectfully traversed for at least the following
`
`reasons.
`
`It appears that the Office is examining the rejected claims as product-by-process claims
`
`while assessing the adequacy of written description for the process. Applicant submits, however,
`
`that MPEPinstructs for consideration of adequate written description based on the product. For
`
`example, MPEP § 2113 states: “[E]ven though product-by-process claims are limited by and
`
`defined by the process, determination ofpatentability is based on the productitself. The
`
`patentability of a product does not depend on its method ofproduction” (emphasis added).
`
`Even if the Office were to consider the pending claims as product-by- process claims, MPEP §
`
`2163 provides guidance that disclosure of a mere single method of making the claimed subject
`
`matter is sufficient in such an instance: “Disclosure of only a method of making the invention
`
`and the function maynotbe sufficient to support a product claim other than a product-by-
`
`process claim” (emphasis added).
`
`Turning to the claimed product, Applicant submits that the instant application’s
`
`disclosure is sufficient for demonstration of possession of the claimed nucleic acid cDNA
`
`library. For example, Example 8 of the speciation describes two different reaction conditions on
`
`separate chips for synthesis of 100-mer nucleic acids. Chip 1 is uniformly coated with a
`
`coupling reagent, while chip 2 is not. Samples are collected from each chip. Spots 6-10 (from
`
`chip 2) yield an average error rate of less than 1 in 800 bases (1 in 1015 bases). In contrast,
`
`spots 1-5 (from chip 1) yield an average error rate of more than 1 in 800 bases. One ofskill in
`
`the art would clearly appreciate the synthesis method associated with chip 2 as a workable
`
`method for generation of highly accurate construction oligonucleotides for assembly of a cDNA
`
`nucleic acid library commensurate with the scope of claim 1.
`
`Applicant notes that the Office’s reliance on higher error rates from methods described in
`
`Examples 9 and 14 does not detract from the result described from the oligonucleotides
`
`generated from Chip 2 in Example 8. Examples 9 and 14 described oligonucleotide synthesis by
`
`different methods than that of Example 8. As such, pursuant to the MPEP guidance quoted
`
`above, the disclosed method of making the construction oligonucleotides in Chip 2 as described
`
`in Example 8 is more than sufficient to support adequate written description for generation of the
`
`nucleic acid cDNAlibrary of claim 1.
`
`

`

`U.S. Serial No. 15/603,013
`Response to Non-Final Office Action dated July 10, 2018
`
`Attorney Docket No. 44854-701.402
`
`Forat least these reasons, Applicant respectfully requests that the rejection to
`
`independent claim 1 and dependentclaims 2-7, 9, 10, 12, 13 and 17-21 for lack of written
`
`description be withdrawn.
`
`II)
`
`Claim Rejections — 35 USC § 102
`
`Claims 1-7, 9, 10, and 17-21 are rejected under 35 U.S.C. § 102(a)(1) as allegedly being
`
`anticipated by Gaoet al. (PNAS, 99(2)):12612-12616) (hereinafter “Gao”) as evidenced by
`
`Janda (US 6,472,1477). The rejection of claim 21 is alledgedly evidenced by Cruseetal. (Atlas
`
`of Immunology, Third Edition.” Boca Raton: CRCPress, 2010. Pages 282-283) (hereinafter
`
`“Cruse”). This rejection is respectfully traversed for at least the following reasons.
`
`MPEP § 2131 requires that “[a] claim is anticipated only if each and every elementas set
`
`forth in the claim is found, either expressly or inherently described, in a single prior art
`
`reference.” Verdegaal Bros. vy. Union Oil Co. of California, 814 F.2d 628, 631, 2 USPQ2d 1051,
`
`1053 (Fed. Cir. 1987).
`
`Amended independentclaim 1 recites a nucleic acid cDNAlibrary comprising “nucleic
`
`acids synthesized based on instructions provided in a computer readable non-transient medium
`
`for synthesis of preselected cDNA sequences encoding for at least 1000 genes,[1] wherein the
`
`nucleic acids encode cDNA sequences with an aggregate error rate of less than I in 800 bases
`
`without correcting errors in the nucleic acids comparedto the preselected cDNA sequences
`
`received in the instructions provided in the computer readable non-transient medium,[2]
`
`wherein each of the nucleic acids comprises at least one barcode sequence for identification of
`
`said nucleic acids, and wherein each of the nucleic acidsis at least 0.5 kb in length.” (annotation
`
`and emphasis added). Applicant submits that Gao does not disclose a nucleic acid cDNAlibrary
`
`having at least these two features recited in claim 1.
`
`Forat least these reasons, Applicant respectfully requests that the rejection to
`
`independent claim 1 and dependentclaims therefrom under 35 U.S.C. § 102 be withdrawn.
`
`IV) Claim Rejections — 35 USC § 103
`
`A)
`
`Claims 1-7, 9, 10, 17, 19, and 21 are rejected under 35 U.S.C. § 103 as allegedly being
`
`obvious over Baynes (US 2008/0287320) (hereinafter “Baynes ‘320”) in view of Gao. This
`
`rejection is respectfully traversed for at least the following reasons.
`
`-6-
`
`

`

`U.S. Serial No. 15/603,013
`Response to Non-Final Office Action dated July 10, 2018
`
`Attorney Docket No. 44854-701.402
`
`MPEP§ 2143.03 requires the “consideration” of every claim feature in an obviousness
`
`determination. To render claim 1 obvious, however, the Office must do more than merely
`
`“consider” each and every feature for this claim. Instead, the cited reference(s) must also be
`
`shown teaching or suggesting each and every claim feature. See In re Royka, 490 F.2d 981, 180
`
`USPQ 580 (CCPA 1974)(to establish primafacie obviousness of a claimed invention, all the
`
`claim features must be taught or suggested by the priorart).
`
`Amended independentclaim 1 recites a nucleic acid cDNAlibrary comprising nucleic
`
`acids synthesized based on instructions provided in a computer readable non-transient medium
`
`for synthesis of preselected cDNA sequences encoding for at least 1000 genes, wherein, infer
`
`alia, “each of the nucleic acids comprisesat least one barcode sequenceforidentification of said
`
`nucleic acids.” Applicant submits that neither Gao or Baynes ‘320 disclose or suggest a nucleic
`
`acid cDNA library having quoted feature recited in claim 1. Moreover, the combination of
`
`references provides no motivation to modify the library of Gao such that “each of the nucleic
`
`acids comprises at least one barcode sequencefor identification of said nucleic acids” as recited
`
`in claim 1.
`
`Forat least these reasons, Applicant respectfully requests that the rejection to
`
`independent claim 1 and dependentclaims therefrom under 35 U.S.C. § 103 be withdrawn.
`
`B)=Claims 12 and 13 are rejected under 35 U.S.C. § 103 as allegedly being obvious over
`
`Baynes ‘320 in view of Gao, and further in view of Baynes (WO 2008/054543) (hereinafter
`
`“Baynes °543”).
`
`Amended independentclaim 1 recites a nucleic acid cDNAlibrary comprising nucleic
`
`acids synthesized based on instructions provided in a computer readable non-transient medium
`
`for synthesis of preselected cDNA sequences encoding for at least 1000 genes, wherein, infer
`
`alia, “each of the nucleic acids comprisesat least one barcode sequenceforidentification of said
`
`nucleic acids.” Applicant submits that neither Baynes ‘320, Gao, nor Baynes 543 disclose or
`
`even suggest a nucleic acid cDNAlibrary having quoted feature recited in claim 1. Moreover,
`
`the combination of references provides no motivation to modify the library of Baynes ‘320 such
`
`that “each of the nucleic acids comprises at least one barcode sequencefor identification of said
`
`nucleic acids” as recited in claim 1.
`
`Forat least these reasons, Applicant respectfully requests that the rejection to claims 12
`
`and 13 under 35 U.S.C. § 103 be withdrawn.
`
`-7-
`
`

`

`U.S. Serial No. 15/603,013
`Response to Non-Final Office Action dated July 10, 2018
`
`Attorney Docket No. 44854-701.402
`
`C)
`
`Claims 18 and 20 are rejected under 35 U.S.C. § 103 as being obvious over Baynes ‘320
`
`in view of Gao, and further in view of Pirrung 2002 (Pirrung, M.C. (2002) Angewandte Chemie
`
`International Edition, 41:1276-1289) (hereinafter “Pirrung”).
`
`Amended independentclaim 1 recites a nucleic acid cDNAlibrary comprising nucleic
`
`acids synthesized based on instructions provided in a computer readable non-transient medium
`
`for synthesis of preselected cDNA sequences encoding for at least 1000 genes, wherein, infer
`
`alia, “each of the nucleic acids comprisesat least one barcode sequenceforidentification of said
`
`nucleic acids.” Applicant submits that neither Baynes ‘320, Gao nor Pirrung disclose or even
`
`suggest a nucleic acid cDNAlibrary having quoted feature recited in claim 1. Moreover, the
`
`combination of references provides no motivation to modify the library of Baynes ‘320 such that
`
`“each of the nucleic acids comprisesat least one barcode sequencefor identification of said
`
`nucleic acids” as recited in claim 1.
`
`Forat least these reasons, Applicant respectfully requests that the rejection to claims 18
`
`and 20 under 35 U.S.C. § 103 be withdrawn.
`
`

`

`U.S. Serial No. 15/603,013
`Response to Non-Final Office Action dated July 10, 2018
`
`Attorney Docket No. 44854-701.402
`
`CONCLUSION
`
`Applicant respectfully solicits the Examiner to expedite examination of this application to
`
`issuance. Should the Examiner have any questions, Applicant requests that the Examiner contact
`
`the undersigned at 858-350-2322. The Commissioneris hereby authorized to charge any fees that
`
`may be required, or credit any overpayment to Deposit Account No. 23-2415, referencing
`
`Attorney Docket No. 44854-701.402.
`
`Respectfully submitted,
`
`WILSON SONSINI GOODRICH & ROSATI
`A Professional Corporation
`
`
`Date: October 9, 2018
`
`By:
`
` /David S. Harburger/
`David S. Harburger
`Registration No. 65,159
`
`650 Page Mill Road
`Palo Alto, CA 94304
`Direct Dial: (858) 350-2322
`Customer No. 021971
`
`-9-
`
`