www.uspto.gov
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 2231371450
`
`15/187,714
`
`06/20/2016
`
`William BANYAI
`
`44854-701304
`
`1444
`
`WILSON, SONSINI, GOODRICH & ROSATI
`650 PAGE MILL ROAD
`PALO ALTO, CA 94304-1050
`
`ZHANG KAUIANG
`
`ART UNIT
`
`1639
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`04/04/2019
`
`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):
`
`patentdoeket@ wsgroom
`
`PTOL-90A (Rev. 04/07)
`
`

`

`0/7709 A0170” Summary
`
`Application No.
`15/187,714
`Examiner
`KAIJIANG ZHANG
`
`Applicant(s)
`BANYAI et al.
`Art Unit
`1639
`
`AIA (FITF) Status
`Yes
`
`- The MAILING DA TE of this communication appears on the cover sheet wit/7 the correspondence address -
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, may a reply be timely filed after SIX (6) MONTHS from the mailing
`date of this communication.
`|f NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1). Responsive to communication(s) filed on 16 November 2018.
`[:1 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2a)D This action is FINAL.
`
`2b)
`
`This action is non-final.
`
`3)[:] An election was made by the applicant in response to a restriction requirement set forth during the interview on
`; the restriction requirement and election have been incorporated into this action.
`
`4)[:] Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Expat/7e Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims*
`5)
`Claim(s)
`
`23—36 is/are pending in the application.
`
`5a) Of the above claim(s)
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`is/are withdrawn from consideration.
`
`E] Claim(s)
`
`is/are allowed.
`
`Claim(s) 23—36 is/are rejected.
`
`[:1 Claim(s)
`
`is/are objected to.
`
`) ) ) )
`
`6 7
`
`8
`
`
`
`are subject to restriction and/or election requirement
`[j Claim(s)
`9
`* If any claims have been determined aflowabie. you may be eligible to benefit from the Patent Prosecution Highway program at a
`
`participating intellectual property office for the corresponding application. For more information, please see
`
`http://www.uspto.gov/patents/init events/pph/index.jsp or send an inquiry to PPeredback@uspto.gov.
`
`Application Papers
`10)[:] The specification is objected to by the Examiner.
`
`11). The drawing(s) filed on 20 June 2016 is/are: a). accepted or b)[:] objected to by the Examiner.
`
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`12)[:] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`a)I:I All
`
`b)D Some**
`
`C)D None of the:
`
`1.[:] Certified copies of the priority documents have been received.
`
`2.[:] Certified copies of the priority documents have been received in Application No.
`
`3:] Copies of the certified copies of the priority documents have been received in this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`
`** See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1)
`
`Notice of References Cited (PTO-892)
`
`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`Paper No(s)/Mail Date See Continuation Sheet
`U.S. Patent and Trademark Office
`
`3) C] Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) CI Other-
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20190327
`
`

`

`Continuation Sheet (PTOL-326)
`
`Application No. 15/187,714
`
`Continuation of Attachment(s) 2) Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date: 9/2/2016, 9/20/2016, 4/20/2017, 9/28/2017, 11/6/2017, 11/16/2018
`
`

`

`Application/Control Number: 15/187,714
`Art Unit: 1639
`
`Page 2
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`DETAILED ACTION
`
`Notice of Pre-AIA or AIA Status
`
`1.
`
`The present application, filed on or after March 16, 2013, is being examined
`
`under the first inventor to file provisions of the AIA.
`
`Election/Restrictions
`
`2.
`
`
`Applicant’s election without traverse of Group II (claims 23-36) in the reply filed
`
`on 11/16/2018 is acknowledged. Applicant has canceled claims 1-13, 18 and 20-22
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`which belong to the non-elected Group |.
`
`3.
`
`Claims 23-36 are currently pending and under examination.
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`Warning for Duplicate Claims
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`4.
`
`Applicant is advised that should claim 31 be found allowable, claim 33 will be
`
`objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two
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`claims in an application are duplicates or else are so close in content that they both
`
`cover the same thing, despite a slight difference in wording, it is proper after allowing
`
`one claim to object to the other as being a substantial duplicate of the allowed claim.
`
`See MPEP § 706.03(k).
`
`Double Patenting
`
`5.
`
`The nonstatutory double patenting rejection is based on a judicially created
`
`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
`
`unjustified or improper timewise extension of the “right to exclude” granted by a patent
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`and to prevent possible harassment by multiple assignees. A nonstatutory double
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`patenting rejection is appropriate where the conflicting claims are not identical, but at
`
`least one examined application claim is not patentably distinct from the reference
`
`

`

`Application/Control Number: 15/187,714
`Art Unit: 1639
`
`Page 3
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`claim(s) because the examined application claim is either anticipated by, or would have
`
`been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46
`
`USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed.
`
`Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum,
`
`686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619
`
`(CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
`
`A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321 (d)
`
`may be used to overcome an actual or provisional rejection based on nonstatutory
`
`double patenting provided the reference application or patent either is shown to be
`
`commonly owned with the examined application, or claims an invention made as a
`
`result of activities undertaken within the scope of a joint research agreement. See
`
`MPEP § 717.02 for applications subject to examination under the first inventor to file
`
`provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) -
`
`706.02(l)(3) for applications not subject to examination under the first inventor to file
`
`provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR
`
`1.321 (b).
`
`The USPTO Internet website contains terminal disclaimer forms which may be
`
`used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application
`
`in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26,
`
`PTO/AlA/25, or PTO/AlA/26) should be used. A web-based eTerminal Disclaimer may
`
`be filled out completely online using web-screens. An eTerminal Disclaimer that meets
`
`all requirements is auto-processed and approved immediately upon submission. For
`
`

`

`Application/Control Number: 15/187,714
`Art Unit: 1639
`
`Page 4
`
`more information about eTerminal Disclaimers, refer to
`
`www.uspto.gov/patents/process/file/efs/guidance/eTD-info-l.jsp.
`
`6.
`
`Claims 23-36 are rejected on the ground of nonstatutory double patenting as
`
`being unpatentable over claims 1-25 of U.S. Patent No. 9,409,139. Although the claims
`
`at issue are not identical, they are not patentably distinct from each other because
`
`claims 1-25 of U.S. Patent No. 9,409,139 teach or render obvious all the features as
`
`instantly claimed.
`
`Specifically, claims 1-25 of U.S. Patent No. 9,409,139 disclose all the essential
`
`features of the instantly claimed method, such as synthesizing a plurality of
`
`polynucleotides (e.g., at least 20,000 or 800,000 polynucleotides) encoding sequences
`
`with an aggregate error rate of less than 1
`
`in 800 bases (e.g., less than 1
`
`in 2000
`
`bases) without correcting errors (see claims 1 and 17 of U.S. Patent No. 9,409,139),
`
`assembling at least 750 or 1,000 (e.g., 6,000. See claim 17 of U.S. Patent No.
`
`9,409,139) preselected nucleic acids (which may be any nucleic acids of interest,
`
`including genes), and treating the assembled nucleic acids with an error correction
`
`enzyme (see claim 16 of U.S. Patent No. 9,409,139). As for the features of “receiving
`
`instructions in a computer readable non-transient medium”, “processing the instructions
`
`in a computer and transmitting synthesis instructions to a material deposition device”
`
`and “releasing synthesis reagents from the material deposition device to synthesize the
`
`plurality of polynucleotides”, such features are obvious and necessary elements for the
`
`microarray-based nucleic acid synthesis method as disclosed in the claims of U.S.
`
`Patent No. 9,409,139, as evidenced by the same specification shared by the instant
`
`application and U.S. Patent No. 9,409,139.
`
`

`

`Application/Control Number: 15/187,714
`Art Unit: 1639
`
`Page 5
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`7.
`
`Claims 23-36 are rejected on the ground of nonstatutory double patenting as
`
`being unpatentable over claims 1-29 of U.S. Patent No. 9,833,761 in view of Church et
`
`al. (WO 2012/154201 A1).
`
`Claims 1-29 of U.S. Patent No. 9,833,761 disclose, explicitly, implicitly or
`
`inherently, all the features of the instantly claimed method, except the step of
`
`“assembling”.
`
`However, Church et al. teach that the use of such library of oligonucleic acids for
`
`the assembly of genes (see the whole document, which is also discussed in details in
`
`the 102/103 rejections below).
`
`It would have been prima facie obvious to one of ordinary skill in the art before
`
`the effective filling date of the claimed invention to use the library of oligonucleic acids
`
`synthesized by the method of claims 1-29 of U.S. Patent No. 9,833,761 for the
`
`assembly of genes as taught by Church et al. thus arriving at the instantly claimed
`
`invention, because such library of oligonucleic acids was recognized in the art as
`
`suitable for the assembly of genes. In addition, combining prior art elements according
`
`to known methods to yield predictable results is considered prima facie obvious (see
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`MPEP 2143.I.A).
`
`Claim Rejections - 35 USC § 102/103
`
`8.
`
`In the event the determination of the status of the application as subject to AIA 35
`
`U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any
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`correction of the statutory basis for the rejection will not be considered a new ground of
`
`

`

`Application/Control Number: 15/187,714
`Art Unit: 1639
`
`Page 6
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`rejection if the prior art relied upon, and the rationale supporting the rejection, would be
`
`the same under either status.
`
`9.
`
`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
`
`form the basis for the rejections under this section made in this Office action:
`
`A person shall be entitled to a patent unless —
`
`(a)(1) the claimed invention was patented, described in a printed publication, or in public use,
`on sale or othenNise available to the public before the effective filing date of the claimed
`invention.
`
`(a)(2) the claimed invention was described in a patent issued under section 151, or in an
`application for patent published or deemed published under section 122(b), in which the
`patent or application, as the case may be, names another inventor and was effectively filed
`before the effective filing date of the claimed invention.
`
`10.
`
`The following is a quotation of 35 U.S.C. 103 which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`A patent for a claimed invention may not be obtained, notwithstanding that the claimed
`invention is not identically disclosed as set forth in section 102, if the differences between the
`claimed invention and the prior art are such that the claimed invention as a whole would have
`been obvious before the effective filing date of the claimed invention to a person having
`ordinary skill in the art to which the claimed invention pertains. Patentability shall not be
`negated by the manner in which the invention was made.
`
`11.
`
`This application currently names joint inventors. In considering patentability of the
`
`claims the examiner presumes that the subject matter of the various claims was
`
`commonly owned as of the effective filing date of the claimed invention(s) absent any
`
`evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to
`
`point out the inventor and effective filing dates of each claim that was not commonly
`
`owned as of the effective filing date of the later invention in order for the examiner to
`
`consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2)
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`prior art against the later invention.
`
`

`

`Application/Control Number: 15/187,714
`Art Unit: 1639
`
`Page 7
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`12.
`
`Claims 23-36 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as
`
`being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Church
`
`et al. (WO 2012/154201 A1).
`
`Regarding claim 23
`
`Church et al. teach, throughout the whole document, a method for computer-
`
`assisted nucleic acid synthesis, comprising: receiving instructions in a computer
`
`readable non-transient medium for synthesis of cDNA sequences encoding for a
`
`plurality of genes (see paragraphs [038], [096] and [099]; Figure 14); processing the
`
`instructions in a computer and transmitting synthesis instructions to a material
`
`deposition device (e.g., chip/array-based oligonucleotide synthesizing device), wherein
`
`the synthesis instructions provide for synthesis of a plurality of polynucleotides that
`
`collectively encode for the cDNA sequences (see paragraphs [069], [074] and [096]);
`
`releasing synthesis reagents from the material deposition device to synthesize the
`
`plurality of polynucleotides (see paragraphs [069], [074] and [096]), wherein the plurality
`
`of polynucleotides encode sequences with an aggregate error rate of less than 1
`
`in 800
`
`bases without correcting errors compared to the cDNA sequences received in the
`
`instructions in the computer readable non-transient medium (see paragraph [0106].
`
`
`When the polynucleotides are 130-mers, the overall error rate, which reflect errors
`
`introduced in both the synthesis step and the subsequent amplification and assembly
`
`steps, is approximately “1/1000 bp”. Thus, the aggregate error rate for the synthesized
`
`polynucleotides, prior to their use in the subsequent amplification and assembly steps
`
`(which also introduce errors), is less than 1/1000 bp.); and assembling a plurality of
`
`nucleic acids from a subset of the plurality of polynucleotides, wherein the plurality of
`
`

`

`Application/Control Number: 15/187,714
`Art Unit: 1639
`
`Page 8
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`nucleic acids comprise sequences encoded by the cDNA sequences encoding for a
`
`plurality of genes (see paragraphs [037] and [096]; Figure 1). Regarding the plurality of
`
`genes used in the method, Church et al. teach or expressly suggest that “750, 1,000 or
`
`more” genes (assembled as “nucleic acid sequence of interest”, each of which
`
`comprises sequence encoded by the cDNA sequence encoding for one of the “750,
`
`1,000 or more” genes, and each of which is assembled using one of the “750, 1,000 or
`
`more” oligonucleotide sets) may be synthesized/assembled (see paragraphs [011]:
`
`“...the nucleic acid sequence of interest is a DNA sequence, e.g., a regulatory element,
`
`a gene, a pathway and/or a genome. In yet other aspects, 50, 100, 500, 750, 1,000 or
`
`more oligonucleotide sets are provided, wherein each set is specific for a unique nucleic
`
`acid sequence of interest.”). Accordingly, the teachings of Church et al. anticipate or at
`
`least render obvious the instantly claimed method.
`
`Regarding claim 24
`
`The method according to Church et al., wherein the plurality of nucleic acids
`
`encode sequences with an aggregate error rate of less than 1
`
`in 1000 bases without
`
`correcting errors compared to cDNA sequences provided in the instructions in the
`
`computer readable non-transient medium (see paragraph [0106]).
`
`Regarding claim 25
`
`The method according to Church et al., wherein each nucleic acid of the plurality
`
`of nucleic acids is isolated (e.g., gel isolated) (see paragraph [0102]).
`
`Regarding claim 26
`
`

`

`Application/Control Number: 15/187,714
`Art Unit: 1639
`
`Page 9
`
`The method according to Church et al., wherein each nucleic acid of the plurality
`
`of nucleic acids is purified (e.g., purified while being gel isolated) (see paragraph
`
`[0102D.
`
`Regarding claim 27
`
`The method according to Church et al., wherein each of the plurality of
`
`polynucleotides extends from a surface (see Figure 1).
`
`Regarding claim 28
`
`The method according to Church et al., further comprising treating the plurality of
`
`nucleic acids with an error correction enzyme (see paragraphs [014], [029], [096] and
`
`[0107D.
`
`Regarding claim 29
`
`The method according to Church et al., wherein each nucleic acid of the plurality
`
`of nucleic acids is at least 0.5 kb long (see paragraph [011]).
`
`Regarding claim 30
`
`The method according to Church et al., wherein each nucleic acid of the plurality
`
`of nucleic acids is at least 3 kb long (see paragraph [011]).
`
`Regarding claims 31 -33
`
`The method according to Church et al., wherein the plurality of polynucleotides
`
`comprises at least 60,000 or 100,000 polynucleotides (see paragraph [033]).
`
`Regarding claim 34
`
`The method according to Church et al., wherein the plurality of polynucleotides
`
`collectively encode and correspond to cDNA sequences for at least 1000 genes (see
`
`paragraphs [011]: “...the nucleic acid seguence of interest is a DNA seguence, e.g., a
`
`

`

`Application/Control Number: 15/187,714
`Art Unit: 1639
`
`Page 10
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`regulatory element, a gene, a pathway and/or a genome. In yet other aspects, 50, 100,
`
`500, 750, 1,000 or more oligonucleotide sets are provided, wherein each set is specific
`
`for a unigue nucleic acid seguence of interest”).
`
`Regarding claim 35
`
`The method according to Church et al., wherein each polynucleotide is 30 to 500
`
`bases in length (see paragraph [034]).
`
`Regarding claim 36
`
`The method according to Church et al., wherein each polynucleotide is 30 to 500
`
`bases in length (see paragraph [034]).
`
`Conclusion
`
`13.
`
`No claims are allowed.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to KAIJIANG ZHANG whose telephone number is
`
`(571)272-5207. The examiner can normally be reached on Monday - Friday, 8:30 am -
`
`5 pm.
`
`Examiner interviews are available via telephone, in-person, and video
`
`conferencing using a USPTO supplied web-based collaboration tool. To schedule an
`
`interview, applicant is encouraged to use the USPTO Automated Interview Request
`
`(AIR) at http://www.uspto.gov/interviewpractice.
`
`lf attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Heather Calamita can be reached on 571-272—2876. The fax phone number
`
`for the organization where this application or proceeding is assigned is 571 -273-8300.
`
`

`

`Application/Control Number: 15/187,714
`Art Unit: 1639
`
`Page 11
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`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
`
`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
`
`you have questions on access to the Private PAIR system, contact the Electronic
`
`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
`
`USPTO Customer Service Representative or access to the automated information
`
`system, call 800-786-9199 (IN USA OR CANADA) or 571 -272-1 000.
`
`/KAIJIANG ZHANG/
`
`Primary Examiner, Art Unit 1639
`
`