www.uspto.gov
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 2231371450
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`15/952,203
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`04/12/2018
`
`Timothy A. Blauwkamp
`
`47697-709201
`
`6884
`
`WILSON, SONSINI, GOODRICH & ROSATI
`650 PAGE MILL ROAD
`PALO ALTO, CA 94304-1050
`
`STRZELECKA~ TERESA E
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`ART UNIT
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`1637
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`PAPER NUMBER
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`NOTIFICATION DATE
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`DELIVERY MODE
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`11/21/2019
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`ELECTRONIC
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
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`following e—mail address(es):
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`patentdoeket@ wsgroom
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`PTOL-90A (Rev. 04/07)
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`

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`017/09 A0170” Summary
`
`Application No.
`15/952,203
`Examiner
`TERESA E STRZELECKA
`
`Applicant(s)
`Blauwkamp et al.
`Art Unit
`AIA (FITF) Status
`1637
`Yes
`
`- The MAILING DA TE of this communication appears on the cover sheet wit/7 the correspondence address -
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 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).
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`Status
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`1). Responsive to communication(s) filed on 10/21/19.
`CI A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2a)[:] This action is FINAL.
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`2b)
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`This action is non-final.
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`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.
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`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 Expade Quay/e, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims*
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`5)
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`Claim(s)
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`115—151 is/are pending in the application.
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`5a) Of the above claim(s) 137—151 is/are withdrawn from consideration.
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`
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`Claim(ss) 115—124 and 126—136 is/are allowed.
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`Claim(s)1_25 Is/are rejected
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`D Claim(ss_) is/are objected to.
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`) ) ) )
`
`S)
`are subject to restriction and/or election requirement
`[j Claim(s
`* If any claims have been determined aflowable. you may be eligible to benefit from the Patent Prosecution Highway program at a
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`participating intellectual property office for the corresponding application. For more information, please see
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`http://www.jjsthQQv/patents/init_event§/pph/index.'sp or send an inquiry to PPeredhack@g§ptg.ggv.
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`Application Papers
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`10). The specification is objected to by the Examiner.
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`11). The drawing(s) filed on 4/12/18 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).
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`Priority under 35 U.S.C. § 119
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`12)D Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
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`a)C] All
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`b)C] Some**
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`c)C] None of the:
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`11:] Certified copies of the priority documents have been received.
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`213 Certified copies of the priority documents have been received in Application No.
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`3B 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)).
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`** See the attached detailed Office action for a list of the certified copies not received.
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`Attachment(s)
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`1) [3 Notice of References Cited (PTO-892)
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`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`Paper No(s)/Mail Date 4/18/18: 10/29/19.
`U.S. Patent and Trademark Office
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`3) E] Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`Other' Notice to Comply
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`4)
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`PTOL-326 (Rev. 11-13)
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`Office Action Summary
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`Part of Paper No./Mai| Date 20191115
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`

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`Application/Control Number: 15/952,203
`Art Unit: 1637
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`Page 2
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`DETAILED ACTION
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`Notice ofPre-AIA 0r AIA Status
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`1.
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`The present application, filed on or after March 16, 2013, is being examined under the
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`first inventor to file provisions of the AIA.
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`Election/Restrictions
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`2.
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`Applicant’s election without traverse of Group 1 (claims 115—136) in the reply filed on
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`October 21, 2019 is acknowledged. Applicant further elected species B, G, Q and AC. Since no
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`references were found teaching or suggesting claim 115, all elected claims of Group I were
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`considered.
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`3.
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`Claims 137—151 are withdrawn from further consideration pursuant to 37 CFR 1.142(b)
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`as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
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`Election was made without traverse in the reply filed on October 21, 2019.
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`4.
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`Claims 115 —136 are under consideration.
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`Information Disclosure Statement
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`5.
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`The information disclosure statement (IDS) submitted on April 18, 2018 is in compliance
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`with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being
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`considered by the examiner.
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`6.
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`The information disclosure statement (IDS) submitted on October 29, 2019 was filed
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`after the mailing date of the Requirement for Restriction/Election on August 20, 2019. The
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`submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information
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`disclosure statement is being considered by the examiner.
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`Sequence Rules Compliance
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`7.
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`This application contains sequence disclosures that are encompassed by the definitions for
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`nucleotide and/or amino acid sequences set forth in 37 CFR. § l.82l(a)(l) and (a)(2). However, this
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`

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`Application/Control Number: 15/952,203
`Art Unit: 1637
`
`Page 3
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`application fails to comply with the requirements of 37 CFR. §§ 1.821-1.825 for the reason(s) set forth
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`on the attached Notice To Comply With Requirements For Patent Applications Containing Nucleotide
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`Sequence And/Or Amino Acid Sequence Disclosures. Applicant must comply with the requirements of
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`the sequence rules (37 CFR 1.821 - 1.825) before the application can be examined under 35 U.S.C. §§
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`131 and 132.
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`APPLICANT IS GIVEN time of response to this office action WITHIN WHICH TO COMPLY
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`WITH THE SEQUENCE RULES, 37 CFR. §§ 1.821-1.825. Failure to comply with these requirements
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`will result in ABANDONMENT of the application under 37 CFR. § 1.821(g). Extensions of time may
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`be obtained by filing a petition accompanied by the extension fee under the provisions of 37 CFR. §
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`1.136. In no case may an applicant extend the period for response beyond the six month statutory period.
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`Direct the response to the undersigned. Applicant is requested to return a copy of the attached Notice to
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`Comply with the response.
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`Specifically, paragraphs 329, 332, 334, 337, 339, 346 and 350 contain nucleic acid sequences
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`without identifying SEQ ID NOs. If these sequences are already present in the sequence listing on record,
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`Applicant needs to amend the specification to include the SEQ ID NOs. If these sequences are not present
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`in the sequence listing on record, a new sequence listing needs to be submitted and the specification
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`amended to include the SEQ ID NOs.
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`Claim Rejections - 35 US C § 112
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`8.
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`The following is a quotation of 35 U.S.C. 112(b):
`(b) CONCLUSION.7The specification shall conclude with one or more claims particularly pointing
`out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the
`invention.
`
`The following is a quotation of 35 U.S.C. 112 (pre—AIA), second paragraph:
`The specification shall conclude with one or more claims particularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
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`9.
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`Claim 125 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre—AIA), second
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`paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject
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`

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`Application/Control Number: 15/952,203
`Art Unit: 1637
`
`Page 4
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`matter which the inventor or a joint inventor, or for pre—AIA the applicant regards as the
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`invention.
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`Claim 125 contains the trademark/trade name SMARTer (without the trademark symbol).
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`SMARTEer® is a trademark of Takara Bio. Where a trademark or trade name is used in a claim
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`as a limitation to identify or describe a particular material or product, the claim does not comply
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`with the requirements of 35 U.S.C. 112, second paragraph. See Ex parte Simpson, 218 USPQ
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`1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be
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`used properly to identify any particular material or product. A trademark or trade name is used to
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`identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does
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`not identify or describe the goods associated with the trademark or trade name. In the present
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`case, the trademark/trade name is used to identify/describe a fluorescent dye and, accordingly,
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`the identification/description is indefinite.
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`10.
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`Claims 115 —124 and 126—136 are allowed. No references were found teaching or
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`suggesting a method of performing primer extension on a sample comprising a mixture of single—
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`stranded DNA and RNA molecules by ligating adapters to both DNA and RNA molecules and
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`performing primer extension using primers which hybridize to the adapters. The closest prior art
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`reference, Reuter et al. (Nature Methods, vol. 13, pp. 953—958, November 2016; cited in the IDS)
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`teach preparation of sequencing libraries from a sample comprising double—stranded DNA and
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`RNA (see Figure l, for example).
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`Conclusion
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to TERESA E STRZELECKA whose telephone number is
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`(571)272—0789. The examiner can normally be reached on M—F 9—7.
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`

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`Application/Control Number: 15/952,203
`Art Unit: 1637
`
`Page 5
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`Examiner interviews are available via telephone, in—person, and video conferencing using
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`a USPTO supplied web—based collaboration tool. To schedule an interview, applicant is
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`encouraged to use the USPTO Automated Interview Request (AIR) at
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`http://www.uspto.gov/interviewpractice.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Gary Benzion can be reached on 571—272—0782. The fax phone number for the
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`organization where this application or proceeding is assigned is 571—273—8300.
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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—1000.
`
`/TERESA E STRZELECKA/
`
`Primary Examiner, Art Unit 1637
`November 15, 2019
`
`

`

`_
`
`t° °°"“"y
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`15/952,203
`
`”mm"
`Blauwkamo et al.
`
`TERESA E STRZELECKA
`
`1637
`
`Yes
`
`NOTICE TO COMPLY WITH REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING
`
`NUCLEOTIDE SEQUENCE AND/OR AMINO ACID SEQUENCE DISCLOSURES
`
`Applicant must file the items indicated below within the time period set the Office action to which the Notice is
`attached to avoid abandonment under 35 U.S.C. § 133 (extensions of time may be obtained under the provisions
`of 37 CFR 1.136( )).
`
`The nucleotide and/or amino acid sequence disclosure contained in this application does not comply with the
`requirements for such a disclosure as set forth in 37 C.F.R.1 .821 1.825 for the following reason(s):
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`1. This application clearly fails to comply with the requirements of 37 C.F.R. 1.821 -1 .825. Applicant's attention
`is directed to the final rulemaking notice published at 55 FR 18230 (May 1, 1990), and 1114 OG 29 (May 15,
`1990)
`If the effective filing date is on or after July 1, 1998, see the final rulemaking notice published at 63 FR 29620
`(June 1, 1998) and 1211 OG 82 (June 23, 1998).
`
`C] 2.This application does not contain, as a separate part of the disclosure on paper copy, a “Sequence Listing”
`as required by 37 C.F.R.1.821( ).
`
`D 3. A copy of the “Sequence Listing” in computer readable form has not been submitted as required by
`37 C.F.R.1.821( ).
`
`[:1 4. A copy of the “Sequence Listing” in computer readable form has been submitted. However, the content of
`the computer readable form does not comply with the requirements of 37 C.F.R.1.822 and/or 1.823, as
`indicated on the attached copy of the marked -up “Raw Sequence Listing.”
`
`El 5. The computer readable form that has been filed with this application has been found to be damaged and/or
`unreadable as indicated on the attached CRF Diskette Problem Report. A Substitute computer readable form
`must be submitted as required by 37 C.F.R.1.825(d).
`
`E] 6. The paper copy of the “Sequence Listing” is not the same as the computer readable form of the “Sequence
`Listing” as required by 37 C.F.R.1.821( ).
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`7. Other: Sequences present in paragraphs 329, 332, 334, 337, 339, 346 and 350 do not contain SEQ ID NOS
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`Applicant Must Provide:
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`An initial or substitute computer readable form (CRF) copy of the “Sequence Listing”.
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`An initial or substitute paper copy of the “Sequence Listing”, as an amendment specifically directing its
`entry into the application.
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`A statement that the content of the paper and computer readable copies are the same and, where applicable
`, include no new matter, as required by 37 C.F.R.1 .821 (e) or 1.821 (f) or 1.821 (g) or 1 .825(b) or 1 .825(d).
`
`
`
`For questions regarding compliance to these requirements, please contact:
`
`For Rules Interpretation, call (571) 270-5300
`For CRF Submission Help, call (571) 272-2510
`Patentln Software Program Support
`Technical Assistancef -866-217-9197
`
`Patentln Software is Available At www.USPTO.gov
`
`PLEASE RETURN A COPY OF THIS NOTICE WITH YOUR REPLY
`
`/TERESA E STRZELECKA/
`
`Primary Examiner, Art Unit 1637
`
`US. Patent and Trademark Office
`PTO-2301 (Rev. 03- 12)
`
`

`

`Notice to Comply with Sequence Discloure Requirements
`
`Pa” 0f Paper NO- 20191115
`
`