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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`17/434,464
`
`08/27/2021
`
`Hae Jin KIM
`
`PK002174951
`
`1008
`
`NOVICK, KIM & LEE, PLLC, dba NKL Law
`3251 Blenheim Blvd.
`SUITE 500
`FAIRFAX, VA 22030
`
`SABILA, MERCY HELLEN
`
`1654
`
`PAPER NUMBER
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`NOTIFICATION DATE
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`DELIVERY MODE
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`03/08/2024
`
`ELECTRONIC
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`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):
`docket0O1 @nkllaw.com
`docket02 @nkllaw.com
`skim @nkllaw.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`
`
`Disposition of Claims*
`1-6 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) _ is/are withdrawn from consideration.
`C] Claim(s)
`is/are allowed.
`Claim(s) 1-6 is/are rejected.
`(] Claim(s)__ is/are objectedto.
`C] Claim(s
`are subjectto restriction and/or election requirement
`)
`* If any claims have been determined allowable, you maybeeligible 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 PPHfeedback@uspto.gov.
`
`) ) ) )
`
`Application Papers
`10)( The specification is objected to by the Examiner.
`11) The drawing(s) filed on 08/27/2021 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:
`_—_c)L) None ofthe:
`b)L) Some**
`a)Y) All
`1.) Certified copies of the priority documents have been received.
`2.1.) Certified copies of the priority documents have been received in Application No. |
`3.2.) Copies of the certified copies of the priority documents have been receivedin 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
`U.S. Patent and Trademark Office
`
`3)
`
`4)
`
`(LJ Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`(Qj Other:
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20240224
`
`Application No.
`Applicant(s)
`171434,464
`KIM et al.
`
`Office Action Summary Art Unit|AIA (FITF)StatusExaminer
`Mercy H Sabila
`1654
`Yes
`
`
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORYPERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensionsof time may be available underthe provisions of 37 CFR 1.136(a). In no event, however, may a reply betimely filed after SIX (6) MONTHSfrom the mailing
`date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHSfrom 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, evenif timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
`
`Status
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`1) Responsive to communication(s) filed on 08/27/2021.
`C} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
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`2a)() This action is FINAL. 2b)¥)This action is non-final.
`3) An election was madeby the applicant in responseto a restriction requirement set forth during the interview
`on
`; the restriction requirement and election have been incorporated into this action.
`4)(2) 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 Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`

`

`Application/Control Number: 17/434,464
`Art Unit: 1654
`
`Page 2
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`DETAILED ACTION
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`Notice of Pre-AlA or AIA Status
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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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`Priority
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`This application was filed on and is a U.S. national Stage application under 35 U.S.C. 371
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`of International Patent Application No. PCT/KR2020/003132 filed 03/05/2020, which claims the
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`benefit of the priority of Korean Patent Application No. 10-2019-0028654filed 03/13/2019.
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`Receipt is acknowledgedof certified copies of papers required by 37 CFR 1.55.
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`Information Disclosure Statement
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`The information disclosure statements submitted on 08/27/2021, 03/25/2022 and
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`07/12/2022 have been considered by the examiner.
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`Claims 1-6 are being examined on the merits in this office action.
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`Claim Status
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`Claim Rejections - 35 USC § 101
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`35 U.S.C. 101 reads as follows:
`
`Whoever invents or discovers any new and useful process, machine, manufacture, or composition of
`matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the
`conditions and requirementsofthis title.
`
`

`

`Application/Control Number: 17/434,464
`Art Unit: 1654
`
`Page 3
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`Claims 1-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to
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`natural phenomenon withoutsignificantly more. Claim 1 recites a naturally occurring
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`peptide/protein fragment, which is not markedly different from its naturally occurring
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`counterpart because it conveys the same amino acid sequences at the residues 11-19 for
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`instant SEQ ID NO: 1 of the naturally occurring protein, as evidenced by UniProt ID
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`AQA940X1P5_9BACI, isolated from Bacillus suaedae and residues 64-72 for instant SEQ ID NO: 1
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`of the naturally occurring protein, as evidenced by UniProt ID AAA8W8HY57_CRAGI, isolated
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`from Crassostrea gigas (Pacific oyster). The claim(s) does/do not include additional elements
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`that are sufficient to amountto significantly more than the judicial exception for the following
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`reasons. This judicial exception is not integrated into a practical application because the
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`peptide being claimed is naturally occurring. The claim(s) does/do not include additional
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`elements that are sufficient to amount to significantly more than the judicial exception because
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`for the following reasons.
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`The rationale for this determination is explained below and is based on the analysis
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`presented in the USPTO's "2014 Interim Eligibility Guidance" as set forth on December 16,
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`2014, Revised Guidance set forth on May 2016, and 2019 Revised patent Subject Matter
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`Eligibility Guidance set forth on January 7, 2019. Please see MPEP 2106.
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`Step 1 : Is the claim to a process, machine, manufacture or composition of matter? The
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`instant claims are directed to a statutory patent-eligible subject matter category, a composition
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`of matter.
`
`

`

`Application/Control Number: 17/434,464
`Art Unit: 1654
`
`Page 4
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`Step 2a Prong 1: Is the claim directed to a law of nature, a natural phenomenon
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`(Product of nature), or an abstract idea? The claims are directed to a natural phenomenon,
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`specifically a natural-based product limitation.
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`Step 2a Prong 2: Does the claim recite additional elements that integrate the judicial
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`exception into a practical application? This judicial exception is not integrated into a practical
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`application because the peptides being claimed are naturally occurring.
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`As evidenced by UniProt ID AOA940X1P5_9BACI and UniProt ID ADA8W8HY57_CRAGI,
`
`(see amino acids 11-19 and residues 64-72, enclosed), instant SEQ ID NO: 1 is a fragments of the
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`naturally occurring proteins isolated from Bacillus suaedae and from Crassostrea gigas (Pacific
`
`oyster).
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`Myriad clarified that not every change to a product will result in a marked difference,
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`and that the mererecitation of particular words (e.g., "isolated") in the claims does not
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`automatically confer eligibility. Id. at 2119. See also Mayo, 132 S. Ct. at 1294 (eligibility does not
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`"depend simply on the draftsman’ s art").
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`Step 2b: Does the claim recite additional elements that amountto significantly more
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`than the judicial exception? The claims, as a whole, do not recite any additional elements that
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`amountto significantly more than the judicial exception. Specifically, the claims do not include
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`any elements in addition to the natural product. Examiner notes the recitation of
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`“oharmaceutical composition” does not account to significantly more because naturally
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`occurring water may also be used as an excipient for making the pharmaceutical composition.
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`In sum, when the relevant steps are analyzed, they weigh against a significant
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`difference. Accordingly, claims 1-6 does not qualify as eligible subject matter.
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`

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`Application/Control Number: 17/434,464
`Art Unit: 1654
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`Page 5
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`EXAMINER’S COMMENT
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`The instant SEQ ID NO: 1 is free of prior art. Examiner further notes that with regards to
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`the limitation citing “prevention”, the instant invention provides data to support prevention of
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`insulitis and Diabetes. Further, it is known in the art that several agents are known to prevent
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`both insulitis and Diabetes.
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`Conclusion
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`No claims are allowed.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to Mercy H. Sabila whose telephone number is (571)272-2562. The
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`examiner can normally be reached Monday - Friday 5:00 am - 3:00 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.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, James Alstrum- Acevedo can be reached on (571)272-5548. The fax phone number
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`for the organization where this application or proceeding is assigned is 571-273-8300.
`
`Information regarding the status of published or unpublished applications may be
`
`obtained from Patent Center. Unpublished application information in Patent Center is available
`
`to registered users. To file and manage patent submissions in Patent Center,visit:
`
`https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for
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`

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`Application/Control Number: 17/434,464
`Art Unit: 1654
`
`Page 6
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`moreinformation about Patent Center and https://www.uspto.gov/patents/docx for
`
`information about filing in DOCX format. For additional questions, contact the Electronic
`
`Business Center (EBC) at 866-217-9197(toll-free). If you would like assistance from a USPTO
`
`Customer Service Representative, call 800-786-9199 (IN USA OR CANADA)or 571-272-1000.
`
`/MERCYH SABILA/
`Examiner, Art Unit 1654
`
`/ARADHANA SASAN/
`Primary Examiner, Art Unit 1615
`
`