www.uspto.gov
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and TrademarkOffice
`Address; COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`16/569, 159
`
`09/12/2019
`
`Nora KHALDI
`
`048262-091330USD1
`
`8412
`
`DAVID S. RESNICK
`NIXON PEABODYLLP
`EXCHANGEPLACE,53 STATE STREET
`BOSTON,MA 02109
`
`KOMATSU, LIN
`
`1658
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`06/25/2021
`
`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):
`
`bostonpatent @ nixonpeabody.com
`ipairlink @nixonpeabody.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`
`
`Application No.
`Applicant(s)
`16/569, 159
`KHALDI et al.
`
`Office Action Summary Art Unit|AIA (FITF) StatusExaminer
`LIN KOMATSU
`1658
`Yes
`
`
`
`-- The MAILING DATEofthis communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensions of 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
`
`1) Responsive to communication(s) filed on 6/3/2021.
`C} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`2a)¥) This action is FINAL.
`2b) (J This action is non-final.
`3)02 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\0) 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.
`
`Disposition of Claims*
`1-8 and 12-25 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) 13-19 is/are withdrawn from consideration.
`1) Claim(s)__ is/are allowed.
`Claim(s) 1-8,12 and 20-25 is/are rejected.
`)
`Claim(s) 1,4,12 and 22-24 is/are objected to.
`O Claim(s
`are subject to 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:/Awww.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto.gov.
`
`Application Papers
`10)C) The specification is objected to by the Examiner.
`11) The drawing(s) filed on 11/19/2019 is/are: a) accepted or b)C) 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)LJ None ofthe:
`b)LJ Some**
`a)Y) All
`1.4) 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)
`
`3) (J Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`(Qj Other:
`4)
`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`
`Paper No(s)/Mail Date5/10/2021and6/16/2021.
`U.S. Patent and Trademark Office
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20210610a
`
`

`

`Application/Control Number: 16/569,159
`Art Unit: 1658
`
`Page 2
`
`DETAILED ACTION
`
`1.
`
`The present application, filed on or after March 16, 2013, is being examined
`
`under the first inventor to file provisions of the AIA.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`Amendment after Non-final office action filed on 6/3/2021 is acknowledged.
`
`Claims 9-11 have been cancelled.
`
`New claims 21-25 have been added.
`
`Claims 1-8 and 12-25 are pending in this application.
`
`Claims 13-19 remain withdrawn from consideration pursuant to 37 CFR 1.142(b),
`
`as being drawnto non-elected inventions, there being no allowable generic or linking
`
`claim.
`
`7.
`
`Applicant elected without traverse of Group 1 (claims 1-12 and 20) and elected
`
`the peptide of SEQ ID NO: 423 (identical to the peptide of instant SEQ ID NO: 344) as
`
`species of peptide; and powder as species of form of the composition in the replyfiled
`
`on 1/19/2021.
`
`Restriction requirement was deemed proper and made FINAL in the previous
`
`office action. Group 1
`
`is drawn to a composition formulated for topical administration,
`
`the composition comprising a peptide having up to 50 amino acids and comprising the
`
`amino acid sequence of SEQ ID NO: 343 or 344, or an anti-inflammatory variant
`
`thereof, wherein the variant comprises no more than 3 amino acid changes compared
`
`with the amino acid sequence of SEQ ID NO: 3483 or 344; and a personal care
`
`composition, or a cosmetic pharmaceutical composition, comprising such composition.
`
`A search was conducted on the elected species; and these appearto befree of prior
`
`art. A search was extended to the genus in claim 1; and this too appearsto be free of
`
`

`

`Application/Control Number: 16/569,159
`Art Unit: 1658
`
`Page 3
`
`prior art. Therefore, the withdrawn claims 5, 7 and 8 are hereby rejoined. Claims 1-8,
`
`12 and 20-25 are examined on the merits in this office action.
`
`Withdrawn Objections and Rejections
`
`8.
`
`Objection to thetitle is hereby withdrawn in view of Applicant's amendmentto the
`
`title.
`
`9.
`
`Objection to the abstract is hereby withdrawnin view of Applicant's amendment
`
`to the abstract.
`
`10.
`
`Objection to the specification is hereby withdrawnin view of Applicant's
`
`amendment to the specification and Applicant's persuasive arguments.
`
`11.|Objection to the drawings is hereby withdrawn in view of Applicant's amendment
`
`to the description of the drawings in the specification.
`
`12.
`
`Objection to claims 2, 3, 6 and 9-11 is hereby withdrawnin view of Applicant's
`
`amendment to the claim.
`
`13.|Rejection to claims 1, 2, 6, 9-12 and 20 under 35 U.S.C. 112(b) or 35 U.S.C. 112
`
`(pre-AlA), second paragraph is hereby withdrawnin view of Applicant's amendmentto
`
`the claim.
`
`14.
`
`Rejection to claims 1-3, 6, 9, 12 and 20 under 35 U.S.C. 102(a)(1) as being
`
`anticipated by La Rosa et al (US 2004/0123343 A1) is hereby withdrawnin view of
`
`Applicant's amendmentto the claim.
`
`Maintained/Revised Objections
`
`15.
`
`(Revised due to Applicant's amendmentto the claim) Claim 1 remains
`
`

`

`Application/Control Number: 16/569,159
`Art Unit: 1658
`
`Page 4
`
`objected to for the following minor informality: Applicant is suggested to amend claim 1
`
`as "A composition formulated for topical administration, wherein the composition
`
`comprises a peptide that is up to 50 amino acids in length and comprisesthe
`
`amino acid sequence of SEQ ID NO: 343 or 344...".
`
`16.
`
`(Revised due to Applicant's amendmentto the claim) Claim 4 remains
`
`objected to for the following minor informality: Applicant is suggested to amend claim 4
`
`as "... wherein the peptide consists of the amino acid sequence of SEQ ID NO: 343 or
`
`344".
`
`Responseto Applicant's Arguments
`
`17.
`
`Applicant fails to addressall the minor issues in instant claims 1 and 4.
`
`Therefore, these objections are deemed proper and are hereby maintained.
`
`Maintained/Revised Rejections
`
`Claim Rejections - 35 U.S.C. § 112 paragraph (a)
`
`Written Description
`
`18.
`
`The following is a quotation of 35 U.S.C. 112(a):
`(a) INGENERAL.—Thespecification shall contain a written description of the
`invention, and of the manner and process of making and using it, in suchfull,
`clear, concise, and exact terms as to enable any person skilled in the art to which
`it pertains, or with which it is most nearly connected, to make and use the same,
`and shall set forth the best mode contemplated by the inventor or joint inventor of
`carrying out the invention.
`
`The following is a quotation of 35 U.S.C. 112 (pre-AlA), first paragraph:
`The specification shall contain a written description of the invention, and of the
`manner and process of making and using it, in suchfull, clear, concise, and exact
`terms as to enable any person skilled in the art to which it pertains, or with which
`it is most nearly connected, to make and use the same and shall set forth the
`best mode contemplated by the inventor of carrying out his invention.
`
`

`

`Application/Control Number: 16/569,159
`Art Unit: 1658
`
`Page 5
`
`19.
`
`(Revised due to Applicant's amendmentto the claim) Claims 1, 2, 5-8, 12
`
`and 20-25 remain/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), first
`
`paragraph, asfailing to comply with the written description requirement. The claim(s)
`
`contains subject matter which wasnot described in the specification in such a way as to
`
`reasonably conveyto one skilled in the relevant art that the inventor or a joint inventor,
`
`or for pre-AlA the inventor(s), at the time the application wasfiled, had possession of
`
`the claimed invention.
`
`The MPEP lists factors that can be used to determine if sufficient evidence of
`
`possession has been furnished in the disclosure of the application. These include “level
`
`of skill and knowledge in the art, partial structure, physical and/or chemical properties,
`
`functional characteristics alone or coupled with a known or disclosed correlation
`
`between structure and function, and the method of making the claimed invention.
`
`Disclosure of any combination of such identifying characteristics that distinguish the
`
`claimed invention from other materials and would lead one of skill in the art to the
`
`conclusion that the applicant was in possession of the claimed speciesis sufficient”
`
`(MPEP § 2163).
`
`A claimed genus maybe satisfied through sufficient description of a
`
`representative number of species or disclosure of relevant, identifying characteristics
`
`such as functional characteristics coupled with a known or disclosed correlation
`
`between function and structure (MPEP § 2163(8)a(II)). The number of species that
`
`describe the genus must be adequateto describe the entire genus; if there is
`
`substantial variability, a large number of species must be described.
`
`

`

`Application/Control Number: 16/569,159
`Art Unit: 1658
`
`Page 6
`
`The analysis for adequate written description considers (a) actual reduction to
`
`practice, (b) disclosure of drawings or structural chemical formulas, (c) sufficient
`
`relevant identifying characteristics in the way of complete/partial structure or physical
`
`and/or chemical properties or functional characteristics when coupled with knownor
`
`disclosed correlation with structure, and (d) representative number of samples.
`
`In the instant case, claims 1, 2, 5-8, 12 and 20-24 recite an anti-inflammatory
`
`variant that is up to 50 amino acids in length and comprises no more than 3 amino acid
`
`changes compared with the amino acid sequence of SEQ ID NO: 343 or 344; and
`
`instant claim 25 recites an anti-inflammatory variant that is up to 50 amino acidsin
`
`length and comprises 1 amino acid change comparedwith the amino acid sequenceof
`
`SEQ ID NO: 343 or 344.
`
`The genus of instant claimed anti-inflammatory variant broadly includes any
`
`peptide that is up to 50 amino acids in length and comprises no more than 3 amino acid
`
`changes and/or 1 amino acid change compared with the amino acid sequence of SEQ
`
`ID NO: 343 or 344.
`
`The instant specification discloses the peptide of instant SEQ ID NO: 344 as an
`
`anti-inflammatory peptide.
`
`The issue at question is whether a person of ordinary skilled in the art would be
`
`able to determine whatstructural feature/amino acid sequenceis required for the instant
`
`claimed polypeptide that is up to 50 amino acids in length and comprises no more than
`
`3 amino acid changes and/or 1 amino acid change compared with the amino acid
`
`sequence of SEQ ID NO: 343 or 344 to have the functional characteristics of being an
`
`anti-inflammatory peptide or not.
`
`

`

`Application/Control Number: 16/569,159
`Art Unit: 1658
`
`Page 7
`
`(a) actual reduction to practice and (b) disclosure of drawings or structural chemical
`
`formulas:
`
`In the instant case, the instant specification discloses the peptide of instant SEQ
`
`ID NO: 344 (consisting of the amino acid sequence GYYGEQQQQPGMTR)asan anti-
`
`inflammatory peptide; and instant SEQ ID NO: 344 as a variant of instant SEQ ID NO:
`
`343 (consisting of the amino acid sequence SEEGYYGEQQQQPGMTR)wherein three
`
`amino acids at the N-terminus of instant SEQ ID NO: 348 are deleted.
`
`Other than instant SEQ ID NO: 344 as an anti-inflammatory variant of instant
`
`SEQ ID NO: 348, the instant specification fails to disclose any other variant of peptide of
`
`instant SEQ ID NO: 348 and/or anyvariant of peptide of instant SEQ ID NO: 344 being
`
`an anti-inflammatory peptide; and/or the amino acid sequence of instant SEQ ID NO:
`
`343 or 3444 that are required for the functional characteristics of being an anti-
`
`inflammatory peptide.
`
`Taken all these together, other than the limited examples (1 example) of instant
`
`claimed polypeptide, the instant specification fails to describe a general correlation
`
`between structure and function for the claimed genus of polypeptide that is up to 50
`
`amino acids in length and comprises no more than 3 amino acid changes and/or 1
`
`amino acid change compared with the amino acid sequence of SEQ ID NO: 3483 or 344
`
`as an anti-inflammatory peptide.
`
`(c) sufficient relevant identifying characteristics in the way of complete/partial structure
`
`or physical and/or chemical properties or functional characteristics when coupled with
`
`known or disclosed correlation with structure:
`
`

`

`Application/Control Number: 16/569,159
`Art Unit: 1658
`
`Page 8
`
`As discussed above, in the instant case, based on the disclosure of instant
`
`specification, other than the limited examples of instant claimed polypeptide, a person of
`
`ordinary skilled in the art would not be able to determine a general correlation between
`
`structure and function for the claimed genus of polypeptide that is up to 50 amino acids
`
`in length and comprises no more than 3 amino acid changes and/or 1 amino acid
`
`change compared with the amino acid sequence of SEQ ID NO: 343 or 344 as an anti-
`
`inflammatory peptide.
`
`With regards to a polypeptide that is up to 50 amino acids in length and
`
`comprises no more than 3 amino acid changes and/or 1 amino acid change compared
`
`with the amino acid sequence of SEQ ID NO: 343 or 344, La Rosa et al (US
`
`2004/0123343 A1, cited and enclosedin the previous office action) teach peptide of
`
`SEQ ID NO: 187493 with the amino acid sequence KGLWEKGYYGEQQQQPGMTRV
`
`RLTRARQYAAQILSMCRVKSKYV, for example, SEQ ID NO: 187493 in the sequence
`
`yey NAN AS
`SS. The
` listing available on {3
`
`peptide of SEQ ID NO: 187493 in La Rosa et al is 43 amino acids in length, comprises
`
`the amino acid sequence of instant SEQ ID NO: 344, and comprises 2 amino acid
`
`changes compared with the amino acid sequenceof instant SEQ ID NO: 343.
`
`However, La Rosaet al do not teach such peptide is an anti-inflammatory peptide.
`
`In addition, it is well known in the peptide/protein art that even single amino acid
`
`changes or differences in the amino acid sequenceof a protein/polypeptide can have
`
`dramatic effects on the protein/polypeptide’s function. As an example of the
`
`unpredictable effects of mutations on protein/polypeptide function, Drumm et al (Annu.
`
`Rev. Pathol. Mech. Dis., 2012, 7, pages 267-282, cited and enclosedin the previous
`
`

`

`Application/Control Number: 16/569,159
`Art Unit: 1658
`
`Page 9
`
`office action) teach cystic fibrosis is an autosomal recessive disorder caused by
`
`mutations in the CFTR (cystic fibrosis transmembrane conductance regulator) gene, for
`
`example, page 268, Section “CYSTIC FIBROSIS”. Drumm etal further teach several
`
`mutations can causecystic fibrosis, including two mutations G551D and G5518; and
`
`clinical consequencesare quite different for these two changes, as the G551D variant
`
`has virtually no detectable activity, and consequently a classic, severe phenotypeis
`
`associated; G551S, however, has reduced but clearly detectable function and is
`
`associated with a much milder presentation of CF, for example page 269, left column,
`
`the last paragraph. Drumm etal also teach that in the most common cystic fibrosis
`
`mutation AF508 (the absence of amino acid 508 of the normally 1,480-amino acid
`
`protein) gives rise to the cystic fibrosis phenotype, for example, page 268, right column,
`
`the 2"4 paragraph. Thus, even the substitution or deletion of a single amino acid can
`
`have dramatic and unpredictable effects on the function of the protein/polypeptide. The
`
`unpredictability of the effect of amino acid substitution on the function and/or property of
`
`polypeptide/protein is further confirmed and discussed in Yampolsky et al (Genetics,
`
`2005, 170, pages 1459-1472, cited and enclosed in the previous office action).
`
`Yampolsky et al teach even conservative substitution can significantly affect the function
`
`of the protein/polypeptide, for example, page 1465, Table 3. Although the disclosures
`
`of Drumm et al and Yampolskyet al are directed to proteins/peptides other than an anti-
`
`inflammatory peptide, theyillustrate the inherent unpredictability with respect to the
`
`biological activity of a given protein/peptide after even minor changes to the primary
`
`amino acid sequence.
`
`

`

`Application/Control Number: 16/569,159
`Art Unit: 1658
`
`Page 10
`
`Therefore, based on the state of art, a person of ordinary skilled in the art would
`
`not be able to determine a general correlation between structure and function for the
`
`claimed genus of polypeptide that is up to 50 amino acids in length and comprises no
`
`more than 3 amino acid changes and/or 1 amino acid change compared with the amino
`
`acid sequence of SEQ ID NO: 348 or 344 as an anti-inflammatory peptide.
`
`(d) representative numberof samples:
`
`In the instant case, the instant claimed anti-inflammatory variant broadly includes
`
`any peptide that is up to 50 amino acids in length and comprises no more than 3 amino
`
`acid changes and/or 1 amino acid change compared with the amino acid sequenceof
`
`SEQ ID NO: 343 or 344.
`
`And, as discussed in (a) and (b) above, the instant specification discloses the
`
`peptide of instant SEQ ID NO: 344 as an anti-inflammatory peptide and instant SEQ ID
`
`NO: 344 as a variant of instant SEQ ID NO: 343 wherein three amino acids at the N-
`
`terminus of instant SEQ ID NO: 343 are deleted. However, other than instant SEQ ID
`
`NO: 344 as an anti-inflammatory variant of instant SEQ ID NO: 348, the instant
`
`specification fails to disclose any other variant of peptide of instant SEQ ID NO: 343
`
`and/or any variant of peptide of instant SEQ ID NO: 344 being an anti-inflammatory
`
`peptide; and/or the amino acid sequenceof instant SEQ ID NO: 3483 or 3444 that are
`
`required for the functional characteristics of being an anti-inflammatory peptide.
`
`Considering the broadnessof instant claimed polypeptide, the instant
`
`specification fails to provide sufficient examples to describe the entire genus of the
`
`polypeptide claimed.
`
`

`

`Application/Control Number: 16/569,159
`Art Unit: 1658
`
`Page 11
`
`Taken all these together, considering the state of the art and the disclosurein
`
`instant specification, it is deemed that the instant specification fails to provide adequate
`
`written description for the claimed genus of polypeptide that is up to 50 amino acids in
`
`length and comprises no more than 3 amino acid changes and/or 1 amino acid change
`
`compared with the amino acid sequence of SEQ ID NO: 343 or 344 as an anti-
`
`inflammatory peptide; and does not reasonably conveyto one skilled in the relevant art
`
`that the inventor(s), at the time the application wasfiled, had possession of the entire
`
`scope of the claimed invention.
`
`Responseto Applicant's Arguments
`
`20.
`
`Applicant argues that "Applicants have amendedthe claims to remove the
`
`reference to 70% sequence homology. Instead, claims as amendedherein nowrecite
`
`that the anti-inflammatory variant has no more than 3 amino acid changes compared
`
`with the peptide sequences recited in claim 1. A person skilled in the art has sufficient
`
`knowledge, based on the Specification which includes working examplesto test for anti-
`
`inflammatory activity, to determine and identify the claimed variants having no more
`
`than 3 amino acid changes compared with the peptide sequence of claim 1. Applicants
`
`submit that SEQ ID 344 is an example of an ant-inflammatory variant of SEQ ID 343 (3
`
`amino acid difference) and a working example is provided at least in Examples 1 and 2."
`
`21.
`
`Applicant's arguments have been fully considered but have not been found
`
`persuasive.
`
`In response to Applicant's arguments about instant rejection, the Examiner
`
`understands that one of ordinary skilled in the art has sufficient knowledge on how to
`
`

`

`Application/Control Number: 16/569,159
`Art Unit: 1658
`
`Page 12
`
`test for anti-inflammatory activity. However, the Examiner would like to point out that
`
`written description requirement is not about whether one of ordinary skilled in the art
`
`knows howto test whether a polypeptide that is up to 50 amino acids in length and
`
`comprises no more than 3 amino acid changes and/or 1 amino acid change compared
`
`with the amino acid sequence of SEQ ID NO: 348 or 344 is an anti-inflammatory peptide
`
`or not. As stated in Section 19 above, the issue at question is whether a person of
`
`ordinary skilled in the art would be able to determine what structural feature/amino acid
`
`sequenceis required for the instant claimed polypeptide that is up to 50 amino acids in
`
`length and comprises no more than 3 amino acid changes and/or 1 amino acid change
`
`compared with the amino acid sequence of SEQ ID NO: 343 or 344 to have the
`
`functional characteristics of being an anti-inflammatory peptide or not. And in the
`
`instant case, as stated in Section 19 above, the instant claimed anti-inflammatory
`
`variant broadly includes any peptide that is up to 50 amino acids in length and
`
`comprises no more than 3 amino acid changes and/or 1 amino acid change compared
`
`with the amino acid sequence of SEQ ID NO: 3483 or 344. The only anti-inflammatory
`
`variant disclosed in the instant specification is instant SEQ ID NO: 344, whichis a
`
`variant of instant SEQ ID NO: 343 wherein three amino acids at the N-terminus of
`
`instant SEQ ID NO: 343 are deleted. However, other than instant SEQ ID NO: 344 as
`
`an anti-inflammatory variant of instant SEQ ID NO: 343, the instant specification fails to
`
`disclose any other variant of peptide of instant SEQ ID NO: 348 and/or anyvariant of
`
`peptide of instant SEQ ID NO: 344 being an anti-inflammatory peptide. Furthermore,
`
`considering the state of art regarding to the instant claimed anti-inflammatory variant,
`
`and the inherent unpredictability with respect to the biological activity of a given
`
`

`

`Application/Control Number: 16/569,159
`Art Unit: 1658
`
`Page 13
`
`protein/peptide after even minor changes to the primary amino acid sequence, it is
`
`deemedthat the instant specification fails to provide adequate written description for the
`
`claimed genus of polypeptide that is up to 50 amino acids in length and comprises no
`
`more than 3 amino acid changes and/or 1 amino acid change compared with the amino
`
`acid sequence of SEQ ID NO: 343 or 344 as an anti-inflammatory peptide; and does not
`
`reasonably conveyto one skilled in the relevant art that the inventor(s), at the time the
`
`application wasfiled, had possession of the entire scope of the claimed invention.
`
`Taken all these together, the rejection is deemed proper and is hereby
`
`maintained.
`
`22.|Thenonstatutory double patenting rejection is based onajudicially created
`
`Obviousness Double Patenting
`
`doctrine groundedin 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
`
`and to prevent possible harassment by multiple assignees. A nonstatutory double
`
`patenting rejection is appropriate where the claims at issue are notidentical, but at least
`
`one examined application claim is not patentably distinct from the reference 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,
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`686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619
`
`(CCPA 1970); and /n re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
`
`

`

`Application/Control Number: 16/569,159
`Art Unit: 1658
`
`Page 14
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`A timelyfiled terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321 (d)
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`may be used to overcome an actual or provisional rejection based on a nonstatutory
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`double patenting ground provided the reference application or patent either is shown to
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`be commonly ownedwith this application, or claims an invention made as a result of
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`activities undertaken within the scopeof a joint research agreement. A terminal
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`disclaimer must be signed in compliance with 37 CFR 1.321 (b).
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`The USPTOinternet Web site contains terminal disclaimer forms which may be
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`used. Please visit http:/Awww.uspto.gov/forms/. The filing date of the application will
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`determine what form should be used. A web-based eTerminal Disclaimer maybefilled
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`out completely online using web-screens. An eTerminal Disclaimer that meetsall
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`requirements is auto-processed and approved immediately upon submission. For more
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`information about eTerminal Disclaimers, refer to
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`
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`23.
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`(Revised due to Applicant’s amendment to the claim) Claims 1-5, 7, 8, 12, 20
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`and 25 remain/are rejected on the ground of nonstatutory obviousness-type double
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`patenting as being unpatentable over claims 1-5 of US patent 10463591 B2 in view of
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`Kircik et al (Supplement to Practical Dermatology, 2010, pages 1-16) and Peersetal
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`(US 5837218 A).
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`Although the conflicting claims are not identical, they are not patentably distinct
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`from each other becauseif one of ordinary skill in the art practiced the claimed invention
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`of instant claims 1-5, 7, 8, 12, 20 and 25, one would necessarily achieve the claimed
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`

`

`Application/Control Number: 16/569,159
`Art Unit: 1658
`
`Page 15
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`invention of claims 1-5 of US patent 10463591 B2 in view of Kircik et al and Peersetal,
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`and vice versa.
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`24.
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`‘Instant claims 1-5, 7, 8, 12, 20 and 25 are drawn to a composition formulated for
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`topical administration, the composition comprising a peptide having up to 50 amino
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`acids and comprising the amino acid sequence of SEQ ID NO: 348 or 344, or an anti-
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`inflammatory variant thereof, wherein the variant comprises no more than 3 amino acid
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`changes compared with the amino acid sequence of SEQ ID NO: 343 or 344; and a
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`personal care composition, or a cosmetic pharmaceutical composition, comprising such
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`composition.
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`25.
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`Claims 1-5 of US patent 10463591 B2 are drawn to a comestible powder
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`composition comprising a peptide that is up to 50 amino acids in length and comprises
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`the amino acid sequence of SEQ ID NO: 343 or 344; and a methodof reducing
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`inflammation in a mammalin need thereof, the method comprises orally administering
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`to the mammal such comestible powder composition.
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`The peptide of SEQ ID NO: 343 or 344 recited in claims 1-5 of US patent
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`10463591 B2is identical to the peptide of instant SEQ ID NO: 348 or 344.
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`26.
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`The difference between claims 1-5 of US patent 10463591 B2 and the
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`composition recited in instant claims 1-5, 7, 8, 12, 20 and 25 is that claims 1-5 of US
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`patent 10463591 B2 do not teach the comestible powder composition is formulated for
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`topical administration and is a personal care composition or cosmetic composition; and
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`the limitations of instant claims 7 and 8.
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`

`

`Application/Control Number: 16/569,159
`Art Unit: 1658
`
`Page 16
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`However, Kircik et al teach that in addition to lotion and so on, powder is one of
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`the eight topical dosage forms recognized by FDA, for example, page 8, the first
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`paragraph in Section "Topical Dosage Forms"; and Table 1.
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`Furthermore, with regards to the compositions recited in instant claims 12 and
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`20, in the instant case, the only component in the recited compositions is the
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`composition of instant claim 1.
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`Therefore, in view of the teachings of Kircik et al, one of ordinary skilled in the art
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`would understand and reasonably expect the composition recited in claims 1-5 of US
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`patent 10463591 B2 meetsall the structural limitations of the composition recited in
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`instant claims 1-5, 12, 20 and 25; andis suitable for topical administration and/or being
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`a cosmetic product
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`In addition, Peers et al teach that “N- and C-terminal modification of peptidesis
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`common practice in the art of preparation of peptides having greater stability,
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`particularly for in vivo use. Such modifications include the action of protecting groups
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`such as the protecting groups used conventionally in the art of organic synthesis.
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`Suitable N-terminal protecting groups include, for example, lower alkanoyl groupsof the
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`formula R-C(O)- in whichRis a linear or branched loweralkyl...A preferred group for
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`protecting the N-terminal end of the present compoundsis the acetyl group, CH3C(O)”
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`(see column 3, lines 15-26). Peers et al further teach that suitable C-terminal protecting
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`groupsinclude groups which form ketonesor amides at the carbon atom of the C-
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`terminal carboxyl; and amide-forming groups include amino functions such as primary
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`amines (-NHz2) and many others (see column 3, lines 28-40).
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`

`

`Application/Control Number: 16/569,159
`Art Unit: 1658
`
`Page 17
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`Therefore, in view of the combined teachings of Kircik et al and Peersetal, it
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`would have been obvious to one of ordinary skilled in the art to modify the peptide in the
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`composition recited in claims 1-5 of US patent 10463591 B2 and develop the
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`compositions recited in instant claims 1-5, 7, 8, 12, 20 and 25.
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`Thus, if one of ordinary skill in the art practiced the claimed invention of instant
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`claims 1-5, 7, 8, 12, 20 and 25, one would necessarily achieve the claimed invention of
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`claims 1-5 of US patent 10463591 B2 in view of Kircik et al and Peers et al, and vice
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`versa.
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`Responseto Applicant's Arguments
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`27.
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`Applicant argues that "Applicants submit that the claims as amended herein and
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`the claims of the '591 patent are patentably distinct from each other. The claims in the
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`'591 patent are directed to a comestible powder comprising the peptides. In contrast,
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`the pending claims are directed to a topical composition comprising the peptides. As
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`one of skill in the art is well aware, a comestible powder and a topical composition are
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`distinct and not interchangeable with each other. As such, claims directed to a
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`comestible powder are patentably distinct from claims directed a topical composition."
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`28.
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`Applicant's arguments have been fully considered but have not been found
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`persuasive.
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`Please note: due to Applicant's amendment to the claim, Kircik et al
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`(Supplementto Practical Dermatology, 2010, pages 1-16) and Peerset al (US 5837218
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`A) are cited as prior art references in instant rejection.
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`

`

`Application/Control Number: 16/569,159
`Art Unit: 1658
`
`Page 18
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`In responseto Applicant's arguments about instant rejection, the Examiner
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`understandsthat claims 1-5 of US patent 10463591 B2 are directed to a comestible
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`powder comprising the peptides. However, in the instant case, as stated in Section 26
`
`above, Kircik et al teach that in addition to lotion and so on, powder is one of the eight
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`topical dosage forms recognized by FDA. Furthermore, with regards to the
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`compositions recited in instant claims 12 and 20, in