UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 2231371450
`www.uspto.gov
`
`16/249,275
`
`01/16/2019
`
`Michael Soeberdt
`
`47TER10003VA
`
`9044
`
`759°
`”006
`DINSMORE & SHOHL LLP
`
`09’1””
`
`900 Wilshire Drive
`Suite 300
`my 44444044
`
`GARYU' LIANKO G
`
`1658
`
`MW
`
`NOTIFICATION DATE
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`DELIVERY MODE
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`09/19/2019
`
`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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`MichiganPatTM@dinsmore.com
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`PTOL-90A (Rev. 04/07)
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`

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`0/7709 A0170” Summary
`
`Application No.
`16/249,275
`Examiner
`Lianko G Garyu
`
`Applicant(s)
`Soeberdt et al.
`Art Unit
`1658
`
`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
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`1). Responsive to communication(s) filed on 08 March 2019.
`[: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.
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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 Expat/7e Quay/e, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims*
`5)
`Claim(s)
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`1—14is/are pending in the application.
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`5a) Of the above claim(s)
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`is/are withdrawn from consideration.
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`E] Claim(s)
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`is/are allowed.
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`Claim(s) fl is/are rejected.
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`[:1 Claim(s) _ is/are objected to.
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`) ) ) )
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`6 7
`
`8
`
`
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`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
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`participating intellectual property office for the corresponding application. For more information, please see
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`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
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`is/are: a)D accepted or b)l:] 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:
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`a). All
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`b)I:J Some**
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`c)C] None of the:
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`1.. Certified copies of the priority documents have been received.
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`2.[:] Certified copies of the priority documents have been received in Application No.
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`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.
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`Attachment(s)
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`1)
`
`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 M.
`U.S. Patent and Trademark Office
`
`3) C] Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) CI Other-
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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 20190915
`
`

`

`Application/Control Number: 16/249,275
`Art Unit: 1658
`
`Page 2
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`DETAILED ACTION
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`Notice of Pre-AIA or AIA Status
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`The present application,
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`filed on or after March 16, 2013, is being examined
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`under the first inventor to file provisions of the AIA.
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`Status of Clains
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`Claims 1-14 are pending and under examination.
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`Priority
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`Acknowledgment
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`is made of applicant’s claim for foreign priority under 35 U.S.C.
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`119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR
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`1.55.
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`Information Disclosure Statement
`
`The information discbsure statement (IDS) submitted on March 8, 2019 complies
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`with the provisions of 37 CFR 1.97. Accordingly,
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`the information disclosure statement is
`
`being considered by the examiner.
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`Claim Rejections - 35 USC § 112
`
`The following is a quotation of 35 U.S.C. 112(b):
`(b) CONCLUSION.—The 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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`Claims 8, 9 and 11- 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C.
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`112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point
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`out and distinctly claim the subject matter which the inventor or a joint inventor, or for
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`pre-AIA the applicant regards as the invention.
`
`

`

`Application/Control Number: 16/249,275
`Art Unit: 1658
`
`Page 3
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`Claims 8, 9, and 11 recite the limitation “wherein the inflammatory disease” in
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`line 1 of the claims. There is insufficient antecedent basis for the limitation in the
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`claims because there are multiple recitations of inflammatory diseases (i.e., acute and
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`chronic) previously recited and it
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`is unclear if the reference to inflammatory disease
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`refers to acute inflammatory disease, chronic inflammatory disease or both. Claim 12
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`which depends from claim 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-
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`AIA), second paragraph, as this claim incorporates by dependency the indefiniteness of
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`Claim 11.
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`Claim 13 recites the limitations “method of claim 10" and “the inflammatory
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`bowel disease” in line 1. There is insufficient antecedent basis for these limitations in
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`the claim because claim 10 is not a method claim and there is no earlier recitation of an
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`inflammatory bowel disease.
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`Claim 14 recites the limitations “method of claim 10" and “the inflammatory
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`bowel of the gastrointestinal
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`tract” in lines 1-2. There is insufficient antecedent basis
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`for these limitations
`
`in the claim because claims 10 is not a method claim and there is
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`no earlier recitation of an inflammatory disease of the gastrointestinal tract.
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`Claim Rejections - 35 USC § 103
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`In the event the determination of the status of the application as subject to AIA
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`35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect,
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`any correction of the statutory basis for the rejection will not be considered a new
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`ground of rejection if the prior art relied upon, and the rationale supporting the
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`rejection, would be the same under either status.
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`

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`Application/Control Number: 16/249,275
`Art Unit: 1658
`
`Page 4
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`The following is a quotation of 35 U.S.C. 103 which forms the basis for all
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`obviousness rejections set forth in this Office action:
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`A patent fora claimed invention may not be obtained, notwithstanding that the claimed
`invention is not identically disclosed as set forth in section 102, ifthe 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 bythe manner in which the invention was made.
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`This application currently names joint inventors. In considering patentability of
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`the claims the examiner presumes that the subject matter of the various claims was
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`commonly owned as of the effective filing date of the claimed invention(s) absent any
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`evidence to the contrary. Applicant
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`is advised of the obligation under 37 CFR 1.56 to
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`point out the inventor and effective filing dates of each claim that was not commonly
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`owned as of the effective filing date of the later invention in order for the examiner to
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`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.
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`The factual inquiries set forth in Graham v. John Deere C0., 383 U.S. 1, 148
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`USPQ 459 (1966), that are applied for establishing a background for determining
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`obviousness under 35 U.S.C. 103 are summarized as follows:
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`1. Determining the scope and contents of the prior art.
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`2. Ascertaining the differences between the prior art and the claims at issue.
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`3. Resolving the level of ordinary skill
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`in the pertinent art.
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`4. Considering objective evidence present in the application indicating
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`obviousness or nonobviousness.
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`

`

`Application/Control Number: 16/249,275
`Art Unit: 1658
`
`Page 5
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`Claims 1-12 and 14 are rejected under 35 U.S.C. 103 as being
`
`unpatentable over Ferreira et al. (US 5,389,615; 1995) and Brzoska et al. (“a-
`
`Melanocyte-Stimulating Hormone and Related Tripeptides: Biochemistry,
`
`Antiinflammatory and Protective Effects in Vitro and in Vivo, and Future Perspectives for
`
`the Treatment of Immune-Mediated Inflammatory Diseases", Endocrine Reviews, 2007;
`
`pp. 581-602) in view of Zomaro (US 5,718,882; 1998), Gentilucci et al. (“Chemical
`
`Modifications Designed to Improve Peptide Stability:
`
`Incorporation of Non-Natural
`
`Amino Acids, Pseudo-Peptide Bonds, and Cyclization", Current Pharmaceutical Design,
`
`2010, pp. 3185-3203; cited in the IDS), Chatterjee et al. (N-Methylation of Peptides: A
`
`New Perspective in Medicinal Chemistry”, Accounts of Chemical Research, 2008, pp.
`
`1331-1342), and The National Center for Biotechnology Information (“6-Amino-2—
`
`(dimethylamino)hexanoic acid" (2007); “N-Methyl—L—valine" (2005) and “N-MethyI-L-
`
`threonine" (2006)).
`
`Ferreira et al. teach the tripeptides Lys-Pro-Thr, Lys-D-Pro—Thr, Lys-Pro-Val and
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`Lys-D-Pro-Val (see col.
`
`lines 46-48), medicaments comprising the tripeptides and
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`methods of treating pain with the tripeptides thereof (see e.g., the abstract; col. 1, lines
`
`30-51; col. 3, line 53-col. 5, line 3). Brzoska et al. teach the tripeptides are anti-
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`inflammatory peptides (see e.g., Table 6, §8. oc-MSH in experimentally induced acute
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`pancreatitis sand §IV. Anti-inflammatory Effects of oc-MSH-Related Tripeptides Ih Vitro
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`and I)?
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`I/Ii/o) and further suggest administering the tripeptides to treat immune-
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`mediated inflammatory diseases, e.g., pancreatitis, eczema (inflammatory disease of
`
`the skin), allergic asthma, rheumatoid arthritis (inflammatory disease of the joints), and
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`

`

`Application/Control Number: 16/249,275
`Art Unit: 1658
`
`Page 6
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`inflammatory bowel disease because of the activity of the KPV tripeptide is very similar
`
`to oc-MSH (see p. 596, right co|.-1St para.-p. 597, right col. continuing paragraph).
`
`The difference between the tripeptides of Ferreira et al. and Brzoska et al. and
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`the peptides of claims 1-12 and 14 is the methylation of the N- and C-termini amino
`
`acids (i.e., N“,N0°,dimethyl-lysine and/or the C-terminal Na-methyl-Thr-OH, Na-methyl-
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`Val-OH of Na-methyl-Thr-NHz).
`
`Zomaro teaches that an increase in resistance to protease degradation in
`
`peptides can be accomplished with the substitution of the terminal amino acids with
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`amino acids having unnatural chirality, such as methylated amino acids (see col. 7, lines
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`40-49).
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`Gentilucci et al. teach using N-methyl amino acids advantageously results in
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`anabgues with improved pharmacological properties and stability (see §3.2.2. N-
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`Alkylated Amino Acids; e.g., 5th paragraph). Gentilucci et al. further teach N-alkyl
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`amino acids are commercially available (see §3.2.2. N-Alkylated Amino Acids; e.g., 2nd
`
`paragraph).
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`Chatterjee et al. teach multiple methylation of peptides can improve the
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`metabolic stability and intestinal permeability of peptides (see e.g., the abstract).
`
`The National Center for Biotechnobgy Information teaches that methylated Thr,
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`Lys and Val were known to the public as of deposition date of 2007 (see PubChem CID:
`
`14298176, 7010355 and 444080).
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`At the time of the effective filing date, it would have been obvious to one
`
`ordinary skill
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`in the art to methylate the N-terminal Lys and/or the C-terminal Thr—OH,
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`

`

`Application/Control Number: 16/249,275
`Art Unit: 1658
`
`Page 7
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`Thr—NH2 and Val-OH of the tripeptides of Ferreira et al. and Brzoska et al. to arrive at
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`the presently claimed invention. The artisan of ordinary skill would have been
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`motivated to do so with a reasonable expectation of protecting the peptide from
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`protease degradation and thereby increasing the metabolic stability and intestinal
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`permeability of the peptide as taught by Zomaro, Gentilucci et al. and Chatterjee et al.
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`Using the known technique of modifying the terminal ends of peptide with methylated
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`amino acids for protection against degradation would have been obvious to one
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`ordinary skill.
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`Therefore, at the time of the effective filing date, the presently claimed invention
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`was pr/ma faCIe obvious to one of ordinary skill
`
`in the art.
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`Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over
`
`Ferreira et al. (US 5,389,615; 1995) and Brzoska et al. C‘oc-Melanocyte-Stimulating
`
`Hormone and Related Tripeptides: Biochemistry, Antiinflammatory and Protective
`
`Effects in Vitro and in Vivo, and Future Perspectives for the Treatment of Immune-
`
`Mediated Inflammatory Diseases", Endocrine Reviews, 2007; pp. 581-602) in view of
`
`Zomaro (US 5,718,882; 1998), Gentilucci et al. (“Chemical Modifications Designed to
`
`Improve Peptide Stability:
`
`Incorporation of Non-Natural Amino Acids, Pseudo-Peptide
`
`Bonds, and Cyclization”, Current Pharmaceutical Design, 2010, pp. 3185-3203; cited in
`
`the IDS), Chatterjee et al. (“N-Methylation of Peptides: A New Perspective in Medicinal
`
`Chemistry”, Accounts of Chemical Research, 2008, pp. 1331-1342), and The National
`
`Center for Biotechnology Information (“6-Amino-2-(dimethylamino)hexanoic acid”
`
`

`

`Application/Control Number: 16/249,275
`Art Unit: 1658
`
`Page 8
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`(2007); “N-Methyl—L—valine" (2005) and “N-Methyl—L—threonine" (2006)) as applied to
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`claims 1 and 10 above, and further in view of Grip et al. (“Use of atorvastatin as an
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`anti-inflammatory treatment in Chron’s Disease”, British Journal of Pharmacology, 2008,
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`pp. 1085-1092).
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`The teachings of Ferreira et al. Brzoska et al. Zomaro, Gentilucci et al.,
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`Chatterjee et al. and The National Center for Biotechnobgy Information are discussed
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`above. Ferreira et al. Brzoska et al. Zomaro, Gentilucci et al., Chatterjee et al. and The
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`National Center for Biotechnology Information do not teach Chron’s disease as claimed.
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`Grip et al. teach administering the anti-inflammatory agent atorvastatin to treat
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`Chron’s Disease (see e.g., the abstract).
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`It would have been obvious to one of ordinary skill
`
`in the art at the time of the
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`effective filing date to substitute the tripeptides of Ferreira modified with an N-
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`methylated amino acid at the N- and/or C-termini because the tripeptides are anti-
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`inflammatory peptides as taught Brzoska et al. The substitution of known equivalents is
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`pr/ma faCIe obvious to one ordinary skill
`
`in the art.
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`Therefore, at the time of the effective filing date, the presently claimed invention
`
`was prima facie obvious to one of ordinary skill
`
`in the art.
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`No claim is allowed.
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`Conclusion
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`Correspondence
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Lianko G Garyu whose telephone number is (571)270-
`
`

`

`Application/Control Number: 16/249,275
`Art Unit: 1658
`
`Page 9
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`7367. The examiner can normally be reached on Monday through Friday 8:30 AM -
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`
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`
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`
`is encouraged to use the USPTO Automated Interview Request
`
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`
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`
`supervisor, Karlheinz R Skowronek can be reached on 571-272-9047. The fax phone
`
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`
`Information regarding the status of an application may be obtained from the
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`
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`
`/I_IANKO G GARYU/
`Primary Examiner, Art Unit 1658
`
`Lianko G. Garyu, Ph.D.
`Primary Examiner
`Art Unit 1658
`
`