DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 3/27/2024, 6/12/2025, and 4/14/2026 before the mailing of a first office action. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-16, filed 3/27/2024, are pending. Claims 1-16 are under examination.
Claim Objections
Claims 4 and 12-16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
35 USC § 101 Analysis
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 requirements of this title.
A rejection under U.S.C. 101 was considered, but was not made for the following reasons:
Regarding claim 1, claim 1 recites a peptide having the activity of preventing hair loss or promoting hair growth, comprising an amino acid sequence of SEQ ID NO: 1.
UniProt Accession No. Q96F46 · I17RA_HUMAN (deposited 12/1/2001, accessed 6/10/2026) is aligned below:
EMBOSS_001 151 VDPDQEYEVTVHHLPKPIPDGDPNHQSKNFLVPDCEHARMKVTTPCMSSG 200
||||||
EMBOSS_001 1 ------------HLPKPI-------------------------------- 6
Step 2A, prong two:
The claim recites a peptide sequence which is naturally occurring and it is not markedly different from its naturally occurring counterpart because it is same sequence and the claim contains no other elements.
Step 2B:
The claim includes the limitation that the claimed peptide possesses the activity of promoting hair growth or hair loss. The sequence above is associated with an Interleukin-17 receptor, which cannot be shown to possess this activity.
Consequently, no rejection under U.S.C 101 is made for claim 1 or any dependent claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 and 5-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by UniProt Accession No. Q96F46 · I17RA_HUMAN (deposited 12/1/2001, accessed 6/10/2026).
Regarding claim 1, claim 1 recites a peptide having the activity of preventing hair loss or promoting hair growth, comprising an amino acid sequence of SEQ ID NO: 1.
UniProt Accession No. Q96F46 · I17RA_HUMAN (deposited 12/1/2001, accessed 6/10/2026) is aligned below:
EMBOSS_001 151 VDPDQEYEVTVHHLPKPIPDGDPNHQSKNFLVPDCEHARMKVTTPCMSSG 200
||||||
EMBOSS_001 1 ------------HLPKPI-------------------------------- 6
Regarding the claimed activity, MPEP 2112.01(II) states: “"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.”
The recited activity is necessarily present.
Consequently, claim 1 is anticipated by UniProt and rejected.
Regarding claim 2, claim 1 is anticipated as described above. Claim 2 further recites the case wherein the peptide promotes the proliferation or activity of cells related to hair formation.
Regarding the claimed activity, MPEP 2112.01(II) states: “"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.”
The recited activity is necessarily present.
Consequently, claim 2 is anticipated by UniProt and rejected.
Regarding claim 3, claim 1 is anticipated as described above. Claim 3 recites a composition for preventing hair loss or promoting hair growth, comprising the peptide of claim 1.
Regarding the claimed activity, MPEP 2112.01(II) states: “"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.”
The recited activity is necessarily present.
Consequently, claim 3 is anticipated by UniProt and rejected.
Regarding claim 5, claim 3 is anticipated as described above. Claim 5 further recites the case wherein the composition induces the formation of hair by promoting the activity of one or more cells selected from the group consisting of dermal papilla cells, outer root sheath cells and germinal matrix cells.
Regarding the claimed activity, MPEP 2112.01(II) states: “"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.”
The recited activity is necessarily present.
Consequently, claim 5 is anticipated by UniProt and rejected.
Regarding claim 6, claim 3 is anticipated as described above. Claim 6 further recites the case wherein the composition induces one or more phosphorylation selected from the group consisting of AKT and ERK in dermal papilla cells.
Regarding the claimed activity, MPEP 2112.01(II) states: “"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.”
The recited activity is necessarily present.
Consequently, claim 6 is anticipated by UniProt and rejected.
Regarding claim 7, claim 3 is anticipated as described above. Claim 7 further recites the case wherein the composition induces the activation of β-catenin in dermal papilla cells.
Regarding the claimed activity, MPEP 2112.01(II) states: “"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.”
The recited activity is necessarily present.
Consequently, claim 7 is anticipated by UniProt and rejected.
Regarding claim 8, claim 3 is anticipated as described above. Claim 8 further recites the case wherein the composition promotes one or more expressions selected from the group consisting of LEF-1, c-Myc and cyclin D1 in dermal papilla cells.
Regarding the claimed activity, MPEP 2112.01(II) states: “"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.”
The recited activity is necessarily present.
Consequently, claim 8 is anticipated by UniProt and rejected.
Regarding claim 9, claim 3 is anticipated as described above. Claim 9 further recites the case wherein the composition inhibits the expression of DKK-1 protein in dermal papilla cells.
Regarding the claimed activity, MPEP 2112.01(II) states: “"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.”
The recited activity is necessarily present.
Consequently, claim 9 is anticipated by UniProt and rejected.
Regarding claim 10, claim 3 is rejected as described above. Claim 10 further recites the case wherein the composition promotes one or more expressions selected from the group consisting of Ha3-II, Keratin 5, Keratin 14 and Keratin 19 in outer root sheath cells.
Regarding the claimed activity, MPEP 2112.01(II) states: “"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.”
The recited activity is necessarily present.
Consequently, claim 10 is anticipated by UniProt and rejected.
Regarding claim 11, claim 3 is anticipated as described above. Claim 11 further recites the case wherein the composition promotes at least one expression selected from the group consisting of MSX2 and FOXN1 in germinal matrix cells.
Regarding the claimed activity, MPEP 2112.01(II) states: “"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.”
The recited activity is necessarily present.
Consequently, claim 11 is anticipated by UniProt and rejected.
Allowable Subject Matter
Claims 4 and 12-16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 4, no teaching, suggestion or motivation in the prior art exists to use the peptide at this concentration. Therefore, this claim is free of the prior art.
Regarding claims 12-16, No teaching, suggestion, or motivation exist in the prior art to use the peptide of UniProt in a pharmaceutical composition or a cosmetic composition because UniProt does not disclose any activity that would motivate a person of ordinary skill in the art to in such compositions. Therefore, these claims are free of the prior art.
Conclusion
No claim is allowed.
Claims 1-3 and 5-11 are rejected.
Claims 4 and 12-16 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David Paul Bowles whose telephone number is (571)272-0919. The examiner can normally be reached Monday-Friday 8:30-5:00.
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, Lianko Garyu can be reached on (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID PAUL BOWLES/ Examiner, Art Unit 1654
/LIANKO G GARYU/ Supervisory Patent Examiner, Art Unit 1654
Prosecution Insights