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
The present application claims status as a 371 (National Stage) of PCT/KR2022/014530 filed 09/28/2022, and claims priority under 119(a)-(d) to Korean Application No. KR10-2021-0130816 filed on 10/01/2021
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d) for Korean Application No. KR10-2021-0130816, which papers have been placed of record in the file. Please note that the application is in a foreign language and thus cannot be verified.
Status of Claims
Claims 1-16 were originally filed on 03/26/2024.
Information Disclosure Statement
The IDSs filed on 03/26/2024, 06/12/2025 and 04/16/2026 have been considered by the Examiner.
Sequence Interpretation
Regarding claim 1, the scope of the peptide comprising an amino acid sequence is being interpreted as open-ended requiring 100% identity to SEQ ID NO: 1, with any N-/C-terminal additions.
Improper Markush Grouping
Claim 10 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of “Ha3-II, Keratin 14, and keratin 19” is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: Keratin 14 and Keratin 19 are well-documented markers for outer root sheath (ORS) cells, while Ha3-II (Hair Keratin 3-II) is not.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 101
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.
1. Claims 1-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a natural product) without significantly more. Claim 1 is drawn to a peptide having, comprising an amino acid sequence of SEQ ID NO: 1. Please refer to the “Sequence Interpretation” section above for the scope of claim 1. Briefly, the scope of the peptide requires 100% identity to an amino acid sequence represented by SEQ ID NO: 1 (i.e., CPRHFNPVC), but the peptide can be part of a larger sequence with any N- and/or C-terminal additions.
Claims 3-16 are directed to compositions that comprise the claimed peptide as recited in instant claim 1. Thus, the claimed invention is directed to a product or composition of matter, which is one of the statutory categories of invention.
A UniProt reference discloses an 84 length amino acid sequence of a Serine protease inhibitor Kazal-type 2 isolated from Homo sapiens where residues 44-52 are 100% identical to instant SEQ ID NO: 1 (See UniProt Consortium. Serine protease inhibitor Kazal-type 2- P20155. UniProt Knowledgebase (2025) available at https://www.uniprot.org/uniprotkb/P20155/entry, accessed on 06/05/2026) (hereinafter the “UniProt ”) thereby constituting a peptide comprising an amino acid sequence of SEQ ID NO: 1 as claimed in instant claim 1.
Thus, claims 3-16 encompass a naturally occurring peptide which is not markedly different from its naturally occurring counterpart because it conveys the same genetic information. Therefore, the claimed invention is directed to a judicial exception.
These judicial exceptions are not integrated into a practical application because claims 1-16 fail to recite a practical application of the peptide and composition. It is further noted, that the claims drawn to a composition (i.e., claims 3-11), pharmaceutical composition (i.e., claims 12-13), and cosmetic composition (i.e., claims 14-16) do not include any elements in addition to the natural product (i.e., CPRHFNPVC). Although the compositions are intended to “prevent hair loss or promote hair growth”, such recitation is merely indicating how the claimed invention might be used. Thus, the intended use of the judicial exception does not add a meaningful limitation to the claimed invention, as it is at such high level of generality that it fails to integrate the natural product into a practical application. Thereby, claims 3-11 are nothing more than an attempt to generally link the product of nature to a particular technological environment.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the structure of the claimed peptide and compositions comprising the claimed peptide, do not require a modification that is significantly more than the naturally occurring products in order to result in markedly different peptide and markedly different compositions.
Accordingly, it is the Examiner’s position that the claimed peptide and compositions are directed to a “product of nature” exception without significantly more because it does not exhibit markedly different characteristics from the naturally occurring counterparts in the natural state. Thus, claims 1-16 encompass patent ineligible subject matter.
Claim Rejections - 35 USC § 102
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.
2. Claims 1-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 10,047,125 B2 Date of Patent; Aug. 14, 2018 (herein after “US ‘125”).
Regarding claims 1-16, US. ‘125 discloses a peptide having an activity to improve skin condition, the peptide consisting of the amino acid sequence of SEQ ID NO: 2, wherein (i) the C-terminal end of the peptide is modified by the presence of a hydroxyl group, an amino group, or an azide group, or (ii) the N-terminal end of the peptide comprises a protecting group (see column 13, claim 1).
US ‘125’s SEQ ID NO: 2 is a 9 amino acid residue sequence represented by Cys-Pro-Arg-His-Phe-Asn-Pro-Val-Cys (see column 11, sequence listing). Thereby corresponding to instant SEQ ID NO: 1 (i.e., CPRHFNPVC).
With respect to wherein the peptide is included in the composition at a concentration of 0.01µM to 100µM, as recited in instant claim 4.
US ‘125 discloses Examples 1-4, where different concentration ranges (i.e., 1ng/ml to 1ug/ml; 1-10ug/ml; 0.1ug/ml and 1ug/ml; and 10ng/ml, 100ng/ml, 1000 ng/ml) of SEQ ID NO: 2 were used (see columns 8-9). US ‘125 also discloses the molecular weight of SEQ ID NO: 2 to be 1072.2 (see column 8, lines 46-50, and Table 1). As such, the concentration ranges disclosed by US ‘125 anticipates the instantly claimed concentration of 0.01µM to 100µM, because 1ug/ml of US ‘125’s SEQ ID NO: 2 is equivalent to 0.93 µM. Furthermore, pursuant to MEPE 2131.03 (I), "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). Since 1ug/ml of SEQ ID NO: 2, when converted to µM falls within the claimed 0.01µM to 100µM concentration range, thus US ‘125 disclosed concentration of 1ug/ml (i.e., 0.93 µM) anticipates the instantly claimed range. With respect to wherein the cosmetic composition has any one formulation selected from the group consisting of solution, suspension, emulsion, gel, lotion, essence, cream, powder, soap, shampoo, conditioner, pack mask, surfactant-containing cleansing, cleansing foam, cleansing water, oil, liquid foundation, cream foundation and spray, as recited in instant claim 16:
US ‘125 discloses that the cosmetic composition may be formulated into any dosage form that is conventionally prepared, and examples thereof may include a solution, a suspension, an emulsion, a paste, a gel, a cream, a lotion, a powder, a soap, a surfactant-containing cleansing, an oil, a powder foundation, an emulsion foundation, a wax foundation and a spray, but are not limited thereto (see column 4, lines 36-42). More specifically, the cosmetic composition of the present invention may be prepared in a dosage form of emollient lotion, nourishing lotion, nourishing cream, massage cream, essence, eye cream, cleansing cream, cleansing foam, cleansing water, pack, spray or powder (see column 4, lines 42-47).
Additionally, MPEP 2112.01 states that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not inherently possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
In the instant case, SEQ ID NO: 2 as disclosed by US ‘125 reads on the instantly claim peptide comprising an amino acid sequence of SEQ ID NO: 1. Therefore, the claimed activity of preventing hair loss or promoting hair growth, would inherently be present; because US ‘125’s sequence is 100% identical to instant SEQ ID NO: 1, thus the claimed properties/functions would have been obvious to one skilled in the art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in 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 conflicting claims are not identical, 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, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
3. Claims 1-3 and 5-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 10,047,125 B2 Date of Patent; Aug. 14, 2018 (herein after “US ‘125”). Although the claims at issue are not identical, they are not patentably distinct from each other because:
US ‘125 claims a peptide having an activity to improve skin condition, the peptide consisting of the amino acid sequence of SEQ ID NO: 2, wherein (i) the C-terminal end of the peptide is modified by the presence of a hydroxyl group, an amino group, or an azide group, or (ii) the N-terminal end of the peptide comprises a protecting group (see column 13, claim 1).
Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). This is pertinent because in US ‘125, SEQ ID NO: 2 is a 9 amino acid residue sequence represented by Cys-Pro-Arg-His-Phe-Asn-Pro-Val-Cys (see column 11, sequence listing). Thereby corresponding to instant SEQ ID NO: 1 (i.e., CPRHFNPVC).
Additionally, MPEP 2112.01 states that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not inherently possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. In the instant case, SEQ ID NO: 2 as disclosed by US ‘125 reads on the instantly claim peptide comprising an amino acid sequence of SEQ ID NO: 1. Therefore, the claimed activity of preventing hair loss or promoting hair growth, would inherently be present; because US ‘125’s sequence is 100% identical to instant SEQ ID NO: 1, thus the claimed properties/functions would have been obvious to one skilled in the art.
4. Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 18/695,068 PG Pub US20240415920A1 (reference application) claim set filed on 03/25/2024, in view of US 10,047,125 B2 Date of Patent; Aug. 14, 2018 (herein after “US ‘125”), as evidenced by Advanced Dermatology PC, Blog “Are you losing your hair due to a skin condition?”, first available online on Sep. 28, 2017 at https://www.advanceddermatologypc.com/blog/are-you-losing-your-hair-due-to-a-skin-condition/, retrieved on 06/12/2026 (herein after “Advanced Dermatology”) .
Regarding instant claims 1-16, Copending Application ‘068 claims:
A peptide having the activity of preventing hair loss or promoting hair growth, comprising an amino acid sequence of SEQ ID NO: 1 (see Copending App ‘068, claim 1); wherein the peptide promotes the proliferation or activity of cells related to hair formation (see Copending App ‘068, claim 2); and compositions for preventing hair loss or promoting hair growth, comprising the peptide of claim 1 (see Copending App ‘068, claims 3-16).
Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). This is pertinent because in copending Application ‘068, SEQ ID NO: 1 is represented by GCGLFVAAC (see specification, filed 03/25/2024, pg. 22, Table 1).
As such, the difference between Copending Application ‘068 claims 1-16 and instant claims 1-16 is instant SEQ ID NO: 1 (i.e., CPRHFNPVC).
Since, the disclosure of US ‘125 (i.e., SEQ ID NO: 2, a 9 amino acid residue sequence represented by Cys-Pro-Arg-His-Phe-Asn-Pro-Val-Cys), reads on the instantly claimed sequence; an ordinary skilled artisan would have been motivated to arrive at the claimed invention by substituting SEQ ID NO 1 (i.e., GCGLFVAAC) in Copending Application ‘068 with US ’125 SEQ ID NO: 1 (CPRHFNPVC). An ordinary skilled artisan would have been motivated to do so because SEQ ID NO: 1 (CPRHFNPVC) in US ’125, is known for having an activity to improve skin condition (see US ‘125, column 13, claim 1). As evidenced by Advanced Dermatology, various skin conditions have been linked to increased hair loss (see Advanced Dermatology, pg. 2, second paragraph). Therefore, an ordinary skill artisan would have been motivated with reasonable expectation of success to substitute SEQ ID NO 1 (i.e., GCGLFVAAC) in Copending Application ‘068 with US ’125 SEQ ID NO: 1 (CPRHFNPVC), in order to arrive at the instantly claimed invention, because it was known that a peptide having the identical sequence to instant SEQ ID NO: 1 improves skin condition, and since hair loss has been liked to various skin conditions; it would have been obvious to make the substitution.
Additionally, MPEP 2112.01 states that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Although the claims at issue are not identical, they are not patentably distinct from each other because an under an obviousness rationale, an ordinary skilled artisan would have been motivated to substitute GCGLFVAAC for the claimed sequence CPRHFNPVC.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
5. Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 18/695,526 PG Pub US20250281378A1 (reference application) claim set filed on 08/30/2024, in view of US 10,047,125 B2 Date of Patent; Aug. 14, 2018 (herein after “US ‘125”), as evidenced by Advanced Dermatology PC, Blog “Are you losing your hair due to a skin condition?”, first available online on Sep. 28, 2017 at https://www.advanceddermatologypc.com/blog/are-you-losing-your-hair-due-to-a-skin-condition/, retrieved on 06/12/2026 (herein after “Advanced Dermatology”) .
Regarding instant claims 1-16, Copending Application ‘526 claims:
A peptide having the activity of preventing hair loss or promoting hair growth, comprising an amino acid sequence of SEQ ID NO: 1 (see Copending App ‘526, claim 1); wherein the peptide promotes the proliferation or activity of cells related to hair formation (see Copending App ‘526, claim 2); and compositions for preventing hair loss or promoting hair growth, comprising the peptide of claim 1 (see Copending App ‘526, claims 3-16).
Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). This is pertinent because in Copending App ‘526, SEQ ID NO: 1 is represented by KLQEHLDM (see specification, filed 03/26/2024, pg. 22, Table 1).
As such, the difference between Copending Application ‘526 claims 1-16 and instant claims 1-16 is instant SEQ ID NO: 1 (i.e., CPRHFNPVC).
Since, the disclosure of US ‘125 (i.e., SEQ ID NO: 2, a 9 amino acid residue sequence represented by Cys-Pro-Arg-His-Phe-Asn-Pro-Val-Cys), reads on the instantly claimed sequence; an ordinary skilled artisan would have been motivated to arrive at the claimed invention by substituting SEQ ID NO 1 (i.e., KLQEHLDM) in Copending App ‘526 with US ’125 SEQ ID NO: 1 (CPRHFNPVC). An ordinary skilled artisan would have been motivated to do so because SEQ ID NO: 1 (CPRHFNPVC) in US ’125, is known for having an activity to improve skin condition (see US ‘125, column 13, claim 1). As evidenced by Advanced Dermatology, various skin conditions have been linked to increased hair loss (see Advanced Dermatology, pg. 2, second paragraph). Therefore, an ordinary skill artisan would have been motivated with reasonable expectation of success to substitute SEQ ID NO 1 (i.e., KLQEHLDM) in Copending Application ‘526 with US ’125 SEQ ID NO: 1 (CPRHFNPVC), in order to arrive at the instantly claimed invention, because it was known that a peptide having the identical sequence to instant SEQ ID NO: 1 improves skin condition, and since hair loss has been liked to various skin conditions; it would have been obvious to make the substitution.
Additionally, MPEP 2112.01 states that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Although the claims at issue are not identical, they are not patentably distinct from each other because an under an obviousness rationale, an ordinary skilled artisan would have been motivated to substitute KLQEHLDM for the claimed sequence CPRHFNPVC.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
6. Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 18/695,853 PG Pub US20240390453A1 (reference application) claim set filed on 03/27/2024, in view of US 10,047,125 B2 Date of Patent; Aug. 14, 2018 (herein after “US ‘125”), as evidenced by Advanced Dermatology PC, Blog “Are you losing your hair due to a skin condition?”, first available online on Sep. 28, 2017 at https://www.advanceddermatologypc.com/blog/are-you-losing-your-hair-due-to-a-skin-condition/, retrieved on 06/12/2026 (herein after “Advanced Dermatology”) .
Regarding instant claims 1-16, Copending Application ‘853 claims:
A peptide having the activity of preventing hair loss or promoting hair growth, comprising an amino acid sequence of SEQ ID NO: 1 (see Copending App ‘853, claim 1); wherein the peptide promotes the proliferation or activity of cells related to hair formation (see Copending App ‘853, claim 2); and compositions for preventing hair loss or promoting hair growth, comprising the peptide of claim 1 (see Copending App ‘853, claims 3-16).
Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). This is pertinent because in Copending App ‘853, SEQ ID NO: 1 is represented by HLPKPI (see specification, filed 03/27/2024, pg. 22, Table 1).
As such, the difference between Copending Application ‘853 claims 1-16 and instant claims 1-16 is instant SEQ ID NO: 1 (i.e., CPRHFNPVC).
Since, the disclosure of US ‘125 (i.e., SEQ ID NO: 2, a 9 amino acid residue sequence represented by Cys-Pro-Arg-His-Phe-Asn-Pro-Val-Cys), reads on the instantly claimed sequence; an ordinary skilled artisan would have been motivated to arrive at the claimed invention by substituting SEQ ID NO 1 (i.e., HLPKPI) in Copending App ‘853 with US ’125 SEQ ID NO: 1 (CPRHFNPVC). An ordinary skilled artisan would have been motivated to do so because SEQ ID NO: 1 (CPRHFNPVC) in US ’125, is known for having an activity to improve skin condition (see US ‘125, column 13, claim 1). As evidenced by Advanced Dermatology, various skin conditions have been linked to increased hair loss (see Advanced Dermatology, pg. 2, second paragraph). Therefore, an ordinary skill artisan would have been motivated with reasonable expectation of success to substitute SEQ ID NO 1 (i.e., HLPKPI) in Copending Application ‘853 with US ’125 SEQ ID NO: 1 (CPRHFNPVC), in order to arrive at the instantly claimed invention, because it was known that a peptide having the identical sequence to instant SEQ ID NO: 1 improves skin condition, and since hair loss has been liked to various skin conditions; it would have been obvious to make the substitution.
Additionally, MPEP 2112.01 states that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).Although the claims at issue are not identical, they are not patentably distinct from each other because an under an obviousness rationale, an ordinary skilled artisan would have been motivated to substitute HLPKPI for the claimed sequence CPRHFNPVC.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
7. Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 18/695,838 PG Pub US20250129120A1 (reference application) claim set filed on 01/13/2025 2 of 2, in view of US 10,047,125 B2 Date of Patent; Aug. 14, 2018 (herein after “US ‘125”) as evidenced by Advanced Dermatology PC, Blog “Are you losing your hair due to a skin condition?”, first available online on Sep. 28, 2017 at https://www.advanceddermatologypc.com/blog/are-you-losing-your-hair-due-to-a-skin-condition/, retrieved on 06/12/2026 (herein after “Advanced Dermatology”) .Regarding instant claims 1-16, Copending Application ‘838 claims:
A peptide having the activity of preventing hair loss or promoting hair growth, comprising an amino acid sequence of SEQ ID NO: 1 (see Copending App ‘838, claim 1); wherein the peptide promotes the proliferation or activity of cells related to hair formation (see Copending App ‘838, claim 2); and compositions for preventing hair loss or promoting hair growth, comprising the peptide of claim 1 (see Copending App ‘838, claims 3-16).
Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). This is pertinent because in Copending App ‘838, SEQ ID NO: 1 is represented by GGVPG (see specification, filed 01/13/2025, pg. 22, Table 1).
As such, the difference between Copending Application ‘838 claims 1-16 and instant claims 1-16 is instant SEQ ID NO: 1 (i.e., CPRHFNPVC).
Since, the disclosure of US ‘125 (i.e., SEQ ID NO: 2, a 9 amino acid residue sequence represented by Cys-Pro-Arg-His-Phe-Asn-Pro-Val-Cys), reads on the instantly claimed sequence; an ordinary skilled artisan would have been motivated to arrive at the claimed invention by substituting SEQ ID NO 1 (i.e., GGVPG) in Copending App ‘838 with US ’125 SEQ ID NO: 1 (CPRHFNPVC). An ordinary skilled artisan would have been motivated to do so because SEQ ID NO: 1 (CPRHFNPVC) in US ’125, is known for having an activity to improve skin condition (see US ‘125, column 13, claim 1). As evidenced by Advanced Dermatology, various skin conditions have been linked to increased hair loss (see Advanced Dermatology, pg. 2, second paragraph). Therefore, an ordinary skill artisan would have been motivated with reasonable expectation of success to substitute SEQ ID NO 1 (i.e., GGVPG) in Copending Application ‘838 with US ’125 SEQ ID NO: 1 (CPRHFNPVC), in order to arrive at the instantly claimed invention, because it was known that a peptide having the identical sequence to instant SEQ ID NO: 1 improves skin condition, and since hair loss has been liked to various skin conditions; it would have been obvious to make the substitution.
Additionally, MPEP 2112.01 states that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).Although the claims at issue are not identical, they are not patentably distinct from each other because an under an obviousness rationale, an ordinary skilled artisan would have been motivated to substitute GGVPG for the claimed sequence CPRHFNPVC.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
8. Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 18/695,562 PG Pub US20250127844A1 (reference application) claim set filed on 01/08/2025, in view of US 10,047,125 B2 Date of Patent; Aug. 14, 2018 (herein after “US ‘125”), as evidenced by Advanced Dermatology PC, Blog “Are you losing your hair due to a skin condition?”, first available online on Sep. 28, 2017 at https://www.advanceddermatologypc.com/blog/are-you-losing-your-hair-due-to-a-skin-condition/, retrieved on 06/12/2026 (herein after “Advanced Dermatology”) .
Regarding instant claims 1-16, Copending Application ‘562 claims:
A peptide having the activity of preventing hair loss or promoting hair growth, comprising an amino acid sequence of SEQ ID NO: 1 (see Copending App ‘562, claim 1); wherein the peptide promotes the proliferation or activity of cells related to hair formation (see Copending App ‘562, claim 2); and compositions for preventing hair loss or promoting hair growth, comprising the peptide of claim 1 (see Copending App ‘562, claims 3-16).
Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). This is pertinent because in Copending App ‘562, SEQ ID NO: 1 is represented by QHNQIRYFEE (see specification, filed 01/08/2025, pg. 22, Table 1).
As such, the difference between Copending Application ‘562 claims 1-16 and instant claims 1-16 is instant SEQ ID NO: 1 (i.e., CPRHFNPVC).
Since, the disclosure of US ‘125 (i.e., SEQ ID NO: 2, a 9 amino acid residue sequence represented by Cys-Pro-Arg-His-Phe-Asn-Pro-Val-Cys), reads on the instantly claimed sequence; an ordinary skilled artisan would have been motivated to arrive at the claimed invention by substituting SEQ ID NO 1 (i.e., QHNQIRYFEE) in Copending App ‘562 with US ’125 SEQ ID NO: 1 (CPRHFNPVC). An ordinary skilled artisan would have been motivated to do so because SEQ ID NO: 1 (CPRHFNPVC) in US ’125, is known for having an activity to improve skin condition (see US ‘125, column 13, claim 1). As evidenced by Advanced Dermatology, various skin conditions have been linked to increased hair loss (see Advanced Dermatology, pg. 2, second paragraph). Therefore, an ordinary skill artisan would have been motivated with reasonable expectation of success to substitute SEQ ID NO 1 (i.e., QHNQIRYFEE) in Copending Application ‘562 with US ’125 SEQ ID NO: 1 (CPRHFNPVC), in order to arrive at the instantly claimed invention, because it was known that a peptide having the identical sequence to instant SEQ ID NO: 1 improves skin condition, and since hair loss has been liked to various skin conditions; it would have been obvious to make the substitution.
Additionally, MPEP 2112.01 states that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Although the claims at issue are not identical, they are not patentably distinct from each other because an under an obviousness rationale, an ordinary skilled artisan would have been motivated to substitute QHNQIRYFEE for the claimed sequence CPRHFNPVC.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/CLAUDIA ESPINOSA/Patent Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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