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 .
Response to Election/Restriction filed on January 27, 2026 is acknowledged.
Claims 1-11 are pending in this application.
Sequence Non-compliant
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because it does not contain a "Sequence Listing" as a separate part of the disclosure or a CRF of the “Sequence Listing.”.
Required response - Applicant must provide:
A "Sequence Listing" part of the disclosure; together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.821(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
If the "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5); and
A statement according to item 2) a) or b) above.
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because the application does not contain a statement that the CRF is identical to the "Sequence Listing" part of the disclosure, as described above in item 1), as required by 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii).
Required response - Applicant must provide such statement.
Specific deficiency - This application contains a “Sequence Listing as a PDF file (37 CFR 1.821(c)(2)) or as physical sheets of paper (37 CFR 1.821(c)(3)), but fails to comply with the requirements of 37 CFR 1.821 - 1.825 because a copy of the "Sequence Listing" in computer readable form (CRF) has not been submitted as required by 37 CFR 1.821(e)(1)(i) or 1.821(e)(2)(i) as indicated in item 2) above.
Required response - Applicant must provide:
A new CRF of the “Sequence Listing” in accordance with 37 CFR 1.821(e)(1)(i) or 1.821(e)(2)(i) and
A statement that the content of the CRF is identical of the “Sequence Listing” part of the disclosure, submitted as a PDF file (37 CFR 1.821(c)(2)) or on physical sheets of paper (37 CFR 1.821(c)(3)), as required by 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii).
Please see paragraph [0090] of instant specification US 2023/0390356.
Priority
4. Applicant claims foreign priority to JAPAN 2020-159776 (9/24/2020). The certified copy has been received by the Office. However, English translation has not been provided. Therefore, the foreign priority date has not been perfected. Thus, the priority date of instant application is 9/24/2021 until the foreign priority date is perfected.
Restriction
5. Applicant’s election without traverse of Group 1 (claims 1-10) and elected to following species:
PNG
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84
310
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Greyscale
and head hair as the species of site of application in the reply filed on January 27, 2026 is acknowledged. Restriction is deemed to be proper and is made FINAL in this office action. Claim 11 is withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected invention, there being no allowable generic or linking claim. Claims 1-10 are examined on the merits in this office action.
Objections
6. The abstract is objected to for the following minor informality:
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc.
In the instant case, the abstract recites, “To provide a hair growth agent…such agents are made to contain an active ingredient in the form of…”. The abstract appears to be an incomplete sentence. Additionally, the abstract is recommended to be separated into different sentences to be more concise. Additionally, the term “diaminobutyloyl” appears to be a misspelling. Applicant should correct these informalities. See MPEP 608.01(b). For example, the abstract can recite, “A topical agent that exhibits hair growth effects comprising…is described.”
7. The specification is objected to for the following: The term “diaminobutyloyl” appears to be misspelled (see throughout the specification, for example, paragraphs [0001], [0005], [0012]-[0015], [0024]-[0028], [0030]-[0031], [0033]-[0034], [0049]-[0051], [0060], [0063], [0066], [0068] and so on). Applicant is required to correct these errors.
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
8. Claims 1-3 are objected to for the following: Claims 1-3 recite the term “palmitoyl dipeptide-5 diaminobutyloyl hydroxythreonine”. The term diaminobutyloyl appears to be misspelled. Applicant is required to correct this term to diaminobutyroyl.
Rejections
U.S.C. 112(b)
9. 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.
10. Claims 4-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
11. Claims 4-8 are drawn to the agent of claim 1 “used for” or “for use” certain purposes. The phrases “used for” implies a process, but the claims are drawn to products. A product and process in the same claim is indefinite under 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). For the purpose of examination, the claims will be interpreted as product claims.
U.S.C. 112(d)
12. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
13. Claims 4-8 and 10 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
14. Claims 4-8 and 10 depend from claim 1 and recites “used for” and “for use in” various hair improvements. The “used for” and “for use in” limitations do not structurally limit the claims as they are only intended uses. Thus, the scope of claims 4-8 and 10 is not different from the scope of claim1. Therefore, claims 4-8 and 10 do not further limit claim 1.
U.S.C. 102
15. 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.
16. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
17. Claim(s) 1 and 4-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mintel GNPD (http://www.gnpd.com, pp. 1-5, 2016, filed with IDS).
18. Mintel GNPD teaches an All-in-One Shampoo comprising palmitoyl dipeptide-5 diaminobutyroyl hydroxythreonine (see p. 3 or the product description), meeting the limitation of instant claim 1. Mintel GNPD teaches shampoo, thus the product meets the limitation of instant claims 9-10. Instant claim 1 recites, “A hair growth agent which is a topical agent that contains palmitoyl dipeptide-5 diaminotutyroyl hydroxythreonine.” The transitional term “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., > Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) (“like the term comprising,’ the terms containing’ and mixture’ are open-ended.”).< Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003) (“The transition comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps.”); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) (“Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (“comprising” leaves “the claim open for the inclusion of unspecified ingredients even in major amounts”). >In Gillette Co. v. Energizer Holdings Inc., 405 F.3d 1367, 1371-73, 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005), the court held that a claim to “a safety razor blade unit comprising a guard, a cap, and a group of first, second, and third blades” encompasses razors with more than three blades because the transitional phrase “comprising” in the preamble and the phrase “group of” are presumptively open-ended. “The word comprising’ transitioning from the preamble to the body signals that the entire claim is presumptively open-ended.” Id.
In regards to claims 4-8, the claims recite intended use. The MPEP states that intended use has not been given any patentable weight, since they do not further limit the compound. With respect to the limitation “for use in causing” in instant claims 4-8 and 10, an intended use limitation does not impart patentability to product claims where the product is otherwise anticipated by the prior art.
With respect to the limitation in the preamble of claims 1 and 4-10, “A/The hair growth agent which is a topical agent…”, please note that MPEP 2111.02 II states “a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention.” In the instant case, the preamble does not affect the components involved in the product and/or the structures of the components involved in the product. The preamble in this case recites a statement of purpose or use, and therefore was not treated as a claim limitation.
Because the reference teaches ALL of the active components, the reference anticipates instant claims 1 and 4-10.
19. Claims 1 and 4-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nalabolu reference (WO 2015/157692, filed with IDS).
20. Nalabolu reference teaches a topical composition comprising palmitoyl dipeptide-5 diaminobutyroyl dihydoxythreonine (see paragraph [0093]), meeting the limitation of instant claim 1. Nalabolu reference teaches a composition comprising combination either all or in part of…complex (palmitoyl dipeptide-5 diaminobutyroyl hydroxythreonine and palmitoyl dipeptide-5 diaminohydroxybutyrate, glycerin and water (see for example, paragraph [0143]), meeting the limitation of instant claims 1 and 4-10. Instant claim 1 recites, “A hair growth agent which is a topical agent that contains palmitoyl dipeptide-5 diaminotutyroyl hydroxythreonine.” The transitional term “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., > Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) (“like the term comprising,’ the terms containing’ and mixture’ are open-ended.”).< Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003) (“The transition comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps.”); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) (“Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (“comprising” leaves “the claim open for the inclusion of unspecified ingredients even in major amounts”). >In Gillette Co. v. Energizer Holdings Inc., 405 F.3d 1367, 1371-73, 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005), the court held that a claim to “a safety razor blade unit comprising a guard, a cap, and a group of first, second, and third blades” encompasses razors with more than three blades because the transitional phrase “comprising” in the preamble and the phrase “group of” are presumptively open-ended. “The word comprising’ transitioning from the preamble to the body signals that the entire claim is presumptively open-ended.” Id.
In regards to claims 4-8, the claims recite intended use. The MPEP states that intended use has not been given any patentable weight, since they do not further limit the compound. With respect to the limitation “for use in causing” in instant claims 4-8 and 10, an intended use limitation does not impart patentability to product claims where the product is otherwise anticipated by the prior art.
With respect to the limitation in the preamble of claims 1 and 4-10, “A/The hair growth agent which is a topical agent…”, please note that MPEP 2111.02 II states “a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention.” In the instant case, the preamble does not affect the components involved in the product and/or the structures of the components involved in the product. The preamble in this case recites a statement of purpose or use, and therefore was not treated as a claim limitation.
Because the reference teaches ALL of the active components, the reference anticipates instant claims 1 and 4-10.
21. Claims 1 and 4-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ziegler et al (US 2009/0155347, filed with IDS).
22. Ziegler et al teach topical skin compositions comprising Palm-Lys-Val-Dab-OH and Palm-Lys-Val-Dab-Thr-OH (see for example, paragraph [0022]). As evidenced by instant specification, palmitoyl dipeptide-5 diaminobutyroyl hydroxythreonine is Palm-Lys-Val-Dab-Thr-OH (see paragraph [0033]). Instant claim 1 recites, “A hair growth agent which is a topical agent that contains palmitoyl dipeptide-5 diaminotutyroyl hydroxythreonine.” The transitional term “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., > Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) (“like the term comprising,’ the terms containing’ and mixture’ are open-ended.”).< Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003) (“The transition comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps.”); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) (“Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (“comprising” leaves “the claim open for the inclusion of unspecified ingredients even in major amounts”). >In Gillette Co. v. Energizer Holdings Inc., 405 F.3d 1367, 1371-73, 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005), the court held that a claim to “a safety razor blade unit comprising a guard, a cap, and a group of first, second, and third blades” encompasses razors with more than three blades because the transitional phrase “comprising” in the preamble and the phrase “group of” are presumptively open-ended. “The word comprising’ transitioning from the preamble to the body signals that the entire claim is presumptively open-ended.” Id.
In regards to claims 4-8, the claims recite intended use. The MPEP states that intended use has not been given any patentable weight, since they do not further limit the compound. With respect to the limitation “for use in causing” in instant claims 4-8 and 10, an intended use limitation does not impart patentability to product claims where the product is otherwise anticipated by the prior art.
With respect to the limitation in the preamble of claims 1 and 4-10, “A/The hair growth agent which is a topical agent…”, please note that MPEP 2111.02 II states “a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention.” In the instant case, the preamble does not affect the components involved in the product and/or the structures of the components involved in the product. The preamble in this case recites a statement of purpose or use, and therefore was not treated as a claim limitation.
Therefore, Ziegler et al anticipates instant claims 1 and 4-10.
23. Claims 1 and 4-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heidl et al (US Patent No. 8541361).
24. Heidl et al teach a composition comprising a peptide Palm-Lys-Val-Dab-Thr-OH (SEQ ID NO: 6) (see for example, abstract, column 2, lines 25-42). As evidenced by instant specification, palmitoyl dipeptide-5 diaminobutyroyl hydroxythreonine is Palm-Lys-Val-Dab-Thr-OH (see paragraph [0033]). Heidl et al teach that the composition is for topical preparation and the topical preparation is a cosmetic compositions that can be topically applied to mammalian keratinous tissue such as e.g. human skin or hair (including eyelashes, the eyebrows) or the nails (see column 3, lines 39-52), meeting the limitation of instant claim 1. Heidl et al teach that the composition comprises 0.001 to 12.5% wt%, particularly 0.01 to 2 wt%, most particularly 0.1 to 0.5 wt % of the peptide (see column 1, lines 47-49). Furthermore, Heidl et al teach that the compositions can be in the form of a solution, a viscous liquid or in the form of a gel (see column 3, lines 25-27), meeting the limitation of instant claim 9. Instant claim 1 recites, “A hair growth agent which is a topical agent that contains palmitoyl dipeptide-5 diaminotutyroyl hydroxythreonine.” The transitional term “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., > Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) (“like the term comprising,’ the terms containing’ and mixture’ are open-ended.”).< Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003) (“The transition comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps.”); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) (“Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (“comprising” leaves “the claim open for the inclusion of unspecified ingredients even in major amounts”). >In Gillette Co. v. Energizer Holdings Inc., 405 F.3d 1367, 1371-73, 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005), the court held that a claim to “a safety razor blade unit comprising a guard, a cap, and a group of first, second, and third blades” encompasses razors with more than three blades because the transitional phrase “comprising” in the preamble and the phrase “group of” are presumptively open-ended. “The word comprising’ transitioning from the preamble to the body signals that the entire claim is presumptively open-ended.” Id.
In regards to claims 4-8, the claims recite intended use. The MPEP states that intended use has not been given any patentable weight, since they do not further limit the compound. With respect to the limitation “for use in causing” in instant claims 4-8 and 10, an intended use limitation does not impart patentability to product claims where the product is otherwise anticipated by the prior art.
With respect to the limitation in the preamble of claims 1 and 4-10, “A/The hair growth agent which is a topical agent…”, please note that MPEP 2111.02 II states “a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention.” In the instant case, the preamble does not affect the components involved in the product and/or the structures of the components involved in the product. The preamble in this case recites a statement of purpose or use, and therefore was not treated as a claim limitation.
Because Heidl et al teach all of the active components of instant claim, the reference anticipates instant claims 1 and 4-10.
25. Claim(s) 1-10 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Nakamura et al (US 2022/0387283, filed on 9/23/2020, priority date is 10/18/2019, publication date is 12/8/2022).
The applied reference has a common assignee and common Inventors (Nakamura, Takahashi, Nakaike, Tsuji and Ogawa) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
26. Nakamura et al teach a hair growth agent which is a topical agent comprising the active ingredient in the form of palmitoyl dipeptide-5 diaminobutyroyl hydroxythreonine and palmitoyl dipeptide-5 diaminohydroxybutyrate (see abstract and claims 1-11). Instant claim 1 recites, “A hair growth agent which is a topical agent that contains palmitoyl dipeptide-5 diaminotutyroyl hydroxythreonine.” The transitional term “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., > Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) (“like the term comprising,’ the terms containing’ and mixture’ are open-ended.”).< Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003) (“The transition comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps.”); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) (“Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (“comprising” leaves “the claim open for the inclusion of unspecified ingredients even in major amounts”). >In Gillette Co. v. Energizer Holdings Inc., 405 F.3d 1367, 1371-73, 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005), the court held that a claim to “a safety razor blade unit comprising a guard, a cap, and a group of first, second, and third blades” encompasses razors with more than three blades because the transitional phrase “comprising” in the preamble and the phrase “group of” are presumptively open-ended. “The word comprising’ transitioning from the preamble to the body signals that the entire claim is presumptively open-ended.” Id. Therefore, Nakamura et al meets the limitation of instant claim 1. Nakamura et al further teach that the hair growth agent is in liquid solution for, and is for use in head hair, eyelashes, and/or eyebrows (see claims 10-11), meeting the limitation of instant claims 9-10. Nakamura et al further teach that the active agent is in an amount that is 0.001 wt% to 20 wt % (see claim 2) and 0.005 wt% to 10 wt% (see claim 3), meeting the limitation of instant claims 2-3. Nakamura et al teach that the hair growth agent is for new hair growth or hair shaft growth promotion (see claim 5), for improvement in hair shaft elongation rate (see claim 6), for improvement in maximum hair shaft length (see claim 7), for increase in hair shaft diameter (see claim 8), and for increase in number of hairs (see claim 9), meeting the limitation of instant claims 4-8.
Furthermore, in regards to claims 4-8, the claims recite intended use. The MPEP states that intended use has not been given any patentable weight, since they do not further limit the compound. With respect to the limitation “for use in causing” in instant claims 4-8 and 10, an intended use limitation does not impart patentability to product claims where the product is otherwise anticipated by the prior art.
With respect to the limitation in the preamble of claims 1 and 4-10, “A/The hair growth agent which is a topical agent…”, please note that MPEP 2111.02 II states “a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention.” In the instant case, the preamble does not affect the components involved in the product and/or the structures of the components involved in the product. The preamble in this case recites a statement of purpose or use, and therefore was not treated as a claim limitation.
Because Nakamura et al teach all of the active components of instant claim, the reference anticipates instant claims 1-10.
U.S.C. 103
27. 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.
28. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the 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 by the manner in which the invention was made.
29. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
30. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
31. Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nalabolu reference (WO 2015/157692, filed with IDS) in view of Widgerow reference (US 2012/0058167).
32. Nalabolu reference teaches a topical composition comprising palmitoyl dipeptide-5 diaminobutyroyl dihydoxythreonine (see paragraph [0093]), meeting the limitation of instant claim 1. Nalabolu reference teaches a composition comprising combination either all or in part of…complex (palmitoyl dipeptide-5 diaminobutyroyl hydroxythreonine and palmitoyl dipeptide-5 diaminohydroxybutyrate, glycerin and water (see for example, paragraph [0143]), meeting the limitation of instant claims 1 and 4-10. Instant claim 1 recites, “A hair growth agent which is a topical agent that contains palmitoyl dipeptide-5 diaminotutyroyl hydroxythreonine.” The transitional term “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., > Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) (“like the term comprising,’ the terms containing’ and mixture’ are open-ended.”).< Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003) (“The transition comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps.”); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) (“Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (“comprising” leaves “the claim open for the inclusion of unspecified ingredients even in major amounts”). >In Gillette Co. v. Energizer Holdings Inc., 405 F.3d 1367, 1371-73, 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005), the court held that a claim to “a safety razor blade unit comprising a guard, a cap, and a group of first, second, and third blades” encompasses razors with more than three blades because the transitional phrase “comprising” in the preamble and the phrase “group of” are presumptively open-ended. “The word comprising’ transitioning from the preamble to the body signals that the entire claim is presumptively open-ended.” Id.
In regards to claims 4-8, the claims recite intended use. The MPEP states that intended use has not been given any patentable weight, since they do not further limit the compound. With respect to the limitation “for use in causing” in instant claims 4-8 and 10, an intended use limitation does not impart patentability to product claims where the product is otherwise anticipated by the prior art.
With respect to the limitation in the preamble of claims 1 and 4-10, “A/The hair growth agent which is a topical agent…”, please note that MPEP 2111.02 II states “a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention.” In the instant case, the preamble does not affect the components involved in the product and/or the structures of the components involved in the product. The preamble in this case recites a statement of purpose or use, and therefore was not treated as a claim limitation.
Because the reference teaches ALL of the active components, the reference meets the limitation of instant claims 1 and 4-10.
The difference between the Nalabolu reference and the instant claims is that the reference does not teach the % amount of the palmitoyl dipeptide-5 diaminobutyroyl hydroxythreonine.
33. However, Widgerow reference teaches, for example, a topical composition formulated as moisturizers, body washes…nail care, hair care…and other cosmetics (see for example, paragraph [0072]), and the composition comprises 0.1-5.0% Centella Asiatica extract…the topical composition may also comprise…one or more of the following ingredients listed on Table 1 in addition to, or instead of, the ingredients listed above…comprising 0.0001 to 1.0 wt% of palmitoyl dipeptide-5 diaminobutyroyl hydroxythreonine and 0.0001 to 1.0 wt% palmitoyl dipeptide-5 diaminohydroxybutyrate(see paragraph [0049], Table 1).
34. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Nalabolu reference and Widgerow reference to produce a topical agent comprising 0.001 wt% to 20 wt% of palmitoyl dipeptide-5 diaminobutyroyl hydroxythreonine because both Nalabolu reference and Widgerow reference teach a topical composition comprising at least a dipeptide-5 diaminobutyroyl hydroxythreonine. One of ordinary skill in the art would have been motivated to combine with a reasonable expectation of success, since Nalabolu reference teaches a topical composition comprising palmitoyl dipeptide-5 diaminobutyroyl hydroxythreonine used as a skin conditioning agent and having other beneficial properties, and Widgerow reference teaches a topical composition comprising palmitoyl dipeptide-5 diaminobutyroyl hydroxythreonine within the weight range (0.0001 to 1%) for topical cosmetic or dermatological and hair care purpose. The MPEP states that “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).” One of ordinary skill in the art would be motivated to optimize the wt% of palmitoyl dipeptide-5 diaminobutyroyl hydroxythreonine with a reasonable expectation of success, since “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” Therefore, it is deemed that the combined teachings are prima facie obvious over instant claims 1-10.
35. Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Heidl et al (US Patent No. 8541361) in view of Widgerow reference (US 2012/0058167).
36. Heidl et al teach a composition comprising a peptide Palm-Lys-Val-Dab-Thr-OH (SEQ ID NO: 6) (see for example, abstract, column 2, lines 25-42). As evidenced by instant specification, palmitoyl dipeptide-5 diaminobutyroyl hydroxythreonine is Palm-Lys-Val-Dab-Thr-OH (see paragraph [0033]). Heidl et al teach that the composition is for topical preparation and the topical preparation is a cosmetic compositions that can be topically applied to mammalian keratinous tissue such as e.g. human skin or hair (including eyelashes, the eyebrows) or the nails (see column 3, lines 39-52), meeting the limitation of instant claim 1. Heidl et al teach that the composition comprises 0.001 to 12.5% wt%, particularly 0.01 to 2 wt%, most particularly 0.1 to 0.5 wt % of the peptide (see column 1, lines 47-49). Furthermore, Heidl et al teach that the compositions can be in the form of a solution, a viscous liquid or in the form of a gel (see column 3, lines 25-27), meeting the limitation of instant claim 9. Instant claim 1 recites, “A hair growth agent which is a topical agent that contains palmitoyl dipeptide-5 diaminotutyroyl hydroxythreonine.” The transitional term “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., > Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) (“like the term comprising,’ the terms containing’ and mixture’ are open-ended.”).< Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003) (“The transition comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps.”); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) (“Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (“comprising” leaves “the claim open for the inclusion of unspecified ingredients even in major amounts”). >In Gillette Co. v. Energizer Holdings Inc., 405 F.3d 1367, 1371-73, 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005), the court held that a claim to “a safety razor blade unit comprising a guard, a cap, and a group of first, second, and third blades” encompasses razors with more than three blades because the transitional phrase “comprising” in the preamble and the phrase “group of” are presumptively open-ended. “The word comprising’ transitioning from the preamble to the body signals that the entire claim is presumptively open-ended.” Id.
In regards to claims 4-8, the claims recite intended use. The MPEP states that intended use has not been given any patentable weight, since they do not further limit the compound. With respect to the limitation “for use in causing” in instant claims 4-8 and 10, an intended use limitation does not impart patentability to product claims where the product is otherwise anticipated by the prior art.
With respect to the limitation in the preamble of claims 1 and 4-10, “A/The hair growth agent which is a topical agent…”, please note that MPEP 2111.02 II states “a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention.” In the instant case, the preamble does not affect the components involved in the product and/or the structures of the components involved in the product. The preamble in this case recites a statement of purpose or use, and therefore was not treated as a claim limitation.
Because Heidl et al teach all of the active components of instant claim, the reference anticipates instant claims 1 and 4-10.
The difference between the Heidl et al and instant claims is that the reference does not teach the % amount of the palmitoyl dipeptide-5 diaminobutyroyl hydroxythreonine.
37. However, Widgerow reference teaches, for example, a topical composition formulated as moisturizers, body washes…nail care, hair care…and other cosmetics (see for example, paragraph [0072]), and the composition comprises 0.1-5.0% Centella Asiatica extract…the topical composition may also comprise…one or more of the following ingredients listed on Table 1 in addition to, or instead of, the ingredients listed above…comprising 0.0001 to 1.0 wt% of palmitoyl dipeptide-5 diaminobutyroyl hydroxythreonine and 0.0001 to 1.0 wt% palmitoyl dipeptide-5 diaminohydroxybutyrate(see paragraph [0049], Table 1).
38. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Heidl et al and Widgerow reference to produce a topical agent comprising 0.001 wt% to 20 wt% of palmitoyl dipeptide-5 diaminobutyroyl hydroxythreonine because both Heidl et al and Widgerow reference teach a topical composition comprising at least a dipeptide-5 diaminobutyroyl hydroxythreonine. One of ordinary skill in the art would have been motivated to combine with a reasonable expectation of success, since Heidl et al teach a topical composition comprising palmitoyl dipeptide-5 diaminobutyroyl hydroxythreonine used as a skin conditioning agent and having other beneficial properties and that the composition comprises 0.001 to 12.5% wt%, particularly 0.01 to 2 wt%, most particularly 0.1 to 0.5 wt % of the peptide, and Widgerow reference teaches a topical composition comprising palmitoyl dipeptide-5 diaminobutyroyl hydroxythreonine within the weight range (0.0001 to 1%) for topical cosmetic or dermatological and hair care purpose. The MPEP states that “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).” One of ordinary skill in the art would be motivated to optimize the wt% of palmitoyl dipeptide-5 diaminobutyroyl hydroxythreonine with a reasonable expectation of success, since “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” Therefore, it is deemed that the combined teachings are prima facie obvious over instant claims 1-10.
CONCLUSION
No claim is allowed.
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/JULIE HA/Primary Examiner, Art Unit 1654
3/25/2026
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