DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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 for the cited rejections 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.
3. Response to Election/Restriction filed on 11/21/2025 is acknowledged.
4. Claim filed on 11/21/2025 is acknowledged.
5. Claims 1-35 have been cancelled.
6. Claims 36-55 are pending in this application.
7. Claims 38 and 40-46 are withdrawn from consideration as being drawn to non-elected species.
8. Claims 36, 37, 39 and 47-55 are under examination.
Election/Restrictions
9. Applicant’s election with traverse of a composition comprising the peptide Pal-KTSKS formulated as capsules in the form a nano emulsion as species of composition; skin as species of site of applying the composition; and smoothing acne atrophic traces as species of effect and/or condition of the treatment in the reply filed on 11/21/2025 is acknowledged. The traverse is on the ground that “there would not be a serious burden on the Examiner to search the subject matter of the claims without the required restrictions.” This is not found to be persuasive because: for US 371 application of PCT application, burden is not a reason for traverse. Therefore, Applicant’s arguments are moot. And the requirement is deemed proper and is made Final in this office action.
Please note: It is unclear to the Examiner what is encompassed within the term “capsules in the form a nano emulsion”. Such term is unknown in the art, and is not defined in instant specification. Therefore, for the purpose of this examination, the Examiner is interpretating the elected species of composition as a composition comprising the peptide Pal-KTSKS and wherein the composition is in the form of nanocapsules.
The instant claims 36-55 are drawn to a method of treating keratinic materials of skin and its integuments, comprising applying to skin, scalp, hair and/or nails of a subject in need thereof of at least one peptide of the following general Formula 1 or a composition comprising the at least one peptide and a physiologically acceptable medium: X-(Xaa)nK*TSK*X'aa-(Xaa)m-Z (1). A search was conducted on the elected species; and prior art was found. Claims 38 and 40-46 are withdrawn from consideration as being drawn to non-elected species. Claims 36, 37, 39 and 47-55 are examined on the merits in this office action.
Sequence Non-Compliance
10. This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth below. All sequences disclosed in the application must comply with the requirements of 37 C.F.R. 1.821-1.825, not only those recited in the claims.
In the instant case, instant specification discloses the peptides X-KTSKX'aa-Z and X-KTSKS-Z on page 7 of instant specification. However, these peptides are not disclosed in the filed sequence listing.
All such sequences are relevant for the purposes of building a comprehensive database and properly assessing prior art. It is therefore essential that all sequences, whether only disclosed or also claimed, be included in the database.
Objections
11. The specification is objected to for the following minor informality: The specification discloses the peptides X-KTSKX'aa-Z and X-KTSKS-Z on page 7 of instant specification. However, these peptides are not disclosed in the filed sequence listing; and they are missing their respective sequence identifier. Furthermore, the instant specification discloses peptide Pal-KTSKS and many others throughout the specification. However, they are missing their respective sequence identifier. Applicant is required to amend the specification to comply with 37 CFR 1.821(c) and 1.821(d).
In addition, Applicant is suggested to amend the recited sequence identifier as “SEQ ID NO: “, as an example, SEQ ID NO: 1.
12. The specification is objected to for the following minor informality: The specification recites the hyperlink “www.croda.com” on page 31, the 2nd paragraph of instant specification. The embedded hyperlinks and/or other forms of browser-executable code are impermissible and require deletion. It is suggested that Applicant places a URL between these symbols “< >” to inactivate the hyperlinks.
13. The use of trademarks has been noted in this application, for example, Matrixyl® and many others throughout instant specification. Each letter of the trademarks should be capitalized wherever it appears and be accompanied by the generic terminology. Although the use of trademarks is permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks.
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 (see MPEP § 608.01).
14. Claim 36 is objected to for the following minor informality: Applicant is suggested to amend claim 36 as “A method of treating keratinic materials of skin and its integuments in a subject in need thereof, wherein the method comprises applying to skin, scalp, hair and/or nails of the subject at least one peptide of Formula 1 or a composition comprising the at least one peptide and a physiologically acceptable medium: X-(Xaa)nK*TSK*X'aa-(Xaa)m-Z (1), wherein: K* is independently selected from lysine, hydroxylysine, ornithine, diaminobutyric acid, diaminopropionic acid, or their formyl, acetyl, trifluoroacetyl, methanesulfonyl or succinyl derivatives; Xaa is independently selected from G, A, P, V, L, I and F; n and m are independently an integer between 0 and 5; X'aa is selected from threonine or serine; X is selected from H, -CO-R1, -SO2-R1 or a biotinoyl group; Z is selected from OH, OR1, NH2, NHR1 or NR1R2; and R1 and R2 are independently selected from alkyl, aryl, aralkyl, alkylaryl, alkoxy, saccharide, or aryloxy group, wherein said group is linear, branched, cyclic, polycyclic, unsaturated, hydroxylated, carbonylated, and/or phosphorylated, wherein said group has no more than 24 carbon atoms, and wherein said group optionally comprises one or more heteroatoms selected from O, S and/or N in its backbone”.
15. Claim 37 is objected to for the following minor informality: Applicant is suggested to amend claim 37 as “The method according to claim 36, wherein the method is for: treating the epidermal stratum corneum for protecting…".
16. Claim 39 is objected to for the following minor informality: Applicant is suggested to amend claim 39 as “The method according to claim 37, wherein the method is for smoothing acne atrophic traces".
17. Claim 47 is objected to for the following minor informality: Applicant is suggested to amend claim 47 as "The method according to claim 36, wherein the at least one peptide is in a formulation selected from the group consisting of…”.
18. Claim 48 is objected to for the following minor informality: Applicant is suggested to amend claim 48 as “…wherein K* is independently lysine or ornithine”.
19. Claim 50 is objected to for the following minor informality: Applicant is suggested to amend claim 50 as "…wherein n and m are independently 0, 1 or 2”.
20. Claim 51 is objected to for the following minor informality: Applicant is suggested to amend claim 51 as “…wherein X is not H and/or Z is not OH”.
21. Claim 52 is objected to for the following minor informality: Applicant is suggested to amend claim 52 as "…wherein R1 and R2 are independently C1-24 alkyl”.
22. Claim 53 is objected to for the following minor informality: Applicant is suggested to amend claim 53 as "…wherein R1 and R2 are independently C3-24 alkyl”.
23. Claim 54 is objected to for the following minor informality: Applicant is suggested to amend claim 54 as "The method according to claim 36, wherein X is -CO-R1, and Z is selected from OH, OMe, OEt or NH2”.
24. Claim 55 is objected to for the following minor informality: Applicant is suggested to amend claim 55 as “The method according to claim 36, wherein the peptide is Pal-KTSKS (SEQ ID: 5)”.
Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (b)
25. 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.
26. Claims 36, 37, 39 and 47-54 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 pre-AIA the applicant regards as the invention.
27. Claim 36 recites “…the two K* possibly being identical or different…” and “…R1 and R2 are, independently of one another, chosen from an alkyl, aryl, aralkyl, alkylaryl, alkoxy, saccharide and aryloxy group, which may be linear, branched, cyclic, polycyclic, unsaturated, hydroxylated, carbonylated, phosphorylated and/or sulfurized, side group having from 1 to 24 carbon atoms and possibly having in its backbone one or more O, S and/or N heteroatoms…”. First, the term “possibly” renders the claim vague and indefinite. Second, with regards to the term “sulfurized”, the instant specification fails to define it. Therefore, it is unclear what is encompassed within the recited “sulfurized”. Taken all these together, the metes and bounds of instant claim 36 is vague and indefinite. Because claims 37, 39 and 47-54 depend from indefinite claim 36, and none of the dependent claims clarifies the point of confusion, they must also be rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
28. Claim 37 recites the term “such as”. The term “such as” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention (see MPEP § 2173.05(d)).
Furthermore, claim 37 recites “uniformizing skin epidermis” and “treating skin pores”. With regards to the recited “uniformizing skin epidermis” and “treating skin pores”, the instant specification fails to defined them. Therefore, it is unclear what is encompassed within the recited “uniformizing skin epidermis” and “treating skin pores”. Thus, the metes and bounds of instant claim 37 is vague and indefinite.
29. Claim 47 recites the terms “for example” and “such as”. The terms “for example” and “such as” render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention (see MPEP § 2173.05(d)).
Furthermore, in the instant case, it is unclear where the example followed the term “for example” and/or “such as” ends.
In addition, with regards to the terms “vectorized form” and “exins” recited in instant claim 47, the instant specification fails to defined them. It is unclear what is encompassed within the recited “vectorized form” and “exins”.
Taken all these together, the metes and bounds of instant claim 47 are vague and indefinite.
Claim Rejections - 35 U.S.C. § 102(a)(1)
30. 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.
31. Please note: during the search for the elected species, prior art was found for the non-elected species of effect and/or condition of the treatment.
Claims 36, 37 and 47-55 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ludin et al (US 2005/0065090 A1, filed with IDS).
The instant claims 36, 37 and 47-55 are drawn to a method of treating keratinic materials of skin and its integuments, comprising applying to skin, scalp, hair and/or nails of a subject in need thereof of at least one peptide of the following general Formula 1 or a composition comprising the at least one peptide and a physiologically acceptable medium: X-(Xaa)nK*TSK*X'aa-(Xaa)m-Z (1).
Ludin et al, throughout the patent, teach peptide compound that increases synthesis of collagen and fibronectin; and a method of enhancing wound healing and/or delaying or treating skin aging, in particular the formation of wrinkles, in a subject in need thereof, wherein the method comprises applying a composition comprising such peptide compound on the skin of the subject, wherein the peptide compound can be Palm-Lys-Thr-Ser-Lys-Ser-OH (identical to the peptide of instant SEQ ID NO: 5), and wherein the composition is in the form of nanocapsules, for example, Abstract; page 2, paragraph [0035]; page 3, paragraph [0059]; page 4, paragraphs [0062]-[0064]; and page 5, Tables 1 and 2. With regards to the term “smoothing epidermis relief” recited in instant claim 37, the instant specification discloses that “smoothing the relief of the skin, in particular epidermal scars such as residual traces of acne lesions (such as atrophic scars)” (see for example, the 1st paragraph on page 4 of instant specification). Therefore, in the broadest reasonable interpretation, treating wrinkles is smoothing epidermis relief recited in instant claim 37. Thus, the method in Ludin et al reads on a composition comprising the peptide Pal-KTSKS formulated as capsules in the form a nano emulsion as the elected species of composition; and skin as the elected species of site of applying the composition. And it meets the limitations of instant claims 36, 37 and 47-55.
Furthermore, the MPEP states the following: A genus does not always anticipate a claim to a species within the genus. However, when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (see MPEP § 2131.02).
Since the reference teaches all the limitations of instant claims 36, 37 and 47-55; the reference anticipates instant claims 36, 37 and 47-55.
Claim Rejections - 35 U.S.C. § 103
32. 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 of this title, 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.
33. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
34. Claims 36, 37, 39 and 47-55 are rejected under 35 U.S.C. 103 as being unpatentable over Ludin et al (US 2005/0065090 A1, filed with IDS) in view of Gozali et al (J Clin Aesthet Dermatol., 2015, 8, pages 33-40).
The instant claims 36, 37, 39 and 47-55 are drawn to a method of treating keratinic materials of skin and its integuments, comprising applying to skin, scalp, hair and/or nails of a subject in need thereof of at least one peptide of the following general Formula 1 or a composition comprising the at least one peptide and a physiologically acceptable medium: X-(Xaa)nK*TSK*X'aa-(Xaa)m-Z (1).
Ludin et al, throughout the patent, teach peptide compound that increases synthesis of collagen and fibronectin; and a method of enhancing wound healing and/or delaying or treating skin aging, in particular the formation of wrinkles, in a subject in need thereof, wherein the method comprises applying a composition comprising such peptide compound on the skin of the subject, wherein the peptide compound can be Palm-Lys-Thr-Ser-Lys-Ser-OH (identical to the peptide of instant SEQ ID NO: 5), and wherein the composition is in the form of nanocapsules, for example, Abstract; page 2, paragraph [0035]; page 3, paragraph [0059]; page 4, paragraphs [0062]-[0064]; and page 5, Tables 1 and 2. With regards to the term “smoothing epidermis relief” recited in instant claim 37, the instant specification discloses that “smoothing the relief of the skin, in particular epidermal scars such as residual traces of acne lesions (such as atrophic scars)” (see for example, the 1st paragraph on page 4 of instant specification). Therefore, in the broadest reasonable interpretation, treating wrinkles is smoothing epidermis relief recited in instant claim 37. Thus, the method in Ludin et al reads on a composition comprising the peptide Pal-KTSKS formulated as capsules in the form a nano emulsion as the elected species of composition; and skin as the elected species of site of applying the composition. And it meets the limitations of instant claims 36, 37 and 47-55.
The difference between the reference and instant claims 36, 37, 39 and 47-55 is that the reference does not explicitly teach smoothing acne atrophic traces as the elected species of effect and/or condition of the treatment; and the limitation of instant claim 39.
However, Gozali et al, throughout the literature, teach increasing collagen production for treating atrophic acne scar, for example, page 35, left column, the 1st paragraph in Sections “Pyruvic acid” and “Deep peels (phenol)”, and the 2nd paragraph in Section “CROSS technique/dot peeling”; page 36, left column, the 2nd, 3rd and 5th paragraphs; and page 37, Sections “OTHER TISSUE AUGMENTING AGENTS” and “NEEDLING”.
Therefore, it would have been obvious to one of ordinary skilled in the art to combine the teachings of Ludin et al and Gozali et al to develop a method for smoothing acne atrophic traces in a subject in need thereof, wherein the method comprises applying a composition comprising the peptide Palm-Lys-Thr-Ser-Lys-Ser-OH (identical to the peptide of instant SEQ ID NO: 5) on the skin of the subject, and wherein the composition is in the form of nanocapsules. It reads on smoothing acne atrophic traces as the elected species of effect and/or condition of the treatment.
One of ordinary skilled in the art would have been motivated to combine the teachings of Ludin et al and Gozali et al to develop a method for smoothing acne atrophic traces in a subject in need thereof, wherein the method comprises applying a composition comprising the peptide Palm-Lys-Thr-Ser-Lys-Ser-OH (identical to the peptide of instant SEQ ID NO: 5) on the skin of the subject, and wherein the composition is in the form of nanocapsules, because Gozali et al, throughout the literature, teach increasing collagen production for treating atrophic acne scar.
A person of ordinary skilled in the art would have reasonable expectation of success in combining the teachings of Ludin et al and Gozali et al to develop a method for smoothing acne atrophic traces in a subject in need thereof, wherein the method comprises applying a composition comprising the peptide Palm-Lys-Thr-Ser-Lys-Ser-OH (identical to the peptide of instant SEQ ID NO: 5) on the skin of the subject, and wherein the composition is in the form of nanocapsules.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI N KOMATSU whose telephone number is (571)270-3534. The examiner can normally be reached Mon-Fri 8am-4pm EST.
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, Melissa Fisher can be reached on 5712707430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LI N KOMATSU/Primary Examiner, Art Unit 1658