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. Amendment after Non-final office action filed on 6/26/2026 is acknowledged.
3. Claim filed on 6/26/2026 is acknowledged.
4. Claims 1-35, 39 and 52 have been cancelled.
5. Claims 36-38, 40-51 and 53-55 are pending in this application.
6. Claims 37, 38 and 40-46 remain/are withdrawn from consideration as being drawn to non-elected species.
7. Applicant elected 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.
Please note: As stated in the previous office action, 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, in view of Applicant’s amendment to claim 47, 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 (one type of nanoparticle recited in instant claim 47).
Restriction requirement was deemed proper and made FINAL in the previous office action. The instant claims 36-38, 40-51 and 53-55 are drawn to a method of smoothing acne atrophic traces in a subject in need thereof, comprising applying to 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). A search was conducted on the elected species; and prior art was found. Claims 37, 38 and 40-46 remain/are withdrawn from consideration as being drawn to non-elected species. Claims 36, 47-51 and 53-55 are examined on the merits in this office action.
Withdrawn Objections and Rejections
8. Objection to the specification is hereby withdrawn in view of Applicant’s amendment to the specification and Applicant’s filing of updated sequence listing.
9. Objection to claims 37, 39, 48 and 52 is hereby withdrawn in view of Applicant’s amendment to the claim.
10. Rejection to claims 36, 37, 39 and 48-54 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is hereby withdrawn in view of Applicant’s amendment to the claim.
11. Rejection to claims 36, 37 and 47-55 under 35 U.S.C. 102(a)(1) as being anticipated by Ludin et al (US 2005/0065090 A1, filed with IDS) is hereby withdrawn in view of Applicant’s amendment to the claim.
Maintained/Revised Objections
12. (Revised due to Applicant’s amendment to the claim) Claim 36 remains objected to for the following minor informality: Applicant is suggested to amend claim 36 as “A method of smoothing acne atrophic traces in a subject in need thereof, wherein the method comprises applying to…medium: X-(Xaa)nK*TSK*X'aa-(Xaa)m-Z (1), wherein: K* is independently selected from…diaminopropionic acid, or their formyl, acetyl, trifluoroacetyl, methanesulfonyl or succinyl derivatives; Xaa is…I or F…X'aa is selected from threonine or serine…and R1 and R2 are independently selected from alkyl, aryl…wherein the group has no more than 24 carbon atoms, and wherein the group optionally…”.
13. (Revised due to Applicant’s amendment to the claim) Claim 47 remains objected to for the following minor informality: Applicant is suggested to amend claim 47 as "…selected from the group consisting of vectorized form; macro-, micro- or nanoparticles; micro- or nano-emulsions; and adsorbed on powdery…”.
14. (Revised due to Applicant’s amendment to the claim) Claim 50 remains 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”.
15. (Revised due to Applicant’s amendment to the claim) Claim 51 remains objected to for the following minor informality: Applicant is suggested to amend claim 51 as “The method according to claim 36, wherein X is not H and/or Z is not OH”.
16. (Revised due to Applicant’s amendment to the claim) Claim 53 remains objected to for the following minor informality: Applicant is suggested to amend claim 53 as "…wherein R1 and R2 are independently C3-24 alkyl”.
17. (Revised due to Applicant’s amendment to the claim) Claim 54 remains 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…”.
18. (Revised due to Applicant’s amendment to the claim) Claim 55 remains objected to for the following minor informality: Applicant is suggested to amend claim 55 as “The method according to claim 36, wherein the peptide…”.
Response to Applicant's Arguments
19. Applicant either fails to add all the minor issues in these claims or additional minor issues are noticed in the these claims. Therefore, these objections are deemed proper and are hereby maintained.
Maintained/Revised Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (b)
20. 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.
21. Claim 47 remains 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.
22. (Revised due to Applicant’s amendment to the claim) Claim 47 recites the term “vectorized form”. With regards to the term “vectorized form”, the instant specification fails to defined it. It is unclear what is encompassed within the recited “vectorized form”. Therefore, the metes and bounds of instant claim 47 is vague and indefinite.
Response to Applicant's Arguments
23. Applicant argues that “Applicant has amended the identified claims as
suggested by the Examiner.”
24. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant’s arguments about instant rejection, the Examiner would like to point out that there is no amendment suggested by the Examiner. Furthermore, Applicant fails to properly address this rejection. Therefore, the rejection is still deemed proper and is hereby maintained.
Claim Rejections - 35 U.S.C. § 103
25. 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.
26. 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.
27. (Revised due to Applicant’s amendment to the claim) Claims 36, 47-51 and 53-55 remain 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, cited and enclosed in the previous office action).
The instant claim claims 36, 47-51 and 53-55 are drawn to a method of smoothing acne atrophic traces in a subject in need thereof, comprising applying to 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).
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, liposomes, or macro-, micro- or nanoparticles, for example, Abstract; page 2, paragraph [0035]; page 3, paragraph [0059]; page 4, paragraphs [0062]-[0064]; and page 5, Tables 1 and 2. It 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 the peptide and/or composition recited in instant claims 36, 47-51 and 53-55.
The difference between the reference and instant claims 36, 47-51 and 53-55 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 “smoothing acne atrophic traces” recited in instant claim 36.
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 of 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, liposomes, or macro-, micro- or nanoparticles. 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 of 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, liposomes, or macro-, micro- or nanoparticles, 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 of 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, liposomes, or macro-, micro- or nanoparticles.
Response to Applicant's Arguments
28. Applicant argues that a person of ordinary skill in the art would not have been motivated and/or would not have a reasonable expectation of success to combine the teachings of Ludin et al and Gozali et al and develop the method recited in instant claims 36, 47-51 and 53-55 because: All of the techniques in Gozali et al result in a degree of damage/destruction of components of the skin; and the teaching of Ludin et al and/or the disclosure of instant specification instant application is very different from the harsh techniques described in Gozali et al.
29. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant’s arguments that a person of ordinary skill in the art would not have been motivated and/or would not have a reasonable expectation of success to combine the teachings of Ludin et al and Gozali et al and develop the method recited in instant claims 36, 47-51 and 53-55:
The Examiner understands that the treatments/agents discussed in Gozali et al appear to cause various degrees of destruction of components of skin. However, in the instant case, as stated in Section 27 above, Gozali et al explicitly teach increasing collagen production for treating atrophic acne scar. And Ludin et al explicitly teach peptide compound, such as Palm-Lys-Thr-Ser-Lys-Ser-OH (identical to the peptide of instant SEQ ID NO: 5), 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. Therefore, in the instant case, in view of the teachings of Ludin et al as a whole (as explicitly stated in Applicant’s Arguments/Remarks), one of ordinary skilled in the art would understand and reasonably expect that in contrast to the agents/treatments taught in Gozali et al, the peptide compound in Ludin et al would achieve a positive outcome on the skin via increasing synthesis of collagen and fibronectin without the adverse effect of causing various degrees of destruction of components of skin. Thus, in view of the combined teachings of Ludin et al and Gozali et al as set forth in Section 27 above, one of ordinary skilled in the art would have been motivated to and/or a person of ordinary skilled in the art would have reasonable expectation of success to develop the method recited in instant claims 36, 47-51 and 53-55.
Furthermore, with regards to the expectation of success, the MPEP states: “Absolute predictability is not a necessary prerequisite to a case of obviousness. Rather, a degree of predictability that one of ordinary skill would have found to be reasonable is sufficient. The Federal Circuit concluded that “[g]ood science and useful contributions do not necessarily result in patentability.” Id. at 1364, 83 USPQ2d at 1304.” (see MPEP § 2145).
Taken all these together, the rejection is still deemed proper and is hereby maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658
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