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 .
Amendment after Non-final office action filed on January 30, 2026 is acknowledged.
Claims 22-23 have been cancelled.
New claims 36-37 have been added.
Claims 16-21 and 24-37 are pending in this application.
Applicant elected Group 1 (claims 16-21, 24-32 and new claims 36-37) and elected the peptide RFAACAA as the species of the peptide sequence, tocopherol as the species of an antioxidant or a stabilizer, emulsion as the species of a form, urushiol as the species of an allergen and allergic contact dermatitis as the species of an allergic reaction in the reply filed on June 16. 2025. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election had been treated as an election without traverse (MPEP 818.01(a)). Restriction was deemed to be proper and was made FINAL in the previous office action. Claims 33-35 remain withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. The elected species RFAACAA was searched and a prior art was found. The search also yielded prior art on several additional species. Claims 16-21, 24-32 and 36-37 are examined on the merits in this office action.
This application contains claims 18 and 19, drawn to an invention nonelected without traverse in the paper of 1/3/2013. A complete reply to the final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144). See MPEP § 821.01.
Priority
7. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome art rejections because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP 215 and 216.
Withdrawn Objections and Rejection
8. Objection to the drawing is hereby withdrawn in view of Applicant filing replacement sheets on January 30, 2026.
9. Objection to claim 17 is hereby withdrawn in view of Applicant’s amendment to the claims.
10. Rejections of claims 16-32 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are hereby withdrawn in view of Applicant’s amendment to the claims.
11. Rejection of claims 16-23 and 25-32 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph (written description), is hereby withdrawn in view of Applicant’s amendment to the claims.
12. Rejection of claims 16-23 and 25-32 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph (enablement), is hereby withdrawn in view of Applicant’s amendment to the claims.
13. Rejection of claims 16, 20-21, 23 and 25-32 under 35 U.S.C. 102(a)(1) as being anticipated by Manion (US 2005/0239715, cited in the previous office action), is hereby withdrawn in view of Applicant’s amendment to the claims.
14. Rejection of claims 16, 20-23 and 25-32 under 35 U.S.C. 103 as being unpatentable over Etnawati et al (Dermatology Reports, 2019, 11(s1): pp. 4-6, cited in the previous office action) in view of Manion (US 2005/0239715, cited in the previous office action), is hereby withdrawn in view of Applicant’s amendment to the claims.
15. Rejection of claims 16-21, 23 and 25-32 under 35 U.S.C. 103 as being unpatentable over Manion (US 2005/0239715, cited in the previous office action) in view of Sweeney et al (US 2017/0027852, cited in the previous office action), is hereby withdrawn in view of Applicant’s amendment to the claims.
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.
Maintained and Revised Rejections
U.S.C. 103
16. 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.
17. 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.
18. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
19. 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.
20. 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.
21. Claim(s) 16-21, 24-27, 29-32 and 36-37 remain/are rejected under 35 U.S.C. 103 as being unpatentable over Pastorin et al (US 2020/0390670, filed with IDS) in view of Sweeney et al (US 2017/0027852, cited in the previous office action). This rejection is maintained and revised in view of Applicant’s amendment to the claims.
22. Pastorin et al teach the elected peptide sequence RFAACAA (see SEQ ID NO: 1, paragraph [0221]). Peptide preparations were prepared using each peptide (see for example, paragraph [0419]), meeting the limitation of instant claims 16. Pastorin et al teach that “the selection of these additional substances is made by the skilled artisan according to the desired properties of the composition…in each case in the amounts of 0.0001 to 25% by weight, in particular of 0.0005 to 15% by weight based on the total weight of the composition…” (see paragraph [0196]). Additionally, Pastorin et al teach that the compositions may be produced in the form of a lotion, a gel, a spray, an aerosol, or a pump foam (see paragraph [0197], for example). Pastorin et al further teach that compositions may also include other active substances (see for example, paragraph [0195]). In regards to the treatment of allergic contact dermatitis caused by urushiols, the property is inherent to the prior art because a chemical composition and its properties are inseparable (MPEP 2112.01). The MPEP § 2112 states: “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning tending to show inherency, the burden shifts to the Applicant to show an unobvious difference ‘[t]he PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same...[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977)).”
Since the reference teaches ALL of the active components of instant claims, i.e., the same peptide (RFAACAA), in a preparation form (i.e., a gel or a spray) at the % weight (i.e., 0.01% to 10% by weight), the reference anticipates instant claims.
The difference between the reference and instant claims is that the refence does not teach antioxidant (vitamin E) and the preparation has a pH of 4 to 7.
23. However, Sweeney et al teach a topical skin care composition comprising combination of stabilized antioxidants, oat derived avenanthramide and biofunctional peptides (see abstract, for example). Sweeney et al teach tocopherol complex present in an amount ranging from 0.05% to 3% by weight of the topical skin care composition…(see paragraph [0032], for example). Sweeney et al further teach that the biofunctional peptides are present in the amount of 0.05% by weight to 1.0% by weight (see claim 6, for example).
24. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Pastorin et al and Sweeney et al since both teach topical cosmetic composition comprising biofunctional peptides. One of ordinary skill in the art would be motivated to combine the teachings with a reasonable expectation of success, since Sweeney et al teach a topical day cream composition that comprises biofunctional peptide and antioxidant (vitamin E) at pH 4.95-5.25, and the biofunctional peptides are present in the amount of 0.05% by weight to 1.0% by weight. One of ordinary skill in the art would be motivated to optimize the concentrations and the pH 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 of percentages.”. The MPEP states the following: 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).
Therefore, the combined art is prima facie obvious over instant claims 16-21, 24-27, 29-32 and 36-37.
Response to Applicant’s Arguments
25. Applicant argues “
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26. Applicant’s arguments have been fully considered but are not found persuasive. Pastorin et al explicitly teach the elected species, RFAACAA (see SEQ ID NO: 1). Therefore, the peptide preparation of a composition comprising the Ac-RFAACAA is anticipated. As indicated in the rejection above, the inherent property of the peptide must be the same since the same peptide is present in a solution form that can be applied to the skin. “Products of identical chemical composition cannot have mutually exclusive properties.” In re spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. “The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.”) (see MPEP 2112.01 II). Therefore, since Pastorin et al teach the chemical composition comprising the peptide Ac-RFAACAA, and since the chemical composition and its properties are inseparable, the peptide composition comprising Ac-RFAACAA would inherently have all of the activities and functionalities of instant preparation comprising the same peptide of instant claims.
Pastorin explicitly teaches preparation with each peptide. Sweeney et al explicitly teach a topical skin care composition containing combination of stabilized antioxidants, oat derived avenanthramide and biofunctional peptides and tocopherol complex present in an amount ranging from 0.05% to 3.0% by weight of the topical skin care composition. Sweeney et al teach that the source of vitamin E is a palm tocotrienol/tocopherol complex. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Pastorin et al and Sweeney et al since both teach topical cosmetic composition comprising biofunctional peptides. One of ordinary skill in the art would be motivated to combine the teachings with a reasonable expectation of success, since Sweeney et al teach a topical day cream composition that comprises biofunctional peptide and antioxidant (vitamin E) at pH 4.95-5.25, and the biofunctional peptides are present in the amount of 0.05% by weight to 1.0% by weight. One of ordinary skill in the art would be motivated to optimize the concentrations and the pH 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.”. The peptide of instant SEQ ID NO: 2 in Pastorin et al in a preparation would have all the same activity and functionality of instant claims. Thus, the combination of arts is obvious over instant claims 16-21, 24-27, 29-32 and 36-37.
DOUBLE PATENTING
27. 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.
28. Claims 16-21, 24-32 and 36-37 are/remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26, 29-38 and 42-47 of copending Application No. 17/759634 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims and vice versa.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
29. Instant claims are drawn to:
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30. Copending claims are drawn to:
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31. The scope of instant claims are similar with the copending claims. The preparation recited in both applications involve the same peptide sequences GSH, HHHHHH, Ac-RFAACAA, Ac-RFAALAA, RFAALAA, RFAACAA, Ac-RAACAA, RAACAA, Ac-RFACAA, RFACAA, Ac-RFACA and RFACA. Therefore, if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims, and vice versa.
32. Claims 16-21, 24-32 and 36-37 remain/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 36-55 of copending Application No. 17/759636 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims and vice versa.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
33. Instant claims are drawn to:
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34. Copending claims are drawn to:
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35. The scope of instant claims are similar with the copending claims. The peptide and the preparation recited in both applications involve the same sequences GSH, HHHHHH, Ac-RFAACAA, Ac-RFAALAA, RFAALAA, RFAACAA, Ac-RAACAA, RAACAA, Ac-RFACAA, RFACAA, Ac-RFACA and RFACA. Instant claims do not require that the peptide preparation is effective in the treatment of allergic contact dermatitis caused by urushiols. However, this property is inherent to the reference claims because chemical composition and its properties are inseparable (MPEP 2112.01). The scope of instant claims are similar to copendintg claims. Therefore, if one of ordinary skilled in the art practiced instant claims, one would necessarily achieve the claimed invention of copending claims and vice versa.
Therefore, if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims, and vice versa.
Response to Applicant’s Arguments
36. Applicant argues that “Applicant respectfully request that these provisional rejections by held in abeyance until an agreement of allowable claims has been reached in this and the co-pending applications. Applicants will then decide whether the filing of terminal disclaimers is warranted.”
37. Applicant’s arguments have been fully considered but art not found persuasive. While a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP 714.02). Until a proper Terminal Disclaimer is filed and approved by the Office, the rejection is maintained.
New Rejections
35 U.S.C. 112(a)
New Matter Rejection
38. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
39. Claims 16-21, 24-32 and 36-37 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a preparation, wherein the preparation is topically applicable and comprises one or more peptides selected from GSH (Gly-Ser-His), HHHHHH (SEQ ID NO: 1)…(ii) has a pH from 4 to 7. The claims in question recite a “GSH (Gly-Ser-His)”.
Lack of Ipsis Verbis Support
40. The specification is void of any literal support for the “GSH (Gly-Ser-His)” peptide claimed. In the context of substrate, the word “(Gly-Ser-His)” is not present anywhere in the specification. The words “Gly-Ser-His” was searched in the context of “GSH” peptide, however, this tripeptide Gly-Ser-His was not found in the specification. The specification has the following in regards to GSH: “…the peptide glutathione (GSH) or γ-L-glutamyl-L-cysteinylglycine are also for example preferred peptides having a reactive side chain. γ-L-Glutamyl-L-cysteinylglycine is a tripeptide having the sequence glutamic acid-cysteine-glycine (Glu-Cys-Gly) (see paragraph [0082], for example); Glutathione (GSH), also known as γ-L-glutamyl-L-cysteinylglycine, is a tripeptide having the sequence glutamic acid-cysteine-glycine (see paragraph [0097]).
Lack of Implicit or Inherent Support
41. “While there is not in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure.” See MPEP 2163. Thus support can be furnished implicitly or inherently for a specifically claimed limitation. However, the specification lacks any implicit or inherent support for the claimed “Gly-Ser-His” peptide. As explained above, there is no support for any concept of “Gly-Ser-His” peptide in the specification.
35 U.S.C. 103
42. 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.
43. 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.
44. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
45. 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.
46. 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.
47. Claim(s) 16-21, 24-32 and 36-37 remain/are rejected under 35 U.S.C. 103 as being unpatentable over Pastorin et al (US 2020/0390670, filed with IDS) in view of Sweeney et al (US 2017/0027852, cited in the previous office action) and Kim et al (US 2021/0236406).
48. The teachings of Pastorin et al in view of Sweeney et al are described above. The difference between the references and instant claim is that the references do not teach that the formulation is in emulsion.
49. However, Kim et al teach a cosmetic or pharmaceutical composition may specifically be a formulation for external application to the skin, and the formulation for external application to the skin may include any one selected from the group consisting of solution, suspension, emulsion, paste, gel, cream, lotion, powder, soap…(see paragraph [0054]). Furthermore, Kim et al teach peptides containing 2 to 8 amino acids and the cysteine peptide sequence RFAACAA (see paragraph [0048]).
50. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Pastorin et al, Sweeney et al, and Kim et al, since all references teach cosmetic composition comprising peptides. One of ordinary skill in the art would be motivated to combine the teachings with a reasonable expectation of success, since Sweeney et al teach a topical day cream composition that comprises biofunctional peptide and antioxidant (vitamin E) at pH 4.95-5.25, and the biofunctional peptides are present in the amount of 0.05% by weight to 1.0% by weight, and Kim et al teach that the cosmetic formulation for external application can be in many different formulations, including gels and emulsion. One of ordinary skill in the art would be motivated to optimize the concentrations and the pH 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 of percentages.”. The MPEP states the following: 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).
Therefore, the combined art is prima facie obvious over instant claims 16-21, 24-32 and 36-37.
EXAMINER’S COMMENTS
51. Claim 16 has been amended to recite that the peptide GSH is Gly-Ser-His. Therefore, the art rejections teachings cosmetic composition for topical application comprising glutathione, also known as GSH, have been withdrawn. If Applicant amends the claims to revert back to the recitation where GSH is glutathione, those rejections may be reinstated.
CONCLUSION
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm EST.
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/JULIE HA/Primary Examiner, Art Unit 1654
3/5/2026