Notice of Pre-AIA or AIA Status
In view of the appeal brief filed on November 26, 2025 PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant filed an appeal brief on November 26, 2025.
An appeal conference was held on January 21, 2026.
After an appeal conference, the final office action is withdrawn and a second non-final office action is set forth herein.
Claims 22-25 and 27-28 have been cancelled in the amendment filed on April 3, 2025.
New claims 42-47 have been added in the amendment filed on April 3, 2025.
Claims 26 and 29-47 are pending in this application.
Applicant elected Group 1 (claims 22-38) and elected Ac-RFAACAA as the species of the peptide sequence, thiol as the species of reactive group, histidine as the species of amino acid, emulsion as the species of type of preparation, and vitamin E as the species of antioxidant or stabilizer in the reply filed on November 15, 2024. 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 (see MPEP 818.01(a)). Restriction was deemed to be proper and was made FINAL in the previous office action. Claims 39-41 remain withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected invention, there being no allowable generic or linking claim.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 26, 29-38 and 42-47 are examined on the merits in this office action.
Withdrawn Objections and Rejections
9. Objection to the specification is hereby withdrawn in view of Applicant’s amendment to the specification.
10. Objection to the drawing is hereby withdrawn in view of Applicant filing replacement sheets on April 3, 2025.
11. Objection to the specification is hereby withdrawn in view of Applicant’s amendment to the specification.
12. Objection to claims 25 and 29 is hereby withdrawn in view of Applicant’s amendment to the claims.
13. Rejection of claims 22-24, 26-28 and 30-38 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is hereby withdrawn in view of Applicant’s amendment to the claims.
14. Rejection of claims 22-24, 26-28 and 30-38 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is hereby withdrawn in view of Applicant’s amendment to the claims. However, a new rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph (written description), is set forth below.
15. Rejection of claims 22-24, 26-28 and 30-38 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.
16. Rejection of claims 22-25 under 35 U.S.C. 102(a)(1) as being anticipated by Williams (US 2002/0012658, cited in the previous office action), is hereby withdrawn in view of Applicant’s cancellation of claims 22-25.
17. Rejection of claim(s) 22-30 and 32-38 under 35 U.S.C. 103 as being unpatentable over Groux et al (US Patent No. 8703431, 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 persuasive arguments.
Maintained and Revised Rejections
U.S.C. 102
18. 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.
19. 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)(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.
20. Claim(s) 26, 29, 36-38 and 42-44 remain/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Groux et al (US Patent No. 8703431, cited in the previous office action). This rejection is maintained but revised in view of Applicant’s amendment to the claims.
21. Groux et al teach the peptide of elected species, instant SEQ ID NO: 2 (see SEQ ID NO: 19). Groux et al teach SEQ ID NO: 19 (Ac-RFAACAA-NH2) in 100 mM Tris-HCl at pH 8.3 (see Example 2, column 12, lines 37-45, for example). Groux et al teach that “said test compound is able to form part of the composition of a dermatological or cosmetic composition” (see column 8, lines 35-36), meeting the limitation of instant claims 26 and 29. In regards to instant claims 26, 36-38 and 42-44, the claims recite an inherent property or an intended use. The recitation of “…(i) prevents or reduces a penetration and/or…(ii) prevents or reduces a penetration and/or accumulation…(iii) prevents or reduces allergic reactions in or on the skin” of claim 26, “…prevents allergies of Type I and/or Type 4” of claim 42, “…effective against chemical allergens” of claim 43, and “…effective against chemically electronegative allergens” of claim 44, these are inherent properties of the peptide preparation. 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)).”
Please note that it is regarded that "intended use" of a composition or product will not further limit claims drawn to a composition or product. See, e.g., Ex parte Masham, 2 USPQ2d 1647 (1987) and In Re Hack 114, USPQ 161. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitation.
Since the reference teaches ALL of the active components of instant claims, i.e., the same peptide (Ac-RFAACAA-NH2), in a preparation form (i.e., Tris-HCl at pH 8.3), the reference anticipates instant claims 26, 29, 36-38 and 42-44.
Response to Applicant’s Arguments
22. Applicant argues that, “…GROUX does not relate to any preparation which when applied to skin (1) prevents or reduces a penetration and/or accumulation of foreign substances and/or allergens on skin and/or in skin and/or (ii) prevents and/or (iii) prevents or reduces allergic reactions in or on the skin.” Applicant argues that “The polypeptide specifically relied upon by the Examiner, i.e., the peptide with SEQ ID NO: 19, is employed in Example 2 of GROUX merely as a positive control to gauge the effectiveness of the polypeptide disclosed in GROUX for the in vitro assessment of the sensitizing potential of a test compound of interest. The solution used for this purpose contained, in addition to a polypeptide to GROUX and the positive control instead of a test compound, inter alia, acetonitrile (see Example 1 of GROUX)…” Applicant further argues that “It further is pointed out that the “test compound” mentioned in column 8, lines 35-36 of GROUX specifically relied upon by the Examiner is a compound whose sensitizing potential…is to be determined by the method disclosed in GROUX with the aid of the polypeptide according to GROUX…” Applicant argues that “…Example 2, thereof, does not disclose any preparation which is suitable for topical application to skin in the context of a cosmetic composition. While it may be possible to apply the solution used in Example 2 or GROUX to human skin, this solution cannot reasonably be considered to be suitable for topical application to skin and have any of the positive effects recited in the instant claims without also having a harmful and potentially lethal effect caused by the acetonitrile contained there…”
23. Applicant’s arguments have been fully considered but are not found persuasive.
Groux et al teach the same peptide of instant claims in solution. Although Groux et al teach the SEQ ID NO: 19 in TRIS-HCl, pH 8.3, as a positive control, the fact that the same peptide is in solution would inherently have the same activity and functionality as instant SEQ ID NO: 2 in solution. 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 Groux 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.
In regards to acetonitrile in the Applicant’s arguments, the Example 2 that the Examiner has referred to has no acetonitrile in the solution. In Example 2, the peptide of SEQ ID NO: 19 (the same peptide as the elected species) is in 100 mM Tris-HCl, pH 8.3. The acetonitrile Applicant is referring to is in Example 1. Groux et al further teach that the “test compound is able to be applied to the skin…the sensitizing potential corresponds to the risk of developing a skin allergy” (see column 8, lines 32-34). Additionally, Groux et al teach that “said candidate compound is able to be used on the skin and may be used in a cosmetic or dermatological composition” (see column 10, lines 25-27). Therefore, whether it is a “test compound” or a “positive control compound” the compounds are “suitable for topical application”. Thus, the peptide SEQ ID NO: 19 of Groux et al in 100 mM Tris-HCL, at pH 8.3 is in a preparation and will inherently have the same function and activity as instant peptide Ac-RFAACAA.
Therefore, it is deemed that the rejection is proper and is revised and maintained herein. Groux et al anticipates instant claims 26, 29, 36-38 and 42-44.
24. Claims 26, 29-31, 36-38, 42-44 and 47 remain/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pastorin et al (US 2020/0390670, cited in the previous office action), as evidenced by Morikis et al (US 2018/0057538). This rejection is maintained but revised in view of Applicant’s amendment to the claims.
25. Pastorin et al teach the elected peptide sequence Ac-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 26, 29, 36-38 and 42-44. Pastorin et al teach that the final concentration of lysine peptide was 20 mM in a final reaction volume of 0.3 ml…cysteine-based synthetic peptide was determined in 100 mM sodium phosphate buffer o pH 7.5…the final concentration of cysteine peptide was 20 mM in a final reaction volume of 0.3 ml (see paragraph [0418]). 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), meeting the limitation of instant claims 30-31. In regards to instant claims 26, 36-38 and 42-44, the claims recite an inherent property or an intended use. The recitation of “…(i) prevents or reduces a penetration and/or…(ii) prevents or reduces a penetration and/or accumulation…(iii) prevents or reduces allergic reactions in or on the skin” of claim 26, “…prevents allergies of Type I and/or Type 4” of claim 42, “…effective against chemical allergens” of claim 43, and “…effective against chemically electronegative allergens” of claim 44, these are inherent properties of the peptide preparation. 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)).” Pastorin et al further teach that compositions may also include other active substances…PEG-3 distearate…(see for example, paragraph [0195]). And as evidenced by Morikis et al, PEG is a small linear polyethylene glycol polymer that acts as a solubilizer for the peptide (see for example, claim 1).
Please note that it is regarded that "intended use" of a composition or product will not further limit claims drawn to a composition or product. See, e.g., Ex parte Masham, 2 USPQ2d 1647 (1987) and In Re Hack 114, USPQ 161. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitation.
Since the reference teaches ALL of the active components of instant claims, i.e., the same peptide (Ac-RFAACAA-NH2), 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 26, 29-31, 36-38, 42-44 and 47.
Response to Applicant’s Arguments
26. Applicant argues that “…even if one were to assume that in paragraphs [0418] and [0419] thereof PASTRORIN discloses 0.3 ml of an aqueous stock solution comprising 20 mM of the instantly elected peptide in 100 mM phosphate buffer at pH 7.5 for use in the Direct Peptide Reactivity Assay mentioned in paragraphs [0418] and [0419] of PASTORIN, it is not seen that this stock solution, if it were applied to skin…would not necessarily (i) prevent or reduce a penetration and/or accumulation of foreign substances and/or allergens on skin and/or in skin and/or (ii) prevent or reduce a penetration and/or accumulation of contact allergens on the skin and/or in the skin and/or (iii) prevent or reduce allergic reactions in or on the skin, nor has the Examiner provided any evidence in this regard.” Applicant argues that “…the Examiner is reminded that matter is “inherent” if the extrinsic evidence makes it clear that the matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill. Titanium Metals Corp. v. Banner, 778 F.2d 775 (Fed. Cir. 1985)…Inherency, however, cannot arise from probabilities or possibilities…” Applicant further argues that “…it is submitted that one of ordinary skill in the art is aware that the beneficial effect of an active ingredient in a cosmetic (or dermatological) composition also depends on the presence and concentration of the other constituents of the composition.”
27. Applicant’s arguments have been fully considered but are not found persuasive. Pastorin et al explicitly teach the elected peptide species, Ac-RFAACAA (see SEQ ID NO: 1). Pastorin et al explicitly teach that peptide preparations were prepared using each peptide. 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.
Furthermore, in regards to the % concentration by weight of the one or more peptides in the preparation, instant claim 30 depends from claim 26. Claim 26 does not recite a specific % concentration of the one or more peptides. Because claim 30 depends from claim 26, the preparation of Pastorin would necessarily have a composition that has overlapping concentration range by inference. Because claim 30 depends from claim 26, and claim 26 would encompass “any % concentration of peptide(s)”, the range of the selection of these additional substances…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…” taught by Pastorin is encompassed within the range and is overlapping instant claim 30 (from 0.01% to 10%by weight). For instant claim 30 to be further limiting instant claim 26, the range disclosed in Pastorin must also encompass the range recited in claim 30, thus, claim 26. Applicant has not established the criticality of instant claim 30.
Furthermore, the additional compound, for example, Deferoxamine mesylate (see paragraph [0221] of Pastorin) can be used in topical formulation. As evidenced by Berry et al (J. Cell. Mol. Med., 2024, pp. 1-15), deferoxamine can be added for topical administration (see TITLE and abstract).
Therefore, it is deemed that the rejection is proper and is revised and maintained herein.
35 U.S.C. 103
28. 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.
29. 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.
30. 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.
31. 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.
32. Claim(s) 26, 29-38, 42-44 and 47 remain/are rejected under 35 U.S.C. 103 as being unpatentable over Pastorin et al (US 2020/0390670, cited in the previous office action), as evidenced by Morikis et al (US 2018/0057538) in view of Sweeney et al (US 2017/0027852, cited in the previous office action). This rejection is maintained but revised in view of Applicant’s amendment to the claims.
33. Pastorin et al teach the elected peptide sequence Ac-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 26, 29, 36-38 and 42-44. Pastorin et al teach that the final concentration of lysine peptide was 20 mM in a final reaction volume of 0.3 ml…cysteine-based synthetic peptide was determined in 100 mM sodium phosphate buffer o pH 7.5…the final concentration of cysteine peptide was 20 mM in a final reaction volume of 0.3 ml (see paragraph [0418]). 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), meeting the limitation of instant claims 30-31. In regards to instant claims 26, 36-38 and 42-44, the claims recite an inherent property or an intended use. The recitation of “…(i) prevents or reduces a penetration and/or…(ii) prevents or reduces a penetration and/or accumulation…(iii) prevents or reduces allergic reactions in or on the skin” of claim 26, “…prevents allergies of Type I and/or Type 4” of claim 42, “…effective against chemical allergens” of claim 43, and “…effective against chemically electronegative allergens” of claim 44, these are inherent properties of the peptide preparation. 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)).” Pastorin et al further teach that compositions may also include other active substances…PEG-3 distearate…(see for example, paragraph [0195]). And as evidenced by Morikis et al, PEG is a small linear polyethylene glycol polymer that acts as a solubilizer for the peptide (see for example, claim 1).
Please note that it is regarded that "intended use" of a composition or product will not further limit claims drawn to a composition or product. See, e.g., Ex parte Masham, 2 USPQ2d 1647 (1987) and In Re Hack 114, USPQ 161. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitation.
Since the reference teaches ALL of the active components of instant claims, i.e., the same peptide (Ac-RFAACAA-NH2), 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 26, 29-31, 36-38, 42-44 and 47.
The difference between the reference and instant claims is that the reference does not teach antioxidant (vitamin E) and the preparation has a pH of less than 7.
34. However, Sweeney et al teach a topical skin care composition containing 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 3.0% by weight of the topical skin care composition…(see paragraph [0032], for example). Sweeney et al teach that the source of vitamin E is a palm tocotrienol/tocopherol complex (see claim 2). Sweeney et al further teach that the topical day cream, the pH at 25 degrees centigrade was between 4.95-5.25 (see for example, paragraph [0057] and [0060]). 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).
35. 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 MPEP states that 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 26, 29-38, 42-44 and 47.
Response to Applicant’s Arguments
36. Applicant argues that, “This rejection is respectfully traversed as well, for at least the reason that the rejection is based on the incorrect assessment (see above) that PASTORIN anticipates the subject matter of independent claim 26…SWEENEY fails to cure the noted deficiencies of PASTORIN…nor has the Examiner made any allegations to the contrary in this regard.” Applicant further argues that, “Further and merely by way of example, the fact that the instantly elected peptide is present in a stock solution for use in the Direct Peptide Reactivity Assay mentioned in paragraphs [0418] and [01419] of PASTORIN clearly does not motivate one or ordinary skill in the art to consult SWEENEY in this regard, let alone to add, vitamin E to the stock solution and/or to keep the pH of the stock solution below 7, as there is no apparent advantage of adding vitamin E to the stock solution of PASTORIN…”
37. Applicant’s arguments have been fully considered but are not found persuasive. Pastorin et al explicitly teach the elected peptide species, Ac-RFAACAA (see SEQ ID NO: 1). Pastorin et al explicitly teach that peptide preparations were prepared using each peptide. 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 26, 29-38, 42-44 and 47.
DOUBLE PATENTING
38. 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.
39. Claim 26, 29-38 and 42-47 remain/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-32 of copending Application No. 17759635 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because if one of ordinary skilled 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.
40. Instant claims are drawn to:
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41. Copending claims are drawn to:
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42. 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.
43. Claims 26, 29-38 and 42-47 remain/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-31 of copending Application No. 17759636 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because if one of ordinary skilled 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.
44. Instant claims are drawn to:
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45. Copending claims are drawn to:
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46. 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. 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
47. Applicant argues that “this rejection is not presented for review. Applicants will then decide whether the filing of one or two terminal disclaimers is warranted.”
48. Applicant’s arguments have been fully considered but are 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 rejections are maintained.
New Rejections
U.S.C. 112(b)
49. 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.
50. Claims 26, 29-38 and 42-47 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.
51. Claim 26 recites, “A preparation, wherein the preparation is suitable for topical application to skin and comprises one or more peptides selected from GSH…in a concentration such that when the preparation is applied to skin…” It is unclear what is encompassed within the term “suitable for topical application”. The specification has not defined what is encompassed within the term “suitable for topical application.” The specification has not defined what is encompassed within “suitable for topical application”, “peptide in a concentration such that when the preparation is applied to the skin” that would have the function of “prevents or reduces a penetration…prevents or reduces a penetration and/or accumulation…prevents or reduces allergic reaction…” Because claims 29-38 and 42-47 depend from indefinite claim 26 without clarifying the point of confusion, claims 29-38 and 42-47 are also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
52. Claim 26 recites, “A preparation…comprises one or more peptides selected from GSH…” The term “GSH” is amenable to two plausible constructions: 1) glutathione, and 2) the tripeptide Gly-Ser-His. It is unclear if GSH is referring to a peptide glutathione or a tripeptide. The specification discloses the following: “…the peptide glutathione (GSH)” and “a tripeptide having the sequence glutamic acid-cysteine-glycine (Glu-Cys-Gly)” (see paragraph [0079]). The specification further discloses “Glutathione (GSH)…is a tripeptide” (see paragraph [0095]). Therefore, the acronym “GSH” is used with two different meanings in the specification. Therefore, the metes and bounds of the claim is unclear. Because claims 29-38 and 42-47 depend from indefinite claim 26 without clarifying the point of confusion, claims 29-38 and 42-47 are also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Response to Applicant’s Arguments
53. Applicant argues that, “It is submitted that the instant claims are directed to one of ordinary skill in the art. (Not only) one of ordinary skill in the art will have no difficulty in assessing whether or not a (peptide containing) composition is suitable for topical application to skin…one of ordinary skill in the art will understand that a composition is suitable for topical application to skin if it does not cause any adverse reactions on skin (e.g., due to a pH that causes skin irritation) and is not toxic to the human body…”
54. Applicant’s arguments have been fully considered but are not found persuasive. The Examiner agrees that the composition for topical application to skin does not cause any adverse reactions on skin and is not toxic to the human body. However, a preparation that is in water and any buffer can be “suitable for topical application”. However, for example, the buffer content, the pH and salt, etc., may have different effect on different patient population. Additionally, the claim recites that the “preparation suitable for topical application to skin and comprises one or more peptides…in a concentration such that when the preparation is applied to the skin” must have the following conditions: (i) prevents or reduces a penetration and/or accumulation of foreign substances and/or allergens on skin and/or in skin and/or (ii) prevents or reduces a penetration and/or accumulation of contact allergens on the skin and/or in the skin and/or (iii) prevents or reduces allergic reactions in or on the skin. Therefore, the metes and bounds of the claim is unclear as to what is encompassed within “a preparation suitable for topical application”, “in a concentration such that when the preparation is applied”, and has the same function as recited in claim 26(i)-(iii).
U.S.C. 112(a)
55. 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.
56. Claims 26, 29, 31-38 and 42-47 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 courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP 2163.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co., the court stated:
“A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials. Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus. . . ."). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gostelli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d at 1012, 10 USPQ2d at 1618.
In the instant case, the claims are drawn to a preparation, wherein the preparation is suitable for topical application to skin and comprises one or more peptides selected from GSH, HHHHHH (SEQ ID NO: 1), Ac-RFAACAA (SEQ ID NO: 2), Ac-RFAALAA (SEQ ID NO: 3)…in a concentration such that when the preparation is applied to skin, the preparation (i) prevents or reduces a penetration and/or accumulation of foreign substances and/or allergens on skin and/or in skin and/or (ii) prevents or reduces a penetration and/or accumulation of contact allergens on the skin and/or in the skin and/or (iii) prevents or reduces allergic reactions in or on the skin. The generic statements in a concentration such that when the preparation is applied to skin, the preparation (i) prevents or reduces a penetration and/or accumulation of foreign substances and/or allergens on skin and/or in skin and/or (ii) prevents or reduces a penetration and/or accumulation of contact allergens on the skin and/or in the skin and/or (iii) prevents or reduces allergic reactions in or on the skin do not provide ample written description for the compounds since the claims do not describe a single structural feature. The specification does not clearly define or provide examples of what qualify as a concentration that would have the same function as recited in (i)-(iii) of the claimed invention.
As stated earlier, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable claim 26 is broad generics with respect all possible concentrations encompassed by the claims. The possible concentration variations are limitless to any different peptides and different concentration that will have the same function as recited in claim 26 (i)-(iii). It must not be forgotten that the MPEP states that if a peptide is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. Here, though the claims may recite some functional characteristics, the claims lack written description because there is no disclosure of a correlation between function and structure of the compounds beyond compounds and concentrations disclosed in the examples in the specification. Moreover, the specification lack sufficient variety of species to reflect this variance in the genus since the specification does not provide examples of all peptides recited in the independent claim 26.
Instant claims recite twelve (12) peptides. The specification discloses that the peptide concentrations were varied in the range of 4, 2, 0.5 and 0.25 mM (see paragraph [0173] of instant specification). The specification further discloses that the sequence HHHHHH (SEQ ID NO: 1) achieved a barrier effect against metals and against nickel in particular (see paragraph [0175]). The specification discloses 0.5 mM AcRFAACAA (see paragraph [0120], FIG. 2). The specification is limited to the peptides HHHHHH (SEQ ID NO: 1) and Ac-RFAACAA (SEQ ID NO: 2), and tested at 0.5 mM. The specification does not describe any other peptides and any other peptide concentrations in the preparation that would function to (i) prevents or reduces a penetration and/or accumulation of foreign substances and/or allergens on skin and/or in skin and/or (ii) prevents or reduces a penetration and/or accumulation of contact allergens on the skin and/or in the skin and/or (iii) prevents or reduces allergic reactions in or on the skin. Description of HHHHHH (SEQ ID NO: 1) and Ac-RFAACAA (SEQ ID NO: 2) at 0.5 mM peptide concentration is not sufficient to encompass numerous other peptides and different concentrations that belong to the same genus. For example, Pastorin et al (US 2020/0390670, cited in the previous office action) teach two peptides, e.g., cysteine peptide (Ac-RFACAA-COOH) and lysine peptide (RFAAKAA-COOH) (see paragraph [0221]). Pastorin et al teach that the final concentration of lysine peptide (Ac-RFALAA) was 20 mM in a final reaction volume of 0.3 ml; the cysteine peptide (Ac-RFACAA) was 20 mM in a final reaction volume of 0.3 ml (see paragraph [0418]). Table 19 of Pastorin et al describe the compound preparation of cysteine and lysine based peptides at 20 mM concentration. Pastorin et al teach that different peptides had different skin protection effects (see for example, paragraphs [0412], [0423]-[0426]).
Therefore, there is not sufficient amount of examples provided to encompass the numerous characteristics of the whole genus claimed.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
U.S.C. 103
57. 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.
58. 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.
59. 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.
60. 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.
61. 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.
62. Claim(s) 26, 29-38, 42-45 and 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pastorin et al (US 2020/0390670, cited in the previous office action) in view of Sweeney et al (US 2017/0027852, cited in the previous office action), as evidenced by Morikis et al (US 2018/0057538), as applied to claims 26, 29-38 and 42-44 and 47 above, further in view of Wei et al (US 2002/0004485).
63. The rejection of claims 26, 29-38, 42-44 and 47 are described above. The difference between the references and instant claim is that the references do not teach an emulsion.
64. However, peptides in an emulsion are well known in the art. For example, Wei et al teach peptide antagonists in a emulsion adapted to enhance bioavailability (see for example, claim 2).
65. 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 Wei et al, since Pastorin et al and Sweeney et al both teach topical cosmetic composition comprising biofunctional peptides. And Wei et al teach peptide in emulsion. 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. Therefore, 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 Wei et al teach that emulsion can be adapted to enhance bioavailability. Additionally, 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 MPEP states that 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, combined art is prima facie obvious over instant claims 26, 29-38, 42-45 and 47.
Response to Applicant’s Arguments
66. Applicant did not respond to this rejection.
67. As indicated in the rejection above, it is deemed that combined art is prima facie obvious over instant claims 26, 29-38, 42-45 and 47.
CONCLUSION
No claim is allowed.
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
1/28/2026