DETAILED ACTION
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 .
Status of Claims
Amendment filed on 11/11/2025 is acknowledged.
Claims 5-7 and 9-15 are cancelled. Claims 1-3 are amended.
Claims 1-4 and 8 are pending and being examined on merits herein.
Priority
This instant application 18330750, filed on 06/07/2023, does not claim benefit of priority.
Withdrawn Objections/Rejections
All previous claim Objection(s) / Rejection(s) as set forth in the previous Office action (mailed 08/11/2025) that are not repeated and/or maintained in the instant Office action are withdrawn, in light of applicant’s amendment and remark filed on 11/11/2025.
Claim Interpretation
Claims 1-4 are interpreted as following.
Claim 1 is interpreted as a composition comprising about 0.8% of a hydroxy pyridone, from about 0.005% to about 0.1% niacinamide, and from about 0.005% to about 0.2% panthenol, wherein the weight amount is based on total weight of the composition.
The phrases “personal care” and “wherein there is a synergistic antioxidant activity” are interpreted as properties and “intended use” and inherent property of the composition, because they do not contribute to the structural limitations of the composition.
The term "about" is interpreted as having its ordinary and customary meaning to a POSITA as "approximately" (see MPEP 2111.01 IV A), i.e. in general, within a range of plus or minus 10%. Thus, “about 0.8% “ results in range of 0.72% to 0.88%, “about 0.005% to about 0.1%” results in range of 0.0045% to 0.11%, and “about 0.005% to about 0.2%” results in range of 0.0045% to 0.22%, respectively.
Similarly, Claims 2-3 are interpreted as a composition comprising specific ingredients at specific percentage weight amount defined by exact value of percentage in the claims, or defined by the range resulted from the term of “about”. The phrases of “personal care” and “wherein there is synergistic antioxidant activity” are interpreted as properties and “intended use” of the composition.
Claim 4 is interpreted as the property or “intended use” of the composition according to claim 1, because “selected from group consisting of a shampoo, conditioner, leave-on, tonic and mixtures thereof” does not provide structural contribution to the composition.
New Rejections
The following are new claim rejections necessitated by amendments.
Claim Rejections - 35 USC § 103
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.
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.
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.
Claims 1-4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Lane (US20200214953, 07/09/2020, IDS of 02/13/2024).
Lane throughout the reference directs to a scalp care composition comprising an aqueous carrier, a nonionic water-soluble cross-linked N-vinyl lactam homopolymer and zinc salt (e.g., Abstract).
Regarding instant claims 1-3 and 8, Lane teaches suitable scalp health agents such as hydroxy pyridines, octopirox (piroctone olamine) [0051-0052], vitamin B3 compounds such as niacinamide [0028], panthenol compounds [0029]. Lane exemplifies the hair care composition comprising piroctone olamine (corresponding to instant claim 8) at 0.45% in Examples 1-2, niacinamide at 0.10% in Examples 1-4, panthenol at 0.10% in Examples 1-4 [0097] and Lane indicates that values disclosed are not to be understood as being strictly limited to the exact numerical values recited. Instead, unless otherwise specified, both the recited value and a functionally equivalent range surrounding that value are implied [0098].
In light of claim interpretation, as term “about” conveys a plus or minus 10% from the about value, hydroxy pyridone amount range about 0.8% of instant claim 1 results in 0.72% to 0.88% as interpreted, from about 0.5% to about 0.8% of instant claim 3 results in from 0.45% to 0.88% as interpreted, and at 0.5% as recited in instant claim 2, respectively. The amount 0.45% of piroctone olamine in Lane’s examples 1-2 as discussed above represents the exact amount of lower point from 0.45% to 0.88% range as in instant claim 3, very close to the amount (0.45/0.5 = 90%) in instant claim 2.
In addition, Lane teaches Piroctone olamine can be added as anti-microbial actives for the scalp treating composition (e.g. [0058]), and the reference further teaches anti-microbial actives can be added in various amount, for example, from about 0.01% to 10% (e.g., [0066]; Claim 8); from about 0.1% to 9%; from about 0.25% to 8%; from 0.5% to 6% (e.g. [0066]), overlapping with range of hydroxy pyridone 0.72% to 0.88% as interpreted amount in instant claim 1, or 0.45% to 0.55% as interpreted in instant claim 2, 0.45% to 0.88% in instant claim 3.
Similarly, niacinamide amount at 0.10% in Lane examples 1-2 falls within from 0.0045% to 0.11% as interpreted range (from about 0.005% to about 0.1% as instantly recited) in instant claims 1 and 3 i), or falls within from 0.0045% to 1.1% as interpreted range (from about 0.005% to about 1% as instantly recited) in instant claim 2 i). Niacinamide amount in Lane reads on the amount ranges in instant claims 1-3. Moreover, Lane teaches that niacinamide can be added in the composition in the range of 0.1% to 7.5% (e.g., Claim 12).
Panthenol amount 0.1% in Lane’s examples 1-2 falling within the interpreted range from 0.0045% to 0.22% of claim 1, and representing the same amount as at 0.1% as recited in instant claim 2 iii) and claim 3 ii). Lane also teaches that panthenol can be added in the composition in the range of 0.01% to 2.0% (e.g., Claim 14), overlapping with ranges from 0.009% to 0.055% as interpreted in instant claim 2ii), or from 0.0045% to 0.055% as interpreted as in instant claim 3i).
In summary, Lane teaches a personal care composition can comprise piroctone olamine (e.g., 0.5% to 6%) (overlapping with amounts in claims 1-3), niacinamide (e.g., 0.1%) and panthenol (e.g., 0.01 to 2.0%), overlapping with both amounts in instant claim 1, at least claim 2 ii), and at least claim 3 i).
Regarding instant claim 4, Lane indicates that the formulations of the invention may be present in typical hair care compositions in the form of solutions or dispersion as hair tonics, treatment, and styling products, and treatment products; and any other form that may be applied to the hair and further it may be applied to the scalp and/or hair and scalp [0095], and can be rinse off shampoo [0079], or leave-on composition (claim 16).
Lane does not teach single embodiments comprising the specified amount ranges for corresponding components as recited in instant claims 1-3.
It would have been prima facie obvious for one person with ordinary skills in the art to adjust component amounts to arrive at current invention. Because Lane already teaches the exact components in the composition, it would have been routine practice for artisans in the field to experiment different amounts of the ingredients to optimize compositions. For this instance, most of the amount ranges of hydroxy pyridone, niacinamide, and panthenol overlap with the amounts taught by prior art, as discussed above. As discussed above, the Lane reference teaches include antimicrobial in various amount such as from 0.5 to 6%, and the reference teaches piroctone olamine (which is a type of hydroxy pyridone) is an antimicrobial, and thus it would have been obvious for a POSITA to vary or optimize the amount of the antimicrobial agent in a scalp treating composition to achieve the desired outcome of treating scalp with microbial infection. “It would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
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. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003).
Regarding the synergistic antioxidant activity, it is interpreted as the property or “intended use” of the composition because it does not provide structural limitation to the composition of subject matter (see claim interpretation above). Since the composition is obviously taught by prior art, the synergistic oxidative activity as inherent property or “intended use” of the composition exists in Lane’s teaching. MPEP 2145 II. states that “prima facie obviousness is not rebutted by merely recognizing additional advantages or latent properties present but not recognized in the prior art”, see In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991) (Appellant argued that the presence of DEHP as the plasticizer in a blood collection bag unexpectedly suppressed hemolysis and therefore rebutted any prima facie showing of obviousness. However, the closest prior art utilizing a DEHP plasticized blood collection bag inherently achieved same result, although this fact was unknown in the prior art.).
Response to Arguments
Applicant remarks/arguments filed on 11/11/2025 have been fully considered, art rejections have been updated based on amendments as presented in this office action above.
Applicant asserted that claim rejections under 35 U.S.C 102(a)(1) are improper because Lane does not disclose or teach all of the claim limitations, such as about 0.8% of piroctone olamine in instant claim 1, which is significantly higher than that in prior art.
The assertion was made regarding the previous claim set. The previous claim 1 language contained the improper conditional phrases “when the” and “when”, which rendered indefinite claim scope with unclear ingredient amount ranges. Now that the claims have been amended, the rejections under 35 U.S.C 102 (a)(1) have been updated to 35 U.S.C. 103 because prior art does not teach all specified amounts in a single embodiment.
Regarding the piroctone olamine amount at about 0.8%, while in prior art it is 0.45%, applicant asserts it is significantly higher. As discussed above, the Lane reference teaches include antimicrobial in various amount such as from 0.5 to 6%, and the reference teaches piroctone olamine (which is a type of hydroxy pyridone) is an antimicrobial, and thus it would have been obvious for a POSITA to vary or optimize the amount of the antimicrobial agent in a scalp treating composition to achieve the desired outcome of treating scalp with microbial infection.
Prior art teaches overlapping amounts for the ingredients, and differences in concentration generally do not support the patentability of subject matter, as presented in office action and copied below for reference:
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. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003).
Applicant asserted that the ingredients in instant claim 1 with specified concentrations result in surprising and unexpected synergistic oxidative activity and is not disclosed by Lane.
The claims are interpreted as a composition comprising the essential specific ingredients at specific concentrations, and the synergistic oxidative activity is the property or “intended use” of the composition because it does not provide structural limitation to the composition of subject matter (see claim interpretation above). Since the composition is obviously taught by prior art as presented in this office action above, the synergistic oxidative activity as inherent property or “intended use” of the composition exists in Lane’s teaching. Regarding the synergy factor data from hydroxy pyridone amount at about 0.8%, together with the specific amount ranges of niacinamide and panthenol in instant specification, the data does not present direct comparisons using hydroxy pyridone amount 0.45%, which is the one in Lane’s examples 1-2, and since Lane teaches the niacinamide and panthenol amount overlapping with instantly claimed ranges, the synergistic oxidative activity cannot be excluded from prior art teaching. MPEP 2145 II. states that “prima facie obviousness is not rebutted by merely recognizing additional advantages or latent properties present but not recognized in the prior art”, see In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991) (Appellant argued that the presence of DEHP as the plasticizer in a blood collection bag unexpectedly suppressed hemolysis and therefore rebutted any prima facie showing of obviousness. However, the closest prior art utilizing a DEHP plasticized blood collection bag inherently achieved same result, although this fact was unknown in the prior art.).
Applicant also argued that instant claim 2 requires piroctone olamine is at 0.5%, there is synergistic antioxidant activity with panthenol and niacinamide specified amount ranges, and Lane does not disclose the synergistic antioxidant activity.
The amount of piroctone olamine at 0.45% is very close to instantly claimed amount 0.5% (at 90%). Similar to the response above regarding instant claim 1, the synergistic oxidative activity is interpreted as property or intended use of the composition. MPEP 2145 II. states that “prima facie obviousness is not rebutted by merely recognizing additional advantages or latent properties present but not recognized in the prior art”, see In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991) (Appellant argued that the presence of DEHP as the plasticizer in a blood collection bag unexpectedly suppressed hemolysis and therefore rebutted any prima facie showing of obviousness. However, the closest prior art utilizing a DEHP plasticized blood collection bag inherently achieved same result, although this fact was unknown in the prior art.). Even if the synergistic antioxidant activity is not recognized in prior art, the composition as taught by prior art would necessarily present the instantly claimed property or “intended use”. The data of synergistic antioxidant activity as shown in synergy factor values in specification does not exclude the inherent property Lane’s composition constitutes the same as such, only if there is direct evidence from comparisons showing otherwise.
Applicant also argued that instant claim 3 requires piroctone olamine is from about 0.5% to about 0.8%, and there is synergistic antioxidant activity with panthenol and niacinamide specified amount ranges, while Lane does not disclose piroctone olamine at this amount range and the surprising and unexpected synergistic antioxidant activity.
In light of claim interpretation, the piroctone olamine amount from about 0.5% to about 0.8% is from 0.45% to 0.88%, thus, Lane teaches the low point of the range, as presented in this office action above. Regarding the synergistic antioxidant activity, it is interpreted as property or intended use of the composition which is obviously taught by Lane. Also, there is no direct evidence indicating that 0.45% piroctone olamine would not have the synergistic antioxidant activity from Lane’s compositions. MPEP 2145 II. states that “prima facie obviousness is not rebutted by merely recognizing additional advantages or latent properties present but not recognized in the prior art”, see In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991).
In summary, the arguments are not persuasive. The prior art teaches instant invention. Please refer to the entire office action as a complete response to the arguments.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/DX.Z./Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616