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 .
Claim Status
Applicant’s claim amendments and arguments in the response filed 23 March 2026 are acknowledged.
Claims 15, 20-24 & 26 are pending.
Claims 15, 23 & 24 are amended.
Claims 1-14, 16-19, 25 & 27-28 are cancelled.
No claims are withdrawn.
Claims 15, 20-24 & 26 are under consideration.
Examination is to the extent of the following species:
Low-molecular weight lipidic peptide or pharmaceutically useable salt: N-Palmitoyl-Gly-His
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
It is noted foreign priority has not been perfected. An English language translation of the foreign application has not been filed. Should Applicant choose to file an English translation, the English language translation should be accompanied with a statement that the translation of the certified copy is accurate. See 37 CFR 1.55 and MPEP §§ 215 and 216.
Withdrawn Rejections
The rejection of claim 28 under 35 USC 112(a)-New Matter is withdrawn due to cancellation of the claim.
The rejection of claim 28 under 35 USC 112(b) is withdrawn due to cancellation of the claim.
The rejection of claims 18, 19 & 27-28 under 35 USC 103(a) is withdrawn due to cancellation of the claims.
The rejection of Claims 15, 20-22 & 26-28 under 35 U.S.C. 103 over Iwama in view of How to Wash Your Hair Salon Style; and claims 23 & 24 are rejected under 35 U.S.C. 103 as being unpatentable over Iwama, How to Wash Your Hair Salon Style, and Erkens is withdrawn due to claim 15 amendments to recite inclusion of stearic acid and a polyhydric alcohol.
New & Maintained Rejections
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.
Claims 15, 20-24 & 26 are rejected under 35 U.S.C. 103 as being unpatentable over Iwama (US Publication No. 2013/0084305; Published: 04/04/2013; previously cited; previously cited) in view of How to Wash Your Hair Salon Style (https://www.tomoyukiandco.com/post/how-to-wash-your-hair-salon-style; Published: 11/23/2018; previously cited) and Erkens (US 2019/0110970; April 18, 2019; previously cited).
Claim 15 Analysis: The terms, “wash” or “washing” are not defined by the specification and encompasses the hair being “washed with distilled water” (i.e. rinsing; Specification [0123]).
With regard to claim 15, Iwama in Example 2-Table 2 teaches a formulation comprising Palmitoyl Gly-His TFA salt (i.e. trifluoroacetic acid) and in Example 10-Table 8 teaches a formulation comprising the free form of palmitoyl-Gly-His as lipid peptide based gelators (i.e. Pal-GH; [0034]; Table 2-[0213]; Table 8-[0224]). With regard to claims 15 & 26, Iwama teaches these lipid peptide-based gelators, which include the free and TFA salt of Pal-GH, are formulated into hair care products which include shampoos, hair rinses and conditioners [0162]. With regard to claim 15, the ordinary skilled artisan, before the effective filing date, knew that shampoos comprise anionic surfactants. With regard to claim 15, more broadly, Iwama teaches formulating their invention as a surfactant and a disinfectant as a cleansing component and inclusion of anionic surfactants, nonionic surfactants, cationic surfactants, amphoteric surfactants, polymer surfactants, and the like ([0110] & [0143]). With regard to claims 20-22, Iwama teaches the lipid peptide-based gelator works as a gelator and/or thickener in cosmetic which include hair products and is present in an amount which is preferably 0.1 to 5% w/v ([0151], [0152] & [0168]). With regard to the composition forming a coating film of the surface of the hair as set forth by claim 15, Iwama teaches the lipidic gelator gradually releases the low molecular weight compound when applied the hair to provide a moisturizing effect (emphasis added; [0090]).
Iwama does not teach the shampoo is applied to the surface of hair, washing the hair to which the film forming composition has been applied, drying the hair to which the film-forming composition has been applied, or inclusion of a polyhydric alcohol and stearic acid.
In the same field of invention of shampooing hair, with regard to claim 15, How to Wash Your Hair Salon Style teaches to wash/cleanse your hair, shampoo is applied, with gentle application needed to not damage the hair’s cuticle (i.e. the shampoo is applied to a surface of hair), that high quality shampoo’s don’t create a build up on hair (i.e. the shampoo is applied to a surface of hair), and that for medium or long hair the shampoo foam is spread throughout the length (i.e. the shampoo is applied to a surface of hair; pg. 5-7). With regard to claim 15, How to Wash Your Hair Salon Style teaches after the shampoo is applied to the hair surface, hair is rinsed (i.e. washing the hair to which the film-forming composition has been applied; pg. 7). With regard to claim 15, How to Wash Your Hair Salon Style teaches after rinsing hair, the hair is dried (pg. 9).
In the same field of invention of shampoos, with regard to claims 15, 23 & 24, Erkens in Example 7 teaches a shampoo comprising 29.5% 1,3-propanediol (i.e. polyhydric alcohol) and 8.0% stearic acid (pg. 13). More broadly, Erkens teaches inclusion of auxiliary and additive substances including structuring substances and conditioning substances [0312].
The Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
With regard to the method steps, at least rationale (G) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have combined How to Wash Your Hair Salon Style’s method of shampooing hair to Iwama’s hair shampoo because How to Wash Your Hair Salon Style’s method of shampooing hair is for use with shampoos and Iwama’s composition is formulated as a shampoo. The ordinary skilled artisan would have been motivated to so, with an expectation of success, in order to clean and moisturize hair with a shampoo composition that is suitable for use in a method of shampooing hair.
Here, with regard to the shampoo reagents, at least rationale (B), may be employed in which it would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to modify the method suggested by Iwama by substituting Iwama’s generically taught shampoo with Erkens’ Example 7 shampoo comprising 29.5% 1,3-propanediol and 8.0% stearic acid because Iwama and Erkens are drawn to shampoo compositions and methods of using a shampoo to cleanse hair. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to provide Iwama’s shampoo in a formulation form suitable for cleansing hair in a process for cleansing hair with the added benefits of delivering conditioning/moisturizing compounds to hair and structuring/- gelling the formulation.
With regard to the recited amounts of low-molecular-weight lipidic peptide, polyhydric alcohol and stearic acid, the combined teachings of Iwama, How to Wash Your Hair Salon Style, and Erkens suggest these parameters with values which overlap with the recited ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Response to Arguments
Applicant acknowledges that Iwama describes their low-molecular lipid peptide may be used in a shampoo but does not suggest or describe that the shampoo would form a coating film in the process of shampooing (pg. 5). Applicant points to paragraph [0030] of Iwama to teach that the compositions permeate into skin and hair and that one would expect the non-absorbed components of the compositions of Iwama to be rinsed away in shampooing (reply, pg. 5). Applicant argues there is nothing that would have led one to have expected that shampoo Iwama as modified by Erkens to have unexpectedly resulted in the composition being able to form a film in the shampoo process (reply, pg. 5).
This is not persuasive. Paragraph [0008] of the instant specification discloses “The present inventors have conducted extensive studies…and as a result have found that a coating film is formed on the skin or the hair surface only by using at least one lipidic peptide compound” (emphasis added). Iwama teaches the lipidic peptide. As such, Iwama’s lipidic peptides, Pal-GH and Palmitoyl Gly-His TFA salt necessarily form a film because the instant specification teaches it to be so and "Products of identical chemical composition cannot have mutually exclusive properties." 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. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). This assertion is supported Iwama’s teaching that the lipidic gelator gradually releases the low molecular weight compound when applied the hair to provide a moisturizing effect (emphasis added; [0090]). A film must necessarily be present due to the presence of the lipidic peptide compound and the fact that the lipidic gelator gradually releases the low molecular weight compound.
Applicant argues Iwama does not describe a shampoo that includes at least one surfactant, a polyhydric alcohol, and stearic acid as required by the present claims and nothing in the cited prior art would have led one to expect that including a polyhydric alcohol and stearic acid with a low-molecular lipid peptide would have unexpectedly resulted in the composition being able to form a film in the shampooing process (reply, pg. 5).
This is not persuasive and not in accordance to the teachings of Applicant’s own specification. Applicant is reminded that paragraph [0008] of the instant specification discloses “The present inventors have conducted extensive studies…and as a result have found that a coating film is formed on the skin or the hair surface only by using at least one lipidic peptide compound” (emphasis added). Per Applicant’s own specification, all it takes to form a film is the at least one lipidic peptide compound. Iwama teaches a shampoo and the lipidic peptide. The ordinary skilled artisan knew before the effective filing date that shampoos contain detersive surfactants; that is how they clean. Iwama also teaches formulating their invention as a surfactant and a disinfectant as a cleansing component and inclusion of anionic surfactants, nonionic surfactants, cationic surfactants, amphoteric surfactants, polymer surfactants, and the like ([0110] & [0143]). Iwama teaches a shampoo. Erkens’ Example 7 shampoo comprises the surfactant TIPA laureth sulfate (a surfactant), 29.5% 1,3-propanediol (i.e. polyhydric alcohol) and 8.0% stearic acid (pg. 13). It would have been prima facie obvious to the ordinary skilled artisan to have substituted Iwama’s generically taught shampoo with Erken’s shampoo because Iwama and Erken are drawn to shampoo compositions to cleanse hair. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to provide Iwama’s shampoo in a formulation form suitable for cleansing hair with the added benefits of delivering conditioning/- moisturizing compounds to hair and structuring/gelling the formulation.
Conclusion
No claims are 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 LORI K MATTISON whose telephone number is (571)270-5866. The examiner can normally be reached 9-7 (M-F).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David J Blanchard can be reached at 5712720827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LORI K MATTISON/ Examiner, Art Unit 1619
/NICOLE P BABSON/ Primary Examiner, Art Unit 1619
Prosecution Insights