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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/20/26 has been entered.
Claim Status
Claims 1-7 are pending.
Withdrawn rejections
Applicants’ amendments and arguments filed on 7/20/26 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Drovetskaya et al. (US20100209377) and Drovetskaya et al. (WO2009006212; hereinafter DroveskayaWO2009) as evidenced by the product data sheet for GLYDANT ([online] retrieved on 9/17/24 from: http://www.petrakemindo.co.id/wp-content/uploads/2013/02/ProductDataSheets_Glydant_PDS.pdf; 2 pages) and Aranaz et al. (Polymers 2018;10: 25 pages).
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103.
Applicant claims:
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The claimed ranges are reasonably within the disclosed ranges of the specification. See [0022-0023].
Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a hair cosmetic research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from hair cosmetic formulation techniques and components— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 1 and 3, Drovetskaya et al. disclose a hair styling and conditioning composition (Title) comprising hydroxyproplymethylcellulose (HPMC) and chitosan in a cosmetically acceptable medium of water (Example 1, Table 1, [0036-0043]; claims 1, 4, 5). Drovetskaya et al. disclose in Examples 3 and 4, that 0.3 grams of the dry film was dissolved in 12 g of water [0048, 0051]. Drovetskaya et al. disclose in Batch 1 in Table 1 that the final dry film has 56% HPMC and 24 wt% chitosan, then one finds that in the 0.3 grams there are 0.072 g of the chitosan and 0.168 g of the HPMC for a final wt% in the hair treatment solution upon dilution of 0.3 g in 12 g of water being 0.072g/(12g + 0.3g) X 100 = 0.58 wt% chitosan and 0.168g/(12g + 0.3g) X 100 = 1.37 wt% HPMC based on the total weight of the hair treatment composition.
Regarding claims 1-2, Drovetskaya et al. teach dissolving the dry film in water to make in-situ formulations for application to hair [0048, 0051, 0068]. Drovetskaya et al. teach that the film can comprise about 40-95% of film forming agent (Claim 6), which can be HPMC (Claim 4), as well as about 5-30 wt% chitosan (Claim 8). Drovetskaya et al. also teach an aqueous component present in an amount sufficient to dissolve the film (Claim 16) and optimize the viscosity of the resulting gel with various ratios of dry film to water such as from about 1:10 to about 1:50 (Claims 1-19). Consequently, a hypothetical example is dilution of the about 5 wt% chitosan with water by about 1:10 to about 1:50 provides a range of 0.1 to 0.5 wt% chitosan in solution, which overlaps the claimed range of about 0.01 wt% to about 0.5 wt% and from about 0.05 wt% to about 0.375 wt%. Similarly, dilution of about 40% film forming agent HPMC provides a range of about 0.8 wt% to 4 wt%, where the claimed “about 0.5 wt%” and “about 0.4 wt%” are nearly touching.
Regarding claim 4, Drovestkaya et al. disclose adding GLYDANT preservative to the composition [0043] and as evidenced by the product data sheet for GLYDANT, it has 44-46% water content. Drovestkaya et al. also disclose adding PLANTAREN 2000 as a 50% solution (Table 1).
Regarding claim 6, Drovestkaya et al. disclose adding pH adjuster citric acid, emollient glycerin and non-ionic surfactant PLANTAREN 2000 Decyl Glucoside to the composition (Table 1) as well as, additional film forming agents, emollients, moisturizers, conditioners, oils, sunscreens, surfactants, emulsifiers, preservatives, rheology modifiers, colorants, preservatives, pH adjustors, propellants, reducing agents, fragrances, foaming or de-foaming agents, tanning agents, depilatory agents, flavors, astringents, antiseptics, deodorants, antiperspirants, insect repellants, bleaches, lighteners, anti-dandruff agents, adhesives, polishes, strengtheners, fillers, barrier materials, or biocides, or an active ingredient selected from skin care actives, nail care actives, or hair care actives (Claim 15).
Regarding claim 7, Drovestkaya et al. applied the composition of Example 1 comprising chitosan and HPMC to hair (Examples 3-4; [0048-0057]). The strength of the hair was inherently improved. Especially given that the film strength of the chitosan and HPMC film is added to the hair [0060] and, as evidenced by Aranaz et al., chitosan films increase hair strength (Page 12, 2nd paragraph).
Regarding claims 1-2, DroveskayaWO2009 teach personal care dissolvable films with chitosan and a film forming agent (Claims 1-2) that is HPMC (Claims 5-6) in an amount of from about 0.1% to about 69.99% by weight of the dry film (Claim 7). DroveskayaWO2009 also teaches gels containing an aqueous component to dissolve the dissolvable film (Claims 18-22).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Drovetskaya et al. is that Drovetskaya et al. do not expressly teach from about 0.01 wt% to about 0.5 wt% or from about 0.1 wt% to about 0.4 wt% hydroxypropyl methylcellulose. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the hair treatment composition of Drovetskaya et al. with about 0.01 wt% to about 0.5 wt% or from about 0.1 wt% to about 0.4 wt% hydroxypropyl methylcellulose HPMC based on the total weight of the composition, as suggested by DroveskayaWO2009, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because of the following rationales. First, the Examiner notes MPEP 2144.05(I): “Similarly, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).” In the present case, as explained above, a hypothetical example is dilution of the about 5 wt% chitosan with water by about 1:10 to about 1:50 (Claim 17) provides a range of about 0.1 to 0.5 wt% chitosan in solution, which overlaps the claimed range of about 0.01 wt% to about 0.5 wt% and from about 0.05 wt% to about 0.375 wt%. Similarly, dilution of about 40% film forming agent HPMC provides a range of about 0.8 wt% to 4 wt%, where the claimed “about 0.5 wt%” and “about 0.4 wt%” are nearly touching with “about 0.8 wt%”. The values are so close that the ordinary artisan would expect similar properties and thus the claimed ranges are obvious without more.
Secondly, it is merely routine optimization of the amount of each component already suggested by Drovetskaya et al. and DroveskayaWO2009 and/or optimization of the gel viscosity. Claim 16 guides the artisan to add sufficient aqueous component to dissolve the film and that is further limited/narrowed by the ratios set in claim 17. And DroveskayaWO2009 teach employing much lower amounts of HPMC and still produce a personal care dissolvable film. Thus, larger ratios of dry film to water are within the scope of Drovetskaya et al. and smaller amounts of HPMC are suggested in the art. So, having a hypothetical ratio of 1:100 dry film to water provides 0.05 wt% chitosan and 0.4% HPMC in solution, which reads on the claimed ranges. Consequently, in the present case there is guidance for the artisan to discard the limits set by the example in Drovetskaya et al. and optimize the variables to arrive at the claimed invention with a reasonable expectation of success. DroveskayaWO2009 is proof that lower amounts of HPMC can be employed successfully. This is simple dilution and not inventive without more. See MPEP 2144.05 (II)(A): 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).
Claim 5 is rejected under 35 U.S.C. 103(a) as being unpatentable over Drovetskaya et al. (US20100209377) and Drovetskaya et al. (WO2009006212; hereinafter DroveskayaWO2009) as evidenced by the product data sheet for GLYDANT ([online] retrieved on 9/17/24 from: http://www.petrakemindo.co.id/wp-content/uploads/2013/02/ProductDataSheets_Glydant_PDS.pdf; 2 pages) and Aranaz et al. (Polymers 2018;10: 25 pages), as applied to claims 1-4, 6 and 7 above, in further view of Trueb, RM (Abstract of: J Dtsch Dermatol Ges. 2007;5(5):356-65; 1 page).
Applicant claims:
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The references of Drovetskaya et al., DroveskayaWO2009, Glydant product sheet and Aranaz et al. are discussed in detail above and that discussion is incorporated by reference.
Further regarding claim 5, Drovetskaya et al. teach making a gel by combining the dissolvable film with an aqueous component (Claims 16-19). Drovetskaya et al. also teach adding other hair care products such as surfactants, conditioners, strengtheners or hair care actives (Claim 15) to the hair styling and conditioning composition. Drovetskaya et al. teach that the invention can further incorporate other ingredients known in the art of hair care formulations [0022].
Regarding claim 5, Trueb teaches that shampoos are made of surfactants, which are cleansing agents and can be a blend of different surfactants, conditioning agents and special care ingredients (Abstract).
The difference between the instant application and Drovetskaya et al. is that Drovetskaya et al. do not expressly teach that the hair treatment composition comprises at least one of a shampoo, rinse-off conditioner, leave-on conditioner. This deficiency in Drovetskaya et al. is cured by the teachings of Trueb. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to make the hair treatment composition of Drovetskaya et al. with at least one of a shampoo, rinse-off conditioner, leave-on conditioner or a styling product, as suggested by the combined references, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because of the following reasons. First, Drovetskaya et al. expressly teach and suggest that the composition is a hair styling and conditioning composition. It is then prima facie obvious to combine the hair styling and conditioning composition of Drovetskaya et al. with other hair styling and conditioning products, including leave-on and rinse-off conditioners, to create another product useful for the same purpose. See MPEP 2144.06(I) COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose.” (In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980); In re Susi, 58 CCPA 1074, 1079--80, 440 F.2d 442,445 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.2d 274, 276-77 (1960)). As explained in Crockett, the idea of combining them flows logically from there having been individually taught in the prior art. Secondly, Drovetskaya et al. teach and suggest adding surfactants (Claim 15), which includes cationic, anionic, non-ionic and amphoteric surfactants, as well as hair care actives. (Note that Drovetskaya et al. teach using anionic, cationic, amphoteric or nonionic chitosan polymers as well. [0011]). The ordinary artisan in this art is well aware that shampoos contain surfactants/blends of surfactants and conditioning agents through the teachings of Trueb. Consequently, it is obvious to combine the hair conditioning/styling composition of Drovetskaya et al. with a surfactant containing shampoo product for the added cleansing effect of the surfactants in the shampoo. The ordinary artisan would do so with a reasonable expectation of success.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the before the effective filing date, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments:
Applicants’ arguments filed on 7/20/26 have been carefully considered but are not persuasive.
Applicant asserts: “Where claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. See e.g., MPEP §2144.05. Here, however, that is no longer the case. As amended, Claim 1 requires from about 0.01 wt% to about 0.5 wt% chitosan and from about 0.01 wt% to about 0.5 wt% hydroxypropyl methylcellulose (HPMC), based on the total weight of the hair treatment composition. This range is not taught or suggested by Drovetskaya. Nor is there any evidence in Drovetskaya that would motivate one of skill in the art to investigate or go beyond the wt% ranges described therein.” Respectfully, the Examiner has a different perspective. As explained above, the amount of water used to dissolve the dry film is not limited by claim 16 of Drovetskaya. Consequently, to derive the claimed ranges the ordinary artisan merely uses an appropriate amount of water as shown above in a hypothetical example. Simple dilution is not inventive without more. “It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent…” MPEP 2144.05(II)(A)). See MPEP 2144.05(I): “In re Dreyfus, 73 F.2d 931, 934, 24 USPQ 52, 55 (CCPA 1934)(the prior art, which taught about 0.7:1 of alkali to water, renders unpatentable a claim that increased the proportion to at least 1:1 because there was no showing that the claimed proportions were critical)”. Applicant has not demonstrated that the claimed proportions are critical compared to the proportions taught by Drovestkaya. From MPEP 2144.05(III)(A): “Applicants can rebut a prima facie case of obviousness by showing the criticality of the range…the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)… In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933) (“It is well established that, while a change in the proportions of a combination shown to be old, such as is here involved, may be inventive, such changes must be critical as compared with the proportions used in the prior processes, producing a difference in kind rather than degree.”); In re Wells, 56 F.2d 674, 675, 12 USPQ 430 (CCPA 1932) (“Changes in proportions of agents used in combinations . . . in order to be patentable, must be critical as compared with the proportions of the prior processes.”)”. And the Examiner has shown with the art of DroveskayaWO2009 that lower amounts of HPMC are routinely employed in such compositions. Thus, a reasonable expectation of success is provided. Applicant has not shown the criticality of the claimed ranges. In this record, there is no comparison with the closest prior art of Drovetskaya. (MPEP 716.02(e)). Accordingly, the claims remain rejected as obvious over the applied references. Respectfully, Applicant’s arguments are not persuasive.
MPEP 2141 III states: “The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” Respectfully, after review of all the facts, Applicant’s arguments are not persuasive. The Examiner has reached a determination that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts, which is more convincing than the evidence which has been offered in opposition to it.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613
