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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/22/2025 has been entered.
Withdrawn Rejections:
Applicant's amendments and arguments filed on 03/22/2025 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 Any rejection and/or objection not specifically addressed below is herein withdrawn.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.
Claims 1-8, 11-15, 18-23 are pending, claims 1-8, 11-15, 18, 21-23 are under examination.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 21-22 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 21-22 fail to further limit the subject matter of claim 1 or 18 upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 of this title, 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, 3-8, 11-15, 18, 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Sakata (US20230062111).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Sakata teaches new material for preventing adhesion of pollutants by forming a film on skin or on the surface of hair to prevent the skin and surface of hair from being polluted due to the pollutants. Provided is an anti-pollution material characterized by containing a lipid-peptide compound in which a peptide moiety formed from repetition of at least two amino acids which are the same or different binds to a lipid moiety comprising an aliphatic group having 10-24 carbon atoms (abstract). The amount of the lipidic peptide compound contained in the anti-pollution material is preferably 0.05 to 1% by mass, relative to the total mass of the anti-pollution material ([0074]). The anti-pollution material of the present invention may contain, besides the aforementioned lipidic peptide compound, water, an alcohol, a polyhydric alcohol, or a mixed solution thereof ([0077]). The aforementioned alcohol refers to a monohydric alcohol. Examples of the monohydric alcohol include C1-6 alcohols and higher alcohols, such as oleyl alcohol and phenoxy alcohol. The aforementioned polyhydric alcohol refers to a di- or more-valent alcohol. Examples of the polyhydric alcohol include propylene glycol, 1,3-butanediol, 2-ethyl-1,3-hexanediol, glycerin, isopentyldiol ([0079-0080]). In the present invention, when the anti-pollution material contains a polyhydric alcohol, the amount of the polyhydric alcohol may be, for example, 1% by mass to 60% by mass, preferably 1% by mass to 30% by mass, relative to the total mass of the anti-pollution material ([0081]). If necessary, the anti-pollution material of the present invention may contain additives generally usable as additives for cosmetic products, quasi-drugs, and pharmaceutical products. Examples of additive ingredients such as physiologically active substances and functional substances contained in external formulations for skin (e.g., cosmetic products, quasi-drugs, or pharmaceutical products) include pigments, oily bases, humectants, texture improvers, surfactants other than those described above, polymers, thickeners, gelators, solvents, antioxidants, reducing agents, oxidizers, preservatives, antimicrobial agents, antiseptics, chelating agents, pH adjusters ([0084-0085]). The amount of such an additive contained in the anti-pollution material may vary depending on the type of the additive. The amount of the additive may be, for example, 0.001% by mass to 20% by mass or about 0.01% by mass to 10% by mass, relative to the total mass of the anti-pollution material ([0086]). The oil bases includes amino-modified silicones such as amodimethicone ([0089]). Humectants includes cyclodextrin (alpha or beta) and citric acid ([0090]). The surfactant includes sorbitan fatty acid ester ([0091]). The thickener includes xanthan gum ([0092]). The example of solvent includes propylene carbonate ([0092]). The chelating agent includes citric acid ([0098]). In working example, the amount of monohydric alcohol (Cetanol and Myristyl alcohol) is 0.4% ([0161, table 2).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Sakata is that Sakata is not specific enough for anticipation.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce the instant invention.
Regarding claims 1, 3, 5-8, 10-13, Sakata teaches a composition for treating hair comprising lipid-peptide (0.05 to 1%), alcohol (0.4%), glycerin as polyhydric alcohol (1-30%), citric acid (chelating agent, also as humectant agent) at 0.01% to 10%, alpha-cyclodextrin (as humectant agent) at 0.01 to 10%, propylene carbonate (solvent) at 0.01 to 10%, xanthan gum (thickener) at 0.01 to 10%, amodimethicone as oil bases at 0.01 to 10% and water. When lipid-peptide is 1%, alcohol is 0.4%, glycerin is 1%, citric acid is 2%, alpha-cyclodextrin is 2%, propylene carbonate is 10%, xanthan gum is 1%, amodimethicone is 1%, water amount is about (100-1-0.4-1-2-2-10-1-1)%= about 81.6% since no other ingredient is required. The ratio of citric acid and alpha-cyclodextrin is 1:1 when each one is 2%. The glycol is recited as alternative ingredient to glycerin, is not required.
Regarding claim 4, since both citric acid and cyclodextrin are recognized as humectant agent, it is obvious to have the mixture of citric acid and cyclodextrin as humectant agent, and mix citric acid and cyclodextrin first to have the humectant agent mixture before adding this chelating mixture with other ingredients. MPEP 2144.06. "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 to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Mixture of two known herbicides held prima facie obvious. Furthermore, this is product by process.
With respect to the USC 103 rejection above, please note that in product-by-process claims, “once a product appearing to be substantially identical is found and a 35 U.S.C. 102/103 rejection [is] made, the burden shifts to the applicant to show an unobvious difference.” MPEP 2113. This rejection under 35 U.S.C. 102/103 is proper because the “patentability of a product does not depend on its method of production.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicants’ hydrated (vitrified matrix) collagen gel differs and, if so, to what extent, from that of the discussed reference. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
Regarding claims 14-15, Sakata teaches about 0.01% to 10% of surfactant such as sorbitan fatty acid ester.
Regarding claims 16, Sakata teaches about 0.01 to 10% of pH adjuster.
Regarding claims 21-22, none of ingredient cited in claims 21-22 is required.
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 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 art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Sakata (US20230062111), as applied for above 103 rejection for claims 1, 3-8, 11-15, 18, 21-22, in view of Press et al. (US20230293419).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Sakata teaching has already been discussed in the above 103 rejection and is incorporated herein by reference.
Press et al. teaches a cosmeceutical composition for hair care for reducing or preventing damage from environmental pollutant (claims 30-32). The cosmeceutical compositing has pH from 3-7 ([0021]).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Sakata is that Sakata does not expressly teach pH range. This deficiency in Sakata is cured by the teachings of Press et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Sakata, as suggested by Press et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to have pH of the composition form about 3 to about 6 because this is optimization under prior art condition or through routing experimentation. MPEP 2144.05. Under guidance from Press et al. teaching hair care composition with pH 3-7, it is obvious for one of ordinary skill in the art to have pH of the composition form about 3 to about 6 and produce instant claimed inventio with 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 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 art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Argument:
Applicants argue about hindsight.
In response to this argument: this is not persuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). The 103 rejection is still proper.
Applicants argue about lipopeptide in Sakata teaching.
In response to this argument: this is not persuasive. Since applicant’s claims recite “comprising” that allows additional ingredient such as lipopeptide, the 103 rejection is still proper.
Applicants argue that the 103 rejection choosing ingredients from a long list of optional ingredient Sakata teaching.
In response to this argument: this is not persuasive. Firstly, all prior art teaching including optional ingredients can be relied on. Secondly, as long as a ingredient or combination is named from a list, each ingredient or combination is obvious no matter how many other ingredients are cited because the citing of other ingredients does not make any particular ingredients less obvious. Where, the prior art patent disclosed a genus of 1200 effective combinations of compounds, including the claimed combination, it was held that “[d]isclos[ure of] a multitude of effective combinations does not render any particular formulation less obvious.” Merk &Co., Inc. v. Biocraft Laboratories, inc., 874 F.2d 804, 807 (Fed. Cir.1989). Therefore, the 103 rejection is still proper.
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 weighing all the evidence, 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.
Double Patenting
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.
Claims 1-8, 11-15, 18, 21-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 11-20 of copending Application No. 17332695 in view of Sakata (US20230062111) and Press et al. (US20230293419). The reference application teaches a hair care composition comprising ß-cyclodextrin (0.1-1%), water and additional solvent such as polyol (claim 5-6), xanthan gum (0.1-1%, claim 10) and citric acid (claim 15), but silent about propylene carbonate, glycerin, amodimethicone and surfactant as well as pH range in claim 2, in view of Sakata teaching water (about 82% as discussed in the above 103 rejection), propylene carbonate (as solvent, 0.01-10%), glycerin (as polyol, 1-30%l), amodimethicone (0.1 to 10%) and sorbitan fatty acid ester (surfactant, 0.01-10%) as suitable ingredients in hair care composition; Press et al. teaching cosmeceutical compositing has pH from 3-7; it is obvious to include propylene carbonate (as solvent, 0.01-10%), glycerin (as polyol, 1-30%l), amodimethicone (0.1 to 10%) and sorbitan fatty acid ester (surfactant, 0.01-10%) and procure instant claimed invention with reasonable expectation of success. Since no additional ingredient is required, the limitation of “consisting of” in claim is also met.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613
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