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 the Claims
Acknowledgement is made of the response filed on July 2, 2026. In that response, claims 1, 5, 6, and 11 were amended. Claims 1, 3-8, 11, and 13 are treated on the merits in this action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claims 1 and 11 are objected to because of the following informalities: in the last clause in each of claims 1 and 11, a “wherein” should precede “a mass content ratio…2 to 30” for consistency with the other “wherein” clauses. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1, 3-8, 11, and 13 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.
First, claims 1 and 11 have been amended to recite “wherein component (B) comprises component (B1) a polymer with a molecular weight of 1 x 105 or more and a polymer having a molecular weight of less than 1 x 105”. The underlined phrase contains a grammatical error in missing one or more word(s). The word(s) would identify the relationship between component (B1) and “a polymer with molecular weight… less than 1 x 105”. For example the phrase could recite “component (B1) is one of a polymer with a molecular weight… less than 1 x 105”, “component (B1) consists of a polymer with a molecular weight… less than 1 x 105”, or “component (B1) which includes a polymer with a molecular weight… less than 1 x 105”, among others.
The Specification has been consulted, however there is no disclosure of the limitation regarding “a molecular weight of less than 1 x 105” (see rejection under 35 U.S.C. 112(a), below), and thus the Specification does not aid in understanding the claim phrase at issue.
Applicant sates, Mukai (of record) “does not teach the use of both a polymer having a molecular weight of 1 x 105 or more and a polymer having a molecular weight of less than 1 x 105”, and “present application requires component (B) to include both a polymer having a molecular weight of 1 x 105 or more and a polymer having a molecular weight of less than 1 x 105 as recited in the present claims”. (Remarks, 9 second para., July 2, 2026.) However as discussed above the claims do not recite such a requirement, and further the “present application” does not disclose such a requirement either because there is no disclosure regarding “a molecular weight of less than 1 x 105” as discussed below in the rejection under 35 U.S.C. 112(a).
For the purposes of examination now this claim term is construed as any of the example phrases listed above.
Second, in addition to “wherein component (B) comprises component (B1)”, claims 1 and 11 further recite “wherein a mass content ratio of the component (B1) to a total content of the component (B), ((B1)/(B)), is 0.5 or more”. The underlined phrases make it clear that (B1) is a part of component (B). In other words the concentration of (B1) cannot be higher than “the total content of the component (B)”. Therefore “0.5 or more” does not make sense. This is because “0.5 or more” means any quantity greater than 0.5, e.g., 1.8 or 7000. However according to the claims as written the maximum possible (B1)/(B) is 1. This ratio cannot be greater than 1 because “component (B) comprises (B1)”. The Specification also does not appear to disclose any embodiments where (B1)/(B) is greater than 1. Therefore “wherein a mass content ratio of the component (B1) to a total content of the component (B), ((B1)/(B)), is 0.5 or more” is baffling and further renders claims 1 and 11 vague and indefinite.
None of the dependent claims resolves these issues and therefore they are also rejected on these grounds.
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.
Claims 1, 3-8, 11, and 13 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. Claims 1 and 11 recite “…and a polymer having a molecular weight of less than 1 x 105” which lacks support in the disclosure.
The methodology for determining adequacy of written description entails (1) for each claim, determining what the claim as a whole covers, (2) reviewing the entire application to understand how applicant provides support for the claimed invention including each element and/or step, and (3) determining whether there is sufficient written description to inform a skilled artisan that applicant was in possession of the claimed invention as a whole at the time the application was filed. MPEP §2163(II). Also the “written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice …, reduction to drawings …, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.” MPEP §2163(II)(A)(3)(a)(ii) (citations omitted). The “Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 ‘merely by clearly describing one embodiment of the thing claimed’.” Id. (citations omitted).
(1) Claim 1 as a whole covers a composition which forms a coating when electrostatically sprayed onto skin, comprising the components (A), (B), and (C), wherein component (B) comprises a component (B1), the mass content ratio of (B1)/(B) is “0.5 or more”, and the mass content ratio of (B)/(C) is 2 to 30. Claim 11 encompasses a method of producing such a coating. Both claims recite that component (B1) could be “a polymer having a molecular weight of less than 1 x 105”.
(2) The entire application has been reviewed to understand how applicant provides support for the claimed invention including “a polymer having a molecular weight of less than 1 x 105”. There is no explicit disclosure of “a polymer having a molecular weight of less than 1 x 105” of “a molecular weight of less than 1 x 105“ in the Specification. Implicitly the Specification discloses “component (B) [having] a number average molecular weight of 4.5 x 104 or more…preferably 4.6 x 104 or more, more preferably 4.7 x 104 or more…” (Specification, p.16). While the number average molecular weights 4.5 x 104 or 4.7 x 104 are within the range of “less than 1 x 105”, the defining limit of “less than 1 x 105” is not disclosed. Also the claims do not refer to the number average molecular weight.
(3) Therefore it is determined that there is not sufficient written description to inform a skilled artisan that applicant was in possession of the claimed invention as a whole at the time the application was filed.
None of the dependent claims resolves this issue and therefore they are also rejected on this ground.
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 1, 3-8, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Mukai (WO 2018/194132 A1; citations are to US 2021/0196613) as evidenced by Polyvinyl Acetal Resin S-LEC B / K (KS) (available at https://www.sekisui.co.jp/cs/eng/products/1400626_33175.html, accessed on 3/27/2026).
Regarding claims 1, 3-5, 7, 11, and 13, Mukai teaches “a coating comprising fibers having an excellent adhesivity to the skin,” formed by “directly electrostatically spraying on the skin” a coating composition (abstract; see title; paras.0018-21, 0027-44, 0148-62). The coating composition comprises, component (a) a volatile substance chosen from an alcohol and ketone; component (b) a water-insoluble polymer for fiber formation; and component (c) water (abstract). Table 1 (p.15) shows Example 8 comprising ethanol and water at a total of 90%, and PVB-3 or polyvinyl butyral (S-LEC BH-3 having molecular weight 10.8x104 (para.0156; see Polyvinyl Acetal Resin S-LEC B / K (KS), “Grades and properties“, available at https://www.sekisui.co.jp/cs/eng/products/1400626_33175.html, accessed on 3/27/2026) at 10.0%. Ethanol and water comprise component (A) in instant claim 1, and polyvinyl butyral comprises component (B). The mass ratio of component (B) to component (A) is 0.11 (10.0/90.0) which is within the range in claim 7.
Example 8 does not comprise a polyol. However Mukai teaches “[t]he spraying composition A may contain only the above components (a) to (c), or may contain other components in addition to the components (a) to (c)” and “[e]xamples of the other components include a polyol, a liquid oil, …”. “When the spraying composition contains other component(s), the content ratio of the other components is … more preferably 0.5 mass % or more and 20 mass % or less.” (Para.0043 (emphasis added).) The mass ratio of component (B) to component (C) or the polyol in the case of Example 8 therefore ranges from 20 to 0.5, e.g., 20 ((B)/(C) = 10/0.5 to 10/20) which range overlaps that in claim 1. For result-effective variables, in the case where claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP § 2144.05 (citations omitted). Also optimization within prior art conditions or through routine experimentation does not support patentability absent comparative evidence of criticality of the claimed range. See MPEP § 2144.05 (II) (citations omitted).
Regarding claim 6, the skilled person would have been motivated to include glycerol or a polyol such that the ratio (B)/(C) is 5, within the range in claim 6, because Mukai’s Examples 2, 4, and 6 comprise 2.0% glycerol which yields the ratio (B)/(C) of 5. Examples 2, 4, and 6 differ in composition from Example 8 solely in comprising polyvinyl butyral, PVB-1, having a lower molecular weight than the PVB-3 of Example 8.
Regarding claim 8, as noted above Mukai teaches including “other components” including a liquid oil, in its coating compositions (para.0043; see para.0109).
Response to Arguments
Although new rejections are made above Applicant’s arguments are addressed now to the extent they have not been rendered moot and are relevant to the above rejections.
Applicant's arguments filed July 2, 2026 have been fully considered but they are not persuasive. Applicant argues that Mukai teaches the water-insoluble polymer concentration of 1-30 % by mass and a polyol concentration as low as 0.1 % by mass which indicates a “very broad range possible” of (B)/(C) from which to select the recited range. (Remarks, 9-10, July 2, 2026.) Furthermore “Mukai does not recognize [this ratio] as a results-effective and therefore capable of being optimized”. (Id.)
In response it is noted that Mukai teaches preferred, i.e., narrower, ranges of both components (B) and (C) here: “even more preferably 7 mass % or more… [f]urther, 30 mass % or less is preferable ,…” of the water-insoluble polymer (para.0037), and 2.0% of glycerol in Examples 2, 4, etc. As for the other components that include polyols, Mukai teaches the concentration is “more preferably 0.5 mass % or more and 20 mass % or less” (para.0043). Preferred narrower ranges would guide the skilled person.
Moreover “the situation where a ‘parameter optimized was not recognized to be a result-effective variable’ [is] an ‘exception' to the general principle in Aller that 'the discovery of an optimum value of a variable in a known process is normally obvious.” MPEP §2144.05(III)(C)((citations omitted)). “Our subsequent cases have confirmed that this exception is a narrow one… Applicants must articulate why the variable at issue would not have been recognized in the prior art as result-effective. “ (Id.) Here (B)/(C) is a parameter based on each of (B) and (C). Mukai teaches varying the concentration of the water-insoluble polymer or component (B) (para.0037) as well as polyols and liquid oil (para.0043), specifically including glycerol (paras.0122, 0124) or component (C). Therefore the skilled person would have known to optimize their concentrations for a particular application at hand.
Applicant next argues that the compositions “of the present claims is associated with unexpected results”. (Remarks, 10.)
In response it is noted that any evidence of non-obviousness must be reasonably commensurate in scope with the claimed invention. MPEP § 2145 (citations omitted). Here the claims do not reasonably reflect the two examples in Table 4. For broader claims some reasonable basis for extrapolating the comparative data in Table 4 to such broader scope is necessary.
CITATION OF RELEVANT ART
Imai (US 2020/0046618) teaches “A method for producing a coating on skin, the method comprising: A) a step of electrostatically spraying a composition X comprising the following component (a) and the following component (b) directly on the skin to thereby form a coating on a skin surface: (a) one or more volatile substances selected from the group consisting of water, an alcohol, and a ketone, and (b) a polymer having a coating forming ability; and B) a step of applying a composition Y, other than the composition X, containing the following component (c) and the following component (d) to the skin: (c) 5% by mass or more and 20% by mass or less of an adhesive polymer, and (d) 1% by mass or more and 40% by mass or less of a polyol, in this order or in reverse order.” (Abstract). Component (b) preferably comprises a number-average molecular weight of “50,000 or more and 3,000,000 or less and more preferably 100,000 or more and 2,500,000 or less” (para.0037).
CONCLUSION
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 H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614
