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
The preliminary amendment of 09/09/2024 is acknowledged. Claims 4-7 are amended and claims 8-11 are new. Claims 1-11 are currently pending and are examined on the merits herein.
Priority
The instant application filed 09/09/2024, is a 371 filing of PCT/JP2023/003247, filed 02/01/2023, which claims foreign priority to JP2022-075148, filed 04/28/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/09/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112(b)
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 4 and 8 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.
Regarding claims 4 and 8, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5 and 8-9 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Sakikawa, N., (WO 2021060224 A1; published 04/01/2021; US 11833321 B2 used as translation; PTO-892), hereinafter Sakikawa.
Sakikawa discloses a stimuli-responsive polymer that reversibly changes to being hydrophilic and to being hydrophobic in response to an external stimulus to allow impregnation and release of an active ingredient to be applied to the skin (abstract).
Regarding claim 1: The impregnation material of Sakikawa is made of a temperature-responsive polymer and a hydrophilic polymer (col. 5, lines 64-66; col. 3-4, “Temperature-Responsive Polymer” section; col 4-5, “Hydrophilic Polymer” section). The stimuli-responsive polymer (i.e., temperature-responsive) and hydrophilic polymer form an interpenetrating polymer network structure or a semi-interpenetrating polymer network structure (claim 3; col. 2, lines 25-33; col. 3, lines 59-62; col. 5, lines 24-29). The impregnation material is impregnated with a solution containing an active ingredient. The active ingredient is a cosmetically effective cosmetic ingredient in one embodiment (col. 6, para. 2; col. 23, lines 6-8), meaning the impregnated polymer network of Sakikawa reads on a cosmetic.
Regarding claim 2: The stimuli-responsive polymer is one whose affinity with water reversibly changes in response to heat, that is, a temperature-responsive polymer, absorbs moisture and releases the absorbed moisture in a reversible manner due to a change in temperature. Such a temperature-responsive polymer is not particularly limited provided that the polymer has a lower critical solution temperature (LCST) (col. 3, lines 14-22). When a degree of the external stimulus is less than a predetermined level (i.e., a predetermined temperature), the stimuli-responsive polymer is highly likely to absorb moisture, and when the degree of the external stimulus is the predetermined level or greater, the stimuli-responsive polymer is highly likely to release moisture (col. 22-23, lines 67-5). Such a functional effect reads on the functional effect as described in the instant claims. However, despite this teaching by Sakikawa, the composition anticipated by Sakikawa is identical to the composition claimed. Thus, the composition must necessarily have the characteristics claimed as an inherent property. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
Regarding claim 3: The impregnation material made of the temperature-responsive polymer releases the active ingredient upon applying heat. For example, as the stimuli-responsive polymer gel, a temperature-responsive polymer gel having an LCST (i.e., lower critical solution temperature) slightly lower than 37° C, which is a human body temperature, is used as the impregnation material (col. 6, lines 41-49; col. 10, First Embodiment). A specific example teaches a LCST of 33° C (col. 12, Second Embodiment), which falls within the instantly claimed range.
Regarding claims 4 and 8: Specific examples of the temperature-responsive polymer include: poly(N-alkyl (meth)acrylamide); poly(N-vinyl alkylamide); poly(N-vinylpyrrolidone); poly(2-alkyl-2-oxazoline); polyvinyl alkyl ethers; copolymers of polyethylene oxide and polypropylene oxide; poly(oxyethylene vinyl ether); cellulose derivatives; and copolymers of the polymers described above (col. 3, lines 34-52). All of these temperature-responsive polymers read on those recited in the instant claims.
Regarding claims 5 and 9: Specific examples of the hydrophilic polymer include: polysaccharides such as alginic acid or hyaluronic acid; chitosan; cellulose derivatives; copolymers and composites including poly(meth)acrylic acid; polyethylene glycol; and copolymers of such polymers. The hydrophilic polymer is more preferably a cross-linked body thereof (col. 5, lines 5-23). All of these hydrophilic polymers read on those recited in the instant claims.
Claims 1-5 and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xiuyu Li, et al. (2008). Synthesis and properties of thermo-responsive guar gum/poly(N-isopropylacrylamide) interpenetrating polymer network hydrogels, Carbohydrate Polymers, Volume 71, Issue 3, Pages 394-402 (PTO-892), hereinafter Li.
Li discloses thermo-responsive guar gum (GG)/poly(N-isopropylacrylamide) (PNIPAAm) hydrogels with interpenetrating polymer networks (IPN) (abstract).
Regarding claim 1: The thermo-responsive hydrogel is an interpenetrating polymer network comprising guar gum, which reads on a hydrophilic polymer, and poly(N-isopropylacrylamide) (PNIPAAm), which reads on a temperature-responsive polymer (abstract; Section 2.2). Regarding the recitation of “cosmetic” in the instant claims, where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation. In the instant case, the entire structure of the functional polymer as recited in the body of the claim, is taught by Li. Even in the case where such a limitation is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See MPEP 2111.02. Li teaches the hydrogels are expected as good candidates for controlled drug delivery systems (abstract), meaning such a hydrogel could also be used in the context of delivering a cosmetic active to the body, therefore reading on a cosmetic.
Regarding claims 2-3: Li teaches that poly(N-isopropylacrylamide) (PNIPAAm) hydrogel is a typically thermo-responsive material which undergoes a phase transition around lower critical solution temperature (LCST) about 33 °C in aqueous media. Specifically, it absorbs water to a swollen state at a temperature below the LCST (i.e., the predetermined temperature), and shrinks with an abrupt volume decrease when the temperature goes above the LCST because of the rapid alteration in hydrophilicity and hydrophobicity (Intro, paragraph 1). The LCSTs of GG/PNIAAm hydrogels determined from their DSC thermograms are shown in Fig. 4. Hydrogels GN10, GN12 and GN13 showed similar LCSTs around 34 °C (Section 3.3, Fig. 4), which falls within the instantly claimed range. Overall, the LCST swelling behavior reads on the functional effect described in the instant claims. Despite this teaching, the composition anticipated by Li is identical to the composition claimed. Thus, the composition must necessarily have the characteristics claimed as an inherent property. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
Regarding claims 4 and 8: The IPN hydrogels comprise poly(N-isopropylacrylamide) (PNIPAAm) as the temperature-sensitive polymer, which reads on a poly(N-alkyl (meth)acrylamide) as claimed.
Regarding claims 5 and 9: The IPN hydrogels comprise guar gum as the hydrophilic polymer.
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.
1. Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Sakikawa in view of Ron, E., et al. (WO 9848768 A1; 11/05/1998; PTO-892), hereinafter Ron.
The teachings of Sakikawa are discussed above. As discussed above, the impregnation material of Sakikawa is formed of the temperature-responsive polymer and the hydrophilic polymer. The impregnation material is impregnated with a solution containing an active ingredient, such as a serum or a chemical solution (col. 5-6, bridging paragraph). The active ingredient is a component such as a cosmetically effective cosmetic ingredient or a pharmaceutically effective medicinal ingredient (col. 6, lines 6-8).
The teaching of Sakikawa differ from that of the instant invention in that Sakikawa does not explicitly disclose a powder or liquid formulation as defined in claims 6-7 and 10-11.
Ron discloses a cosmetic composition comprising a reverse thermal viscosifying polymer network comprising at least one poloxamer component capable of aggregation in response to a change in temperature randomly bonded to at least one poly(acrylic acid) component (abstract; claim 1). The polymer network gel compositions exhibit a reversible gelation at body temperature (25-40°C) (p. 10, lines 24-25). Specifically, the cosmetic composition is of low viscosity at or below room temperature and is of high viscosity at or around body temperature (p. 11, lines 24-28). Exemplary cosmetic and personal care applications, for which the reversibly gelling polymer network composition may be used include baby powders, fragranced powders, face powders, and foot powders (p. 18-19, bridge paragraph; claim 19), all of which read on the powder cosmetic of claim 6 and 10. The composition may also be formulated and applied as a liquid (p. 12, lines 10-11). Exemplary cosmetic formulations include shampoos, bath oils, rinses, mouthwashes, detergents, and various other products which would be in liquid form (p. 18-19, bridge paragraph; claim 19), thereby reading on the liquid cosmetic of claims 7 and 11.
It would have been prima facie obvious, prior to the effective filing date of the claimed invention, to formulate the temperature responsive polymer network of Sakikawa into a powder or liquid cosmetic as taught by Ron since these are known and routine cosmetic formulations in the art as taught by Ron. One of ordinary skill in the art could have incorporated the temperature responsive polymer network of Sakikawa into any of the cosmetic formulations taught by Ron according to known methods to predictably yield the instant invention. Sakikawa teaches the impregnation of cosmetically active agents into the polymer networks, meaning it would be especially obvious to formulate these cosmetically active, impregnated polymers into any cosmetic formulation known in the art. The selection of a powder or liquid formulation entails no more than choosing from a finite number of identified, predictable solutions. One of ordinary skill in the art would have had a reasonable expectation of success in incorporating the polymer network of Sakikawa into the cosmetic forms taught by Ron, since Ron teaches these forms as compatible with similar temperature responsive polymer networks.
Conclusion
No claims allowed.
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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