DETAILED ACTION
Claims 1-8 are currently pending and under examination.
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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Japan on 08/09/2023. It is noted, however, that applicant has not filed a certified copy of the JP2023-129694 application as required by 37 CFR 1.55.
Information Disclosure Statement
Applicant’s Informational Disclosure Statement, filed on 06/14/2024 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
Claim Objections
Claims 3 and 7 are object to because of the following informalities: Claims 3 and 7 contain the limitation SVCT2, SLC7A11 and ABCC1 which are abbreviations not previously defined in the instant claims. Appropriate correction is required.
Claims 1, 2, 3, 5 and 7 are object to because of the improper Markush claim language. It is recommended to amend claims with “at least one selected from the group consisting of…and…”. For the purpose of examination, “at least one of a group consisting of…and…” is interpreted as at least one is selected from a list of alternatively useable members.
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 1-8 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.
Claims 1-2 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: the point of application. Instant claims 1 and 2 are directed to methods for amplifying expression of transport related genes in epidermal cells wherein the method steps are applying a diacylglycerol PEG adduct. Instant claims 1 and 2 do not recite the point of application which would result in the amplified expression in epidermal cells. Claims 3-8 are further rejected as dependent on claims 1-2 and do not cure the ambiguity.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-4 and 7-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2022/0160755.
Regarding claims 1-3 and 7, the limitation of a method for amplifying expression of a transporter-related gene in epidermal cells, the method comprising applying a diacylglycerol PEG adduct having a structure claimed, wherein the diacylglycerol PEG adduct is at least one of a group consisting of PEG-12 glycerol dimyristate, PEG-12 glycerol distearate, PEG 23 glycerol distearate, PEG-23 glycerol dipalmitate and PEG 12 glycerol dioleate is met by the ‘755 publication teaching method for enhancing expression of an antioxidant-related substance in an epidermis is provided which includes applying a diacylglycerol PEG adduct to the epidermis as an active ingredient. The diacylglycerol PEG adduct is selected form the group consisting of PEG-12 glycerol dimyristate, PEG-12 glycerol distearate, PEG 23 glycerol distearate, PEG-23 glycerol dipalmitate and PEG 12 glycerol dioleate (abstract).
Regarding the amplifying expression of a transporter related gene in epidermal cells, specifically SVCT2, SLC7A11, glutathione reductase, ABCC1 and aquaporin 3 is met by the ‘755 publication teaching the active step of application to the epidermis of the claimed compositions, which would inherently result in the amplified expression of a transporter related gene absent factual evidence to the contrary. “Products of identical chemical composition can not 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).
Regarding claims 4 and 8, the limitation of wherein the diacylglycerol PEG adduct permeates into epidermis in a solution state or a vesicle state is met by the ‘755 publication teaching the diacylglycerol PEG adduct permeates an epidermis in a vesicle state [0010].
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.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0160755 in view of US 2003/0032680.
Regarding claims 1-3 and 7, the limitation of a method for amplifying expression of a transporter-related gene in epidermal cells, the method comprising applying a diacylglycerol PEG adduct having a structure claimed, wherein the diacylglycerol PEG adduct is at least one of a group consisting of PEG-12 glycerol dimyristate, PEG-12 glycerol distearate, PEG 23 glycerol distearate, PEG-23 glycerol dipalmitate and PEG 12 glycerol dioleate is met by the ‘755 publication teaching method for enhancing expression of an antioxidant-related substance in an epidermis is provided which includes applying a diacylglycerol PEG adduct to the epidermis as an active ingredient. The diacylglycerol PEG adduct is selected form the group consisting of PEG-12 glycerol dimyristate, PEG-12 glycerol distearate, PEG 23 glycerol distearate, PEG-23 glycerol dipalmitate and PEG 12 glycerol dioleate (abstract).
Regarding the amplifying expression of a transporter related gene in epidermal cells, specifically SVCT2, SLC7A11, glutathione reductase, ABCC1 and aquaporin 3 is met by the ‘755 publication teaching the active step of application to the epidermis of the claimed compositions, which would inherently result in the amplified expression of a transporter related gene absent factual evidence to the contrary. “Products of identical chemical composition can not 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).
Regarding claims 4 and 8, the limitation of wherein the diacylglycerol PEG adduct permeates into epidermis in a solution sate or a vesicle state is met by the ‘755 publication teaching the diacylglycerol PEG adduct permeates an epidermis in a vesicle state [0010].
Regarding claim 6, the limitation of further comprising hydroquinone is met by the ‘755 publication teaching hydroquinone being contained in cosmetic as a skin whitening ingredient wherein it is possible to suppress oxidation of hydroquinone with PEG adduct ([0057], [0171]-[0177]).
The ‘755 publication does not specifically teach the cosmetic or the skin external preparation further comprising at least one of ascorbic acid, an ascorbic acid derivative, glutathione and cysteine (claim 5).
The ‘680 publication teaches oil in water emulsion containing hydroquinone and retinol (abstract). Hydroquinone is well-recognized as an efficacious skin-lightening agent. When topically applied it produces a reversible depigmentation of the skin by inhibiting the enzymatic oxidation of tyrosine as well as suppressing other metabolic processes [0005]. The composition is administered to the skin [0015]. The hydroquinone compristion may contain additional ingredients. Typical optional additional ingredients in the hydroquinone compristion include antioxidants. Examples include ascorbic acid and cysteine and the like. The amount of antioxidant may vary and is provided that is sufficient to give hydroquinone the desired stability ([0040], Example 1). Hydroquinone is taught to have a sensitivity to oxygen [0043]. The preparation may be in the form of a cream [0063].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to include ascorbic acid in the compristion taught by the ‘755 publication because the ‘755 publication teaches compositions including hydroquinone and the ‘680 publication teaches the inclusion of ascorbic acid in compositions which include hydroquinone. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to include ascorbic acid in the composition of the ‘755 publication because the ‘680 publication teaches the inclusion of ascorbic acid to stabilize hydroquinone and the ‘755 publication teaches compositions which include hydroquinone. One of ordinary skill in the art before the filing date of the claimed invention would be a reasonable expectation of success as the ‘755 publication and the ‘680 publication are both directed to hydroquinone containing compositions to be applied topically in cream form.
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 1-4 and 7-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,642,369. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘369 patent teaches a method of enhancing expression of an antioxidant in an epidermis comprising applying a diacylglycerol PEG adduct including PEG-12 glycerol dimyristate wherein the PEG adduct permeates the epidermis in a vesicle state. The ’369 patent teaches the same compositions applied to the skin as instant claimed and thus would inherently result in the amplifying expression of a transport-related gene in epidermis cells, absent factual evidence to the contrary.
Claim 1-4 and 7-8 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of copending Application No. 18/744,384 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘384 application teaches a method of amplifying expression of an epidermal barrier function-related gene comprising applying a diacylglycerol PEG adduct including PEG-12 glycerol dimyristate wherein the PEG adduct permeates the epidermis in a vesicle state. The ‘384 publication teaches the same compositions applied to the skin as instant claimed and thus would inherently result in the amplifying expression of a transport-related gene in epidermis cells, absent factual evidence to the contrary.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/ Examiner, Art Unit 1613