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 .
Priority
Examiner acknowledges that, according to the Filing receipt received 12/10/2024, that the instant application 18/962,371 filed 11/27/2024 is a continuation of 18/065,772 filed 12/14/2022, which claims domestic benefit of U.S. provisional applications 63/289,780 filed 12/15/2021 and 63/370,740 filed 08/08/2022. All of the instant claims have been awarded the effective filing date of 12/15/2021.
Information Disclosure Statement
The Information Disclosure Statements filed on 11/27/2024, 08/13/2025, and 06/15/2026 are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of list of references cited from the IDS is included with this Office Action.
Claim Objections
Claim 1 is objected to because of the following informalities: "sufloxide" should read "sulfoxide". Appropriate correction is required.
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 and 3-10 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.
Claim 1 recites “about 20% to about 30% of dimethyl sulfoxide”. The amounts “20%” and “30%” are not associated with any particular units (e.g., w/w or v/v) and are therefore unclear. Claims 3-10 require and do not clarify the limitation at issue and are also rejected. Clarification is requested.
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.
Claim(s) 1 and 3-8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Osborne (US 2022/0031705 A1; filed July 27, 2021; IDS filed 11/27/2024).
Osborne teaches a formulation #11 that comprises 0.5% w/w SHR0302 and 30% w/w DMSO (p. 8, col. 1, par. 0083). Formulation #11 further comprises laureth-4 in an amount of 4.0% w/w (p. 8, col. 1, par. 0083). In paragraph [0045], Osborne discloses that SHR0302 is also known as ARQ-250 and has the following structure.
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Osborne teaches that formulation #11 is a cream (p. 8, col. 1, par 0084).
The above applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claim(s) 1, 3-5, and 8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Osborne et al. (US 2022/0152033 A1; effectively filed 2020; IDS filed 11/27/2024).
Osborne et al. discloses a composition, which comprises 0.3% w/w SHR0302 and 30% w/w DMSO (p. 6, Table 1). Osborne et al. further discloses that the composition is a cream (p. 6, par. 0072).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claim(s) 1, 3-5, and 8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Osborne et al. (US 11628177 B2; effectively filed 2020; IDS filed 11/27/2024).
Osborne et al. discloses a composition, which comprises 0.3% w/w SHR0302 and 30% w/w DMSO (col. 14, Table 1). Osborne et al. further discloses that the composition is a cream (col. 14, lines 36-38).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claim(s) 1, 3-5, and 8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Osborne et al. (US 2023/0226083 A1; effectively filed 2020; IDS filed 11/27/2024).
Osborne et al. discloses a composition, which comprises 0.3% w/w SHR0302 and 30% w/w DMSO (p. 8, Table 1). Osborne et al. further discloses that the composition is a cream (p. 6, par. 0091).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claim(s) 1, 3-5, and 8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Osborne et al. (US 2023/0414511 A1; effectively filed 2020; IDS filed 11/27/2024).
Osborne et al. discloses a composition, which comprises 0.3% w/w SHR0302 and 30% w/w DMSO (p. 6, Table 1). Osborne et al. further discloses that the composition is a cream (p. 6, par. 0072).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claim(s) 1, 3-5, and 8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Osborne (US 2023/0338383 A1; effectively filed 2020; IDS filed 11/27/2024).
Osborne discloses a composition comprising 0.5% w/w SHR0302, 30% w/w DMSO, and 4.0% w/w laureth-4 (p. 8, Experimental Example 9, Formulation 11). Osborne further discloses that the composition is a cream (p. 9, par. 0085).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claim(s) 1, 3-5, and 8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Osborne (WO 2022/027041 A1; effectively filed 2020; IDS filed 11/27/2024).
Osborne discloses a composition comprising 0.5% w/w SHR0302, 30% w/w DMSO, and 4.0% w/w laureth-4 (p. 25, Experimental Example 9, Formulation 11). Osborne further discloses that the composition is a cream (p. 26, par. 0095).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claim(s) 1, 3-5, and 8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Higham et al. (US 2022/0133728 A1; filed October 28, 2021; IDS filed 11/27/2024).
Higham et al. teaches a formulation (ARQ-252 0.3% Cream) comprising 30.0% w/w DMSO and 0.3% w/w SHR0302 (p. 6, col. 1).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
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.
Claims 1-2 and 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (EP 3714887 A1; 2020) in view of Herschler (US 3,711,602 A; IDS) and Kushwaha (Journal of Bioequivalence & Bioavailability; 2018).
Jiang et al. teaches a composition, Embodiment 2, comprising 2 g, or 2% w/w, of an active ingredient (3aR, 5s, 6aS)-N-(3-methoxy-1,2,4-thiadiazol-5-yl)-5-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino) hexahydrocyclo-penta[c]pyrrole-2(1H)-carboxamide (p. 5, table 1, embodiment 2) with the following structure (p. 2 par 0005).
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Jiang et al. further discloses that Embodiment 2 is stable under long-term conditions at 25⁰C ± 2⁰C at 6 months, 9 months, and 12 months (p. 8, pars 0038-0039, Table 5). As stated in the instant specification, paragraph [00055], controlled room temperature is defined as 20 to 25⁰C. Examiner additionally notes it would be reasonable for one of ordinary skill in the art to conclude that Embodiment 2 is also stable at 8 months. The disclosed compositions are described as ointments (p. 6, par. 0030) wherein Embodiment 2 further comprises water-miscible (i.e., hydrophilic) components PEG400 and PEG4000 (p. 5, table 1, embodiment 2).
Jiang et al. does not teach that the composition further comprises laureth-4, or that laureth-4 is present at an amount between about 0.5% w/w to about 5% w/w. Jiang et al. does not teach that the formulation comprises dimethyl sulfoxide in an amount of about 20% to about 30 or 20 to about 27% w/w. However, these limitations are obvious over Herschler and Kushwaha.
Herschler teaches compositions for topical application comprising at least 10% by weight DMSO in a preferred embodiment (col. 6, lines 8-9). Herschler further discloses that DMSO can be used to increase permeability of tissues, resulting in increased penetration rates when applied with physiologically active agents (col. 3, lines 15-19). Furthermore, the concentration of DMSO can be varied to account for desired results, such as a lower concentration of DMSO for a localized effect (col. 5, lines 41-46).
Kushwaha teaches a topical formulation comprising 5% w/w laureth-4 and that laureth-4 functions as a penetration enhancer (p. 50, col. 2, par. 3 and Table 1).
It would have been prima facie obvious to one of ordinary skill in the art to combine DMSO with Embodiment 2 of Jiang et al. One would have been motivated to do so because Jiang et al. discloses that the motivation of the composition is to enhance penetration of the stratum corneum (p. 2, par 0006). There would have been reasonable expectation of success because DMSO can act as a penetration enhancer.
It would have been prima facie obvious to one of ordinary skill in the art to optimize the amount of DMSO in the formulation to between about 20% w/w and about 30% w/w, and further to 20% to about 27% w/w. One would have been motivated to do so because the range of at least 10% by weight disclosed by Herschler overlaps with the range of the instant invention. Furthermore, the claimed ranges are greater than at least 10% by weight. There would have been reasonable expectation of success because Herschler further discloses that the amount of DMSO present in the formulation can be optimized for local topical application.
It would have been prima facie obvious to one of ordinary skill in the art to combine laureth-4, in an amount of 5% w/w, with Embodiment 2 of Jiang et al. One would have been motivated to do so because Jiang et al. discloses that the motivation of the composition is to enhance penetration of the stratum corneum (p. 2, par 0006). There would have been reasonable expectation of success because laureth-4, at a concentration of 5% w/w, can act as a penetration enhancer in a topical formulation.
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 and 3-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11730740 (“the ‘740 patent”; IDS filed 11/27/2024).
Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed toward a topical pharmaceutical composition comprising SHR0302, laureth-4, and dimethyl sulfoxide (claims 1-4). Claim 6 is additionally directed toward compositions selected from an oil-in-water emulsion, a water-in-oil emulsion, a microemulsion, a nanoemulsion, a foam, a spray, a hydrophilic ointment, or a hydrophobic ointment. When looking to the specification to construe the scope of claim 1, Formulation 11 in column 15 specifically delineates a composition comprising 0.5% w/w SHR0302 and 30% w/w DMSO and 4.0% w/w laureth-4. Thus, the scope of the instant claims and those of the '740 patent overlap such that it would be prima facie obvious for one of ordinary skill in the art to arrive at the instant invention.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-14 of U.S. Patent No. 12161643 (“the ‘643 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 9 of the ‘740 patent is directed toward a topical pharmaceutical composition comprising a pharmaceutically effective amount of SHR0302 and about 25% w/w of dimethyl sulfoxide. Claim 10 limits the amount of SHR0302 to 0.1-1% w/w. Claims 11-12 further limit the composition to comprising laureth-4 in an amount of 0.5-5% w/w. Claim 13 is directed toward compositions selected from an oil-in-water emulsion, a water-in-oil emulsion, a microemulsion, a nanoemulsion, a foam, a spray, a hydrophilic ointment, or a hydrophobic ointment. Claim 14 is directed toward a topical pharmaceutical composition comprising a pharmaceutically effective amount of SHR0302 and about 20-30% w/w of dimethyl sulfoxide, wherein the pharmaceutical composition inhibits crystal growth at controlled room temperature for 6 months. Claims 9-14 of the ‘740 patent therefore anticipate at least instant claims 1-3 and 6-8.
When looking to the specification to construe the scope of claims 9 and 14 of the ‘740 patent, column 15 (Table 1) discloses Formulation A comprising 0.3% w/w SHR0302 and 30% w/w dimethyl sulfoxide. Column 18 (Example 2) discloses Formulation C comprising 0.3% w/w SHR0302, 25% w/w dimethyl sulfoxide, and 4% laureth-4 which exhibited stability at room temperature for up to 12 months. Thus, the scope of the instant claims and those of the '643 patent overlap such that it would be prima facie obvious for one of ordinary skill in the art to arrive at claims 4-5 and 9-10 of the instant invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADELINE E BRAUN whose telephone number is (703)756-4533. The examiner can normally be reached M-F 8:30am-5:00pm ET.
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/MADELINE E BRAUN/Examiner, Art Unit 1624 09/25/2026
