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
The present application is a continuation of and claims priority to U.S. Application No. 18/216,089, filed June 29, 2023, which is a continuation of and claims priority to U.S. Application No. 17/443,699, filed July 27, 2021, now U.S. Patent No. 11,730,740, which claims priority to U.S. Provisional Application No. 63/057,503 filed July 28, 2020.
Status of Claims
Claims 1-20 are pending.
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 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.
§ 103 Rejection over Xi in view of Crutchley
Claims 1-3, 5-13, and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over H. Xi et. al. (US 2020/0276109 A1, "Xi" cited in the IDS dated 08/06/2024) in view of N. Crutchley (WO 2020/025910 A1, 02/06/2020, "Crutchley" cited in the IDS dated 08/06/2024).
Xi teaches a pharmaceutical composition comprising a JAK inhibitor, SHR0302 or a pharmaceutically acceptable salt thereof, and diethylene glycol monoethyl ether. [Xi, pg. 1, 0007]. Xi teaches that the JAK inhibitor, SHR0302 has the following chemical structure:
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Xi teaches that SHR0302 “has a poor ability to penetrate the skin barrier and stay in the skin, and the pharmaceutical composition thereof has a risk of uneven content”. [pg. 1, 0006]. Xi teaches that the content of SHR0302 in the composition is about 0.1% to 20%, preferably about 0.1% to 10%, and can be for example, 0.51%. based on the total weight of the pharmaceutical composition [pg. 2, 0012].
The primary difference between Xi and the instant claims is that Xi does not teach SHR0302 in combination with laurth-4.
Crutchley teaches a composition for topical application comprising a continuous aqueous phase, a discontinuous liquid oil phase and crisaborole that achieve improved skin penetration. [pg. 3, lines 5-10]. Crutchley teaches preferably, the composition comprises one or more further pharmaceutically active agents useful for the treatment of atopic dermatitis or psoriasis, including JAK inhibitors. [pg. 10, lines 5-25]. Crutchley teaches that the topical composition preferably comprises two surfactants, a first surfactant incorporated into the discontinuous liquid oil phase, and the second different surfactant incorporated into the continuous aqueous phase [pg. 8 lines 35-38]. Crutchley teaches that most preferably, the first surfactant is Laureth-4 (polyoxyethylene (4) monododecyl ether), and the second surfactant is Polysorbate 20, wherein the composition has a total surfactant content of less than 5 wt% by weight of the composition [pg. 9 lines 8-11].
In Example 1, Crutchley teaches the following exemplary topical composition.
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While Crutchley’s Example 1 above does not include JAK inhibitor, Crutchley’s Example 1 comprises a solvent and laureth-4 in an amount of 0.7%. However as discussed above, Crutchley specifically teaches that his disclosed formulations are used in combination with a JAK inhibitor.
One of ordinary skill seeking to treat atopic dermatitis is motivated to include 0.51% of the JAK inhibitor SHR0302 (as taught by Xi) in Crutchley’s Example 1 topical formulation (that comprises 0.7 wt% laureth-4) because Crutchley expressly teaches that the compositions preferably include additional active agents useful for the treatment of atopic dermatitis or psoriasis, including JAK kinase inhibitors and Xi teaches that SHR0302 is JAK inhibitor useful for the treatment of atopic dermatitis or psoriasis. The ordinary artisan is further motivated because Xi specifically teaches that SHR0302 in the amount of 0.51% is effective. One of ordinary skill in the art would have been greatly motivated to use Crutchley’s laureth-4 to formulate Xi’s SHR0302 to solve poor skin penetration of SHR0302 because Crutchley teaches that using the discontinuous liquid oil phase, achieves improved skin penetration [pg. 3, line 10-13], wherein the discontinuous liquid oil phase is preferably Laureth-4 (polyoxyethylene (4) monododecyl ether). [pg. 9, line 8]. One of ordinary skill is further motivated to topically apply this composition to a patient with atopic dermatitis to treat the atopic dermatitis. One of ordinary skill thus meets each and every limitation of claim 1.
Claims 2, 12 and 18 are met because Xi teaches that the amount of SHRO303 is 0.51% based on the total weight of the pharmaceutical composition
Claims 3, 13 and 19 are met because the amount of laureth-4 is 0.7%.
Regarding to claim 5, Crutchley’s Example 1’s capric triglyceride corresponds to the claim 6 recitation of any of “a emulsifier, a moisturizer, or a thickener”.
Regarding to claim 6, Crutchley’s Example 1 composition meets the claim 6 recitation of “oil in water emulsion” because Critchley teaches that “the composition is in the form of an oil-in-aqueous dispersion”. [pg. 10, lines 36].
regarding claims 7 and 15, Crutchley teaches that the composition further comprises one or more pharmaceutically active agents useful for the treatment of atopic dermatitis or psoriasis, include but not limited to topical corticosteroids [pg. 10 lines 5-23]. one of ordinary skill is motivated to further include a corticosteroid in the composition because Crutchley expressly teaches that the composition may further include topical corticosteroids. [pg10, lines 10-15].
Regarding claims 9 and 10, Xi teaches that the disclosed pharmaceutical composition is useful for treating or preventing an immune system disorder or disease, for example, psoriasis, rash, atopic dermatitis. [pg. 3, 0034]. Crutchley teaches that the disclosed composition or combination as described is for use in the treatment of atopic dermatitis or psoriasis. [pg. 16, lines 26-27]. Crutchley further teaches that the composition is for the treatment of atopic dermatitis or psoriasis in human or animal subject and can also be used to treat other inflammatory dermatological conditions [pg. 16, lines 33-37].
Respecting claim 11, Crutchley teaches the composition or combination is preferably administered at least once a week, more preferably at least once a day [Crutchley, pg. 17, lines 13-14], which meets the limitation of claim 11.
Claims 8, 16 and 17 are also obvious over the above proposed combination of Crutchley and Xi for the following reasons. Claim 8 further limits claim 1 by “wherein skin penetration of the topical pharmaceutical composition is enhanced by 5-fold to 30-fold relative to a topical pharmaceutical formulation without laureth-4 as measured by in vitro permeation testing” and claims 18 and 19 recite similar functional limitations. The combination of Xi and Crutchley teach substantially identical composition as claimed, specifically the amount of the laureth-4 as taught in the specification [0014]. As such, it is reasonable to presume that the prior arts composition will also have the same functional properties. Applicants are reminded that the office does not have the facilities and resources to determine the skin penetration of the topical composition. In the absence of evidence to the contrary, the burden is on applicants to show that this property is different from those taught by prior art and to establish patentable differences. See in re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977).
§ 103 Rejection over Xi in view of Crutchley, further in view of Arkin
Claims 4, 14 and 20 are rejected over H. Xi et. al. (US 2020/0276109 A1, "Xi" cited in the PTO-892) in view of N. Crutchley (WO 2020/025910 A1, 02/06/2020, "Crutchley" cited in the PTO-892) as applied above to claims 1-3, 5-13 and 15-19 in further view of M. Arkin et. al. (US 2020/0197397 Al, 06/25/2020, "Arkin" cited in the IDS dated 08/06/2024).
The disclosures set forth above in the 103 rejection over the same Xi and Crutchley references are herein incorporated by reference.
The combination of Xi and Crutchley does not teach that the composition further comprises dimethyl sulfoxide.
Arkin teaches a topical composition for treatment, prevention or alleviation of a skin or mucosal disorder selected from the group consisting of psoriasis, palmoplantar psoriasis, acquired palmoplantar keratosis, eczema, ichtyosis vulgaris, etc., comprising administering to a subject in need thereof a therapeutically effective amount of at least one EGFR inhibitor and at least one additional first active agent selected from a corticosteroid, calcipotriene, tapinarof, a Janus kinase inhibitor (JAK inhibitor), a phosphodiesterase-4 inhibitor (PDE4 inhibitor), and combinations thereof [Arkin 0012]. Arkin teaches that the topical composition further comprises at least one penetration enhancer selected from: DMSO (dimethyl sulfoxide), a polyethylene glycol, ethanol, oleic acid, etc., wherein the penetration enhancer has dual functionality and may act also as solvent [Arkin 0064].
One of ordinary skill is motivated to incorporate dimethyl sulfoxide taught by Arkin in the above-discussed topical JAK composition taught by the combination of Xi and Crutchley because as taught by Arkin, dimethyl sulfoxide enhances skin penetration of actives in topical compositions. Thus, one of ordinary skill is motivated to further add dimethyl sulfoxide to the JAK inhibitor, SHR0302 formulation to further enhance the skin penetration of the topical treatment and achieve better treatment.
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.
Double Patenting over USPN 11,730,740 B2
Claims 1-6, 8-14, and 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of USPN 11,730,740 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 1-20 recite “A topical pharmaceutical composition, a method of treating an inflammatory skin disease, disorder, or condition in a subject in need thereof, and a method for enhancing the skin penetration in a human subject comprising SHR0302, laureth-4, and a solvent, wherein the SHR0302 is present in an amount of about 0.1 to about 1.0% w/w, wherein the laureth-4 is present in an amount of about 0.5 to about 5% w/w, wherein the composition further comprising dimethyl sulfoxide, comprising an antioxidant, a preservative, an emulsifier, a moisturizer, or a thickener, a corticosteroid, timolol, methotrexate, or cyclosporine, wherein said composition is selected from the group consisting of 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, wherein the composition administered one or more times per day, and wherein skin penetration of the topical pharmaceutical composition is enhanced by 5-fold to 30-fold relative to the same topical pharmaceutical formulation without laureth-4.
USPN 11,730,740 B2recites in claims 1-16 “a topical pharmaceutical composition comprising SHR0302, laureth-4, and a solvent, a method of treating an inflammatory skin disease, disorder, or condition in a subject in need thereof, and a method for enhancing the skin penetration in a human subject, wherein the SHR0302 is present in an amount of about 0.1 to about 1.0% w/w, wherein the laureth-4 is present in an amount of about 0.5 to about 5% w/w, wherein the composition further comprising dimethyl sulfoxide, an antioxidant, a preservative, an emulsifier, a moisturizer, or a thickener, wherein said composition is selected from the group consisting of 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, wherein the pharmaceutical compositions is administered to the subject one or more times per day, wherein skin penetration of the topical pharmaceutical composition is enhanced by 5-fold to 30-fold relative to the same topical pharmaceutical formulation without laureth-4.
Therefore, USPN 11,730,740 B2meets the limitations of claims 1-6, 8-14 and 16-20
Claims 7 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of USPN 11,730,740 B2 as applied above to claims 1-6, 8-14 and 16-20, in view of N. Crutchley (WO 2020/025910 A1, 02/06/2020, "Crutchley" cited in the PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because:
USPN 11,730,740 B2 does not recite that the topical pharmaceutical composition further comprising a corticosteroid, timolol, methotrexate, or cyclosporine.
Crutchley teaches as discussed above, page 4.
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of instantly claimed invention to include dermatitis and psoriasis drugs, corticosteroid, timolol, methotrexate, or cyclosporine in USPN 11,730,740 B2 SHR0302 and laureth-4 composition for treating dermatitis and psoriasis. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because Crutchley teaches composition for treating dermatitis or psoriasis and teaches that the composition further includes active agents, JAK inhibitor, corticosteroids, cyclosporine, and teaches that the corticosteroid are the known treatment for dermatitis or psoriasis. Moreover, USPN 11,730,740 B2 teaches SHR0302 for treating dermatitis and psoriasis Crutchley teaches that corticosteroids and cyclosporine are active agent for treating dermatitis or psoriasis, 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 there having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Double Patenting over USPN 12,083,122 B2
Claims 1-6, 8-10, 12-14 and 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of USPN 12,083,122 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 1-20 recite “A topical pharmaceutical composition, a method of treating an inflammatory skin disease, disorder, or condition in a subject in need thereof, and a method for enhancing the skin penetration in a human subject comprising SHR0302, laureth-4, and a solvent, wherein the SHR0302 is present in an amount of about 0.1 to about 1.0% w/w, wherein the laureth-4 is present in an amount of about 0.5 to about 5% w/w, wherein the composition further comprising dimethyl sulfoxide, comprising an antioxidant, a preservative, an emulsifier, a moisturizer, or a thickener, a corticosteroid, timolol, methotrexate, or cyclosporine, wherein said composition is selected from the group consisting of 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, wherein the composition administered one or more times per day, and wherein skin penetration of the topical pharmaceutical composition is enhanced by 5-fold to 30-fold relative to the same topical pharmaceutical formulation without laureth-4.
USPN 12,083,122 B2 recites in claims 1-14 “a method for preparing a topical pharmaceutical composition comprising: combining SHR0302, water, and at least one solvent with laureth-4, wherein the amount of laureth-4 is sufficient to improve the skin penetration of SHR0302 relative to the same topical pharmaceutical composition without laureth-4, wherein the SHR0302 is present in an amount of about 0.1 to about 1.0% w/w, wherein the laureth-4 is present in an amount of about 0.5 to about 5% w/w, wherein the solvent is dimethyl sulfoxide, wherein said composition is selected from the group consisting of 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, wherein the amount of laureth-4 is sufficient to improve the skin penetration of SHR0302 by 5-fold to 30-fold relative to the same topical pharmaceutical formulation without laureth-4. Therefore, USPN 12,083,122 B2 meets the limitations of claims 1-6, 8 and 17-20.
Consistent with Sun Pharmaceutical Industries v. Eli Lilly and Col, 611 F. 3d 1381, 1387 (CAFC 2010), it is permissible to use a compound claim to reject a method of use claim where that method of use is disclosed in the specification of the application claiming the compound. According to the Sun Pharma. Court, “[i]t would shock one' s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. . .”. in the instant case, the specification of USPN 12,083,122 B2 discloses that the composition of SHR0302, solvent, laureth-4, and dimethyl sulfoxide is used for treating inflammatory skin diseases, e.g., dermatitis or psoriasis [col. 4, ln. 25-33]. Therefore, USPN 12,083,122 B2 meets the limitations of claims 9-10, 12-14 and 16.
Claims 7, 11 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of USPN 12,083,122 B2 as applied above to claims 1-6, 8-10, 12-14 and 16-20, in view of N. Crutchley (WO 2020/025910 A1, 02/06/2020, "Crutchley" cited in the PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because:
USPN 12,083,122 B2 does not recite that the topical pharmaceutical composition further comprising a corticosteroid, timolol, methotrexate, or cyclosporine.
Crutchley teaches as discussed above, page 4.
The obviousness rationale is the same as the rationale of the non-statutory double patenting rejection above, page 10.
Double Patenting over USPN 12,161,643 B2
Claims 1-6, 8-10, 12-14 and 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of USPN 12,161,643 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 1-20 recite “A topical pharmaceutical composition, a method of treating an inflammatory skin disease, disorder, or condition in a subject in need thereof, and a method for enhancing the skin penetration in a human subject comprising SHR0302, laureth-4, and a solvent, wherein the SHR0302 is present in an amount of about 0.1 to about 1.0% w/w, wherein the laureth-4 is present in an amount of about 0.5 to about 5% w/w, wherein the composition further comprising dimethyl sulfoxide, comprising an antioxidant, a preservative, an emulsifier, a moisturizer, or a thickener, a corticosteroid, timolol, methotrexate, or cyclosporine, wherein said composition is selected from the group consisting of 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, wherein the composition administered one or more times per day, and wherein skin penetration of the topical pharmaceutical composition is enhanced by 5-fold to 30-fold relative to the same topical pharmaceutical formulation without laureth-4.
USPN 12,161,643 B2 recites in claims 1-14 “a topical pharmaceutical composition comprising a pharmaceutically effective amount of SHR0302, wherein SHR0302 is in an amount of about 0.1% w/w to about 1.0% w/w, wherein the topical pharmaceutical composition of claim 1, further comprising laureth-4 and dimethyl sulfoxide, wherein the laureth-4 is present in an amount of about 0.5% w/w to about 5% w/w, wherein the pharmaceutical composition is selected from the group consisting of a cream, a lotion, an oil-in-water emulsion, a water-in-oil emulsion, a microemulsion, a nanoemulsion, a foam, a spray, a gel, a hydrophilic ointment, or a hydrophobic ointment. Therefore, USPN 12,161,643 B2meets the limitations of claims 1-6 and 18-20.
Consistent with Sun Pharmaceutical Industries v. Eli Lilly and Col, 611 F. 3d 1381, 1387 (CAFC 2010), it is permissible to use a compound claim to reject a method of use claim where that method of use is disclosed in the specification of the application claiming the compound. According to the Sun Pharma. Court, “[i]t would shock one' s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. . .”. in the instant case, the specification of USPN 12,161,643 B2 discloses that the composition of SHR0302, solvent, laureth-4, and dimethyl sulfoxide is used for treating inflammatory skin diseases, e.g., dermatitis or psoriasis [col. 8, ln. 53-57]. Therefore, USPN 12,161,643 B2 meets the limitations of claims 9-10 and 12-14.
Claims 8, 16 and 17 are obvious over USPN 12,161,643 B2 for the same rationale discussed in the obviousness rejection above, page 6.
Claims 7, 11 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of USPN 12,161,643 B2 as applied above to claims 1-6, 8-10, 12-14 and 16-20, in view of N. Crutchley (WO 2020/025910 A1, 02/06/2020, "Crutchley" cited in the PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because:
USPN 12,161,643 B2 does not recite that the topical pharmaceutical composition further comprising a corticosteroid, timolol, methotrexate, or cyclosporine.
Crutchley teaches as discussed above, page 4.
The obviousness rationale is the same as the rationale of the non-statutory double patenting rejection above, page 10.
Double Patenting over Copending Application No. 18/962,371
Claims 1-6, 8-10, 12-14 and 16-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 18/962,371 (US PG-PUB 20250090535A1). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 1-20 recite “A topical pharmaceutical composition, a method of treating an inflammatory skin disease, disorder, or condition in a subject in need thereof, and a method for enhancing the skin penetration in a human subject comprising SHR0302, laureth-4, and a solvent, wherein the SHR0302 is present in an amount of about 0.1 to about 1.0% w/w, wherein the laureth-4 is present in an amount of about 0.5 to about 5% w/w, wherein the composition further comprising dimethyl sulfoxide, comprising an antioxidant, a preservative, an emulsifier, a moisturizer, or a thickener, a corticosteroid, timolol, methotrexate, or cyclosporine, wherein said composition is selected from the group consisting of 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, wherein the composition administered one or more times per day, and wherein skin penetration of the topical pharmaceutical composition is enhanced by 5-fold to 30-fold relative to the same topical pharmaceutical formulation without laureth-4.
Copending Application No. 18/962,371 recites in claims 1-10 “a topical pharmaceutical composition comprising a pharmaceutically effective amount of SHR0302 and about 20% to about 30% of dimethyl sulfoxide, wherein the topical pharmaceutical composition comprising SHR0302 in an amount of about 0.1 to about 1.0% w/w, about 0.6% w/w, about 0.5% w/w, wherein the topical pharmaceutical composition further comprising laureth-4, wherein the laureth-4 is present in an amount of about 0.5 to about 5% w/w, wherein the pharmaceutical composition is selected from the group consisting of a cream, a lotion, an oil-in-water emulsion, a water-in-oil emulsion, a microemulsion, a nanoemulsion, a foam, a spray, a gel, a hydrophilic ointment, or a hydrophobic ointment. Therefore, copending Application No. 18/962,371 meets the limitations of claims 1-6 and 18-20.
Consistent with Sun Pharmaceutical Industries v. Eli Lilly and Col, 611 F. 3d 1381, 1387 (CAFC 2010), it is permissible to use a compound claim to reject a method of use claim where that method of use is disclosed in the specification of the application claiming the compound. According to the Sun Pharma. Court, “[i]t would shock one' s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. . .”. in the instant case, the specification of copending Application No. 18/962,371 discloses that the composition of SHR0302, solvent, laureth-4, and dimethyl sulfoxide is used for treating inflammatory skin diseases, e.g., dermatitis or psoriasis [col. 8, ln. 53-57]. Therefore, copending Application No. 18/962,371 meets the limitations of claims 9-10 and 12-14.
Claims 8, 16 and 17 are obvious over Co-pending Application No. 18/962,371 for the same rationale discussed in the obviousness rejection above, page 6.
Claims 7, 11 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 copending Application No. 18,962,371 (US PG-PUB 2025/0090535 A1) as applied above to claims 1-6, 8-10, 12-14 and 16-20, in view of N. Crutchley (WO 2020/025910 A1, 02/06/2020, "Crutchley" cited in the PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Copending Application No. 18,962,371 does not recite that the topical pharmaceutical composition further comprising a corticosteroid, timolol, methotrexate, or cyclosporine.
Crutchley teaches as discussed above, page 4.
The obviousness rationale is the same as the rationale of the non-statutory double patenting rejection above, page 10.
Conclusion
Claims 1-20 are rejected. No claim is allowed.
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/M.M.A./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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