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 .
Election/Restrictions
Acknowledgement is made to Applicant’s response filed 04/07/2026.
Claims 17-23 are pending.
Claims 17-23 are currently under consideration to the extent that they read upon Applicant’s elected species.
NOTE: Applicant elected –
-an active ingredient comprising spironolactone
a primary particle size distribution of the spironolactone is characterized by a D90 value of less than about 20 μm
a silicone selected from the group consisting of dimethicone and cyclomethicone.
Drawings
The drawings filed on 05/16/2023 are objected to because the title of the graphs is missing from Figures 1-6. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Abstract
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art. If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives. Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps. Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length. See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract is objected to because it includes non-objective, promotional language (e.g., "surprising discovery") and unnecessary self-referential phrasing (e.g., “inventors of the present invention”). Such language is inconsistent with the requirement that the abstract provide a concise, factual summary of the disclosure. Correction is required to ensure the abstract is written in formal, technical, and non-persuasive language. See MPEP § 608.01(b), which requires that the abstract be a brief statement of the technical disclosure and should not include statements of alleged advantages or merits, as well as any language that departs from an objective presentation of the invention.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/16/2023, 08/30/2023 ,04/30/2024, 10/11/2024, 03/25/2025, 12/10/2025, 03/24/2026, 04/27/2026, 05/21/2026 and 06/04/2026 are being considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
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.
Claims 17-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by MEHTA et al. (CN111278466A; as submitted on IDS of 05/16/2023).
MEHTA teaches a composition in the form of a liquid comprising imatinib (which reads on an active pharmaceutical ingredient) with a particle size of D90 of less than 20um, 10um, 5um, about 1um or 0.5um (See e.g. page 18, first full paragraph) (which reads on the sizes claimed in claims 17, 19 and 20). MEHTA further teaches that imatinib can be part of a formulation with dimethicone (See e.g. Example 5, Table 7, step 7 on page 23) (which reads on claim 17). MEHTA discloses that the formulation can be topical (See e.g. p. 6, para 5 and page 10, para 1). MEHTA teaches that the dosage comprises about 0.01 to about 25% w/v (See e.g. claim 1, which reads on an effective amount and the limitations of claim 18, since this amount encompasses the range claimed).
Although MEHTA et al. does not expressly teach that the formulation is delivered to the pilosebaceous unit and is capable of achieving dermal penetration, this delivery and dermal penetration is inherent to the formulation taught by MEHTA et al. because the ingredients, delivery formulation/type and amounts and particle size are the same as that claimed by Applicant. Therefore, the functional effects would be inherent based upon the fact that the formulation is for topical administration and contains the instantly claimed ingredients, particle size and amounts.
Therefore, the reference anticipates the instantly claimed invention.
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.
Claims 17-22 are rejected under 35 U.S.C. 103 as being unpatentable over Shanler et al. (US 20190060311 A1; as submitted on IDS of 05/16/2023) in view of Rowe et al (Handbook of Pharmaceutical Excipients, 6th ed., 2009; as submitted on IDS of 05/16/2023), and of Xi et al. (US 20200276109 A1; as submitted on IDS of 05/16/2023), and further in view of Mainero et al. (WO2019143971A2; as submitted on IDS of 05/21/2026).
Regarding instant claims 17-20, Shanler teaches a pharmaceutical composition comprising a JAK/STAT modulating compound for treating dermatological conditions, wherein SHR0302 is encompassed as an embodiment and may be present in amounts of about 0.5% to about 5% w/w of the composition (abstract; [0001]- [0004], [0126]; claims 1, 9 and 15). Shanler further teaches that the composition may be formulated for topical or transdermal administration ([0001], [0091], claims 6 and 21), thereby disclosing a topical pharmaceutical composition comprising a therapeutically effective amount of SHR0302 or a pharmaceutically acceptable salt thereof. Shanler discloses the JAK/STAT modulating compound is in a pharmaceutical composition further comprising a pharmaceutically acceptable excipient ([0002]).
Shanler teaches formulations comprising nanoparticle, nanoparticle suspension, or nanosuspension ([0002], [0063], [0093]), which essentially correspond to particle populations in the submicron size range. Accordingly, the disclosed nanoparticle systems inherently fall within the claimed particle size distribution limitation of a D90 < 20 µm, < 10 µm, and < 5 µm. In this regard, nanoscale systems are fully submicron, such that their entire particle size distribution resides below the claimed limit, and cumulative distribution values, including D100, would likewise fall below the restricted limitation < 5 µm. Particle size distribution parameters such as D10, D50, and D90 represent conventional, art-recognized statistical descriptors used to characterize known particle populations and do not impart any structural distinction over the disclosed particle size. Where the prior art discloses overlapping or encompassing size ranges, optimization of particle size is considered a matter of routine experimentation (see MPEP 2144.05). Accordingly, it would have been obvious to a person of ordinary skill in the art at the time of the invention to characterize Shanler’s nanoparticles using routine particle size analysis techniques and to express the resulting distributions in terms of D-values during routine formulation development. Such routine characterization would necessarily yield values falling within the claimed ranges as a property of the disclosed nanoscale system.
Xi teaches a pharmaceutical composition comprising SHR0302
((3aR,5s,6aS)-N-(3-methoxy-1,2,4-thiadiazol-5-yl)-5-(methyl(7H-pyrrolo[2,3- d]pyrimidin-4-yl)amino)hexahydrocyclopenta[c]pyrrole-2(1H)-carboxamide)
(see instant paragraph [00055]), or a pharmaceutically acceptable salt thereof, in an amount of 0.1-20 wt.% based on the total composition (reference claim 5). Xi further teaches use of the composition for treating or preventing immune system disorders, including skin diseases (e.g., psoriasis, rash, atopic dermatitis) and skin cancers (e.g., cutaneous T-cell and B-cell lymphomas) (reference paragraph [0033]-[0035]). Xi also teaches that the active ingredient has a particle size ≤ 50 μm, including ranges from 50-2 μm, preferably ≤ 30 μm, more preferably ≤ 20 μm (reference paragraph [0029]; claims 12 and 22). Xi therefore teaches particle size ranges that overlap with the ranges recited in instant claims 1 and 4-7. Such overlap establishes a prima facie case of obviousness. The D-values recited in the instant claims is a characterization of particle size distribution as a common practice in the art and does not impart any structural change of the particle size recited in instant claims. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation (see, MPEP § 2144.05). It would have been obvious to one of the ordinary skill in the art at the time of the invention to explore different conditions through routine optimization to achieve the desired particle size and characterize the particle size distribution by D-values as claimed in the instant application.
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Shanler in view of Xi to employ nanoparticle formulations having particle size distributions within the claimed range and to characterize such distributions using conventional D-values.
Shanler teaches that the composition may include pharmaceutically acceptable carriers and excipients selected according to conventional formulation practices for topical administration ([0091], [0110], [01121]). This disclosure encompasses excipients routinely used in topical formulations. Rowe et al. evidences that silicon-based excipients, including cyclomethicone and dimethicone of various viscosities, are well-known pharmaceutically acceptable excipients for topical use. Although Shanler does not explicitly disclose silicone excipients, the selection of such excipients would have been an obvious matter of routine formulation optimization. Mainero teaches topical cream formulation comprising JAK inhibitors (e.g., JAK1, JAK2, JAK3 inhibitors), wherein the active agent is present in amounts of about 0.001% to about 20% by weight, and expressly discloses dimethicone as a component (claims 1, 9, 17; [000114]). Accordingly, it would have been obvious to a person of ordinary skill in the art at the time of the invention to modify the composition of Shanler to include a silicone excipient, such as dimethicone, as taught by Mainero, motivated by the known benefits of such excipients in topical formulations (e.g., improved spreadability, skin feel, and barrier properties). The combination involves the use of a known excipient for its known purpose and would have yielded predictable results.
Regarding instant claims 21-22, the limitation that the composition is “delivered to the pilosebaceous unit” and “achieves dermal penetration of at least 1 mm in the subject” is directed to an intended use and does not further limit the claimed composition. Statements of intended use do not impart structural limitations where the claim otherwise recites a complete invention (See MPEP §2111.02). Therefore, the compositions disclosed by Shanler meet all structural and functional limitations of the claimed subject matter.
Claim(s) 17-23 are rejected under 35 U.S.C. 103 as being unpatentable over Shanler et al. (US 20190060311 A1; as submitted on IDS of 05/16/2023) in view of Rowe et al (Handbook of Pharmaceutical Excipients, 6th ed., 2009), and of Xi et al. (US 20200276109 A1; as submitted on IDS of 05/16/2023), and further in view of Mainero et al. (WO2019143971A2; as submitted on IDS of 05/21/2026) as applied to claim 17-22 above, and further in view of Brichta (WO 2019236596; as submitted on IDS of 05/16/2023).
The teachings of Shanler, Rowe, Xi and Mainero et al have been set forth above. However, they do not expressly disclose including spironolactone as the active pharmaceutical ingredient. Brichta remedies this deficiency.
Brichta teaches topical compositions comprising JAK/STAT inhibitors and one or more penetration enhancer and methods for treating hair loss (i. e. vitiligo, alopecia, etc.) with composition thereof (abstract, [0002]], [0005], [0009], [0043], claims 1-23). Brichta teaches the compositions may further contain a secondary active agent, for example, spironolactone ([0009], [0011], [0033], claims 13-14). Brichta teaches embodiments in various forms, “for example, microcapsules or nanocapsules, nanoemulsions, submicron emulsions, miniemulsions, solid lipid nanoparticles, multiple emulsions, microemulsions, liposomes” ([0053]). Brichta also teaches embodiments comprising liposomal base formulations that include dimethicone ([0043]).
It would have been obvious to one of the ordinary skill in the art at the time of invention to modify the pharmaceutical composition comprising JAK inhibitor ( i. e. SHR03202 ) taught by Shanler, Rowe, Xi and Mainero by combining the teachings of spironolactone as active pharmaceutical ingredient taught by Brichta to arrive at the instant invention with reasonable expectation of success, because at the time the invention was made it was known that SHR03202, a JAK inhibitor, could be combined with active agent to provide a pharmaceutical composition for treating skin disorder as taught by Shanler, Rowe, Xi and Mainero and Brichta.
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.
Claim 17-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-10 of US 11628177 B2.
Claims 1 and 3-10 of reference US 11628177 are directed to a pharmaceutical composition comprising spironolactone and a silicone selected from the group consisting of dimethicone and cyclomethicone which anticipate instant claims 17-23. “Spironolactone characterized by a D90 value of less than about 6 µm” recited in reference claims 1 and 8 of US.11,628,177 is a species of “an active pharmaceutical ingredient characterized by a D90 value of less than about 20 µm” recited in instant claim 17. Reference claims 9 and 10 anticipates “pharmaceutical ingredient is delivered to the pilosebaceous unit” recited in instant claim 21 and “capable of achieving dermal penetration of at least 1 mm” recited in instant claim 22.
The instant application shares at least one common inventor and applicant with the reference patent. Further, the instant application is not related to the US 11628177, thus no 35 USC 121 shield exists. See MPEP 804.01. Therefore, US. US 11628177. anticipates instant application.
Claim 17-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-10 of US 12053481.
Claims 1 and 3-10 of reference US 12053481 are directed topically administering to the subject a pharmaceutical composition comprising: (a) a therapeutically effective amount of SHR0302 or a pharmaceutically acceptable salt thereof, wherein a primary particle size distribution of the SHR0302 is characterized by a D90 value of less than about 20 μm; and (b) a silicone selected from the group consisting of dimethicone and cyclomethicone which anticipate instant claims 17-23. “Spironolactone characterized by a D90 value of less than about 6 µm” recited in reference claims 6-9 of US12053481 is a species of “an active pharmaceutical ingredient characterized by a D90 value of less than about 20 µm” recited in instant claim 17.
The instant application shares at least one common inventor and applicant with the reference patent. Further, the instant application is not related to the US 12053481, thus no 35 USC 121 shield exists. See MPEP 804.01. Therefore, US 12053481 anticipates instant application.
Claim 17 -22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 18/787,360.
Claims 1-9 of reference US application No. 18/787,360 are directed to a pharmaceutical composition comprising spironolactone “. A topical pharmaceutical composition comprising: (a) a therapeutically effective amount of SHR0302 or a pharmaceutically acceptable salt thereof, wherein a primary particle size distribution of the SHR0302 is characterized by a D90 value of less than about 20 µm; and (b) a silicone selected from the group consisting of dimethicone and cyclomethicone” which anticipate instant claims 17 -22.
The instant application shares at least one common inventor and applicant with the reference application. Further, the instant application is not related to the US application No. 18/787,360., thus no 35 USC 121 shield exists. See MPEP 804.01. Therefore, claims 1, 5 and 8 of US application No. 18/787,360 anticipates instant application.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET JOSEPH whose telephone number is (571)270-1372. The examiner can normally be reached Monday and Thursday 0730-1730 Eastern.
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/JANET JOSEPH/Patent Examiner, Art Unit 1611
/ISIS A GHALI/Primary Examiner, Art Unit 1611
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