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 .
Receipt of claim amendments and reply filed on 05/20/2026 is acknowledged. Claims 1-11 are currently pending.
Priority
The Instant application claims priority as follows:
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Election/Restrictions
Applicant’s election, without traverse, of Group I, claims 1-11, in the reply filed on May 20, 2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Claims 12-26 have been canceled.
Claims 1-11 are the subject of this Office Action.
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, 7 and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Lee et al. (WO 2019/078619-cited by applicant in the IDS of 10/16/2024).
Lee teaches a compound of Formula 1 or a pharmaceutically acceptable salt thereof. Particularly, Lee teaches compound 283
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or a pharmaceutically acceptable salt thereof. See at least page 185 and claims 7 and 8. A pharmaceutically acceptable salt thereof of the compounds is as follows (see page 61):
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.
Therefore, Lee teaches the hydrochloride salt, hydrobromide salt, phosphate salt and mesylate salt of compound 283
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and composition comprising the same, as claimed in instant claims 1-4, 7 and 10-11.
With regards to the intended use and the purpose of the product as in claims 10-11 (“composition for treating or preventing atopic dermatitis”), nothing precludes the use of the composition of Lee as instantly claimed (see MPEP 2112.02(II)), nor does the recitation impart any structural characteristic that would distinguish it from the prior art composition.
See MPEP 2111.02 (II) regarding preamble statements reciting purpose or intended use: “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction”.
In the instant case, the body of the claims intrinsically set forth all of the limitations of the composition of claims 10-11 (that is, the compound and the pharmaceutically acceptable salt of the compound). Accordingly, any composition disclosed in the prior art having the elements recited in the body of the instant claims is considered to be capable of the intended use and purpose recited in the claims.
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 1-11 are rejected under 35 U.S.C. 103 as being obvious over Lee et al. (WO2019/078619- as above) in view of Swarbrick et al. (Encyclopedia of Pharmaceutical Technology 13 (Marcel Dekker, NY 1996) pages 453-499) or Bastin et al., (Organic Process Research & Development 2000, 4, 427-435) and their combinations.
Applicant claims organic salts of the compound of formula
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, and a composition comprising the compound or pharmaceutically acceptable salt.
Determining the scope and content of the Prior art (MPEP §2141.012)
As discussed in the 102 rejection above, Lee teaches a compound of Formula 1 or a pharmaceutically acceptable salt thereof, and the use of these as protein kinase inhibitors for the treatment of various diseases. See pages 1 and 2. Particularly, Lee teaches compound 283
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or a pharmaceutically acceptable salt thereof. See at least page 185 and claims 7 and 8. A pharmaceutically acceptable salt thereof of the compounds is as follows (see page 61):
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Swarbrick specifically discusses that salt formation is a simple chemical manipulation performed to alter the physicochemical, formulation, biopharmaceutical and therapeutic properties of a drug without modifying the basic chemical structure. Swarbrick particularly discussed salt formation to improve drug solubility. Swarbrick teaches that Anionic Pharmaceutical Salt Forms Currently in Use include camsylate, hydrobromide, hydrochloride, mesylate, napadisylate, oxalate, phosphate, etc. See Table 1, pages 454-455. The salts in Swarbrick have a ratio of 1:1 unless their name says otherwise. See that Table 1 has also dihydrochloride, and other di- or bi-salts.
Bastin et al., mentions hydrobromide, hydrochloride, mesylate and phosphate anions as common pharmaceutical salt-formers (Table 1, p. 428) and discusses specific factors to be considered for salt selection (greater water solubility, less toxicity, or a slower dissolution rate- at right column of page 2).
Ascertainment of the Difference Between the Prior Art and the Claims
(MPEP §2141.012)
The difference between the claims and the prior art is that applicants are claiming a different salt of an old drug.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
The skill level in the art of salt selection is relatively high, as seen in the secondary references cited above. It would have been obvious for one of ordinary skill in the art to form the hydrochloride, hydrobromide, phosphate, camsylate, oxalate, mesylate and napadisylate pharmaceutically acceptable salts of the known active compound of Lee et al. because hydrochloride, hydrobromide, phosphate, camsylate, oxalate, mesylate and napadisylate are common and currently used to form pharmaceutically acceptable salts. The ordinary artisan knew that to get the hydrochloride instead of the dihydrochloride salt, the ratio is from 1:1.
Because typical problems encountered in drug development includes insufficient solubility, etc., a person of ordinary skill in the art would be highly motivated to make said claimed salts of the abovementioned compound to optimize the pharmacological profile of the compound, especially when salt formation is a commonly known technique used by a person of ordinary skill in the art in order to increase drug solubility. The motivation derives from the “normal desire of scientists or artisans to improve upon what is already generally known." In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003).
The factual situation is thus largely the same as in Pfizer, Inc. v. Apotex, Inc. 82 USPQ2d 1321, which was directed to the amlodipine besylate drug. One of ordinary skill in the art would look in pharmacopeias and compendia to find an anion having precedence for use within the pharmaceutical industry and to try salts from the known list. The secondary references above provide a reasonable expectation of success in making and using the claimed salts for the same use taught by the reference Lee.
Regarding claims 10-11: With regards to the intended use and the purpose of the product as in claims 10-11 (“composition for treating or preventing atopic dermatitis”), nothing precludes the use of the composition of Lee as instantly claimed (see MPEP 2112.02(II)), nor does the recitation impart any structural characteristic that would distinguish it from the prior art composition.
See MPEP 2111.02 (II) regarding preamble statements reciting purpose or intended use: “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction”.
In the instant case, the body of the claims intrinsically set forth all of the limitations of the composition of claims 10-11 (that is, the compound and the pharmaceutically acceptable salt of the compound). Accordingly, any composition disclosed in the prior art having the elements recited in the body of the instant claims is considered to be capable of the intended use and purpose recited in the claims.
Conclusion
Claims 1-11 are rejected. No claim is allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE RODRIGUEZ-GARCIA whose telephone number is (571)270-5865. The examiner can normally be reached Monday-Friday 9:30am-5:30pm.
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/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621
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