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 .
DETAILED ACTION
Priority and Status of Claims
1. This application claims benefit of the foreign application: CHINA CN202310198493.3 03/03/2023. However, the instant certified foreign priority document has not filed to the Office. Applicants are requested to file the certified foreign priority document to obtain the priority.
2. Amendment including cancelation of claims 1-10, and addition of claims 11-21 in the amendment filed on 6/10/2026 is acknowledged. Claims 11-21 are pending in the application. No new matter has been found. Since the newly added claims 11-21 are commensurate within the scope of invention, claims 11-21 are prosecuted in the case.
Responses to Amendments/Arguments
3. Since claims 1-10 have been canceled, therefore the rejection of claims 1-10 under 35 U.S.C. 112 (b) and 35 U.S.C. 103 (a) has been obviated herein.
New Grounds of Claim Rejections - 35 USC § 103
4. The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 non-obviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior art under 35 U.S.C. 103(a).
Claims 11-21 are rejected under 35 U.S.C. 103(a) as being obvious over Aimei
et al. CN 107693500, or see English-translated version of Aimei et al. CN 107693500.
Applicants claim a composition for using in preparation of a drug for treatment of
skeletal muscle degeneration disease, the composition comprising a compound of
formula (I) as follows:
PNG
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230
368
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(i.e., maraviroc), or a geometric isomer
thereof, or a pharmaceutically acceptable salt, solvate or hydrate thereof, see claim 11.
Dependent claims 12-20 further limit the scope of composition, i.e., compound of
formula (I) blocks CCL-5-CCR5 signal pathway, specific amount of compound,
formulation including solid including tablet or capsule, or semi-solid preparation
including gel or ointment, and carriers.
Determination of the scope and content of the prior art (MPEP §2141.01)
Aimei et al. ‘500 discloses a composition comprising maraviroc, calcium sulfate,
starch, lactose, and magnesium stearate, see Example 1 -3 on page 4.
Lin et al. disclose methods of use using CCR5 inhibitor maraviroc (i.e., the instant compound of formula (I)) to promote smooth muscle cells proliferation (e.g. treatment of muscle degeneration).
Determination of the difference between the prior art and the claims (MPEP
§2141.02)
The difference between instant claims and Aimei et al. ‘500 and Lin et al. is that the instant claims are embraced within the scope of Aimei et al. ‘500 and Lin et al. Lin et al. disclose a broader methods for promoting smooth cells proliferation or regeneration. It is noted that the instant claims are drawn to a product per se, and the preamble “for treatment of skeletal muscle degenerative disease” does not obtain any patent weight.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 11-21 prima facie obvious because one would be motivated to employ the compositions of Aimei et al. ‘500 and Lin et al. to obtain instant invention.
The motivation to make the claimed compositions derived from the known compositions of Aimei et al. ‘500 would possess similar activity to that which is claimed in the reference.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REI TSANG SHIAO whose telephone number is (571)272-0707. The examiner can normally be reached on 8:30 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached on 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
July 13, 2026
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