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 is a 371 of PCT/EP2023/056619 03/15/2022, which claims benefit of the foreign application: FRANCE FR2202266 03/15/2022.
2. Claims 16-37 are pending in the application.
Claim Rejections - 35 USC § 112
3. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 16-37 are rejected under 35 U.S.C. 112(a) or 35 U.S.C.
112, first paragraph (pre- AIA ), because the specification does not reasonably provide
enablement of the instant “2-phenylindole group” without limitation (i.e., no named
compounds). The specification does not enable any person skilled in the art to which it
pertains, or with which it is most nearly connected, to make the invention commensurate
in scope with these claims.
ln In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining
whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first
paragraph, have been described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or Iack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
In the instant case:
The nature of the invention
The nature of the invention is a method of use using “2-phenylindole group” without limitation (i.e., no named compounds), see claim 16, 28 and 36.
The state of the prior art and the predictability or Iack thereof in the art
The state of the prior art is Adelman et al. US 2020/0022617 A1, it discloses a
similar compound of formula (I), see column 14.
The amount of direction or guidance present and the presence or absence
of working examples
The only direction or guidance present in the instant specification is the description of a number of “2-phenylindole group” on pages 7-10 of the specification. There is no data present in the instant specification for the “2-phenylindole group” without limitation (i.e., no named compound).
The breadth of the claims
The instant breadth of the rejected claims is broader than the disclosure,
specifically, the instant “2-phenylindole group” is without limitation (i.e., no named compound).
The quantity or experimentation needed and the Ievel of skill in the art
While the level of the skill in the chemical arts is high, it would require
undue experimentation of one of ordinary skill in the art to resolve any “2-phenylindole group” without limitation. There is no guidance or working examples present for constitutional any “2-phenylindole group” without limitation for the instant invention. Incorporation of the limitation of “2-phenylindole group” supported by specification (i.e., claims 22, 30 and 37) into claim 16, 28 and 36 respectively would overcome this rejection.
4. 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.
Claims 16, 28 and 36 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 pre-AIA the applicant regards as the invention.
Claims 16, 28 and 36 independently recite the limitation “comprising” is ambiguous and indefinite, see line 2 in claim 16, line2 in claim 28 and line 3 in claim 36. A compound or drug product claim cannot use open-ended language when defining the parameters of the gene or compound, see M.P.E.P. 2111.03. Replacement of the limitation “comprising” with a limitation “which is” would overcome this rejection.
5. 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.
Claim Rejections - 35 USC § 103
6. 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 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 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 16-37 are rejected under 35 U.S.C. 103(a) as being obvious over
Adelman et al. US 2002/0022617 A1, Oydanich et al. American Journal of Physiology, 2019, 316(6): R832-R838, and Xiao et al. Arthritis Research & Therapy, 2016, 18: 151/1-151/9.
Applicants claim a method of treating a pathology associated with a muscle fragility comprising administering an estrogen receptor modulator (SERM) comprising a 2-phenylindole group to a subject, see claim 16. Dependent claims 17-27 further limit thescope of methods, i.e., specific 2-phenylindole group compound, dose and administration strategy.
Applicants claim a method of improving muscle survival or muscle resistance to stress, the method comprising administering a selective estrogen receptor modulator (SERMV) comprising a 2-phenylindole group to a subject, see claim 28. Dependent claims 29-35 further limit the scope of methods, i.e., specific 2-phenylindole group compound, dose and administration strategy.
Applicants claim a method comprising: culturing myoblasts, myotubules, or muscle fibers; and adding to the culture a selective estrogen receptor modulator (SERM) comprising a 2-phenylindole group, see claim 36. Dependent claim 37 further limit the scope of methods, i.e., specific 2-phenylindole group compound.
Determination of the scope and content of the prior art (MPEP §2141.01)
Adelman et al. ‘617 discloses a method for increasing or maintaining nitric oxide synthase activity in a mammal, the method comprising administering to a mammal in need thereof a pharmaceutically effective amount of a compound (i.e., 2-phenylindole group compound) of the formulae I or II, i.e.,
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Oydanich et al. disclose that nitic oxide is a modulator for increasing muscle exercise performance and for treating muscle fragility.
Xiao et al. disclose estrogen receptor modulator bezedodozifene is used for treating osteoporosis and has direct effect on muscle performance or treating muscle fragility.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Adelman et al. ‘617, Oydanich et al.
and Xiao et al. is that the instant claims are embraced within the scope of Adelman et al. ‘617, Oydanich et al. and Xiao et al. It is noted that the instant claims are silent on the scope of 2-phenylindole group compound.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 16-37 prima facie obvious because one would be motivated to employ methods of use of Adelman et al. ‘617, Oydanich et al. and Xiao et al. to obtain instant invention.
The motivation to make the claimed methods of use derived from the known methods of use of Adelman et al. ‘617, Oydanich et al. and Xiao et al. 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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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
September 08, 2026
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