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/JP2022/015012 03/28/2022, which claims benefit of the foreign applications: JAPAN JP2021-055436 03/29/2021.
2. Claims 1-31 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 1-31 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 “salt of citric acid” without limitation (i.e., no named salts). 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 “salt of citric acid” without limitation (i.e., no named salts), see claim 1, 20, 27 and 31.
The state of the prior art and the predictability or Iack thereof in the art
The state of the prior art is Wang et al. CAS: 163: 399070, 2015, it discloses a
compound sodium citrate dihydrate.
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 “salt of citric acid” on pages 40-46 of the specification. There is no data present in the instant specification for the “salt of citric acid” without limitation (i.e., no named salts).
The breadth of the claims
The instant breadth of the rejected claims is broader than the disclosure,
specifically, the instant “salt of citric acid” are without limitation (i.e., no named salts).
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 “salt of citric acid” without limitation. There is no guidance or working examples present for constitutional any “LSD1inhibitor” without limitation for the instant invention. Incorporation of the limitation of “salt of citric acid r” supported by specification (i.e., claim 4) into claim 1, 20, 27 and 31 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.
Claim 31 is 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.
Claim 31, lines 2-4, recites the limitation “a total content of said composition does not exceed 100% by mass with respect to a total mass of solid content of said composition” is ambiguous and indefinite. It is unclear what the scope or amount of the solid content of composition. Clarification is required.
Conclusion
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
January 26, 2026