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/EP2022/057386 03/21/2022, which claims benefit of the foreign applications: EPO EP21382301.6 04/08/2021, and EPO EP21382676.1 07/23/2021.
2. Claims 1, 3-5, 7,13, 31-32, 34-42, 44 and 60-61 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, 3-5, 7,13, 31-32, 34-42, 44 and 60-61 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 “LSD1 inhibitor” 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 “LSD1 inhibitor” without limitation (i.e., no named compounds), see claim 1, 13, and 32.
The state of the prior art and the predictability or Iack thereof in the art
The state of the prior art is Munoz et al. US 2014/0256729, it discloses a compound
of formula (I) as a LSD1inhibitor, see column 108.
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 “LSD1inhibitor” on pages 10-15 of the specification. There is no data present in the instant specification for the “LSD1inhibitor” 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 “LSD1inhibitor” are 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 “LSD1inhibitor” 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 “LSD1inhibitor” supported by specification (i.e., claim 3) into claim 1, 13 and 32 would overcome this rejection.
4. 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
5. 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).
Claim 1, 3-4, 13, 31-32, 34-35, 37 and 60 are rejected under 35 U.S.C. 103(a)
as being obvious over Munoz et al. US 2014/0256729 A1 and Eguchi et al. US
2016/0339020 A1.
Applicants claim a combination product comprising, in the same pharmaceutical formulation or in separate pharmaceutical formulations, an LSD1 inhibitor or a pharmaceutically acceptable salt thereof and gilteritinib or a pharmaceutically acceptable salt thereof, see claim 1. Dependent claims 3-4 and 31 further limit the scope of methods, i.e., LSD1 inhibitor is iadademstat or its salt, and used for treating myeloid or blood cancer.
Applicants claim an article of manufacture (I.e., process) comprising, in the same pharmaceutical formulation or in separate pharmaceutical formulations, an LSD1 inhibitor or a pharmaceutically acceptable salt thereof and gilteritinib or a pharmaceutically acceptable salt thereof, see claim 13.
Applicants claim a method for treating a myeloid cancer in a patient in need thereof, comprising administering to the patient a therapeutically effective amount of an LSD1 inhibitor, or a pharmaceutically acceptable salt thereof, and a therapeutically effective amount of gilteritinib, or a pharmaceutically acceptable salt thereof, see claim 32. Dependent claims 34-35, 37 and 60 further limit the scope of methods, i.e., LSD1 inhibitor is iadademstat or its salt, used for treating leukemia, and oral administration.
Determination of the scope and content of the prior art (MPEP §2141.01)
Munoz et al. ‘729 disclose a compound/composition of LSD1 inhibitor, and the
LSD1 inhibitor is a compound of formula (I) or its salt, i.e.,
PNG
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152
294
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, wherein D is cycloalkyl (i.e., cycloalkane) , A is
aryl(i.e., phenyl), and B is hydrogen, see claims 1, 7 and 116 in columns 108, 112 and
121. A specific compound (i.e., iadademstat ) has been exemplified in Example 18 and
21, see columns 85-86. Munoz et al. ‘729 compounds/compositions are used for
treating blood cancer including leukemia. Munoz et al. ‘729 compositions can be
formulated as oral administration including tablets or capsules, see section [0679] in
column 51.
Eguchi et al. ‘020 disclose a composition comprising 6-ethyl-3-({3-methoxy-4-[4-
(4-methylpiperazin-1-yl)piperidin-1-yl]phenyl}amino)-5-(tetrahydro-2H-pyran-4-
ylamino)pyrazine-2-carboxamide (i.e., gilteritinib) or a pharmaceutically acceptable salt
thereof, and a pharmaceutically acceptable excipient, and it is used for treating cancer,
see claim 1 in column 10.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Munoz et al. ‘729 and Eguchi et al. ‘020 is that the instant claims are embraced within the scope of Munoz et al. ‘729 and Eguchi et al. ‘020. Munoz et al. ‘729 and Eguchi et al. ‘020 read on the instant claims 1, 3-4, 13, 31-32, 34-35, 37 and 60. It is noted that the instant claim is silent the scope of LSD1 inhibitor in claim 1.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 1, 3-4, 13, 31-32, 34-35, 37 and 60 prima facie obvious because one would be motivated to employ the methods of use and processes of Munoz et al. ‘729 and Eguchi et al. ‘020 to obtain instant invention.
It is prima facie obvious to combine teachings from Munoz et al. ‘729 and Eguchi
et al. ‘020 which provide methods of use using a composition comprising
LSD1 inhibitor and gilteritinib each of which is taught by the prior art to be useful for
the same purpose, i.e., for treatingcancer including leukemia. Therefore idea of
combining them flows logically from theirs having been individually taught in the prior
art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), see
MPEP 2144.06.
The motivation to make the claimed methods of use derived from the known methods of use of Munoz et al. ‘729 and Eguchi et al. ‘020 would possess similar activity to that which is claimed in the reference.
Conclusion
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
January 26, 2026