DETAILED ACTION
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 .
Priority
This application, filed 17 May, 2024, is a CON of PCT/CN2022/132831, filed 18 November, 2022, which claims foreign benefit of applications PCT/CN2022/105673, filed 14 July, 2022, and PCT/CN2021/131734, filed 19 November, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11 September, 2024 is acknowledged and has been considered.
Status of the Application
Receipt is acknowledged of Applicant's claimed invention, filed 17 May, 2024, in the matter of Application N° 18/667,441. Said documents have been entered on the record.
No additions, amendments, or cancellations have been made to the originally-filed claims. The issue of new matter is moot.
Thus, Claims 1-22 represent all claims currently under consideration.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 5-6, 8-10, 12-15, 18-19, and 21-22 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only, and cannot depend from any other multiple dependent claim. See MPEP § 608.01(n).
Accordingly, the claims have not been further treated on the merits.
Claim 22 is objected to because of the following informalities: “A method of treat cancer…” is likely meant to be “…treating…”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claim 22 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating breast or lung cancer (Instant Specification, Pg 35, Para 078 and Pgs 180-185, Para 298-306, Table 2, Examples 48-49), does not reasonably provide enablement for treating ALL cancers. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims without undue experimentation.
Claim 22 encompasses treatment of all cancers. However, the specification provides efficacy data only in breast and lung cancer models. The specification does not identify a molecular target, biological pathway, biomarker, or other scientific rationale from which one of ordinary skill in the art could reasonably predict efficacy across the full scope of cancers encompassed by the claim. Because cancer comprises a highly diverse class of diseases with differing biological mechanisms and therapeutic responses, undue experimentation would be required to determine the cancers for which the claimed method is effective. Accordingly, the specification does not enable the full scope of the claimed invention.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 20 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “RA is independently selected from…; or RB is independently selected from…” such that it is unclear whether the recited “or” is intended to define alternative claim scope or is merely a drafting error. Accordingly, the scope of Claim 1 cannot be determined with reasonable clarity.
Claim 20 is incomplete in itself because it incorporates subject matter from the specification (“…the compounds described in Table 1”). Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993). See MPEP §2173.05(s).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4, 16-17 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 3 requires Group C to be an optionally substituted phenyl, whereas Claim 4, which depends upon Claim 3, requires Group C to be an optionally substituted pyridinyl. Accordingly, Claim 4 is inconsistent with and does not further limit Claim 3.
Claim 2 recites compounds of Formulas (I-a), (I-b), or (I-c), each of which contains a fused phenyl ring in the Ring A position. Claims 16 and 17 recite Formulas (I-b2), (I-c2), (I-c3), or (I-c4) in which Ring A is defined according to the broader Ring A definition of Claim 1, thereby encompassing embodiments in which Ring A is other than phenyl. Accordingly, Claims 16-17 include embodiments not encompassed by Claim 2 and therefore are not in proper dependent form.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Hoerlein and Geiger (Archiv der Pharmazie und Berichte der Deutschen Pharmazeutischen Gesellschaft (1971), 304(3), 167-75 CODEN: APBDAJ; ISSN: 0376-0367) and Patani and LaVoie (Chemical Reviews, 1996, Vol. 96, No. 8).
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Regarding Claim 1, Hoerlein and Geiger teach Compound 2b (1971, Pg. 167), shown top right, which significantly overlaps the instant Formula I (as in instant Claim 1), shown bottom right, wherein Ring A is phenyl, m is 0, Rd is -C(O)OR3 and R3 is a C1 aliphatic (methyl), X is O=, L is a bond, Group C is a C1 aliphatic (methyl), and p is 0.
Hoerlein and Geiger teach Rb is -OH, instead of the instant C1 aliphatic (methyl).
However, Patani and LaVoie teach that hydroxyl and alkyl substituents are well-recognized bioisosteres, as evidenced by Grimm’s Hydride Displacement Law, which places -OH and -CH3 within the same bioisosteric grouping (1996, Pg. 3148, Table 1.)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to replace the hydroxyl substituent with a methyl as a routine and predictable modification, with a reasonable expectation of success.
Claims 1 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Geissman and Cho (Journal of Organic Chemistry (1959), 24, 41-3 CODEN: JOCEAH; ISSN: 0022-3263 DOI: 10.1021/jo01083a013) and Patani and LaVoie (Chemical Reviews, 1996, Vol. 96, No. 8).
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Regarding Claim 1, Geissman and Cho teach Compound VIIa (1954, Pg. 42), shown top right, which significantly overlaps the instant Formula I (as in instant Claim 1), shown bottom right, wherein Ring A is phenyl, m is 0, Rb is a C1-alkoxy (methoxy), Rd is -C(O)OR3 and R3 is H (as in instant Claim 15), X is O=, L is a bond, and p is 0.
Geissman and Cho teach Group C is H, instead of an instant C1-aliphatic (methyl).
However, Patani and LaVoie teach that methyl is a well-recognized bioisostere of hydrogen, (1996, Pg. 3152, § Fluorine and Hydroxyl, Amino, or Methyl Groups as Replacements for Hydrogen (Grimm’s Hydride Displacement Law.)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to replace the H substituent with a methyl as a routine and predictable modification, with a reasonable expectation of success.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Kunick et al. (Journal of Medicinal Chemistry (2004), 47(1), 22-36 CODEN: JMCMAR; ISSN: 0022-2623 DOI: 10.1021/jm0308904), hereinafter Kunick, and Patani and LaVoie (Chemical Reviews, 1996, Vol. 96, No. 8).
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Regarding Claim 1, Kunick teaches Compound 78 (2004, Pg. 25), shown top right, which significantly overlaps the instant Formula I (as in instant Claim 1), shown bottom right, wherein Ring A is pyridinyl, m is 0, Rd is -C(O)OR3 and R3 is ethyl, X is O=, L is a bond, and p is 0.
Kunick teaches Rb is -OH, instead of the instant C1 aliphatic (methyl), and Group C is H, instead of an instant C1-aliphatic (methyl).
However, Patani and LaVoie teach that hydroxyl and alkyl substituents are well-recognized bioisosteres, as evidenced by Grimm’s Hydride Displacement Law, which places -OH and -CH3 within the same bioisosteric grouping (1996, Pg. 3148, Table 1) and methyl is a well-recognized bioisostere of hydrogen, (1996, Pg. 3152, § Fluorine and Hydroxyl, Amino, or Methyl Groups as Replacements for Hydrogen - Grimm’s Hydride Displacement Law.) The ability of a group of bioisosteres to elicit similar biological activity has been attributed to common physicochemical properties, and in exchanging such bioisosteres, the medicinal chemist is able to hone physicochemical effects such as electronegativity, steric size, and lipophilicity.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to replace H and/or hydroxyl substituents with methyl, as a routine and predictable modification, with a reasonable expectation of success.
Allowable Subject Matter
Claims 2-3, 7, and 11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Donna M. Nestor whose telephone number is (703)756-5316. The examiner can normally be reached generally (w/flex): 5:30a-5p EST M-Th.
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/D.M.N./Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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