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
The preliminary amendment filed 06/14/2024 amended claims 3-9, 11, 13, 15, 17, 19-20, 24, and 26-28.
Claims 1-29 are pending.
Priority
This application claims the following priority:
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Election/Restrictions
Applicant’s election without traverse of Group I, the compounds and compositions thereof, and:
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as the species of instant Formula (I), in the reply filed on 08/12/2026, is acknowledged.
The species is allowable over the prior art.
The examination of the Markush claim has been extended. If a Markush grouping as set forth in a claim is proper and election of species has been required, the examiner must continue to search the species of the claim unless the claim has been found to be unpatentable over prior art. MPEP 803.02.
As detailed in the following prior art rejections, the generic claim encompassing the elected species was not found patentable. Therefore, the provisional election of species is given effect, the examination is restricted to the elected species only and claims not reading on the elected species are held withdrawn. MPEP 803.02; Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (Bd. Pat. App. lnt. 1987).
Should applicant, in response to this rejection of the Markush-type claim, overcome the rejection through amendment, the amended Markush-type claim will be reexamined to the extent necessary to determine patentability of the Markush-type claim. See MPEP 803.02.
Claims 25 and 27-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim.
It is noted that many of the species of instant claim 26 are outside the scope of instant Formula (I).
Claims 1-24 and 26 are examined on the merits herein.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7, 9-20, 24 and 26 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2022/166844 to Dai (effectively filed 02/05/2021, IDS of 06/14/2024).
Regarding claims 1-2, Dai teaches the following compounds:
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(pg. 42);
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(pg. 44; claim 20).
Regarding claims 1-7, 9-20, and 24, compound 156 meets the limitations of instant Formula (I) when:
A is a 6-membered heteroaryl with 1 nitrogen heteroatom, i.e., pyridinyl
R1 is the halo Cl and -NR2aR2b, wherein R2a and R2b are H
x is 2
y is 0
z is 1
L is S
R4 is H
X is CR3aR3b, wherein R3a and R3b are H, i.e., CH2
B is a fused phenyl
R7 is cyano, CN.
Specifically, regarding claim 14, the claim is interpreted as if R5 is present, then these limitations apply. Since y is 0, the limitations of claims 14 are considered met.
Specifically, regarding claim 20, compound 156 meets the limitations of instant formula (IIIc).
Specifically, regarding claim 24, compound 156 meets the limitations of instant formula (IVb).
Regarding claim 26, Dai teaches pharmaceutical compositions comprising its compounds and a pharmaceutically acceptable excipient (pg. 232, claim 21).
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 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.
Claims 1-24 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2022/166844 to Dai (effectively filed 02/05/2021, IDS of 06/14/2024).
Dai is applied to claims 1-7, 9-20, 24 and 26, as discussed above and incorporated herein.
Regarding claim 8, compound 156 of Dai,
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, does not exemplify the instant L position as a bond.
Dai teaches that the L position of its compounds can be absent, i.e., a bond; S; O; or NH (pg. 198, claim 1). Dai specifically teaches L as absent (claim 13) or L as absent or S (claims 14-16) and exemplifies compounds wherein L is absent or S (claim 20).
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to substitute the -S- of
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, with a bond, to arrive at instant claim 8. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because Dai teaches that its “L” position can preferably be S or absent (i.e., a bond) and exemplifies such species (claim 20 of Dai).
As such, an ordinary skill artisan would have been motivated to make such a substitution, to predictably arrive at structurally and functionally similar compound, which is effective to inhibit SHP2 activity (pg. 232, claim 22).
Regarding claim 21, modified compound 156 of Dai,
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, does not exemplify the instant B position as a pyridine ring.
Dai teaches that the B position of its compounds can be a benzene ring or a pyridine ring (pg. 198, claim 1).
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to substitute the phenyl ring of
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, with a pyridine ring, to arrive at instant claim 21. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because Dai teaches that its “B” position can be benzene or pyridine, and exemplifies such species.
As such, an ordinary skill artisan would have been motivated to make such a substitution, to predictably arrive at structurally and functionally similar compound, which is effective to inhibit SHP2 activity (pg. 232, claim 22).
Regarding claims 22-23, while Dai teaches a compound of instant formula (IIa-1), it differs from that of instant claims 22-23, in that it does not teach R4 as -CH3.
Dai exemplifies compounds with CH3 at the 2-position of the pyrazolopyridine ring (pgs. 219, 224, #’s 117, 180) and Dai teaches its Cy1, which is the instant pyrazolopyridine ring, as optionally substituted with -CH3 (pgs. 198-198, 201, claims 1, 9-11, 14).
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to substitute the hydrogen in the instant R4 position of claim 21, with a -CH3, to arrive at instant claims 22-23. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because Dai teaches that its central pyrazolopyridine ring can be substituted with -CH3 at the 2-position, and exemplifies such species.
As such, an ordinary skill artisan would have been motivated to make such a substitution, to predictably arrive at structurally and functionally similar compound, which is effective to inhibit SHP2 activity (pg. 232, claim 22).
Conclusion
Claims 1-24, and 26 are rejected.
Claims 25 and 27-29 are withdrawn from consideration.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN WELLS/Primary Examiner, Art Unit 1622
