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 .
Status of the Claims
Claims 1-2, 4-5, 7, 10, 11, 12, 15, 49, 55-56, 62, 64-65, 69-70, 73, 75, 83, and 88 are pending.
Claim 83 is withdrawn (see election/restriction below).
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a national stage entry of and claims priority to Application Serial No. PCT/US2022/026520, filed 04/27/2022; and further claims priority to PRO Patent Application numbers 63/180,876, filed on 04/28/2021.
Information Disclosure Statement
All references from IDS(s) received 12/20/2023, 06/11/2025, and 6/18/2026 have been considered unless marked with a strikethrough.
Election/Restrictions
Applicant’s election of the compound below without traverse in the reply filed on 06/18/2026 is acknowledged.
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Claim 83 would be withdrawn from further consideration pursuant to 37 CFR 1.142(b) as not reading on the elected species.
No anticipatory art was found of the elected specie, so the Examiner expanded her scope pursuant to MPEP 803. The expanded species, which applies to instant claims 1, 2, 5, 7, 10, 12, 55, 62, 65, 69, 70, and 73, is rejected in a 103 rejection below. The remaining claims are considered allowable subject matter and the closest prior art and reasons a 103 rejection could not be made for the claims can be found below.
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.
Claims 1, 2, 5, 7, 10, 12, 55, and 73 are rejected under 35 U.S.C. 103 as being unpatentable over Astrazeneca (WO2007040440A1; “Astrazeneca”).
This rejection applies to an expanded specie, where G is F, R1 is H, RN1 is H, A is a 5-membered heteroaryl group, Y is a bond, and R3 is a heterocycle.
Astrazeneca teaches an overlapping genus structure with the instant Formula I (Claim 1).
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Astrazeneca teaches a compound example with all the limitations of the expanded species, except that instant -G and -R1 are in opposite positions, see below.
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However, Astrazeneca teaches that -R8 and -R9 (correlating to instant -G and -R1) can either be -H or a halogen. Therefore, Astrazeneca teaches all the embodiments of the expanded species, as required by instant claims 1, 2, 5, 7, 10, and 12. Astrazeneca also teaches the compounds for use in treating Alzheimer’s disease, which falls within the limitations of instant claims 55 and 73.
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR example rationale (B), it would have been prima facie obvious to extract the structure taught by Astrazeneca and substitute/swap the embodiments of -R8 and -R9 of the structural example to arrive at the expanded species. A person would be motivated to do so because teaches that -R8 and -R9 (correlating to instant -G and -R1) can either be -H or a halogen. Therefore, claims 1, 2, 5, 7, 10, 12, 55, and 73 would be obvious to a person skilled in the art at the time.
Claims 1, 2, 5, 7, 10, 12, 55, 62, 65, 69, 70, and 73 are rejected under 35 U.S.C. 103 as being unpatentable over Astrazeneca (WO2007040440A1; “Astrazeneca”) in view of Jansa, P. et al. (US20130324566A1; “Jansa”) as evidenced by Schmid, A. et al. (Biochim Biophys Acta. 2014 Jul 23;1842(12 0 0):2584–2592; “Schmid”).
This rejection applies to an expanded specie, where G is F, R1 is H, RN1 is H, A is a 5-membered heteroaryl group, Y is a bond, and R3 is a heterocycle.
Astrazeneca teaches an overlapping genus structure and as discussed above, a compound that falls within the limitations of claim 1 that can be used in the instant method claims.
Astrazeneca also teaches the compounds as glycogen synthase inhibitors for use in treating Alzheimer’s disease, which falls within the limitations of instant claims 55 and 73.
Astrazeneca fails to teach the compounds for use in inflammatory conditions including psoriasis or conditions of the eye or liver, as required by instant claims 62, 64, 65, and 70.
Jansa teaches an overlapping genus structure with Astrazeneca and the instant formula I:
Similar to Astrazeneca, Jansa teaches the compounds can be used as glycogen synthase inhibitors (para 0013). Jansa teaches the compounds can be used in various inflammatory conditions (Abstract) including, but not limited to: psoriasis (para 0061, line 8), inflammatory conditions of the liver, such as liver cancer (para 0062), and inflammatory conditions of the eye (para 0061, line 10), as required by instant claims 62, 65, 69, and 70. Therefore, it would be obvious to a person skilled in the art that the compounds taught by Astrazeneca, which fall within the limitations of claim 1, can be used in various diseases outside of Alzheimers, such as those required by instant claims 62, 65, 69, and 70.
With respect to claims 75 and 88, neither Astrazeneca or Jansa teach the use of the compound in inhibiting adenylyl cyclase or as a contraceptive treatment. However, it is known that adenlyl cyclase is widely expressed intracellular source of cAMP in mammalian cells, as evidenced by Schmid, which means every patient population would have the presence of sAC. Therefore, it would be obvious to a person skilled in the art that administering the compound for the uses taught by Astrazeneca and Jansa that it would inherently meet the limitations of claims 75 and 88.
Applying KSR example rationale (A), it would have been prima facie obvious to extract the method of using glycogen synthase inhibitors for treating disease as taught by Astrazeneca and use the compounds for diseases known to be treated by similar structures, such as inflammatory conditions including psoriasis or conditions of the eye or liver, as required by instant claims 62, 65, 69, and 70. Therefore, claims 1, 2, 5, 7, 10, 12, 55, 62, 65, 69, 70, and 73 would be obvious to a person skilled in the art at the time.
Claim Objections
Claims 4, 11, 15, 49, 56, and 64 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. The closest prior art is cited below.
1. WO2007040440A1; cited in IDS filed 12/20/2023; “Astrazeneca”: Astrazeneca teaches an overlapping genus structure with the instant claims. Astrazeneca fails to teach an embodiment where instant A is the following structure, as required by instant claims 4, 11, and 15:
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Since Astrazeneca teaches the compounds as glycogen synthase inhibitors and not soluble adenylyl cyclase inhibitors, as required by the instant claims, a person skilled in the art would not be motivated to modify this structure to arrive at the instant invention. With respect to claims 49, 56, 62, 64-65, 69-70, Astrazeneca fails to teach the compound for use in any of the diseases listed in these instant claims. Therefore, this prior art could not be used in a 103 rejection.
2. US20130324566A1, cited in IDS filed 12/20/2023; “Jansa”: Jansa teaches an overlapping genus structure with the instant claims. Jansa fails to teach an embodiment where instant A is the following structure, as required by instant claims 4, 11, and 15:
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Since Jansa teaches the compounds as glycogen synthase inhibitors, similar to Astrazeneca above, a person skilled in the art would not be motivated to modify this structure to arrive at the instant invention. With respect to claims 49, 56, 64, Astrazeneca fails to teach the compound for use in any of the diseases listed in these instant claims. Therefore, this prior art could not be used in a 103 rejection.
3. US7691855B2; cited in IDS filed 12/20/2023; “Furet”: Furet teaches an overlapping genus structure with the instant claims:
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Although Furet teaches a more similar 5-membered ring, in comparison to AstraZeneca and Jansa, as required by instant claims 4, 11, and 15, Furet still fails to teach the ring in the appropriate conjugation (where -R3 and R3’ would be on the same side of the ring, as required by the instant claims). Since Furet teaches the compounds for use in EGFR and not sAC, as required by the instant claims, the Examiner could not argue that it would be obvious to a person skilled in the art to use a ring positional isomer to arrive at the instant claims. Therefore, Furet could not be used for a rejection.
Conclusion
Claims 1, 2, 5, 7, 10, 12, 55, 62, 65, 69, 70, 73, 75 and 88 are rejected.
Claims 4, 11, 15, 49, 56, and 64 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clint Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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