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
Instant application 18/265,156 filed on 06/02/2023 claims benefit as follow:
CONTINUING DATA:
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Status of the Application
Claims 1-12 and 18-25 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/02/2023 was in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 04/07/2026 is acknowledged.
Claims 18 and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/07/2026.
Regarding species election, Applicant’s election, without traverse, of Example 13:
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in the reply filed on 04/07/2026 is acknowledged.
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Examination will begin with the elected species. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
As per MPEP 803.02, the Examiner will attempt to determine whether the entire scope of the claims is patentable. Applicants' elected species, as shown above, does make a contribution over the prior art. Therefore, according to MPEP 803.02: should the elected species appear allowable; the search of the Markush-type claim will be extended. The search and examination should be continued until either (1) prior art is found that anticipates or renders obvious a species that falls within the scope of a proper Markush grouping that includes the elected species, or (2) it is determined that no prior art rejection of any species that falls within the scope of a proper Markush grouping that includes the elected species can be made. The Examiner need not extend the search beyond a proper Markush grouping.
Species Election
A careful review of the prior art has indicated that elected species is free of the prior art. A claim directed to the elected species in independent form would be free of the prior art.
The examiner has moved onto alternative species embodied within the general formula recited in the instant claim 1, and subsequent examination is based on this species expansion.
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 1-11 and 20-25 are rejected under 35 U.S.C. 103 as being unpatentable over VALADE (WO-2016055479-A1 – made of record on the IDS) in view of Ruiz (US-8524894-B2).
VALADE teaches modulators of D1:
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For example, VALADE teaches compound 38 (see page 131):
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Regarding instant claim 4 it should be noted that the above compound 38 bears CH2 group in a position corresponding to instant Z variable.
Regarding instant claim 5, it should be noted that the above compound bears alkyl substituted with one hydroxy in a position corresponding to instant R4 variable.
Further, VALADE teaches compound 99 (see page 160):
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It should be noted that the above compound bears substituted phenyl moiety corresponding to instant Gc group wherein X is C-H, R2 and R3 are halogens (Cl) and R1 is C1 alkyl substituted by one hydroxy (as required by instant claims 21, 23 and 25), and the position corresponding to instant R5 is hydrogen (as required by instant claims 22 and 24).
Further, regarding instant formula IB-aa recited in instant claim 7, VALADE teaches compound 114 (see page 169), bearing H in position corresponding to instant R6 variable and C1 alkyl substituted with 3 halogens (CF3) in the position corresponding to instant R7 (as required by instant claim 10). Valade teaches that said compounds are efficacious at treating cognitive disorders, such as Alzheimer’s disease in a subject in need (page 2 lines 25-30, claims 1, 28-32).
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The compounds disclosed by VALADE comprise tetrahydroquinoline moiety wherein the instant compounds comprise fully saturated isoquinoline moiety at the corresponding position.
However, Ruiz teaches compounds bearing fully saturated isoquinoline moiety (decahydroisoquinoline) for treatments of cognitive disorders (see abstract).
For example, Ruiz, teaches (see example Ik2, column 203-204, the first compound in the table):
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It should be noted that Ruiz teaches the compound may be used for treating cognitive disorders including Alzheimer’s disease (see abstract):
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Further, Ruiz teaches that both tetrahydroisoquinoline moiety and a fully saturated, decahydroisoquinoline moiety may be selected to obtain compounds useful in treatments of cognitive disorders (see claim 14):
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Starting from the compounds disclosed by VALADE and applying KSR prong (B) - simple substitution of one known element for another to obtain predictable results - 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 substitute a tetrahydroisoquinoline moiety for a fully saturated isoquinoline moiety (decahydroisoquinoline) to arrive at the instant formula (I) with a reasonable expectation of success. One of ordinary skill would have been motivated to prepare further examples of D1 positive allosteric modulators and would expect retention of activity after the substitution because Ruiz teaches that compounds bearing decahydroisoquinoline moiety are advantageous in treatments of cognitive disorders.
Further, regarding instant claim 20, VALADE teaches and claims:
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Therefore, one of ordinary skill would be motivated to prepare pharmaceutical compositions comprising compounds bearing fully saturated isoquinoline moiety.
Regarding instant claim 11 it should be noted that VALADE teaches compound 99 bearing phenyl moiety substituted with halogens, corresponding to instant Gc group wherein X is C-H, R2 and R3 are halogens (Cl) and R1 is C1 alkyl substituted by one hydroxy. It should be noted that compound 99 of VALADE bears hydrogen and the position corresponding to instant R5 variable. In addition, VALADE teaches compound 114, bearing H in position corresponding to instant R6 variable and C1 alkyl substituted with 3 halogens in the position corresponding to instant R7. Therefore, Applying KSR prong (A) – Combining prior art elements according to known methods to yield predictable results - 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 combine the substituents disclosed by VALADE (see VALADE, Formula (I)) to arrive at the compounds of formula IB-aa recited in the instant claims 7 and 11 with a reasonable expectation of success.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-11 and 20-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-9 of U.S. Patent No. 10,105,359-B2 in view of Ruiz (US-8524894-B2).
The claims of U.S. Patent No. 10,105,359-B2 recite:
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The compounds recited by U.S. Patent No. 10,105,359-B2 comprise tetrahydroisquinoline moiety wherein the instant compounds comprise fully saturated isoquinoline moiety at the corresponding position.
However, Ruiz teaches compounds bearing fully saturated isoquinoline moiety (decahydroisoquinoline) for treatments of cognitive disorders (see abstract).
For example, Ruiz, teaches (see example Ik2, column 203-204, the first compound in the table):
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It should be noted that Ruiz teaches the compound may be used for treating cognitive disorders including Alzheimer’s disease (see abstract):
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Further, Ruiz teaches that both, tetrahydroisoquinoline moiety and a fully saturated, decahydroisoquinoline moiety, may be selected to obtain compounds useful in treatments of cognitive disorders (see claim 14):
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Starting from the compounds disclosed by U.S. Patent No. 10,105,359-B2 and applying KSR prong (B) - simple substitution of one known element for another to obtain predictable results - 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 substitute a tetrahydroisoquinoline moiety for a fully saturated isoquinoline moiety (decahydroisoquinoline) to arrive at the instant formula (I) with a reasonable expectation of success. One of ordinary skill would have been motivated to prepare further examples of D1 positive allosteric modulators and would expected retention of activity after the substitution because Ruiz teaches that compounds bearing decahydroisoquinoline moiety are advantageous in treatments of cognitive disorders.
Allowable Subject Matter
Claim 12 is 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.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 pm.
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, Clinton A 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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/I.S./Examiner, Art Unit 1621
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
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