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 .
Claims 1-17, submitted on 14 June 2024, represent all claims currently under consideration.
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.
Priority
This application is a 371 of PCT/US2022/052614, filed 13 December 2022, which claims priority of provisional U.S. 63/290,974, filed 17 December 2021. The effective filing date is 17 December 2021.
Information Disclosure Statement
Two Information Disclosure Statements (IDS), submitted on 23 October 2024 and 21 January 2026, are acknowledged and have been considered.
Claim Rejections - 35 USC § 112(b)
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.
Claim 3 is 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 3 is indefinite because there is no period at the end of the claim, causing it to be unclear if there is any remaining material which is to be claimed.
Claim 11 is 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 11 is indefinite due to a reference to a table found within the specification. 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) (citations omitted). (See MPEP § 2173.05 (s)).
Claim Rejections - 35 USC § 102
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.
Claims 1, 5, 7, 9, and 12-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nolte (WO 2008/063671; Publication Date: 29 May 2008).
Nolte (See IDS, 23 October 2024) discloses heterobicyclic containing pharmaceutical agents, and in particular, heterobicyclic metalloprotease inhibitor compounds (Abstract). The compounds of the invention are useful in the treatment of metalloprotease mediated diseases (Page 3, Lines 4-5). Compounds of the invention include
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(Page 87), which has variable R1 as 5-membered heteroaryl, R2 as H, R3 as F, and variable R4 as F and Cl;
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(Page 90), which has variable R1 as fluorine, R2 and R3 each as H, and R4 as Cl and F;
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(Page 91), which has R1, R2, and R3 each as H, and R4 as methyl and fluorine; and
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(Page 91), which has R1 and R2 each as H, R3 as Br, and R4 as methyl and fluorine. Another aspect of the invention relates to a pharmaceutical composition comprising an effective amount of the compound according to any of the disclosed embodiments (Page 91, Lines 3-5). Another aspect of the invention relates to a pharmaceutical composition comprising an effective amount of a compound according to the invention, a pharmaceutically acceptable carrier, and a drug , agent or therapeutic selected from a disease modifying antirheumatic drug, a non-steroidal anti-inflammatory drug, a COX-2 selective inhibitor, a COX-1 inhibitor, an immunosuppressive, a steroid, a biological response modifier, and a small molecule inhibitor of pro-inflammatory cytokine production (Page 92, Lines 1-10). In another embodiment, in conjunction with any above or below embodiments, the disease to be treated using methods of the invention is selected from… herpes, herpes viruses… (Page 92, Line 17 -Page 94, Lines 13-14).
Claims 1, 4, 7, 9, and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McCarthy (WO 2021/224636; Publication Date: 11 November 2021).
McCarthy discloses compounds of Formula I, their preparation, pharmaceutical compositions comprising them, and their use in treatment of diseases or conditions in which adenosine A2a receptor activity is implicated, such as cancer (Abstract). One compound disclosed is example 85 (Page 287)
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, which has variables R1 and R3 each as H, and variable R2 as heteroaryl. Claim 19 claims a pharmaceutical composition comprising a compound of the invention. Claim 21 claims a pharmaceutical composition comprising a compound of the invention for use in the treatment of cancer in combination with other forms of cancer immunotherapy, anti-cancer chemotherapeutic agents, adenosine pathway modulators, and anti-PD-1, anti-PDL-1, or anti-CTLA-4 antibodies.
Claims 1, 5 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN RN 2411456-99-8 (Entered STN: 8 March 2020).
STN RN 2411456-99-8
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has variables R1 and R2 each as H, and variable R3 as phenyl substituted with chlorine.
Claims 1, 5, and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN RN 2317946-23-7 (Entered STN: 26 May 2019).
STN RN 2317946-23-7
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has variable R1 as phenyl, R2 and R3 each as H, and variable R4 as chlorine.
Claims 1 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN RN 2317093-52-8 (Entered STN: 26 May 2019).
STN RN 2317093-52-8
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has variable R1 as phenyl, variables R2 and R3 as H, and variable R4 as methyl.
Claims 1 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN RN 2317074-74-9 (Entered STN: 26 May 2019).
STN RN 2317074-74-9
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has variable R1 as phenyl, variables R2 and R3 as H, and variable R4 as fluorine.
Claims 1, 7, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN RN 2309166-25-2 (Entered STN: 16 May 2019).
STN RN 2309166-25-2
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has variable R1 as cyclopropyl, variable R2 as phenyl substituted with OMe, and variable R3 as H.
Claims 1 and 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN RN 2309164-79-0 (Entered STN: 16 May 2019).
STN RN 2309164-79-0
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has variable R1 as cyclopropyl, variable R2 as phenyl substituted with OMe, variable R3 as H, and variable R4 as chlorine.
Claims 1 and 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN RN 2309132-98-5 (Entered STN: 16 May 2019).
STN RN 2309132-98-5
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has variables R1 and R2 each as cyclopropyl, variable R3 as H, and variable R4 as chlorine.
Claims 1, 7, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN RN 2308900-76-5 (Entered STN: 16 May 2019).
STN RN 2308900-76-5
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has variables R1 as cyclopropyl, variable R2 as phenyl, variable R3 as H, and variable R4 as fluorine.
Claims 1 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN RN 1348934-55-3 (Entered STN: 5 December 2011).
STN RN 1348934-55-3
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has variables R1 through R3 each as H and variable R4 as fluorine and methyl.
Claims 1 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN RN 1340898-42-1 (Entered STN: 4 November 2011).
STN RN 1340898-42-1
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has variable R1 as heterocycle, variables R2 and R3 each as hydrogen, and variable R4 as fluorine.
Claims 1, 7, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN RN 1048560-42-4 (Entered STN: 11 September 2008).
STN RN 1048560-42-4
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has variable R1 as phenyl substituted with fluorine, variable R2 as phenyl, variable R3 as H.
Claims 1, 7, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN RN 1046903-24-5 (Entered STN: 7 September 2008).
STN RN 1046903-24-5
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has variable R1 as phenyl substituted with OMe, variable R2 as phenyl, variable R3 as H, and R4 as CF3.
Claim Rejections - 35 USC § 103
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, 5, 7, 9, and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Nolte (WO 2008/063671; Publication Date: 29 May 2008) in view of Daniels (J. Advanced Practical Oncology, 2019; 10(7):730-735).
The teachings of Nolte are previously described and are fully incorporated into this rejection.
Nolte does not teach a composition which includes letermovir, or a method of treating herpesvirus with the compounds claimed and letermovir.
Daniels teaches the use of letermovir for the treatment and/or prophylaxis of cytomegalovirus infections. Cytomegalovirus (CMV) is a ubiquitous double-stranded DNA herpes virus that infects over 50% of adults by age 40 (Page 730). In 2017, a first-in-class viral teminase complex subunit inhibit, letermovir, became the only U.S. FDA approved medication to prevent CMV reactivation after allogeneic HCT (e.g., as prophylaxis). In a phase III trial, patients who were randomized to letermovir prophylactically had decreased rates of CMV viremia leading to preemptive therapy (Abstract). Letermovir inhibits CMV replication mechanisms, which prevents CMV from spreading to and infecting other cells (Mechanism of Action and Pharmacokinetics).
Daniels and Nolte are considered analogous to the claimed invention as all are involved in the treatment of herpes virus infections. Therefore, it would have been prima facie obvious to one of ordinary skill in the art the time of the effective filing date of the instant application to combine the compounds of Nolte, which can be used in methods for the treatment of herpes virus infections, with letermovir, as Daniels teaches that letermovir is useful for the treatment of cytomegalovirus infections, which is a type of herpes virus. Nolte teaches a combination product of compounds which meet the limitations of what is claimed, as well as methods for the treatment of herpes and/or herpesvirus. As Daniels teaches, letermovir is known in the art to be useful for the treatment of cytomegalovirus, which is a member of the herpes virus family. Thus, its use in methods of treatment of herpes virus infections is prima facie obvious. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (See MPEP § 2144.06 I).
Allowable Subject Matter
Claims 2, 6, and 10 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.
Claims 3 and 11 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.
The following is an examiner’s statement of reasons for allowance: There is no prior art which teaches the compounds of Claims 2, 3, 6, or 10, nor is there any art teaching the specific compounds of Claim 11 (See STN Search, Search Notes). The closest prior art is cited above, and does not teach the specific heterocyclic moieties which are claimed in the compounds of the invention, nor is there any suggestion or motivation found within the art to insert these moieties into these compounds.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Claims 1, 3-5, 7-9, and 11-17 are rejected.
Claims 2, 6, and 10 are objected to as dependent upon a rejected claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP MATTHEW RZECZYCKI whose telephone number is (703)756-5326. The examiner can normally be reached Monday Thru Friday 730AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.M.R./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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