DETAILED ACTION
Claims 1-28, filed November 18, 2022 with a domestic benefit date of June 17, 2022, are pending in the application and are objected or rejected to for the reasons set forth below.
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 18, 2022 were in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement was considered by the examiner. A signed copy of each form 1449 is enclosed herewith.
Election/Restrictions
Applicant's election with traverse of the invention of group I, claims 1-28, in the reply filed on December 26, 2024 is acknowledged. The traversal is on the ground there is no undue burden on the examiner in this case. Applicants submit that in accordance with Section 803 of the Manual of Patent Examining Procedure, there is no prohibition against claiming a reasonable number of species and therefore there should be no undue burden on the Examiner. This is found unpersuasive because the invention of group I (claims 1-28) classified in C07D405/14 is drawn to a compound of formula I-A-1, (product) while the invention of group II (claim 29) classified in C07D401/10 is drawn to a process of use. Furthermore, the limitations of formula of I-A-1 recite a diverse selection of functional groups, chemical bonding and structural compositions with mutually exclusive characteristics for each identified species. Searching these inventions and species together would require different search queries, databases, and classifications.
The requirement is still deemed proper and is therefore made FINAL.
Claim 29 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on December 26, 2024. Claims 3-4, 6-7, 9-10, and 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected species. Claims 1-2, 5, 8, 11-25, 27 and 28 read on the elected species and are under current examination in the instant application.
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.
The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim.
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.
Allowable Subject Matter
Claim 27 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.
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 (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 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 1-2, 5, 8, 11-13 and 24-25 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by CAplus Registry Number: RN 2230201-35-9. [Database Registry Chemical Abstracts Service, Columbus, Ohio, Accession No. RN 2230201-35-9, Entered STN: 09 Jul 2018].
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RN 2230201-35-9 anticipates the instant claims wherein R2 is methyl, X is CH, R3’ is C(O)R3a wherein R3a is methyl, R3 is H, V is CH2 wherein C(R6b)-C(R6c) and R6b R6c are H, B is piperidine, A is pyridine, Y is O, R5a and R5b are H and R1 is phenol.
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(Compound I-A-1 of the instant application)
Registry number 2230201-35-9 is available as prior art as of 09 Jul 2018, the day it was indexed into the CAplus database.
Claims 1, 15-23 and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAplus Registry Number: RN 1066991-68-1. [Database Registry Chemical Abstracts Service, Columbus, Ohio, Accession No. RN 1066991-68-1, Entered STN: 27 Oct 2008].
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RN 1066991-68-1 anticipates the instant claims wherein X is CH, R3’ is H, R3 is H, V is CH2 wherein the R6b R6c of C(R6b)(R6c) are H, ring B is piperidine, ring A is pyrimidine substituted with Z1a wherein Z1a is aryl substituted with Z1b and Z1b is O-methyl, Y is S, R5a and R5b are H, and R1 is alkyl substituted alkoxy.
Regarding the compositions of claim 28, comprising the anticipatory compounds and an excipient, the Registry entry for Registry no. 1066991-68-1 discloses a mass solubility of 0.00069 g/L, in unbuffered water at pH 7.39. The Registry entries for registry no. 2230201-35-9 discloses a mass solubility of 0.0013 g/L, in unbuffered water at pH 7.49 and the registry entry for registry no. 2403765-36-4 discloses a mass solubility of 0.0019 g/L, in unbuffered water at pH 6.19.These teachings of water anticipates the claimed composition, wherein the compounds are present with an excipient (i.e., water).
Claims 1, and 13-14 is rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by CAplus Registry Number: RN 2403765-36-4. [Database Registry Chemical Abstracts Service, Columbus, Ohio, Accession No. RN 2403765-36-4, Entered STN: 09 Jan 2020].
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RN 2403765-36-4 anticipates the instant claims wherein X is CH, R3’ is C(O)-OR3a wherein R3a is H, R3 is H, R2 is 2-ethyloxetane (
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), V is CH2, ring B is piperidine, ring A is pyridine, Y is O, R5a and R5b are H, R1 is phenyl substituted with 2 Z1 wherein each Z1 is F and CN.
See MPEP 2128 II: ELECTRONIC PUBLICATIONS AS PRIOR ART Status as a "Printed Publication" An electronic publication, including an on-line database or Internet publication, is considered to be a “printed publication” within the meaning of 35 U.S.C. 102(a) and (b) provided the publication was accessible to persons concerned with the art to which the document relates. See In re Wyer, 655 F.2d 221, 227, 210 USPQ 790, 795 (CCPA 1981) Since this date represents the date that each compound entered the CAPlus database on STN, this represents the date that each compound was made accessible to the public.
The aforementioned compounds anticipate the instantly claimed compounds: It is further noted that for the purposes of determining if a reference is a “printed publication” for the purposes of 102(b), MPEP 2128 I states the following:
“A reference is proven to be a "printed publication" "upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it." In re Wyer, 655 F.2d 221, 210 USPQ 790 (CCPA 1981) (quoting I.C.E. Corp. v. Armco Steel Corp., 250 F. Supp. 738, 743, 148 USPQ 537, 540 (SDNY 1966)) ("We agree that ‘printed publication’ should be approached as a unitary concept.”
Where “prior art disclosures…on an on-line database are considered to be publicly available as of the date the item was publicly posted.” Since each of the database entries above lists the date that each compound was entered into the on-line database, the compounds were made publicly available as of that date in each citation, and the claims are anticipated.
Conclusion/Correspondence
All claims are rejected, no claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNESTO VALLE JR whose telephone number is (703)756-5356. The examiner can normally be reached 0730-1700 M-F EST, 1st Friday off.
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/E.V./
Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623