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 .
Priority
This application filed on 11/07/2023, is a national phase application under 35 U.S.C. § 371 of International Application No. PCT/US2022/028372 filed on 05/09/2022, which claims benefit of U.S. Application No. 63/185,839 filed on 05/07/2021.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 11/07/2023, complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits, except where noted.
Status of claims
The premilitary amendment filed on 12/06/2023, that amended claims 1, 21, 32-35, 37, 39, 41-43, 47, and 54 and cancelled claims 2-20, 22-29, 45-46, and 49-53, is acknowledged.
Claims 1, 21, 30-44, 47-48, 54 are pending.
Abstract
The Abstract of the disclosure is objected to because the Abstract recites “the present disclosure relates to”. Applicant is reminded of the proper language and format for an abstract of the disclosure. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “…-C(O)(CH)n-, or -C(O)NH2(CH)n-, wherein n is an integer from 0 to 6; …”. The recitation (CH)n-, and NH2(CH)n- is objected to because it includes embodiments that are chemically not possible (the C in (CH)n- has only 3 bonds, and N in -C(O)NH2(CH)n- has 4 bonds when n is 1). This error can be corrected by amending the groups to give carbon four bonds and nitrogen three bonds.
Appropriate correction is required.
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.
(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 and 21 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by H. Imogai et al. (US PG PUB 2007/0275984A1, 11/29/2007, “Imogai” cited in the PTO-892).
Imogai discloses thieno-pyrimidine derivatives of Formula (I). [Abstract]. Imogai discloses species of Formula (I), for example, compound 11, [Table 1, page 31]:
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Compound 11 anticipates claim 1 Formula I, wherein R1 is H; R2 is CH3; R3 is CH3; Z is CH; X is C1 alkyl; (Y) is a bond; A is aryl; and B is aryl.
Claim 21 is met because B is aryl.
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.
Claims 1, 21, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over H. Imogai et al. (US PG PUB 2007/0275984A1, 11/29/2007, “Imogai” cited in the PTO-892).
The disclosures set forth above in the 102 Rejection over the same Imogai et al. reference is herein incorporated by reference.
Imogai is applied to claims 1 and 21 as set forth above in the 102 Rejection.
Imogai discloses compound 56 below as species of Formula (I), [Table 1, page 36], wherein Imogai’s compound 56 differs from claim 38 compound in the region highlighted with the red circle as depicted in the table below for facile comparison:
Imogai’s compound 56
Claim 38, page 8 col. 3, 9th comp.
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278
632
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92
244
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As provided in MPEP 2144.09, a prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963). Compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.). Prior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious. In re Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979) (Claimed and prior art compounds were both directed to heterocyclic carbamoyloximino compounds having pesticidal activity. The only structural difference between the claimed and prior art compounds was that the ring structures of the claimed compounds had two carbon atoms between two sulfur atoms whereas the prior art ring structures had either one or three carbon atoms between two sulfur atoms. The court held that although the prior art compounds were not true homologs or isomers of the claimed compounds, the similarity between the chemical structures and properties is sufficiently close that one of ordinary skill in the art would have been motivated to make the claimed compounds in searching for new pesticides.). The presumption of obviousness based on a reference disclosing structurally similar compounds may be overcome where there is evidence showing there is no reasonable expectation of similar properties in structurally similar compounds. In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (appellant produced sufficient evidence to establish a substantial degree of unpredictability in the pertinent art area, and thereby rebutted the presumption that structurally similar compounds have similar properties); In re Schechter, 205 F.2d 185, 98 USPQ 144 (CCPA 1953). A prima facie case of obviousness based on structural similarity is rebuttable by proof that the claimed compounds possess unexpectedly advantageous or superior properties. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (affidavit evidence which showed that claimed triethylated compounds possessed anti-inflammatory activity whereas prior art trimethylated compounds did not was sufficient to overcome obviousness rejection based on the homologous relationship between the prior art and claimed compounds); In re Wiechert, 370 F.2d 927, 152 USPQ 247 (CCPA 1967) (a 7-fold improvement of activity over the prior art held sufficient to rebut prima facie obviousness based on close structural similarity). However, a claimed compound may be obvious because it was suggested by, or structurally similar to, a prior art compound even though a particular benefit of the claimed compound asserted by patentee is not expressly disclosed in the prior art. It is the differences, in fact, in their respective properties which are determinative of nonobviousness. If the prior art compound does in fact possess a particular benefit, even though the benefit is not recognized in the prior art, applicant’s recognition of the benefit is not in itself sufficient to distinguish the claimed compound from the prior art. In re Dillon, 919 F.2d 688, 693, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990) (en banc).
In the instant case, and in view of MPEP 2144.09, the claimed compound and the prior arts compounds are:
homologs, because as stated in the 103 Rejection above, the claimed compound only differs by successive addition of the same chemical group, e.g., by -CH2- groups (only one CH2). Please note that the MPEP stated that “Prior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious “;
the claimed compound and the prior art compound have very close structural similarities;
Imogai discloses species with A region (highlighted region) is -CH3 or -CH2CH3, [Table 1, page 31-33, comp. 7, 26, 29, 34, etc.]; and
Applicant does not provide evidences of unexpectedly advantageous or superior properties of the claimed compounds over the prior art compounds.
Therefore, Imogai’s compound render claim 38 obvious.
Reasons for Allowance
Claims 30-37, 39-44, 47-48, 54 are allowed.
The following is an examiner’s statement of reasons for allowance:
The closest prior art is considered to be H. Imogai et al. (US PG PUB 2007/0275984A1, 11/29/2007, “Imogai” cited in the PTO-892).
Imogai discloses thieno-pyrimidine derivatives of Formula (I). [Abstract]. Imogai discloses species of Formula (I), for example, compound 11, [Table 1, page 31]:
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Compound 11 reads on claim 30 Formula IA, wherein R1 is H; R3 is CH3; Z is CH; X is C1 alkyl; and differs from Formula IA in that Imogai’s compound 11 does not read on R2 and B, as depicted in the below table, wherein the relevant regions are highlighted by the circles:
Imogai’s compound 11
Claimed Formula IA
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In In order to arrive at a compound falling within the instant claim 31 compound of Formula IA, one of ordinary skill in the art would have to modify Imogai’s above compound 11 to replace the highlighted phenyl ring with one of the rings listed in claim 31, and replace the highlighted CH3 with C2-C6 alkenyl, heteroaryl, heteroalkyl, -OR4, -SR4, or -NR5R6 to arrive at a compound of claim 31. However, Imogai’s disclosure does not provide sufficient guidance and motivation to one of ordinary skill in the art to perform the functional modifications to arrive at the instantly claimed compounds. Therefore, the claims are neither anticipated nor rendered obvious by Imogai’s.
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, 21, and 38 are rejected. Claims 30-37, 39-44, 47-48, 54 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANAHIL MIRGHANI ALI ABDALHAMEED whose telephone number is (571)272-1242. The examiner can normally be reached M-F 7:30 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H Alstrum-Acevedo can be reached at 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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/M.M.A./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622