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 .
DETAILED ACTION
Claims 1-22 are pending in the application. Claims 1, 2, 5-11, 14, 16 and 18 are rejected. Claims 3, 4, 12, 13, 15, 17 and 19-22 are withdrawn.
Restriction/Election of Species
Applicant's election with traverse of Group I, claims 1-18, and further elected species of Compound 39 having the structure below in the reply filed on December 2, 2025 is acknowledged:
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The traversal is on the ground(s) that the reference compound (i.e., Compound 100) indicated in the Restriction Requirement mailed August 14, 2025 does not satisfy one of the instantly required provisos as recited in instant claim 1. See page 36 of Applicant’s Remarks dated December 2, 2025. However, this is not found persuasive as the instant claims are- regardless- both anticipated and rendered obvious by the prior art. See rejections under 35 U.S.C. § 102 and 35 U.S.C. § 103 below.
The requirement is still deemed proper and is therefore made FINAL.
Pursuant to MPEP § 803.02, the Markush claims that read on the elected species were examined fully with respect to the elected species. Upon examination, the elected species were found to be anticipated or rendered obvious by prior art; therefore, the Markush claim and claims to the elected species will be rejected. The claim(s) and subject matter that do not read on the elected species have NOT been examined and searched and are withdrawn from further consideration by the examiner. Any subject matter addressed under 35 U.S.C. § 112(b) and 35 U.S.C. § 102 or in the nonstatutory double patenting rejection below was discovered incidental to the examination of the elected species above. Rejections addressing such subject matter is presented solely in the interest of compact prosecution.
Claims 1, 2, 5-11, 14, 16 and 18 read on the elected species. Claims 3, 4, 12, 13, 15, 17 and 19-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on December 2, 2025.
Priority
This application is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/US21/45924, filed on August 13, 2021, which claims benefit of Provisional Application No. 63/151,600, filed on February 19, 2021, which claims benefit of Provisional Application No. 63/066,074, filed on August 14, 2020.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS) filed on February 13, 2023 and December 2, 2025 are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the Examiner has considered the IDS documents and signed copies of the 1449 forms are attached.
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 16 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 16 recites the expressions “first eluting isomer” and “second eluting isomer” on page 16 and is rejected as indefinite. Both expressions are in reference to the following chemical structure:
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It is unclear how the scope of the claim is being limited by the expressions “first eluting isomer” and “second eluting isomer.” It is suggested that Applicant cancel these expressions and also delete one instance of the above chemical structure in the claim to overcome this issue of indefiniteness.
Claim 16 recites the expressions “First eluting isomer” and “Second eluting isomer” on page 21 and is further rejected as indefinite. Both expressions are in reference to the following chemical structure:
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It is unclear how the scope of the claim is being limited by the expressions “First eluting isomer” and “Second eluting isomer.” It is suggested that Applicant cancel these expressions and also delete one instance of the above chemical structure in the claim to overcome this issue of indefiniteness.
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)(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.
(1 of 2) Claims 1, 2, 5-11, 14 and 18 are rejected under 35 U.S.C. § 102(a)(2) as being anticipated by EP20382456.0 filed on May 28, 2020.
The prior art teaches the following chemical structure on page 69:
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Regarding instant claims 1, 2, 5-11 and 14, the above prior art structure is encompassed by variable definitions of the instantly claimed compound of Formula I, wherein A1, A3 and A4 are each independently CH; A2 is CR1, further wherein R1 is halo; R2 is C3 alkyl; Y is O; R6 is hydrogen; R7 is hydrogen; X is O; R4 is hydrogen; and R5 is heteroaryl.
Regarding instant claim 18, the prior art teaches “a composition comprising a pharmaceutically acceptable carrier and, as active ingredient, a therapeutically effective amount of a compound of the invention.” See e.g., page 34.
(2 of 2) Claims 1, 2, 5-11, 14, 16 and 18 are rejected under 35 U.S.C. § 102(a)(2) as being anticipated by EP20382456.0 filed on May 28, 2020.
The prior art teaches the following chemical structure on page 69:
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Regarding instant claims 1, 2, 5-11 and 14, the above prior art structure is encompassed by variable definitions of the instantly claimed compound of Formula I, wherein A1, A3 and A4 are each independently CH; A2 is CR1, further wherein R1 is halo; R2 is C3 alkyl; Y is O; R6 is hydrogen; R7 is hydrogen; X is O; R4 is hydrogen; and R5 is C4 cycloalkyl substituted with two Z1, further wherein one Z1 is C1 alkyl and the other Z1 is -OH.
Regarding instant claim 16, the above prior art structure corresponds to the first instantly recited chemical structure.
Regarding instant claim 18, the prior art teaches “a composition comprising a pharmaceutically acceptable carrier and, as active ingredient, a therapeutically effective amount of a compound of the invention.” See e.g., page 34.
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.
Claim 16 is rejected under 35 U.S.C. § 103 as being unpatentable over EP20382456.0 filed on May 28, 2020.
Determining the scope and contents of the prior art (See MPEP § 2141.01)
The prior art teaches the following chemical structure on page 69:
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Ascertainment of the differences between the prior art and the claims (See MPEP § 2141.02)
Regarding instant claim 16, the prior art compound does not read on Applicant’s elected species (i.e., instant Compound 39- recited as the fifth compound on page 11 of the Claims filed on December 12, 2025 and reproduced below).
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The prior art compound structurally differs from instant Compound 39 only with respect to the attachment point of the pyrimidine moiety (i.e., instant variable R5) to the core structure.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Accordingly, it would have been obvious for a person of ordinary skill in the art to arrive at Applicant’s elected species (i.e., instant Compound 39) based on the prior art which teaches a positional isomer of instant Compound 39. See e.g., page 69. Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or 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 MPEP § 2144.09 (II). Therefore, a person of ordinary skill in the art would be motivated to make the instantly claimed compound with the expectation that the resulting compound would possess similar properties and utilities to the prior art compound.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
The analysis employed for an obviousness-type double patenting rejection parallels the analysis for a determination of obviousness under 35 U.S.C. § 103. 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, 2, 5-11, 14, 16 and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 10-12 of copending U.S. Application No. 18/837,817 (‘817). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-3 and 10-12 of ‘817 are drawn towards compounds encompassed by variable definitions of the instantly claimed compound of Formula I.
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For instance, Compound No. 2 (structure reproduced above) as recited in claim 1 of ‘817 is encompassed by variable definitions of the instantly claimed compound of Formula I, wherein A1, A3 and A4 are each independently CH; A2 is CR1, further wherein R1 is halo; R2 is OR11, further wherein R11 is C3 cycloalkyl substituted with C1 alkyl; Y is O; R6 is hydrogen; R7 is hydrogen; X is O; R4 is hydrogen; and R5 is heteroaryl substituted with halo.
Conclusion
No claims are allowed.
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/D.M.S./Examiner, Art Unit 1626
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626