DETAILED ACTION
Notice of 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
The earliest effective filing date afforded the instantly claimed invention has been determined to be 3/02/2023, the filing date of PCT/CN2023/079360, of which this Application is a U.S. National Stage Application submitted under 35 U.S.C. 371.
Acknowledgment is made of Applicant’s claim for foreign priority based on a prior application filed in China on 3/03/2022. However, Applicant has not been granted the benefit of foreign priority because a certified English translation of the foreign application has not been provided.
Election/Restrictions
Applicant’s election with traverse of Group I in the reply filed on 8/27/2026 is acknowledged. As argued by Applicant, the claims as newly amended “constitute a special technical feature... that defines a contribution over CN 114075190A” (Applicant Arguments, Page 21).
The argument is not found persuasive for the reasons discussed in the rejection of claims under 35 U.S.C. 103(a) as being unpatentable over Chen et al (CN 114075190 A (published 2/22/2022); of record – based on WO 2022/037649 as the English language equivalent). As such, the requirement is still deemed proper and is therefore made FINAL.
Claims 61-62 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant’s election with traverse of a single species in the reply filed on 8/27/2026 is also acknowledged. As argued by Applicant, “[t]here would be no burden if all of the species were searched together” (Applicant Arguments, Page 22).
The argument is not found persuasive. The instant Application is a 371 of PCT/CN2023/079360. As discussed by MPEP 823, “[t]he analysis used to determine whether the Office may require restriction differs in national stage applications submitted under 35 U.S.C. 371”. Significantly, that analysis does not include search burden.
The elected species read upon claims 49, 53 and 59-60. Claims 50-52 and 54-58 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Expansion of Election of Species Requirement
Applicant’s elected compound species, a compound of example 60 having the following structure:
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, has been searched and is rejected below.
The following additional compound species were identified during that search, and are also rejected below:
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; and
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.
Claim Objections
Claims 49, 53 and 59-60 are objected to as comprising the minor informalities:
Claim 49 recites:
“A compound, or a tautomer, stereoisomer, or pharmaceutically acceptable salt thereof, wherein the compound is selected from:
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” and so on.
The recitation of “compound of example 51” and the like, as well as the inclusion of “or” between some compounds but not others, is cumbersome and unnecessary.
Applicant should amend the claims to conform to the following format:
(Claim 49) A compound selected from the group consisting of:
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... and
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or a tautomer, stereoisomer, or pharmaceutically acceptable salt thereof.
Applicant is further encouraged to verify that the amended claim(s) provide(s) support for all dependent claims including any WITHDRAWN dependent claims. For example, WITHDRAWN claims 55 and 57-58 are each independently drawn to the compound of claim 49, wherein the compound is example 30 (claim 55), example 55 (claim 57), or example 56 (claim 58). However, examples 30, 55 and 56 are not recited by claim 49.
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.
Claim 49 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS RN 2762043-57-0 (entered into STN on 3/11/2022).
Claim 49 is drawn to a compound:
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The compound is taught by CAS RN 2762043-57-0.
Accordingly, claim 49 is anticipated.
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.
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 49, 53 and 59-60 are rejected under 35 U.S.C. 103(a) as being unpatentable over Chen et al (CN 114075190 A (published 2/22/2022); of record – based on Chen et al (WO 2022/037649) as the English language equivalent).
Claims 49, 53 and 59 are drawn to the following compound:
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.
Chen et al teach “compounds of formula (I)... as inhibitors of Bruton’s tyrosine kinase (BTK) and C481 mutant” (Abstract), including the following compound:
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(Page 11, Compound 8),
identified as amongst the most potent BTK inhibitors (exhibiting an IC50 for BTKWT of 1.2 nM and BTKC481S of 0.8 nM (Page 84, Table 1)) – which differs from the instantly claimed compound in the location of substituents on the cycloalkyl ring as indicated by arrow.
As discussed by MPEP 2144.09(I), a prima facie case of obviousness may be made when chemical compounds have very close structural similarities to chemical compounds in the prior art, based on “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” (quoting In re Payne, 606 F.2d 303 (CCPA 1979)). Significantly, as further stated by MPEP 2144.09(II), citing In re Wilder, 563 F.2d 457 (CCPA 1977), “[c]ompounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus)... are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties”.
Accordingly, it would have been prima facie obvious to shift a nitrogen atom in the heteroaryl ring of Compound 8 taught by Chen et al to arrive at the instantly claimed compound. It would have been obvious to do so in an effort to make a related compound, in the expectation that compounds similar in structure will have similar properties, and with a reasonable expectation of success considering that “[c]ompounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus)... are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties”.
As such, claims 49, 53 and 59 are rejected as prima facie obvious.
Claim 60 is drawn to a pharmaceutical composition comprising a compound of claim 49 and pharmaceutically acceptable excipients.
Chen et al further teach “pharmaceutical compositions comprising compounds of Formula (I)... and one or more pharmaceutically acceptable carriers or excipients” (Page 19, Lines 5-8).
As such, claim 60 is also rejected as prima facie obvious.
Claims 49 and 60 are ADDITIONALLY rejected under 35 U.S.C. 103(a) as being unpatentable over Guisot et al (WO 2017/046604).
Claim 49 is drawn to the following compound:
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(example 27).
Guisot et al teach “inhibitors of Bruton’s tyrosine kinase (BTK)” (Abstract), including the following compound:
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(Paragraphs 00530-00531, Examples 94 and 95),
identified as amongst the most potent and selective BTK inhibitors (exhibiting an IC50 for BTKWT and BTKC481S of < 10 nM, OCLI-Ly10 antiproliferative activity between 10 nM and 100 nM, and weak off target binding to EGFR (Page 167, Table 5)) – which differs from the instantly claimed compound in the location of substituents on the cycloalkyl ring as indicated by arrow.
As discussed by MPEP 2144.09(I), a prima facie case of obviousness may be made when chemical compounds have very close structural similarities to chemical compounds in the prior art, based on “the motivation of one skilled in the art to make a related claimed compound, in the expectation that compounds similar in structure will have similar properties” (quoting In re Payne, 606 F.2d 303 (CCPA 1979)). Significantly, as further stated by MPEP 2144.09(II), citing In re Wilder, 563 F.2d 457 (CCPA 1977), “[c]ompounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus)... are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties”.
Accordingly, it would have been prima facie obvious to shift the substituents on the cyclohexyl ring of Examples 94 and 95 taught by Guisot et al a single position to arrive at the instantly claimed compound. It would have been obvious to do so in an effort to make a compound, in the expectation that compounds similar in structure will have similar properties, and with a reasonable expectation of success considering that “[c]ompounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus)... are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties”.
As such, claim 49 is rejected as prima facie obvious.
Claim 60 is drawn to a pharmaceutical composition comprising a compound of claim 49 and pharmaceutically acceptable excipients.
Guisot et al further teach “a pharmaceutical composition, wherein the composition comprises a compound of the invention and pharmaceutically acceptable excipients” (Paragraph 00121).
As such, claim 60 is also rejected as prima facie obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG D RICCI whose telephone number is (571) 270-5864. The examiner can normally be reached on Monday through Thursday, and every other Friday, 7:30 am - 5:00 pm ET. 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, Bethany Barham can be reached on (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611
