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 9 February, 2024, is a national stage application of PCT/CN2022/111395, filed 10 August, 2022, which claims foreign benefit of applications CN202111500231.5, filed 9 December, 2021, CN202111142090.4, 28 September, 2021, and CN202110913249.1, filed 10 August, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9 February, 2024 is acknowledged and has been considered.
Status of the Application
Receipt is acknowledged of Applicant's claimed invention, filed 13 May, 2026, in the matter of Application N° 18/682,647. Said documents have been entered on the record.
Claims 1-2, 14-17, and 20-21 have been amended. No new matter was introduced.
Thus, Claims 1-18 and 20-21 are pending.
Election/Restrictions
PNG
media_image1.png
147
255
media_image1.png
Greyscale
Applicant's election with traverse of Group I: claims 1-16 and 18, drawn to Compounds and Compositions of Formula I, Formula IA, and Species; and more specifically, Compound 2, shown right, from the elected Species 1 (compounds of Formula I) in the reply filed on 13 May, 2026 is acknowledged.
Applicant’s traversal of the restriction requirement has been considered but is not persuasive.
Applicant argues that the claimed subject matter is unified because compounds of Formula IA serve as intermediates in the preparation of compounds Formula I, the claimed methods of preparation produce compounds of Formula I, and the claimed methods of use require compounds of Formula I (Remarks, Pg 14-15). Applicant further contends that Formula IA is a sub-formula of Formula I and that the claimed compounds represent the core product invention defined by a common novel tricyclic scaffold and substitution pattern (Remarks, Pg 15).
The Examiner acknowledges that the claimed compounds share a common tricyclic scaffold and that compounds of Formula IA are disclosed as intermediates useful in the preparation of compounds of Formula I. However, Formula IA is not merely a narrowing of Formula I. A sub-formula or subgenus narrows the scope of a broader formula by further limiting structural elements required by the broader formula. In contrast, Formula IA lacks structural elements required by Formula I, including the sulfonyl (SO2) linkage, linker L, and Ring A. Accordingly, Formula IA defines a structurally distinct class of intermediate compounds rather than a structural sub-formula encompassed by Formula I.
Furthermore, although compounds of Formula IA are disclosed for use in preparing compounds of Formula I, and the methods of preparation and use ultimately relate to compounds of Formula I, the mere fact that one claimed invention serves as an intermediate in the synthesis of another does not, by itself, establish that the claims are so linked as to form a single general inventive concept. Rather, the claims remain directed to distinct subject matter requiring separate examination.
The fact that one invention may be useful in preparing another invention does not, by itself, establish unity of invention where the claims are directed to distinct subject matter.
Upon completion of examination, the restriction requirement is modified as follows.
The election of Group I is maintained. Accordingly, the compound claims within the elected invention, including claims directed to compounds of Formula I and Formula IA, have been examined on the merits in the present Office action.
The election of species requirement is withdrawn with respect to the elected Species 1. The search conducted during examination was commensurate with the scope of the elected Formula I genus. Accordingly, separate examination of individual Formula I species is no longer necessary.
Claim 17, directed to the non-elected process invention (Group II), including methods of preparing compounds of Formula I from compounds of Formula IA, 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.
Claims 20-21, directed to the method of use invention (Group III) have been rejoined, as they are directed to the use of compounds encompassed by the elected Formula I invention and are properly examined with the elected compound claims.
The requirement is still deemed proper and is therefore made FINAL.
Thus, Claims 1-16, 18 and 20-21 represent all claims currently under consideration.
Claim Rejections - 35 USC § 112
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 15 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.
Formula IA recites the variable Ring B, but Ring B is not defined within the Markush. Accordingly, the metes and bounds of the claimed subject matter cannot be determined with reasonable certainty.
For purposes of examination, Claim 15 is interpreted as having the same Ring B definition as found in Claim 1.
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.
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.
PNG
media_image2.png
254
317
media_image2.png
Greyscale
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Assmann and Friederichsen (Heterocycles (1989), 29(6), 1003-4 CODEN: HTCYAM; ISSN: 0385-5414), and further in view of Patani and LaVoie (Chemical Reviews, 1996, Vol. 96, No. 8).
[AltContent: oval][AltContent: oval]
PNG
media_image3.png
180
231
media_image3.png
Greyscale
Assmann and Friederichsen teach Compound 9 (1989, Pg 1003, also evidenced by CAS RN 124815-09-4), shown top right, which significantly overlaps instant Formula IA, shown bottom right, wherein Ring B is a tetrahydropyranyl, q is 0, R3 is -C(O)OR6 wherein R6 is methyl, and R4 is H.
Assmann and Friederichsen’s Compound 9 differs from Formula IA at the 3-position of the isoxazole which bears a methyl substituent, wherein the instant genus is substituted at the corresponding position with an amino group.
However, Patani and LaVoie teach that substitution with monovalent isosteres (e.g., -NH2, -CH3) results in analogues with similar biological activity (1996, Introduction, Pg. 3152, §II.4, and Tables 2 and Table 11-13).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of invention to modify Assmann and Friederichsen’s Compound 9 by replacing the methyl (-CH3) with an amino substituent (-NH2), as taught by Patani and LaVoie. One of ordinary skill in the art would have been motivated to make such a substitution as a predictable variation in order to obtain an analogue expected to retain similar biological properties while potentially optimizing routine characteristics such as steric profile, lipophilicity, metabolic stability, or pharmacokinetic behavior. Further, in view of Patani and LaVoie’s express teaching that such isosteric substitutions yield compounds with comparable biological activity, one of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed compound and obtaining similar utility.
Allowable Subject Matter
Claims 1-14, 18 and 20-21 are allowed.
Claim 16 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.
PNG
media_image4.png
165
108
media_image4.png
Greyscale
The closest prior art appears to be Lei et al. (WO2020/048548A1, cited in IDS as US2022/0119376A1), which teaches CRBN protein inhibitor compounds that share the same tricyclic core, as shown to the right. However, Lei’s compounds differ in substituent requirement, to include a lack of the requisite sulfonamide as instantly claimed.
Lei neither suggests, nor allows generically, the claimed substituents off the overlapping tricyclic rings, and therefore provides no motivation to modify the compounds shown.
PNG
media_image5.png
164
215
media_image5.png
Greyscale
PNG
media_image6.png
238
439
media_image6.png
Greyscale
Lei, Formula I, Col 1, Para 0008
Instant Formula I, Claim 1
As such, Lei represents the closest known prior art but does not anticipate or render obvious the allowable Claims 1-14, 18 and 20-21 in the present application.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Donna M. Nestor whose telephone number is (703)756-5316. The examiner can normally be reached generally (w/flex): 5:30a-5p EST M-Th.
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, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/D.M.N./Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
Prosecution Insights