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 .1
Election/Restrictions
Claims 8, 13, 17-20 and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II and non-elected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 10, 2026.
Applicant’s election without traverse of Group I and the species of formula I below, in the reply filed on July 10, 2026 is acknowledged.
Applicant elected the species compound of formula I:
BSJ-03-096 (Compound (31)
PNG
media_image1.png
126
458
media_image1.png
Greyscale
5-(4-((4-(6-((6-acetyl-8-cyclopentyl-5-methyl-7-oxo-7,8-dihydropyrido[2,3-d]pyrimidin-2-yl)amino)pyridin-3-yl)piperazin-1-yl)methyl)piperidin-1-yl)-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione
Note, the examined species has been expanded to include compound (4) of claim 14, thus necessitating the rejoinder of formerly withdrawn claim 4. Compound (4) is present in examined claim 14.
PNG
media_image2.png
272
426
media_image2.png
Greyscale
Claims 1-7,9-12 and 14-15 are under examination as directed to elected Group I and compound species.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on March 7, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Allowable Subject Matter
Claim 14 is objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1-7, 9-12 and 15 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The Claimed Invention
The claimed invention (claim 1) is directed to a compound of formula I, as detailed above, where L, T, L1, A, Cy, R, R1, R2, R3, R4, where the linkage sites * and # are defined therein.
PNG
media_image3.png
210
442
media_image3.png
Greyscale
wherein L is
PNG
media_image4.png
86
394
media_image4.png
Greyscale
.
Certain narrower embodiments of the claimed invention are presented in various dependent claims. Some of these claims further limit the claimed groups and substituents as detailed therein. Claim 14 recites the claimed and elected species and other individual species. Claim 14 is NOT rejected for written description.
The Supporting Disclosure
Applicants’ supporting disclosure contains certain descriptions and embodiments of the claimed invention.
In the present case, the important factors leading to the conclusion of inadequate written description is the absence of sufficient working examples of the invention as claimed, and the lack of predictability in the art.
In the present case there is no disclosure of compounds having the broad and full scope definitions of the groups and substituents of claim 1. In fact, the scope of compounds that provide adequate written description are the 32 compounds of claim 14 and found on Table 1, pages 32-41 of the specification.
In contrast to the broad claimed scope of L, T, L1, A, Cy, R, R1, R2, R3, R4, where the linkage sites * and # are defined therein of the claims, the supporting disclosure (claim 14, Table 1, pages 32-41 and associated experimental examples starting at page 48), are limited to the following:
where A is azetidine, pyrrolidine, piperidine, piperazine and azetidine, which are ONLY mono- or bi-substituted with methyl or Fluor;
Cy is limited only to cyclobutyl.
Applicant’s disclosure of the about 32 compounds of claim 14, is not a sufficient representation of all the claimed compounds of claim 1 (and rejected dependent claims) as presently pending.
Other than the working examples of the specification (about 32 compounds of Table 1 starting at page 48; Figs.1-11 and Brief Description of the Drawings, starting paragraph 10; biological assay starting at paragraph 245; computation structure analysis starting at paragraph 254; MST assay at paragraph 258; flow cytometry starting at paragraph 259; proteomics at paragraph 261; and balance of in vivo studies starting at paragraph 262, etc.), Applicant has not reasonably described a scientific or “systematic” approach to synthesize the full scope of claim 1 and claims dependent. See MPEP 2163.02, the standard for determining compliance with the written description.2 Despite the written description support of the compounds of claim 14, Applicant has not provided reasonably provided a description the support the broader scope of the claimed compounds of formula I.
Accordingly, Applicants have not adequately described the invention for the breadth that is claimed. It thus appears that Applicants were not in possession of the claimed invention at the time the application was filed, the full scope of compounds of formula I, and that Applicants’ species do not support the claimed genus.
Conclusion and Correspondence
In summary no claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can normally be reached M-F.
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, Adam C. Milligan can be reached at (571) 270-7674. 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.
/WILLIAM Y LEE/Examiner, Art Unit 1623
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
1 CONTINUING DATA
This application is a 371 of PCT/US2022/042928 09/08/2022
PCT/US2022/042928 has PRO 63/241,787 09/08/2021
2 Whenever the issue arises, the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, inventor was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991). An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68,119 S.Ct. 304,312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"
Prosecution Insights