DETAILED ACTION
This action is in response to Applicant’s submission dated May 24, 2026, in which Applicant elected the species, Compound 43, without traverse and for search purposes only. Once it was not found in the art, the full scope of the claimed invention was searched.
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 .
Claim Rejections - 35 USC § 112
Notice of AIA Status
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.
Claims 1-20 are rejected under 35 U.S.C. 112(a), because the specification, while being enabling for degrading SMARCA2/4 and while being enabling for inducing anti-proliferative activity in myeloma and NSLC by administering the compounds of Formula (I), does not reasonably provide enablement for degrading every target protein or enablement for treating every disease dependent upon SMARCA2/4 by administering the compounds of Formula (I). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The instant claims are drawn to a method of degrading a target protein comprising administering to a cell therapeutically effective amount of a compound of formula (I) according to claim 1 wherein the compound is effective for degrading the target protein. The instant specification fails to provide information that would allow the skilled artisan to practice on all target proteins with the aforementioned compounds.
[In re Sichert, 196 USPQ 209 (CCPA 1977)]
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).1
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention, state and predictability of the art, and relative
skill level
The invention relates to a method of degrading a target protein comprising administering to a cell therapeutically effective amount of a compound of formula (I) according to claim 1 wherein the compound is effective for degrading the target protein and to a method for treating diseases or disorders dependent upon SMARCA2/4 in a subject comprising administering a compound of formula (I). The relative skill of those in the art is high, that of an MD or Ph.D. That factor is outweighed; however, by the unpredictable nature of the art. As illustrative of the state of the art, Examiner cites the fact that while Applicant demonstrated in the specification that the compounds of the instant invention were effective in degrading SMARCA2/4 and while enabling for inducing anti-proliferative activity in myeloma and non-small cell lung cancer (NSCLC), nowhere in the specification did Applicant demonstrate degradation of every target protein. Likewise, Applicant stated in the specification that inhibition of SMARCA2/4 did not lead to inhibition of tumor proliferation and that actual silencing and/or degradation of SMARCA2/4 led to anti-tumor proliferative activity. As a result, Examiner maintains that treating a disease or disorder dependent upon SMARCA2/4 would not necessarily lead to actual treatment of any disease as discussed in Applicant’s own specification. Therefore, Applicant would need to amend the claims to recite “a method for alleviating diseases or disorders treatable by degradation of SMARCA2/4” in order to obviate said enablement rejection. Since Applicant has yet to demonstrate treatment of every single disease or cancer dependent upon SMARCA2/4 and given that Applicant has failed to demonstrate degradation of every target protein by administering said compounds of formula (I), Examiner maintains that Applicant has yet to enable the breadth of the claims.
2. The breadth of the claims
The claims are thus very broad insofar as they recite “degrading a SMARCA2/4 protein in a cell”. While such “treatment of NSCLC and myeloma” might theoretically be possible for some target proteins or diseases, as a practical matter it is nearly impossible to achieve a treatment for all possible diseases with the same compound.
3. The amount of direction or guidance provided and the presence or absence of working examples
The specification provides no direction or guidance for the use of the aforementioned compounds to treat every single disorder or disease subtypes dependent upon SMARCA2/4 or for degrading every single target protein in existence. No reasonably specific guidance is provided concerning useful therapeutic protocols for said degradation or said treatment, other than degradation of SMARCA2/4 and treatment of myeloma and NSLC as delineated in tables 29-31. The latter is corroborated by the working examples on pages 161-164.
4. The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed compounds of Formula (I) could be predictably used for the treatment of every single disorder or disease dependent upon SMARCA2/4 and for degrading every single target protein in existence as inferred by the claims and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Provisional Non-Statutory Double Patenting
The non-statutory 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 non-statutory 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 §§ 706.02(l)(1) - 706.02(l)(3) 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.
Claims 1-4, 6, 9, 16-17, and 19-20 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2, 4, 6-10, and 15 of U.S. Patent Application No. 17/018,811 (hereinafter Muralidhara US Patent Application No. ‘811). Although the conflicting claims are not completely identical, they are not patentably distinct from each other because both applications are directed to a method of treating cancer comprising administering SMARCA2/4 degraders. The claimed invention is rendered obvious by U.S. Patent Application Muralidhara ‘811 as the claimed invention teaches a broad genus of a compound of Formula (I) that are SMARCA2/4 degraders and to a method of treating a prostate disease that is dependent on SMARCA2/4, including prostate cancer comprising administering SMARCA2/4 degraders whereas Muralidhara ‘811 teaches a subgenus of a treatment of prostate cancer comprising identifying the subject as a responder to treatment with SMARCA2/4 degraders and administering a therapeutically effective of a broad genus of at least one SMARCA2/4 degrader. While the instant invention is silent on identifying a subject as a responder, the examiner contends that identifying a patient that will respond to such treatment is obvious and can be performed during routine experimentation. Thus, the aforementioned claims of the instant application are rendered obvious over the cited claims of corresponding U.S. Patent Application No. 17/018,811.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Closest Art
The closest art is Ramachandra Muralidhara, et al. (WO 2021/048799 A1), which teaches a method of identifying responders to SMARCA2/4 degraders in a subject that are responders to said treatment (i.e. including prostate cancer subjects; see Abstract). Specifically, Muralidhara, et al. teach compounds that are anticipated by instant formula (I). However, Muralidhara et al. was published after the effective filing date of the instant invention and thus is not considered prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ERICH A LEESER whose telephone number is (571) 272-9932. The Examiner can normally be reached Monday through Friday from 10-6 PST, M-F. PST.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Mr. James Alstrum-Acevedo can be reached at (571) 272-5548. The fax number for the organization where this application is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) toll-free at 866-217-9197. If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ERICH A LEESER/Primary Examiner, Art Unit 1622
United States Patent and Trademark Office
Tel. No.: (571) 272-9932
1 As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is “undue”, not “experimentation”.
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