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
This office action is in response to applicant’s reply filed on November 12, 2025.
Restrictions/Elections.
Applicant’s election without traverse of Group I (Claims 22-24) in the reply filed on November 12, 2025, is acknowledged.
Claim Rejoinder.
Claims 22-24 are directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claims 25-29, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 09/12/2025 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a continuation or divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Status of Claims
Claims 22-29 are currently pending and are the subject of this office action.
Claims 22-29 are presently under examination.
Priority
The present application is a 371 of PCT/US2021/062656 filed on 12/09/2021 and claims priority to provisional application No. 63/123,358 filed on 12/09/2020.
Allowable Subject Matter
Claims 22-24 are allowed as presently advised.
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.
Claims 25-29 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. This is an enablement rejection.
To be enabling, the specification of the patent application 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 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
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 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). 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".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 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
Claim 25 recites:
A method of degrading one or more of SMARCA2, SMARCA4, and PB 1 protein in a patient or biological sample comprising administering to said patient, or contacting said biological sample with a compound according to claim 22, or a pharmaceutical composition thereof.
Claims 26-29 recite:
A method of treating one or more SMARCA2-mediated, SMARCA4-mediated, or PB1-mediated disorder, disease, or condition in a patient comprising administering to said patient a compound according claim 22, or a pharmaceutical composition thereof.
Wherein the disease can be any of the ones disclosed in claims 28-29.
2. The relative skill of those in the art
The relative skill of those in the art is high, generally that of an M.D. or Ph.D. The artisan using Applicant’s invention would generally be a physician with a M.D. degree and several years of experience.
3. The state and predictability of the art
As illustrative of the state of the art regarding the treatment of any cancer comprising the administration of a composition comprising a SMARCA2 and/or SMARCA degradation compounds the Examiner refers to:
Reichl et. al. (Expert Opinion on Therapeutic Patents (2024) 34:159-169, Reichl 1) and Reichl et.al. (Expert Opinion on Therapeutic Patents (2024) 34:211-229, Reichl 2.).
Reichl 1 teaches that there are currently no approved SMARCA2 and/or SMARCA4 degradation compounds approved for the treatment of any cancer. Reichl 1 teaches that there is only one clinical candidate as a potential treatment for relapsed/refractory AML and MDS and metastatic uveal melanoma, with no clinical results yet (see page 167 under 6. Expert opinion). Reichl 1 concludes that: “much remains to be explored in this area, however, including further refinement of SMARCA2 selective ATPase inhibitors which are still in the early stages of development (page 168)
Reichl 2 also teaches that there is only one SMARCA2 degrader in clinical trials and is being evaluated in metastatic solid tumors (see page 277, right column, last paragraph), with no experimental results yet provided.
These articles demonstrate that the art of treating any cancer with SMARCA2 and/or SMARCA4 degraders is extremely unpredictable.
Further, a search of the literature provided absolutely no association between SMARCA2 and/or SMARCA degradation and any of the diseases listed in claim 28 like: neurodegenerative disease, viral diseases, autoimmune diseases, inflammatory disorders, etc.
Finally, a search of the literature showed that the compounds of claim 22 are novel and as such there is no biological data associated with them.
4. The amount of direction or guidance provided and the presence or absence of working examples
MPEP 2164.03 states: “The scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required. A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971). However, in applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). This is because it is not obvious from the disclosure of one species, what other species will work”.
The specification does not provide any experimental data showing that the claimed compounds are SMARCA2 and/or SMARCA4 degraders. Further the specification does not provide any data in vitro or in vivo that correlates the claimed compounds or any SMARCA2/4 degrader with the efficacy of treating any specific cancer like the ones listed in claim 29 or any of the diverse set of diseases listed in claim 28.
While it is understood that the absence of working examples should never be the sole reason for rejecting a claim as being broader than an enabling disclosure, the criticality of working examples in an unpredictable art, such as the treatment of all the conditions listed in instant claims 28-29 is required for practice of the claimed invention.
5. The quantity of experimentation necessary
As discussed above (see: 3. the state and predictability of the art), there is absolutely no data correlating the claimed compounds or any other SMARCA2/4 degrading compound with any type of disease treatment. Based on this, and in the absence of experimental evidence commensurate in scope with the claims (see: 4. The amount of direction or guidance and the presence or absence of working examples above), the skilled in the art will not accept that a composition comprising any of the compounds of instant claim 22 as claimed, will be effective in treating any disease inferred by the claims and contemplated by the specification because neither the prior art nor the specification disclose that the claimed compounds are indeed SMARCA2 or SMARCA2 degraders. Further, even if the compounds of claim 22 were effective SMARCA2 and/or SMARCA4 degraders, the prior art does not offer any example of SMARCA2 or SMARCA 4 degraders being effective in treating any disease.
So, determining if the compounds of claim 22, will be effective in treating any disease, will require assaying these compounds in an assay that correlates with the treatment of any disease, and then further determine their efficacy in a validated animal model.
All this is undue experimentation given the limited guidance and direction provided by Applicants.
7. Conclusion
Accordingly, the inventions of claims 25-29 do not comply with the enablement requirement of 35 U.S.C 112, first paragraph, since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation with no assurance of success.
Conclusion
Claims 22-24 are allowed.
Claims 25-29 are rejected.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
February 3, 2026.