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 .
Response to Amendment
The 2026 June 25 amendment containing newly amended claims 1, 2, 5, 7, 10, 17, 35, 38, 42, 48-50, 52, 61, 76, 78, 84, 90, and 91 is examined on the merits. A search of newly amended claim 1 has been extended to the following scope: examined variable n is one or two; examined variable a is zero and a combination of examined variables L1 and B form a methyl, butyl, hexyl, heptyl, octyl, or decyl group. The 35 U.S.C. 102 rejections are overcome due to several reasons: variable a is now limited to zero, one, or two; and the nitrogen ring atom is substituted by H, RN anymore. KOVACS (Peptides, 2007, 28, 821-829) describes compounds in which variable a is four. CHUNG (EP 045506, published 1991 January 2) describes compounds in which the nitrogen ring atom is substituted with a CH[C(O)-NH2]-benzyl group.
Claims 2, 5, 7, 10, 17, 35, 38, 42, 48, and 49 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2026 February 19.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application No. 63 / 174389 and 63 / 303364, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application No. 63 / 174389 provides support for variables R and RN forming a 5-membered ring with each other but not a 6-membered ring. Based on this teaching the effective filing date of claim 2 is 2021 April 13. Application No. 63 / 303364 provides support for variables R and RN forming a 6-membered ring with each other but not a 5-membered ring. Consequently, the effective filing date of the examined application is 2022 April 13.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2026 June 25 was submitted in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 52, 61, 90, and 91 are 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.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
The nature of the invention and (2) the breadth of the claims:
The claims are drawn to treatment or prevention of a disease with a compound of formula (I’). Thus, the claims taken together with the specification imply a compound of formula (I’) can treat or prevent a disease.
The state of the prior art and (4) the predictability or unpredictability of the art:
COLLINS (Biochemical Journal, 2017, 474, 1127-1147) describes that E3 ligase cereblon (also known as CRBN)-dependent ubiquitylation requires more research in (page 1132, figure 3) the relationship between itself and disorders (page 1144, paragraph 4 to page 1145, paragraph 1),
The relative skill of those in the art:
While the artisan generally would have an advanced degree in [area of claims], their high level of skill and knowledge is insufficient to overcome the lack of understanding as to how cereblon functions in the body or to overcome the art recognition that this disease is poorly understood and treatments have generally failed.
The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided guidance for in vitro testing of compounds as CRBN modulators in targeted protein degradation (page 291, paragraph [0617] to page 300, paragraph [0636]).
The specification does not provide enablement for treating or preventing a disease.
The quantity of experimentation necessary:
Considering the state of the art as discussed by the references above, particularly with regards to treating or preventing a disease with a compound of formula (I’) and the high unpredictability in the art as evidenced therein, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
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.
Claims 1 and 50 are 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.
Claims 1 and 50 recites the limitation that only one instance of B is a binder of a target. There is insufficient antecedent basis for this limitation in the claim because newly amended variable B is not defined as a binder of a target.
Response to Amendments and Arguments
The amendment filed 2026 June 26 does not overcome the 35 U.S.C. 112 (a) because the state of the art shows that disorders linked to CRBN is more than undue research. Although the specification shows that compounds of the application bind proteins, the prior art shows that more research is needed to understand the relationship between CRBN and diseases. Collins describes that use of molecules that promote protein degradation as chemical tools is an exciting area and that optimization of the physiochemical properties of high molecular mass bifunctional molecules for human administration remains difficult (abstract; pages 1144-1145, “Conclusions and Future Perspectives” section)
Claim Rejections - 35 USC § 102
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 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(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CLARK (Journal of Chemical Society, 1958, 3283-3289). Clark describes two compounds (page 3286, table 1, compound no. 3; page 3288, paragraph 6,”DL-α-acetamidoglutarimide”). In these two compounds, the following examined definitions apply: n is one or two; RN is H; a is zero; L1-B is methyl. When L1-B is methyl, two interpretations are encompassed: L1 is C1-alkyl; B is H; and L1 is a bond; B is a methyl group.
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Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by FOX (Journal of Medicinal Chemistry, 2002, 45, 360-370). Fox describes compounds 13-17 (page 363, scheme 2; page 364, scheme 3 and table 2). In these two compounds, the following examined definitions apply: n is two; RN is H; a is zero; L1-B is butyl, hexyl, heptyl, octyl, or decyl.
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Conclusion
Claims 1, 50, 52, 61, 90, and 91 are not allowed.
The following is a statement of reasons for the indication of allowable subject matter: the elected species is free of the prior art of record because Chung (EP 045506, published 1991 January 2) does not describe a compound in which examined variable L1-B is an octylene-NH-JQ1 group.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOBLE E JARRELL whose telephone number is (571)272-9077. The examiner can normally be reached 8:00 AM to 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699
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