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 .
Election/Restrictions
Applicant’s election without traverse of compound JQ1-AcQ in the reply filed on 2026 February 18 is acknowledged. In light of the election, set L8 shows the extent of the search done: an acyclic peptide of zero to five units is connected to a C(=Q)-alkylene-[Q-C(=Q)-ak-cy or C(=Q)-Q-ak-cy] group in which each instance of Q is any heteroatom and cy is any cyclic group. Claims 1, 2, 5-7, 10, 17, 34, 35, 38, 42, 48, 49, 50, 52, 53, 61, 76, 78, and 84 are pending. As a result of the election, claims 1, 2, 5-7, 17, 34, 35, 38, 42, 48, 49, 50, 52, 53, 61, 76, 78, and 84 are examined on the merits with respect to the scope above.
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Claim 10 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 18.
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 application, Application numbers. 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. In these priority applications, variable a is 0-2 or 1-3. In the examined case variable a is 0-5. Hence the effective filing date of the examined application is 2022 April 13.
63/174389
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63/303364
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Information Disclosure Statement
The information disclosure statements (IDS) submitted on 2024 January 12 and 18 and 2026 February 18 were submitted in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1, 2, 5-7, 17, 34, 35, 38, 42, 48, 50, 52, 53, 61, 76, 78, and 84 are objected to because of the following informalities: replacement of a heteroatoms with O, S, or NRA is not a replacement because these groups are already heteroatoms. Appropriate correction is required.
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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, 53, and 61 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, 2, 5-7, 17, 34, 35, 38, 42, 48, 49, 50, 52, 53, 61, 76, 78, and 84 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, 2, 5-7, 17, 50, 52, 53, 61, 76, 78, and 84 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: the structural requirements of an instance of variable B when it is a binder of a target, wherein the target is selected from a protein, polypeptide, peptide, carbohydrate, and a small molecule. Claims 1 does not specify what chemical elements forms the binder.
In claim 6, the metes and bounds of a derivative of amino acid side chain are not clear. Neither the claims nor the specification define how an amino acid side chain can be modified to be considered a derivative.
Claim 34, 35, 38, 42, and 48 recite various limitation of examined variable B. There is insufficient antecedent basis for this limitation in the claim because claim 1 does not specify the metes and bounds of a binder.
What aryl hydrocarbon receptors are targeted in claim 34? HAHN (Chemico-Biological Interactions, 2002, 141, 131-160) describes various aryl hydrocarbon receptors (pages 135-136, table 1). Are these the type of aryl hydrocarbon receptors that applicants intend to be part of claim 34?
Claim 49 recites compounds in which variable B is various compounds, such as JQ-1 (the first compound of claim 49). There is insufficient antecedent basis for these limitations in the claim because parent claim 1 does not recite clear metes and bounds for variable B.
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, 2, 5, 6, 7, and 50 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by KOVACS (Peptides, 2007, 28, 821-829). Kovacs describes compound Asu6-GnRH-III, shown below (page 823, figure 1). In this compound the following examined definitions apply: N-RN of the succinimide ring is N-substituted alkyl; n is one; a is three; L1-B is CH(CH2-imidazole)-NH-C(O)-[2-oxo-pyrrol-5-yl. These compounds bind to luteinizing hormone, follicle-stimulating hormone, MCF-7, and MDA-MB-231 (page 825, figure 5). Compositions are described (page 822, section 2.2.2).
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Claim(s) 1, 2, 5, 6, 7, and 50 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CHUNG (EP 045506, published 1991 January 2). Chung describes two compounds (page 12, lines 39 and 42; example 28, page 47, lines 33-51; example 24, page 43, lines 35-52). In these compounds the following examined definitions apply: N-RN of the succinimide ring is N-substituted alkyl; n is one; a is two; L1-B is O-t-butyl. These compounds bind to CCK-8 (page 95, table 2). Compositions are described (page 97, line 21 to page 98, line 5).
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Conclusion
Claims 1, 2, 5-7, 17, 34, 35, 38, 42, 48, 49, 50, 52, 53, 61, 76, 78, and 84 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.
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 9:00 AM to 5:00 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