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
Status of Claims
Claims 1-3, 5, 7-15, 17, 19-22, and 24 are pending in the instant application.
Claims 2-3,5,7,9-11,13-14,17,20-22 and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
An action on the merits of claims 1,8,12,15, and 19 is contained herein. The elected species was found free of the prior art and search expanded to cover this species more broadly.
Previous Objections/Rejections
Any rejections or objections stated of record in the office action mailed on 1/30/2026 that are not explicitly addressed herein below, are hereby withdrawn in light of applicant's arguments and/or amendments filed 4/28/2026.
Status of Rejections
35 USC § 112 (b)
The rejection of claims 1 ,8, 12, 15, and 19 is maintained.
Applicant’s amendments and arguments, see Remarks, filed 4/28/2026, with respect to the rejection set forth in the Non-Final Office Action mailed 1/30/2026, have been fully considered but are not found persuasive.
In regard to claim 8, recall that variable Y2 and a definition associated with it is recited in the claim albeit it is not embraced the formula for group A. Thus the claim is indefinite. The amendment filed does not address the issue and thus the rejection is maintained.
In reference to the definition of variable A in claim 1 “wherein A is a ligand for the bromodomains of at least one of BPTF, CECR2, BRD9, and PCAF/GCN5”; recall that the definition recites functional language wherein the particular structures needed to achieve the function are not described. “Notwithstanding the permissible instances, the use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008) (noting that the Supreme Court explained that a vice of functional claiming occurs "when the inventor is painstaking when he recites what has already been seen, and then uses conveniently functional language at the exact point of novelty") (quoting General Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364, 371 (1938)); see also United Carbon Co. v. Binney & Smith Co., 317 U.S. 228, 234 (1942) (holding indefinite claims that recited substantially pure carbon black "in the form of commercially uniform, comparatively small, rounded smooth aggregates having a spongy or porous exterior"). Further, without reciting the particular structure, materials or steps that accomplish the function or achieve the result, all means or methods of resolving the problem may be encompassed by the claim. Ariad Pharmaceuticals., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353, 94 USPQ2d 1161, 1173 (Fed. Cir. 2010) (en banc). See also Datamize LLC v. Plumtree Software Inc., 75 USPQ2d 1801 (Fed. Cir. 2005) where a claim directed to a software based system for creating a customized computer interface screen recited that the screen be "aesthetically pleasing," which is an intended result and does not provide a clear cut indication of scope because it imposed no structural limits on the screen.” Therefore the scope of the claim and claims which depend from them which do not rectify the issue are considered indefinite. In terms of prior art, the examiner cannot reasonably apply any art not being the elected species until the issues are resolved.
Applicants argue that the language is definite when read in light of the specification along with the disclosure disclosing eight fully working examples. This is found unpersuasive.
For example regarding the argument when referencing the specification; claims should be complete within themselves as evident by MPEP 2173.05(s). The skilled artisan would need to refer to the disclosure and/or drawings as Applicants are suggesting to ascertain the structures of these compounds which does not comply with 35 U.S.C. 112 2nd. See Ex parte Fressola, 27 USPQ2d 1608:
“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 in utility applications 1 that define the invention entirely by reference to the specification and/or drawings, so-called “omnibus” or “formal” claims, while perhaps once accepted in American patent practice, are properly rejected under Section 112 Para. 2 as failing to particularly point out and distinctly claim the invention. See MPEP Section 706.03(h) (5th ed., rev. 14, Nov. 1992); Landis, Mechanics of Patent Claim Drafting, Section 2 (1974). This analysis is limited to claims in utility applications. Plant patent claims are defined “in formal terms to the plant shown and described.” Claims in design patents are recited in formal terms to the ornamental design “as shown” or, where there is a properly included special description of the design, the ornamental design “as shown and described.” MPEP Section 1503.01…….The general rule is that the claims should be self-contained; that is, they should not expressly rely upon the description or drawing to give them meaning. . . . The terms “substantially as described” and the like, once much used in claims (GLASCOCK 1943 Section 5640) are now rarely seen. The Office disregards them in interpreting claims. . . . Claims consisting only in a reference to the disclosure, as “The features of novelty herein disclosed,” are not allowed except in design cases.…..A claim which refers to the specification defeats the purpose of a claim.”
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Furthermore, the disclosure does not state what these specific ligands are as pointed out by the examiner initially. Applicants also make reference to FIG. 1B to correct the deficiency but the latter does not address the examiner’s concerns and is simply a “tree of various bromodomain families”. Thus without any specific articulation within the claims themselves or even the specification as filed the language is considered indefinite.
35 USC § 112 (a)
The rejection of claims 1 ,8, 12, 15, and 10 is maintained.
Applicant’s amendments and arguments, see Remarks, filed 4/28/2026, with respect to the rejection set forth in the Non-Final Office Action mailed 1/30/2026, have been fully considered but are not found persuasive.
To reiterate the rejection of record, the skilled artisan would not have adequate reason to believe that Applicant had possession of the claimed “prodrugs” of formula I. No where does the specification allude to the specific identities of these structures. There are no working examples of these unknown prodrugs in the disclosure. Once again, little to no guidance is provided in the disclosure. Thus, how would one skilled in the art expect that Applicant was indeed of possession of the claimed prodrugs of formula I? Within the specification, “specific operative embodiments or examples of the invention must be set forth. Examples and description should be of sufficient scope as to justify the scope of the claims. Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula.” See MPEP 608.01(p). Note also the following:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
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The courts have applied this criteria in a more recent decision stating the following referencing genus claims drawn to chemical compounds:
“For example, a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.” see Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., 94 USPQ2d 1161 (Fed. Cir. 2010).
Therefore, based on the lack of working examples and nature of the described genus, Applicants are not in possession of the claimed prodrugs.
Applicants argue that the disclosure provides general definitions of “prodrugs” at [0097] along with disclosing parent compounds of Formula I to meet the written description requirement. The examiner respectfully disagrees. A statement referring to a general definition of prodrugs and potential classes associated therein does not suggest that Applicant had possession of these “prodrugs” of the Formula I. There are no working examples of these unknown prodrugs in the disclosure as far as the examiner is aware. Applicant has not admitted on record that these prodrugs were prepared or even may exist. Once again, little to no guidance is provided in the disclosure. Thus, how would one skilled in the art expect that Applicant was indeed of possession of the claimed prodrugs of formula I? Within the specification, “specific operative embodiments or examples of the invention must be set forth. Examples and description should be of sufficient scope as to justify the scope of the claims. Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula.” See MPEP 608.01(p).
The argument that the parent compounds of Formula I does not address the issue as well.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
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The courts have applied this criteria in a more recent decision stating the following referencing genus claims drawn to chemical compounds:
“For example, a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.” see Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., 94 USPQ2d 1161 (Fed. Cir. 2010).
Therefore, based on the lack of working examples and nature of the described genus, Applicants are not in possession of the claimed prodrugs and the rejection is maintained.
New Rejections
Claim Rejections - 35 USC § 112
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.
Claim 8 is 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 pre-AIA the applicant regards as the invention.
The variable X1 is recited as being attached to L1 but variable X1 is not recited in the chemical formula nor is defined in the claim. Thus the claim is indefinite.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 8 is 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
For example, claim 8 has been amended extensively to recite subject matter (e.g. new definitions for variable Z2 and X4) that raise the issue of new matter. Applicant has not provided appropriate guidance as to where to find support for these amendments in the instant disclosure. Applicants refer to sections such as [0034] for support. However the latter section of the disclosure is simply directed to general definitions of specific embodiments such as “heterocyclyl”, etc. There is no direction or guidance in the disclosure suggesting that these variables may consist of these specific embodiments. There needs to be guideposts, working examples, or explicit recitation in the specification to justify that these embodiments may be used for the variables in the amended claim 8. The latter is lacking in the specification as filed.
See MPEP § 2163.06, “with respect to newly added or amended claims, applicant should show support in the original disclosure for the new or amended claims”. A statement such as “No new matter has been added by these amendments that are supported by the specification” is insufficient.
Thus, the rejection is appropriately applied. An amendment to the claims or the addition of a new claim must be supported by the description of the invention in the application as filed. In re Wright, 866 F.2d 422, 9 USPQ2d 1649 (Fed. Cir. 1989).
Conclusion
No claims are allowed.
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 BRIAN E MCDOWELL whose telephone number is (571)270-5755. The examiner can normally be reached on 8:30-6 MF.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN MCDOWELL/
Primary Examiner, Art Unit 1624
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