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 .
Status of the Claims
Claims 1-19 are pending.
Domestic Benefit
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. Instant application is a continuation-in-part of PCT/US2023/017201, filed 03/31/2023. PCT/US2023/017201 claims domestic benefit of U.S. Provisional Application Nos. 63/482,670, filed 02/01/2023, and 63/326,625, filed 04/01/2022. Therefore, the effective filing date is 04/01/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/10/2024 and 08/03/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Restriction/Election Requirement
Applicant’s election without traverse of Group I, claims 1-15, drawn to transcription modulator molecules, in the reply filed on 08/03/2026 is acknowledged. Applicant further elected the species compound A-77, shown below, which reads on instant claims 1-9, 13, and 15.
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The scope of the search has been limited to the above elected species and any 102 prior art discovered in the search.
Claims 10-12, 14, and 16-19 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 08/03/2026.
Claim Objections
Claim 9 is objected to because of the following informalities:
Claim 9 reads “…that modulates express of a gene…”, and should read “…that modulates expression of a gene…”.
Appropriate correction is required.
Improper Markush Grouping
Claims 1-9 and 15 are rejected on the basis that they contain an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of the “transcription modulator molecule” is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the various permutations of variables in Formula (A-1), and the undefined structure of the second terminus and oligomeric backbone, result in compounds which do not contain a significant structural similarity. The largest structural similarity are two amide groups linked by an ethyl chain, which does not constitute a significant structural similarity. The varying permutations are not recognized to belong to the same physical or chemical class or to be the same art-recognized class. For example, in the cooperative patent classification system, compounds containing amides are classified in class A61K8/42, A61K 31/16, C04B 24/124, C11D 3/32, etc.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use. The scope of transcription modulator molecules (inclusive of the elected species) that would form a proper Markush grouping would be at least where: 1) X1-8 and Y1-8 are defined, 2) the second terminus is defined, or 3) the oligomeric backbone is defined. There would appear to be several different ways in which a proper Markush grouping could be derived from the scope instantly claimed. However, defining one of the three core structures of the transcription modulator molecule appears to be a minimum requirement, since the options for variables, and the undefined structure of the second terminus and oligomeric backbone, result in numerous dissimilar permutations.
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 1-9, 13, and 15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for compounds of Formula (A-1) where X1-8 is NR2; R2 is H or Me; W1 is H; R1 is H or NH2; W2 is
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, wherein W2 is attached to the oligomeric backbone; the oligomeric backbone is
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; and the second terminus is as defined in instant claim 15, does not reasonably provide enablement for compounds of Formula (A-1). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
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:
The nature of the invention
The nature of the invention relates to transcription modulator compounds comprising Formula (A-1), an oligomeric backbone, and a second terminus in claim 1. Such compounds are useful for the modulation of Huntington’s disease. This invention is also directed to compositions comprising said compounds.
Predictability of the art
The hypothetical transcription modulator compounds, which comprise Formula (A-1), an oligomeric backbone, and a second terminus, would be unpredictable in terms of one skilled in the art being able to synthesize every possible compound claimed in the instant claims. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
In terms of the law, MPEP 2107.03 states “evidence of pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is a reasonable correlation between the activity in question and the asserted utility. Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler, 626 F.2d 853, 206 USPQ 881 (CCPA 1980).” If correlation is lacking, it cannot be relied upon, Ex parte Powers, 220 USPQ 924; Rey-Bellet and Spiegelberg v. Engelhardt v. Schindler, 181 USPQ 453; Knapp v. Anderson, 177 USPQ 688. Indeed, the correlation must have been established “at the time the tests were performed”, Hoffman v. Klaus, 9 USPQ2d 1657.
Level of skill in the art
An ordinary artisan in the area of drug development would have experience in synthesizing and screening chemical compounds for particular activities, such as a medical doctor or chemist. Screening of new drug candidates, while complex, is routine in the art. The process of finding new drugs that have in vitro activity against a particular biological target, (i.e., receptor, enzyme, etc.) is well known. Additionally, while high throughput screening assays can often be employed, developing a therapeutic method, as claimed, is generally not well-known or routine, given the complexity of certain biological systems.
4. The breadth of the claims
The scope of the claims involves compounds comprising Formula (A-1) (shown below), an oligomeric backbone, and a second terminus.
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The claims are extremely broad in terms of the number of variables and the options of substituents for each variable. There is an indefinite amount of hypothetical compounds included in the instant claims.
5. The amount of direction provided, the presence or absence of working examples, and the quantity of experimentation necessary
The specification provides the synthesis of 85 compounds. In all of the compounds synthesized, X1-8 is NR2; R2 is H or Me; W1 is H; R1 is H or NH2; W2 is
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; the oligomeric backbone is
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; and the second terminus is as defined in instant claim 15.
Synthesis methods are not taught in the specification to provide for the aforementioned variables to include all of the possible substituents listed in the claims. It would be expected that the different heteroatoms in rings X1-8, the varying sizes and chemical properties of W1, R1, R2, and the undefined structure of the oligomeric backbone and second terminus would change the reactivity of the compounds, and therefore would require alternate synthesis methods. It would require one skilled in the art, such as a chemist, to perform thousands of reactions to determine which transcription modulator compounds of the instant claims can be prepared and would likely require synthesis methods other than those provided in the specification. This is undue experimentation given the limited guidance and direction provided by Applicants.
Accordingly, the instant claims do not comply with the enablement requirement of 35 U.S.C. 112(a), 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.
Claims 1-9, 13, and 15 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 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Specifically, claim 1 recites the limitation “the second terminus comprises a moiety capable of binding to a regulatory molecule that modulates an expression of a gene by binding a target” and “oligomeric backbone” in the definition for a transcription modulator molecule having a first terminus, a second terminus, and an oligomeric backbone, or a pharmaceutically acceptable salt or solvate thereof for which the specification does not provide an adequate written description to convey that the inventors where in possession of the full scope of the claimed invention.
Regarding the requirement for adequate written description of chemical entities, Applicant's attention is directed to the MPEP §2163. In particular, Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), holds that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, "not a mere wish or plain for obtaining the claimed chemical invention.” Eli Lilly, 119 F.3d at 1566. The Federal Circuit has adopted the standard set forth in the Patent and Trademark Office ("PTO") Guidelines for Examination of Patent Applications under the 35 U.S.C. 112.1 "Written Description" Requirement ("Guidelines"), 66 Fed. Reg. 1099 (Jan. 5, 2001), which state that the written description requirement can be met by "showing that an invention is complete by disclosure of
sufficiently detailed, relevant identifying characteristics," including, inter aria, "functional characteristics when coupled with a known or disclosed correlation between function and structure..." Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 316, 1324-25 (Fed. Cir. 2002) (quoting Guidelines, 66 Fed. Reg. at 1106 (emphasis added)). Moreover, although Eli Lilly and Enzo were decided within the factual context of DNA sequences, this does not preclude extending the reasoning of those cases to chemical structures in general. Univ. of Rochester v. G.D. Searle & Co., 249 Supp. 2d 216, 225 (W.D.N.Y. 2003).
Medicinal chemistry and pharmacology are unpredictable areas. Even carefully designed transcription modulator molecules do not always function as expected. It is generally unpredictable whether a molecule would possess the ability to modulate the expression of Huntington’s disease. For strong modulation, for example, some structure-activity-relationship may be ascertained from structurally similar derivatives; however, the degree of structural similar must be high in order to expect similar properties. For new or untested compounds, modulating Huntington’s disease is largely unpredictable.
Regarding “oligomeric backbones”, as evidenced by Fuller (Chapter 1: Introductory Concepts and Definitions, The Elements of Polymer Science & Engineering, 2013, pages 1-5), an oligomer is any low-molecular-weight polymer that contains at least two monomer units (page 2). The repeating units of an oligomeric backbone can vary widely in structure, as exemplified by Formulas 1-4 to 1-11 on pages 3-4, and Formulas 1-1a, 1-5a, 1-6a, and 1-8a on page 5, which contain no structural similarities. Additionally, Applicant has not shown to have possession of said oligomeric backbones in the above listed representative Formulas.
Applicants have not described the genus of a transcription modulator molecule having a first terminus, a second terminus, and an oligomeric backbone, or a pharmaceutically acceptable salt or solvate thereof in a manner that would allow one skilled in the art to immediately envisage all the compounds contemplated for use. As such, the claims lack adequate written description for the many compounds embraced by the claimed molecules.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.") Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
This rejection can be overcome by amending claim 1 to structurally define the oligomeric backbone and by including the formulas for the second terminus disclosed in claim 15.
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 1-9, 13, and 15 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.
The inventor or joint inventor should note that the phrase “optionally substituted”, in claims 1, 2, 8, and 13, is a relative phrase which renders the claims indefinite. The phrase “optionally substituted” is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification, in paragraph [00432], uses open language, such as “without limitation” to define optional substituents, using a boiler plate list of functional groups, such as “alkyl”, etc., and further discloses that the substituents themselves may be further substituted; however, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the “substituted” transcription modulator molecules have been rendered indefinite by the use of the phrase “optionally substituted”.
Moreover, the inventor or joint inventor should further note that “[C]laims which depend from indefinite claims are also indefinite.” {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}. Therefore, claims 3-7, 9, and 15 are also rejected as being indefinite.
The inventor or joint inventor should note that the term “about” is a relative term, which renders claim 7 indefinite. The term “about” is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention.
Consequently, the transcription modulator molecules of claim 7 have been rendered indefinite by the use of the term “about”. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
Regarding claims 1-9, 13, and 15, the transcription modulator molecule is defined as comprising a “second terminus” and an “oligomeric backbone”, where the structures are not clear or defined. Organic molecules can be explicitly recited by art recognized chemical names or molecular formulas. Using functional language (i.e., “the second terminus comprises a moiety capable of binding to a regulatory molecule that modulates an expression of a gene by binding a target”) renders the scope of the claim vague and indefinite.
Note that although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Also see, In re Zletz, 13 USPQ2d 1320, 1322. “An essential purpose of patent examination is to fashion claims that are precise, clear, correct and unambiguous.”
The rejection can be overcome by amending claim 1 to structurally define the oligomeric backbone and by including the formulas for the second terminus disclosed in claim 15.
Claim Rejections - 35 USC § 102
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.
Claims 1, 3, and 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sugiyama et al. (US 2019/0343873 A1).
Sugiyama teaches, in claim 6, a conjugate comprising a pyrrole-imidazole polyamide and a bromodomain inhibitor, shown below, which reads on instant claims 1, 3, 7, 8, where, in Formula (A-1), W2 is C(O)-NR1AR1B; R1A is H; R1B is C5 heteroalkyl; n1 is 2; n0 is 1; m1 is 1; Z1 is absent; p1 is 3; all instances of R1 are H; j1 is 1; X7, both instances of X6, X5, X4, both instances of X1, X2, X3, and X8 are NMe; Y7, one instance of Y6, Y5, and one instance of Y1 are CH; one instant of Y6, Y4, one instance of Y1, Y2, Y3, and Y8 are N; and W1 is attached to the oligomeric backbone.
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The above compound is taught, in paragraph 50, to bind HATs, including P300/CBP family such as P300 (KAT3B), CBP (KAT3A), and TAF1 (KAT4), as in instant claim 9.
Nonstatutory Double Patenting
The nonstatutory 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 nonstatutory 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-9, 13, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-44, 46-56, and 69 of copending Application No. 19/525,400 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The compounds of Application ‘400 read directly on the instant claims, including Formula (A-1) of reference claim 1 and the second terminus of the elected species shown below from reference claim 69.
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9, 13, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-42, 44-54, and 67 of copending Application No. 19/525,403 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The compounds of Application ‘403 read directly on the instant claims, including Formula (A-1) of reference claim 1 and the second terminus of the elected species shown below from reference claim 67.
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9, 13, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26, 94, 96, and 97 of copending Application No. 19/525,408 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The compounds of Application ‘408 read directly on the instant claims, including Formula (A-9) of reference claim 1 and the second terminus of the elected species shown below from reference claim 96.
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 17, 18, 20, 21, 28, 53, 56, and 90-93 of copending Application No. 18/875,086 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The compounds of Formula (I) in reference claim 1 overlap in scope with the instant transcription modulator molecules.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9, 13, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 8, 10, 11, 13, 16, 18, 24, 25, and 38 of copending Application No. 18/863,942 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The compounds of Application ‘942 read directly on the instant claims, including Formula (A-1) of reference claim 1 and the second terminus of the elected species shown below from reference claim 25.
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/726,567 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The compounds of reference claims 1-20 read directly on instant claims 1-8.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 7, 9-11, 13, 18, 19, and 21 of copending Application No. 18/256,864 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The transcription modulator compounds of reference claim 1 comprising Formula (A-2’), a second terminus, and a linker moiety read directly on instant claims 1-8.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6, 8, 15, 17, 18, 25, and 29 of copending Application No. 18/260,549 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The transcription modulator molecules of reference claim 1 comprising Formula (A-2), a second terminus, and an oligomeric backbone read directly on instant claims 1-8.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 15 of copending Application No. 18/480,117 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The transcription modulator molecules of reference claim 1 comprising Formula (A-1), an oligomeric backbone, and a second terminus, such as the one shown below from reference claim 15, read directly on instant claims 1-9 and 15.
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, 19, 21, 22, and 43 of copending Application No. 17/790,459 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The transcription modulator molecules of reference claim 1 comprising Formula (A-11), a second terminus, and an oligomeric backbone, such as the compound shown below from reference claim 43, read directly on instant claims 1-8.
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 71 and 73-81 of copending Application No. 17/759,944 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The transcription modulator compounds of reference claim 1 comprising Formula (A-2), a second terminus, and an oligomeric backbone read directly on instant claims 1-9.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-9, 13, and 15 are rejected.
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/R.M.S./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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