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 .
Claims 1, 6, 7, 9-11, 13, 18, 19, 21, 28, 31, 34, 39, 62, 65, and 66 are pending in the instant application. Claims 65 and 66 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected subject matter. The withdrawn subject matter is patentably distinct from the elected subject matter as it differs in structure and element and would require separate search considerations. In addition, a reference which anticipates one group would not render obvious the other. Claims 1, 6, 7, 9-11, 13, 18, 19, 21, 28, 31, 34, and 62 are rejected. Claim 39 is objected.
Information Disclosure Statements
The information disclosure statements filed on September 18, 2023, November 18, 2024 and April 3, 2026 have been considered and signed copies of form 1449 are enclosed herewith.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 6, 7, 9-11, 13, 18, 19, 21, 28, 31, 34, 39, and 62, and the compound 177 in the response filed on April 3, 2026 is acknowledged. Upon further search and consideration, however, the election of species requirement has been withdrawn (i.e., the full scope of the subject matter of claims 1, 6, 7, 9-11, 13, 18, 19, 21, 28, 31, 34, 39, and 62 has been searched and examined in its entirety).
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.
Claims 1, 6, 7, 9-11, 13, 18, 19, 21, 28, 31, 34, and 62 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.
Specifically, claim 1 is drawn to a transcription modulator molecule having a first terminus, a second terminus, and a linker moiety, or a pharmaceutically acceptable salt or solvate thereof whose structural make-up is not clear. Organic molecules can be explicitly recited by art recognized chemical names or molecular formulae. Using functional language (i.e., “the second terminus comprises a protein-binding moiety capable of binding to a regulatory molecule that modulates an expression of a gene comprising the nucleotide repeat sequence CTG”) 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 include the formulae for the second terminus disclosed in claim 39.
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, 6, 7, 9-11, 13, 18, 19, 21, 28, 31, 34, and 62 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 protein-binding moiety capable of binding to a regulatory molecule that modulates an expression of a gene comprising the nucleotide repeat sequence CTG” in the definition for a transcription modulator molecule having a first terminus, a second terminus, and a linker moiety, 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 dmpk. See [0023]. 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 the expression of dmpk is largely unpredictable.
Applicants have not described the genus of a transcription modulator molecule having a first terminus, a second terminus, and a linker moiety, 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 include the formulae for the second terminus disclosed in claim 39.
Claim Objections
Claim 39 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTIN ANN VAJDA whose telephone number is (571)270-5232. The examiner can normally be reached Mon-Fri 6:00-4:00.
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/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622
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