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 1-80 are pending in the instant application. Claims 2-4, 13-15, 27, 28, 32-45, 47, 49, and 60-79 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected subject matter. The withdrawn subject matter is patentably distinct from the elected subject matter as it differs in structure and element and would require separate search considerations.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, 5-12, 16-19, 22-24, 46, and 48 are rejected. Claims 20, 21, 25, 26, 29-31, 50-59, and 80 are objected.
Information Disclosure Statements
The information disclosure statements filed on October 19, 2023 and December 8, 2025 have been considered and signed copies of form 1449 are enclosed herewith.
Drawings
The drawings are objected to because the font on some of the figures (i.e., 1-4 and 6-8) is difficult to read or is illegible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Election/Restrictions
Applicant’s election with traverse of Group I, claims 1 and 5-80, and the species VU0467154 in the response filed on January 16, 2026 is acknowledged. The traversal is on the ground(s): there is no undue burden. This is not found to be persuasive because the inventions are independent and distinct because there is no patentable co-action between the groups and a reference anticipating one member will not render another obvious. Each group is directed to art recognized divergent subject matter which require different searching strategies for each group. Moreover, the examiner must perform a commercial database search on the subject matter of each group in addition to a paper search, which is quite burdensome to the examiner. Therefore, the restriction requirements are still deemed proper and are hereby made final. Upon further search and consideration, however, the search of the species has been expanded to compounds of Formula I (see claims 20 and 21).
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, 5-12 and 16-19 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: administering to the mammal an effective amount of a composition comprising one or more “mAChR4 positive allosteric modulators” 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 modulators do not always function as expected. It is generally unpredictable whether any mAChR4 positive allosteric modulator would possess the ability to prevent, inhibit or treat liver disease in a mammal. For strong positive allosteric modulation of the M4 receptor, 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, M4 receptor modulation is largely unpredictable.
The examples of mAChR4 positive allosteric modulators disclosed in the specification are listed on pages 19-25 and 35-42 or described as fitting within the chemical formulae I-XVIII (see pages 16-19 and 25-35). However, Applicant has not described the genus 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 myriad of compounds embraced by the claimed mAChR4 positive allosteric modulators.
It is also noted that the only mAChR4 positive allosteric modulator used in the working examples in the specification is VU0467154. See pages 46-54.
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.
Although the prior art discloses a number of different mAChR4 positive allosteric modulators, a person of ordinary skill in the art could not reasonably predict whether an untested compound would be able to function as a mAChR4 positive allosteric modulator because definitive structure-function correlations have not been established in the prior art. It is even more difficult to be able to predict whether an untested mAChR4 positive allosteric modulator would be able to be used to prevent, inhibit or treat liver disease in a mammal. Some exceptions may extend to compounds that share a high degree of structural similarity to known mAChR4 positive allosteric modulators (i.e., VU0467154), for example, in the prior art. However, the claim encompasses both known and unknown compounds that are structurally divergent from known mAChR4 positive allosteric modulators. The examples in the specification (see pages 19-25 and 35-42) and the prior art do not sufficiently represent the vast structural diversity of small molecules and biomolecules embraced by the claims. Due to the high degree of unpredictability generally associated with modulation and the lack of structure-function correlation, a person of ordinary skill in the art would reasonably conclude that the inventors did not possess all of the mAChR4 positive allosteric modulators claimed. Because the specification does not provide sufficient structural information to distinguish the claimed modulators from other entities, the claims lack written description. Also, since Applicant provides no description beyond what a person of skill in the art would already know, Applicant has not demonstrated possession of the instantly claimed method.
This rejection can be overcome by amending the claims to be limited to the use of the mAChR4 positive allosteric modulators of chemical formulae I-XVIII (see pages 16-19 and 25-35) or the specific examples listed on pages 19-25 and 35-42.
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 46 and 48 are rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Specifically, claim 46 and 48 refer to structures in the specification (e.g., see pages 21-23). Claims must, under modern claim practice, stand alone to define an invention, and incorporation into claims by express reference to the specification is not permitted. Ex parte Fressola, 27 USPQ 2d 1608 (1993). This rejection can be overcome by amending the claims to include the structures referenced.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 22-24 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Specifically, claims 22 and 24 further define W1-W4 and claim 1, from which they depend, does not disclose a formula including W1-W4. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Objections
Claims 20, 21, 25, 26, 29-31, 50-59, and 80 are 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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