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 1-43 are pending in the instant application. Claims 19-43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected subject matter. The withdrawn subject matter is patentably distinct from the elected subject matter as it differs in structure and element and would require separate search considerations.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 1-3, 6-8 and 10-18 are rejected. Claims 4, 5 and 9 are objected.
Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d), certified English translations of the foreign applications must be submitted in reply to this action.
Failure to provide certified translations may result in no benefit being accorded for the non-English applications.
Drawings
The drawings are objected to because the font on Figure 4 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.
Information Disclosure Statements
The information disclosure statements filed on November 24, 2023, March 4, 2024, June 6, 2025, and November 6, 2025 have been considered and signed copies of form 1449 are enclosed herewith.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-18, and with traverse of the species Compound 2 in the response filed on April 16, 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 1-18 has been searched and examined in its entirety). The restriction requirement (between groups) is still deemed proper and is hereby made final.
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 1-3, 6-8 and 10-18 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 a subject “an agent having C3a receptor antagonist activity” 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 agent having C3a receptor antagonist activity would possess the ability to reduce the risk of or treat intractable pruritus in a subject or specifically modulate C3a receptor activity and even more so with regards to the particular limitations disclosed in claims 2, 3 and 15. For strong antagonists of the C3a 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, C3a receptor antagonist activity is largely unpredictable.
It is disclosed in the specification that the "C3a receptor antagonist" may be “a competitive antagonist or a non-competitive antagonist. C3a receptor antagonists include low molecular weight compounds, aptamers composed of oligonucleotides, peptides and the like, and biological preparations such as neutralizing antibodies. In the present description, it may also be an inhibitor of C3a receptor expression.” See page 8.
The only specific examples of agents having C3a receptor antagonist activity disclosed in the specification are low molecular weight compounds of formula (1) or formula (2), such as Compound 1 and Compound 2, and hexapeptides with partial common sequences. See pages 8-12. 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 many compounds embraced by the claimed agents having C3a receptor antagonist activity.
It is also noted that the working examples in the specification (i.e., Examples 4-6 on pages 60-65) all involve Compounds 1 and 2 as agents having C3a receptor antagonist activity.
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 classes of agents having C3a receptor antagonist activity, a person of ordinary skill in the art could not reasonably predict whether an untested compound would be able to function as an antagonist of C3a receptor activity 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 generic agent having C3a receptor antagonist activity would be able to be used to reduce the risk of or treat intractable pruritus in a subject. Some exceptions may extend to compounds that share a high degree of structural similarity to known agents having C3a receptor antagonist activity, for example, in the prior art. However, the claim encompasses both known and unknown compounds that are structurally divergent from known agents having C3a receptor antagonist activity. The examples in the specification (i.e., Compound 1 and Compound 2) 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 receptor activity 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 agents having C3a receptor antagonist activity claimed. Because the specification does not provide sufficient structural information to distinguish the claimed modulators from other entities, the claims lack written description. Therefore, 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 specific agents having C3a receptor antagonist activity of claims 4, 5 and 9.
Claim Objections
Claims 4, 5 and 9 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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