DETAILED ACTION
The Office Action is in response to the Applicant's reply filed September 15, 2026 to the restriction requirement made on July 15, 2026.
Applicant's election with traverse of
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, and prurigo nodularis in the reply filed on September 15, 2026 is acknowledged.
Applicant’s argument that there is no patentable difference between the species is not persuasive. In a group restriction, a species election is only made for examination purposes. If the species elected is not found in the prior art then Examiner will continue search to other species claimed.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 11/24/23, 3/1/24, 6/6/25, 11/6/25, 7/23/26 is in compliance with the provisions of S7 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
The rejections are as below:
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 23, 25-27, 29-33, 35-38, and 40 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 23 recites the limitation: administering to a subject “a C3a receptor antagonist” 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 25, 26 and 29-30.
Claim Rejections - 35 U.S.C. 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 23, 25-27, 29-33, 35-38, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Rowley et al. (Potent Thiophene Antagonists of Human Complement C3a Receptor with Anti-Inflammatory Activity. J. Med. Chem. 2020, 63, 529−541) in view of Davidson et al. (WO 2020214855 A1).
Rowley et al. teaches “a new compound JR14a was among the most potent of the new antagonists in vitro, assessed by (a) inhibition of intracellular calcium release (IC50 10 nM) induced in human monocyte-derived macrophages by 100 nM C3a, (b) inhibition of β-hexosaminidase secretion (IC50 8 nM) from human LAD2 mast cells degranulated by 100 nM C3a, and (c) selectivity for human C3aR over C5aR. JR14a was metabolically stable in rat plasma and in rat liver microsomes and efficacious in rats when given orally to suppress rat paw inflammation, macrophage and mast cell activation, and histopathology induced by intraplantar paw administration of a C3aR agonist. Potent C3aR antagonists are now available for interrogating C3a receptor activation and suppressing C3aR-mediated inflammation in mammalian physiology and disease.” “Human C3a binds to and activates a discrete G-protein-coupled receptor (C3aR) expressed on innate immune and other cell types. Activation of this receptor stimulates important immune and metabolic responses and is now believed to play important pathological roles in inflammatory and metabolic diseases and cancers. The development of potent, selective, and bioavailable small-molecule ligands for C3aR could lead to a new therapy for treating inflammation-driven diseases.”
While the reference teaches the treatment of inflammation-driven diseases, the reference fails to specify prurigo nodularis claimed.
Davidson et al. teaches an inflammatory skin disease is prurigo nodularis.
It would have been obvious to one of ordinary skill in the art at the time of filing to treat prurigo nodularis. The motivation to treat prurigo nodularis with JR14a is because Rowley et al. teaches human C3a binds to and activates a discrete G-protein-coupled receptor (C3aR) expressed on innate immune and other cell types. Activation of this receptor stimulates important immune and metabolic responses and is now believed to play important pathological roles in inflammatory and metabolic diseases. Hence, a skilled artisan would have had reasonable expectation of successfully treating an inflammatory disease such as prurigo nodularis.
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 23, 25-27, 29-33, 35-38, and 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-43 of copending Application No. 18/518,816 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because '816 is directed to method for selecting an agent having C3a receptor antagonist activity and that can reduce the risk of or treat intractable pruritus in a subject, the method comprising: administering to a subject an agent having C3a receptor antagonist activity; measuring an effect on the subject associated with the administering; and selecting the agent having C3a receptor antagonist activity based on the effect on the subject associated with the administering while the claims herein are drawn to a method for ameliorating intractable pruritus, the method comprising administering an effective amount of C3a receptor antagonist to a subject in need thereof. Both drawn to pruritus and treatment by administering an effective amount of C3a receptor antagonist to a subject in need thereof.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/LAYLA SOROUSH/Primary Examiner, Art Unit 1622
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