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 .
DETAILED ACTION
RESPONSE TO ELECTION/RESTRICTION
Applicant’s election without traverse of group I, drawn to compounds of the formula I and simple compositions thereof and elected species:
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in the reply filed on 10/16/2025 is acknowledged. The examiner notes that the species incorporates an extra hydrogen group at the amide moiety where the formula I shows that no additional substituent is present. However for the sake of compact prosecution the examiner accepts this election and any discrepancy will be addressed in the office action.
The requirement is still deemed proper and is therefore made FINAL.
Claim 31 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
An action on the merits of claims 1-6, 8-11, 13-20, and 24 is contained herein. Applicant’s elected species was found free of the art and the search extended to cover similar species wherein a hydrogen atom is incorporated into the amide moiety of formula I, R9 = H, and R8 = unsaturated heterocyclyl.
Priority
This application is a Continuation of International Patent Application No. PCT/EP2021/074432, filed on September 6, 2021, which claims benefit of priority to International Patent Application 5 No. PCT/CN2020/113771, filed on September 7, 2020. Benefit for the foreign application is not accorded for all claims under examination with the exception of claim 20 since subject matter disclosed within the instant application is not supported (e.g. to make and use the claimed formula I possessing a divalent nitro atom at the amide linkage along with the last two species in claim 19 not being supported). The claims in a U.S. application are entitled to the benefit of a foreign priority date or the filing date of a provisional application if the corresponding foreign application or provisional application supports the claims in the manner required by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. In re Ziegler, 992 F.2d 1197, 1200, 26 USPQ2d 1600, 1603 (Fed. Cir. 1993); Kawaiv.Metlesics, 480 F.2d 880, 178 USPQ 158 (CCPA 1973); In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989).
Information Disclosure Statement
The examiner has considered the references cited in the information disclosure statement filed of record.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-6, 8-11, 13, 16, and 24 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 2, 5-11, 14, and 16-21 of copending Application No. 18/404,194. Although the conflicting claims are not identical, they are not patentably distinct from each other because there is significant overlap between the two applications.
The genus structure of the instant application may encompass some of the claimed compounds and compositions thereof of formula I in the copending application with respect to compounds being selected from pharmaceutically acceptable salts. Note that the copending application specifically claims quarternary ammonium salts with respect to variable R1 for example with other variables overlapping:
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which anticipates the claimed salts of the instant application generally. Specific compounds (e.g. salts of the claimed compounds) are even recited within the copending application such as
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wherein R2,3 = halo, R3 = alkoxy, R5,6,9 = H, R1,7 = alkyl, p = 1, R9 =
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, and the amide moiety in formula I is attached to a hydrogen atom to fulfill its valence. Thus the claims are not independent and distinct from each other. Note that the “for use” limitations in the copending claims 17-21 do not make the claims patentable when the prior art teaches all of the claimed structural limitations, see In re Schreiber, 128F.3d 1473, 1477 (Fed. Cir. 1997) and Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003), “a statement of intended use cannot distinguish over a prior art apparatus that discloses all the recited limitations and is capable of performing the recited function,” see In re Schreiber, 128F.3d 1473, 1477 (Fed. Cir. 1997) and Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003)
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
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, 8-11, 13-18, and 24 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 pre-AIA the applicant regards as the invention.
The amide moiety of the formula I shows that no additional substituent is present and is divalent in nature (dangling valence). The claimed compounds should not have dangling valences. Claims of the “dangling valence” type in which only the portion of the structure responsible for the activity is defined in the claim are indefinite because the claims are of indeterminate in scope and generally broader than any possible supporting disclosure. Ex parte Diamond, 123 USPQ 167 (POBA 1959). Thus the claim and claims dependent on them which do not rectify the issue are considered indefinite. Correction is required. The examiner will assume that any group may be present to fulfill the nitrogen valency in terms of prior art until the issue is addressed.
Claim Rejections - 35 USC § 112
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 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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 19-20 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. Claims 19-20 recite species which incorporate an extra hydrogen group at the amide moiety where the formula I shows that no additional substituent is present.
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6, 8-11, 13, 16, and 24 are rejected under 35 U.S.C. 102(a)(2) as being anticipated over US Patent Publication 2024/0376073 which is related to WO 2023/280733-mentioned in IDS.
US Patent Publication 2024/0376073 teaches the following intermediate compound (see page 46, example E10):
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wherein R2,3 = halo, R3 = alkoxy, R5,6,9 = H, R7 = methyl, p = 1, R9 = unsubstituted heterocycle, and the amide moiety in formula I is attached to a hydrogen atom to fulfill its valence. Thus the claims are anticipated. Applicants are to be aware of all species (species recited in the provisional application for example wherein compositions are described in the abstract and therein) in this document which may potentially anticipate the claims.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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, 8-11, 13-18, and 24 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The skilled artisan would not have adequate reason to believe that Applicant had possession of the claimed genus of formula I possessing a divalent nitrogen at the amide moiety. based on the information provided in the specification. The only working examples described in the specification consists of compounds which have proper valences such as the elected species. Thus, how would one skilled in the art expect that Applicant was indeed of possession of the claimed genus if no working embodiments were presented in the disclosure? Within the specification, “specific operative embodiments or examples of the invention must be set forth. Examples and description should be of sufficient scope as to justify the scope of the claims. Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula.” See MPEP 608.01(p). Note also the following:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
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A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation.
The courts have applied this criteria in a more recent decision stating the following referencing genus claims drawn to chemical compounds:
“For example, a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.” see Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., 94 USPQ2d 1161 (Fed. Cir. 2010).
Therefore, based on the lack of working examples, nature of the described genus, and indefiniteness of the claims (see rejections herein), Applicants are not in possession of the claimed genus.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E MCDOWELL whose telephone number is (571)270-5755. The examiner can normally be reached on 8:30-6 MF.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E MCDOWELL/Primary Examiner, Art Unit 1624