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 with traverse of the following elected species:
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in the reply filed on 5/11/2026 is acknowledged. The traversal is on the ground(s) that the examiner has not shown that there is lack of unity due to simply stating a CAS Registry Number and now clearly articulating how said compound anticipates or rendered obvious the claims. This is not found persuasive because Applicants are aware of this chemical species since it was provided in the IDS and the search report. To address Applicant’s concerns however, the species anticipates the generic claim 1 wherein X is ethyl, R1,2,4 is H, and R3 is cycloalkyl. In reference to Applicants arguments that the species themselves possessing a common scaffold of formula I is enough to show unity of invention, it is found unpersuasive. Again, there is an examination and search burden for these patentably distinct species due to their mutually exclusive characteristics. The species require a different field of search (e.g. searching different classes/subclasses or electronic resources, or employing different search queries); and/or the prior art applicable to one species would not likely be applicable to another species.
Should applicant traverse on the ground that the species are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the species to be obvious variants or clearly admit on the record that this is the case. The examiner notes that Applicants have not presented any evidence of record or stated clearly that the species are obvious variants. Regardless, the prior art has shown that the claims do not possess unity of invention.
An action on the merits of claims 1-13 is contained herein. The scope of the claims have been searched to cover species wherein X is ethyl, R1,2,4 is H, and R3 is saturated cycloalkyl or alkynyl.
Priority
The present application is a filing under 35 U.S.C. 371 as the National Stage of
International Application No. PCT/EP2022/073004, filed August 17, 2022, entitled
"NOVEL SEROTONIN DERIVATIVES AND THEIR USES FOR TREATING IRON-ASSOCIATED DISORDERS," which claims priority to European Application No.
21306124.5 filed with the European Patent Office on August 17, 2021. Benefit for the foreign application is not accorded since subject matter disclosed within the instant application is not supported (e.g. full scope of variable R3). 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.
Specification
The abstract of the disclosure does not commence on a separate sheet in accordance with 37 CFR 1.52(b)(4) and 1.72(b). A new abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text.
Claim Objections
Claims 1-13 are objected to because of the following informalities:
The preamble of claim 1 should include an “A” at the beginning (e.g. A compound of formula (I)). Thus the claim and claims dependent on it are objected to. Correction is required.
Claim 7 should recite proper Markush language in the preamble such as “being selected from the group consisting of..” or something similar thereof.
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 2, 5-7, 9-11, and 13 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.
Regarding the claims, the phrase "such as", “preferably”, “advantageously”, etc. renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The examiner recommends that this language is removed from the claims. This language is embraced in claim 6 reciting “C2-C12 alkynyl” but previously the claim recites “C2-C6 alkynyl” for these variables. The former is actually broader than the originally cited group that also makes the claim indefinite.
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.”
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.
Claim 8 is 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. Claim 8 does not further limit claim 1 with the recitation “for use as a drug” as it does not limit the compound materially or recite a statutory method of treatment.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(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 1-5 and 7-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated over
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mentioned in IDS.
CAS Registry teaches the following compound wherein X is ethyl, R1,2,4 is H, and R3 is cycloalkyl which anticipates the claims:
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.
Note that the “for use” limitations 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).
Claims 1-13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated over WO 2024/008341.
WO 2024/008341 teaches Applicant’s elected species and compositions thereof (see page 57, compound A3 and page 47 for compositions). Thus the claims are anticipated. Applicants are to be aware of all species in this document which may anticipate the claims.
Note that the “for use” limitations 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).
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
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