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 .
The applicant's election of Group I and species, claims 1-3 and 6-8, with traverse in their reply dated 8/21/2026 is acknowledged. Claims 4-5 and 9-10 were withdrawn. Claims 1-3 and 6-8 are considered on the merits below.
Examiner’s note: in the restriction requirement of 6/26/2026, there was a typo in the species restriction section. The claims drawn to an ammonium cation are 2 and 3 (not 2-4). Thus since the ammonium claims were elected, claims 1-3 and 6-8 will be considered on the merits below.
Election/Restrictions
Applicant's election with traverse of claims 1-3 and 6-8 in the reply filed on 8/21/2026 is acknowledged. The traversal is on the ground(s) that there is no serious search burden. This is not found persuasive because the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
The requirement is still deemed proper and is therefore made FINAL.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statements filed on 9/1/2023, 5/24/2024, 2/19/2025, 2/17/2026 are in compliance with the provisions of 37 CFR 1.97 and have been considered. An initialed copy of the Form 1449 is enclosed herewith.
Drawings
The drawings are objected to because Figures 8, 10, and 11 are blurry. 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.
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 1-3 and 6-8 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the preamble of the claim indicates that the claim is drawn to estrogen derivation however there is no step of deriving estrogen nor any steps in the claim. For examination purposes, the examiner interprets that estrogen derivation is making any derivative of estrogen.
Dependent claims follow the same reasoning.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-3 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nishio et al. (Journal of Pharmaceutical and Biomedical Analysis 44 (2007) 786–795, provided on the IDS on 9/1/2023).
Regarding claim 1, Nishio describes an estrogen derivatization method (abstract and figure 1) using a quaternary cation-containing 5-fluoro-2,4-dinitrophenyl compound represented by Formula (1):
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wherein, in Formula (1), X is a quaternary cation (page 790 figure 1
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).
Regarding claims 2 and 3, Nishio describes the estrogen derivatization method according to claim 1, wherein in Formula (1), the quaternary cation is a quaternary ammonium cation, wherein the quaternary ammonium cation is a group represented by any of Formula (2) to (4):
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wherein, in Formula (4), Y is substituted or unsubstituted, linear or branched alkyl group having 1 to 20 carbon atoms (page 790 figure 1
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, is Formula (2) of the claim.).
Regarding claim 8, Nishio describes a mass spectrometry method comprising derivatizing estrogen by the estrogen derivatization method according to claim 1 (page 787 “LC–MS(/MS) LC–MS(/MS) was performed”).
Allowable Subject Matter
Claims 6 and 7 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Reference Nishio et al. (Journal of Pharmaceutical and Biomedical Analysis 44 (2007) 786–795, provided on the IDS on 9/1/2023) describes the limitations of claim 1, however fail to teach or suggest the limitations of claims 6 and 7 “further using an organic base, wherein the organic base is a tertiary amine”.
None of the prior art discovered describes all the limitations alone or in combination, thus the prior art fails to teach or suggest all the limitations of claims 6 and 7.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY R BERKELEY whose telephone number is (571)272-9831. The examiner can normally be reached M-Th 9-6.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
/EMILY R. BERKELEY/
Examiner
Art Unit 1796
Prosecution Insights