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 .
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.
Current Status of 18/837, 118
This Office Action is in response to the amended claims of 08/08/2024.
Claims 2 and 11 are original; and 2-9 and 12-17 are currently amended.
Claims 2-9 and 11-17 and examined in this office action
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 12/19/2024. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Priority
Effected filing date is 02/10/2022.
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.
Claim 2-9 is 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.
The term “reduced likelihood” in claims 2 and 9 is a relative term which renders these claims indefinite. The term “reduced likelihood” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As drafted, the term “reduced likelihood” renders the metes and bounds of claims 2, 7-8, and 12 undefined (hence rendering claims 2 and 9 indefinite) since the artisan has no idea by which objective standard “reduced likelihood” should be measured (since neither the claims nor Specification provide an objective standard or definition of “reduced likelihood”).
Similarly, claims 3-8 are also rejected as indefinite because they refer back to claim 2 but do not remedy the bases for the rejection of claim 2.
Claim 11-17 is 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.
The term “increased likelihood” in claims 11 and 17 is a relative term which renders these claims indefinite. The term “increased likelihood” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As drafted, the term “increased likelihood” renders the metes and bounds of claims 11 and 17 undefined (hence rendering claims 11 and 17 indefinite) since the artisan has no idea by which objective standard “reduced likelihood” should be measured (since neither the claims nor Specification provide an objective standard or definition of “increased likelihood”).
Similarly, claims 12-16 are also rejected as indefinite because they refer back to claim 11 but do not remedy the bases for the rejection of claim 11.
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.
Claim(s) 2-9 and 11-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gemzell-Danielsson et.al. (European Gynecology and Obstetrics, 11 November 2021 (2021-11-11), page 82).
Gemzell-Danielsson teaches clinical studies on the combined use of estetrol (15 mg daily) and drospirenone (3 mg daily) (corresponding to instant dosage of claims 2, 4,11 and 13) for oral contraception (28-day cycle treatment with 24 days daily administration followed by a 4-day break) in women (16 or 18 - 50 years old, claims 7,8,15, 16) determined to have a BMI above or below 30 kg/m2 in the range of 18-35 kg/m2, BMI is predetermined, as stated in claims 5-6 and 14. Gemzell-Danielsson is silent on day 25 to day 3 of consecutive 28-days cycles using BRI examiner interpret to be day 25 to day 3 of consecutive 28-days cycles.
In the two BMI groups, unscheduled B/S(bleeding and spotting) for users with BMI <30 kg/m2 and > 30 kg/m2 occurred in 23.2% and 27.6% in cycle 1, respectively; 19.3% and 18.6% in cycle 2, respectively; and 13.1 % and 11.9%, in cycle 12, respectively (thus reduced schedule bleeding than a woman having BMI< 30.0 kg/m2 in scheduled bleeding thus anticipating claims 2 and 9). Therefore, lower percentage of unscheduled B/S is interpreted as increase in schedule bleeding in a woman with BMI<30.0kg/m2 than a woman having BMI> 30.0kg/m2 thus anticipating claims 11 claims 17).
Gemzell-Danielsson is silent on the form of estetrol, using BRI examiner interpret estetrol to be estetrol monohydrate anticipating claims 3 and 12. (whole documents of Gemzell-Danielsson).
Conclusion
No claims are allowable as written.
Examiner did not issue 103 rejections because applicant claimed surprising results as claimed in the specification page 23-25.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rehana Ismail whose telephone number is (703)756-4776. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew D Kosar can be reached at (571)272-913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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