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
This office action is in response to applicant’s reply filed on September 8, 2025.
Restrictions/Elections.
Applicant’s election without traverse of Group IV (Claims 16 and 20) in the reply filed on September 8, 2025, is acknowledged.
Status of Claims
Claims 13-22 are currently pending and are the subject of this office action.
Claims 13-15, 17-19 and 21-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 8, 2025.
Claims 16 and 20 are presently under examination.
Priority
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Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application
Claim Rejections - 35 USC § 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.
Claim(s) 16 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hayashi et. al. (US 2017/0035705) in view of Nojiri et. al. (Sysmex Journal Web (2012) 13:1-8, cited by Applicant, abstract translated) and in view of Tanaka et. al. (The 2011 Annual Meeting Record I.E.E, Japan (2011) 3:28-29, cited by Applicant, partial; translation).
For claims 16 and 20, Hayashi teaches a method of treating dysuria and/or detrusor hyperactivity with impaired contractility (DHIC) ((both are considered lower urinary tract disorders) comprising the administration of an effective amount of the compound 3-(15-hydroxypentadecyl)-2,4,4-trimethyl-2-cyclohexen-2-one represented by Formula (I):
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(See [0002]-[0004] and claims 1-2).
Hayashi further teaches that the method improves the maximum voided volume (i.e. improves voiding efficiency, see [0004]). Further, in a rat dysuria model, the above compound improved the residual urine volume (0.28 mL) compared to the control (0.57 mL) (see Test Example 2 and Table 1) meaning that the administration of compound of Formula (I) above to a rat model of dysuria improved voiding efficiency (i.e. increased the volume of urine voided compared to a control).
Hayashi does not teach that the patient has a residual urine volume of 50 mL or more or 100 mL or more. However, Nojiri teaches that elderly patients may develop urinary retention due to a manifestation of impaired urinary output. The authors describe a method of residual urine measurement using a Bladder Scan System BV16100. If the residual urine volume exceeds 100 mL or more the authors recommend continuing observation. Tanaka teaches that: “the lower limit was set at 50 mL, since 50 mL is generally considered to be the standard for normal residual volume”.
Before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to improve voiding efficiency in a patient having a lower urinary tract disorder (dysuria and/or DHIC) comprising the administration of an effective amount of the compound 3-(15-hydroxypentadecyl)-2,4,4-trimethyl-2-cyclohexen-2-one as taught by Hayashi. The skilled in the art will be further motivated to treat patients with a residual volume of 50 ml or more or 100 ml or more since the prior art teaches that 50 mL is the standard for normal residual volume, as such a patient with a residual urine volume of 50 ml or more will be considered not normal and a candidate for improving voiding efficiency.
All this will result in the practice of claims 16 and 20 with a reasonable expectation of success.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
September 16, 2025.