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 .
Claims 1-20 are pending. Claims 1-20 are rejected herein. Claims 21-36 were previously canceled.
In the claims received 04 September 2025 claim 1 was amended.
Priority
This application claims priority to provisional application 61/951,415. This application has an effective priority date of 11 March 2014.
Terminal Disclaimer
The terminal disclaimer filed on 04 September 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 11798659 B2 has been reviewed and is accepted. The terminal disclaimer has been recorded.
The terminal disclaimer filed on 04 September 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 10572628 B2 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Distinguishing Subject Matter
The cited prior art of record fails to expressly teach or suggest, either alone or in combination, the features found within independent claims 1 and 18 as best understood by the Examiner. In particular, the cited prior art of record fails to expressly teach or suggest “determining by the process an effective estradiol dosage and an effective testosterone dosage using dosage calculation methods selected based on the automated male-to-female input parameters, and male-to-female tracking parameters in response to receiving an input indicating that the patient sex is male-to-female; determining by the processor an effective testosterone dosage using dosage calculation methods selected based on the automated female-to-male input parameters, and female-to-male tracking parameters in response to receiving an input indicating that the patient sex is female-to-male;” (claim 1) and “ordering, by the processor, a plurality of pellet sizes from largest to smallest; subtracting, by the processor, a largest of the plurality of pellet sizes from the effective dosage; and if a result of the subtraction is greater than zero, assigning, by the processor, the largest of the plurality of pellet sizes as the estradiol pellet size insertion or the testosterone pellet size insertion; if a result of the subtraction is less than zero, subtracting, by the processor, a next smallest one of the plurality of pellet sizes from the effective dosage until the result is greater than zero; calculating, by the processor, an absolute value of the result of the subtraction that is less than zero and an absolute value of the result of the subtraction that is greater than zero; and assigning, by the processor, one of the plurality of pellet sizes as the estradiol pellet size insertion or the testosterone pellet size insertion corresponding to the result having a lesser absolute value” (claim 18).
Double Patenting – Non-Statutory
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US12136474 B2 in view of Zhou (A parsimonious personalized dose-finding model via dimension reduction). US 12136474 B2 independent claim determines the effective estradiol dosage using three factors: patient status, automated male-to-female input parameters, and male to female tracking parameters in response to receiving an input indicating that the patient sex is male-to-female;…. The instant application independent claim determines the effective estradiol dosage using two of these factors: automated male-to-female input parameters, and male to female tracking parameters in response to receiving an input indicating that the patient sex is male-to-female;…. The difference between the amended claim 1 and US 12136474 B2 claim 1 is that the patient status has been removed from the received data and patient status has also been removed from the factors used for determination of the effective estradiol and testosterone dosages. A similar situation exists for the testosterone dosage calculations.
As a result, the scope of claim 1 of US12136474 B2 falls within the scope of claim 1 of instant application, except for the embodiment of the invention based on dosage calculations that include only two factors, which is still an acceptable embodiment given broadest reasonable interpretation of the claimed subject matter in the instant application. This embodiment is not covered by the protections granted in US 12136474 B2. As a result there is one new embodiment in the instant application not outlined in the reference patent. Therefore, the changes resulted overlapping scope with a previously granted patent and created an additional embodiment, necessitating the obviousness type double patenting.
This analysis required an additional rationale for the incorporation of the embodiment of the invention described by calculations based on only two factors. The additional rationale was derived from Zhou at the summary: learning an individualized dose rule in personalized medicine is a challenging statistical problem and that existing methods often suffer from the curse of dimensionality, especially when the decision function is estimated nonparametrically. Finally, Zhou teaches to tackle this problem, a dimension reduction framework that effectively reduces the estimation to an optimization on a lower-dimensional subspace of the covariates is proposed (Zhou at the summary).
Response to Arguments
Double Patenting - Statutory
Applicant has amended claim 1 of the subject application such that the claims are now patentably distinct in scope and requests the rejection to be withdrawn.
The Examiner agrees that the statutory double patenting rejection stemming from the scope conflict between U.S. Patent No. 12136474 and claims 1-20 has been resolved.
Double Patenting – Nonstatutory
Applicant has filed a terminal disclaimer herewith to overcome these rejections.
The terminal disclaimer has been specifically addressed at the beginning of this office action. The properly filed terminal disclaimer was accepted and the non-statutory double patenting removed.
The amended claims still overlap in scope with U.S. Patent No. 12136474 as detailed above in the non-statutory double patenting rejection explanation. Per the rejection instructions an additional terminal disclaimer is necessary to overcome this new basis of rejection brought in response to the amended claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Balcerek, Matthew(Feminizing Hormone Therapy Prescription Patterns and Cardiovascular Risk Factors in Aging Transgender Individuals in Australia) teaches the use of hormone therapy on a transgender population.
US 20030040662 A1 (hereafter Keys) teaches a system, method and computer program for monitoring and managing medications which is tangentially relevant in that it is a medication administration scheme.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/T.I.E./Examiner, Art Unit 3683
/CHRISTOPHER L GILLIGAN/Primary Examiner, Art Unit 3683