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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/21/2026 has been entered.
Status of Claims
This action is in response to applicant arguments filled on 08/11/2025 for application 18/215111.
Claim 1 has been amended.
Claims 5-8, 13-14 and 18 have been canceled.
Claims 1-4, 9-12, 15-17 are currently pending and have been examined.
Detailed Action
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4, 9-12, 15-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1:
Claims 1-4, 9-12, 15-17 are drawn to a method and system, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One:
Independent claim 1 recites determining a testosterone base dosage and an estradiol base dosage; determining a testosterone base dosage by retrieving a base dosage value from the lookup table when the patient gender is male; adjusting the at least one retrieved base dosage using at least one age adjustment; adjusting the first intermediate dosage using at least one patient specific clinical adjustment; determining a final hormone treatment dosage.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity by identifying and reporting events preceding a pattern in a set of user data. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea (Step 2A Prong One: YES).
Step 2A Prong Two:
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including a user interface, processor, and a computerized device, which are additional elements that are recited at a high level of generality such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The claims recite the additional element of receiving an input and administering to the patient the final hormone treatment dosage, which are considered limitations directed to insignificant extra-solution activity that does not amount to an inventive concept because the limitations do not impose meaningful limits on the claim such that is it not nominally or tangentially related to the invention. In the claimed context, the claimed receiving limitations are incidental to the performance of the recited abstract idea of identifying and reporting events preceding a pattern in a set of user data, and the administering step is an extra solution activity. See: MPEP 2106.05(g)
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Hence, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic components cannot provide an inventive concept. See: MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The originally filed specification supports this conclusion at Figure 1, and
Paragraph 32, where “[0032] Although described in terms of various components used to implement the methods, the present invention can be used in a variety of system configurations, such as, but not limited to, mobile phone applications, portable computer applications, PDA applications, and the like. Also, various system components may be combined into a few or even one hardware component(s) without affecting overall functionality.”
Paragraph 38, where “[0038] Referring now to FIG. 2, there is provided a more detailed block diagram of the communication device 102. The communication device 102 will be described herein as comprising a mobile phone or a smart phone. However, the present invention is not limited in this regard. For example, the communication device can alternatively comprise a PDA, a tablet Personal Computer ("PC"), or the like.”
Paragraph 11, where “[0011] In another aspect of the invention, the electronic circuit determines the dosage female booster patient by receiving information such as patient previous estradiol dosage, previous testosterone dosage, whether patient is pre- menopausal, estradiol level, and whether patient has migraines, and then, if patient is not pre- menopausal, or is pre-menopausal with estradiol level less than 10 or migraines, an estradiol dosage is determined according to:”
The claims recite the additional element of receiving an input and administering to the patient the final hormone treatment dosage, which amounts to extra-solution activity concerning mere data gathering and post solution activity. The specification (e.g., as excerpted above) does not provide any indication that the additional elements are anything other than well‐understood, routine, and conventional functions when claimed in a merely generic manner (as they are here). See: MPEP 2106.05(g).
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claim(s) 2-4, 9-12, and 15-17 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
Response to Arguments
Applicant arguments/amendments over come the art rejection.
Applicant argues the 101 rejection. The Applicant argues that the claims recite a method of treating a patient, including determining a hormone treatment dosage using patient specific clinical and condition specific factors and administering the determined dosage to a patient. Such claims are squarely within the category of patient eligible methods of medical treatment, not mental process or methods of organizing human activity. The Examiner respectfully disagrees. Looking up information related to patients using tables is directed towards a method of organizing human activity. Administering the dosage is an extra solution activity.
The Applicant argues that even assuming that the claims recite an abstract idea, the claims integrate any such idea into a practical application by requiring administration of a hormone treatment dosage to a patient ad requiring a therapeutically effective physiological outcome. This is precisely the type of practical application recognized as patent-eligible in USPTO example 29 and Example 33 and is distinguished from ineligible diagnostic or advisory claims. The Examiner respectfully disagrees. Administering dosage after using a table to look up dosage is an extra solution activity and is not integrated into the claim as a whole. It is similar to “e.g., a printer that is used to output a report of fraudulent transactions, which is recited in a claim to a computer programmed to analyze and manipulate information about credit card transactions in order to detect whether the transactions were fraudulent.” This is different than example 33 wherein the claim as a whole effects a transformation of the fat and water into different chemicals by the means of specific and unconventional steps.
The Applicant argues that the claims further recite an inventive concept by requiring administration to produce a therapeutic physiological outcome, condition-specific problem factors not conventionally combined in hormone dosing, and multi factor clinical adjustments. These elements, taken together, represent non-routine and non-conventional treatment steps in hormone replacement and therefore supply “significantly more” than any alleged abstract idea. The Examiner respectfully disagrees. As noted in the rejection above, the steps are determine dosage, adjusting dosages, and determining dosages are directed towards an abstract idea of organizing human activity and administering the dosage is an extra/post solution activity.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAROUN P KANAAN whose telephone number is (571)270-1497. The examiner can normally be reached Monday-Friday 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached on (571) 270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MAROUN P. KANAAN
Primary Examiner
Art Unit 3687
/MAROUN P KANAAN/Primary Examiner, Art Unit 3687