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 .
Status of Claims
This action is in reply to Applicant’s communication filed on February 12, 2026.
Claims 21-40 have been added.
Claims 1-20 have been canceled.
Claims 21-40 are currently pending and have been examined.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 12, 2026 has been entered.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 21 recites “administering at least one of the diuretic dosage and the beta-blocker dosage, wherein the beta-blocker dosage is increased where the first input and second input indicate the patient is tachycardic, the beta-blocker dosage is decreased where the first input and second input indicate the patient is hypotensive, the diuretic dosage is increased when the first input and the second input indicate the patient is swollen and warm, and the diuretic dosage is decreased when the first input and the second input indicate the patient is dry and dizzy”. Applicant’s specification describes titrating diuretics and beta-blockers based on individualized patient's needs (see page 24 of Applicant’s specification). However, the specification does not sufficiently describe the conditions or circumstances under which a dosage is determined to be adjusted. For example, there is no description of what symptoms must be present in order to determine that the dosage of the diuretic needs to be increased/decreased. Therefore, Applicant’s specification does not provide a sufficient description for the claimed limitations.
Claims 22-40 are further rejected as being dependent on a rejected base claim.
Relevant Prior Art of Record Not Currently Being Applied
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure.
Damiano et al. (JP 6243546B2) discloses offline glucose control based on data from a preceding online period. The correct bolus dose is calculated individually in real-time during offline operations. When the controller receives the instruction to generate a correction dose, the algorithm uses the current luces measurement and the latest glucose sample value to obtain an estimated glucose value for the most recent sampling interval.
Ludomirsky et al. (US 20060047205) discloses A delivery method and system for noninvasively monitoring cardiac physiologic parameters used to evaluate patients with cardiovascular conditions. A closed-loop drug delivery system may be envisioned. Data from an implant can be fed directly to a drug delivery device (which may or may not be implanted and may or may not be an integral part of the implant). This approach would allow continuous adjustment of medications for pulmonary-hypertension-related conditions with minimal physician intervention. See Ludomirsky abstract; paras 38-39.
Zhang et al. (US 20090043289) discloses a method for titrating a drug to provide a medical therapy to a patient. The method includes the steps of providing an implantable medical device having a controller, providing one or more implantable sensors configured to sense physical parameters of the patient and configured to transmit signals to the controller. The implantable medical devices may be cardiac rhythm management devices (CRM), such as pacemakers, implantable cardioverter defibrillators (ICD), and cardiac resynchronization therapy (CRT). The CRM’s may sense cardiac events and output pacing pulses to the heart in accordance with a programmed pacing mode. The controller may continue to monitor the patient's side effects to determine if they worsen. The system may include sensors such as an accelerometer to detect whether the patient is generally at rest or active and a heart electrocardiogram sensor, where the sensor data is transmitted to an external device for processing. Zhang further teaches titrating beta-blocker doses, administering beta-blockers, and a maximum drug dosage according to medical professional consensus. See Zhang abstract; paras 1, 5, 16, 19-21, 24-26, 30, 37, 54, 56; Figure 2.
Response to Arguments
Regarding rejections under 35 USC § 112(b) to Claims 18-20, this rejection is rendered moot upon cancelation of claims 18-20.
Regarding rejections under 35 USC § 101 to Claims 21-40, Applicant’s arguments have been fully considered and are persuasive. The rejection has been withdrawn in light of latest amendments.
Regarding rejections under 35 USC § 102/103 to Claims 21-40, Applicant’s arguments have been fully considered and are persuasive regarding the newly added limitations. Therefore, the rejection has been withdrawn.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIMBERLY VANDER WOUDE whose telephone number is (703)756-4684. The examiner can normally be reached M-F 9 AM-5 PM.
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/K.E.V./Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681
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