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 .
Specification
The use of the term “blue tooth”, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
Claim 43 contains the trademark/trade name “blue tooth”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe wireless connectivity and, accordingly, the identification/description is indefinite.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/08/2025 has been entered.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 23-34 and 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pat Pub No. 20030045910 to Sorensen et al. (hereinafter “Sorensen”) to US Pat Pub No. 20060217772 to Libbus et al. (hereinafter “Libbus”) and US Pat Pub No. 20150117645 to Carlson et al. (hereinafter “Carlson”).
Regarding claim 23. (Currently Amended) Sorensen discloses a method for generating a pacing rate (para 0007), the method comprising: activating a blood pressure device to sense a blood pressure of a user (para 0021 “a pressure sensor”); receiving selected parameters for blood pressure regulation wherein the selected parameters comprise at least one of a blood pressure treatment interval or a desired pacing change per the treatment interval (para 0010 “determine when to administer cardiac pacing therapy to the patient based on the position parameter and the pressure parameter [] apply an increased pacing rate effective”, 0021, etc.); determining, by a processor, that the blood pressure deviates from a target blood pressure by at least a threshold amount (para 0022 “predefined threshold”, 0052, 0067, 0069, etc., fig. 3); determining, by the processor, pacing instructions, the pacing instructions comprising a pacing rate for a pacing device based on the selected parameters and based on determining that the blood pressure deviates from a target blood pressure by at least a threshold amount (para 0068-0070, fig. 3), the acceleration parameters comprising one or more of a magnitude of acceleration of pacing or a duration of acceleration of pacing and the deceleration parameters comprising one or more of a magnitude of deceleration of pacing or a duration of deceleration of pacing (para 0069 “faster pacing rate”), wherein the one of acceleration parameters or deceleration parameters are determined based on the blood pressure deviating from a target blood pressure by at least the threshold amount (para 0068-0070, fig. 3, etc.): and outputting, by the processor, the pacing instructions to the pacing device, the pacing device configured to output pacing signals based on the pacing instructions (fig. 3, 5, para 0036). But fails to disclose controlling the pacing frequency.
Libbus, from a similar field of endeavor teaches the controller to include a stimulation mode module that includes adjustable parameters such as frequency, etc. wherein the parameters of the pacing modules are able to be adjusted to selectively provide a stimulation signal (para 0071). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the disclosure of Sorensen with the teachings of Libbus to provide the predictable result of selectively adjusting the parameters of the pacing.
Sorensen as modified by Libbus renders the limitations above obvious but fails to disclose encrypting the pacing instructions.
Carlson, from a similar field of endeavor shows that it is known for the IMD to be encrypted to secure sensitive information including programming instructions (para 0003, 0006-0009, etc.). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the disclosure of Sorensen as modified by Libbus with the known teachings of Carlson to provide the predictable result of securing the sensitive information.
Regarding claim 24. (Currently Amended) Sorensen as modified by Libbus and Carlson renders obvious the method of claim 23, further comprising: providing the pacing rate to the pacing device; and causing the pacing device to be modified based on the pacing rate (figs 3 and 5, see rejection of claim 23).
Regarding claim 25. (Previously Presented) Sorensen as modified by Libbus and Carlson renders obvious the method of claim 23, wherein the blood pressure is provided by a wearable device (Sorensen, para 0051).
Regarding claim 26. (Previously Presented) Sorensen as modified by Libbus and Carlson renders obvious the method of claim 23, wherein the blood pressure is one or more of a systolic blood pressure, a diastolic blood pressure, or a mean atrial pressure (Sorensen, para 0050).
Regarding claim 27. (Previously Presented) Sorensen as modified by Libbus and Carlson renders obvious the method of claim 23, wherein the blood pressure is received using a wireless communication medium (Sorensen, para 0051, 0046, Libbus para 0042).
Regarding claim 28. (Previously Presented) Sorensen as modified by Libbus and Carlson renders obvious the method of claim 23, wherein the pacing device is one of an atrial pacemaker, a dual chamber pacemaker, a right atrial pacemaker, an automatic implanted cardiac defibrillator (AICD), a combined pacemaker/AICD, or a cardiac resynchronization therapy (CRT) bi-ventricular pacemaker (Sorensen, para 0007, etc. Libbus para 0002).
Regarding claim 29. (Previously Presented) Sorensen as modified by Libbus and Carlson renders obvious the method of claim 23, wherein the blood pressure is provided by one of a pneumatic cuff or a non-pneumatic cuff (Sorensen, para 0051, Libbus, para 0041).
Regarding claim 30. (Previously Presented) Sorensen as modified by Libbus and Carlson renders obvious the method of claim 23, wherein the determining the pacing rate further comprises: receiving a lower limit blood pressure or an upper limit blood pressure (para 0068-0070, first and second threshold); and wherein determining the pacing rate of the pacing device is further based on determining a difference between a current blood pressure and one of the lower limit blood pressure or the upper limit blood pressure (para 0068-0070, fig. 3,).
Regarding claim 31. (Previously Presented) Sorensen as modified by Libbus and Carlson renders obvious the method of claim 23, further comprising: determining an incremental pacing frequency, wherein the incremental pacing frequency is between a current pacing frequency and the pacing frequency; providing the incremental pacing frequency to the pacing device at a first time; and providing the pacing rate to the pacing device at a second time after the first time (Sorensen para 0047, cl 12 “adjusting a cardiac pacing rate from a first pacing rate to a second pacing rate effective to counteract effects of orthostatic hypotension”).
Regarding claim 32. (Previously Presented) Sorensen as modified by Libbus and Carlson renders obvious the method of claim 23, further comprising: receiving a current pacing frequency after the pacing device applies the pacing rate for a period of time; determining that the current pacing frequency deviates from an upper pacing frequency or a lower pacing frequency by a threshold pacing amount; and determining an updated pacing rate of the pacing device based on determining that the current pacing frequency deviates from the upper pacing frequency or the lower pacing frequency by the threshold pacing amount (Sorensen see rejection of claim 23, fig 3, closed loop).
Regarding claim 33. (Previously Presented) Sorensen as modified by Libbus and Carlson renders obvious the method of claim 23, further comprising: receiving a blood pressure device identifier; verifying the blood pressure device identifier; and receiving the blood pressure based on verifying the blood pressure device identifier (Carlson, para 0110 decrypt the data, it is understood that encrypting-decrypting data would include identifying the device).
Regarding claim 34. (Previously Presented) Sorensen as modified by Libbus and Carlson renders obvious the method of claim 23, wherein the pacing frequency is one of a higher pacing frequency or a lower pacing frequency than a current pacing frequency of the pacing device (see rejection of claim 23, Libbus, 0048-0049, etc.).
Regarding claim 43. (NEW) Sorensen as modified by Libbus and Carlson renders obvious the method of claim 23, wherein the encrypting the pacing instruction includes encrypting the pacing instructions based on blue tooth connectivity (Carlson, para 0031).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANA SAHAND whose telephone number is (571)272-6842. The examiner can normally be reached M-Th 8:30 am -5:30 pm; F 9 am-3 pm.
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/SANA SAHAND/Examiner, Art Unit 3796