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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 12, 2025 has been entered. Currently claims 1-17- and19-21 are pending in this application.
Response to Arguments
Applicant's arguments filed June 25, 2025 have been fully considered but are not persuasive inasmuch as they apply to the amended rejections required by the amendments to the claims. Examiner notes that the amendments to the claims have required new rejections under 35 USC 112 first and second paragraphs. As such, it is unclear what further limitations the new amendments have included in the claims and the device of Kieval discloses the claimed invention as best the claims can be understood.
Claim Rejections - 35 USC § 112
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 1-17 and 19-21 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. The claim limitation, “a control unit electrically connected to and disposed outside a boundary of the first unit and the second unit” of claim 1 is not described in the specification as originally filed in such a way as to reasonable convey that the inventor had possession of the claimed invention. The specification as originally filed does not disclose the limitation “disposed outside a boundary” nor it is a term that is well known in the art, and thus it is unclear what the term means. In addition, at no time does the specification as originally filed disclose a control unit that is separated in any way from the two units and thus it is unclear how the control unit could be “disposed out a boundary.”
Claim Rejections - 35 USC § 112 – Second Paragraph
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-17 and 19-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 line 2 recites the phrase “[a]n implantable medical device configured to be planted within a subject.” It is unclear how a device can be configured to be planted within a subject. Examiner suggests amendment the phrase to “configured to be implanted.”
Claim 1, lines 7-8 recites the limitation “a control unit electrically connected to and disposed outside a boundary of the first unit and the second unit.” The term “outside the boundary of the first and second unit” is unclear, as it is not known what boundary is being referred to. It is also unclear what consists of “outside a boundary” as the term is not included in the specification as originally filed, so it is not known how this term further limits the claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-7, 10-16, and 19-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kieval (US 2009/0018596).
Regarding claims 1, and 10, as best the claim can be understood, Kieval discloses the claimed implantable medical device and associated method and non-transitory machine readable medium configured to be implanted within a subject, the medical device comprising (e.g. device 600 as shown in Figure 5B herein the baroreflex activation device and cardiac rhythm management device are combined in a single device; paragraph [0011]):
a first unit configured to detect pulses and output a first pulse to perform a first treatment (e.g. CRM device 522);
a second unit configured to output a second pulse to perform a second treatment (e.g. BAT device 556); and
a control unit electrically connected to the first unit and the second unit, wherein the control unit is configured to: monitor pulses and activities of the first unit and the second unit; and prevent the first unit from mistakenly outputting the first pulses or failing to output the first pulses when a first body part of the subject needs the first pulses for the first treatment (e.g. the control unit of both the CRM and BAT electronics work to modify the BAT treatment if CRM treatment is detected, as shown in Figure 8A).
Regarding claims 2 and 11, Kieval additionally discloses wherein the control unit includes: a processor (e.g. processor as described in paragraph [0081]); and a monitor unit connected to the processor (e.g. sensor 760 as shown in Figure 6), the monitor unit being configured to monitor pulses and generate monitor results based on the pulses detected wherein the processor analyzes the monitor results and determines whether the detected pulses originates from the second unit or from the first body part in need of the first pulses for the first treatment, the processor notifies the first unit to not generate the first pulses if the detected pulses are determined to originate from the second unit (e.g. as shown in Figure 8A, when “therapy two” (CRM therapy) is detected at step 5, the BAT therapy is modified so the therapy is not overlapping).
Regarding claims 3 and 12, Kieval additionally discloses wherein the control unit includes: a first parameter associated with pulses generated by the first body part in need of the first pulses for the first treatment (e.g. pacing pulse that is detected in box 3 of Figure 8A) and a second parameter associated with the second pulses originating from the second unit (e.g. BAT therapy device); wherein the second unit notifies the control unit before outputting the second pulses, the processor then analyzes the monitor results based on the second parameter; wherein the processor analyzes the monitor results based on the first parameter after the second unit has finished outputting the second pulses (e.g. notification of modification of the BAT therapy as shown in step 6 of Figure 8A).
Regarding claims 4 and 13, Kieval additionally discloses wherein the control unit includes: a processor (e.g. processor as described in paragraph [0081]); and a monitor unit connected to the processor (e.g. sensor 760 as shown in Figure 6), the monitor unit being configured to monitor pulses and generate monitor results based on the pulses detected, wherein the processor analyzes the monitor results and determines whether the pulses detected originates from the second unit or from the functioning first body part, the processor notifies the first unit if the pulses detected are determined to originate from the second unit (e.g. as shown in Figure 8A).
Regarding claims 5 and 14, Kieval additionally discloses wherein the control unit includes a second parameter associated with the second pulses originating from the second unit; the second unit notifies the control unit before outputting the second pulses, the processor then analyzes the monitor results based on the second parameter (e.g. as shown in Figure 8A)
Regarding claims 6 and 15, Kieval additionally discloses wherein the second unit notifies the control unit before outputting the second pulses, the control unit notifies the first unit before the second units outputs the second pulses, the first unit then monitors pulses based on a second parameter associated with the second pulses from the second unit (e.g. as shown in Figure 8A).
Regarding claim 7 and 16, Kieval additionally discloses first unit is at least one of an implantable cardioverter defibrillator (ICD) and a pacemaker, the first unit configured to deliver the first treatment as at least one of defibrillation impulses and pacemaker impulses (e.g. CRM device 522), and the second unit is a baroreflex activation therapy stimulator, the second unit configured to deliver the second treatment as baroreflex activation therapy impulses (e.g. BAT device 566).
Regarding claim 19, Kieval discloses the claimed implantable medical device comprising (e.g. device 600 as shown in Figure 5B herein the baroreflex activation device and cardiac rhythm management device are combined in a single device; paragraph [0011]):
a first unit disposed in a single device that is at least one of an implantable cardioverter defibrillator (ICD) and a pacemaker configured to detect pulses and output a first pulse to perform a first treatment that is (e.g. CRM device 522 which can be either a cardiac pacemaker, implantable defibrillator, or a combination, which will necessarily provide defibrillation pulses and pacing pulses);
a second unit disposed in the single device and configured to output a second pulse to perform a second treatment as baroreflex activation therapy impulses (e.g. BAT device 556 which provides baroreflex activation therapy); and
a control unit electrically connected to the first unit and the second unit (e.g. controller 1023).
Regarding claim 20, as best the claim can be understood, Kieval additionally discloses a control unit configured to monitor pulses and activities of the first unit and the second unit; and prevent the first unit from mistakenly outputting the first pulses or failing to output the first pulses when a first body part of the subject needs the first pulses for the first treatment (e.g. the control unit of both the CRM and BAT electronics work to modify the BAT treatment if CRM treatment is detected, as shown in Figure 8A).
Regarding claims 21, as best the claim can be understood, Kieval additionally discloses wherein the control unit includes
a processor (e.g. processor as described in paragraph [0081]);
a monitor unit connected to the processor (e.g. sensor 760 as shown in Figure 6), the monitor unit being configured to monitor pulses and generate monitor results based on the pulses (e.g. as shown in Figure 8A, when “therapy two” (CRM therapy) is detected at step 5, the BAT therapy is modified so the therapy is not overlapping).
wherein the processor is configured to:
determine whether the detected pulses originates from the second unit or from the first body part in need of the first pulses for the first treatment (e.g. as shown in Figure 8A, when “therapy two” (CRM therapy) is detected at step 5, the BAT therapy is modified so the therapy is not overlapping);
determine whether the pulses detected originates from the second unit or from the functioning first body part, the processor notifies the first unit if the pulses detected are determined to originate from the second unit (e.g. as shown in Figure 8A);
notify the first unit of the determining by the processor (e.g. as shown in Figure 8A, when “therapy two” (CRM therapy) is detected at step 5, the BAT therapy is modified so the therapy is not overlapping).
Claim Rejections - 35 USC § 103
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.
Claims 8-9, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kieval in view of Caparso (US 2022/0218988).
Regarding claims 8 and 17, Kieval discloses the claimed invention except the express mention of a wireless unit electrically connected to the control unit, the wireless unit being configured to receive first data from the control unit and wirelessly output the first data to an external device, the wireless unit being configured to wirelessly receive second data from the external device and transfer the second data to the control unit. Caparso discloses that it was well known in the art of implantable stimulation device to include a wireless unit (e.g. antenna 17) electrically connected to a control unit (e.g. electronics assembly 19) and wirelessly output a first data to an external device (e.g. communication from electronics assembly 19 to antenna 17 to external controller 21), the wireless unit being configured to wirelessly receive second data from the external device and transfer the second data to the control unit (e.g. communication back from external controller 21 to antenna 17 and back to electronics assembly 19). It would have been obvious to one having ordinary skill in the art to include the wireless communication of Caparso in the device of Kieval in order to provide the system with the predictable results of a reliable means of wireless communication.
Regarding claim 9, Kieval discloses the claimed invention except the express mention of a wireless unit electrically connected to the control unit, the wireless unit being configured to wirelessly receive update data from an external device, the wireless unit transferring the update data to the control unit for performing parameter update or firmware update on at least one of the first unit, the second unit, the control unit, and the wireless unit. Caparso discloses that it was known in the art of implantable electrical stimulators to include a wireless unit electrically connected to the control unit (e.g. antenna 17 connected to electronics assembly 19), the wireless unit being configured to wirelessly receive update data from an external device, the wireless unit transferring the update data to the control unit for performing parameter update or firmware update on at least one of the first unit, the second unit, the control unit, and the wireless unit (e.g. updates that are communicated from server 216 to controller 100 and to neuromodulation device 20; paragraph [0033]). It would have been obvious to one having ordinary skill in the art to include the wireless communication of Caparso in the device of Kieval in order to provide the system with the predictable results of a reliable means of wireless communication.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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/Amanda K Hulbert/Primary Examiner, Art Unit 3792