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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/23/26 has been entered.
Response to Arguments
Applicant’s arguments, see Remarks, filed 1/23/26, with respect to the rejection(s) of claim(s) 2-6 and 8-13 under Ghosh in view of Stanley have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ghosh in view of Stanley (U.S. Pub. 2017/0028189).
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.
Claim(s) 1-2, 4-6, 8-10 and 12-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ghosh (U.S. Pub. 2019/0290918) in view of Stanley (U.S. Pub. 2017/0028189 hereinafter “Stanley”).
Regarding claims 1 and 10, Ghosh discloses an implantable device (e.g. 10) for stimulating a heart and lowering blood pressure, comprising: a stimulation unit (e.g. Fig. 5; 204) configured to stimulate the His bundle or the left-bundle branch of the heart (e.g. ¶¶62-64), and a sensing unit (e.g. Fig. 5; 200,202) for detecting atrial activity of the heart, the stimulation unit is configured to stimulate the His bundle or the left bundle branch immediately before or immediately after detection of an atrial activity (e.g. Fig. 5; 202, 204; ¶¶62-64). Ghosh discloses the claimed invention except for the system suspending stimulation after a predetermined number of heart cycles. However, Stanley teaches a similar system that suspends stimulation after a predetermined number of cycles being between 1 and 10 as set forth in paragraph 177 to provide a means for preventing the heart from having muscle fatigue from uninterrupted stimulation. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Ghosh, with suspending stimulation after a set number of cycles being between 1 and 10 as taught by Stanley, since such a modification would provide the predictable results of suspending stimulation to prevent the heart from having muscle fatigue from uninterrupted stimulation as clearly shown in paragraph 177.
Regarding claim 2, meeting the limitations of claim 1 above, Ghosh further discloses wherein the atrial sensing unit is configured to detect atrial activity of the heart using a ground electrode contact located outside the heart (e.g. ¶24).
Regarding claim 4, meeting the limitations of claim 1 above, Ghosh further discloses wherein the stimulation unit is configured to stimulate the His bundle or the left-bundle branch less than 80ms after detection of an atrial activity (¶¶62-64).
Regarding claim 5, meeting the limitations of claim 1 above, Ghosh further discloses wherein the implantable device is configured to suspend the stimulation of the His bundle, and/or of the left bundle branch (e.g. ¶¶65-68; “blanking interval”).
Regarding claim 6, meeting the limitations of claim 1 above, Ghosh further discloses wherein the implantable device is configured to suspend the stimulation after a predetermined time period (e.g. ¶¶65-68; “blanking interval for a predetermined time period”).
Regarding claim 8, meeting the limitations of claim 1 above, Ghosh further discloses wherein the implantable device comprises an electrode lead electrically connected to the stimulation unit and the sensing unit, wherein the electrode lead comprises a first electrode contact configured to be fixed to a proximal portion of the His bundle and to stimulate the His bundle and a second electrode contact for sensing said atrial activity (e.g. Fig. 2; (48, 50)).
Regarding claim 9, meeting the limitations of claim 1 above, Ghosh further discloses wherein the implantable device comprises an electrode lead comprising an electrode contact configured to be positioned in the region of the ventricular septum (e.g. ¶¶ 4-5 and 56-57), wherein the implantable device is configured to stimulate the left bundle branch (e.g. ¶¶ 4-5 and 56-57; “stimulation of septum is capable of stimulating the left bundle branch”).
Regarding claim 12, meeting the limitations of claim 1 above, Ghosh further discloses wherein the stimulation unit is configured to stimulate the His bundle or the left-bundle branch less than 10 ms after detection of an atrial activity (¶¶62-64).
Regarding claim 13, meeting the limitations of claim 1 above, Stanley further discloses, wherein the implantable device is configured to control suspension of the stimulation depending on one or more parameters recorded by the implantable device (e.g. see Figs. 14a-14d; “sensed t-wave trigger”).
Claim(s) 3, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ghosh in view of Stanley as applied to claims 1-2, 4-10 and 12 and above, and further in view of Mika et al. (U.S. Pat. 9,333,352 hereinafter “Mika”).
Regarding claims 3 and 11, Ghosh in view of Stanley discloses the claimed invention except for explicitly stating that the system stimulates 80ms or less before the detections of the atrial activity. However, Mika teaches that it is known to stimulate the HIS bundle less than 80ms before the detection of an atrial activity as set forth in Column 26, lines 21-46 and Column 32, lines 25-27 to provide stimulation to lower blood pressure through reduction of ventricular filling. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Ghosh in view of Stanley, with stimulation before atrial activity as taught by Mika, since such a modification would provide the predictable results of stimulating the HIS bundle less than 80ms before the detection of an atrial activity for providing stimulation to lower blood pressure through reduction of ventricular filling.
Conclusion
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/REX R HOLMES/Primary Examiner, Art Unit 3796