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 .
Examiner Comment
Claim 13 was changed so the letters for steps c and d were changed from e and f without the change being indicated. The examiner notes this does not change the scope of the claim and is noting this change for clarity from the Examiner’s comment in the 10/29/2025 office action.
Response to Arguments
The amendment to the specification dated 1/29/2026 is sufficient to overcome the previous specification objection.
Applicant's arguments filed 1/29/2026 have been fully considered but they are not persuasive. Applicant argues that the prior art does not have automatic application of the stored stimulation parameter values. The examiner respectfully disagrees as Column 12 lines 56-Column 13 line 7 discloses causing the switch to couple the pulse generator to the unipolar electrode pacing configuration. Column 11 lines 7-20 disclose autocapture conducting autocapture tests with the unipolar pacing electrode configuration so if lead failure is noted the further action will continue pacing and safety of the patient. Column 13 lines 24-29 discloses increasing the back-up pulses so that the user can detect and alert the physician of the failure followed by returning to the unipolar pacing output consistent with the measured capture threshold and selected safety margin. It is further noted that Column 2 lines 45-50 disclose that the stimulation threshold of a heart chamber can change over time. Hence, pacemakers that incorporate autocapture are generally able to periodically and automatically perform autocapture tests. In this way, the variations or changes in stimulation threshold can be accommodated. Therefore, while the device automatically switches to a previously stored unipolar pacing value and then the device includes the ability to then run tests to change the stimulation threshold based on any changes which may have changed.
In addition, this is part of a contingent limitation. Claims 1 and 12-14 recited “in case of the occurrent of an electrode failure …”. However in light of Ex parte Schulhauser, see MPEP 2111.04(II), a method of a contingent limitation, the performance recited by the step need not be carried out in order for the claimed method to be performed. Since this step is only performed in case the occurrence of an electrode failure, the limitation is contingent and would not be required in case there is not an occurrence of electrode failure. The examiner also notes that the device comprises electrodes and stimulation unit and therefore would have the structure to perform the function should the condition occur as suggested by Column 12 lines 56-Column 13 line 7. The examiner suggest amending the claim to state “detecting an occurrence of an electrode failure of the electrode when operating the electrode in a bipolar manner which results in automatically switching from …” to overcome the contingent limitation interpretation.
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.
Claim 13 is 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 13 was amended to recite “a non-volatile memory”; however, the instant disclosure does not explicitly recite this type of memory. The examiner notes “memory” or “memory unit” is recited in the instant disclosure, but does not explicitly teach the species non-volatile memory. The examiner notes all non-volatile memory is non-transitory, but not all non-transitory memory is strictly non-volatile. Therefore, the amendment appears to be further limiting the memory to a specific species, which is not explicitly taught. The examiner suggests using “non-transitory memory”.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levine et al (US Patent 7,308,310).
Referring to Claim 1, Levine et al teaches implantable medical device for stimulating a human or animal heart, comprising a housing, a processor, a memory unit (e.g. Figure 1, device 10 with housing 40 and Figure 2 processor 60 and memory 94), a stimulation unit configured to stimulate a cardiac region of a human or animal heart, and a detection unit configured to detect an electrical signal at the cardiac region of the same heart, wherein the stimulation unit comprises an electrode having a first electrode pole and a second electrode pole (e.g. Figures 1 and 2 electrodes 21-38), wherein in that the memory unit comprises a computer-readable program that causes the processor to perform the following steps when executed on the processor: a) determining appropriate stimulation parameter values of a stimulation pulse to be delivered to a cardiac region of a human or animal heart by the first electrode pole in a unipolar manner (e.g. Column 11 lines 7-20 and Column 12 lines 56- Column 13 line 7); b) storing the determined stimulation parameter values in the memory unit (e.g. Column 13 lines 24-29 disclose unipolar pacing consistent with the measured capture threshold and the selected safety margin); c) checking an occurrence of an electrode failure of the electrode when operating the electrode in a bipolar manner (e.g. Column 12 line 56- Column 13 line 7); d) in case of the occurrence of an electrode failure, automatically switching from a bipolar operation of the electrode to a unipolar operation of the electrode and automatically applying the stored stimulation parameter values for a unipolar stimulation of the cardiac region (e.g. Column 12 line 56- Column 13 line 7).
Referring to Claim 2, Levine et al teaches implantable medical device according to claim 1, wherein the detection unit comprises the same electrode as the stimulation unit, wherein the computer-readable program causes the processor to perform the following steps prior to step d): determining appropriate sensing parameter values for sensing an electrical signal at the cardiac region by the first electrode pole in a unipolar manner and storing the determined sensing parameter values in the memory unit, wherein the computer-readable program causes the processor to perform additionally the following in step d): applying the stored sensing parameter values for sensing an electrical signal at the cardiac region (e.g. Column 12 lines 56- Column 13 line 7 and Column 13 lines 47-61).
Referring to Claim 3, Levine et al teaches implantable medical device according to claim 1, wherein the stimulation parameter comprise a value of an amplitude and/or a value of a pulse width of a stimulation pulse (e.g. Column 2 lines 27-30 disclose the stimulation parameter is amplitude).
Referring to Claim 4, Levine et al teaches implantable medical device according to claim 1, wherein the cardiac region is a right ventricle of the human or animal heart (e.g. Figure 1).
Referring to Claim 5, Levine et al teaches implantable medical device according to claim 1, wherein the cardiac region is a His bundle of the human or animal heart (e.g. Figure 1. The functional language and statement of intended use has been carefully considered but are not considered to impart any further structural limitations over the prior art. Since Levine discloses electrodes that can be placed in the heart to detect electrical energy. Levine is therefore capable of having the electrodes placed adjacent the His bundle to detect electrical signals at this region. In addition, nothing in Levine prevents the electrodes from being used to detect an electrical signals of the His bundle).
Referring to Claim 6, Levine et al teaches implantable medical device according to claim 1, wherein steps a), b), c) are, independently from each other, carried out automatically or upon a user's request (e.g. Column 11 lines 7-20 and Column 12 lines 56- Column 13 line 29).
Referring to Claim 7, Levine et al teaches implantable medical device according to claim 1, wherein step c) is cyclically repeated (e.g. Figure 3).
Referring to Claim 8, Levine et al teaches implantable medical device according to claim 1, wherein step c) is carried out by measuring an impedance between the first electrode pole and the second electrode pole and by determining whether the measured impedance is lower than a predetermined lower impedance threshold value or higher than a predetermined upper impedance threshold value (e.g. Figure 3, Element 126).
Referring to Claim 9, Levine et al teaches arrangement comprising an implantable medical device according to claim 1 and a programming device for programming the implantable medical device (e.g. Figure 2, Element 102).
Referring to Claim 10, Levine et al teaches arrangement according to claim 9, wherein the programming device is designed and arranged to enable an adjustment of stimulation parameter values of a stimulation pulse to be delivered to a cardiac region of a human or animal heart by a first electrode pole of an electrode in a unipolar manner and/or to enable storing of the stimulation parameter values (the functional language and statement of intended use has been carefully considered but are not considered to impart any further structural limitations over the prior art. Since Levine non-invasively programs the implantable device using an external device such as a programmer is designed and arranged to enable an adjustment of stimulation parameter values of a stimulation pulse to be delivered to a cardiac region of a human or animal heart by a first electrode pole of an electrode in a unipolar manner and/or to enable storing of the stimulation parameter values, see e.g. Column 8 lines 49-55, Column 11 lines 7-20, and Column 12 lines 56- Column 13 line 29).
Referring to Claim 11, Levine et al teaches arrangement according to claim 9, wherein the programming device is designed and arranged to enable an adjustment of sensing parameter values for sensing an electrical signal at the cardiac region of a human or animal heart by a first electrode pole of an electrode in a unipolar manner and/or to enable storing of the sensing parameter values (the functional language and statement of intended use has been carefully considered but are not considered to impart any further structural limitations over the prior art. Since Levine non-invasively programs the implantable device using an external device such as a programmer is designed and arranged to enable an adjustment of sensing parameter values for sensing an electrical signal at the cardiac region of a human or animal heart by a first electrode pole of an electrode in a unipolar manner and/or to enable storing of the sensing parameter values, see e.g. Column 8 lines 49-55, Column 12 lines 56- Column 13 line 7 and Column 13 lines 47-61).
Referring to Claim 12, Levine et al teaches method for automatically switching an operational mode of an implantable medical device for stimulating a human or animal heart according to claim 1, the method comprising the following steps: a) determining appropriate stimulation parameter values of a stimulation pulse to be delivered to a cardiac region of a human or animal heart by a first electrode pole of an electrode of a stimulation unit of the implantable medical device in a unipolar manner (e.g. Column 11 lines 7-20 and Column 12 lines 56- Column 13 line 7); b) storing the determined stimulation parameter values in a memory unit of the implantable medical device (e.g. Column 13 lines 24-29); c) checking an occurrence of an electrode failure of the electrode when operating the electrode in a bipolar manner (e.g. Column 12 line 56- Column 13 line 7); d) in case of the occurrence of an electrode failure, automatically switching from a bipolar operation of the electrode to a unipolar operation of the electrode and automatically applying the stored stimulation parameter values for a unipolar stimulation of the cardiac region (e.g. Column 12 line 56- Column 13 line 7).
Referring to Claim 13, Levine et al teaches computer program product a non-volatile memory having comprising computer-readable code stored thereon that causes a processor to perform the following steps when executed on the processor: a) determining appropriate stimulation parameter values of a stimulation pulse to be delivered to a cardiac region of a human or animal heart by a first electrode pole of an electrode of a stimulation unit of an implantable medical device in a unipolar manner (e.g. Column 11 lines 7-20 and Column 12 lines 56- Column 13 line 7); b) storing the determined stimulation parameter values in a memory unit of the implantable medical device (e.g. Column 13 lines 24-29); e) checking an occurrence of an electrode failure of the electrode when operating the electrode a bipolar manner (e.g. Column 12 line 56- Column 13 line 7); f) in case of the occurrence of an electrode failure, automatically switching from a bipolar operation of the electrode to a unipolar operation of the electrode and automatically applying the stored stimulation parameter values for a unipolar stimulation of the cardiac region (e.g. Column 12 line 56- Column 13 line 7).
Referring to Claim 14, Levine et al teaches method of treatment of a human or animal patient in need of such treatment with an implantable medical device for stimulating a human or animal heart, wherein the implantable medical device comprises a housing, a processor, a memory unit (e.g. Figure 1, device 10 with housing 40 and Figure 2 processor 60 and memory 94), a stimulation unit configured to stimulate a cardiac region of a human or animal heart, and a detection unit configured to detect an electrical signal at the cardiac region of the same heart, wherein the stimulation unit comprises an electrode having a first electrode pole and a second electrode pole (e.g. Figures 1 and 2 electrodes 21-38), the method comprising the following steps: a) determining appropriate stimulation parameter values of a stimulation pulse to be delivered to a cardiac region of a human or animal heart by the first electrode pole in a unipolar manner (e.g. Column 11 lines 7-20 and Column 12 lines 56- Column 13 line 7); b) storing the determined stimulation parameter values in the memory unit (e.g. Column 13 lines 24-29); c) checking an occurrence of an electrode failure of the electrode when operating the electrode in a bipolar manner (e.g. Column 12 line 56- Column 13 line 7); d) in case of the occurrence of an electrode failure, automatically switching from a bipolar operation of the electrode to a unipolar operation of the electrode and automatically applying the stored stimulation parameter values for a unipolar stimulation of the cardiac region (e.g. Column 12 line 56- Column 13 line 7); e) delivering a stimulation pulse to the cardiac region by the first electrode pole using the stored stimulation parameter values (e.g. Column 11 lines 4-10 and Column 13 lines 16-29 disclose switching the electrode configuration to a unipolar pacing configuration).
Referring to Claim 15, Levine et al teaches method according to claim 14, wherein prior to step d) additionally appropriate sensing parameter values for sensing an electrical signal at the cardiac region by the first electrode pole in a unipolar manner are determined and stored in the memory unit; in that in step d) the stored sensing parameter values for a unipolar sensing of the cardiac region are applied; in that after step d) an electrical signal is sensed at the cardiac region in a unipolar manner by the first electrode pole using the stored sensing parameter values (e.g. Column 12 lines 56- Column 13 line 7 and Column 13 lines 47-61).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William J Levicky/Primary Examiner, Art Unit 3796
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