DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
This Office Action is responsive to the amendment filed on 30 April 2026. As directed by the amendment: No claims have been amended, added, or cancelled. Claims 11-21 were previously withdrawn due to a Restriction Requirement. Thus, Claims 1-10 are presently under consideration.
Terminal Disclaimer
The terminal disclaimers filed on 30 April 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent Nos. 11,938,330; 11,759,646; 9,802,054; and 10,744,332 have been reviewed and are accepted. The terminal disclaimers have been recorded.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1 and 7-10 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Greatbatch (US Patent No. 4,157,720, previously cited) in view of Olson et al. (US Publication No. 2006/0247688, previously cited).
Regarding Claims 1 and 9, Greatbatch discloses a leadless pacemaker (10, Figs. 1-5; Abstract), comprising:
a cell (battery cell, 34a,b, Fig. 3) having a negative terminal and a positive terminal (36a,b and 38a,b; Fig. 3; Col. 3, Lines 25-50);
a housing (housing 12/16/14; Figs. 1-4; 48a,b, Fig. 5) within which the cell is disposed and electrically coupled to the negative terminal of the cell (housing connected to negative terminals through connector 40, Fig. 3; Col. 3, Lines 41-55; Col. 3, Lines 55-60);
a tip electrode (20, Figs. 1-5) electrically isolated from the housing within which the cell is disposed (see insulator 26, 28, Figs. 1-5; Col. 3, Lines 1-16); and
pacing electronics (32, Fig. 3) configured to cause the housing within which the cell is disposed, which is electrically coupled to the negative terminal of the cell (housing connected to negative terminals through connector 40, Fig. 3; Col. 3, Lines 41-55; Col. 3, Lines 55-60), to serves as a positive electrode (housing is positive/indifferent, Col. 4, Lines 58-62; Col. 3, Lines 58-61) when a stimulation pulse is provided from the housing to the tip electrode through cardiac tissue (electrode 20 is negative electrode during stimulation pulse, Col. 4, Lines 50-65).
However, Greatbatch does not explicitly disclose wherein the pacing electronics include a capacitor configured to be selectively charged using the cell and selectively discharged into the housing within which the cell is disposed, and wherein the positive terminal of the cell is selectively electrically coupled to the pacing electronics.
Olson et al. teaches an implantable pacemaker (Abstract; Paragraph 0003) wherein the pacing electronics include a capacitor (capacitors 182, Fig. 20; capacitors 356, 358, 360, and 362, Fig. 21) configured to be selectively charged using the cell battery (battery 312, Fig. 21; Paragraph 0116) and selectively discharged into the housing within which the cell battery is disposed (capacitors selectively charged with battery, and discharged for pacing into housing/electrodes, Paragraph 0105, 0107, 0115-0119), wherein a positive terminal of the cell battery (battery 312, Fig. 21; Paragraph 0116) is selectively coupled to the pacing electronics (switching circuit connects/disconnects positive terminal of battery to pacing/charge circuits, Paragraph 0116-0117) with a switching circuit (314, Fig. 21; Paragraph 0116-0117).
It would have been obvious to one having ordinary skill in the art at the time of the invention to configure the circuitry in the pacemaker disclosed by Greatbatch to include a capacitor configured to be selectively charged using the cell and selectively discharged into the housing within which the cell is disposed, and switching circuitry to selectively couple a positive terminal of the cell to the pacing electronics, as taught by Olson et al., in order to provide the pacing pulses to the housing/electrode and to prevent inadvertent discharge of the battery/pacing pulses during non-pacing and/or charging time periods.
Regarding Claim 7, Greatbatch discloses a leadless pacemaker (10, Figs. 1-5; Abstract), further wherein the leadless pacemaker is devoid of an additional housing disposed around the housing within which the cell is disposed (integrated housing of the cell, Col. 4, Lines 20-45).
Regarding Claim 8, Greatbatch discloses a leadless pacemaker (10, Figs. 1-5; Abstract), further wherein the leadless pacemaker is devoid of an additional electrode disposed around the housing within which the cell is disposed (no additional ring electrodes, Col. 4, Lines 50-65; Col. 3, Lines 55-61).
Regarding Claim 10, Greatbatch discloses a leadless pacemaker (10, Figs. 1-5; Abstract), further wherein an anode (negative terminal/anode, 36a,b and 38a,b; Fig. 3; Col. 3, Lines 25-50) of the cell is arranged along an inside wall of, and electrically coupled to, the housing within which the cell is disposed (housing 12/16/14; Figs. 1-4; 48a,b, Fig. 5).
Allowable Subject Matter
Dependent Claims 2-6 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
The previous Double Patenting rejections have been withdrawn due to the terminal disclaimers filed on 30 April 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent Nos. 11,938,330; 11,759,646; 9,802,054; and 10,744,332.
The Applicant has requested rejoinder of previously withdrawn Claims 11-21. The Examiner will consider the possibility of rejoinder when allowable subject matter has been indicated, and if all of the allowable subject matter is incorporated into the withdrawn claims.
The Applicant's arguments filed in the Response filed 30 April 2026 with respect to the previous 35 U.S.C. 103(a) rejections of Claims 1 and 7-10 have been fully considered but they are not persuasive.
The Applicant specifically argues (Pages 10-11 of Remarks):
Accordingly, Greatbatch does not disclose "a housing within which the cell is disposed and electrically coupled to the negative terminal of the cell." Rather, in Greatbatch it is the output of the pulse generator 32 that is electrically coupled to the housing 10 by the lead 40….. Continuing with this line-of reasoning, the positive terminals 36a, 36b of the battery cells 34a, 34b and the negative terminals 38a, 38b of the battery cells 34a, 34b would all be electrically coupled to the housing. This would not be possible because if the negative terminals 38a, 38a of the battery cells 34a, 34b and the positive terminals 36a, 36b of the battery cells 34a, 34b were all connected to the housing 10 they would be shorted to one another and the cardiac pacemaker 10 of Greatbatch would not work for its intended purpose. A modification to a prior art invention is improper if it renders the device of the prior art inoperable or destroys its intended purpose. See In re Gordon, 733 F.2d 900 (Fed. Cir. 1984)….
As noted above, claims 1 requires "a housing within which the cell is disposed and electrically coupled to the negative terminal of the cell." Because the housing is electrically coupled to the negative terminal of the cell, one of ordinary skill in the art would think that the cell housing would serve as a negative electrode when a stimulation pulse is provided from the cell housing to the tip electrode through cardiac tissue. However, that is not the case..
However, the Examiner disagrees with these arguments. Greatbatch discloses a leadless pacemaker (10, Figs. 1-5; Abstract), comprising a housing (housing 12/16/14; Figs. 1-4; 48a,b, Fig. 5) within which the cell is disposed and electrically coupled to the negative terminal of the cell (housing connected to negative terminals through connector 40, Fig. 3; Col. 3, Lines 41-55; Col. 3, Lines 55-60); and pacing electronics (32, Fig. 3) configured to cause the housing within which the cell is disposed, which is electrically coupled to the negative terminal of the cell (housing connected to negative terminals through connector 40, Fig. 3; Col. 3, Lines 41-55; Col. 3, Lines 55-60), to serves as a positive electrode (housing is positive/indifferent, Col. 4, Lines 58-62; Col. 3, Lines 58-61).
In particular, Greatbatch specifically discloses (Col. 4, Lines 52-61), "electrode 20, which is the negative electrode of the pacemaker, is connected into the heart tissue of the patient, and the portion of the housing 10 including the insulating layer 28 is adjacent or in contact with the heart tissue. The remaining portion of the housing, in particular surface 14, will contact neighboring tissue and serves as the indifferent or positive electrode." Therefore, the Examiner maintains that Greatbatch explicitly discloses “a housing within which the cell is disposed and electrically coupled to the negative terminal of the cell” and “selectively discharged into the housing within which the cell is disposed, which is electrically coupled to the negative terminal of the cell, to thereby cause the housing to serve as a positive electrode” as recited in Claim 1.
Figs. 3-5 of Greatbatch have been reproduced below showing the connections/housing.
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In response to the Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (e.g., explicit direct electrical connections of the housing portions/cell/terminal structures, see Page 12 of Remarks) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The Applicant further argues (Pages 13-14 of Remarks):
Applicant has reviewed the entirety of Olson, including the paragraphs [0105], [0107], and [0115]-[0119], which were cited to in the Office Action, and none of these portions of Olson teach or suggest these specific features of independent claim 1. Further, even assuming for argument's sake that a negative terminal of a cell within in the housing of the SubQ ICD of Olsons was coupled to the housing of the SubQ ICD, Olson never teaches or suggests that the housing [which is electrically coupled to the negative terminal of the cell] serves as a positive electrode when a stimulation pulse is provided from the housing to the tip electrode through cardiac tissue, as specified by independent claim 1.
However, the Examiner disagrees with these arguments. It is noted that Olson et al. was only used to teach wherein the pacing electronics include a capacitor configured to be selectively charged using the cell and selectively discharged into the housing within which the cell is disposed, and wherein the positive terminal of the cell is selectively electrically coupled to the pacing electronics.
As described above, Olson et al. teaches an implantable pacemaker (Abstract; Paragraph 0003) wherein the pacing electronics include a capacitor (capacitors 182, Fig. 20; capacitors 356, 358, 360, and 362, Fig. 21) configured to be selectively charged using the cell battery (battery 312, Fig. 21; Paragraph 0116) and selectively discharged into the housing within which the cell battery is disposed (capacitors selectively charged with battery, and discharged for pacing into housing/electrodes, Paragraph 0105, 0107, 0115-0119), wherein a positive terminal of the cell battery (battery 312, Fig. 21; Paragraph 0116) is selectively coupled to the pacing electronics (switching circuit connects/disconnects positive terminal of battery to pacing/charge circuits, Paragraph 0116-0117) with a switching circuit (314, Fig. 21; Paragraph 0116-0117).
In particular, Olson et al. discloses (Paragraph 0116):
The negative terminal of high voltage battery 312 is directly coupled to system ground. Switch circuit 314 is normally open so that the positive terminal of high voltage battery 312 is disconnected from the positive power input of the high voltage charge circuit 364. The high voltage charge command HVCHG is also conducted via conductor 349 to the control input of switch circuit 314, and switch circuit 314 closes in response to connect positive high voltage battery voltage EXT B+ to the positive power input of high voltage charge circuit 364.
Olson et al. also discloses (Paragraph 0106, referencing Fig. 21):
…cardioversion-defibrillation shocks typically employing an ICD IPG housing electrode coupled to the COMMON output 332 of high voltage output circuit 340 and one or two cardioversion-defibrillation electrodes disposed in a heart chamber or cardiac vessel coupled to the HVI and HV-2 outputs (313 and 323, respectively) of the high voltage output circuit 340.
Therefore, the Examiner maintains that Olson et al. teaches wherein the pacing electronics include a capacitor configured to be selectively charged using the cell and selectively discharged into the housing within which the cell is disposed, and wherein the positive terminal of the cell is selectively electrically coupled to the pacing electronics. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to configure the circuitry in the pacemaker disclosed by Greatbatch to include a capacitor configured to be selectively charged using the cell and selectively discharged into the housing within which the cell is disposed, and switching circuitry to selectively couple a positive terminal of the cell to the pacing electronics, as taught by Olson et al., in order to provide the pacing pulses to the housing/electrode and to prevent inadvertent discharge of the battery/pacing pulses during non-pacing and/or charging time periods. Therefore, the Examiner maintains that Greatbatch and Olson et al. teach all of the claimed elements of Claim 1.
Therefore, Claims 1 and 7-10 remain rejected as described in detail above. Dependent Claims 2-6 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to the Applicant's disclosure:
Drasler et al. (US Publication No. 2007/0135883) discloses a leadless cardiac pacemaker (Abstract, 120, Fig. 1,3), comprising pacing electronics (Paragraph 0037, 0039-0040), a cell housing (128, 121, Fig. 5-6); an energy source (122, Fig. 3, Paragraph 0039-0040) disposed in the cell housing, a negative terminal of the energy source being electrically connected to the cell housing (122, Fig. 3, 128, 121, Fig. 5-6, Paragraph 0039-0043), wherein during a first time period (switch 124 in position 1, Paragraph 0039-0041): the pacing electronics are powered, and the energy source charges at least a first capacitor (125, Fig. 3, Paragraph 0039-0040); and wherein during a second time period the first capacitor is disconnected from the energy source (switch 124 in position 3, Paragraph 0041-0044) and is connected to the cell housing (tip electrode 129 within cell housing, Fig. 5).
Yonezawa et al. (US Publication No. 2012/0116483) discloses a stimulation system (Abstract) wherein during a charging phase, the stimulation electronics are powered by an energy source (DS1, DS2, Figs. 1-3, switches SW1-4 connect and disconnect the energy source, capacitor, electrodes, and remaining electronics, Paragraph 0046, 0048, 0053-0054), and during a stimulation phase, a capacitor (C, Fig. 1-3) is disconnected from the energy source (DS1, DS2, Figs. 1-3, Paragraphs 0048- 0050), and the stimulation electronics (remaining electronics 100, Figs. 1-3) are electrically disconnected from the energy source (Paragraphs 0048-0050, 0056), and the pacing electronics are powered by the first capacitor (switches SW1-3 connect and disconnect the remaining electronics 100 during charging/stimulation phases, Paragraph 0045, 0053-0058).
Ganion et al. (US Publication No. 2005/0075677) discloses a pacemaker system (Abstract) comprising first and second capacitors (Paragraph 0007, 0011,0045-0046, 0055, 0059, 0062, Claim 17, 19), and electrodes comprising housing electrodes (32, 36, 40, 48, Figs. 2-3, Paragraph 0036-0037), wherein during a first period of time, an energy source charges the second capacitor (Paragraph 0007, 0011,0045-0046, 0055, 0059, 0062, Claim 17, 19), and during a second period of time, the energy source is disconnected from the first and second capacitors, and the second capacitor is
discharged into the electrodes (Paragraph 0007, 0011,0045-0046, 0055, 0059, 0062,
Claim 17, 19) including housing electrodes (32, 36, 40, 48, Figs. 2-3, Paragraph 0036-
0037), and the first capacitor is not discharged into the electrodes (Paragraph 0007,
0011,0045-0046, 0055, 0059, 0062, Claim 17, 19).
THIS ACTION IS MADE FINAL. 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 PAMELA M BAYS whose telephone number is (571)270-7852. The examiner can normally be reached 10:00am - 6:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796
