DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Claims 11-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species B, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11 December 2025 of Species A, directed to Claims 1-10.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, and 7-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-17 of U.S. Patent No. 11,938,330. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to nearly identical leadless pacemakers, with the same elements and minor rewording of the claimed details.
Claim 1 of the instant application corresponds to and is fully encompassed by Claims 1, 12, and 14 of U.S. Patent No. 11,938,330.
Claim 2 of the instant application corresponds to and is fully encompassed by Claims 1, 4, 7, 12, 14, 16, and 17 of U.S. Patent No. 11,938,330.
Claim 7 of the instant application corresponds to and is fully encompassed by Claims 2 and 14 of U.S. Patent No. 11,938,330.
Claim 8 of the instant application corresponds to and is fully encompassed by Claims 2 and 14 of U.S. Patent No. 11,938,330.
Claim 9 of the instant application corresponds to and is fully encompassed by Claim 4 of U.S. Patent No. 11,938,330.
Claim 10 of the instant application corresponds to and is fully encompassed by Claims 7 and 16 of U.S. Patent No. 11,938,330.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-19 of U.S. Patent No. 11,759,646. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to nearly identical leadless pacemakers, wherein U.S. Patent No. 11,759,646 encompasses a method implementing the pacemaker system of the instant application, with the same elements and minor rewording of the claimed details.
Claim 1 of the instant application corresponds to and is fully encompassed by Claims 1, 2, and 10 of U.S. Patent No. 11,759,646.
Claim 2 of the instant application corresponds to and is fully encompassed by Claims 3, 8, 11, 15, 16, and 19 of U.S. Patent No. 11,759,646.
Claim 3 of the instant application corresponds to and is fully encompassed by Claims 8, 9, 15, and 16 of U.S. Patent No. 11,759,646.
Claim 4 of the instant application corresponds to and is fully encompassed by Claims 9 and 16 of U.S. Patent No. 11,759,646.
Claim 5 of the instant application corresponds to and is fully encompassed by Claim 17 of U.S. Patent No. 11,759,646.
Claim 6 of the instant application corresponds to and is fully encompassed by Claim 17 of U.S. Patent No. 11,759,646.
Claim 7 of the instant application corresponds to and is fully encompassed by Claim 17 of U.S. Patent No. 11,759,646.
Claim 8 of the instant application corresponds to and is fully encompassed by Claim 17 of U.S. Patent No. 11,759,646.
Claim 9 of the instant application corresponds to and is fully encompassed by Claims 1, 3, 4, 5, 8, 10, 11, 12, and 15 of U.S. Patent No. 11,759,646.
Claims 1, 2, 3, 6, 8, and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-13 of U.S. Patent No. 9,802,054. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to nearly identical leadless pacemakers, with the same elements and minor rewording of the claimed details.
Claim 1 of the instant application corresponds to and is fully encompassed by Claims 1, 6, and 10 of U.S. Patent No. 9,802,054.
Claim 2 of the instant application corresponds to and is fully encompassed by Claims 1, 6, 7, and 10 of U.S. Patent No. 9,802,054.
Claim 3 of the instant application corresponds to and is fully encompassed by Claims 6 and 9 of U.S. Patent No. 9,802,054.
Claims 6 and 8 of the instant application corresponds to and is fully encompassed by Claim 13 of U.S. Patent No. 9,802,054.
Claim 9 of the instant application corresponds to and is fully encompassed by Claims 1, 7, and 10 of U.S. Patent No. 9,802,054.
Claims 1-4 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-14 of U.S. Patent No. 10,744,332. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to nearly identical leadless pacemakers, wherein U.S. Patent No. 10,744,332 encompasses a method implementing the pacemaker system of the instant application, with the same elements and minor rewording of the claimed details.
Claim 1 of the instant application corresponds to and is fully encompassed by Claims 1, 11, and 12 of U.S. Patent No. 10,744,332.
Claim 2 of the instant application corresponds to and is fully encompassed by Claims 1, 11, and 13 of U.S. Patent No. 10,744,332.
Claim 3 of the instant application corresponds to and is fully encompassed by Claims 1, 6-10, and 13 of U.S. Patent No. 10,744,332.
Claim 4 of the instant application corresponds to and is fully encompassed by Claim 2 of U.S. Patent No. 10,744,332.
Claim 9 of the instant application corresponds to and is fully encompassed by Claim 11 of U.S. Patent No. 10,744,332.
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) in view of Olson et al. (US Publication No. 2006/0247688).
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 would be allowable if rewritten or if Terminal Disclaimers are filed to overcome the Double Patenting rejections set forth in this Office action above, and to include all of the limitations of the base claim and any intervening claims.
Conclusion
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 9:00am - 6:00pm EST.
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796