DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/8/24 has been entered.
Response to Arguments
Applicant's arguments filed 11/8/24 have been fully considered and are mostly persuasive. However, regarding the energy harvesting MEMS as amended, this is shown in Regnier (Paragraph 52). See also Hastings (US 2006/0085041: Paragraph 161).
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1, 2, 4, 6, 10-11, 13-14, 16-17, 28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Regnier (US 2012/0330392).
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Regarding claims 1, 2, 4, 11, 14, Regnier discloses the same invention as claimed (Figures 2 and 6A shown above for example), including a multi-part pacemaker (abstract; Figures 1-3) comprising a power source and control circuitry (Figure 3; Paragraphs 51-52), wherein said circuitry includes MEMS configured to harvest energy from the heart (Paragraph 52), at least one first part and at least one second part (abstract; e.g. Figure 6A), said first part including an electrode that is implantable in a mammalian heart separate from said second part (e.g. Figure 6A: lower base 200; Paragraph 62: base with anchoring tine may comprise electrode), and coupled to one or more receivers which are configured to deliver electrical impulses to the heart to pace the myocardium (another one of the implantable units; pacing consecutively in a spiral direction from the apex toward the base of the heart is a method limitation which does not impart structural limitations on the device), said second part including a case and circuitry sealed within said case (e.g. Figure 6A: upper sealed case 100), wherein said second part is separately implantable to connect with said first part when said first part is implanted in said mammalian heart (Figure 6A; abstract; e.g. Paragraph 29: replacing battery).
Further regarding claim 4, Regnier discloses the first part includes both cathode and anode as recited (Paragraph 62).
Regarding claim 6, Regnier discloses threaded connections as recited (Figures 6A-B).
Regarding claim 10, Regnier discloses various apertures that may be interpreted as mounting eyes (Figures 4A, 7C).
Regarding claims 13, 16, Regnier discloses a mounting socket as recited (Figure 6A: 124; Paragraph 69).
Regarding claim 17, Regnier discloses wireless communication circuitry for one or more receivers as recited (Figures 1-3; Paragraphs 48-52).
Regarding claim 28, Regnier discloses the MEMS is within the case (Paragraph 52).
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) 7, 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Regnier (US 2012/0330392).
Regarding claim 7, Regnier discloses threaded connections as recited (Figures 6A-B). Regnier discloses sealing as recited (Paragraphs 58, 62). Regnier discloses a socket configuration where the first part comprises the socket. However, mere reversal of parts is held to be an obvious modification. See In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955) and MPEP 2144.04(VI)(A). Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Regnier to include the opposite socket configuration where the second part comprises the socket as recited, since mere reversal of parts is held to be an obvious modification.
Regarding claim 29, Regnier discloses a microchip controlling the device (Figure 3: 30). Regnier does not explicitly disclose two separate microchips as recited. However, mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) and MPEP 2144.04(VI)(B). There does not appear to be any significance between having one chip control two functions or two chips controlling two functions. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Regnier to include two separate microchips as recited, since such a modification would have amounted to merely duplicating another microchip to perform an existing function.
Claim(s) 18, 19, 21, 23, 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Regnier (US 2012/0330392) in view of Ewert (US 2014/0128932).
Regarding claims 18, 19, 21, 23, 25, Regnier discloses substantially the same invention, as described above. Regnier does not explicitly disclose pacing the myocardium consecutively, in a spiral direction, from the apex toward the base of the heart. However, Ewert teaches configuring a plurality of receivers to pace the myocardium consecutively, in a spiral direction, from the apex toward the base of the heart (Paragraphs 58, 62, 63), in order to produce an optimal heart contraction. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Regnier as taught by Ewert to include pacing in a spiral direction as recited, in order to produce an optimal heart contraction.
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Regnier (US 2012/0330392) in view of Hastings (US 2006/0085041).
Regarding claim 27, Regnier does not explicitly disclose harvesting kinematic energy. However, Hastings teaches miniature pacing seeds which include a MEMS energy harvesting circuit configured to harvest the kinematic energy of the heart and convert the energy to electrical energy (Paragraph 161), in order to sufficiently power the device and stimulate the heart. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Regnier as taught by Hastings to include harvesting kinematic energy as recited, in order to sufficiently power the device and stimulate the heart.
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, 4, 6, 7, 10-11, 13-14, 16-19, 21, 23, 25-29 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-6 of U.S. Patent No. 11103710. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the Patent anticipate the instant claims.
Allowable Subject Matter
Claim 26 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims and if a terminal disclaimer is filed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Greatbatch (US 4,157,720), Bilitch (US 4,256,115) show epicardial pacemakers.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eugene T Wu whose telephone number is (571)270-5053. The examiner can normally be reached M-F 8am-5pm.
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/Eugene T Wu/Primary Examiner, Art Unit 3792
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