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 .
Election/Restrictions
Applicant’s election without traverse of Species B in the reply filed on 1/5/2026 is acknowledged. Claims 29 and 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/23/2023 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: the first paragraph should reference every parent application found in the ADS filed on 10/24/2023, as well as the current status of each application.
Appropriate correction is required.
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.
Claims 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Owen et al. (US 2003/0055460, hereinafter Owen).
Regarding claims 19 and 20, Owen discloses a wearable cardioverter defibrillator (WCD) system for an ambulatory patient, the WCD having a first defibrillation electrode and a second defibrillation electrode (par. 0030) with a support structure configured to be worn by an ambulatory patient so as to maintain the first and the second defibrillation electrodes on a body of the ambulatory patient (par. 0069). Owen discloses a housing 40 having a first defibrillation node and a second defibrillation node, in which the first defibrillation electrode and the second defibrillation electrode are configured to be coupled to the housing so as to make electrical contact with the first defibrillation node and the second defibrillation node (par. 0067, 0068, 0118 and Fig 2). The WCD includes a charge storage device (i.e., capacitors 69) within the housing and configured to store charge amounting to at least 50 Joule of energy, the charge storage device having a first terminal and a second terminal (par. 0119 and claim 31). Owen discloses a diverting resistor coupled “between” the first and the second terminals of the charge storage device (par. 0139 and 0074 and figures 14A and 14B that shows resistors in parallel to and between the terminals of capacitors). Owen discloses a discharge circuit within the housing and including a high-voltage switch coupled between the first terminal of the charge storage device and the first defibrillation node, the high- voltage switch configured to switch on and to switch off so as to respectively couple and uncouple the first terminal and the first defibrillation node (see claims 3 and 4, par. 0134 and 0140 and figures 14A-14C).
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 21-28 are rejected under 35 U.S.C. 103 as being unpatentable over Owen in view of Badelt et al. (US 2011/0245888, hereinafter Badelt)
Regarding claims 21 and 23-24, Owen discloses the claimed invention except for a detector configured to detect a current leaked through the diverting resistance, and to output a detection signal responsive to the detected leaked current. Badelt also discloses a defibrillator and thus is analogous art with Owen. Badelt teaches that it is known to use a detector configured to detect a current leaked through the diverting resistance, and to output a detection signal responsive to the detected leaked current [see par. 0075 and 0077 (i.e., current sensor circuit 431 includes a resistive load provided in series with a positive or negative node of the switch network, which forms a current sensing resistor and also includes an amplifier 434, such that a comparator is equivalent to a very high gain amplifier with balanced inputs. A relatively low voltage potential/drop is formed across the resistive load 432 when leakage current flows in line 429) and par. 0017 (e.g. vibratory warning signal and audible warning signal upon detecting that the leakage measurement exceeds the leakage threshold to determine if there is excess leakage that could prove dangerous to the patient)]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Owen with a detector configured to detect a current leaked through the diverting resistance, and to output a detection signal responsive to the detected leaked current, as taught by Badelt, since such a modification would provide the predictable results of determining if there is excess leakage that could prove dangerous to the patient.
Regarding claim 22, Owen discloses in which the diverting resistance includes a resistor (par. 0139).
Regarding claim 25, Owen discloses the claimed invention except for in which the detector further includes an analog-to-digital converter. Badelt teaches that it is known to use a detector that includes an analog-to-digital converter as set forth in Fig. 5 and par. 0083 (e.g. sensing circuitry 534 includes an A/D converter) and [0079] (e.g. circuit indicates an alternative embodiment of leakage detection system 500) to produce a digital signal for later processing). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system as taught by Owen such that the detector further includes an analog-to-digital converter as taught by Badelt, since such a modification would provide the predictable results of producing a digital signal for later processing.
Regarding claim 26, Owen discloses the claimed invention except for a memory; and a processor coupled to the detector and configured to record in the memory an event responsive to the detection signal. Badelt teaches that it is known to use a memory; and a processor coupled to the detector and configured to record in the memory an event responsive to the detection signal as set forth in par. 0041 (e.g. device includes a microcontroller with a microprocessor and RAM or ROM memory) and [0096] (e.g. the device logs into memory any leakage measurements and the state of various components within the device) to log the leakage and determine if remedial action in warranted). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system as taught by Owen with a memory and a processor coupled to the detector and configured to record in the memory an event responsive to the detection signal as taught by Badelt, since such a modification would provide the predictable results of logging the leakage for review and determining if remedial action is warranted.
Regarding claim 27, Owen discloses the claimed invention except for a user interface configured to emit a human-perceptible indication responsive to the detection signal. Badelt teaches that it is known to use a user interface configured to emit a human-perceptible indication responsive to the detection signal as set forth in par. 0017 (e.g. the controller is configured to issue at least one of a vibratory warning signal and an audible warning signal upon detecting that the leakage measurement exceeds the leakage threshold) so that a patient or operator may be alerted to a condition requiring medical attention). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system as taught by Owen with a user interface configured to emit a human-perceptible indication responsive to the detection signal as taught by Badelt, since such a modification would provide the predictable results of alerting a patient or operator to a condition requiring medical attention.
Regarding claim 28, Owen discloses a communication module configured to transmit a message responsive to the detection signal (par. 0121 and 0156)
Claims 31, 32, 34 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Owen in view of Lopin et al. (US 6,096,063, hereinafter Lopin).
Regarding claim 31, Owen discloses the claimed invention except for the discharge circuit includes an H-bridge circuit coupled between the first terminal and the second terminal of the charge storage device, the H-bridge circuit including the high-voltage switch and an H-bridge switch that is joined with the high-voltage switch at an intermediate node, and the diverting resistance is coupled between the second terminal of the charge storage device and the intermediate node. Lopin also discloses a defibrillator and thus is analogous art with Owen. Lopin teaches that it is known to use a discharge circuit that includes an H-bridge circuit coupled between the first terminal and the second terminal of the charge storage device, the H-bridge circuit including the high-voltage switch and an H-bridge switch that is joined with the high-voltage switch at an intermediate node, and the diverting resistance is coupled between the second terminal of the charge storage device and the intermediate node as set forth in Fig 2 (e.g. intermediate node at bottom of H-bridge 48) to produce a biphasic waveform and allow the electric current to pass through the patient's body in one direction, then the opposite direction while isolating patient from leakage current (Col. 4, lines 23-65). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system as taught by Owen, with in which the discharge circuit includes an H-bridge circuit coupled between the first terminal and the second terminal of the charge storage device, the H-bridge circuit including the high-voltage switch and an H-bridge switch that is joined with the high-voltage switch at an intermediate node, and the diverting resistance is coupled between the second terminal of the charge storage device and the intermediate node as taught by Lopin, since such a modification would provide the predictable results of producing a biphasic waveform and allowing the electric current to pass through the patient's body in one direction, then the opposite direction while isolating patient from leakage current.
Regarding claims 32 and 35, Owen discloses the claimed invention except for a main switch coupled between the first terminal and the H-bridge circuit. Lopin teaches that it is known to use a main switch coupled between the first terminal and the H-bridge circuit as set forth in Fig. 2 (e.g. relay switch 17) to allow current to pass through to the patient. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system as taught by Owen, with a main switch coupled between the first terminal and the H-bridge circuit as taught by Lopin, since such a modification would provide the predictable results of allowing current to pass through to the patient.
Regarding claim 34, Owen discloses the claimed invention except for in which the intermediate node coincides with the first defibrillation node. Lopin teaches that it is known to use in which the intermediate node coincides with the first defibrillation node as set forth in Fig. 2 (e.g. electrodes 21 or 23, each connected to nodes within H-bridge circuit 48, based on whether switches are opened or not) to protect the patient from leakage currents. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system as taught by Owen, with in which the intermediate node coincides with the first defibrillation node as taught by Lopin, since such a modification would provide the predictable results of protecting the patient from leakage currents.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Owen and Lopin, as applied above, and further in view of Badelt.
Regarding claim 33, the modified Owen discloses the claimed invention except for a detector configured to detect a current leaked through the diverting resistance, and to output a detection signal responsive to the detected leaked current. Badelt teaches that it is known to use a detector configured to detect a current leaked through the diverting resistance, and to output a detection signal responsive to the detected leaked current as set forth in par. 0075 and 0017 to determine if the leakage measurement satisfies the leakage threshold. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system as taught by the modified Owen, with a detector configured to detect a current leaked through the diverting resistance, and to output a detection signal responsive to the detected leaked current as taught by Badelt, since such a modification would provide the predictable results of determining if the leakage measurement satisfies the leakage threshold to ensure the safety of the patient.
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 19-28 and 31-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,260,237. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the current claims as they include all the limitations of the current claims, as well as additional claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric D Bertram whose telephone number is (571)272-3446. The examiner can normally be reached Monday-Friday 8am-6pm Central Time.
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/Eric D. Bertram/Primary Examiner, Art Unit 3796