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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/11/2025 has been entered. Claims 1-6, 12, 14-22,24-27, 34 and 37 are currently pending and under examination.
Claim Rejections - 35 USC § 112
In view of the amendment filed on 9/11/2025 clarifying the language of claim 6 the 112 rejections made against claim 6 in the office action of 9/11/2025 have been withdrawn.
Claim Rejections - 35 USC § 102
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) 15-18, 20, 24-26, 34 and 37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 5,755,742 to Schuelke et al. (Schuelke) (previously cited)
In reference to at least claim 24
Schuelke discloses an implantable cardiac device (e.g. pacemaker/cardioverter/defibrillator (PCD) 100, Fig. 1) comprising: a first defibrillation lead configured to be positioned at least in part inside the heart (e.g. a pair of defibrillation leads, Fig. 1, abstract Col. 2, ll. 43-60, Col. 4, l. 66 – Col. 5, l.28, Col. 15, l. 59 – Col. 16, l. 4); a second separate non-defibrillation lead configured to be positioned at least in part inside the heart at a different location than said first defibrillation lead (e.g. one or more pacing leads, Fig. 1, abstract, Col. 2, ll. 32-48, Col. 15, l. 59 – Col. 16, l. 4); circuitry for controlling said leads and for measuring impedance (e.g. circuitry, Figs. 2-5), said circuitry configured to apply a test pulse to measure impedance between said first defibrillation lead and said second non-defibrillation lead (e.g. measure lead selected and an impedance value is derived, abstract, Col. 13, l. 66 – Col. 15, l. 8) and to determine a condition of at least one of said defibrillation lead and said non-defibrillation lead according to the measured impedance value (e.g. measure lead selected and an impedance value is derived, abstract, Col. 13, l. 66 – Col. 15, l. 8; comparison of measured impedances to determine lead integrity, abstract, Col. 5, ll. 29-37, Col. 14, l. 56 – Col. 15, l. 25, co.. 21, ll. 1-18), wherein the circuitry is configured to assess a condition of said first and said second leads, when said leads are positioned in a same chamber of the heart (e.g. “ventricular lead 116 includes ventricular ring (VRING) and distal tip (VTIP) electrodes 124 and 126 and associated lead conductors coupled to terminals 164 and 166.”, therefore the leads may be within a same chamber, Col. 17, ll. 39-44), wherein the circuitry is configured to assess a condition of said first and said second leads, when said leads are positioned in a same single chamber of the heart (e.g. “The "lead impedance" of such a defibrillation lead is also defined as including the impedance of these components of the defibrillation lead as well as any impedance of the connection of the connector element with the IPG terminal. These definitions encompass any combination of two or more pacing leads or defibrillation leads incorporated into the same lead body and any combinations of pacing lead(s) and defibrillation lead(s) in the same lead body.”, Col. 2, ll. 48-55; “In order to derive the impedance of the second defibrillation lead, the steps are repeated with substitution of the second defibrillation lead for the first defibrillation lead. Additional defibrillation lead impedances may be derived in the same manner by use of any combination of the defibrillation lead under test and two other pacing or defibrillation leads.”, Col. 5, ll. 22-28; “Moreover, any combination of three pacing and defibrillation leads may be used in the derivation of the lead impedance of each lead under test by appropriate substitutions of the remaining two leads in the successive injections of first and second impedance test pulses and measurements of the injected currents and induced voltages.”, Col. 23, ll. 57-63; therefore the circuitry is “configured to” asses a condition when leads are positioned in a same single chamber of the heart such as a ventricular chamber). It is further noted that each lead has at least a portion that is positioned within the right artium (e.g. each lead has at least a portion positioned in the right artium, Fig. 1)
In reference to at least claim 15
Schuelke discloses first defibrillation lead including includes a coil, a ring electrode and a tip electrode (e.g. leads include a coil, ring and a tip electrode, Figs. 1-5, 7, abstract, Col. 2, ll. 32-48, Col. 15, l. 59 – Col. 16, l. 4), the second non-defibrillation lead including includes a ring electrode and a tip electrode (e.g. a pair of defibrillation leads, abstract, Col. 2, ll. 43-60, Col. 4, l. 66 – Col. 5, l.28, Col. 15, l. 59 – Col. 16, l. 4; leads include a coil, ring and a tip electrode, Figs. 1-5), the circuitry is configured for controlling and activating said coil and electrodes, said circuitry including at least one grounded resistor electrically connected to said second non- defibrillation lead (e.g. various resistors used to measure impedance, Figs. 1-5,7; measure lead selected and an impedance value is derived, abstract, Col. 13, l. 66 – Col. 15, l. 8); said circuitry configured to measure current across said grounded resistor in response to an applied test pulse to obtain an indication of a condition of at least said first defibrillation lead or a portion thereof (e.g. various resistors used to measure impedance, Figs. 1-5,7; measure lead selected and an impedance value is derived using resistors in which the lead under test is held at system ground, abstract and/or any of Col. 13, l. 66 – Col. 15, l. 8, Col. 15 l. 59 – Col. 16, l. 23, col. 18, ll. 34-55, Col. 19, ll. 36-42).
In reference to at least claim 16
Schuelke discloses wherein said circuitry is at least partially disposed within a housing of said cardiac device, said leads extending from within said housing (e.g. circuitry within housing, Figs. 2-5).
In reference to at least claim 17
Schuelke discloses wherein said current measured across said grounded resistor in response to an applied test pulse is used for calculating impedance between said coil and said device housing (e.g. various resistors are used to measure impedance, Figs. 1-5,7; measure lead selected and an impedance value is derived including using the can, abstract and/or any of Col. 13, l. 66 – Col. 15, l. 8, Col. 15 l. 59 – Col. 16, l. 23, Col. 18, ll. 34-65, Col. 19, ll. 31-42).
In reference to at least claim 18
Schuelke discloses wherein said circuitry is configured to calculate said impedance between said coil and device housing using a pre-determined linearizing factor (e.g. various resistors used to measure impedance, Figs. 1-5,7; measure lead selected and an impedance value is derived including using the can, abstract and/or any of Col. 13, l. 66 – Col. 15, l. 8, Col. 15 l. 59 – Col. 16, l. 23, col. 18, ll. 34-65, Col. 19, ll. 20-42).
In reference to at least claim 20
Schuelke discloses wherein said non- defibrillation lead comprises a cardiac contractility modulation lead (e.g. one or more pacing leads, abstract, Col. 2, ll. 32-48, Col. 15, l. 59 – Col. 16, l. 4) and said circuitry is programmed for timing said measurement of current on said grounded resistor during applying of a cardiac contractility modulation signal (e.g. known to perform during delivery of a pacing pulse, Col. 3, ll. 22-35).
In reference to at least claim 25
Schuelke discloses wherein said second non- defibrillation lead is configured for applying cardiac contractility modulation stimulation (e.g. one or more pacing leads, abstract and/or any of Col. 2, ll. 32-48, Col. 15, l. 59 – Col. 16, l. 4).
In reference to at least claim 26
Schuelke discloses wherein said circuitry is configured to time said test pulse during applying of the cardiac contractility modulation stimulation via said second non-defibrillation lead (e.g. known to perform during delivery of a pacing pulse, Col. 3, ll. 22-35).
In reference to at least claim 34
Schuelke discloses wherein said non- defibrillation lead comprises a cardiac contractility modulation lead or a pacing lead (e.g. one or more pacing leads, abstract, Col. 2, ll. 32-48, Col. 15, l. 59 – Col. 16, l. 4).
In reference to at least claim 37
Schuelke discloses wherein said circuitry is configured to control said first and said second leads using logic suitable for said leads being in a right ventricle of said heart (e.g. “The "lead impedance" of such a defibrillation lead is also defined as including the impedance of these components of the defibrillation lead as well as any impedance of the connection of the connector element with the IPG terminal. These definitions encompass any combination of two or more pacing leads or defibrillation leads incorporated into the same lead body and any combinations of pacing lead(s) and defibrillation lead(s) in the same lead body.”, the lead impedance encompasses any combination of two or more pacing leads or defibrillation lead even those incorporated into the same lead body therefore the circuitry is configured to asses a condition when leads are positioned in a right ventricle, Col. 2, ll. 48-55). Schuelke further discloses a lead with RV pace/sense electrodes 124 and 126 and a lead with RV coil electrode 122 which are positioned within the right ventricle (e.g. Figs. 5,7, Col. 7, ll. 33-40,Col. 9, ll. 30-32).
Claim(s) 16, 24-26 and 34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2014/0135860 to Pei (Pei) (previously cited).
In reference to at least claim 24
Pei discloses an implantable cardiac device (e.g. cardiac rhythm management device (CRMD) 10, Figs. 1,4,6) comprising: a first defibrillation lead configured to be positioned at least in part inside the heart (e.g. lead with defibrillation electrodes, para. [0033], [0035], [0046]); a separate second non-defibrillation lead configured to be positioned at least in part inside the heart at a different location than said first defibrillation electrode (e.g. lead with pacing electrodes, para. [0033], [0035], [0046]); circuitry for controlling said leads and for measuring impedance (e.g. circuitry, Fig. 7, para. [0035]-[0046]), said circuitry configured to apply a test pulse to measure impedance between said first defibrillation lead and said second non-defibrillation lead (e.g. “measure an impedance value along cross-lead, “In one example, values representative of impedance are measured along various single-lead vectors (i.e. intra-lead vectors) between pairs of electrodes of each individual lead, such as between the tip and ring electrodes of the RV lead and between the tip and ring electrodes of the RA lead. Values representative of impedance are also measured along various cross-lead vectors (i.e. inter-lead vectors) between electrodes of different leads, such as between the tip of the RV lead and the ring of the RA”, any of para. [0003] [0016], [0019]-[0020], [0023], [0027]) and to determine a condition of at least one of said defibrillation lead and said non-defibrillation lead according to the measured impedance value (e.g. comparison of measured impedances to determine lead integrity, para. [0030], [0047]); wherein the circuitry is configured to assess a condition of said first and said second leads, when said leads are positioned in a single same chamber of the heart (e.g. “e.g. measure an impedance value along cross-lead, “Values representative of impedance are also measured along various cross-lead vectors (i.e. inter-lead vectors) between electrodes of different leads, such as between the tip of the RV lead and the ring of the RA”, para. [0003], “The impedance measuring circuit 412 is advantageously coupled to the switch 474 so that any desired electrode or combination of electrodes may be used. “, para. [0045], “A cross-lead impedance measurement system 405 is operative to measure or input signals representative of impedance along cross-lead (inter-lead) vectors between electrodes of different leads”, para. [0047], Pei discloses inter-lead impedance measurements and that any desired electrode or combination electrode may be used by the impedance measuring circuit, therefore the circuitry is “configured to assess a condition of said first and said second leads, when said leads are positioned in a single same chamber of the heart”).
In reference to at least claim 16
Pei discloses wherein said circuitry is at least partially disposed within a housing of said cardiac device, said leads extending from within said housing (e.g. circuitry within housing 10, Figs. 1,4,6-7).
In reference to at least claim 25
Pei discloses wherein said second non- defibrillation lead is configured for applying cardiac contractility modulation stimulation (e.g. lead with pacing electrodes, para. [0033], [0035], [0046]).
In reference to at least claim 26
Pei discloses wherein said circuitry is configured to time said test pulse during applying of the cardiac contractility modulation stimulation via said second non-defibrillation lead ((e.g. “measure an impedance value along cross-lead, “In one example, values representative of impedance are measured along various single-lead vectors (i.e. intra-lead vectors) between pairs of electrodes of each individual lead, such as between the tip and ring electrodes of the RV lead and between the tip and ring electrodes of the RA lead. Values representative of impedance are also measured along various cross-lead vectors (i.e. inter-lead vectors) between electrodes of different leads, such as between the tip of the RV lead and the ring of the RA”, any of para. [0003] [0016], [0019]-[0020], [0023], [0027]; measured around the same time of day, [0029])
In reference to at least claim 34
Pei discloses wherein said non- defibrillation lead comprises a cardiac contractility modulation lead or a pacing lead (e.g. lead with pacing electrodes, para. [0033], [0035], [0046]).
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) 1-6,12,14,21-22 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0135860 to Pei (Pei) in view of US 2011/0054554 to Swerdlow (Swerdlow) (previously cited).
In reference to at least claim 1
Pei discloses a method of testing a lead condition in an implanted cardiac device (e.g. cardiac rhythm management device (CRMD) 10, Figs. 1,4,6) comprising a first defibrillation lead (e.g. lead with defibrillation electrodes, para. [0033], [0035], [0046]); a second non-defibrillation lead (e.g. lead with pacing electrodes, para. [0033], [0035], [0046]); the method comprising: measuring impedance between said first defibrillation lead and said second non- defibrillation lead by applying a test pulse (e.g. measure an impedance value along cross-lead, any of para. [0003] [0016], [0019]-[0020], [0023], [0027]); and determining a condition of at least one of said defibrillation lead and said non- defibrillation lead according to the measured impedance value (e.g. comparison of measured impedances to determine lead integrity, para. [0030], [0047]) said first defibrillation lead and said second non-defibrillation lead are separate and positioned in a same single chamber of the heart (e.g. “e.g. measure an impedance value along cross-lead, “Values representative of impedance are also measured along various cross-lead vectors (i.e. inter-lead vectors) between electrodes of different leads, such as between the tip of the RV lead and the ring of the RA”, para. [0003], “The impedance measuring circuit 412 is advantageously coupled to the switch 474 so that any desired electrode or combination of electrodes may be used. “, para. [0045], “A cross-lead impedance measurement system 405 is operative to measure or input signals representative of impedance along cross-lead (inter-lead) vectors between electrodes of different leads”, para. [0047], Pei discloses inter-lead impedance measurements and that any desired electrode or combination electrode may be used by the impedance measuring circuit, therefore the measuring of the impedance may be between separate leads positioned in a same single chamber of the heart.). However, Pei does not teach wherein a timing of said applying is during a ventricle refractory period.
Swerdlow teaches a method and apparatus for detection of lead conductor anomalies using dynamic electrical parameters which discloses delivering a test pulse to the lead and measuring an impedance to determine anomalies (e.g. abstract, para. [0005]-[0008], [0021]-[0022], [0042]). Swerdlow discloses applying the test pulse during an absolute refractory period with a low amplitude so the risk of capturing the heart is minimal (e.g. para. [0048]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Pei to include applying the test pulse during a ventricle refractory period, as taught by Swerdlow, to minimize the risk of capturing the heart.
In reference to at least claim 2
Pei modified by Swerdlow renders obvious a method according to claim 1. Swerdlow further discloses wherein a timing of said applying of said test pulse is selected so as not to stimulate contraction (e.g. applying the test pulse during an absolute refractory period with a low amplitude so the risk of capturing the heart is minimal, para. [0048]).
In reference to at least claim 3
Pei modified by Swerdlow renders obvious a method according to claim 1. Swerdlow further discloses wherein a duration of said test pulse is short enough so as to avoid or reduce pain caused by said test pulse to a patient in which said cardiac device is implanted (e.g. applying the test pulse during an absolute refractory period with a short duration and a low amplitude so the risk of capturing the heart is minimal, para. [0048]).
In reference to at least claim 4
Pei modified by Swerdlow renders obvious a method according to claim 1. Pei further discloses wherein said second non-defibrillation lead is configured for applying cardiac contractility modulation stimulation (e.g. lead with pacing electrodes, para. [0033], [0035], [0046]).
In reference to at least claim 5
Pei modified by Swerdlow renders obvious a method according to claim 1. Pei further discloses wherein said applying a test pulse is during applying of the cardiac contractility modulation stimulation (e.g. measure lead selected and an impedance value along cross-lead, any of para. [0003]-[0004], [0016], [0019]-[0020], [0023], [0027],; measured around the same time of day, [0029]).
In reference to at least claim 6
Pei modified by Swerdlow renders obvious a method according to claim 1. Swerdlow further discloses applying a test pulse before or after applying of the cardiac contractility modulation stimulation (e.g. during an absolute refractory period after applying stimulation with a low amplitude so the risk of capturing the heart is minimal, para. [0048]).
In reference to at least claim 12
Pei modified by Swerdlow renders obvious a method according to claim 1. Pei further discloses wherein at least a portion of said first lead and at least a portion of said second lead is implanted in contact with a wall of the right ventricle of the heart (e.g. right ventricle leads, abstract, any of para. [0003], [0033], [0036], [0038], [0040], [0042]).
In reference to at least claim 14
Pei modified by Swerdlow renders obvious a method according to claim 1. Pei further discloses wherein said non- defibrillation lead comprises a cardiac contractility modulation lead or a pacing lead (e.g. lead with pacing electrodes, para. [0033], [0035], [0046]).
In reference to at least claim 21
Pei modified by Swerdlow renders obvious a method according to claim 1. Pei further discloses the defibrillation lead having comprises a coil (e.g. lead with defibrillation electrodes, para. [0033], [0035], [0046]; leads include coil, tip and ring electrodes, 1,4,6, para. [0002]-[0003], [0019], [0020], [0023], [0033]) and at least one the non-defibrillation lead having comprises at least one electrode (e.g. lead with pacing electrodes, para. [0033], [0035], [0046]; leads include coil, tip and ring electrodes, 1,4,6, para. [0002]-[0003], [0019], [0020], [0023], [0033],), the method comprising: applying a test pulse to measure a baseline impedance between the defibrillation coil and the device housing (e.g. measure impedance to determine deviation, therefore it is inherent that a “baseline” impedance it made to compare recent impedance to, para. [0003]-[0004], [0021], [0027], [0029]); applying, a test pulse to measure a baseline impedance between the electrode of the non-defibrillation lead and the defibrillation coil (e.g. measure impedance to determine deviation, therefore it is inherent that a “baseline” impedance it made to compare recent impedance to, para. [0003]-[0004], [0021], [0027], [0029]); applying, periodically, a test pulse to measure impedance between the electrode of the non-defibrillation lead and the defibrillation coil (e.g. measure an impedance value along cross-lead, any of para. [0003] [0016], [0019]-[0020], [0023], [0027]); and estimating, according to a difference between a currently measured impedance level measured at said third applying and one or both of said baseline measurements (e.g. measure impedance to determine deviation, para. [0003]-[0004], [0021], [0027], [0029]), and one or both of said baseline measurements, a current impedance between the coil and said device housing to assess a condition of said defibrillation lead (e.g. measure impedance to determine deviation, para. [0003]-[0004], [0021], [0027], [0029]; comparison of measured impedances to determine lead integrity, para. [0030], [0047]).
In reference to at least claim 22
Pei modified by Swerdlow renders obvious a method according to claim 1. Pei further discloses wherein said third applying is performed more frequently than said first and second applying (e.g. measure an impedance value along cross-lead, any of para. [0003] [0016], [0019]-[0020], [0023], [0027]; measured around the same time of day, [0029]).
In reference to at least claim 27
Pei teaches a device according to claim 25. However, Pei does not teach wherein a timing of said applying is during a ventricle refractory period.
Swerdlow teaches a method and apparatus for detection of lead conductor anomalies using dynamic electrical parameters which discloses delivering a test pulse to the lead and measuring an impedance to determine anomalies (e.g. abstract, para. [0005]-[0008], [0021]-[0022], [0042]). Swerdlow discloses applying the test pulse during an absolute refractory period with a low amplitude so the risk of capturing the heart is minimal (e.g. para. [0048]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Pei to include timing the test pulse during a ventricle refractory period, as taught by Swerdlow, to minimize the risk of capturing the heart.
Claim(s) 19 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 5,755,742 to Schuelke et al. (Schuelke) in view of US 2011/0054554 to Swerdlow (Swerdlow).
In reference to at least claims 19 and 27
Schuelke teaches a device according to claims 15 and 25. However, Schuelke does not teach timing said test pulse during an expected total refractory period of the cardiac cycle or during a ventricle refractory period.
Swerdlow teaches a method and apparatus for detection of lead conductor anomalies using dynamic electrical parameters which discloses delivering a test pulse to the lead and measuring an impedance to determine anomalies (e.g. abstract, para. [0005]-[0008], [0021]-[0022], [0042]). Swerdlow discloses applying the test pulse during an absolute refractory period with a low amplitude so the risk of capturing the heart is minimal (e.g. para. [0048]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Schuelke to include timing the test pulse during an absolute refractory period, as taught by Swerdlow, to minimize the risk of capturing the heart.
Response to Arguments
Applicant's arguments filed 9/11/2025 have been fully considered but they are not persuasive.
35 USC §102 Rejections (p. 8-9 of response filed 9/11/2025)
Applicant argues that neither Schuelke nor Pei discloses the amended claim language ““a first defibrillation lead configured to be positioned at least in part inside the hear; a second separate non-defibrillation lead configured to be positioned at least in part inside the heart at a different location than said first defibrillation lead”. And that “leads are positioned in a same single chamber of the heart.” And “the recitation “leads are positioned in a same single chamber of the heart”, the examiner respectfully disagrees. Schuelke discloses a first defibrillation lead configured to be positioned at least in part inside the heart (e.g. a pair of defibrillation leads, Fig. 1, abstract Col. 2, ll. 43-60, Col. 4, l. 66 – Col. 5, l.28, Col. 15, l. 59 – Col. 16, l. 4); a second separate non-defibrillation lead configured to be positioned at least in part inside the heart at a different location than said first defibrillation lead (e.g. one or more pacing leads, Fig. 1, abstract, Col. 2, ll. 32-48, Col. 15, l. 59 – Col. 16, l. 4). Further, each lead has at least a portion that is positioned within the right artium (e.g. each lead has at least a portion positioned in the right artium, Fig. 1). Regarding the circuitry, Schuelke discloses that “The "lead impedance" of such a defibrillation lead is also defined as including the impedance of these components of the defibrillation lead as well as any impedance of the connection of the connector element with the IPG terminal. These definitions encompass any combination of two or more pacing leads or defibrillation leads incorporated into the same lead body and any combinations of pacing lead(s) and defibrillation lead(s) in the same lead body.”, see Col. 2, ll. 48-55. Schuelke further discloses that “In order to derive the impedance of the second defibrillation lead, the steps are repeated with substitution of the second defibrillation lead for the first defibrillation lead. Additional defibrillation lead impedances may be derived in the same manner by use of any combination of the defibrillation lead under test and two other pacing or defibrillation leads.”, see Col. 5, ll. 22-2 and “Moreover, any combination of three pacing and defibrillation leads may be used in the derivation of the lead impedance of each lead under test by appropriate substitutions of the remaining two leads in the successive injections of first and second impedance test pulses and measurements of the injected currents and induced voltages.”, see Col. 23, ll. 57-63. Therefore the circuitry is configured to asses a condition when leads are positioned in a same chamber of the heart such as a ventricular chamber. Regarding Pei, Pei discloses a first defibrillation lead configured to be positioned at least in part inside the heart (e.g. lead with defibrillation electrodes, para. [0033], [0035], [0046]) and a separate second non-defibrillation lead configured to be positioned at least in part inside the heart at a different location than said first defibrillation electrode (e.g. lead with pacing electrodes, para. [0033], [0035], [0046]). In regards to the circuitry limitations, Pei discloses “e.g. measure an impedance value along cross-lead, “Values representative of impedance are also measured along various cross-lead vectors (i.e. inter-lead vectors) between electrodes of different leads, such as between the tip of the RV lead and the ring of the RA”, see para. [0003] and that “The impedance measuring circuit 412 is advantageously coupled to the switch 474 so that any desired electrode or combination of electrodes may be used. “,see para. [0045]. Pei further discloses that “A cross-lead impedance measurement system 405 is operative to measure or input signals representative of impedance along cross-lead (inter-lead) vectors between electrodes of different leads”, para. [0047]. Therefore, since Pei discloses inter-lead impedance measurements and that any desired electrode or combination electrode may be used by the impedance measuring circuit, the circuitry within Pei is “configured to assess a condition of said first and said second leads, when said leads are positioned in a single same chamber of the heart”.
35 USC §103 Rejections (p. 9-10 of response filed 9/11/2025)
Applicant argues “First, This Method in which the first defibrillation lead and the second non- defibrillation lead are separate and positioned in a same single chamber of the heart (with “same single chamber” having the meaning previously clarified in Applicant’s response to the §102 rejection of claim 24), is not disclosed or suggested by any of the cited prior art.”, the examiner respectfully disagrees. This argument regarding Pei has been fully addressed in the response to the 102 arguments provided above.
Applicant argues “Second, the Applicant respectfully asserts that Pei in view of Swerdlow would not lead to the claimed invention of claim 1. The Applicant believes that a person of ordinary skill in the art would not be motivated to combine Pei and Swerdlow.” In particular “Instead, Pei’s relatively simple impedance- sensing approach is intended to support basic functions, potentially serving as a foundation for further applications (as further described in Par. [0019]), but not to modify its underlying timing or sensing methodology. Accordingly, Pei provides for additions built upon its conventional approach, but does not disclose any modification or suggestion to alter that approach in the manner proposed. Therefore, the combination with Swerdlow relies on hindsight rather than any teaching or motivation from the prior art.”, the examiner respectfully disagrees. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the motivation to combine is from Swerdlow, Swerdlow discloses applying the test pulse during an absolute refractory period with a low amplitude so the risk of capturing the heart is minimal (e.g. para. [0048]). Utilizing the combined teachings, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Pei to include applying the test pulse during a ventricle refractory period, as taught by Swerdlow, to minimize the risk of capturing the heart.
Applicant argues “Third, Pei’s relatively simple impedance-sensing approach is intended to support basic functions. By contrast, Swerdlow introduces a different, frequency- dependent impedance measurement strategy, in which multiple frequencies are applied in a sweep and impedance variations across the frequency spectrum are analyzed to detect anomalies. This is fundamentally different from Pei’s reliance on a single, conventional impedance detection pulse for routine monitoring. Accordingly, a person of ordinary skill in the art would not be motivated to combine Pei’s simple foundation approach with Swerdlow’s complex, frequency-based method, as the two systems serve different purposes and operate on different principles.”, the examiner respectfully disagrees. Both Pei and Swerdlow are in the same field of endeavor related to detecting lead conductor anomalies. Pei already discloses embodiments that include the use of intra-lead and inter-lead measurements so it is unclear why applicant has stated that modifying Pei with Swerdlow would add considerable complexity. Swerdlow discloses delivering a test pulse to the lead and measuring an impedance to determine anomalies (e.g. abstract, para. [0005]-[0008], [0021]-[0022], [0042]) and applying the test pulse during an absolute refractory period with a low amplitude so the risk of capturing the heart is minimal (e.g. para. [0048]). Utilizing the combined teachings, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Pei to include applying the test pulse during a ventricle refractory period, as taught by Swerdlow, to minimize the risk of capturing the heart.
Conclusion
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/JENNIFER L GHAND/Examiner, Art Unit 3796