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 .
Response to Arguments
Regarding the 101 rejection, applicant’s arguments have been fully considered, but are not persuasive. Specifically, applicant’s arguments are not commensurate in scope with the claim language. In their remarks, applicant argues that the claimed single channel sensing is an improvement in technology and/or a technical field. The examiner disagrees, as the claims are not limited to only a single channel, i.e. other sensing channels are not precluded from the claims (see the claim interpretation section which has been included in every rejection throughout the prosecution history of the application). Furthermore, a single channel is generally defined as two electrodes, i.e. an electrode pair, one that operates as a cathode and the other as anode to sense the heart's electrical activity by detecting voltage differences between the positive (anode) and negative (cathode) electrode. Applicant’s own specification supports this well-known and commonly understood concept that any two electrodes define a single channel (at least Par 0009 of applicant’s specification). Therefore, single channel sensing is not an improvement in technology or significantly more than the abstract idea itself, as this is the conventional manner in which ECG data is obtained, i.e. via a single channel defined by an anode and cathode, i.e. electrode pair. In fact, this is seemingly the only way ECG data can be obtained, i.e. via a single channel. To reiterate the examiner’s position, single channel sensing is merely generic and conventional data gathering using an electrode pair to obtain/sense electrical activity from the heart (ECG). Again, it is emphasized that the current claim language does not preclude additional channels from being used. In particular, “the transitional term ‘comprising’, which is synonymous with ‘including,’ ‘containing,’ or ‘characterized by,’ is inclusive or open-ended and does not exclude additional, unrecited elements or method steps.”. Therefore, multi-channel sensing is not precluded by the claims, as multi-channel sensing is merely the use of more than one single channel. Therefore, applicant’s remarks that distinguish between single channel sensing and multi-channel sensing are not commensurate in scope with the claim language because multi-channel sensing is not precluded by the current claim language.
Furthermore, in terms of the required electrodes, only one of the recited electrodes is required, e.g. a right atrial electrode positioned within the right atrium. This is also considered conventional and well-understood data gathering, i.e. a POSITA would understand that it’s necessary to place an electrode near the anatomy from which the sensed electrical activity/signal is desired. For example, if the necessary/desired data, i.e. the information needed/desired to perform the claimed analysis/mental process, is electrical activity from the right atrium, then it is only logical to place the electrode in the right atrium to gather this data. If applicant were to amend the claims to preclude other/additional channels, i.e. limit the method steps to requiring only/just a single channel, and/or that both electrodes and respective positionings thereof are required, then the examiner would have to reconsider their position. Therefore, the 101 rejection is maintained.
Regarding the 103 rejection, applicant’s remarks merely repeat what has already been addressed/answered in the Non-Final. The examiner maintains the position that the combination of Yang and Karst teaches/suggests the claimed method steps; see response to arguments on pages 2-3 of the NF mailed 10/2/2025. Applicant is reminded that “the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981)”. Therefore, the 103 rejection is maintained.
Claim Interpretation
For clarity, the examiner would like to point out that the claims do not preclude multiple channels, all that is currently required is a single channel, i.e. a single vector or pair of electrodes defined by an anode and cathode, that monitor electrical activity of the heart to obtain both atrial and ventricular events. Other/additional channels are not precluded, based on the use of the transitional phrase of “comprising” (The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. MPEP 2111.03).
Furthermore, as is known in the prior art, near field sensing is defined as sensing event that occur in the heart chamber in which the implantable device is located, e.g. if the implantable device is located in the right atrium, then right atrium events are considered near-field sensing. Conversely, far field sensing relates to monitoring events in a heart chamber other than the chamber in which the implantable device is located, e.g. if the implantable device is located in the right atrium, then left ventricle, right ventricle or left atrium events are considered far-field sensing. Therefore, applicant’s current claims relate to a single channel, i.e. vector or electrode pair, that performs both near-field and far-field sensing to determine events in both the atrium and ventricle.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 15-19, 24 and 26-28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a mental process without significantly more.
The claims recite the mental process of “identifying atrial and ventricular events based on the obtained electrical activity”. This is a mental process, as a doctor or diagnostician routinely looks at electrical activity of the heart to identify atrial and ventricular events, e.g. by looking at a print-out, chart, map or display of electrical activity a doctor routinely determines/identifies various heart events.
This judicial exception is not integrated into a practical application because the additional elements require only one of the two electrodes claimed. Specifically, a right atrial electrode positioned in the right atrium is the only sensor required by the claims. The sensing accomplished by the right atrial electrode is considered pre-solution activity, specifically data gathering in order to obtain the necessary electrical activity that is then used in the mental process. Stated differently, this data gathering step is the necessary pre-cursor in order to perform the abstract idea. Since only one electrode is required, and this single electrode is being used in the normal/conventional manner, i.e. an atrial electrode is used to obtain electrical data from the atrium. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as explained above, there is no practical application, as nothing is accomplished (in the claims) once the atrial/ventricular events are identified, and the claimed sensing is generic/common pre-solution activity, as an atrial electrode is commonly known/necessary in order to collect electrical information from the atrium. Regarding the claimed single channel, this is inherently how electrodes operate, as an electrode pair, i.e. anode and cathode.
Regarding claim 29, it is emphasized that no 101 rejection is applicable as the claims require “obtaining, with a fully intracardiac leadless device, a single channel of electrical activity using a right atrial electrode of the leadless device positioned within the right atrium of the patient's heart and a tissue-piercing electrode of the leadless device that extends toward the left ventricular myocardium of the patient's heart”. The examiner takes the position that both electrodes positioned in the claimed way, while known, are not conventional or routine. Unlike claim 15 above, both electrodes are required.
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.
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 15-18, 24, 26-32 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0230415 to Yang in view of US 2013/0325081 to Karst OR US 2010/0041919 to Esler OR US 2005/0288719 to Zhang OR US 2010/0030289 to Casavant OR US 2019/0192864 to Koop.
[Claim 15] A method comprising:
obtaining electrical activity using one or both of a right atrial electrode (electrodes 22 and/or 24, Fig. 3; electrodes 722 and/or 724, Fig. 5) positioned within the right atrium to sense electrical activity in the right atrium and a tissue-piercing electrode (dart electrode 12/712 with tip electrode 42/742; Figs. 3 or 5) implanted in one or more of the basal region, septal region, and basal- septal region of the left ventricular myocardium of the patient's heart from the triangle of Koch region of the right atrium through the right atrial endocardium and central fibrous body to sense electrical activity in one or more of the basal region, septal region, and basal-septal region of the left ventricular myocardium (Abstract, Pars 0011 and 0048; Figs. 1 and 2); and
identifying atrial and ventricular events based on the obtained electrical activity (dual chamber sensing; “A dual chamber medical device may sense atrial electrical signals and ventricular electrical signals”; at least Pars 0007 and 0062; “The controller is configured to monitor at least one of electrical activity of the right atrium using the right atrial electrode and electrical activity of the left ventricle using the tissue-piercing electrode implanted in the basal and/or septal region of the left ventricular myocardium of the patient's heart from the triangle of Koch region of the right atrium through the right atrial endocardium and central fibrous body”; Par 0216. The examiner interprets “at least one” to include both. See also Pars 0075-79 which details cardiac event detection based on atrial and ventricular electrical activity. Specifically, atrial events are P-waves and ventricular events are R-waves.).
Yang fails to explicitly teach that a single channel obtains electrical activity that is then used to identify both atrial and ventricular events. In the same field of endeavor, Karst discloses that such a single channel, i.e. vector or electrode pair, is known to monitor or identity both near-field and far-field, i.e. atrial and ventricular, events (Abstract; Pars 0045, 0070 and 0131). Par 0045 states “here, depending on the ratio of electrode surface areas, spacing between electrodes, and tissue contact, a pair of electrodes may be employed to effectively sense both near-field and far-field electrical activity. In some implementations (e.g., as depicted in FIG. 4), a LIMD may be implanted with an electrode used as the cathode in pacing attached endocardially to the myocardium of the heart and an electrode used as the anode protruding into a chamber of the heart. In some implementations, a LIMD may be implanted with the cathode attached at the epicardial surface of the heart and the anode on the other external face of the device. Because of the larger surface area of the anode and its contact to low-impedance fluid, the sensed electrical activity will include a significant far-field component that has less high-frequency content (in addition to the near-field signal of electrical activity near the cathode).” Par 0131 states “the data acquisition system 1352 may be coupled to the right atrial electrodes and the right ventricular electrodes through the switch 1326 to sample cardiac signals across any pair of desired electrodes”. While Par 0070 makes it clear that these near and far field signals are used to identify atrial and ventricular events, i.e. the same P-wave and R-wave events as Yang. Furthermore, any/all of Esler (Par 0027), Zhang (Par 0013), Casavant (Par 0058) and Koop (Par 0085) teach the same concept of using a single- channel to detect/identify both atrial and ventricular events.
Therefore, it would have been obvious to one of ordinary skill in the art to modify the device taught by Yang to explicitly use a single channel to obtain electrical activity from both the artium and ventricle (to ultimately identify both atrial and ventricular events using this obtained electrical activity), as this is known and effective way to obtain electrical activity from both the atrium and ventricle, as taught by Karst, Esler, Zhang, Casavant or Koop. Stated differently, Yang discloses using separate channels to obtain electrical activity from both the artium and ventricle, however, Karst, Esler, Zhang, Casavant and/or Koop, all make it clear that instead of using separate channels, a single channel can be used instead. Making this a simple substitution of one known configuration, i.e. separate/plural channels, for another, i.e. a single channel, to obtain electrical activity from both the artium and ventricle. As explained above, both Yang (at least Pars 0075-79) and Karst (at least Par 0070) explicitly teach using these sensed atrial and ventricular electrical signals/activity to identify atrial and ventricular events.
[Claim 16] Yang discloses obtaining electrical activity between distal and proximal housing electrodes (22/722 and 24/724; Figs. 3 and 5) to identify atrial events (“The distal housing-based electrode 22 and the proximal housing-based electrode 24 may be coupled to the atrial sensing channel 87 for sensing atrial signals” Par 0076). Yang discloses the exact same placement/location for a structurally-equivalent VFA implantable device (compare Figs. 1-4, 5 and 15 of Yang to Figs. 1-5 of the current specification); therefore, in the same sense that applicant’s proximal-housing based electrode (24) is considered a right atrial blood pool electrode, so is the proximal-housing based electrode (24) of Yang, as it is the exact same electrode positioned in the same exact location.
[Claim 17] At least Par 0062 of Yang discloses obtaining electrical activity between the right atrial activity (22 and/or 24) and the tissue-piercing electrode (42)
[Claim 18] Yang discloses “the cardiac event detection circuitry included in each of the channels 87 and 89 may be configured to amplify, filter, digitize, and rectify the cardiac electrical signal received from the selected electrodes to improve the signal quality for detecting cardiac electrical events. The cardiac event detection circuitry within each channel 87 and 89 may include one or more sense amplifiers, filters, rectifiers, threshold detectors, comparators, analog-to-digital converters (ADCs), timers, or other analog or digital components” (Par 0077)
[Claim 24] Pars 0141-144, including the incorporated references, disclose comparing the obtained electrical activity to morphology templates to determine/identify ventricular events. The reference fails to explicit teach using this morphology analysis to determine atrial events, however the examiner considers this an obvious duplication of parts. Specifically, in the situation where both atrial events and ventricular events are identified, i.e. dual chamber sensing, (as detailed in the rejection of claim 15), it would have been obvious to use this same morphology analysis to identify atrial events for the same benefits/reasons as it’s used for ventricular events.
[Claims 26 and 27] As shown in Figs. 1-5, Yang discloses a leadless (Par 0049) pacemaker (Pars 0044 and 0062). Yang discloses the same leadless implantable device (10, Fig. 3 or 710, Fig. 5) as applicant’s (10, Fig. 4 or 310, Fig. 5 of applicant’s specification), including a right atrial electrode (22 and/or 24) and tissue-piercing electrode leadlessly coupled to the housing, in the same way applicant’s is leadlessly coupled (“A leadless electrode may be coupled to the housing of the medical device without using a lead between the electrode and the housing” Par 0049)
[Claim 28] As seen in Fig. 1, the implantable device is wholly implantable within the right atrium (RA); see also Par 0048. Furthermore, these claims do not require that the device is actually wholly implanted in the right atrium, but merely has the capability, i.e. implantable; the examiner contends that Yang’s device meets this capability.
[Claim 29] See explanation for claims 15, 17 (which explains/details the claim limitation of obtaining a single channel of electrical activity using both the right atrial electrode and tissue piercing electrode to identify both atrial and ventricular events) and 26-28 (which explain/detail the claimed “fully intracardiac leadless device”)
[Claims 30-32 and 36] See explanation for claims 16-18 and 24 above, as they recite the exact same claim limitations.
Claims 19 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Yang and Karst, Esler, Zhang, Casavant or Koop as applied to claims 15 and 29 above, and further in view of US 8,391,975 to Corbucci.
Yang and Karst are discussed above, but fail to explicitly teach determining an event window start time when the obtained electrical activity exceeds a sense threshold; and determining one or more of the atrial and ventricular events based on the obtained electrical activity over an event time window following the event window start time. However, in the same field of endeavor, Corbucci (Fig. 8) discloses setting atrial and ventricular event windows (126 and 130) for determining atrial/ventricular events during these windows. Corbucci discloses that the starting times for these windows are based on sensed parameters (e.g. sensed P-wave or R-wave); Col 9, line 55 to Col 10, line 25. The examiner takes the position that these sensed parameters inherently/implicitly require a threshold to be exceeded. Therefore, it would have been obvious to one of ordinary skill in the art to modify the invention of Yang and Karst to include the event windows start times as a known way to determine atrial and ventricular events, as taught by Corbucci.
Conclusion
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 Lynsey C Eiseman whose telephone number is (571)270-7035. The examiner can normally be reached Monday-Thursday and alternating Fridays 7 to 4 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796