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 . Claims 1, 3-14, and 16-27 are currently pending.
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 1 and 3-13, drawn to an implantable medical device.
Group II, claim 14, drawn to an implantable medical device.
Group III, claims 16-27, drawn to a method.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I-III lack unity of invention because even though the inventions of these groups require the technical feature of a plurality of electrodes located as claimed where one is a tissue piercing electrode where the electrodes are connected to therapy and sensing circuits and a controller as claimed, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Yang et al. US 2019/0290905 (see claim 1 and [0121]-[0125]).
During a telephone conversation with Matthew Goeden on 06/23/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1 and 3-13. Affirmation of this election must be made by applicant in replying to this Office action. Claims 14 and 16-27 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 10 is objected to because of the following informalities: the last two lines disclose that the “further comprises determining that the atrial event rate is unreliable based on the obtained atrial electrical activity is unreliable”. The second “is” should be changed to “being” for grammatical purposes. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 3-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "a patient’s right atrium" in line seven, however both the patient and the right atrium were already disclosed above in line three.
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 non-obviousness.
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 1 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. US Publication 2019/0290905 (hereinafter Yang) in view of Seim US Publication 2002/0147407 (hereinafter Seim).
Regarding claim 1, Yang discloses a plurality of electrodes comprising a tissue-piercing electrode implantable from the triangle of Koch region of the right atrium through the right atrial endocardium and central fibrous body positioned in the basal and/or septal region of the left ventricular myocardium ([0011], [0050], [0063], [0160]-[0162], claim 1) and a right atrial electrode positionable within the right atrium ([0011], [0102], claim 1); a therapy delivery circuit operably coupled to the plurality of electrodes ([0069][0075][0080]); a sensing circuit operably coupled to the plurality of electrodes ([0075]-[0078]); and a controller configured to obtain atrial electrical activity of the right atrium and ventricular electrical activity of the left ventricle and to determine tachycardia based on those activities ([0021][0133]– [0136], Figure 9, and claim 7).
Yang teaches determining both the ventricular and atrial event rates ([0079][0136][0245]), but does not detail specifically that the obtained information is used to specifically determine if tachyarrhythmia is occurring (though it is something that is determined in general [0119]). Seim discloses a tachyarrhythmia detection system that includes developing atrial interval rates from sensed atrial events and ventricular interval rates from sensed ventricular events as separate computational steps ([0007][0051]-[0052]; Claims 1-8), and determining tachyarrhythmia based on those rates ([0056][0058][0060][0062][0072] and claim 1). Therefore, as both are directed to dual-chamber implantable cardiac devices for tachyarrhythmia detection, it would have been obvious to the skilled artisan before the effective filing date to implement Seim's rate computation within the sensing of Yang as predictable results would have ensued. The predictable result being providing Yang's controller with discrete atrial and ventricular rate values that may be compared directly against one another, which is the comparison Yang's 1:1 atrioventricular conduction determination ([0137][0139]) and atrial-regularity determination ([0245]) already require. Seim performs this same atrial-to-ventricular rate comparison ([0098]), and each element would perform its known function in the combination.
Regarding claim 12, Yang discloses that the controller is further configured to execute, in response to determination that the patient's heart is undergoing a tachyarrhythmia, delivering antitachycardia pacing therapy using at least the tissue-piercing electrode (Claims 1-2, [0011][152], processing step 206 of Figure 13, as well as embodiment 47 as per [0247]).
Regarding claim 13, Yang discloses that the controller is further configured to execute or the method further comprises, in response to determination that the patient's heart is undergoing a tachyarrhythmia, to communicate with an implantable cardioverter defibrillator to initiate delivery of cardioversion or defibrillation shock therapy from the implantable cardioverter defibrillator ([0051], separate medical device 50, where [0054] details providing shock with an ICD and has a wireless function; [0155]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Seim, and in further view of Krig et al. US Patent 5,978,707 (hereinafter Krig)
Regarding claim 3, Yang as modified by Seim is silent on the rate comparison. Neither discloses determining a ventricular tachyarrhythmia in response to the ventricular event rate being greater than the atrial event rate. Krig discloses applying ventricular tachycardia therapy when the average ventricular rate is greater than the average atrial rate and withholding such therapy when it is not (column 5, lines 42–65; column 6, lines 1–20; Claims 1, 4, 5). It would have been obvious to the skilled artisan before the effective filing date to apply this rate-comparison criterion of Krig within the Yang/Seim combination, as predictable results would have ensued (addresses the same problem of inappropriate ventricular therapy in dual-chamber ICD systems and the criterion is applied in its known manner).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Seim, and in further view of Kroll et al. US Patent 7,139,611 (hereinafter Kroll) and Levine US Patent 7,174,210 (hereinafter Levine).
Regarding claim 4, Yang and Seim are silent as to removing P-wave, R-wave, and T-wave artifacts from the obtained electrical activities prior to determining the atrial and ventricular event rates. Kroll discloses a far-field rejection atrial sensing circuit comprising a timing difference detection circuit (160), a far-field filtering circuit (162), and a downstream atrial event detection circuit (164), wherein the filtering step (step 178, Figure 6) expressly precedes event detection (step 180, Figure 6) such that R-wave artifacts are removed before events are counted (column 8, lines 16-22; column 8, lines 26–55). Kroll further discloses that this filtering principle may be applied to reject far-field atrial signals from the ventricular sensing channel (column 11, lines 21-25). Levine further discloses identifying T-waves appearing simultaneously on both channels as ventricular events and excluding them from the atrial rate count, with classification preceding the rate update (column 15, lines 44-65; column 16, lines 22-32; Claims 1, 5). Therefore, it would have been obvious to the skilled artisan before the effective filing date to incorporate Kroll's pre-detection artifact filtering and Levine's T-wave exclusion into the Yang/Seim combination as predictable results would have ensued (Kroll identifies rate doubling and erroneous shock delivery from uncorrected far-field R-waves as a recognized failure mode (column 2, lines 28–45) and Levine addresses the complementary T-wave oversensing problem in the same device class, both of these provide known methods for addressing possible failure).
Claims 5 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Seim, and in further view of Marcovecchio US Patent 7,039,463 (hereinafter Marcovecchio).
Regarding claim 5, Yang discloses evaluating whether the rhythm has a 1:1 AV conduction signature ([0137]) but still does not make an affirmative determination that the patient's heart is undergoing SVT based on the obtained atrial and ventricular electrical activities, nor disclose withholding antitachycardia pacing therapy in response to such a determination. Marcovecchio discloses classifying a tachyarrhythmia as SVT by comparing the sensed ventricular electrogram morphology to a stored NSR template and withholding therapy upon an SVT determination (column 4, lines 10-65; column 5, lines 1-40; Claims 1, 4, 7-8). It would have been obvious to the skilled artisan before the effective filing date to incorporate Marcovecchio's SVT classification and therapy-withholding logic into the Yang/Seim device, as predictable results would have ensued (identifying inappropriate therapy delivery to SVT patients as the recognized problem the combination addresses; Marcovecchio column 1, lines 20-50).
Regarding claims 8-9, Yang and Seim are silent on determining tachyarrhythmia based on QRS complex morphology of the obtained ventricular electrical activity or comparing that morphology to a QRS complex morphology template indicative of normal sinus rhythm. Marcovecchio discloses determining tachyarrhythmia based on comparison of the sensed ventricular electrogram morphology to a stored NSR morphology template (column 4, lines 10–65; column 5, lines 1-40; Claims 1, 7-10). It would have been obvious to the skilled artisan before the effective filing date to apply Marcovecchio's morphology-based discrimination within the Yang/Seim combination, as predictable results would have ensued (utilizing one morphology for another; Yang incorporates US 8,594,775 Ghosh et al. for morphologic tachycardia analysis [0141][0144]), establishing morphology as a recognized supplemental discriminator within the VFA device context).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Seim, and in further view of Lall US Publication 2012/0179220 (hereinafter Lall).
Regarding claim 6, Yang and Seim are silent on determining SVT in response to the atrial event rate increasing prior to the ventricular event rate. Lall discloses classifying a tachyarrhythmia as SVT when a valid atrial interval decrease is determined to precede a valid ventricular interval decrease within a detection window ([0040]-[0058], Claim 1). It would have been obvious to the skilled artisan before the effective filing date to add the onset criterion of Lall to the Yang/Seim combination as predictable results would have ensued (onset analysis is a complementary discriminator that increases SVT/VT specificity beyond rate comparison alone and all three references address the same problem of inappropriate tachycardia therapy.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Seim, and in further view of Kim et al. US Publication 2008/0183228 (hereinafter Kim).
Regarding claim 7, Yang discloses delivering antitachycardia pacing therapy using the plurality of electrodes ([0152], Claim 2), but is silent on determining SVT based on the obtained electrical activities following ATP delivery. Kim discloses delivering atrial pacing therapy during a detected tachyarrhythmia and classifying the resulting rhythm as SVT or VT based on atrial and ventricular electrical activities observed following therapy delivery ([0033]–[0034][0038]-[0043][0047]; Claims 1, 7, Figures 4, 6-7). It would have been obvious to the skilled artisan before the effective filing date to apply the post-therapy classification of Kim within the Yang/Seim framework, as post-therapy rhythm assessment is a recognized method of improving therapy decisions in the same device class.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Seim and Marcovecchio, as applied to claim 8, and in further view of Stadler et al. US Patent 8,750,976 (hereinafter Stadler).
Regarding claim 10, Yang, Seim, and Marcovecchio are silent on determining that the atrial event rate is unreliable based on the obtained atrial electrical activity. Stadler discloses an implantable medical device in which a control processor determines whether an atrial electrical signal is unreliable for cardiac event detection and, in response, changes the detection algorithm to eliminate use of the atrial signal information (column 4, lines 15–22; claims 1 and 10; see also column 7, lines 25–30; Figure 4, blocks 214–216, 220). Stadler further discloses determining unreliability from P-wave morphology compared to a template (column 6, l. 51 – column 7, l. 10; blocks 204–208), from P-wave amplitude sensed within a predetermined small range of the sensing threshold (column 7, lines 11–24; blocks 210–212), and from simultaneous P-wave and R-wave sensing indicating atrial lead dislodgement (column 7, lines 45–57; block 218). Therefore, it would have been obvious to the skilled artisan before the effective filing date to incorporate the atrial reliability determination of Stadler into the device of Yang as predictable results would have ensued (preventing a corrupted atrial rate from being used in the atrial-to-ventricular rate comparison on which Yang's tachycardia determination relies [0137][0245]).
Yang expressly recognizes that atrial sensing in its configuration is subject to interference from larger-amplitude ventricular signals owing to electrode proximity to ventricular tissue ([0099]), and that P-wave signal strength varies and is evaluated in selecting atrial sensing electrodes ([0094]). Stadler addresses that same recognized variability, stating that atrial electrical activity information can at times be unreliable because of noise corruption, very small P-wave signal amplitude, the confounding presence of ventricular electrical activity appearing as far-field signals on an atrial signal, and dislodgement of the atrial lead (column 1, lines 37–42; see also column 2, lines 3–6).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Seim, and in further view of Marcovecchio and Kim.
Regarding claim 11, Yang discloses the device of claim 1 as set forth above. In response to a tachyarrhythmia determination, Yang evaluates 1:1 AV conduction ([0137]) but does not make an affirmative determination that the patient's heart is undergoing SVT based on the obtained atrial and ventricular electrical activities, nor discloses delivering atrial antitachycardia pacing therapy using at least the right atrial electrode in response to such a determination. Marcovecchio discloses affirmatively classifying a tachyarrhythmia as SVT by comparing the sensed ventricular electrogram morphology to a stored NSR template (column 4, lines 10–65; column 5, lines 1–40; Claims 1, 4). Kim discloses delivering atrial pacing therapy via an atrial electrode in response to an SVT classification ([0030]–[0050]; Claims 1, 2, 7). Yang discloses a right atrial electrode capable of delivering atrial pacing ([0076]–[0081]). It would have been obvious to the skilled artisan before the effective filing date to incorporate Marcovecchio's SVT classification and Kim's atrial ATP delivery into the Yang device, as both Marcovecchio and Kim address the problem of inappropriate ventricular therapy where the tachyarrhythmia originates in the atria, and Yang's right atrial electrode provides the structural basis for atrial ATP delivery without modification.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian M Antiskay whose telephone number is (571)270-5179. The examiner can normally be reached M-F 10am-6pm EST.
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/BRIAN M ANTISKAY/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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