Ex Parte Nelson et alDownload PDFPatent Trial and Appeal BoardNov 14, 201712288746 (P.T.A.B. Nov. 14, 2017) Copy Citation United States Patent and Trademark Office UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O.Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 12/288,746 10/22/2008 Alex T. Nelson PAN.344A 5911 23581 7590 11/16/2017 KOLISCH HARTWELL, P.C. 200 PACIFIC BUILDING 520 SW YAMHILL STREET PORTLAND, OR 97204 EXAMINER MALAMUD, DEBORAH LESLIE ART UNIT PAPER NUMBER 3766 NOTIFICATION DATE DELIVERY MODE 11/16/2017 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): docketing @khpatent.com veronica@khpatent.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ALEX T. NELSON, PATRICIA A. ARAND, and MARCO DALLA GASPERINA1 Appeal 2016-006628 Application 12/288,746 Technology Center 3700 Before ULRIKE W. JENKS, TIMOTHY G. MAJORS, and RACHEL H. TOWNSEND Administrative Patent Judges. JENKS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims directed to a method of determining ventricular depolarization in a subject’s cardiac cycles. The Examiner rejects the claims as anticipated. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 According to Appellants, the Real Party in Interest is Inovise Medical, Inc. Appeal Br. 3. Appeal 2016-006628 Application 12/288,746 STATEMENT OF THE CASE Background: In electrocardiography, the so-called QRS-onset, or Q- onset, in each cardiac-beat, or cardiac cycle, marks the start of electrical depolarization of the heart ventricles. In the context of correlated electroacoustic cardiography, this well-recognized QRS-onset (or Q-onset, a term which is used herein interchangeably with QRS-onset) fiducial is important as a reference for computing the respective durations of a number of important heart-functionality time intervals, such as the electromechanical activation time interval (EMAT) between Q- onset and the closure of the mitral valve. Spec. 1:10-16. Claims 2, 3, and 10 are on appeal, and can be found in the Claims Appendix of the Appeal Brief. Claim 10 is representative of the claims on appeal, and reads as follows: 10. A method employable in the presence of an operating pacemaker for determining the true onset of ventricular depolarization in a subject’s cardiac cycles comprising during a selected, predetermined time span which includes a plurality of the subject’s cardiac cycles, acquiring, externally, ECG waveform data reflected in those cycles, gathering, solely from within such acquired data, and with respect to each included cardiac cycle represented in that data, electrical-event waveform information respecting the two, potential, true-onset event candidates - QRS-intrinsic, and pacemaker-non-intrinsic, and, in relation to the gathered, QRS-intrinsic and pacemaker- non-intrinsic, electrical event waveform information, for each cycle in the mentioned plurality of cycles, and utilizing an appropriately programmed computer, identifying which of the QRS-intrinsic and pacemaker-non-intrinsic events present in the cycle is to be determined as being the one reflecting true ventricular-depolarization onset through (a) time-locating, time-position-sorting, and 2 Appeal 2016-006628 Application 12/288,746 identifying as first-in-time and last-in-time, the respective events in the cycle of a QRS-intrinsic event and of a pacemaker-non-intrinsic event, and identifying, further, each pacemaker-non-intrinsic event as being one of ventricular or bi-ventricular, (b) evaluating, in the gathered waveform information associated with the cycle, the waveform slope therein from a time just preceding the identified first-in-time event to a time just following the identified last-in-time event, (c) based on said evaluating, finding the time of the first substantial waveform slope change, and (d) selecting to be the correct event in the cycle which reflects true ventricular depolarization onset the time-position-sorted event whose time position in the cycle most immediately precedes the time of the found, first-substantial slope change. Appeal Br. 13, Claims Appendix. Appellants request review of the Examiner’s rejection of claims 2, 3, and 10 under pre-AIA 35 U.S.C. § 102(b) as being anticipated by Deno.2 Anticipation by Deno The issue is: Does the preponderance of evidence of record support the Examiner’s finding that Deno teaches a determination of a true ventricular-depolarizing onset using the recited method steps as claimed? 2 Deno et al., US 7,096,064 B2, issued Aug. 22, 2006 (“Deno”). 3 Appeal 2016-006628 Application 12/288,746 Findings of Fact FF1. Deno teaches a method and apparatus for monitoring acute and chronic cardiac dysfunctions as well as delivering therapy. Deno, Abstract. Deno teaches that “[t]he cardiac cycle is completed in the interval between successive PQRST complexes and following relaxation of the atria and ventricles as the right and left atria re-fill with venous blood and oxygenated blood.” Deno 21:32—36. The depolarization impulse that reaches the AV Node conducts down the bundle of His in the intraventricular septum after a delay of about 120 msec. The depolarization wave reaches the apical region of the heart about 20 msec later and is [sic] then travels superiorly though the Purkinje Fiber network over the remaining 40 msec. The aggregate RV and LV depolarization wave and the subsequent T-wave accompanying repolarization of the depolarized myocardium are referred to as the QRST portion of the PQRST cardiac cycle complex when sensed across external ECG electrodes and displayed. When the amplitude of the QRS ventricular depolarization wave passing between a bipolar or unipolar pace/sense electrode pair located on or adjacent to the RV or LV exceeds a threshold amplitude, it is detected as a sensed R-wave. Deno 23:4—26; Ans. 5. FF2. Deno teaches using safety lockout therapy rules to determine if a pacing pulse is to be applied. Fig 14 of Deno, reproduced below, shows a flow diagram for determining therapy needs. 4 Appeal 2016-006628 Application 12/288,746 I Vsvsnt rww c.c i, cydt: foisabte PCSP (and ACPj\ pyfsos this cycie j /'•'....................................."\ FIG. 14 [shows], a flow chart for a safety lockout rule for application of excitatory PESP [(post-extrasystolic potentiation)] stimulation is depicted. It can be appreciated that each new cardiac cycle begins with a ventricular event (Vevent) that is either a Vpace or Vsense. The safety lockout rule has veto power over the decision to deliver excitatory PESP stimulation to the ventricle and possibly atrial coordinated pacing (ACP) during this cycle. If the prior V-V interval is greater than a threshold value, PESP and/or ACP pulses are enabled for this cycle. Should the V-V interval be too short, stimulation therapy is aborted. This prevents stimulation therapy from further adding to the arrhythmic potential of an intrinsic premature ventricular contraction (PVC). Stimulation with a short coupling interval, particularly if immediately following other short intervals is significantly pro-arrhythmic and is, of course, to be avoided. The safety lockout rule also prevents application of excitatory therapy during various tachycardias including sinus tachycardia, supraventricular tachycardia (SVT), ventricular tachycardia (VT), or ventricular fibrillation (VF). The 5 Appeal 2016-006628 Application 12/288,746 threshold used may either be a fixed value or derived from other hemodynamic or electrogram based parameters and is typically 400-600 ms. The safety lockout rules may operate using a variety of timing schemes which are microprocessor or hardware controlled and programmable with input values determined by algorithms or clinicians, such as depicted in the system diagrams of FIG. 3 A and FIG. 3B [(not shown)]. Deno 36:3—27; see Ans. 2. FF3. Deno teaches that a subject’s needs change over time requiring that stimulation parameters also be changed. FIG. 30[3] is composed of two X-Y plots illustrating the need to adjust stimulation parameters to maintain desired level of enhanced function. Variations across and within subjects of response to stimulation occur and can impact the resulting level of enhanced function. For both PESP potentiation and NES [(nonexcitatory electrical stimulation)] neurostimulation this may take the form of shifts in the absolute level of response (or offset) but for convenience this has been removed by normalizing to a non-stimulated baseline in the recent past of 100%. The remaining variation takes the form of shifts in the slope or the NES response, but for PESP takes on both changes of slope (change of dP/dt max per unit time) as well as shifts in the refractory period where no potentiation results. As a result, a stimulation time that once gave the desired level of enhancement may now be associated with no enhancement, more or less mechanical function enhancement of the heart, and a different slope. In order to maintain a level of beneficial effect on cardiac 3 We note that although Deno’s specification recites Figure 30, no such figure is provided in the patent. 6 Appeal 2016-006628 Application 12/288,746 function, some sort of closed loop control of stimulation is necessary. Deno 42:20—38; see Ans. 2. Analysis Deno teaches that a “cardiac cycle is completed in the interval between successive PQRST complexes.” FF1. Deno teaches measuring time between V-V intervals. FF2. Deno teaches that if the V-V time interval is too short then no stimulation therapy is applied while if the time interval exceeds a certain threshold value then pacing is enabled. FF2. Deno in a separate disclosure teaches using feedback control for stimulating therapy. FF3. Deno observes that “a stimulation time that once gave the desired level of enhancement may now be associated with no enhancement, more or less mechanical function enhancement of the heart, and a different slope.” FF3. In other words, Deno explains that when nonexcitatory electrical stimulation (NES) therapy is applied over time the effectiveness of the treatment is reduced. See FF3. Appellants argue that Deno’s disclosure does not teach the claimed elements arranged or combined into the method as claimed. We agree with Appellants. To anticipate a reference must expressly or inherently disclose “within the four comers of the document not only all of the limitations claimed but also all of the limitations arranged or combined in the same way as recited in the claim.” Net Money IN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (2008). In an anticipation rejection, “it is not enough that the prior art reference . . . includes multiple, distinct teachings that [an ordinary] artisan might somehow combine to achieve the claimed invention.” Id. That 7 Appeal 2016-006628 Application 12/288,746 requirement does not mean that the claimed invention be described in Deno in ipsissimis verbis, In re Schaumann, 572 F.2d 312, 317 (CCPA 1978), but the description in Deno must be “sufficient to put the public in possession of the invention.” In re LeGrice, 301 F.2d 929, 933 (CCPA 1962). That is not the case here. Even if we agree with the Examiner that Deno teaches acquiring waveform data in a plurality of cardiac cycles and collecting therefrom information as to QRS intrinsic (FF2) and non-intrinsic electrical wave forms (FF2 & FF3), we find the Examiner has not met the burden of establishing Deno discloses the method as claimed. The Examiner recites two paragraphs of Deno and contends simply that one paragraph discloses steps (a) and (b) and the other discloses steps (c) and (d), but fails to explain how these disclosures meet the specific identifications and evaluations required by the claim to achieve the claimed determination of the true ventricular-depolarization onset. It is not apparent on its face how the disclosure of FF2 of measuring a V-V interval and comparing to a threshold to determine whether to enable a pacing pulse or abort stimulation therapy and FF3 concerning that X-Y plots with slope differences demonstrate a need for “some sort of closed loop control of stimulation,” would be arranged so as to meet the method steps that result in the claim method’s determination of the true ventricular-depolarization onset. (Compare claim 10 (identifying which measured cardiac event is the “true ventricular- depolarization onset”) with FF2 (assessing whether a V-V interval is greater than a threshold to determine whether to enable a pacing pulse or abort stimulation therapy) and FF3 (discussing that X-Y plots with slope 8 Appeal 2016-006628 Application 12/288,746 differences demonstrate a need for “some sort of closed loop control of stimulation”).) A generic disclosure that the various elements may be arranged in numerous ways is not a teaching that they are or should be combined in particular way that would arrive at the limitations as set out in claim 10. See Deno 44:36—39 (“[v]arious components of this invention [can] work together to provide safe and effective stimulation therapies for cardiac dysfunction, including arrhythmias and HF [(heart failure)], among others”). Because the Examiner has not established, at a minimum, that the claim elements are arranged or combined in Deno in the same way as in the claim, we reverse the Examiner’s anticipation rejection. SUMMARY We reverse the rejection of claims 2, 3, and 10 under pre-AIA 35 U.S.C. § 102(b) as anticipated by Deno. REVERSED 9 Copy with citationCopy as parenthetical citation