Ex Parte HaefnerDownload PDFBoard of Patent Appeals and InterferencesJul 12, 201011019497 (B.P.A.I. Jul. 12, 2010) 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. 11/019,497 12/21/2004 Paul Allan Haefner GUID.630PA 1600 51294 7590 07/12/2010 HOLLINGSWORTH & FUNK 8500 Normandale Lake Blvd SUITE 320 MINNEAPOLIS, MN 55437 EXAMINER LEE, YUN HAENG NMN ART UNIT PAPER NUMBER 3766 MAIL DATE DELIVERY MODE 07/12/2010 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES ____________ Ex parte PAUL ALLAN HAEFNER ____________ Appeal 2009-007855 Application 11/019,497 Technology Center 3700 ____________ Before: LINDA E. HORNER, JENNIFER D. BAHR, and STEVEN D.A. MCCARTHY, Administrative Patent Judges. HORNER, Administrative Patent Judge. DECISION ON APPEAL1 1 The two-month time period for filing an appeal or commencing a civil action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing, as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE” (paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery mode) shown on the PTOL-90A cover letter attached to this decision. Appeal 2009-007855 Application 11/019,497 2 STATEMENT OF THE CASE Paul Allan Haefner (Appellant) seeks our review under 35 U.S.C. § 134 of the Examiner’s decision rejecting claims 1-21. Reply Br. 3. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. THE INVENTION Appellant’s claimed invention is an implantable cardiac device and methods of use. Spec. 1:5-7. Claim 1, reproduced below, is representative of the subject matter on appeal. 1. An implantable cardiac device, comprising: a housing having a first face opposing a second face, and an edge extending from a perimeter of the first face to a perimeter of the second face; a pulse generator comprising a controller provided in the housing; and a plurality of electrodes coupled to the pulse generator and arranged in a spaced relationship on the housing; wherein the controller is configured to measure a plurality of signals using a plurality of electrode combinations and to automatically select a particular electrode combination of the plurality of electrode combinations that provides for improved cardiac signal sensing relative to other ones of the plurality of electrode combinations based on the measured signals. THE REJECTIONS Appellant seeks review of the following rejections by the Examiner:2 1. Rejection of claims 1-5, 7, 8, 11-16, and 18-21 under 35 U.S.C. § 102(b) as anticipated by Cao (US 2001/0034487 A1). 2 These rejections are new grounds of rejection in the Examiner’s Answer. The Examiner’s Answer does not include the rejection of claims 1-21 under 35 U.S.C. § 103(a) as unpatentable over Cao and Klein that was made in the Final Office Action. We treat this rejection as withdrawn. Appeal 2009-007855 Application 11/019,497 3 2. Rejection of claims 6, 9, 10, and 17 under 35 U.S.C. § 103(a) as unpatentable over Cao. ANALYSIS 1. Rejection of claims 1-5, 7, 8, 11-16, and 18-21 under 35 U.S.C. § 102(b) as anticipated by Cao (2001/0034487 A1) Claims 1-5, 8, 11-16, and 19-21 Appellant argues claims 1-5, 8, 11-16, and 19-21 as a group.3 Reply Br. 12-18. We select claim 1 as the representative claim, and claims 2-5, 8, 11-16, and 19-21 stand or fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii). The issue before us is whether Cao discloses a controller configured to automatically select the signal, from a plurality of signals produced by electrode combinations, that provides for improved cardiac signal sensing relative to the other signals, as called for in claim 1. Claim 1 is directed to an implantable cardiac device that includes a controller configured to automatically select the signal, from a plurality of signals produced by electrode combinations, that provides for improved cardiac signal sensing relative to the other signals. Appellant’s Specification does not provide a lexicographical definition of an “improved cardiac signal,” and describes, by way of example, that the controller may select the 3 Appellant has not argued claims 12 and 21 separately from claim 1. Appellant mentions independent claims 12 and 21 under a separate heading, and expresses a preference that these claims be considered separately; however, Appellant merely points out a limitation recited by each claim (Reply Br. 17). 37 C.F.R. § 41.37(c)(1)(vii) (2009) (“[a] statement which merely points out what a claim recites will not be considered an argument for separate patentability of the claim.”). Appellant admits that independent claims 12 and 21 “each concern subject matter similar to independent claim 1,” points to no distinction between claims 12 and 21 and claim 1, and relies upon the same arguments made for independent claim 1. Reply Br. 17. Appeal 2009-007855 Application 11/019,497 4 combination of electrodes having “the greatest magnitude cardiac signal.” Spec. 12:7-10. Cao discloses an Insertable Loop Recorder (ILR) that is inserted in a patient’s body to sense physiologic signals. Cao 1, para. [0001]. The ILR includes multiple electrodes 3 for producing multiple sensing vectors between pairs of electrodes, such as electrodes a and b (a-b) producing sensing vector y1, and electrodes c and a (c-a) producing sensing vector y2. Cao 3, paras. [0031], [0035]; 4, para. [0041]; fig. 3A. Cao discloses combination circuits that select from among the multiple sensing vectors the maximum rectified signal (ytotal), where (ytotal) is: ytotal = Max{|y1|, |y2|,…,|yi|}; where i=1, 2,…N or combination of any vectors; and N=Number of vectors. Cao 4, paras. [0036]-[0041]; fig. 4. For example, where there are two sensor vectors, the equation will be ytotal=Max{|y1|, |y2|}. Cao 4, para. [0041]. Given this, Cao discloses a controller (combination circuits shown in Figure 4) configured to automatically select the signal (ytotal) from among a plurality of signals (e.g., sensor vectors |y1|, |y2|) produced by electrode combinations (e.g., a-b, c-a). Further, just as Appellant’s device automatically selects the signal having “the greatest magnitude cardiac signal” (Spec. 12: 7-10), Cao’s controller likewise selects the signal having the maximum rectified signal (Cao 4, paras. [0036]-[0041]; fig. 4). Accordingly, Cao discloses a controller configured to automatically select the signal, from a plurality of signals produced by electrode combinations, that provides for improved cardiac signal sensing relative to the other signals Appeal 2009-007855 Application 11/019,497 5 as called for in claim 1. We are unpersuaded by Appellant’s arguments to the contrary. Appellant argues that ytotal is a combined signal and not a signal from a “particular electrode combination” as called for in claim 1, because Cao refers to ytotal as a “combination signal.” Reply Br. 14-15. Appellant appears to use the term “combined” in the sense that two signals have been summed to become one; however, Cao uses the term “combined” in the sense that the signal (ytotal) may be composed of time segments of a plurality of signal vectors (e.g., y1 and y2). For example, if during a first time period sensor vector y1 is the maximum rectified signal, then sensor vector y1 will be selected to be ytotal for that period, and if during a sequential second time period the sensor vector y2 is the maximum rectified signal, then sensor vector y2 will be selected as ytotal for that period. As such, Cao’s “combination signal” ytotal over a first and second time period would be a combination of y1 and y2. Appellant argues that ytotal is not a signal from a “particular electrode combination” as called for in claim 1, because Cao refers to capturing “signals” for appropriate sensing. Reply Br. 14 (emphasis Appellant’s) (citing Cao 4, para. [0041]). We disagree with Appellant’s reading of Cao. Cao is referring in this instance to the plurality of sensor vectors, and not to the combined signal ytotal. Cao 4, para. [0041]. Appellant makes other arguments based on additional capabilities of Cao’s device, such as user selection of signal vectors (electrode pairs), and automatic selection of a second electrode pair when the signal amplitude of a first electrode pair drops. Reply Br. 12-13, 22. These arguments are not relevant because our finding that Cao discloses automatic signal selection as Appeal 2009-007855 Application 11/019,497 6 called for in claim 1 is based on the embodiment discussed supra, and is not based upon any of these additional capabilities. Appellant argues that Cao’s plurality of signals (e.g., sensor vectors |y1|, |y2|) is delivered to a differential amplifier, and that a differential amplifier does not automatically select a signal as called for in claim 1. Reply Br. 16, 25-264. Again, we disagree with Appellant’s reading of Cao. Cao describes ytotal in detail, specifying that the combined circuit selects the signal vector having the greatest rectified signal. Cao 4, paras. [0036]- [0041]. Following this, Cao describes how ytotal is processed by the remainder of the device, representing the input mechanism 38 in the block diagram of Figure 5 as a differential amplifier “for purposes of simplicity.” Cao 4, para. [0043]; fig. 5. A person of ordinary skill in the art, taking Cao’s disclosure as a whole, would recognize that ytotal is more accurately described by the detailed explanation, rather than by the shorthand reference to a differential amplifier. Cao discloses a controller configured to automatically select the signal, from a plurality of signals produced by electrode combinations, that provides for improved cardiac signal sensing relative to the other signals as called for in claim 1. Claims 2-5, 8, 11-16, and 19-21 fall with claim 1. Claims 7 and 18 The issue with regard to claims 7 and 18 is whether Cao discloses a “predetermined threshold” as called for in claims 7 and 18. The Examiner construed the “predetermined threshold” of claims 7 and 18 to be broad enough to permit the predetermined threshold to be based upon a comparison between the sensed signals. Ans. 4, 9. Based on this 4 Referring to Cao’s input mechanism 38 depicted in Figure 5 and described in Cao 4, para. [0043]. Appeal 2009-007855 Application 11/019,497 7 claim construction, the Examiner found that Cao discloses use of a “non- maximal signal” as a predetermined threshold, meaning that the signal (from an electrode combination) having the second greatest amplitude serves as the predetermined threshold to select the signal having the greatest magnitude. Ans. 9. We conclude that this claim construction is overly broad. Independent claim 1 requires the controller to be configured to automatically select the signal, from a plurality of signals produced by electrode combinations, that provides for improved cardiac signal sensing relative to the other signals. Similarly, independent method claim 12 includes the step of selecting a sense vector that provides for improved cardiac signal sensing relative to the other sense vectors. Consequently, claims 1 and 12 require a comparison of the signals (sense vectors) from particular electrode combinations. Claim 7 depends from independent claim 1 and adds the limitation that the controller selects the electrode combination having an amplitude or signal-to-noise ratio that exceeds a predetermined threshold. Similarly, claim 18 depends from independent claim 12 and adds the limitation of selecting the sense vector that provides for improved cardiac sensing based upon a predetermined threshold. In order for claims 7 and 18 to further limit their respective independent claims, as a dependent claim must, the predetermined threshold requires more than simply comparing the plurality of signals for selection of the signal that provides for improved cardiac signal sensing as called for in independent claims 1 and 12. The Examiner’s claim construction would render the limitations of claims 7 and 18 meaningless as such comparison is already required by independent claims 1 and 12, respectively. Because the Examiner’s finding is based upon an improper claim construction, we agree with Appellant that Appeal 2009-007855 Application 11/019,497 8 Cao’s “non-maximal” signal (the comparison between the plurality of signals from electrode combinations) is not a predetermined threshold as called for in claims 7 and 18. Reply Br. 26. 2. Rejection of claims 6, 9, 10, and 17 under 35 U.S.C. § 103(a) as unpatentable over Cao Claims 6 and 17 The Examiner found that it was well known in the art to sense skeletal muscle activity for the purpose of noise detection, citing to Whigham (US 4,779,617) as evidence. Ans. 5. Appellant argues that neither Cao nor Whigham discloses controller selection of an electrode combination from a plurality of electrodes that preferentially provides for sensing of skeletal muscle activity as called for in claims 6 and 17. Reply Br. 19. The issue before us is whether Cao in combination with well known knowledge in the art would have led one having ordinary skill in the art to a controller that selects an electrode combination from a plurality of electrodes that preferentially provides for sensing of skeletal muscle activity as called for in claims 6 and 17. Claim 6 depends from independent claim 1, adding the limitation that “the arrangement of electrodes facilitates controller selection of a first electrode combination that preferentially provides for sensing of cardiac activity and a second electrode combination that preferentially provides for sensing of skeletal muscle activity.” Similarly, claim 17 depends from independent method claim 12, and adds the limitation of “selecting a first sense vector that preferentially provides for sensing of cardiac activity and a second sense vector that preferentially provides for sensing of skeletal muscle activity.” We interpret claims 6 and 17 to require selection of an Appeal 2009-007855 Application 11/019,497 9 electrode combination (sense vector) that provides for sensing of skeletal muscle activity. We determined in the analysis of the rejection of claim 1, supra, that Cao discloses a controller configured to automatically select the signal, from a plurality of signals produced by electrode combinations, that provides for improved cardiac signal sensing relative to the other signals. Consequently, the distinction between Cao and the subject matter of claims 6 and 17 is use of a second electrode combination for sensing skeletal muscle activity. Whigham5 discloses an implantable pacemaker that includes a system for rejecting noise, to include noise caused by skeletal muscle activity that is sensed in a cardiac signal, was well known in the art at the time of Appellant’s invention. Whigham, col. 1, ll. 5-7; col. 2, ll. 3-5. Whigham’s device detects noise from skeletal myopotentials, which is later analyzed and used to reject noise that occurs during the sensing interval, such as by use of a filter 12 that leaves only cardiac frequencies of interest. Whigham, col. 3, ll. 35-41, 45-49. We conclude a person of ordinary skill in the art armed with the knowledge of Cao’s controller configured to automatically select the signal from a plurality of signals produced by electrode combinations, 5 Appellant contends to have properly traversed the Examiner’s Official Notice, so that Whigham may not be considered. Reply Br. 18-19. However, Appellant simply “invited” the Examiner to provide a reference for the Official Notice, but did not provide evidence or rationale as to why the noticed fact is not considered to be well-known in the art. Response under 37 C.F.R. § 1.111, filed Nov. 20, 2006, page 9. Such is not a proper traverse, and the reference may be considered. See Manual of Patent Examining Procedure § 2144.03C (8th ed., Rev. 8, July 2008) (“To adequately traverse such a finding, an applicant must specifically point out the supposed errors in the examiner's action, which would include stating why the noticed fact is not considered to be well-known in the art.”); see also 37 C.F.R. § 1.111(b); Appeal 2009-007855 Application 11/019,497 10 and the knowledge that skeletal muscle activity can be detected and filtered from cardiac signals of interest, would have been led to the subject matter of claims 6 and 17 for the purpose of noise detection, i.e., to improve signal quality. Claim 9 Claim 9 depends from claim 1, and adds the limitation that “the plurality of electrodes comprises at least three electrodes positioned on the edge of the housing and wrapping over a portion of the first and second faces of the housing.” The issue is whether Cao discloses the at least three electrodes positioned as called for in claim 9. The Examiner found that Cao does not disclose electrodes wrapping over a portion of the first and second faces of the housing, but concluded “it would have been obvious to one of ordinary skill in the art to have the electrodes wrapping over a portion of the first and second faces of the housing since Appellant does not give any criticality to the wrapping-over of the electrodes.” Ans. 5-6, 9-10. We cannot sustain this rejection because the Examiner’s approach does not provide any rationale for the modification, but rather attempts to shift the burden to the Appellant to prove criticality. KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007), quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”). Claim 10 Claim 10 depends from claim 1, and adds the limitation that “the plurality of electrodes comprises at least three electrodes positioned on the first face of the housing and at least three electrodes positioned on the Appeal 2009-007855 Application 11/019,497 11 second face of the housing.” The issue is whether modification of Cao’s device from having at least three electrodes on either the first or the second face of the housing, to having at least three electrodes on each of the first and second faces of the housing would have been an obvious duplication of parts. Appellant does not contend that the subject matter of claim 10 produces a new or unexpected result. Reply Br. passim. Appellant contends that such a modification is not merely a duplication of parts because Cao discloses use of signal vectors across pairs of electrodes in orthogonal relationships, and such use would be “problematic” in the modified device where an electrode pair could be positioned on the first and second faces. Reply Br. 21. Appellant’s argument is unconvincing because it is not commensurate with the claim. Claim 10 requires at least three electrodes on each of the first and second faces of the housing, but does not require use of an electrode combination (pair) for producing a sensor vector consisting of one electrode on the first and one on the second faces. We agree with the Examiner (Ans. 6), that modification of Cao’s device from having at least three electrodes on either the first or the second face of the housing, to having at least three electrodes on each of the first and second faces of the housing would have been an obvious duplication of parts. In re Harza, 274 F.2d 669, 671 (CCPA 1960) (“It is well settled that the mere duplication of parts has no patentable significance unless a new and unexpected result is produced”). DECISION We AFFIRM the Examiner’s decision to reject claims 1-5, 8, 11-16, and 19-21 under 35 U.S.C. § 102(b) as anticipated by Cao. Appeal 2009-007855 Application 11/019,497 12 We REVERSE the Examiner’s decision to reject claims 7 and 18 under 35 U.S.C. § 102(b) as anticipated by Cao. We AFFIRM the Examiner’s decision to reject claims 6, 10, and 17 under 35 U.S.C. § 103(a) as unpatentable over Cao. We REVERSE the Examiner’s decision to reject claim 9 under 35 U.S.C. § 103(a) as unpatentable over Cao. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv) (2009). AFFIRMED-IN-PART nhl HOLLINGSWORTH & FUNK 8500 NORMANDALE LAKE BLVD SUITE 320 MINNEAPOLIS MN 55437 Copy with citationCopy as parenthetical citation