Ex Parte Canfield et alDownload PDFPatent Trial and Appeal BoardSep 30, 201612183688 (P.T.A.B. Sep. 30, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/183,688 07/3112008 27581 7590 10/04/2016 Medtronic, Inc. (CRDM) 710 MEDTRONIC PARKWAY NE MS: LC340 Legal Patents MINNEAPOLIS, MN 55432-9924 FIRST NAMED INVENTOR Monte R. Canfield 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 ATTORNEY DOCKET NO. CONFIRMATION NO. P0024646.00/LG10126 6028 EXAMINER IP,JASONM ART UNIT PAPER NUMBER 3777 NOTIFICATION DATE DELIVERY MODE 10/04/2016 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): medtronic_crdm_docketing@cardinal-ip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MONTER. CANFIELD, MICHAEL R. NEIDERT, and KENNETH GARDESKI Appeal2014--002334 Application 12/183,688 Technology Center 3700 Before MICHAEL L. HOELTER, ANNETTE R. REIMERS, and JILL D. HILL, Administrative Patent Judges. REIMERS, Administrative Patent Judge. DECISION ON APPEAL Appeal2014-002334 Application 12/183,688 STATEMENT OF THE CASE 1,2 Monte R. Canfield et al. (Appellants) appeal under 35 U.S.C. § 134(a) from the Examiner's decision to reject under 35 U.S.C. § 103(a): (1) claims 1 and 13 as unpatentable over Verard (US 2004/0097805 Al; pub. May 20, 2004) and Shin (US 2006/0173373 Al; pub. Aug. 3, 2006), (2) claims 1 and 13 as unpatentable over Verard and Shin and Heath (US 4,419,998; iss. Dec. 13, 1983), (3) claims 1, 8, 10-16, 30, and 38 as unpatentable over Verard, Shin, and Degen, 3 (4) claims 4--7, 9, 17-29, and 39-41 as unpatentable over Verard, Shin, Degen, and Reddy (US 2004/0077941 Al; pub. Apr. 22, 2004). Claims 2, 3, and 31-37 have been cancelled. We have jurisdiction under 35 U.S.C. § 6(b ). We REVERSE and enter a NEW GROUND OF REJECTION pursuant to our authority under 3 7 C.F .R. § 41. 50(b ). 1 The Examiner has withdrawn the rejection of claims 1, 4--29, 3 8--40, 42, and 44 under 35 U.S.C. § 112, second paragraph, for indefiniteness. See Ans. 3. 2 Appellants filed a Supplemental Amendment to claims 42--44 with the Appeal Brief. See Supplemental Amendment filed July 29, 2013. In the Advisory Action, the Examiner states that "[t]he amendment After Final filed on 07 /29/2013 has been considered and is okay to be entered." See Advisory Action mailed Dec. 12, 2013. However, the proposed amendments to claims 42--44 remove claim limitations thereby broadening the scope of the claims. Accordingly, claims 42--44 are not before us for review. 3 Degen et al., "A Pseudodifferential Amplifier for Bioelectric Events with DC-offset Compensation Using Two Wire amplifying Electrodes," IEEE Trans Biomed Eng. Vol. 53, No.2, pp. 300-310 (2006). 2 Appeal2014-002334 Application 12/183,688 CLAIMED SUBJECT MATTER The claimed subject matter relates to "using one or more medical images to assist in navigating an instrument through internal body structures." Spec. para. 1; Figs. 1, 6. Claims 1, 13, 18, 26, 30, 38, 39, and 41 are the independent claims on appeal. Claims 1, 30, and 41 are illustrative of the claimed subject matter and recite: 1. An image guided navigation system for guiding an instrument through a region of a patient, said image guided navigation system compnsmg: an anatomical gating device operable to sense an R-wave and diastole in a cardiac cycle; an imaging device operable to capture image data of the region of the patient; a tracking device operable to track the position of the instrument in the region of the patient; a controller in communication with said anatomical gating device, said imaging device and said tracking device and operable to register said image data \~1ith the region of the patient, said controller further operable to superimpose an icon representing the instrument onto the image data of the region of the patient based upon the position tracked by said tracking device; and a display operable to display the image data of the region of the patient with the superimposed icon of the instrument, the anatomical gating device being operable to generate a diastolic detection window for confirming whether the patient is in diastole before capturing image data, means for determining whether an R-wave has occurred within the diastolic detection window by: (a) means for determining a lack of a DC offset associated with an ECG signal within the diastolic window; and (b) means for generating a gating signal in response to determining the lack of a DC offset associated with the ECG signal. 3 Appeal2014-002334 Application 12/183,688 30. A method of image guiding an instrument in a region of a patient, the method comprising: identifying an R wave; generating a diastolic detection window in response to identifying the R-wave; determining a lack of a DC offset associated with an electrocardiogram (ECG) signal during the diastolic detection window; and generating a gating signal in response to determining a lack of a DC offset associated with the ECG signal. 41. A method of image guiding an instrument in a region of a patient, the method comprising: determining a low slew associated with an electrocardiogram (ECG) signal; and responsive to the determining of the low slew, triggering a guiding instrument. ANALYSIS In this opinion, we first consider the Examiner's rejections of independent claims 30 and 41. \Ve then set forth a nev,r ground of rejection for independent claims 1, 13, 18, 2 6, 3 8, and 3 9, and their respective dependent claims, and consider the prior art rejections of those claims in light of the new ground of rejection. Obviousness over Verard, Shin, and Degen Claim 30 The Examiner finds that Verard and Shin disclose method claim 30 substantially as claimed except for the step of determining DC offset of an ECG signal during the diastolic detection window. Final Act. 16. The Examiner finds that "[ t ]he limitation of determining whether or not a DC offset is associated with the ECG signal is one that is addressed in the art 4 Appeal2014-002334 Application 12/183,688 and well-known, hence it would have been obvious to account for DC offset since the characteristic feature of an R peak is its larger amplitude relative to other peaks in an ECG reading." Id. The Examiner concludes that it would have been obvious "to apply the teachings of [Shin] to the methods of [Verard], [] to provide features pertinent and useful to the goals of [Verard]." Id.; see also Ans. 13. Regarding "lack of a DC" offset, we also note that the Examiner finds that neither Verard nor Shin "specifically disclose the detection of a lack of a DC offset associated with an ECG signal. However, [Degen] teach[ es] the detection of a lack of DC offset in an ECG signal (pgs.300-310)." Final Act. 13. The Examiner concludes that it would have been obvious to modify Verard and Shin with Degen "to provide an account of DC offset in an ECG waveform as it pertains to a subsequent analysis of the ECG waveform." Id. Appellants contend that the motivation for proposed modification is improper, and the proposed modification does not result in the claimed invention. See Appeal Br. 22. Specifically, Appellants contend "[ w ]hile DC offset is known, [the claims include] 'generating a gating signal in response to determining the lack of a DC offset associated with the ECG signal."' Id. Appellants further point out the Examiner cited to pages 300-310 of Degen, the entire document, and provided a "terse rejection [of] little assistance in understanding as to why [Degen] is cited at all .... [Degen] does include DC offset but it is directed to a totally unrelated purpose." Id. Appellants explains that Degen seeks to suppress or remove all DC offset, rather than just determining the lack of DC offset at a particular window of time during the cardiac cycle as in the claimed invention. See id.; see also id. at 21. 5 Appeal2014-002334 Application 12/183,688 In the Answer, the Examiner maintains that "Degen adequately teach[es] the detection of DC offset in a biological signal. [Degen] provides sufficient suggestion to one of ordinary skill that DC offset can be detected for biological waveforms." Ans. 34. In discussing DC offset being a well-known phenomenon detected in biological waveforms, the Examiner has only shown that it is known to try to suppress overall DC offset, not determine a lack of DC in a specific time window, and then generate a signal in response to the lack of DC in that window. Final Act. 13, 16; see also Ans. 34. As such, the Examiner fails to establish by a preponderance of the evidence that the combined teachings of Verard, Shin, and Degen disclose the method of claim 30. Accordingly, we do not sustain the Examiner's rejection of claim 30 as unpatentable over Verard, Shin, and Degen. Obviousness over Verard, Shin, Degen, and Reddy Claim 41 Claim 41 requires a "low slew." We interpret "low slew" to mean below a predetermined threshold value, as set forth in Appellants' Specification. Spec. para. 63. The Examiner finds that Verard and Shin disclose method claim 41 substantially as claimed except for the step of "determining a low slew ... and responsive to the determining of the low slew, triggering." See Final Act. 22. The Examiner finds that neither Verard nor Shin "specifically disclose determining characteristics of slew of an ECG signal." Id. The Examiner finds that Reddy "teach[ es] comparing features of an ECG to features acquired at a previous time ([0053]) and identifying arrhythmias and abnormal heart beats ([0040]; [0053])." Id. The Examiner then concludes 6 Appeal2014-002334 Application 12/183,688 that "[ s ]ince the slew rate of a signal is a maximum rate of change of a signal, it would have been obvious to consider this as a feature of an electrical reading such as an ECG, given the known patterns of ECG readings" and that it would have been obvious to combine Verard and Shin with "the comparison of features" of Reddy "to provide feature comparison." Id. at 22-23. Appellants contend that the motivation for proposed modification is improper, and the proposed modification does not result in the claimed invention. See Appeal Br. 23. Specifically, Appellants contend: Id. Reddy employs a system that associates ECG waveform data with medical imaging data using ECG gating for dose reduction. [Reddy] does not mention slew. [Reddy] appears to gate after detecting the R wave by incorporating a cardiac cycle delay of P msec. Since Reddy does not mention ... slew, Reddy cannot make the independent claims obvious. In response to Appellants' argument, the Examiner states: [ w ]hile DC offset and slew rate are not directly addressed [in Reddy], these two features are commonly known within the field of medical/non-medical signal analysis. Slew rate is generally defined as a rate of change of a signal, and in this particular case, determining measurements and morphology (e.g. shape) of an ECG waveform (paragraph [0053] of Reddy) would surely consider a feature such as the slew. Ans. 35. The references provided by the Examiner do not even mention slew, (i.e., the slope of an ECG signal), as correctly pointed out by Appellants, or show that it is known to determine low slew (i.e. a value of slew below a predetermined threshold value). The Examiner has further not articulated 7 Appeal2014-002334 Application 12/183,688 that it would have been obvious to trigger a guidance in response to determining low slew; rather, the Examiner's reliance on Reddy is only sufficient to show that features (such as slew) can be analyzed. Furthermore, it is noted that both Verard and Shin are directed towards determining that an R-wave is occurring, which results in high slew, rather than the absence of an R-wave, which results in low slew. See Spec. paras. 68---69. As such, based on the foregoing reasons, the Examiner fails to establish by a preponderance of the evidence that the combined teachings of Verard, Shin, Degen, and Reddy disclose the method of claim 41. Accordingly, we do not sustain the Examiner's rejection of claim 41 as unpatentable over Verard, Shin, Degen, and Reddy. NEW GROUND OF REJECTION 35 USC§ 112, Second Paragraph Pursuant to our authority under 37 C.F.R. § 41.50(b ), we reject claims 1, 4--29, and 38--40 under 35 U.S.C. § 112, 2nd paragraph as being indefinite for failing to particularly point out and distinctly claim the subject matter which the applicant regards as the invention. Claim 1 recites means plus function language that presumably invokes 35 U.S.C. § 112, 6th paragraph, (i.e., "means for determining whether an R-wave has occurred within the diastolic detection window," "(a) means for determining a lack of a DC offset associated with an ECG signal within the diastolic window," and "(b) means for generating a gating signal in response to determining the lack of a DC offset associated with the ECG signal.") Use of the term "means" raises a presumption that the inventor used the term 8 Appeal2014-002334 Application 12/183,688 to invoke 35 U.S.C. § 112, 6th paragraph. Altiris, Inc. v. Symantec Corp., 318 F.3d 1363, 1375 (Fed. Cir. 2003). Appellants confirm this presumption. See Appeal Br 15. However, the Examiner does not interpret claim 1 as means-plus- function language. See Ans. 25-26. It is noted that "[t]he first step in construing a means-plus-function claim limitation is to define the particular function of the claim limitation. . . . The next step ... is to look to the specification and identify the corresponding structure for that function (citation omitted)." Golight, Inc. v. Wal-Mart Stores, Inc., 355 F.3d 1327, 1333-34 (Fed. Cir. 2004). However, our reviewing court has also provided instruction that if a patentee "employs means-plus-function language in a claim, [the patentee] must set forth in the specification an adequate disclosure showing what is meant by that language." Blackboard, Inc. v. Desire2Learn, Inc., 574 F.3d 1371, 1382 (Fed. Cir. 2009) (internal quotation marks and citation omitted). "If the specification does not contain an adequate disclosure of the structure that corresponds to the claimed function, the patentee will have failed to particularly point out and distinctly claim the invention [under§ 112, i-f 2], which renders the claim invalid for indefiniteness." Id. (internal quotation marks and citation omitted). In this case, the Specification fails to show what is meant by the means-plus-function language. As a result, we are unsure what specific structure is associated with each individual means-plus-function recitation and therefore cannot ascertain the scope of the claim. Because the Specification sets forth no corresponding structure, one skilled in the art would not understand the scope of claim 1, rendering it unclear and indefinite. Independent claims 13, 18, and 39 recite the same or 9 Appeal2014-002334 Application 12/183,688 similar "means for" language discussed above for claim 1. Accordingly, for the reasons set forth above for claim 1, claims 13, 18, and 3 9 are rendered unclear and indefinite as well. We further note that the recitation "means for determining whether an R-wave has occurred within the diastolic detection window by ... means for generating a gating signal" in claim 1 is not clear as to how the "means for generating a gating signal" determines whether an R-wave has occurred. Rather, upon review of the Specification, it appears that the gating signal is generated in response to determining whether an R-wave has occurred, (i.e., that an R-wave has not occurred in the diastolic detection window). See e.g., Spec., paras. 59, 64. For this reason, we further find the scope of claim 1 to be unclear and indefinite. Independent claims 13, 18, and 39 recite the same or similar language to claim 1. As such, we further find the scope of claims 13, 18, and 39 to be unclear and indefinite. We also note that claims 26 and 38 similarly recite that the determination of whether an R-wave occurred is by generating a gating signal, while the Specification appears to show that a gating signal is generated in response to the determination of whether an R- wave occurred. See e.g., Spec., paras. 59, 64. For this reason, we find the scope of claims 26 and 38 to be unclear and indefinite. Claims 4--12, 14--17, 19--25, 27-29, and 40 are also rejected based on their dependence from the independent claims. Obviousness Rejections Claims 1, 4-29, and 38-40 For the reasons set forth above in the 112, second paragraph new ground of rejection, the "means for" limitations in independent claims 1, 13, 18, and 39, and the "determining whether an R-wave has occurred within the 10 Appeal2014-002334 Application 12/183,688 diastolic detection window by" "generating a gating signal" limitations of claims 1, 13, 18, 26, 38, and 39 render these claims and their respective dependent claims 4--12, 14--17, 19-25, 27-29, and 40 indefinite. These limitations are critical to deciding the propriety of the prior-art rejections. Having determined that claims 1, 4--29, and 38--40 are indefinite, we cannot sustain the rejections of these claims under 35 U.S.C. § 103(a) because to do so would require speculation as to the scope of the claims. In re Steele, 305 F.2d 859, 862-63 (CCPA 1962) (holding that the Board erred in affirming a rejection of indefinite claims under 35 U.S.C. § 103(a), because the rejection was based on speculative assumptions as to the meaning of the claims). Accordingly, we do not sustain the obviousness rejections of claims 1, 4--29, and 38--40. DECISION We REVERSE the decision of the Examiner to reject claim 30 as unpatentable over Verard, Shin, and Degen. We REVERSE the decision of the Examiner to reject claim 41 as unpatentable over Verard, Shin, Degen, and Reddy. We REVERSE the Examiner's decision to reject claims 1, 4--29, and 38--40 under 35 U.S.C. § 103(a). We enter a new ground of rejection, pursuant to 37 C.F.R. § 41.50(b), of claims 1, 4--29, and 38--40. This decision contains a NEW GROUND OF REJECTION pursuant to 37 C.F.R. § 41.50(b), which provides that "[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review." 11 Appeal2014-002334 Application 12/183,688 37 C.F.R. § 41.50(b) also provides that Appellants, WITHfN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new grounds of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new Evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the prosecution will be remanded to the examiner. The new ground of rejection is binding upon the examiner unless an amendment or new Evidence not previously of Record is made which, in the opinion of the examiner, overcomes the new ground of rejection designated in the decision. Should the examiner reject the claims, appellant may again appeal to the Board pursuant to this subpart. (2) Request rehearing. Request that the proceeding be reheard under§ 41.52 by the Board upon the same Record. The request for rehearing must address any new ground of rejection and state with particularity the points believed to have been misapprehended or overlooked in entering the new ground of rejection and also state all other grounds upon which rehearing is sought. Further guidance on responding to a new ground of rejection can be found in the Manual of Patent Examining Procedure§ 1214.01. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(l)(iv). REVERSED; 37 C.F.R. § 41.50(b) 12 Copy with citationCopy as parenthetical citation