Ex Parte Hauck

Patent Trial and Appeal BoardApr 25, 2016

11647272 (P.T.A.B. Apr. 25, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 11/647,272 12/29/2006 55962 7590 Wiley Rein LLP Patent Administration 1776 K Street, NW Washington, DC 20006 04/27/2016 FIRST NAMED INVENTOR John A. Hauck 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. OG-040404US I 82410.0136 CONFIRMATION NO. 1469 EXAMINER NGANGA, BONIFACE N ART UNIT PAPER NUMBER 3769 NOTIFICATION DATE DELIVERY MODE 04/27/2016 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): ptodocket@wileyrein.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JOHN A. HAUCK Appeal2014-003790 Application 11/647,272 Technology Center 3700 Before JILL D. HILL, LISA M. GUIJT, and MARK A. GEIER, Administrative Patent Judges. GUIJT, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE John A. Hauck (Appellant) 1 appeals under 35 U.S.C. Â§ 134(a) from the Examiner's decision to reject claims 1-7, 9-13 and 28-33.2,3 Appeal Br. 4. We have jurisdiction under 35 U.S.C. Â§ 6(b). 1 According to Appellants, St. Jude Medical, Atrial Fibrillation Division, Inc. is the real party in interest. Appeal Br. 2. 2 Although claim 8 is included as rejected in the Final Action mailed February 26, 2013, claim 8 is cancelled. See Amendment dated May 28, 2013. Claims 14--27 and 34--38 are withdrawn. See Response to Species Election dated July 13, 2011. 3 See Non-Final Action dated Feb. 26, 2013 ("Non-Final Act."), from which this Appeal is taken. Appeal2014-003790 Application 11/647,272 We AFFIRM-IN-PART and designate our atlirmance as a NEW GROUND OF REJECTION pursuant to our authority under 37 C.F.R. Â§ 41.50(b). THE CLAIMED SUBJECT MATTER Claims 1 and 28 are independent, and claim 1, reproduced below, is illustrative of the subject matter on appeal. 1. A method of monitoring contact between a probe and a tissue surface, the probe having a sensor at a distal end thereof, the method comprising: placing the probe in proximity to the tissue surface; robotically moving the probe; measuring a tissue parameter at the distal end of the probe using the senor; calculating an amount of change in the measured tissue parameter between successive measurements thereof; and indicating a change in proximity or degree of contact between the probe and the tissue surface based upon the amount of change in the measured tissue parameter. THE REJECTIONS Claims 1-5, 13, and 28-31 stand rejected under 35 U.S.C. Â§ 102(b) as anticipated by Mah (US 6,718,196 Bl; iss. Apr. 6, 2004). Claims 6, 7, 9-12, 32, and 33 stand rejected under 35 U.S.C. Â§ 103(a) as unpatentable Mah and Bryenton (US 2005/0192488 Al; pub. Sept. 1, 2005). Claim 8 stands rejected under 35 U.S.C. Â§ 103(a) as unpatentable over Mah, Bryenton, and Boecker (US 2003/0199904 Al; pub. Oct. 23, 2003). 2 Appeal2014-003790 Application 11/647,272 ANALYSIS Claims 1-5, 13, and 28-31-Anticipation Independent claims 1and28, and dependent claims 2--4, 30, and 31 Regarding independent claim 1, the Examiner found, inter alia, that Mah discloses a method of robotically moving a probe into brain tissue to obtain continuous, real-time measurements of the resistance or density of the tissue, wherein sensors are incorporated into the probe's tip. Non-Final Act. 3 (citing Mah, col. 3, 11. 27-28, 30-33). The Examiner also found that Mah discloses penetrating a subject's brain with a cannula and "measuring the pressure or another parameter acting upon the cannula via one or more strain gauges secured to ... the probe." Id. (citing Mah, col. 5, 11. 20-25, col. 6, 11. 19-23). The Examiner further found that Mah discloses that a "computer system continually detects tissue property changes by performing a calculation comparing the measured tissue properties and/or measured changes to previously referenced tissue properties," and "notifies the surgeon based upon the detection result where the computer system has detected that a change in proximity of tissue to probe has occurred." Id. (Mah, col. 9, 11. 4--18); see also Ans. 3 (citing Mah, col. 11, 11. 41-57). The Examiner made similar findings for independent claim 28. See Non-Final Act. 6. The Examiner concludes that Mah "detect[s] a change in the proximity or degree of contact of the probe to specific types of tissue; not merely the change in the nature of the tissue itself." Ans. 18. First, Appellant argues that Mah does not disclose "'indicating a change in proximity or degree of contact between the probe and the tissue surface[,]"' as required by independent claim 1 and as similarly required by independent claim 28. Appeal Br. 9. Appellants submit that "Mah teaches a 3 Appeal2014-003790 Application 11/647,272 surgical probe that is placed into (rather than onto) and driven through tissue" to detect "a change in the nature of the tissue itself (e.g., from normal to abnormal) as the probe is driven therethrough," whereby "Mah's probe remains in contact with tissue once placed in contact by the physician, such that contact sensing (either proximity or degree) would be unnecessary." Id. We do not agree with Appellant that Mah's probe remains in contact with the tissue surface being monitored once the physician places the probe in contact with any tissue. Rather, Mah discloses detecting the proximity of blood vessels to the probe or detecting that the probe has contacted abnormal tissue within brain tissue, wherein the abnormal brain tissue surface is the tissue surface being monitored. See, e.g., Mah, Abstract. Similar to the tissue surface, or cardiac wall 82, as disclosed in Appellant's Specification, Mah's blood vessels and abnormal tissue are distinguishable from surrounding tissue, and therefore, have "tissue surfaces." Spec. ,-r 69; see also, e.g., Mah, col. 4, 11. 20-25 ("The present instrument may be used [for] . . . detecting the interface between normal tissue."). Thus, when Mah's probe enters and moves through brain tissue, but has not yet detected the proximity of a blood vessel to the probe or detected that the probe has contacted abnormal tissue, Mah's probe is placed in proximity to (i.e., near to, but not contacting)4 a tissue surface of the blood vessel or abnormal tissue, as required by independent claim 1, and Mah's probe has also been introduced 4 Appellant's Specification defines the claim term "proximity" as "the relationship between probe 12 and tissue surface 82 when probe 12 is not in contact with tissue surface 82; it is, in lay terms, a measure of how close 12 is to tissue surface 82." Spec. ,-r 73. 4 Appeal2014-003790 Application 11/647,272 into and is moving within a body of a patient, which includes an internal tissue surface, as implicitly required by independent claim 28. Second, Appellant contends that a change in "the nature of the tissue" cannot be reasonably interpreted as a change in the proximity of the tissue to the probe. Appeal Br. 9. We disagree. When Mah's probe detects that the probe has contacted abnormal tissue, Mah' s probe is also detecting that the probe' s proximity to the abnormal tissue has changed - the probe was in proximity to (i.e., near to, but not contacting) the abnormal tissue and now the probe is contacting the abnormal tissue, such that the probe' s proximity to the abnormal tissue has changed. Claims 1 and 28, as written, only require indicating "a change in proximity," in that the nearness of the spatial relationship between the probe and the tissue surface has changed. 5 Third, Appellant argues that the Examiner erred in finding that Mah' s strain gauges indicate a change in proximity between the probe and tissue surface based on a measured pressure parameter, and that, in any event, "pressure is not a tissue parameter." Appeal Br. 9. Mah discloses that "[t]he resistance of the brain tissue being penetrated is monitored by a ... strain gauge 93 attached to the tip of the biopsy probe 24," and that the strain gauges "measure pressure or another parameter acting on the cannula 22 or probe 24." Mah, col. 6, 11. 19-22; col. 9, 11. 56-59. We agree with the Examiner that the pressure exhibited by the tissue on the probe-cannula 5 Additionally, Mah specifically discloses that probe 24 may include a Laser Doppler blood flow sensor for measuring the proximity of the blood vessels to the cannula tip of the probe-cannula assembly, so that the probe detects blood vessels before it disrupts them. Mah, col. 3, 11. 44--45, col. 7, 11. 57- 59. 5 Appeal2014-003790 Application 11/647,272 assembly is a parameter of the tissue. 6 However, Mah does not expressly describe how pressure is used to detect the proximity of blood vessels to the probe or to detect that the probe has contacted abnormal tissue within brain tissue. Notwithstanding Mah's lack of disclosure regarding the use of pressure measurements, Appellant's Specification discloses that "[t]he tissue parameter may be ... ultrasonic feedback," and Mah specifically discloses using an ultrasound probe to aid in blood vessel detection and tissue identification. Spec. i-f 10; see also Mah, col. 3, 11. 50-52, col. 8, 11. 1-2.7 Thus, Mah discloses measuring a tissue parameter, i.e., ultrasonic feedback, as required by independent claim 1 and 28. Fourth, Appellant argues that "Mah detects changes in the nature of the tissue based not upon an amount of change, but rather the fact of a change in the tissue property vis-a-vis an initial or reference value." Appeal Br. 10. Mah discloses that "computer system 20 detects tissue property changes[], [and] compare[s] the measured tissue properties and/or measured changes in tissue properties to previously learned properties and to reference properties." Mah, col. 9, 11. 14--18. Thus, Mah discloses measuring changes (or the amount of change) in tissue properties and comparing the changes to other values to detect tissue property changes. 6 To the extent Appellant seeks to limit the definition of "tissue parameter" to the list provided in paragraph 10 of the Specification, the list is non- limiting in that the Specification states that "[t]he tissue parameter may be selected from a group consisting of impedance, phase angle, electro gram amplitude, optical feedback, and ultrasonic feedback." Spec. i-f 10 (emphasis added). 7 As noted supra, Mah also discloses the use of Laser Doppler blood flow sensor for measuring the proximity of the blood vessels to the cannula tip, and here, blood flow may be characterized as a parameter of the tissue. Mah, col. 7, 11. 57-59. 6 Appeal2014-003790 Application 11/647,272 Accordingly, we do not find Appellant's arguments persuasive, and we sustain the Examiner's rejection of independent claims 1and28 as anticipated by Mah. Because our analysis relies on disclosures in Mah that were not relied upon by the Examiner, we designate our affirmance as a new ground of rejection to provide Appellant with a full and fair opportunity to respond to the thrust of the rejection. Appellants chose not to present separate arguments for the patentability of dependent claims 2--4, 30, and 31, and thus, these claims fall with independent claims 1 and 28. Dependent claim 13 Claim 13 depends from independent claim 1 and recites "wherein the tissue parameter is selected from the group consisting of impedance, phase angle, electrogram amplitude, optical feedback, and ultrasonic feedback." Appeal Br. 16 (Claims App.). The Examiner found that Mah discloses "wherein the tissue parameter is selected from electrogram amplitude," because Mah discloses using a "microelectrode sensor to measure brain electrical activity." Non-Final Act. 6 (citing Mah, col. 8, 1. 6). Appellant argues that "Mah fails to expressly or inherently teach that this sensor is used to indicate changes in proximity or degree of contact between Mah' s probe and the tissue." Appeal Br. 11. The Examiner responds that "Mah discloses that the probe may include a variety of sensors ... including an ultrasound probe for tissue identification, a [L]aser [D]oppler blood flow sensor for measuring the rate of blood flow, and a microelectrode to measure brain electrical activity." Ans. 22 (citing Mah, col. 3, 11. 43-54, col. 7, 1. 45- col. 8, 1. 10). Appellant contends that "there is no support that ties Mah's alleged disclosure of sensors to its alleged disclosure of a sensor that measures proximity or degree of contact." Reply Br. 5. 7 Appeal2014-003790 Application 11/647,272 We are not persuaded by Appellant's argument. The Examiner correctly found that Mah discloses an ultrasound probe for tissue identification. Mah, col. 7, 1. 63. Claim 13 specifically includes "ultrasound feedback" as a "tissue parameter." Accordingly, we sustain the Examiner's rejection of dependent claim 13. Because claim 13 depends from independent claim 1, and because we designated our affirmance of the Examiner's rejection of claim as a new ground of rejection, we also designate our affirmance of the Examiner's rejection of claim 13 as a new ground of rejection to provide Appellant with a full and fair opportunity to respond to the thrust of the rejection. Dependent claim 29 Claim 29 depends from independent claim 28 and recites "wherein said sensor comprises an electrophysiology sensor." Appeal Br. 16 (Claims App.). The Examiner found that Mah's microelectrode sensor for measuring brain electrical activity corresponds to the claimed electrophysiology sensor. Non-Final Act. 7 (citing Mah, col. 8, 1. 6). Appellant argues that "[a]lthough Mah discloses a 'microelectrode sensor to measure brain activity[,]' Mah fails to expressly or inherently teach that this sensor is used to indicate changes in proximity or degree of contact between Mah's probe and the tissue." Appeal Br. 11; see also Reply Br. 5. We are persuaded by Appellant's argument. Although Mah discloses that the microelectrode sensor is used to measure brain electrical activity, Mah does not describe whether or not such a measurement is also used to detect the proximity of blood vessels to the probe or to detect that the probe has contacted abnormal tissue within brain tissue, as is, for example, the 8 Appeal2014-003790 Application 11/647,272 ultrasound probe or Laser Doppler blood flow sensor. See Mah col. 7, 11. 56-58, 62, col. 8, 1. 7. Accordingly, we do not sustain the Examiner's rejection of dependent claim 29. Claims 6--12, 32, and 33 - Obviousness Appellant chose not to present separate arguments for the patentability of dependent claims 6-12, 32, and 33 apart from contending that "[t]he shortcomings of Mah with respect to [independent] claims 1 and 28, []are neither addressed nor overcome via the addition of Bryenton." Appeal Br. 11-12. Because we are not persuaded by Appellant's arguments regarding deficiencies in Mah, as discussed supra, we also sustain the Examiner's rejection of dependent claims 6-12, 32, and 33. DECISION The Examiner's decision to reject claims 1-5, 13, 28, 30, and 31 under 35 U.S.C. Â§ 102(b) as anticipated by Mah is affirmed and designated as a new ground of rejection. The Examiner's decision to reject claim 29 under 35 U.S.C. Â§ 102(b) as anticipated by Mah is reversed. The Examiner's decision to reject claims 6, 7-12, 32, and 33 under 35 U.S.C. Â§ 103(a) is affirmed. Regarding the affirmed rejection, 37 C.F.R. Â§ 41.52(a)(l) provides "Appellant may file a single request for rehearing within two months from the date of the original decision of the Board." In addition to affirming the Examiner's rejection of one or more claims, this decision contains an affirmance designated as a new ground of 9 Appeal2014-003790 Application 11/647,272 rejection pursuant to 37 C.F.R. Â§ 41.50(b). 37 C.F.R. Â§ 41.50(b) provides "[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review." 37 C.F.R. Â§ 41.50(b) also provides that Appellant, WITHIN 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 proceeding will be remanded to the Examiner .... (2) Request rehearing. Request that the proceeding be reheard underÂ§ 41.52 by the Board upon the same record .... Should Appellant elect to prosecute further before the Examiner pursuant to 37 C.F.R. Â§ 41.50(b)(l), in order to preserve the right to seek review under 35 U.S.C. Â§Â§ 141or145 with respect to the affirmed rejection, the effective date of the affirmance is deferred until conclusion of the prosecution before the Examiner unless, as a mere incident to the limited prosecution, the affirmed rejection is overcome. If Appellant elects prosecution before the Examiner and this does not result in allowance of the application, abandonment or a second appeal, this case should be returned to the Patent Trial and Appeal Board for final action on the affirmed rejection, including any timely request for rehearing thereof. 10 Appeal2014-003790 Application 11/647,272 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a). See 37 C.F.R. Â§ 1.136(a)(l )(iv). AFFIRMED-IN-PART; 37 C.F.R. Â§ 41.50(b) 11