Ex Parte Wang

Patent Trial and Appeal BoardFeb 5, 2019

11959214 (P.T.A.B. Feb. 5, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 11/959,214 12/18/2007 67356 7590 02/07/2019 Marsh Fischmann & Breyfogle LLP 8055 E. Tufts A venue Suite 450 Denver, CO 80237 FIRST NAMED INVENTOR Huisun Wang 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. OB-054400US (50332-00024) CONFIRMATION NO. 2357 EXAMINER WANG, CHANG YU ART UNIT PAPER NUMBER 1649 NOTIFICATION DATE DELIVERY MODE 02/07/2019 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): ptomail@mfblaw.com ASJM_Patents@abbott.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte HUISUN WANG Appeal2018-000841 Application 11/959 ,214 Technology Center 1600 Before JEFFREY N. FREDMAN, DEBORAH KATZ, and JOHN G. NEW, Administrative Patent Judges. KATZ, Administrative Patent Judge. DECISION ON APPEAL Appeal2018-000841 Application 11/959 ,214 Appellant1 seeks our review, under 35 U.S.C. Â§ 134(a), of the Examiner's decision to reject claims 1, 2, 7-9, 24--29, and 33 (Appeal Brief, filed May 2, 2016, ("App. Br.") 3, 7.) We have jurisdiction under 35 U.S.C. Â§ 6(b). We affirm. Appellant's Specification provides a method of determining the position of a catheter in a patient's body by monitoring a change in blood gas measurement. (See Spec. ,r,r 7-9.) The change in blood gas measurement indicates the passage of the catheter from one location in the patient's body to another location. (See id.) Appellant argues independent claims 1 and 24 together, as to both anticipation and obviousness. (See App. Br. 1, 8.) Appellant does not present separate arguments for the patentability of claims 2, 7-9, 24--29, and 33. (See id.) We focus on claim 1 in our review. See 37 C.F.R. Â§ 4I.37(c)(l)(iv). Appellant's claim 1 recites: 1. A method for use in determining a position of a catheter a patient's body, comprising the steps of: transmitting at least one optical signal to tissue from at least a first optical source disposed proximate to a distal end of a catheter inserted into the patient's body; performing a first blood gas measurement using signals received from an optical detector disposed proximate to said distal end of said catheter while said distal end of said catheter is disposed at a first location within the patient's body, wherein said signals from said optical detector are representative of said at least one optical signal as applied to the tissue; 1 Appellant reports that the real party in interest is St. Jude Medical, Atrial Fibrillation Division. (App. Br. 1.) 2 Appeal2018-000841 Application 11/959 ,214 performing a series of blood gas measurements using signals received from said optical detector disposed proximate to said distal end of said catheter while said catheter, said optical source and said optical detector move from said first location toward a second location within the patient's body; and monitoring said series of blood gas measurements as said distal end of said catheter moves toward said second location of the patient's body; identifying a blood gas measurement change, which exceeds a predetermined threshold, of at least one of said series of blood gas measurements relative to said first blood gas measurement; and generating an output indicating said distal end of said catheter is located at said second location based on said blood gas measurement change. (App. Br. 13, Claims App'x.) Independent claim 24 is similar to independent claim 1, but includes the step of performing a medical procedure with the catheter while disposed at the second location. (App. Br. 14, Claims App'x.) The Examiner made the following rejections of the claims (Final Office Action, mailed October 1, 2015, ("Final Act.") 4--24): Claims References Basis of Rejection 1 and2 Burchman 2 35 U.S.C. Â§ I02(e) 1,2, 7-9,24--29,and Hunter, 3 Burchman, 35 U.S.C. Â§ I03(a) 33 and Hill4 1,2, 7-9,24--29,and Corl, 5 Burchman, and 35 U.S.C. Â§ I03(a) 33 Hill 2 Burchman, US 7,729,735 Bl, issued June 1, 2010. 3 Hunter et al., US 7,599,730 B2, issued October 6, 2009. 4 Hill et al., US 2005/0096707 Al, published May 5, 2005. 5 Corl et al., US 2005/0054905 Al, published March 10, 2005. 3 Appeal2018-000841 Application 11/959 ,214 1,2, 7-9,24--29,and Claims 19, 22, and 24 N onstatutory 33 of Application No. obviousness-type 12/345,590 double patenting Findings of Fact 1. Burchman teaches a method for confirming the placement of a catheter by using a light-emitting array and opposed photodetector to analyze oxygen saturation in the blood. (See Burchman Abstract.) 2. Burchman teaches "special spectrophotometric oximetry catheters" that employ fiberoptic wave guides to perform oximetric monitoring of blood near the catheter's end and thereby allow in vivo measurement of venous blood oxygenation. (See Burchman 4:32--47.) 3. Burchman teaches a processor and display that indicates whether the oxygen saturation level comports with venous or arterial blood based on a measured saturation percentage, where a percentage of about 90% or greater indicates arterial blood and a percentage of about 85% or lower indicates venous blood. (See Burchman 7:39--49.) 4. Burchman teaches an extended oximetry catheter that is longer and sufficiently flexible to allow it to be inserted more deeply into a vessel of the central circulatory system in closer proximity to the cardiopulmonary system to provide desired data on oxygen saturation. (See Burchman 8:25- 42.) 5. Hunter teaches a catheter carrying multiple location sensors for identifying the location of the catheter advanced within the cardiovascular structures of the human body. (See Hunter 2:33-39.) 4 Appeal2018-000841 Application 11/959 ,214 6. Hunter teaches the location sensors are located near the distal end of an elongated catheter body. (See Hunter 2:59---60.) 7. Hunter teaches the sensors may provide useful clinical data related to the catheter position, identify a target tissue site at which medical therapy will be delivered, or measure physiological signals such as oxygen saturation. (See Hunter 3 :34--48.) 8. Hunter teaches a method for identifying landmarks within the heart by measuring oxygen via sensors positioned within the catheter to provide real time position and orientation information as the catheter is navigated. (See Hunter 15:21--41; 18:3-17; 22:5-35.) 9. Hunter teaches a method of navigating a catheter to a desired location by identifying landmarks based upon sensed physiological conditions and ablating a portion of the cardiac region with the catheter. (See Hunter 22:5--47.) 10. Corl teaches a probe for in vivo measurement and display of intravascular parameters such as partial pressure oxygen (P02) and partial pressure of carbon dioxide (PC02). (See Corl ,r 23.) 11. Corl teaches a single sensor may make multiple readings to determine a trend in a blood gas parameter, e.g., whether the value is increasing, decreasing, or stable, where the trend is symbolically indicated on a display. (See Corl ,r 50.) 12. Corl teaches the oxygen probe can be inserted into the right atrium of the heart to provide a direct measurement of the oxygen saturation of mixed venous blood. (See Corl ,r 57.) 5 Appeal2018-000841 Application 11/959 ,214 13. Corl teaches advancing a small oxygen sensor mounted on a probe through a guiding catheter to various locations in the heart and the great vessels to sample oxygen saturation in vivo. (See Corl ,r 59.) 14. Hill teaches monitoring oxygen in the systemic and/or pulmonary circulatory systems during a medical procedure. (See Hill ,r 2.) 15. Hill teaches a system for performing a medical procedure, including a sensor to sense the presence of a gas, concentration of a gas, presence of oxygen, concentration of oxygen, presence of carbon dioxide, and/or concentration of carbon dioxide. (See Hill ,r,r 13, 14.) 16. Hill teaches the sensor may be a gas sensor or an optical sensor. (See Hill ,I 17.) 1 7. Hill teaches the medical procedure may be a cardiac procedure or an ablation procedure, including ablation of arrhythmias. (See Hill ,r,r 20, 98.) 18. Hill teaches the method for performing the medical procedure may include sensing a first value of a biological characteristic and sending a first signal, inhibiting the beating of the heart in response to the first signal, performing the medical procedure, sensing a second value of the biological characteristics, and stimulating the beating of the heart in response to the second signal. (See Hill ,r 21.) Analysis 35 USCÂ§ 102(e)-Burchman The Examiner rejected claims 1 and 2 as anticipated by Burchman. The Examiner finds that Burchman discloses a method of determining oxygen saturation by measuring absorption of light by blood passing 6 Appeal2018-000841 Application 11/959 ,214 between a light emitter and a photodetector of a catheter. (See Final Act. 6- 7.) The measured oxygen saturation is used to determine a catheter location and is compared to a signal from a non-invasive co-oximeter at a different location. (See Final Act. 7 .) Appellant argues that the Burchman catheter does not take "a series of blood gas measurements as the catheter moves from a first position to a second position or generate an output indicating the distal end of the catheter is located at the second position based on a change in the blood gas measurements." (App. Br. 6.) Appellant argues that, therefore, Burchman does not disclose performing and monitoring a series of blood gas measurements as the distal end of the catheter moves from a first location to a second location. (See id.) Moreover, Appellant argues that Burchman does not teach the limitation of "generating an output indicating said distal end of the catheter is located at said second location based on said blood gas measurement change." (See App. Br. 7 .) We agree with Appellant that the Examiner erred in rejecting independent claim 1 as anticipated, because we do not find that Burchman discloses the steps of performing a series of blood gas measurements with a catheter as the catheter moves from a first to a second location, nor does Burchman disclose generating an output indicating the catheter is located at the second location. Although Burchman discloses a method of measuring blood gas, including using an extended oximetry catheter that can be inserted into the cardiopulmonary system, the method measures oxygen saturation with the catheter at one location to determine the presence of arterial or venous blood. (FF 1--4.) The Examiner cites Burchman claim 11 7 Appeal2018-000841 Application 11/959 ,214 for a method of analyzing a signal from a non-invasive co-oximeter. (See Final Act. 7.) However, this step of measuring at a second location is not performed by the optical detector located on the catheter as required by the claims. For this reason we reverse the rejection of claim 1, or claim 2, which depends on claim 1, as being anticipated under 35 U.S.C. Â§ 102(e) by Burchman. 35 USCÂ§ 103(a)-Hunter, Burchman, and Hill The Examiner finds that Hunter teaches a navigable catheter carrying multiple localization sensors, which measure and monitor blood pressure and blood oxygen saturation as the navigable catheter moves to different locations. (See Final Act. 12.) The Examiner finds that Hunter does not explicitly teach transmitting an optical signal from a source to a detector, located proximate to the distal end of the catheter. (See id.) The Examiner finds that Burchman teaches a method for determining location of a catheter by determining oxygen saturation with a light emitter and photodetector located proximate to the distal end of the catheter. (See Final Act. 13-14.) The Examiner finds Hill teaches using a catheter to perform a medical procedure based on a blood gas measurement. (See Final Act. 16.) The Examiner determines that it would have been obvious to a person of ordinary skill in the art to combine the teachings of Hunter, Burchman, and Hill to perform a medical procedure based on blood gas measurement using a catheter with a blood gas measurement structure. (See id.) Appellant argues that "none of the cited references disclose generating an output indicating that the distal end of the catheter has moved to a second location based on a change in a blood gas measurement." (App. Br. 11.) 8 Appeal2018-000841 Application 11/959 ,214 More specifically, Appellant argues that Hunter fails to disclose using blood gas measurements for localization purposes or to determine a change in location. (App. Br. 9.) Likewise, Appellant argues that Hill fails to disclose identifying a change between blood gas measurements taken as a catheter moves from a first location and a second location, or generating an output indicating the catheter is located at the second location. (App. Br. 10.) We are not persuaded by Appellant's argument that the combination of prior art as a whole does not teach using blood gas measurements for location purposes and generating an output indicating a catheter has moved to a second location using blood gas measurement. See In re Merck & Co., 800 F.3d 1091, 1097 (Fed. Cir. 1986). Hunter specifically teaches real time measuring of position and orientation to identify landmarks within the heart using a catheter with an oxygen sensor. (See FF 7-8.) Burchman teaches a display that provides an output indicating a desired location based on an oxygen saturation threshold. (See FF 3.) Both Hunter and Hill teach performing medical procedures, e.g. ablating cardiac tissue, with the catheter once the catheter is navigated to a desired location. (See FF 9, 18.) Given that the prior art teaches navigating a catheter to a desired location from an initial location using real time monitoring of a blood gas threshold, we find it would have been within the level of ordinary skill in the art to identify and generate an output of the desired location based on blood gas measurement change. See KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,418 (2007) ("[T]he analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.") 9 Appeal2018-000841 Application 11/959 ,214 Appellant argues Hunter teaches away from using oxygen saturation information to determine location "through the incorporation of the electromagnetic sensors used for localization purposes." (App. Br. 9.) We are not persuaded by Appellant's argument because Hunter's mere disclosure of electromagnetic sensors does not constitute teaching away from oxygen sensors, absent any criticizing, discrediting, or discouraging the use of oxygen sensors. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Appellant argues "it is unclear why one skilled in the art would modify the dedicated localization sensor system of Hunter to generate a system that outputs a position of a distal end of a catheter based on blood gas measurement absent Appellant's disclosure" and that the Examiner utilized impermissible hindsight. (App. Br. 12.) We disagree. As discussed above, the Examiner takes into account only knowledge that was within the level of ordinary skill in the art at the time the invention was made and provided a rationale to combine, i.e., to navigate a catheter to a desired location using blood gas measurements. Therefore, the Examiner properly reconstructs the prior art. See In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). We consequently affirm the Examiner's rejection. 35 US.C. Â§ 103(a)-Corl, Burchman, and Hill The Examiner finds that Corl teaches a method of measuring blood gas with a probe to indicate that the probe is positioned at a desired location and to identify a change in oxygen saturation. (See Final Act. 18.) The Examiner finds that Corl does not teach an optical signal and detector, nor 10 Appeal2018-000841 Application 11/959 ,214 moving a catheter from a first to a second location while taking a series of blood gas measurements and generating an output indicating the catheter is located at the second location. (See Final Act. 19.) As discussed above, the Examiner finds these steps are taught by Burchman and Hill. The Examiner determines it would have been obvious to combine the teachings of Corl, Burchman, and Hill to perform a medical procedure based on blood gas measurements using a catheter having a blood gas measurement structure that transmits and detects optical signals. (See Final Act. 22.) Appellant argues that "Corl is directed to a static apparatus for measuring blood gas parameters of a patient" and "[ t ]he probe 18 of Corl does not move after insertion." (App. Br. 9.) Thus, Appellant argues the probe of Corl does not take a series of blood gas measurements as a catheter moves from a first to a second location. (See id.) We are not persuaded by Appellant's arguments against the combination of Corl, Burchman, and Hill. Corl teaches a blood gas probe that is used to determine trends in a blood gas parameter that can be indicated on a display (FF 11 ). The probe may be inserted into the atrium to provide direct measurement of oxygen saturation of mixed venous blood (FF 12). Moreover, Corl teaches advancing a small oxygen sensor mounted on a probe to various locations in the heart and great vessels to sample oxygen saturation in vivo. (FF 13) As discussed above, Burchman teaches a display output that indicates a desired location based on an oxygen saturation threshold, and Hill teaches performing medical procedures with a catheter once the catheter is navigated to a desired location. (See FF 3, 18.) Given that the prior art teaches navigating a catheter to various locations in the 11 Appeal2018-000841 Application 11/959 ,214 heart to sample oxygen saturation, we find it would have been within the level of ordinary skill in the art to identify and generate an output of the desired location based on blood gas measurement change. Appellant argues "it is unclear why one would modify the stationary inter-vascular measurement probe 18 of Corl with the stationary vascular compartment confirming penetrating catheter of Burchman to arrive at the claimed subject matter." (App. Br. 12.) We are not persuaded by Appellant's argument that the combination of Corl and Burchman "is an exercise of impermissible hindsight." (Id.) As discussed above, Corl is not limited to a stationary device. (See FF 13.) Moreover, the Examiner takes into account only knowledge that was within the level of ordinary skill in the art at the time the invention was made and provided a rationale to combine, i.e., to navigate a catheter to a desired location using blood gas measurements. Therefore, the Examiner properly reconstructs the prior art and we affirm the rejection of the claims. See In re McLaughlin, 443 F.2d at 1395. Obviousness-Type Double Patenting The Examiner provisionally rejected claims 1, 2, 7-9, 24--29, and 33 over claims 19, 22, and 24 of pending Application No. 12/345,590. (See Examiner's Answer 23-24.) Appellant does not argue or otherwise mention the obviousness-type double patenting rejection in their Appeal Brief. We consequently summarily affirm the Examiner's rejections on this ground. See 3 7 C.F .R. Â§ 41.3 7 ( c )(iv) ("[ A ]ny arguments or authorities not included 12 Appeal2018-000841 Application 11/959 ,214 in the appeal brief will be refused consideration by the Board for purposes of the present appeal."). Conclusion Upon consideration of the record and the reasons given, the Examiner's rejection of claims 1 and 2 under 35 U.S.C. Â§ 102( e) over Burchman is not sustained; the Examiner's rejection of claims 1, 2, 7-9, 24--29, and 33 under 35 U.S.C. Â§ 103(a) over Hunter, Burchman, and Hill is sustained; the Examiner's rejection of claims 1, 2, 7-9, 24--29, and 33 under 35 U.S.C. Â§ 103(a) over Corl, Burchman, and Hill is sustained; and the Examiner's rejections of claims 1, 2, 7-9, 24--29 and 33 on the basis of obvious-type double-patenting over claims 19, 22, and 24 of US 12/345,590 is sustained; No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136. AFFIRMED 13