Ex Parte HopenfeldDownload PDFPatent Trial and Appeal BoardNov 7, 201711898673 (P.T.A.B. Nov. 7, 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. 11/898,673 09/14/2007 Bruce Hopenfeld MR3065-35 4832 4586 7590 11/09/2017 ROSENBERG, KLEIN & LEE 3458 ELLICOTT CENTER DRIVE-SUITE 101 ELLICOTT CITY, MD 21043 EXAMINER PORTER, JR, GARY A ART UNIT PAPER NUMBER 3766 NOTIFICATION DATE DELIVERY MODE 11/09/2017 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): ptoactions @rklpatlaw.com ptoactions@yahoo.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte BRUCE HOPENFELD Appeal 2017-000432 Application 11/898,673 Technology Center 3700 Before DEMETRA J. MILLS, ERIC B. GRIMES, and DEBORAH KATZ, Administrative Patent Judges. MILLS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35U.S.C. § 134. The Examiner has rejected all of the pending claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. Appeal 2017-000432 Application 11/898673 STATEMENT OF CASE The device of the invention provides for an effective subcutaneous or surface based system for monitoring ischemia. Spec. 5. In particular, the present invention comprises a system that includes ... an implanted cardiac detection and/or diagnostic device and external equipment. The battery powered implantable cardiac diagnostic device contains electronic circuitry that can detect a cardiac event such as an acute myocardial infarction and warn the patient when the event, or a clinically relevant precursor, occurs. The cardiac diagnostic device can store the patient's electrogram for later readout and can send wireless signals to and receive wireless signals from the external equipment. Spec. 6. The following claim is representative. 16. A device for assessing the condition of a mammalian heart, comprising: a lead comprising two sensors, a processor coupled to the lead, the processor configured to: (i) obtain a signal from the lead, and compute a waveform corresponding to the signal, the waveform being characterized by a plurality of QRS complexes; (ii) compute a plurality of values of a waveform feature from the waveform representing the values of the waveform feature over time; (iii) apply a first filter to the plurality of values of the waveform feature, thereby deriving a first time series filtered waveform; (iv) derive a differenced waveform from the filtered waveform defining a second time series waveform where the differenced waveform is an absolute difference of at least one waveform feature taken in consecutive time intervals within a time segment; 2 Appeal 2017-000432 Application 11/898673 (v) compute from the second time series differenced waveform, a measure of the rate of change in the waveform feature over said time segment where the measure of the rate of change of said waveform feature is calculated as a function of the summation of the absolute difference of said second time series waveform feature taken in consecutive time intervals over said time segment, thereby deriving a change metric; and (vi) apply a test to detect a pathological heart condition, wherein the test is based on the change metric. Cited References Patton US 4,989,610 Feb. 5, 1991 Arand US 5,817,027 Oct. 6, 1998 Starobin US 2002/0165459 A1 Nov. 7, 2002 Grounds of Rejection Claims 16 and 18—21 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Patton in view of Starobin. Claims 22 and 23 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Patton in view of Starobin, and Arand. FINDINGS OF FACT The Examiner’s findings of fact are set forth in the Answer at pages 2-13. PRINCIPLES OF LAW In making our determination, we apply the preponderance of the evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427 (Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings before the Office). 3 Appeal 2017-000432 Application 11/898673 “[OJbviousness requires a suggestion of all limitations in a claim.” CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003) (citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)). Obviousness Rejection 1 The Examiner finds that Regarding Claim 16, Patton discloses inserting a tape holding ECG data from a Holter recording into a device , such as a microcomputer 60 (col. 5, line 35-col. 6, line 10). The ECG data from the tape is passed through filters in order to provide proper samples at 120Hz a channel, thus creating a time series of data (col. 23, lines 27-45). The filtered data is then used to calculate a four-point derivative, which is a differenced waveform representing the difference between the value of the waveform at the present sample and its values four samples in the past. The first derivative is stored in buffer 912. A second derivative is also calculated and stored in a second derivative buffer 914 (col. 33, lines 45-55). The second derivative waveform is the difference between two consecutive first derivative waveforms, each of which contains consecutive four sample time intervals. These rates of change (i.e. derivatives), which represent a summed difference of samples over a time interval. . ., are then utilized to detect and diagnose a pathological condition of the heart using a string of tests 986, 988, 990, etc. (Fig. 47 A; col. 35, line 25-col. 36, line 62). Specifically, the analysis of the ECG data results in beats 80 being placed in a plurality of bins, each representative of a particular diagnosis 88 (col. 6, line 60-col. 7, line 17; Fig. 8). Ans. 2—3. The Examiner acknowledges that Patton discloses analyzing the data with a computer, but discloses that the Holter recorder is a separate system and is not combined with the computer. Ans. 3. The Examiner relies on Starobin for the fact that combining or connecting Holter systems with data 4 Appeal 2017-000432 Application 11/898673 processing systems, such as computers, is well known and well established in the art, as evidenced by Starobin. Ans. 3; Starobin, Fig. 3. The Examiner concludes that “it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device in the Patton reference to include directly connecting the Holter recorder to the computer, as taught and suggested by Starobin, for the purpose of providing real-time data processing.” Ans. 3^4. Appellant contends that the Patton reference does not provide for the computation of a plurality of values of a waveform feature from the waveform ... [deriving] a differenced waveform from the filtered waveform ... [and computing] from the second time series differenced waveform, a measure of the rate of change in the waveform feature ... to detect a pathological heart condition as is recited in Claim 16. Br. 18. Appellant further argues that the Patton reference does not provide for derivation of a differenced waveform where the differenced waveform is an absolute difference of a waveform feature taken in consecutive time intervals within some time segment, nor does the Patton reference provide for the computation from the second time series differenced waveform a measure of the rate of the change of the waveform feature over the time segment in the manner defined by the now amended Claim 16 (where the measure of the rate of change is calculated as a function of the summation of the absolute difference of the second time series waveform feature taken in consecutive time intervals over the time segment). All that Patton is doing is taking a four-point derivative which is the difference between the value of the waveform in a 5 Appeal 2017-000432 Application 11/898673 present sample and the value of samples in the past which is neither the concept nor the processor configuration permitting the subject system concept to be realized. Br. 20; emphasis added. ANALYSIS We do not find that the Examiner has provided evidence to support a prima facie case of obviousness. We are persuaded by Appellant’s argument that the Examiner has not pointed to specific disclosure in Patton of derivation of a differenced waveform where the differenced waveform is an absolute difference of a waveform feature taken in consecutive time intervals within some time segment. App. Br. 20. In particular, we do not find that the Examiner has pointed to specific disclosure in either Patton or Starobin of the claimed feature of “(v) computing] from the second time series differenced waveform, a measure of the rate of change in the waveform feature over said time segment where the measure of the rate of change of said waveform feature is calculated as a function of the summation of the absolute difference of said second time series waveform feature taken in consecutive time intervals over said time segment, thereby deriving a change metric.” In support of this claim limitation, the Examiner points to Patton, column 33, lines 45—55 (Ans. 6), reproduced below. Patton, column 33, lines 45—55, states The data is also processed to calculate a four-point derivative, which is the difference between the value of the waveform at the present sample and its value four samples in the past [.] This data is paced [sic, placed] in a four-point 6 Appeal 2017-000432 Application 11/898673 derivative buffer 912. Further, a four-point second derivative is calculated and stored in a four-point second derivative buffer 914. The four-point second derivative is the difference between two consecutive four-point derivatives. The subroutine GETDAT then increments the sample count and returns to the subroutine call 903 in the DETECT module 916. However, this portion of Patton does not indicate that the waveform feature is calculated as a function of the summation of the absolute difference of the second time series waveform feature taken in consecutive time intervals over the time segment. There is no discussion in the Examiner cited portion, or elsewhere in the Final Action or Answer, of taking a summation of the absolute difference of the second time series waveform. The obviousness rejection over Patton in view of Starobin is reversed. Obviousness rejection 2 in the grounds of rejection suffers from the same deficiency as rejection 1, and is also reversed. CONCLUSION OF LAW The Examiner has not shown that the cited references support the Examiner’s obviousness rejections 1 and 2, which are reversed. REVERSED 7 Copy with citationCopy as parenthetical citation