Ex Parte Greenhut et al

Patent Trial and Appeal BoardOct 30, 2018

14487248 (P.T.A.B. Oct. 30, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/487,248 09/16/2014 27581 7590 11/01/2018 Medtronic, Inc. (CVG) 8200 Coral Sea Street NE. MS:MVC22 MINNEAPOLIS, MN 55112 FIRST NAMED INVENTOR Saul E. Greenhut 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. C00007576.USU5 5052 EXAMINER WU,TONGE ART UNIT PAPER NUMBER 3792 NOTIFICATION DATE DELIVERY MODE 11/01/2018 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): rs.patents.five@medtronic.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MEDTRONIC, INC. 1 Appeal2017-006096 Application 14/487 ,248 Technology Center 3700 Before DEMETRA J. MILLS, FRANCISCO C. PRATS, and JEFFREY N. FREDMAN, Administrative Patent Judges. MILLS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. Â§ 134. The Examiner has rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. Â§ 6(b ). We affirm-in-part. 1 Saul E. Greenhut, Robert W. Stadler, and Xusheng Zhang are listed as the inventors. Appeal2017-006096 Application 14/487,248 STATEMENT OF CASE The claimed invention is directed to improving the operation of an implantable cardioverter defibrillator (ICD). Spec. 1. Upon detecting an abnormal heart rhythm, the ICD delivers an appropriate therapy. Id. "Pathologic forms of ventricular tachycardia can often be terminated by anti- tachycardia pacing therapies. Anti-tachycardia pacing therapies are followed by high-energy shock therapy when necessary. Termination of a tachycardia by a shock therapy is commonly referred to as 'cardioversion.' " Spec. 1. The following claim is selected as representative claim, for each of the rejections indicated in the grounds of rejection ( except the double patenting rejection). 11. A medical device, comprising: a plurality of electrodes capable of forming a plurality of sensing vectors for sensing cardiac signals; and a processor configured to determine a blanking period adjustment metric based on the cardiac signals sensed within a blanking period adjustment window extending from an end of a blanking period, determine whether to increase the blanking period for analysis of the sensed cardiac signals in a first operating state based on the blanking period adjustment metric, advance from the first operating state to a second operating state in response to the analysis of the sensed cardiac signals in the first operating state indicating that a cardiac rhythm is a shockable ventricular fibrillation or a fast ventricular tachycardia or is not shockable, determine whether the blanking period was increased for the analysis of the sensed cardiac signals in the first operating state, and decrease the blanking period for analysis of the 2 Appeal2017-006096 Application 14/487,248 cardiac signals in the second operating state in response to the blanking period being increased for the analysis of the cardiac signals in the first operating state. Grounds of Rejection 1. Claims 11, 12, 15-18, and 21 are rejected under 35 U.S.C. Â§ 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the enablement requirement. 2. Claims 11, 12, 15-18, and 21 are rejected under 35 U.S.C. Â§ 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. 3. Claims 11, 12, 15-18,and21 arerejectedunder35U.S.C. Â§101 because the claimed invention lacks patentable utility. 4. If claim 12 is found allowable, claim 18 will be objected to under 37 CPR 1.75, for double patenting, as being a substantial duplicate thereof. FINDINGS OF FACT The Examiner's findings of fact are set forth in the Final Action at pages 1-9, and in the Answer at pages 2-15. The following fact is highlighted. 3 Appeal2017-006096 Application 14/487,248 1. Figure 10 of the Specification is reproduced below. .... S02 Â·~, l' ................ , .. twtn~*inâ‚¬ W!w.thft (l'!(ll'lfle.:S 51,,,&;oblt H)/ lO W~'.1 h,â€¢ D,1r,~ ti.) B~ _,:1~1:~~râ‚¬i ,,...-fu "''''''''''''''''''''''''''''''''-'"'"-"-"-"-"-"-"-"-"-"-"' ,'1d1tist Bk:t!~,\~ Per-;.~"-d Figure 10 shows a flowchart of a method for adjusting a blanking period during transitioning between operating states, according to an embodiment of the present disclosure. As illustrated in FIG. 10, according to an embodiment of the present disclosure, while in the Concerned State 704, the device determines whether the sensing channels ECG 1 and ECG2 are 4 Appeal2017-006096 Application 14/487,248 shockable, Block 802, using the method for determining whether the sensing channels are shockable or not shockable. Spec. 30. 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). An invention has a well-established utility if (i) a person of ordinary skill in the art would immediately appreciate why the invention is useful based on the characteristics of the invention ( e.g., properties or applications of a product or process), and (ii) the utility is specific, substantial, and credible. If an invention has a well-established utility, rejections under 35 U.S.C. 101 and 35 U.S.C. 112, first paragraph, based on lack of utility should not be imposed. In re Folkers, 344 F.2d 970,975 (CCPA 1965). The Examiner bears the initial burden of showing non-enablement. See In re Wright, 999 F.2d 1557, 1561---62, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). "[E]nablement requires that the specification teach those in the art to make and use the invention without 'undue experimentation.' . . . That some experimentation may be required is not fatal; the issue is whether the amount of experimentation required is 'undue."' In re Vaeck, 94 7 F .2d 48 8, 495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991) (emphasis in original). Some experimentation, even a considerable amount, is not "undue" if, e.g., it is merely routine, or if the Specification provides a reasonable amount of guidance as to the direction in which the experimentation should proceed. See In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). 5 Appeal2017-006096 Application 14/487,248 As noted in Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1334 (Fed. Cir. 2003): The enablement requirement is often more indulgent than the written description requirement. The Specification need not explicitly teach those in the art to make and use the invention; the requirement is satisfied if, given what they already know, the Specification teaches those in the art enough that they can make and use the invention without "undue experimentation." "In the context of the written description requirement, an adequate prima facie case must ... sufficiently explain to the applicant what, in the examiner's view, is missing from the written description." See Hyatt v. Dudas, 492 F.3d 1365, 1370 (Fed. Cir. 2007). The test for determining compliance with the written description requirement is whether the disclosure of the application as originally filed reasonable conveys to the artisan that the inventor had possession at the time of the later claimed subject matter, rather than the presence or absence of literal support in the Specification for the claim language. In re Kaslow, 707 F.2d 1366, 1375 (Fed. Cir. 1983). Enablement The Examiner contends that the enablement, "problem is, the specification is not clear on how exactly we arrive at this initial condition of a blanking period adjustment having been made while in the Concerned state." Final Act. 2. The Examiner argues that, "the specification merely describes an example going from 150 ms to 180 ms and back to 150 ms, and does not actually explain what factors govern the adjustments. For instance, why or why not is this adjustment made at all?" Ans. 9. The Examiner 6 Appeal2017-006096 Application 14/487,248 found three different possible interpretations of how to arrive at a blanking period adjustment. Final Act. 2--4. Appellants contend that the Examiner has mischaracterized the Appellants disclosure of the invention. App. Br. 6. Appellant disagrees with the Examiner, and directs attention to the Specification of the present application, which states, inter alia, "FIG. 10 is a flowchart of a method for adjusting a blanking period during transitioning between operating states, according to an embodiment of the present disclosure." App. Br. 6. (Figure 10 of the Specification is reproduced above (FF 1 ), for the reader's convenience.) Appellants argue that the Specification, Fig. 10 description, states that If it is determined that the device should transition to the Not Concerned State 702, i.e., both of the two heart rate estimates are greater than the heart rate threshold, Yes in Block 806, a determination is made as to whether a blanking period adjustment, described above, was made while in the Concerned State, Block 809. If an adjustment to the blanking period was made, Yes in Block 809, the device adjusts the blanking period, Block 811. For example, according to one embodiment the device may reduce the blanking period by a predetermined amount, or according to another example, the device may adjust the blanking period back to the initial or nominal blanking period setting utilized prior to the adjustment occurring while the device was in the Concerned State. For example, once operation of the device transitions from the Concerned State 704 to the Not Concerned State 702, if the blanking period was adjusted from 150 ms to 180 ms while the device was in the Concerned State, Yes in Block 809, the device adjusts the blanking to period to the initial 150 ms setting, Block 811. If an adjustment to the blanking period was not made, No in Block 809, or once the device adjusts the blanking period back to the nominal or initial setting when in the Not Concerned State, 7 Appeal2017-006096 Application 14/487,248 Block 811, operation of the device is in the Not Concerned State, Block 702. App. Br. 6-7, Spec. 32-33. ANALYSIS We do not find that the Examiner has provided evidence to support a prima facie case of lack of enablement. We find that the Examiner clearly understands the nature of the invention, as set forth in the Examiner's summary of the invention on pages 2-3 of the Answer. According to the Examiner, the claimed invention is directed to how to deal with blanking period adjustments when transitioning between device operating states, and is best shown in Figure 10 (reproduced on next page; relevant description begins at Page 30, line 25). More specifically, this flowchart describes actions taken when the ICD transitions out of the Concerned state ( either escalating to armed, or de-escalating to Not Concerned). The fundamental goal of this process is: If the blanking period had been adjusted during the Concerned state, then reset the blanking period to undo the adjustment. Ans. 3. The Examiner, however, argues that the Specification merely describes an example going from 150 ms to 180 ms and back to 150 ms, but does not actually explain what factors govern the adjustments. Ans. 9. "For instance, why or why not is this adjustment made at all? That is what is meant by the factors that govern 'whether' the blanking period is adjusted or not. And why is it a 30 ms increment?" Ans. 9. We are not persuaded by the Examiner's lack of enablement argument. 8 Appeal2017-006096 Application 14/487,248 The Examiner bears the initial burden of showing non-enablement. See In re Wright, 999 F.2d 1557, 1561---62 (Fed. Cir. 1993). "[E]nablement requires that the specification teach those in the art to make and use the invention without 'undue experimentation.' . . . That some experimentation may be required is not fatal; the issue is whether the amount of experimentation required is 'undue."' In re Vaeck, 947 F.2d 488,495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991) (emphasis in original). Some experimentation, even a considerable amount, is not "undue" if, e.g., it is merely routine, or if the Specification provides a reasonable amount of guidance as to the direction in which the experimentation should proceed. See In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). The Specification states that, "the blanking period is typically set between 150 and 180 ms, if the blanking period was 150 ms, the blanking period adjustment window 513 would be 30 ms." Spec. 25. The Specification further states that, If the current blanking is less than the blanking period threshold, Yes in Block 614, the device determines a blanking period adjustment metric for each 10 vector 102-106 based on the 15 minimum signal differences 519, Block 616. For example, according to an embodiment, the device determines the median of the 15 minimum signal differences 519 for each sensing vector and sets the blanking period adjustment metric for that sensing vector equal to the determined median of the associated minimum signal differences 519. Once a single blanking period 15 adjustment metric is determined for each of the sensing vectors 102-106 in Block 616, the device determines whether an adjustment to the blanking period is to be made for the sensing vectors 102-106, Block 618. One reason for increasing the blanking period is to avoid double counting of R- waves. 9 Appeal2017-006096 Application 14/487,248 Spec. 28. Other supporting language in the Specification states that, If the blanking period adjustment metric is less than the predetermined proportion of one of the two highest ranked vectors and less than a predetermined minimum blanking period threshold, Yes in Block 618, the blanking period is updated, Block 620. For example, the blanking period may be increased to 180 15 ms, or may be increased by a predetermined amount, such as 10 ms. In addition, according to another embodiment, rather than automatically increasing the blanking period, the device may generate an alarm or other stored indication to indicate to the attending medical personnel that the blanking period should be increased so that the increase in the blanking period can be adjusted manually, using a programmer or other input device. Spec. 29. The Examiner has not explained why the Specification, at pages 6-7, 25-29, and Fig 10 (FFl), is insufficient to enable the setting of a blanking period for the medical device, and how to use the medical device. The Examiner has not fully explained why one of ordinary skill in the art would require undue experimentation to practice the claimed invention in view of the disclosure. In light of the Examiner's clear understanding of the nature of the invention, as set forth in the Examiner's summary of the invention on pages 2-3 of the Answerwe are not persuaded that one of ordinary skill in the art would fail to understand how to use the medical device in view of the descriptive examples in the Specification. 10 Appeal2017-006096 Application 14/487,248 While the Examiner argues three possible, separate interpretations2 of how a blanking period might be set, Figure 10 of the drawings and the associated descriptive language in the Specification, at pages 25-27 and 30- 33, appears to be relatively clear. The Specification, page 25, states that, "the blanking period is typically set between 150 and 180 ms, if the blanking period was 150 ms, the blanking period adjustment window 513 would be 30 ms." Figure 7 of the drawings, and its associated descriptive language in the Specification, further provide evidence of an exemplary blanking period after an r-wave, and indicate how a blanking period is typically adjusted. See also, Spec. 26-32. Furthermore, the Examiner seems to question why blanking period adjustments are made, but knowingly states in the Examiner's summary of the invention (Ans. 3) that, "[t]he purpose of the blanking period is to avoid oversensing when monitoring the heartbeat signals ( e.g. one heartbeat being accidentally counted as two heartbeats). The blanking period can be adjusted to optimize detection accuracy. This is consistent with Appellant's usage as reflected in Figures 7-8." Ans. 3. The Examiner has not indicated why one of ordinary skill in the art would not have been enabled to adjust a blanking period, based upon 2 The Examiner repeatedly refers to blanking period adjustment language in Fig. 10, ("described above"), that refers back to blanking period adjustment description in Figs. 7-8, relating to a vector selection process, in his specification interpretations. However, Fig. 10 reasonably appears to analogize that the blanking period adjustment principles described in Figs. 7- 8, and provides a logical scheme for when blanking period adjustments are made. 11 Appeal2017-006096 Application 14/487,248 description in the specification and typical knowledge in the art. 3 The lack of enablement rejection is reversed. Written Description The Examiner argues that the Specification merely describes an example going from 150 ms to 180 ms and back to 150 ms, and does not actually explain what factors govern the adjustments. "For instance, why or why not is this adjustment made at all? That is what is meant by the factors that govern 'whether' the blanking period is adjusted or not. And why is it a 30 ms increment?" Ans. 9. We are not persuaded by the Examiner's argument that the Specification lacks written descriptive support for blanking period adjustments. The Examiner has not explained why the description in the Specification at pages 6-7, and 25-27, and Fig 10 (FFl) is insufficient to describe, for one of ordinary skill in the art, the setting of a typical blanking period for the medical device, and how to use the medical device. It appears well known in the art that "[t]he purpose of the blanking period is to avoid oversensing when monitoring the heartbeat signals ( e.g. one heartbeat being accidentally counted as two heartbeats). The blanking period can be adjusted to optimize detection accuracy. This is consistent with Appellant's usage as reflected in Figures 7-8." Ans. 3. 3 The Specification further directs attention to, incorporated by reference, U.S. Patent No. 7,894,894 to Stadler et al., and U.S. Patent Application No. 14/250,040, to Zhang, for a description of device transitions between device states, r-wave analysis, and heart rate thresholds for shocking or not shocking, and their relationship to blanking period adjustments. Spec. 29 - 32. 12 Appeal2017-006096 Application 14/487,248 The Examiner failed to provide a complete explanation as to why more specification description would have been required to practice the invention by one of ordinary skill in the art aware of typical blanking periods and r-wave analysis, or other disclosure in the Specification regarding the setting of blanking period adjustments. We find that one of ordinary skill in the art would understand that Appellants possessed and invented the claimed medical device in view of the description in the Specification. The written description rejection is reversed. Utility For the reasons given with respect to the enablement rejection, the Examiner argues the claimed invention possesses no utility. Ans. 13. We are not persuaded by the Examiner's lack of utility arguments. The Examiner summarizes the invention on page 2 of the Answer, and finds that the claimed invention is directed to improving the operation of an implantable cardioverter defibrillator (ICD). The Examiner further finds that In the Not Concerned state, the device is monitoring the heart for abnormalities in rhythm. If an abnormality is sensed, the device advances to the Concerned state, during which it attempts to confirm the nature of the abnormality ( e.g. noise, treatable arrhythmia, etc). If the device confirms that the abnormality is a shock-treatable arrhythmia, the device advances to the Armed state, during which the shock capacitors are charged. If the arrhythmia is still present when the device becomes fully charged/ armed, the device advances to the Shock state, where it delivers the therapeutic shock. â€¢ Blanking Period: Generally, a pacemaker or ICD detects a heartbeat when the incoming signal crosses a detection threshold. A blanking period is a time period controlled by the 13 Appeal2017-006096 Application 14/487,248 pacemaker or ICD during which the device intentionally ignores signals which cross the detection threshold. The purpose of the blanking period is to avoid oversensing when monitoring the heartbeat signals ( e.g. one heartbeat being accidentally counted as two heartbeats). The blanking period can be adjusted to optimize detection accuracy. This is consistent with Appellant's usage as reflected in Figures 7-8. Ans. 2-3. Notwithstanding any concerns the Examiner may have had with respect to a complete description, or enablement of the blanking period adjustments which we address herein, we find that the pending claims are directed to a medical device, such as a cardio defibrillator or pacemaker, and that such devices are well known in the art and have a well understood utility. Adjustments to the blanking period have been described in the Specification to allow one of ordinary skill in the art to practice the invention. The lack of utility rejection is reversed. Double Patenting Appellants do not address the double patenting rejection of claim 12, in view of pending claim 18, in the Brief or Reply Brief, and, therefore, this rejection is summarily affirmed. CONCLUSION OF LAW The lack of enablement, lack of written description, and lack of utility rejections are reversed. The double patenting rejection is affirmed. AFFIRMED-IN-PART 14