Ex Parte Libbus et al

Patent Trial and Appeal BoardApr 16, 2013

10746135 (P.T.A.B. Apr. 16, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE ________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ________________ Ex parte IMAD LIBBUS and JOSEPH M. PASTORE ________________ Appeal 2011-003100 Application 10/746,135 Technology Center 3700 ________________ Before MICHAEL L. HOELTER, REMY J. VANOPHEM and ANNETTE R. REIMERS, Administrative Patent Judges. HOELTER, Administrative Patent Judge. DECISION ON APPEAL Appeal 2011-003100 Application 10/746,135 2 STATEMENT OF THE CASE This is a decision on appeal, under 35 U.S.C. § 134(a), from a final rejection of claims 1-431. App. Br. 4. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. THE CLAIMED SUBJECT MATTER The disclosed subject matter “relates generally to implantable medical devices and, more particularly, to baropacing with cardiac pacing to control cardiac output.” Spec. 1:28-29. Independent claim 1 is illustrative of the claims on appeal and is reproduced below: 1. An implantable medical system, including: a baroreflex stimulator to apply a baroreflex stimulation signal through an electrode and provide an indicator signal indicating that the baroreflex stimulation signal is being applied; and a cardiac stimulator to apply a pacing therapy with a pacing rate to maintain a minimum heart rate when the baroreflex stimulation signal is not being applied, receive the indicator signal indicating that the baroreflex signal is being applied from the baroreflex stimulator, and respond to the indicator signal by increasing the pacing rate of the pacing therapy from the first pacing rate to a higher pacing rate to maintain a higher minimum heart rate during application of the 1We note the lack of a specific rejection of claim 10 in the Examiner’s Answer as well as in the Final Action mailed July 22, 2009 (however, claim 10 had been previously rejected in the Non-Final Action mailed July 19, 2007). The additional limitation of claim 10 (which depends from claim 1 that stands rejected under the combination of Obel and Struble infra) is identical to a limitation found in independent claim 38. Claim 38 stands rejected under the combination of Obel, Struble and Shelchuk. Both the Examiner and Appellants understand that claim 10 is rejected and is before us on appeal. Ans. 3 and App. Br. 4. Accordingly, we understand that claim 10 stands rejected based on the combination of Obel, Struble and Shelchuk. Appeal 2011-003100 Application 10/746,135 3 baroreflex stimulation signal to compensate for cardiac output that would otherwise be compromised by applying the baroreflex stimulation signal if the pacing therapy did not use the higher pacing rate. REFERENCES RELIED ON BY THE EXAMINER Obel US 5,199,428 Apr. 6, 1993 Bardy US 5,334,221 Aug. 2, 1994 Elsberry US 5,662,689 Sep. 2, 1997 Webster US 6,292,695 B1 Sep. 18, 2001 Meier US 6,292,703 B1 Sep. 18, 2001 Osorio US 2002/0072776 A1 Jun. 13, 2002 Struble US 2002/0183793 A1 Dec. 5, 2002 Kieval US 6,522,926 B1 Feb. 18, 2003 Shelchuk US 2004/0199210 A1 Oct. 7, 2004 THE REJECTIONS ON APPEAL 1. Claims 1, 3-9, 11-15, 17-20, 24, 29, 37, 39 and 41-43 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Obel and Struble. Ans. 4. 2. Claims 2, 16 and 40 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Obel, Struble and further in view of Elsberry and/or Osorio. Ans. 6. 3. Claims 7, 10 and 38 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Obel, Struble and Shelchuk. Ans. 6, 7. 4. Claims 22, 23, 25-28 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Obel, Struble and Kieval and/or Webster. Ans. 7, 8. 5. Claim 30 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Obel, Struble and Bardy. Ans. 9. 6. Claims 21, 31, 32 and 35 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Obel, Struble and Webster. Ans. 9. Appeal 2011-003100 Application 10/746,135 4 7. Claim 33 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Obel, Struble, Webster and Bardy. Ans. 10. 8. Claims 34 and 36 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Obel, Struble and Meier. Ans. 11. ANALYSIS The rejection of claims 1, 3-9, 11-15, 17-20, 24, 29, 37, 39 and 41-43 as being unpatentable over Obel and Struble Our reviewing court has recently stated that the Board reasonably interprets 37 C.F.R. § 41.37 to require more substantive arguments in an appeal brief than a mere recitation of the claim elements and a naked assertion that the corresponding elements are not found in the prior art. See In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011). This holding is applicable here in that under separate headings for each of independent claims 1, 13, 17, 24, 37, 39 and 41, Appellants proffer a naked assertion that the corresponding elements are not found in Obel, Struble or the Office Action. App. Br. 25-27. These naked assertions under separate headings are not considered to be separate arguments. As such, claims 1, 3-9, 11-15, 17- 20, 24, 29, 37, 39 and 41-43 are deemed to have been argued as a group and accordingly, we select independent claim 1 for review with claims 3-9, 11- 15, 17-20, 24, 29, 37, 39 and 41-43 standing or falling with claim 1. See 37 C.F.R. § 41.37(c)(1)(vii) (2011). Claim 1 includes the limitation of a baroreflex stimulator that provides a stimulation signal and a cardiac stimulator that applies a pacing therapy. Claim 1 further specifies that the cardiac stimulator apply a pacing therapy “to maintain a minimum heart rate when the baroreflex stimulation signal is not being applied” (italics added). Claim 1 also specifies that cardiac Appeal 2011-003100 Application 10/746,135 5 stimulator increase “the pacing rate of the pacing therapy from the first pacing rate to a higher pacing rate to maintain a higher minimum heart rate during application of the baroreflex stimulation signal” (italics added). The Examiner finds that Obel expressly discloses a baroreflex stimulator 108 and a cardiac stimulator 104 that correspond to the claimed baroreflex and cardiac stimulators. Ans. 4, see also 11, 12. In fact, the Examiner finds that Obel discloses all the limitations of claim 1 with the exception that Obel does not disclose a pacing rate which is higher than a minimum rate during application of the baroreflex stimulation signal. Ans. 4, see also 12. For this teaching, the Examiner relies on Struble which discloses an accelerated pacing rate during bradycardia stimulation. Ans. 4- 5 referencing Struble Abstr. and paras. [0003]-[0008], [0012], [0034], [0035], [0046]-[0048] and [0057]-[0065], see also Ans. 12. From these teachings, the Examiner finds that it would have been obvious to modify Obel’s backup bradycardia pacing routine such that the pacing rate of this routine is higher than the lower rate otherwise applied to prevent “ischemic conditions” and to increase “the cardiac output to a level sufficient to meet heart and body perfusion requirements as taught by Struble.” Ans. 5, see also 12, 13. Alternatively, the Examiner finds that it would have been obvious to substitute “one known bradycardia pacing routine for another bradycardia pacing routine” as such a substitution would have yielded a predictable result. Ans. 12, 13, 15. Struble Paragraph [0003] identified by the Examiner states that to manage bradycardia, “many pacemakers have a programmed lower pacing rate” (e.g., Obel’s backup pacemaker 104) and that if the patient’s heart rate drops below this rate, the pacemaker would intervene. However, Struble Appeal 2011-003100 Application 10/746,135 6 also states that “the programmed lower rate is insufficient for maintaining heart and body perfusion requirements” and thus identifies a problem being the “delivery of stimulation pulses at a rate resulting in a lower cardiac output that is insufficient for maintaining heart and body perfusion requirements.” Struble, paras. [0005], [0008]. Struble thus discloses that an embodiment of his invention is a feature “that activates accelerated pacing during periods of sinus arrest and/or extreme bradycardia” and identifies the advantages of “gradually decreasing the pacing rate from the accelerated rate” to the lower rate. Struble Abstr., paras. [0011], [0012]. In view of these specific teachings in the prior art, we conclude that the Examiner has, at a minimum, presented a prima facie case of obviousness concerning both (a) the modification of Obel’s backup bradycardia pacing routine “such that the pacing rate of this routine is higher or greater than” the lower rate otherwise applied and also (b) “the substitution of one known bradycardia pacing routine [i.e., Struble’s] for another bradycardia pacing routine [i.e., Obel’s]” and that such a substitution “would have yielded predictable results to one of ordinary skill in the art at the time of the invention.” Ans. 5, 12. See also KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 416 (2007) (“The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results” and further “when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result”). We are further instructed that “[o]bviousness does not require absolute predictability of success …. For obviousness Appeal 2011-003100 Application 10/746,135 7 under § 103, all that is required is a reasonable expectation of success.” In re O’Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988). Appellants contend that the Examiner (a) failed “to provide a prima facie case of obviousness” and (b) that the proposed modification of Obel “would render Obel et al. unsatisfactory for its intended purpose, and would change the principle of operation of the reference.” App. Br. 16. We are not persuaded by Appellants’ first contention for reasons previously addressed. Regarding Appellants’ second contention, Appellants discuss the Obel reference and its principle of operation and intended purpose and also acknowledge that Obel’s “backup pacing ensures that the neural stimulation does not cause the heart rate to drop further than that which is desired to reduce workload.” App. Br. 16-17. However, Appellants contend that Appellants’ claims and the Obel reference contradict each other in that the claimed subject matter “uses cardiac pacing to increase a heart rate during neural stimulation” whereas “Obel et al. use neural stimulation to decrease workload by decreasing heart rate.” App. Br. 18, see also Reply Br. 2, 4. Appellants’ contention is not persuasive as “[n]on-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references.” In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Further, claim 1 specifies a “minimum heart rate” and, during baroreflex stimulation, “increasing the pacing rate . . . from the first pacing rate to a higher pacing rate to maintain a higher minimum heart rate.” It is this increase over a minimum heart rate which the Examiner found wanting in Obel but found disclosed in Struble. Ans. 4, see also 12. Hence, it is the reference to Struble, not Obel, which Appeal 2011-003100 Application 10/746,135 8 was relied on to teach an increase in heart rate above a minimum rate. Ans. 4, 12. Accordingly, Appellants’ contention is not persuasive. Appellants further contend that “there is no suggestion or motivation to make the proposed modification” and that the “lower heart rate during neural stimulation is the intended purpose of the neural stimulation” of Obel. App. Br. 18. We disagree with Appellants’ contention that the Examiner failed to provide a suggestion or motivation to make the proposed modification. See Ans. 5 and 12-14. Further, Obel expressly states that “an object of the present invention” is to “maintain adequate cardiac rate” within acceptable limits (Obel 3:11-19) and Appellants do not indicate how the modification, or substitution, of Struble’s higher-than-minimum rate to avoid the stated issues with the minimum rate would render Obel’s device incapable of maintaining the patient’s rate within acceptable limits. See also Ans. 13. Accordingly, Appellants’ contention is not persuasive. Appellants also discuss the Struble reference and acknowledge its teaching that “[b]ackup pacing slower than a typical baseline rate may be insufficient for maintaining heart and body perfusion requirements” and that “Struble et al. paces at an accelerated pacing rate.” App. Br. 17, see also Reply Br. 2-3. However, Appellants contend that Obel and Struble are not compatible in that “Obel et al. relate to applying neural stimulation in response to a detected ischemia, not sinus node dysfunction” as disclosed in Struble. App. Br. 19, see also Reply Br. 4. This contention is not persuasive. Struble states that “[e]xtreme bradycardic episodes can lead to extreme ischemic cardiac conditions” (Struble, para. [0002]) and Struble’s Abstract as well as Paragraph [0011] discuss providing accelerated pacing “during periods of sinus arrest and/or extreme bradycardia” (italics added). Appeal 2011-003100 Application 10/746,135 9 Appellants’ focus on Struble’s former disclosure of sinus arrest and not the latter disclosure of extreme bradycardia that can lead to ischemic conditions is not persuasive. In other words, Struble also addresses ischemic conditions and not just sinus node dysfunctions. Appellants further contend that Obel’s stimulation “in response to a detected ischemia would frustrate the attempts of Struble et al. to revert back to the intrinsic rate.” App. Br. 19, see also 20. However, as previously noted, the Examiner did not rely on Struble for teaching a reversion back to an intrinsic rate, but instead, the Examiner relied on Struble for disclosing the application of a higher-than-minimum rate and the advantages associated therewith. Ans. 4-5, see also 12. Appellants further address a reason to modify which was expressed by the Examiner in an earlier Office Action and Appellants contend that this “argument is inconsistent.” App. Br. 20. This contention is not persuasive as Appellants acknowledge that Obel teaches a minimum backup pacing to ensure “that the neural stimulation does not cause the heart rate to drop further than that which is desired to reduce workload” (App. Br. 17) while Struble discloses issues with a programmed minimum rate during periods of extreme bradycardic episodes and, to avoid these issues, Struble teaches an accelerated pacing during such periods. Struble, paras. [0005], [0008], [0011] and [0012]. Appellants do not persuade us of inconsistency in the Examiner’s combination of Obel and Struble. Appellants also argue that Obel teaches the maintenance of “a heart rhythm within acceptable limits” and that this “is not the same as maintaining a heart rate” because “[r]hythm is not equivalent to rate.” App. Br. 21. Appellants’ argument is disingenuous as Appellants acknowledge that the “Office relies on column 3 lines 8-19 of Obel” (App. Br. 20) and Appeal 2011-003100 Application 10/746,135 10 while Obel’s column 3, lines 11-13 refer to “heart rhythm,” the following lines 13-19 of Obel refer to an object of the invention being to “maintain adequate cardiac rate” (italics added). Accordingly, Appellants’ argument is not persuasive. Appellants also contend that the “Office includes a number of assumptions, mixing and matching different portions of Obel et al. and Struble et al. without considering the underlying physiological condition.” App. Br. 21. We disagree. We have been instructed that “[a] reference can be used for all it realistically teaches, and is not limited to the disclosures in its specific illustrative examples.” In re Chapman, 357 F.2d 418, 424 (CCPA 1966). See also Beckman Instruments, Inc. v. LKB Produkter AB, 892 F.2d 1547, 1551 (Fed. Cir. 1989). Here, there is no dispute that Obel discloses a backup minimum rate or that Struble discloses the use of a higher-than-minimum rate. We are not persuaded that the Examiner’s combination of these teachings is in error, and Appellants do not persuade us that the underlying physiological conditions of the patient were not considered. Regarding the Office’s failure to provide the diagram requested by Appellants (App. Br. 22, Reply Br. 5), we are not persuaded that the failure of the Examiner to respond to a level Appellants desire is indicative of reversible error. Likewise, Appellants’ graphs (App. Br. 22-24) do not persuade us that the Examiner’s stated modification/substitution involving Obel and Struble is unreasonable or that the Examiner failed to provide articulated reasoning with rational underpinning to support the legal conclusion of obviousness. KSR, 550 U.S. at 418. Appeal 2011-003100 Application 10/746,135 11 Appellants further contend that the Examiner’s finding of obviousness based on a substitution of one known system for another is improper. Reply Br. 4. More specifically, Appellants distinguish between modification and substitution and contend that “[s]ubstitution would require the ability to replace one routine for the other without modifications” (italics added). Reply Br. 4, see also 8. Appellants’ contention (i.e., a substitution “without modifications” is improper) relies on an underlying failure to bodily incorporate the one into the other. We have been instructed that “[t]he test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference . . . . Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art.” In re Keller, 642 F.2d 413, 425 (CCPA 1981) (citations omitted); see also In re Sneed, 710 F.2d 1544, 1550 (Fed. Cir. 1983) (“[I]t is not necessary that the inventions of the references be physically combinable to render obvious the invention under review.” (citations omitted)); In re Nievelt, 482 F.2d 965, 968 (CCPA 1973) (“Combining the teachings of references does not involve an ability to combine their specific structures.”). Rather, “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” KSR, 550 U.S. at 417. Appellants do not persuade us that the Examiner’s stated substitution is beyond the ability of one skilled in the art. Accordingly, Appellants fail to persuade us that the Examiner’s rejection based on a substitution of known elements is improper. Appeal 2011-003100 Application 10/746,135 12 Appellants further contend that the Examiner's arguments fail to account for the different disease triggers and end rates for Struble and Obel. Reply Br. 5-7. Appellants do not identify where different disease triggers or end rates are expressly recited in the claims and we have been expressly instructed that “[t]hough understanding the claim language may be aided by the explanations contained in the written description, it is important not to import into a claim limitations that are not a part of the claim.” See SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir. 2004). Accordingly, Appellants’ contention is not persuasive. Based on the record presented, we sustain the Examiner’s rejection of claims 1, 3-9, 11-15, 17-20, 24, 29, 37, 39 and 41-43 as being unpatentable over Obel and Struble. The rejections of claims 2, 10, 16, 21, 25-28, 30-36, 38 and 40 as being unpatentable over Obel and Struble in combination with one or more of Elsberry, Osorio, Shelchuk, Kieval, Webster, Brady and/or Meier The Examiner rejected the above claims based on Obel and Struble joined with different combinations of additionally cited art. Ans. 6-11. In each instance, Appellants contend that the additional art does not remedy the deficiencies of Obel and Struble and further that the claim is allowable due to the claim being dependent from an allowable independent claim. App. Br. 28-30. As we find no deficiencies with the Examiner’s combination of Obel and Struble supra, we sustain the rejection of claims 2, 10, 16, 21, 25- 28, 30-36, 38 and 40. Appeal 2011-003100 Application 10/746,135 13 The rejection of claims 22 and 23 as being unpatentable over Obel, Struble and Kieval and/or Webster Appellants argue claims 22 and 23 together and accordingly, we select independent claim 22 for review with claim 23 standing or falling with claim 22. Appellants contend that the Examiner failed to “set forth a proper prima facie case of obviousness because the cited portions of Obel and Struble, either alone or in combination with the reasoning given in the Office Action, do not provide the claimed subject matter.” App. Br. 29. Appellants do not provide specific instances of where the Examiner failed but instead recites the claim limitations and state that “Appellants are unable [to] find in the cited portions of Obel, Struble and the Office Action” the claimed method. App. Br. 29. As indicated supra with respect to In re Lovin, 37 C.F.R. § 41.37 requires more substantive arguments in an appeal brief than a mere recitation of the claim elements and a naked assertion that the corresponding elements are not found in the prior art. Accordingly, Appellants’ contention is not persuasive. DECISION The Examiner’s rejections of claims 1-43 are affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED hh