Medtronic, Inc.

Patent Trials and Appeals Board

Feb 2, 2022

2021003873 (P.T.A.B. Feb. 2, 2022)

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. 15/850,024 12/21/2017 Shantanu Sarkar P0035896.USC6/ LG10126.L33 7876 27581 7590 02/02/2022 Medtronic, Inc. (CVG) 8200 Coral Sea Street NE. MS: MVC22 MINNEAPOLIS, MN 55112 EXAMINER PORTER, JR, GARY A ART UNIT PAPER NUMBER 3792 NOTIFICATION DATE DELIVERY MODE 02/02/2022 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 SHANTANU SARKAR, DOUGLAS A. HETTRICK, AMUL Y. DESAI, RANDOLPH M. BIALLAS, HOLLY S. VITENSE, and JODI L. REDEMSKE Appeal 2021-003873 Application 15/850,024 Technology Center 3700 ____________ Before CHARLES N. GREENHUT, MICHAEL J. FITZPATRICK, and WILLIAM A. CAPP, Administrative Patent Judges. FITZPATRICK, Administrative Patent Judge. DECISION ON APPEAL Appellant, Medtronic Inc.,1 appeals under 35 U.S.C. § 134(a) from the Examiner’s final decision rejecting claims 1-5, 7, 8, 10-14, 16, 17, 19, and 20. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 “Appellant” refers to the applicant as defined in 37 C.F.R. § 1.42 and identifies Medtronic, PLC, as the real party in interest. Appeal Br. 2. Appeal 2021-003873 Application 15/850,024 2 STATEMENT OF THE CASE The Specification The Specification “relates to medical devices and, more particularly, devices for the diagnosis of worsening heart failure and treatment of related ailments.” Spec. 1. The Claims Claims 1-5, 7, 8, 10-14, 16, 17, 19, and 20 are rejected. Final Act. 1. Claims 6, 9, 15 and 18 are canceled, and no other claims are pending. Id.; Appeal Br. 25-27. Claim 1 is illustrative and reproduced below. 1. A method comprising: monitoring primary and secondary diagnostic parameters of a patient associated with heart failure, said primary parameters including intrathoracic impedance, including receiving at least one of said primary parameters from an implanted medical device, said secondary parameters including clinical data not received from the implanted medical device, wherein the clinical data comprises hospitalizations of the patient; deriving an index from the primary and secondary diagnostic parameters by using a Bayesian approach, the index indicating probability of occurrence of a heart failure event; and displaying the derived index; and modifying a therapy delivered to the patient in response to the index. Appeal Br. 25. Appeal 2021-003873 Application 15/850,024 3 The Examiner’s Rejections The following rejections under 35 U.S.C. § 103 are before us: 1. claims 1-3, 5, 8, 10-12, 14, 17, 19, and 20 over Patel,2 Libbus,3 and Patangay4 (Final Act. 4); and 2. claims 1, 2, 4, 5, 7, 8, 11-14, 16, 17, and 20 over Libbus and Patangay (id. at 6). DISCUSSION In its Appeal Brief, Appellant argues Rejection 2 before arguing Rejection 1. Our analysis below follows the same order. Rejection 2 Appellant argues against the rejection of all claims together. Appeal Br. 6-16. We choose claim 1 as representative. 37 C.F.R. § 41.37(c)(1)(iv). The Examiner found that Libbus discloses most of the subject matter of claim 1 except that it “is silent regarding the inclusion of hospitalization history in the clinical data used to assess the patient.” Final Act. 6-7 (citing Libbus ¶¶71, 78, 82-85, 89, 121-26). The Examiner found that “Patangay discloses incorporating hospitalization data into an analysis of cardiac health and therapy efficacy for the purpose of providing more data points that can provide a more detailed picture of cardiac health progression.” Id. at 7 (citing Patangay ¶22, 57). The Examiner concluded: Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Libbus reference to include hospitalization data, as taught and suggested by Patangay, for the 2 US 2007/0239043 A1, published Oct. 11, 2007 (“Patel”) 3 US 2007/0260285 A1, published Nov. 8, 2007 (“Libbus”). 4 US 2008/0103399 A1, published May 1, 2008 (“Patangay”). Appeal 2021-003873 Application 15/850,024 4 purpose of providing a more detailed picture of cardiac health progression. Id. Appellant’s arguments against this rejection are poorly organized for identifying any purported error in the Examiner’s rejection. Appellant begins by asserting: “The claims rejected only under this rejection remain rejected, but the Examiner’s arguments in response to those presented by Applicant in response to both the first and final Office Actions all rely on Patel, which is not part of this rejection.” Appeal Br. 6. Appellant then reproduces Rejection 2 as articulated in the Final Action, referring to it as “the Examiner’s initial argument.” Id. at 6; see id. at 6-7 (reproducing an excerpt from Final Act. 6-7). Next, Appellant presents, not its current arguments against Rejection 2, but rather a reproduction of its previously presented “response to both the initial rejection over Libbus and Patangay [(i.e., Rejection 2)] and to the initial rejection over Patel, Libbus and Patangay [(i.e., Rejection 1)].” Appeal Br. 7; see id. at 8-10 (reproducing an excerpt from June 11, 2020, Amendment at 5-7). Appellant then argues that the Examiner, in an Advisory Action mailed October 19, 2020, “respond[ed]” by relying on Patel, which is not a reference in Rejection 2. Appeal Br. 10. Next, Appellant asserts that, “[i]n the Final Office Action, the Examiner presents only new arguments that specifically rely upon Patel.” Id.; see also id. at 11 (reproducing an excerpt from Final Act. 2-3). Appellant argues that in the “Response to Arguments” section of the Final Action: The Examiner makes no argument that Libbus discloses how to apply data related to the patient’s hospitalizations to determine the patient’[s] clinical condition generally or to determine the Appeal 2021-003873 Application 15/850,024 5 likelihood that the patient is experiencing a heart failure event. Only Patel is cited as providing these teachings. Appeal Br. 11. Ultimately, Appellant asserts that Rejection 1 must have been withdrawn because (1) “No new arguments specific to the rejection over only Libbus and Patangay were added” in the Final Action (Appeal Br. 12); and (2) “In the Advisory Action, there is no mention of the rejection over only Libbus and Patangay, and it appears that only the rejection relying on Patel is maintained” (Appeal Br. 14). The Examiner correctly rejects Appellant’s extensive efforts to characterize the prosecution history as evidencing a withdrawal of Rejection 1. Ans. 8. In that regard, the Examiner notes that Appellant’s June 11, 2020, Amendment lumped together arguments for each of the rejections. Id. In fact, as pointed out by the Examiner, Appellant explicitly argued that “The issue with the rejections over Libbus and Patangay [(i.e., Rejection 2)] is exactly the same as the issue discussed above with regard to the rejections over Patel, Libbus and Patangay [(i.e., Rejection 1)].” Ans. 8 (quoting June 11, 2020, Amendment 3). The Examiner responded to Appellant’s arguments in a format that was logical given how they had been presented. In any event, the Examiner included Rejection 1 in the Final Action and has never withdrawn it. See Final Act. 4-6. In the latter half of page 14 of its Appeal Brief, Appellant finally presents its arguments against Rejection 2. There, Appellant argues as follows: As previously argued by Applicants and now uncontroverted by the Examiner, neither Libbus nor Patangay discloses the use of a patient’s hospitalizations to deliver or modify a therapy in response thereto. With all due respect, as previously argued by Applicant, neither does Libbus. Similarly, Appeal 2021-003873 Application 15/850,024 6 neither Libbus nor Patangay discloses how information regarding a patient’s hospitalizations could be applied to diagnose whether the patient is likely experiencing a heart failure event as required by the claims or even that it could be so used. Appeal Br. 14. Appellant’s argument that “neither Libbus nor Patangay discloses the use of a patient’s hospitalizations to deliver or modify a therapy in response thereto” is not commensurate with the rejection, which relies on a combination of Libbus and Patangay to render obvious such subject matter. See Final Act. 7. Specifically, the Examiner found and concluded: Libbus discloses this data is fed to a Bayesian network (par. [0084-0085]) to derive a heart failure index that is displayed to a user (par. [0121-0126]) and is used to control therapy delivery to a patient (par. [0089]). Libbus is silent regarding the inclusion of hospitalization history in the clinical data used to assess the patient. However, Patangay discloses incorporating hospitalization data into an analysis of cardiac health and therapy efficacy for the purpose of providing more data points that can provide a more detailed picture of cardiac health progression (par. [0022, 0057]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Libbus reference to include hospitalization data, as taught and suggested by Patangay, for the purpose of providing a more detailed picture of cardiac health progression. Final Act. 7. Thus, Appellant’s arguments are not persuasive of error. See In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (“Non- obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references.”). Appeal 2021-003873 Application 15/850,024 7 Appellant also argues that the combination of Libbus and Patangay cannot teach subject matter that neither of them alone teaches. Appeal Br. 15. Specifically, Appellant argues: The Examiner expressly admits that “Libbus is silent regarding the inclusion of hospitalization history in the clinical data used to assess the patient”. Correspondingly, it is necessarily true that Libbus does not teach using the patient’s hospitalization history to diagnose whether a patient is currently experiencing a heart failure event. This teaching, critical to the invention is also missing from Patangay as noted above. Their combination therefore cannot teach it. Correspondingly it is necessarily true that Libbus does not teach that such information can be used to determine whether a therapy should be delivered or modified in response to the un- taught diagnosis of a likely hear failure event based thereon? This teaching, critical to the invention is also missing from Patangay as noted above. Their combination therefore cannot teach it. Id. (emphasis added). The conclusions in Appellant’s arguments, italicized above, demonstrate an unfamiliarity with established law. Contrary to Appellant’s conclusions, “[a] claim can be obvious even where all of the claimed features are not found in specific prior art references, where ‘there is a showing of a suggestion or motivation to modify the teachings of [the prior art] to the claimed invention.’” Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299, 1307 (Fed. Cir. 2006) (quoting SIBIA Neurosciences, Inc. v. Cadus Pharm. Corp., 225 F.3d 1349, 1356 (Fed. Cir. 2000)); see also In re Keller, 642 F.2d 413, 425 (C.C.P.A. 1981) (“The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Appeal 2021-003873 Application 15/850,024 8 Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art.”). Appellant concedes that “Patangay disclose that a patient’s prior hospitalizations may be relevant for some undisclosed purposes related to over-all cardiac heath.” Appeal Br. 15. However, Appellant argues that such a disclosure does not “make it obvious that such information can be used to diagnose whether a patient is currently experiencing a heart failure event.” Id. But here again Appellant is making an argument that is not responsive to the rejection. The Examiner did not conclude that Patangay’s disclosure alone makes it obvious that a patient’s prior hospitalizations can be used to diagnose whether a patient is currently experiencing a heart failure event. Rather, the Examiner’s conclusion of obviousness is based on the disclosure of Patangay in combination with Libbus’s disclosure of a method of managing heart failure that is based in part on a patient’s clinical data “wherein the clinical data includes clinical lab results such as those obtained during a clinical study (par. [0083]), information about drug therapy for the patient (par. [0082-0083]), weight, blood pressure, etc. (par. [0078]).” Final Act. 7-8 (citations are to Libbus). Appellant also argues that Patangay “is not an enabling disclosure” of “how such a diagnosis of a likely heart failure event could be derived based upon the data related to a patient’s prior hospitalizations.” Appeal Br. 15; see also id. at 24 (“By way of analogy, Jules Verne disclosed the desirability of manned spaceflight to the moon. His books would not serve as a valid basis for an obviousness rejection for any claims directed to spacecraft, no Appeal 2021-003873 Application 15/850,024 9 matter how broad they might be.”). This argument is not persuasive of Examiner error. First, the rejection before us is not one for anticipation. Thus, it is neither surprising nor persuasive of error that the Examiner has not identified a disclosure in the prior art of “all of the limitations arranged or combined in the same way as recited in the claim,” let alone an enabling disclosure of the same. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). The rejection before us is for obviousness. Where claimed subject matter has been rejected as obvious in view of a combination of prior art references, a proper analysis under § 103 requires, inter alia, consideration of two factors: (1) whether the prior art would have suggested to those of ordinary skill in the art that they should make the claimed composition or device, or carry out the claimed process; and (2) whether the prior art would also have revealed that in so making or carrying out, those of ordinary skill would have had a reasonable expectation of success. In re Vaeck, 947 F.2d 488, 493 (Fed. Cir. 1991) (citation omitted). “Reasonable expectation of success is assessed from the perspective of the person of ordinary skill in the art.” Life Techs. Inc. v. Clontech Labs. Inc., 224 F.3d 1320, 1326 (Fed. Cir. 2000). As the Examiner points out, the prior art - Libbus - discloses utilizing a Bayesian network as well as the types of information that can be fed into it in order to treat heart failure. Ans. 10-11 (citing Libbus ¶¶75, 84-85). And, as the Examiner further points out, “Paragraphs [0077-0083] then list the numerous types of data sources than can be used to predict a heart failure event using the intelligent system, such data including medical records, observation data (par. [0079]), symptoms (par. [0080]), patient history data (par. [0081]), etc.” Id. at 11. Appeal 2021-003873 Application 15/850,024 10 When viewed with respect to a Bayesian Network, one skilled in the art would most certainly be aware of and know how to incorporate these types of data into the Bayesian Network. Given a known symptom or event and a known outcome, a future probability of the same outcome can be determined given new data points describing a symptom or outcome. The disclosure of Libbus would most certainly be enabling for one skilled in the art and those of ordinary skill in the art would be apprised of how to incorporate the data or Patangay into the Bayesian Network of Libbus. Ans. 11. Although the pertinent issue is whether a person of ordinary skill would have had a reasonable expectation of success and not whether an individual prior art reference is “enabling,”5 the Examiner’s analysis above adequately supports a finding that a reasonable expectation of success exists. See In re O’Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988) (“Obviousness does not require absolute predictability of success. . . . For obviousness under § 103, all that is required is a reasonable expectation of success.”). The person of ordinary skill in the art is already charged with the knowledge of utilizing a Bayesian network to treat heart failure. See Libbus ¶¶75, 84- 85. All the modification requires is using, as input data, “hospitalizations of the patient” (as taught by Patangay) whereas Libbus already teaches using “medical records, observation data” (id. ¶79), “symptoms,” (id. ¶80), “patient history data” (id. ¶81), and “clinical study data” (id. ¶83). 5 Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F. 3d 1313, 1357 (Fed. Cir. 2003) (“Under § 103, however, a reference need not be enabled; it qualifies as a prior art, regardless, for whatever is disclosed therein. . . . enablement of the prior art is not a requirement to prove invalidity under § 103.”); Therasense, Inc. v. Becton, Dickinson and Co., 593 F. 3d 1289, 1297 (Fed. Cir. 2010) (discussing enablement and reasonable expectation of success in the context of an obviousness rejection). Appeal 2021-003873 Application 15/850,024 11 That a person of ordinary skill in the art would have had a reasonable expectation of success in making the proposed modification is supported by the fact that Appellant’s own Specification lacks “any specific discussion of how hospitalization data and associated probabilities are incorporated into the Bayesian network.” Ans. 17. Appellant argues that this could only be relevant to a rejection under 35 U.S.C. § 112, which is not before us. Reply Br. 3. But Appellant is mistaken. See In re Epstein, 32 F.3d 1559, 1568 (Fed. Cir. 1994) (“[T]he Board’s observation that appellant did not provide the type of detail in his specification that he now argues is necessary in prior art references supports the Board’s finding that one skilled in the art would have known how to implement the features of the references.”). We have considered Appellant’s arguments but they fail to apprise us of error. Accordingly, we affirm the Examiner’s rejection of claim 1 as unpatentable over Libbus and Patangay, as well as that of claims 2, 4, 5, 7, 8, 11-14, 16, 17, and 20, which fall therewith. Rejection 1 Appellant argues against the rejection of all claims together. Appeal Br. 16-24. We choose claim 1 as representative. 37 C.F.R. § 41.37(c)(1)(iv). The Examiner found that Patel discloses most of the subject matter of claim 1 except that Patel (1) “does not disclose that the therapy adjustment in response to the index is made in real-time in response to detected episodes”; and (2) “is silent regarding the inclusion of hospitalization history in the clinical data used to assess the patient.” Final Act. 5 (citing Patel ¶¶25, 28, 33, 35-73, 81, 82, Figs. 4, 12). The Examiner found that Libbus Appeal 2021-003873 Application 15/850,024 12 teaches the former feature and Patangay teaches the latter feature. Id. (citing Libbus ¶89; Patangay ¶22, 57). The Examiner concluded: Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Patel reference to include automatically delivering therapy in response to the index from the Bayesian network, as taught and suggested by Libbus, and to include hospitalization data in the index determination, as taught and suggested by Patangay, for the purpose of providing quicker, more effective therapeutic responses as well as a more detailed picture of cardiac health progression. Id. at 6. Appellant argues Patel “shed[s] no light whatsoever on whether or how a patient’s own prior hospitalizations are usefully applied to a Bayesian network to determine whether the patient is likely experiencing a heart failure event.” Appeal Br. 20. Appellant also argues that Patangay provides no “such teaching.” Id. Appellant is again attacking references individually, whereas the rejection is based on a combination of references. See In re Merck & Co., 800 F.2d at 1097 (“Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references.”). The Examiner relies on Patel for disclosing, among other things, “utilizing a processor . . . to derive an index from the impedance parameters and clinical data using a Bayesian approach” and on Patangay for “incorporating hospitalization data into an analysis of cardiac health.” Id. (citing Patel ¶¶26, 38-73; Patangay ¶¶22, 57). In a similar vein, Appellant argues: The only probabilities discussed in paragraphs 47 and 48 [of Patel] are based upon patient symptoms, expert systems or clinical databases. The patient’s hospitalizations are not Appeal 2021-003873 Application 15/850,024 13 mentioned as a possible source for such probabilities and no suggestion as to how such probabilities might be derived from the patient’s prior hospitalizations is suggested. Appeal Br. 21. This argument likewise misses the mark by focusing on Patel alone instead of addressing the combination articulated by the Examiner. Patel “must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole.” In re Merck & Co., 800 F.2d at 1097. We have considered Appellant’s arguments but they fail to apprise us of error. Accordingly, we affirm the Examiner’s rejection of claim 1 as unpatentable over Patel, Libbus, and Patangay, as well as that of claims 2, 3, 5, 8, 10-12, 14, 17, 19, and 20, which fall therewith. DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1-3, 5, 8, 10-12, 14, 17, 19, 20 103 Patel, Libbus, Patangay 1-3, 5, 8, 10-12, 14, 17, 19, 20 1, 2, 4, 5, 7, 8, 11- 14, 16, 17, 20 103 Libbus, Patangay 1, 2, 4, 5, 7, 8, 11- 14, 16, 17, 20 Overall Outcome 1-5, 7, 8, 10-14, 16, 17, 19, 20 Appeal 2021-003873 Application 15/850,024 14 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED