Ex Parte Stahmann et alDownload PDFPatent Trial and Appeal BoardJun 21, 201713933628 (P.T.A.B. Jun. 21, 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. 13/933,628 07/02/2013 Jeffrey E. Stahmann 279.857US3 3252 45458 7590 06/23/2017 smwfPtMan t t tndrf.ro & wofnnnfr/rnf EXAMINER PO BOX 2938 NGUYEN, HUONG Q MINNEAPOLIS, MN 55402 ART UNIT PAPER NUMBER 3736 NOTIFICATION DATE DELIVERY MODE 06/23/2017 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): uspto@slwip.com SLW @blackhillsip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JEFFREY E. STAHMANN, JOHN D. HATLESTAD, and JESSE W. HARTLEY (Applicant: Cardiac Pacemakers, Inc.) Appeal 2016-005496 Application 13/93 3,62 s1 Technology Center 3700 Before DONALD E. ADAMS, FRANCISCO C. PRATS, and RICHARD J. SMITH, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134(a) involves claims to a system that senses thoracic impedance as well as a neurohormone or creatine level. The Examiner rejected the claims as lacking enablement, as indefinite, and for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. STATEMENT OF THE CASE The Specification discloses that, in “pulmonary edema, fluid accumulates in extracellular spaces, such as the spaces between lung tissue 1 Appellants state that the “real party in interest of the above-captioned patent application is the assignee, Cardiac Pacemakers, Inc.” App. Br. 2. Appeal 2016-005496 Application 13/933,628 cells. One cause of pulmonary edema is congestive heart failure (CHF). . . Spec. 1. The Specification explains that pulmonary edema may be detected by “monitoring an impedance of a subject’s thoracic cavity. ... In pulmonary edema, a reduction in thoracic impedance indicates an increase in the amount of fluid inside the subject’s lungs.” Id. at 6. The Specification discloses that thoracic impedance can be measured by measuring the current across electrodes implanted at different locations in a patient’s thorax. Id. at 8. The Specification discloses a system that uses not only a patient’s thoracic impedance as a measure of pulmonary edema, but also uses the patient’s “neurohormone level (particularly the neurohormone level referred to in the art as brain (also known as ‘B-type’) natriuretic peptide (BNP)). . . as a pulmonary edema related factor.” Id. at 21 (reference number omitted). As explained in the Specification, an “increase in BNP may correlate to an indication of pulmonary edema. Serum levels of BNP can help identify CHF as the origin of dyspnea, which is commonly referred to ‘shortness of breath.’ Serum levels of BNP > 500 pg/ml are most consistent with CHF.” Id. Claim 1 is representative, and reads as follows (App. Br. 14): 1. A system comprising: an implantable thoracic impedance measurement circuit, adapted to sense a thoracic impedance signal from a subject; a parameter collection device, adapted to sense or receive physiologic information about the subject, the physiologic information selected from a physiologic information group including at least one of a neurohormone level or a creatinine level; and 2 Appeal 2016-005496 Application 13/933,628 a processor, coupled with the thoracic impedance measurement circuit to accept the thoracic impedance signal, and coupled with the parameter collection device to accept the physiologic information, wherein the processor is adapted to determine a pulmonary edema indication using the thoracic impedance signal and the physiologic information, wherein the thoracic impedance signal is adjusted in view of the physiological information or a thoracic impedance threshold is adjusted in view of the physiological information. The Examiner entered and maintained the following rejections: (1) Claims 5, 6, and 8, under 35 U.S.C. § 112, first paragraph, as failing to comply with the enablement requirement (Final Action 2—3 (entered April 10, 2015); Ans. 2); (2) Claims 5, 6, and 8, under 35 U.S.C. § 112, second paragraph, as indefinite (Final Action 3^4; Ans. 2); (3) Claims 1, 3, 4, 7—9, 12, 14, 16, and 17, under 35 U.S.C. § 103(a), for obviousness over Combs2 and Florio3 (Final Action 5—7; Ans. 2); (4) Claim 2, under 35 U.S.C. § 103(a), for obviousness over Combs, Florio, Zhu,4 and Er5 (Final Action 7—8; Ans. 2); (5) Claim 5, under 35 U.S.C. § 103(a), for obviousness over Combs and Florio, combined with either Kadhiresan6 or Wang7 (Final Action 9; Ans. 2); 2 US 6,512,949 B1 (issued Jan. 28, 2003). 3 US 2004/0186523 A1 (published Sept. 23, 2004). 4 US 2003/0191503 A1 (published Oct. 9, 2003). 5 US 6,266,565 B1 (issued July 24, 2001). 6 US 5,974,340 (issued Oct. 26, 1999). 7 US 2004/0215097 A1 (published Oct. 28, 2004). 3 Appeal 2016-005496 Application 13/933,628 (6) Claims 6 and 13, under 35 U.S.C. § 103(a), for obviousness over Combs, Florio, and Belalcazar8 (Final Action 9-10; Ans. 3); (7) Claims 10 and 11, under 35 U.S.C. § 103(a), for obviousness over Combs, Florio, and Girouard9 (Final Action 11; Ans. 3); and (8) Claim 15, under 35 U.S.C. § 103(a), for obviousness over Combs, Florio, and Er (Final Action 11—12; Ans. 3). INDEFINITENESS In rejecting claims 5, 6, and 8 as indefinite, the Examiner concluded that “the term ‘module’ has not been clearly defined by the specification to be hardware or software and thus renders the claims indefinite. It is noted that paragraph 0056 appears to state that said modules may be software or firmware.” Final Action 4. As the Examiner noted (Ans. 3), the Appeal Brief did not address this rejection. See App. Br. generally. The Reply Brief also does not include argument directed to this rejection. See Reply Br. generally. Given the absence of substantive argument directed to this rejection, we summarily affirm it. See MPEP § 1205.02 (Arguments and evidence not presented in an appeal brief “are waived for purposes of the appeal and the Board may summarily sustain any grounds of rejections not argued.”). ENABLEMENT In rejecting claims 5, 6, and 8 as lacking enablement, the Examiner concluded that Appellants’ Specification “does not make clear what the ‘module’ recited in said claims refers to, therefore preventing one of 8 US 2004/0102712 A1 (published May 27, 2004). 9 US 2003/0055461 A1 (published Mar. 20, 2003). 4 Appeal 2016-005496 Application 13/933,628 ordinary skill in the art from being able to make the device. Thus the claims are not enabled.” Final Action 2—3. As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): [T]he examiner bears the initial burden ... of presenting a prima facie case of unpatentability. . . . After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. Appellants do not argue the claims subject to this ground of rejection separately. We select claim 5 as representative of the rejected claims. 37C.F.R. §41(c)(l)(iv). Claim 5 reads as follows: 5. The system as recited in claim 1, further comprising: a blood impedance measurement circuit, adapted to sense a blood impedance signal from the subject; and a blood impedance correction module coupled with the blood impedance measurement circuit, wherein the blood impedance correction module is adapted to extract from the thoracic impedance signal a blood resistivity-influenced component using the blood impedance signal, and wherein the processor is adapted to determine the pulmonary edema indication using, at least in part, a blood resistivity-compensated thoracic impedance signal. App. Br. 15 (emphasis added). As evidence that a skilled artisan would be able to make the module recited in claim 5 based on the disclosures in the Specification, Appellants cite the following passage: FIG. 3 illustrates one conceptualization of various circuits, sensors, devices, or modules which are implemented either in hardware or as one or more sequences of steps carried 5 Appeal 2016-005496 Application 13/933,628 out on a microprocessor or other controller. Such circuits, sensors, devices, or modules are illustrated separately for conceptual clarity; however, it is to be understood that the various circuits, sensors, devices, or modules of FIG. 3 need not be separately embodied, but may be combined or otherwise implemented, such as in software or firmware. Spec. 18-19. Based on this disclosure, Appellants contend that “a ‘module’ as recited in the claims can be ‘implemented either in hardware or as one or more sequences of steps carried out on a microprocessor or other controller.’ Accordingly, one of skill in the art would be enabled to make such a device.” App. Br. 9. In particular, Appellants contend, “[n]o undue experimentation would be needed to practice the invention. It would be straightforward for a designer to choose the appropriate hardware or software to perform the functions described.” Id. We find that the preponderance of the evidence supports the Examiner’s position. As our reviewing court has explained, while the Specification need not disclose what is well known in the art, “that general, oft-repeated statement is merely a rule of supplementation, not a substitute for a basic enabling disclosure. It means that the omission of minor details does not cause a specification to fail to meet the enablement requirement.” Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366, (Fed. Cir. 1997) (citation omitted). Similar to the situation here, when there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required; there is a failure to meet the enablement requirement that cannot be rectified by asserting 6 Appeal 2016-005496 Application 13/933,628 that all the disclosure related to the process is within the skill of the art. It is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement. This specification provides only a starting point, a direction for further research. Id. Despite their assertion that making a module with the functionality recited in claim 5 would be straightforward, Appellants do not explain with adequate particularity, or advance persuasive evidence demonstrating, how the cited disclosures in the Specification demonstrate that the blood impedance module can be implemented in hardware or software. In particular, neither the passage cited by Appellants, nor Figure 3, provides the specific steps and components that are to be employed to make a blood impedance module having the functionality required by claim 5. We, therefore, affirm the Examiner’s rejection of claim 5 for lack of enablement. Claims 6 and 8 fall with claim 5. 37 C.F.R. § 41(c)(l)(iv). OBVIOUSNESS—COMBS AND FLORIO The Examiner’s Prima Facie Case We select claim 1 as representative of the claims subject to this rejection. 37 C.F.R. § 41(c)(l)(iv). In rejecting claim 1 over Combs and Florio, the Examiner cited Combs as describing a pulmonary edema monitoring system including a thoracic impedance unit, as required by claim 1. Final Action 5. The Examiner found that, similar to claim 1, Combs’ device included a device capable of sensing physiologic information, such as respiration rate, as well as the capability of determining a pulmonary edema indication based on 7 Appeal 2016-005496 Application 13/933,628 measuring the thoracic impedance in combination with the secondary physiologic information. Final Action 5. The Examiner found that Combs’ system differed from the system of Appellants’ claim 1 in that Combs did not “disclose said physiological information being at least one neurohormone level or a creatinine level.” Id. at 6. As evidence that it would have been obvious to monitor at least one neurohormone level or a creatinine level, as required by claim 1, the Examiner cited Florio as disclosing that “BNP - a neurohormone - increases with pulmonary edema.” Id. (citing Florio | 82). The Examiner found, moreover, that it was “well known in the art that indicators of pulmonary edema include at least heart sounds, creatinine level, B-type natriuretic peptide (BNP) level - a neurohormone, excessive perspiration, pallor, and anxiety.” Id. Based on the references’ combined teachings, the Examiner concluded that it would have been obvious to modify Combs’ device to sense or receive a neurohormone level as taught by Florio “to effectively improve the pulmonary edema indicator function of Combs et al by advantageously providing more and different parameters to more accurately determine the onset of pulmonary edema, wherein in combination the thoracic impedance signal is adjusted in view of the physiological information.” Id. Analysis Appellants do not persuade us that preponderance of the evidence fails to support the Examiner’s prima facie case that the system of claim 1 would have been obvious to an ordinary artisan. 8 Appeal 2016-005496 Application 13/933,628 Combs discloses a system composed of “implantable devices including but not limited to tissue stimulators having measurement capability for determining impedance measurements and is particularly well suited to measure long term edema variations within a living body.” Combs 1:7—11. Combs explains that it “is commonly understood that Transthoracic Impedance measurements give a good indication of the level of edema in patients.” Id. at 1:15—17. In one embodiment, Combs discloses that the impedance monitoring circuit can be part of a pacemaker system. Id. at 5:36-40. As the Examiner found, Combs explains that, in that system, as in Appellants’ claim 1, physiologic information in addition to the thoracic impedance information can be used to adjust the threshold at which the device is activated: For additional beneficial data generation purposes other sensors may be included in the implanted device and data therefrom temporally matched with edema data to provide additionally beneficial diagnostic data. Each sensor can be thought of as a system for providing an indication of patient condition, either when it’s [sic] output is taken alone or combined in manners known to those in the art to determine patient condition. Such included sensor systems or subsystems could include, for example, diurnal cycle indicators, position or posture indicators, resting indicators, heart beat cycle indicators, breathing indicators, movement indicators, and so forth, each providing a signal value that could be stored or used to trigger an activity of the implanted device. Id. at 5:43—55 (emphasis added). Combs also focuses on respiratory rate as the type of physiologic information to be used alongside thoracic impedance in its pulmonary edema-monitoring system (Combs 2:39-53), and discloses that the respiration rate and thoracic impedance data can be combined in evaluating 9 Appeal 2016-005496 Application 13/933,628 the patient’s status, as well as adjusting an alarm threshold, as the Examiner also found, and as required by Appellants’ claim 1: A device can be constructed using the respiration rate as described alone or in combination with the DC impedance measurement of edema described above. If both are used a mixed value should ultimately be relied upon to indicate the level of edema the patient is subjected to. Many ways can be devised to combine these signals, including simply adding them throughout the potential range and using the total value for the indicator; relying on one measure only, in situations where it is superior, or simply recording both separately and reporting them out through telemetry for analysis together by a doctor or other attendant (human or automatic). Alarms can be initiated thorough whatever patient or doctor communication system is used with the device at whatever level is programmed in for the variable or variables used to evaluate these measures of edema. Id. at 15:16—30 (emphasis added). Combs does not appear to describe using a neurohormone level or a creatinine level to adjust the threshold of a pulmonary edema indication, as required by claim 1. The Examiner found, nonetheless, and Appellants do not dispute, that increased BNP and creatinine levels were known in the art to be associated with pulmonary edema. Final Action 6. Thus, given that increased BNP and creatinine levels undisputedly were known in the art to be associated with pulmonary edema, and given Combs’ teaching of the desirability of using a variety of physiologic information, such as respiratory rate, to adjust thoracic impedance-based pulmonary edema indication thresholds, we agree with the Examiner that an ordinary artisan had good reason for, and a reasonable expectation of success in, using a neurohormone level or a creatinine level to adjust the threshold of a pulmonary edema indication, as required by claim 1. We, 10 Appeal 2016-005496 Application 13/933,628 therefore, also agree with the Examiner that the system recited in Appellants’ claim 1 would have been obvious to an ordinary artisan. Appellants’ arguments do not persuade us to the contrary. Appellants contend that the Examiner has not explained “how a BNP level would be substituted for the respiratory rate of Combs. BNP level and respiratory rate are different types of indicators for pulmonary edema. There is no reasoning in the Office Action that would make such a substitution work without undue experimentation.” App. Br. 10. As the Examiner contends, however (see Ans. 4), the rejection did not posit substituting BNP and creatinine levels for Combs’ respiratory rate information, but instead posited including evaluations of BNP and/or creatinine levels as part of Combs’ system, including as a measure for indicating a pulmonary edema threshold. See Final Action 6 (“advantageously providing more and different parameters to more accurately determine the onset of pulmonary edema, wherein in combination the thoracic impedance signal is adjusted in view of the physiological information”). Appellants contend: “[Ajlthough Combs et al discusses comparing edema levels to long term values and adjusting therapy depending on the levels, there is no discussion in Combs et al or in Florio of the subject matter of: “the thoracic impedance signal is adjusted in view of the physiological information or a thoracic impedance threshold is adjusted in view of the physiological information,” as recited in claim 1. The combination simply makes no discussion of such adjustments. Accordingly, claim 1 is not obvious in view of the cited references. App. Br. 11; see also Reply Br. 2. 11 Appeal 2016-005496 Application 13/933,628 We are not persuaded. Claim 1 recites that “the thoracic impedance signal is adjusted in view of the physiological information or a thoracic impedance threshold is adjusted in view of the physiological information.” App. Br. 14. As noted above, Combs discloses that “[mjany ways can be devised to combine” thoracic impedance and respiratory rate information, including “simply adding them throughout the potential range and using the total value for the indicator; relying on one measure only, in situations where it is superior, or simply recording both separately and reporting them out through telemetry for analysis together by a doctor or other attendant (human or automatic).” Combs 15:20—26. Immediately thereafter, Combs discloses “[ajlarms can be initiated thorough whatever patient or doctor communication system is used with the device at whatever level is programmed in for the variable or variables used to evaluate these measures of edema.” Id. at 26—30. Thus, contrary to Appellants’ argument, as to adjusting the thoracic impedance threshold based on additional physiologic information, Combs discloses a number of ways that a thoracic impedance signal and additional physiologic information can be combined to adjust an alarm threshold. Appellants do not explain with particularity, or advance specific persuasive evidence explaining, why an ordinary artisan prompted to use a known indicator of pulmonary edema, such as BNP levels, in Combs’ system, would have been unable to include the BNP information into a pulmonary edema threshold indicator, as recited in Appellants’ claim 1, based on Combs’ specific teachings about how other physiologic information is combined with thoracic impedance. Indeed, as noted above, Combs teaches 12 Appeal 2016-005496 Application 13/933,628 that thoracic impedance may be combined with other physiologic data “in manners known to those in the art to determine patient condition.” Combs 5:48-49. Thus, given the absence of specific supporting evidence or a particularized fact-based explanation why the disclosures in Combs would have been insufficient to allow an ordinary artisan to adjust the thoracic impedance threshold based on BNP or creatinine level, Appellants do not persuade us that the Examiner erred in maintaining the obviousness rejection as to claim 1. We, therefore, affirm the Examiner’s rejection of claim 1 over Combs and Florio. Because they were not argued separately, claims 3, 4, 7— 9, 12, 14, 16, and 17 fall with claim 1. 37 C.F.R. § 41(c)(l)(iv). OBVIOUSNESS- COMBS AND FLORIO COMBINED WITH ADDITIONAL REFERENCES In the remaining obviousness rejections, the Examiner relies on Combs and Florio for the teachings discussed above, and cites additional references to show that the features recited in dependent claims 2, 5, 6, 10, 11, 13, and 15 would have been obvious elements in a pulmonary edema monitoring system such as that taught in Combs. Final Action 7—12. As to these rejections, Appellants argue only that the supplemental references cited by the Examiner fail to remedy the deficiencies of the combination of Combs and Florio, discussed above, as to claim 1. App. Br. 12. As discussed above, however, Appellants do not persuade us that the combination of Combs and Florio fails to demonstrate that the system recited in claim 1 would have been obvious. Accordingly, because Appellants do not demonstrate, nor do we discern, error in the Examiner’s 13 Appeal 2016-005496 Application 13/933,628 rejections of claims 2, 5, 6, 10, 11, 13, and 15, we affirm those rejections as well. SUMMARY We affirm each of the Examiner’s rejections. TIME PERIOD No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv). AFFIRMED 14 Copy with citationCopy as parenthetical citation