Jonathan Walter. Krueger et al.Download PDFPatent Trials and Appeals BoardMay 13, 202014825669 - (D) (P.T.A.B. May. 13, 2020) 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. 14/825,669 08/13/2015 Jonathan Walter Krueger 279.L83US1 1897 45458 7590 05/13/2020 SCHWEGMAN LUNDBERG & WOESSNER/BSC PO BOX 2938 MINNEAPOLIS, MN 55402 EXAMINER WU, TONG E ART UNIT PAPER NUMBER 3792 NOTIFICATION DATE DELIVERY MODE 05/13/2020 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): SLW@blackhillsip.com uspto@slwip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte JONATHAN WALTER KRUEGER, DEEPA MAHAJAN, and DAVID L. PERSCHBACHER ____________________ Appeal 2018-007569 Application 14/825,669 Technology Center 3700 ____________________ Before JENNIFER D. BAHR, BENJAMIN D. M. WOOD, and ANNETTE R. REIMERS, Administrative Patent Judges. WOOD, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1 appeals under 35 U.S.C. § 134 from a Non-Final Action entered June 23, 2017 rejecting claims 1–20. 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. Appellant identifies the real party in interest as Cardiac Pacemakers, Inc. Appeal Br. 2. Appeal 2018-007569 Application 14/825,669 2 THE CLAIMED SUBJECT MATTER The claims are directed to atrial fibrillation detection using ventricular rate variability. Claim 11, reproduced below, is illustrative of the claimed subject matter: 11. A method of detecting atrial fibrillation, the method comprising: receiving, at a processor circuit, indications of pairs of first and second ventricular rate changes of three temporally adjacent ventricular heart beats; determining, using the processor circuit, a first court of instances of the pairs in which a combined rate change magnitude characteristic in units of beats per minute (bpm) is less than at least one first criterion having a unit of bpm; determining, using the processor circuit, a second count of instances of the pairs in which both of the first and second ventricular rate changes are negative; and determining, using the processor circuit, atrial fibrillation information using the first and second counts. REFERENCES Name Reference Date Ritscher US 2004/0092836 A1 May 13, 2004 Sarkar US 2006/0247548 A1 Nov. 2, 2006 REJECTIONS Claims 1–20 are rejected under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. Claims 1–20 are rejected under 35 U.S.C. § 112(a) as failing to comply with the enablement requirement. Appeal 2018-007569 Application 14/825,669 3 Claims 1–20 are rejected under 35 U.S.C. § 101 as directed to ineligible subject matter. Claims 1–5, 8, and 11–15 are rejected under 35 U.S.C. § 102(a)(1) as anticipated by Sarkar. Claims 6, 9, 16, and 17 are rejected under 35 U.S.C. § 103 as unpatentable over Sarkar and Ritscher. Claims 7, 10, and 18–20 are rejected under 35 U.S.C. § 103 as unpatentable over Sarkar. ANALYSIS Claims 1–20—Rejected as Failing to Comply with the Written Description Requirement Appellant argues claims 1–20 as a group. Appeal Br. 11–12. We select claim 11 as representative of the group, and decide the appeal of this rejection on the basis of claim 11 alone. 37 C.F.R. § 41.37(c)(1)(iv) (2017). Claim 11 is directed to a method of detecting atrial fibrillation (AF) using “first and second counts” of pairs of ventricular rate changes, measured in beats per minute. Appeal Br. 20 (claims. app.). The Specification defines these first and second counts—i.e., first count a and second count b—as points on a two-dimensional scatter plot (or Lorenz plot), the x-axis value determined by one ventricular rate change of a pair, the y-axis value determined by the other ventricular rate change of the pair. Spec. ¶¶ 34, 50–53, Fig. 4B. Counts falling within a region centered at the origin of the scatter plot (region 409 depicted in Figure 4B, representing a “magnitude” criterion) comprise first count a, and those falling within a region in the lower left quadrant of the scatter plot (region 410 depicted in Figure 4B, representing a “double decrement” criterion) comprise second Appeal 2018-007569 Application 14/825,669 4 count b. The Specification discloses using counts a and b to determine a “First Indication” and “Second Indication,” respectively, of AF. Spec. ¶¶ 51–53, Fig. 5. The First Indication is determined by comparing the first count a to the total number of instances of pairs T of ventricular rate changes in a “window” of temporally consecutive heart beats using the equation . Id. ¶¶ 50–51. The Second Indication is determined by comparing the second count b to the total T of pairs of ventricular rate changes, or . Id. ¶¶ 52–53. According to the Specification, “AF is indicated for a valid window when the first and second indications are satisfied.” Id. ¶ 55 (emphasis added). In rejecting the claims as failing the written-description requirement, the Examiner finds that “[t]he specification merely states, ‘AF is indicated for a valid window when the first and second indications are satisfied’ . . . and completely omits what would be considered meeting or satisfying the indications.” Non-Final Act. 4. According to the Examiner, “[t]he specification describes a multitude of calculations culminating in a first indication and a second indication (Paragraphs 49, 50), but fails to explain how to interpret these two numbers to detect AF.” Id. In response, Appellant refers us to Figures 4B and 7 as providing “pictorial examples of heart rhythm information and corresponding scatter plots,” and asserts that “one o[f] ordinary skill in the art, once having been taught the elements of Appellant’s claims 1, 8 and 11, can provide boundaries and criterion, in combination with the heart rhythm information in FIG. 7, among other places, to ‘provide atrial fibrillation information using the first and second counts.’” Appeal Br. 12. Appeal 2018-007569 Application 14/825,669 5 This is unpersuasive. First, it is attorney argument. Appellant does not explain how one of ordinary skill in the art can provide the necessary “boundaries and criterion” from Figures 7 and 4B. Nor is it self-evident how to do so. Figure 4B explains how ventricular-rate-change pairs can be represented as first count a and second count b, but does not explain how the first and second indications are derived from the first and second counts. As for Figure 7, it is unclear how to quantify first count a, second count b, counts that would not fall into either a or b, or total count T. As the Examiner points out, there is nothing in Figure 7 that “ties back to the first and second indications.” Ans. 12. Even if Appellant is correct that one of ordinary skill in the art could have derived necessary “boundaries and criterion” from the Specification, that would not be enough to satisfy the written-description requirement. As Appellant states, one of ordinary skill in the art would have to “determine a threshold for such counts that rise to the level of atrial fibrillation, or a threshold to determine whether the first or second indications are satisfied.” Reply Br. 5–6. A disclosure that leaves it to the reader to determine thresholds necessary to detect AF does not adequately describe a claim drawn to detecting AF, even if one of ordinary skill in the art would have found it obvious from the disclosure how to do determine the thresholds. See Tronzo v. Biomet, Inc., 156 F.3d 1154, 1158 (Fed. Cir. 1998) (holding that “[a] disclosure in a parent application that merely renders the later- claimed invention obvious is not sufficient to meet the written description requirement; the disclosure must describe the claimed invention with all its limitations”) (internal citation omitted). Accordingly, we agree with the Examiner that the Specification does not adequately describe the claimed Appeal 2018-007569 Application 14/825,669 6 invention, and thus sustain the Examiner’s rejection of claims 1–20 for failing the written-description requirement of 35 U.S.C. § 112(a). Claims 1–20—Rejected as Failing to Comply with the Enablement Requirement The Examiner determines that Claims 1–20 are not adequately enabled by the Specification for the same reasons that the Examiner found the claims to fall short of the written-description requirement. Non-Final Act. 3–4. Appellant responds, inter alia, that “the Examiner has failed to consider the many factors necessary to determine that a claim is not enabled under §112 as required by MPEP § 2164.01(a).” Id. at 12. Section 112 requires a written description to enable “those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.”’ Koito Mfg. Co., Ltd. v. Turn-Key-Tech, LLC, 381 F.3d 1142, 1155 (Fed. Cir. 2004) (internal citation omitted). Whether undue experimentation is needed is not a single, simple factual determination, but is a conclusion reached by weighing many factual considerations. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). The Wands factors include: (a) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. Id. “[T]he PTO bears an initial burden of setting forth a reasonable explanation as to why it believes that the scope of protection provided by that claim is not adequately enabled by the description of the invention provided in the specification of the application.” In re Wright, 999 F.2d 1557, 1561–62 (Fed. Cir. 1993). Appeal 2018-007569 Application 14/825,669 7 The Examiner has not made any findings regarding whether undue experimentation is required for one of ordinary skill in the art to determine the threshold values for the first and second indications to detect AF, much less considered any of the Wands factors. Therefore, the Examiner has not established a prima facie case of lack of enablement, and we do not sustain this rejection. Claims 1–20—Rejected as Directed to Ineligible Subject Matter To determine whether a claim falls within a judicially recognized exception to patent eligibility under 35 U.S.C. § 101, we apply the two-step framework set forth in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), and reaffirmed in Alice Corporation Proprietary Ltd. v. CLS Bank International, 573 U.S. 208 (2014). For the first Alice step (Step 2A of the USPTO’s Patent Subject Matter Eligibility guidance, MPEP § 2106), we determine whether the claims at issue are directed to a patent-ineligible concept such as an abstract idea, law of nature, or natural phenomenon. Alice, 573 U.S. 208 (citing Mayo, 566 U.S. at 78– 79). If so, we advance to the second Alice step (Step 2B of the USPTO’s Patent Subject Matter Eligibility guidance) where “we consider the elements of each claim both individually and ‘as an ordered combination’ to determine whether the additional elements ‘transform the nature of the claim’ into a patent-eligible application” of the otherwise patent-ineligible concept. Id. (quoting Mayo, 566 U.S. at 78–79). We also apply the USPTO’s additional guidance on applying step 2A. See 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. Appeal 2018-007569 Application 14/825,669 8 50 (Jan. 7, 2019) (“Revised Guidance”).2 The Revised Guidance establishes a two-prong inquiry for determining whether a claim is directed to a judicial exception. Id. at 54. In prong one, we determine whether the claim recites a judicial exception, such as a law of nature, natural phenomenon, or abstract idea. Id. If so, we look to whether the claim recites additional elements that integrate the judicial exception into a practical application. Id. at 50. Thus, a claim is directed to a judicial exception only if the claim recites a judicial exception and does not integrate that exception into a practical application. Id. At that point we look to whether the claim adds a specific limitation beyond the judicial exception that is not well-understood, routine, and conventional activity in the field or whether the claim simply appends well- understood, routine, and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. Id. at 56. The Examiner determines that claims 1–20 are “directed to the abstract idea of data mining (i.e. analyzing data in an attempt to discover something useful).” Non-Final Act. 4. The Examiner further determines that the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because “even though a multitude of calculations are required to culminate in a first indication and a second indication , there is no meaningful interpretation or explanation of these first and second indication values.” Id. 2 Available at https://www.govinfo.gov/content/pkg/FR-2019-01- 07/pdf/2018-28282.pdf. Appeal 2018-007569 Application 14/825,669 9 In response, Appellant argues, inter alia, that “the Examiner fails to address any element of claims 1-20 with specificity.” Appeal Br. 10. Appellant notes, in particular, that the Examiner did not address independent claim 8’s recitation of “an ambulatory medical device for use in a patient,” an “atrial fibrillation detection processor circuit,” etc. Id. We assume for purposes of this decision that the Examiner correctly determined in Step 2A that the claims are directed to an abstract idea. We take issue, however, with the Examiner’s application of step 2B. The search for an inventive concept “considers all claim elements, both individually and in combination,” to be “consistent with the general rule that patent claims ‘must be considered as a whole.’” Alice, 573 U.S. at 218 n.3 (internal citation omitted). The Examiner did not address many of the claim elements in considering whether additional elements provided an inventive concept to the claimed abstract idea. For example, the Examiner did not consider the limitations in independent claim 1 reciting a processor circuit and counter circuits; the limitations in independent claim 8 reciting an ambulatory medical device, processor circuit, detector circuit, heart beat sensing circuit, window determiner circuit and counter circuits; and the limitations in independent claim 11 reciting a processor circuit. To be clear, we are not expressing the view that any of the claims is patent eligible; rather, we merely determine, in this particular case, that the Examiner’s analysis of Step 2B in this case is insufficient for Appellant to respond to it or for us to review it. Accordingly, we do not sustain the Examiner’s rejection of claims 1–20 as directed to ineligible subject matter. Appeal 2018-007569 Application 14/825,669 10 Claims 1–5, 8, and 11–15—Rejected as Anticipated by Sarkar The Examiner finds that Sarkar discloses all of the limitations of claims 1–5, 8, and 11–15. Non-Final Act. 5–6. The Examiner specifically finds that Sarkar discloses the limitations in independent claim 1 requiring counter circuits that determine counts of pairs of ventricular rate changes as claimed, and similar limitations in independent claims 8 and 11. Non-Final Act. 5 (citing Sarkar ¶¶ 31, 41, 45, 74, 76, Figs. 1, 6). Appellant responds, inter alia, that Sarkar “fails to disclose or suggest using units of bpm, as required by claims 1, 8, and 11,” but instead discloses “fixed millisecond values.” Appeal Br. 14 (citing Sarkar ¶¶ 41, 57). The Examiner acknowledges that Sarkar uses differences in R-R intervals (the time interval between R-wave events) to detect AF rather than changes in ventricular heart rate, but finds that Sarkar “meets the claim requirements” because “heart rate data in the claim can inherently be expressed in ‘time per beat’ or ‘beats per time.’” Ans. 14. Appellant disputes that the claimed heart-rate limitations are inherently found in Sarkar’s R-R interval disclosure. According to Appellant: Intervals and rates scale differently. Percent changes in rates change differently than percent changes in intervals. Monitored patients do not have a constant heart rate. Variations in heart rate can be vast, such as when a patient is at rest (e.g., 60 bpm) and when the patient is active (e.g., 140 bpm), etc. A two-beat change is always 2 beats, whether at 60 bpm or at 140 bpm. However, in ms [milliseconds], a two-beat change at 60 bpm (from 60 to 62 bpm) is 32 ms; whereas a two-beat change at 140 bpm (from 140 to 142 bpm) is only 6 ms. The ms difference in Sarkar is different than the rate change magnitude characteristics required by Appellant’s claims. Appeal 2018-007569 Application 14/825,669 11 Reply Br. 7. “To anticipate a claim, a prior art reference must disclose every limitation of the claimed invention, either explicitly or inherently.” In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). “Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (citations and internal quotation marks omitted). It is undisputed that Sarkar does not expressly disclose the claimed heart rate limitations. It is also not entirely clear from the record that these limitations can inherently be found in Sarkar’s use of R- R intervals, particularly given Appellant’s point that a given rate change represents a different interval change depending on the baseline heart rate. Because we are not persuaded that Sarkar inherently discloses the heart-rate limitations, we do not sustain the Examiner’s rejection of claims 1–5, 8, and 11–15 as anticipated by Sarkar. Claims 6, 9, 16, and 17—Rejected as Unpatentable over Sarkar and Ritscher The Examiner’s rejection of dependent claims 6, 9, 16, and 17 as unpatentable over Sarkar and Ritscher relies on the erroneous finding that Sarkar inherently discloses the limitations in the independent claims directed to ventricular rate changes in beats per minute. Ritscher is not relied on to cure this deficiency. Therefore, we do not sustain this rejection. Claims 7, 10, and 18–20—Rejected as Unpatentable over Sarkar Because the Examiner’s rejection of dependent claims 7, 10, and 18– 20 relies on the erroneous finding that Sarkar discloses the limitations in the independent claims directed to ventricular rate changes in beats per minute, we do not sustain this rejection. Appeal 2018-007569 Application 14/825,669 12 CONCLUSION The following table summarizes our disposition of the rejections at issue in this appeal: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–20 112(a) Written Description 1–20 1–20 112(a) Enablement 1–20 1–20 101 Eligibility 1–20 1–5, 8, 11–15 102(a)(1) Sarkar 1–5, 8, 11– 15 6, 9, 16, 17 103 Sarkar, Ritscher 6, 9, 16, 17 7, 10, 18–20 103 Sarkar 7, 10, 18–20 Overall Outcome 1–20 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 Copy with citationCopy as parenthetical citation