Joseph WieselDownload PDFPatent Trials and Appeals BoardAug 12, 2021IPR2020-01540 (P.T.A.B. Aug. 12, 2021) Copy Citation Trials@uspto.gov Paper 17 571-272-7822 Date: August 12, 2021 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD APPLE INC., Petitioner, v. JOSEPH WIESEL, Patent Owner. IPR2020-01540 Patent 7,020,514 B1 Before JAMES A. TARTAL, FREDERICK C. LANEY, and ALYSSA A. FINAMORE, Administrative Patent Judges. FINAMORE, Administrative Patent Judge. DECISION Denying Petitioner’s Request on Rehearing of Decision Denying Institution of Inter Partes Review 37 C.F.R. § 42.71(d)(2) IPR2020-01540 Patent 7,020,514 B1 2 I. INTRODUCTION Apple Inc. (“Petitioner”) filed a Petition (Paper 2, “Pet.”) requesting an inter partes review of claims 1–10 and 12–21 of U.S. Patent No. 7,020,514 B1 (“the ’514 patent”) (Ex. 1001). Pet. 1. Joseph Wiesel (“Patent Owner”) filed a Preliminary Response (Paper 7). Thereafter, we issued an Order (Paper 10) authorizing additional briefing addressing the construction of the claim term “irregular.” Paper 10, 3. Pursuant to this authorization, Petitioner filed a Reply (Paper 11), and Patent Owner filed a Sur-reply (Paper 12). On March 16, 2021, we issued a Decision denying institution of an inter partes review (“Institution Decision”) (Paper 15, “Inst. Dec.”).1 Particularly, we found: In view of the Specification’s description that “[w]henever the term ‘irregular’ is used in this application it refers to this random pattern of beats found almost exclusively in atrial fibrillation” (Ex. 1001, 1:48–51), the patentee has acted as a lexicographer and set out a clear definition of “irregular” as “this random pattern of beats found almost exclusively in atrial fibrillation.” Inst. Dec. 12. We applied the lexicographic definition of “irregular” in the Specification, and construed the claim term “irregular” to mean a random pattern of beats found almost exclusively in atrial fibrillation. Id. at 14. With this construction, we found Petitioner failed to sufficiently identify, for purposes of institution, the recited “irregular pulse rhythms” in either Forstner or its proposed combination of Amano and Wilkinson, and, thus, failed to demonstrate a reasonable likelihood that it would prevail with respect to at least one of the challenged claims. Id. at 14–45. 1 This Decision on rehearing incorporates the Institution Decision, including any abbreviations defined therein for citations to the record. IPR2020-01540 Patent 7,020,514 B1 3 Petitioner filed a Request for Rehearing (Paper 16, “Req. Reh’g”) seeking reconsideration of the Institution Decision. For the reasons below, we deny the Request for Rehearing. II. ANALYSIS When reconsidering a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c) (2019). An abuse of discretion occurs if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v. U.S., 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). The party requesting rehearing bears the burden of showing that the decision should be modified. 37 C.F.R. § 42.71(d). The party must identify specifically all matters we misapprehended or overlooked, and the place where each matter was previously addressed. Id. Petitioner requests reconsideration for two reasons. Req. Reh’g 1. First, Petitioner contends we misapprehended or overlooked its arguments demonstrating the recited “irregular pulse rhythms” were in the prior art. Id. (citing Pet. 2, 19–22, 40–42). Second, Petitioner contends we misapprehended or overlooked its arguments regarding the recited “determination of possible atrial fibrillation.” Id. (citing Pet. 15, 21, 42). We address each of Petitioner’s contentions in turn below. A. “irregular pulse rhythms” Petitioner argues the Institution Decision “demands that the prior art teach certain features representing ‘a random pattern of beats associated with IPR2020-01540 Patent 7,020,514 B1 4 atrial fibrillation’—features that are not even described, much less claimed, in the ’514 patent.” Req. Reh’g 4. According to Petitioner, by imposing requirements not described or claimed in the ’514 patent, we overlooked and misapprehended Petitioner’s explanation of how the recited “irregular pulse rhythms” are found in Forstner and Petitioner’s proposed combination of Amano and Wilkinson. Id. (citing Pet. 9–12, 56–59). 1. Forstner Petitioner maintains “the [Institution] Decision effectively requires Forstner to have disclosed analysis of ‘the order’ of pulse beats.” Req. Reh’g 4–5; see also Inst. Dec. 20 (finding Forstner’s distribution of pulse time differences (“Tp”) represented as a histogram contemplates the number of instances a pulse has a particular Tp, but not the order in which the instances occurred). Petitioner argues that neither the plain language of the claims, nor our construction of the recited “irregular pulse rhythms” as a random pattern of beats found almost exclusively in atrial fibrillation, requires analysis of the order of pulse beats. Id. at 5. Petitioner alleges the Specification describes only one technique for detecting irregular pulse rhythms, which does not analyze the order of pulse beats, but instead compares the quotient of the standard deviation of the last ten beats over the mean of these beats to a threshold value. Id. at 6 (citing Ex. 1001, 6:45–51). Petitioner similarly alleges claims 2 and 3, which depend from independent claim 1, embody this technique described in the Specification and therefore confirm the “irregular pulse rhythms” recited in independent claim 1 do not require consideration of the order of the pulse beats. Id. at 6–7. Petitioner also contends we improperly credited Dr. Wiesel’s testimony, which, according to Petitioner, is from an interested witness and is completely IPR2020-01540 Patent 7,020,514 B1 5 unsupported by corroborating evidence. Id. at 7. Furthermore, Petitioner proffers reasons as to why Forstner’s Tp histogram shown in Figure 6 discloses the recited “irregular pulse rhythms,” including: the distribution shown in the Tp histogram of Figure 6 is due to a kind of arrhythmia that might be caused by atrial fibrillation (id. (citing Ex. 1004, 6:27–33)); applying the technique of comparing the quotient of the standard deviation of the last ten beats over the mean to a threshold value as described in the ’514 patent to Forstner’s Tp histogram of Figure 6 would result in a determination of possible atrial fibrillation (id. at 8 (citing Ex. 1001, 6:38–64)); and Bootsma, which the ’514 patent cites, describes using histograms of R-R intervals to identify the randomness of heartbeat patterns found in atrial fibrillation (id. (citing Ex. 1001, 1:45–48; Ex. 10152, Summary, Figs. 2–5)). We have considered Petitioner’s arguments and are unpersuaded that we should modify our Institution Decision. At the outset, we disagree with Petitioner that the Specification and claims 2 and 3 suggest a distinction between the recited “irregular pulse rhythms,” which, in view of the construction of “irregular,” require a random pattern of beats associated almost exclusively with atrial fibrillation, and an analysis of the order in which pulse beats having varying time intervals occur. In alleging such a distinction, Petitioner confounds the detection and analysis of irregular pulse rhythms with a definition of the recited “irregular pulse rhythms,” which are detected and analyzed. 2 Bootsma et al., Analysis of R-R Intervals in Patients with Atrial Fibrillation at Rest and During Exercise, 41 CIRCULATION 783 (1970) (“Bootsma”) (Ex. 1015). IPR2020-01540 Patent 7,020,514 B1 6 The claimed invention detects and analyzes irregular pulse rhythms to determine possible atrial fibrillation. Specifically, independent claim 1 recites a method of determining possible atrial fibrillation comprising the steps of: (a) detecting irregular pulse rhythms from a succession of time intervals between successive pulse beats; (b) analyzing the detected irregular pulse rhythms to make a determination of possible atrial fibrillation; and (c) indicating the possible atrial fibrillation. Id. at 7:30–39. The first two steps of the claimed method recite “irregular pulse rhythms.” The first step detects irregular pulse rhythms, and the second step analyzes the detected irregular pulse rhythms to make a determination of possible atrial fibrillation. Id. at 7:32–37. Petitioner’s cited portion of the Specification describes detecting pulse beats with a sphygmomanometer and analyzing the detected pulse beats by comparing the quotient of the standard deviation over the mean to a threshold value of 0.06 to diagnose atrial fibrillation. Ex. 1001, 6:39–64. Although this portion may be silent as to the order of the pulse beats, Petitioner fails to show this portion is a description of the recited “irregular pulse rhythms,” which are detected and analyzed, rather than a description of the detecting and analyzing steps. Similarly, claims 2 and 3 further define the analysis of the recited “irregular pulse rhythms,” not the recited “irregular pulse rhythms” themselves. Claim 2 depends from independent claim 1, and claim 3 depends from claim 2. Ex. 1001, 7:40–48. Independent claim 1 recites, in pertinent part, the step of “analyzing the detected irregular pulse rhythms to make a determination of possible atrial fibrillation.” Id. at 7:36–37 (emphasis added). Claim 2 further defines the analyzing step as “wherein IPR2020-01540 Patent 7,020,514 B1 7 the analyzing includes ascertaining a mean and a standard deviation of the succession of time intervals, the determination being based upon a quotient formed by dividing said standard deviation by said mean and comparing the quotient with a threshold value.” Id. at 7:40–44 (emphasis added). Claim 3 further prescribes the determination of the analyzing step as “wherein the determination includes determining that the sequence of the pulse beats is irregular in response to the quotient being greater than or equal to the threshold value.” Id. at 7:45–48 (emphasis added). The analysis of the detected irregular pulse rhythms recited in claims 2 and 3 may not contemplate the order of the pulse beats. Nonetheless, the analysis of the detected irregular pulse rhythms does not define or otherwise describe the recited “irregular pulse rhythms.” Regardless of whether there is any distinction between the recited “irregular pulse rhythms,” which require a random pattern of beats associated almost exclusively with atrial fibrillation, and an analysis of the order of pulse beats with varying time intervals, Petitioner has not demonstrated sufficiently, for purposes of institution, that Forstner’s Tp histogram of Figure 6 discloses the recited “irregular pulse rhythms.” As we explained in the Institution Decision, “[a] distribution of Tp, represented as a histogram, contemplates the number of instances a pulse has a particular Tp.” Inst. Dec. 20. We also explained Dr. Wiesel testifies that the distribution of Tp shown in the histogram of Forstner’s Figure 6 can result from multiple premature beats and do not form a random pattern of beats. Id. (citing Ex. 2002 ¶ 40). With or without considering Dr. Wiesel’s testimony, Petitioner has not demonstrated a person of ordinary skill in the art would understand that Forstner’s Tp histogram discloses something more than a IPR2020-01540 Patent 7,020,514 B1 8 distribution of instances a pulse has a particular Tp, much less a random pattern of beats found almost exclusively in atrial fibrillation. In the Institution Decision, we acknowledged Forstner discloses the distribution shown in the Tp histogram of Figure 6 is due to a kind of arrhythmia that might be caused by atrial fibrillation, and we explained why this affiliation between the distribution of Tp shown in the histogram of Figure 6 and atrial fibrillation does not equate the Tp distribution to a random pattern of beats found almost exclusively in atrial fibrillation, as the recited “irregular pulse rhythms” require. Inst. Dec. 20–21. As we found in the Institution Decision, “a diagnosis of atrial fibrillation is not the same as the actual condition.” Id. at 21 (citing Ex. 1001, 2:18–3:32; Ex. 2002 ¶ 25). Notably, the ’514 patent explains that the method and apparatus for detecting atrial fibrillation described therein mitigates the misdiagnoses of atrial fibrillation associated with conventional methods and apparatuses. See Ex. 1001, 2:18–33 (describing that measuring pulse to determine atrial fibrillation is inaccurate due to pulse deficit), 3:24–32 (describing that an algorithm for detecting atrial fibrillation by the irregularity of the pulse beat intervals may be affected by premature beats), 4:31–35 (“What is also needed is a method that can differentiate an irregular pulse rate pattern from a normal pulse rate pattern and from common heart rhythm patterns that are not of significant risk, such as regular sinus rhythm, sinus arrhythmia, atrial premature beats and ventricular premature beats.”). In its Request for Rehearing, Petitioner argues, for the first time, that Forstner’s Tp histogram shown in Figure 6 discloses the recited “irregular pulse rhythms” because applying the technique of comparing the quotient of the standard deviation of the last ten beats over the mean to a threshold value IPR2020-01540 Patent 7,020,514 B1 9 as described in the ’514 patent to Forstner’s Tp histogram of Figure 6 would result in a determination of possible atrial fibrillation. This belated analysis underscores the Petition’s lack of analysis regarding how Forstner’s Tp histogram of Figure 6 discloses the recited “irregular pulse rhythms,” which require a random pattern of beats found almost exclusively with atrial fibrillation. Nonetheless, applying this technique to Forstner’s Tp histogram of Figure 6 does not demonstrate persuasively, for purposes of institution, that the Tp distribution shown in the histogram of Figure 6 represents a random pattern of beats found almost exclusively with atrial fibrillation. As we explain above, the Specification describes this technique in regard to the analysis of detected pulse beats, which is not a description of the recited “irregular pulse rhythms.” Also for the first time in its Request for Rehearing, Petitioner relies on Bootsma’s description of using histograms of R-R intervals to identify the randomness of heartbeat patterns found in atrial fibrillation to support the argument that Forstner’s Tp histogram shown in Figure 6 discloses a random pattern of beats found almost exclusively with atrial fibrillation. Bootsma, however, does not simply use histograms to identify the random nature of heartbeat rhythms. Rather, Bootsma uses both serial autocorrelation coefficients and R-R interval histograms. Ex. 1015, Summary (“Serial autocorrelation functions and histograms of R-R intervals in patients with atrial fibrillation, with and without digitalis, at rest and during exercise, were produced by a computer.”), 3 (“From this tape an IBM 7094-II computer finally produced 50 serial autocorrelation coefficients together with the histogram of the R-R intervals.”), Figs. 2–5 (depicting both histograms and autocorrelograms of R-R intervals). Moreover, in the Petition, Petitioner IPR2020-01540 Patent 7,020,514 B1 10 does not address, much less show, any correlation between Forstner’s Tp histogram and Bootsma’s R-R interval histograms. For these reasons, Petitioner has not persuaded us that, in the Institution Decision, we misapprehended or overlooked its explanation of how Forstner’s Tp histogram shown in Figure 6 discloses the recited “irregular pulse rhythms,” which require a random pattern of beats found almost exclusively in atrial fibrillation. Consequently, Petitioner has not persuaded us to modify the Institution Decision, in which we found Petitioner has not demonstrated sufficiently, for purposes of institution, that Forstner’s Tp histogram of Figure 6 discloses the recited “irregular pulse rhythms.” 2. Petitioner’s Proposed Combination of Amano and Wilkinson Petitioner argues the Institution Decision “separately analyzes the individual disclosures of Amano and Wilkinson in relation to [the] construction of the recited ‘irregular pulse rhythms,’ and in doing so, overlooks Petitioner’s arguments addressing the combination of these references in demonstrating the recited ‘irregular pulse rhythms.’” Req. Reh’g 9–10. According to Petitioner, the Institution Decision “strictly focus[es] on time delays that occur ‘randomly’ and Amano’s alleged lack of disclosure of this feature” and overlooks the possibility that a pulse waveform that is irregular in time and irregular in force (which, as explained in the Petition would have been detectable by the Amano-Wilkinson combination) represents “a random pattern of beats” since the pulse waveform has varying pulse wave signal amplitudes and varying pulse wave intervals. Id. at 10. IPR2020-01540 Patent 7,020,514 B1 11 At the outset, it is not our purview to consider possibilities unexplained in the Petition. Rather, in its Petition, Petitioner must identify, with particularity, the ground on which the challenge to each claim is based. See 35 U.S.C. § 312(a)(3) (requiring that a petition “identifies, in writing and with particularity, each claim challenged, the grounds on which the challenge to each claim is based, and the evidence that supports the grounds for the challenge to each claim”); see also Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (“In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.”). That notwithstanding, we disagree with Petitioner that the Institution Decision does not consider whether a pulse irregular in force and time represents a random pattern of beats. Whether characterized as irregular in force and time, or as having a waveform that varies in amplitude and in the time interval between beats, such a pulse, without more, does not demonstrate persuasively a random pattern of beats found almost exclusively in atrial fibrillation. See Inst. Dec. 42 (“Wilkinson provides no further explanation of these irregularities to teach or suggest that they are a random pattern of beats.”). Petitioner, therefore, has not persuaded us that we misapprehended or overlooked its arguments addressing how the combined teachings of Amano and Wilkinson would have resulted in the recited “irregular pulse rhythms,” which require a random pattern of beats found almost exclusively in atrial fibrillation. B. “determination of possible atrial fibrillation” Petitioner acknowledges the Institution Decision draws a distinction between diagnosis of atrial fibrillation and actual atrial fibrillation, and argues “[u]sing this distinction, the [Institution] Decision appears to reject IPR2020-01540 Patent 7,020,514 B1 12 the prior art as focusing on diagnosing atrial fibrillation, but not detecting actual atrial fibrillation in the form of an associated random pattern of beats.” Req. Reh’g 11–12. According to Petitioner, the Institution Decision “misapprehends or overlooks Petitioner’s arguments that the independent claims of the ’514 patent do not require detection of actual atrial fibrillation.” Id. at 12. Petitioner also acknowledges the Specification draws a distinction between a diagnosis of atrial fibrillation and actual atrial fibrillation and describes a technique to mitigate misdiagnoses of atrial fibrillation. Id. at 12–13. Petitioner maintains that the independent claims do not recite this technique and instead recite a determination of possible atrial fibrillation, and that dependent claims 11 and 22 encompass this technique. Id. at 13. Petitioner further asserts the Specification recognizes this technique does not always accurately detect atrial fibrillation. Id. at 13–14 (citing Ex. 1001, 6:57–64). We agree with the Petitioner that the independent claims recite a determination of possible atrial fibrillation. As we explain above, independent claim 1, for example, recites a method of determining possible atrial fibrillation. Ex. 1001, 7:30–39. In particular, the first step detects irregular pulse rhythms, and the second step analyzes the detected irregular pulse rhythms to make a determination of possible atrial fibrillation. Id. at 7:32–37. The claimed method detects and analyzes irregular pulse rhythms to determine possible atrial fibrillation, but the patentee expressly and unequivocally defined “irregular” as a “random pattern of beats found almost exclusively in atrial fibrillation.” Thus, the claimed method requires detecting and analyzing pulse rhythms having a random pattern of beats IPR2020-01540 Patent 7,020,514 B1 13 found almost exclusively in atrial fibrillation to determine possible atrial fibrillation. Although the claims recite possible atrial fibrillation, the recited “irregular pulse rhythms” nonetheless require a random pattern of beats found almost exclusively in atrial fibrillation. In the Institution Decision, we did not reject the prior art for failing to disclose the recited “determination of possible atrial fibrillation.” Rather, we found Petitioner has not shown sufficiently, for purposes of institution, that the prior art discloses the recited “irregular pulse rhythms,” which require a random pattern of beats found almost exclusively in atrial fibrillation. See, e.g., Inst. Dec. 21 (“Petitioner’s reliance on Forstner’s disclosure of detecting a wide variation in Tp to diagnose atrial fibrillation does not establish that Forstner discloses the recited ‘irregular pulse rhythms,’ which require pulse rhythms having a random pattern of beats associated with atrial fibrillation.”). In view of the foregoing, Petitioner has not persuaded us that, in the Institution Decision, we misapprehended or overlooked its arguments that the independent claims recite a “determination of possible atrial fibrillation” and do not require detection of actual atrial fibrillation. Consequently, Petitioner has not persuaded us to modify the Institution Decision, in which we found Petitioner has not demonstrated sufficiently, for purposes of institution, that the prior art discloses the recited “irregular pulse rhythms.” III. CONCLUSION After considering Petitioner’s arguments in its Request for Rehearing, we conclude Petitioner has not demonstrated that we abused our discretion in determining Petitioner failed to meet its burden to show a reasonable likelihood that it would prevail with respect to at least one of the claims IPR2020-01540 Patent 7,020,514 B1 14 challenged in the Petition. Accordingly, we deny Petitioner’s request to modify the Institution Decision. IV. ORDER In consideration of the foregoing, it is: ORDERED that Petitioner’s Request for Rehearing is denied. IPR2020-01540 Patent 7,020,514 B1 15 For PETITIONER: Walter Renner Jeremy Monaldo FISH & RICHARDSON P.C. axf-ptab@fr.com monaldo@fr.com For PATENT OWNER: Andrew Bochner BOCHNER IP andrew@bochnerip.com Copy with citationCopy as parenthetical citation