Welch Allyn, Inc.Download PDFPatent Trials and Appeals BoardMar 16, 20212020004536 (P.T.A.B. Mar. 16, 2021) 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. 14/450,510 08/04/2014 David E. Quinn 10156.0087US01 9908 92558 7590 03/16/2021 Merchant & Gould- Welch Allyn P.O. Box 2903 Minneapolis, MN 55402 EXAMINER PORTILLO, JAIRO H ART UNIT PAPER NUMBER 3791 NOTIFICATION DATE DELIVERY MODE 03/16/2021 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): USPTO92558@merchantgould.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte DAVID E. QUINN ____________ Appeal 2020-004536 Application 14/450,510 Technology Center 3700 ____________ Before JENNIFER D. BAHR, WILLIAM A. CAPP, and CARL M. DEFRANCO, Administrative Patent Judges. CAPP, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1 seeks our review under 35 U.S.C. § 134(a) of the final rejection of claims 1, 3–7, 9–12, 14–18, 21, and 22. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies Welch Allyn, Inc. as the Applicant and real party in interest. Appeal Br. 3. Appeal 2020-004536 Application 14/450,510 2 THE INVENTION Appellant’s invention relates to blood pressure cuffs. Spec. ¶¶ 1–4. Claim 1, reproduced below, is illustrative of the subject matter on appeal. 1. A non-invasive blood pressure measurement and orthostatic hypotension detection system for use on a human or animal subject, the system comprising: a processing unit; a non-invasive blood pressure cuff configured to transmit a blood pressure signal to the processing unit, wherein the blood pressure cuff comprises: an inflation component having a side defining an x-y plane; an air port on the inflation component, wherein the air port comprises a center; a coupling element rotatably coupled with the air port; and a tubular element coupled with the coupling element; a first altitude sensor positioned on the coupling element of the blood pressure cuff such that a center of the first altitude sensor is at a same location as the center of the air port in a y- axis direction of the x-y plane of the inflation component, wherein the first altitude sensor is configured to generate a first height measurement and transmit the first height measurement to the processing unit; and a second altitude sensor separate from the blood pressure cuff and configured to generate a second height measurement and transmit the second height measurement to the processing unit, wherein the second altitude sensor is configured to connect with the human or animal subject at a level of the subject’s heart, wherein the processing unit is configured to determine a height difference between the first and second height measurements, calculate and store a blood pressure correction parameter, and generate an adjusted blood pressure measurement using the blood pressure correction parameter and the blood pressure signal, Appeal 2020-004536 Application 14/450,510 3 wherein the processing unit is further configured to analyze at least the blood pressure signal, the first height measurement, and the second height measurement to detect orthostatic hypotension in the human or animal subject, and wherein the processing unit is further configured to analyze the first height measurement and the second height measurement, determine that the human or animal subject has moved to a standing position, and automatically send a signal to the blood pressure cuff to initiate a new blood pressure measurement of the human or animal subject. THE REJECTIONS The Examiner relies upon the following as evidence in support of the rejections: NAME REFERENCE DATE Bridger US 6,491,647 B1 Dec. 10, 2002 Kato US 6,872,182 B2 Mar. 29, 2005 Banet US 2005/0216199 A1 Sept. 29, 2005 Tenzer US 2006/0036184 A1 Feb. 16, 2006 Fumuro US 2010/0312127 A1 Dec. 9, 2010 Moon US 2011/0066050 A1 Mar. 17, 2011 Kroll US 7,970,465 B1 June 28, 2011 Evans US 2012/0178689 A1 July 12, 2012 Baym US 2013/0116663 A1 May 9, 2013 Kiani US 8,740,792 B1 June 3, 2014 The following rejections are before us for review: 1. Claims 1 and 3–6 are rejected under 35 U.S.C. § 103 as being unpatentable over Moon, Baym, Kato, Kroll, and Fumuro. 2. Claim 7 is rejected under 35 U.S.C. § 103 as being unpatentable over Moon, Baym, Kato, Kroll, Fumuro, and Banet. Appeal 2020-004536 Application 14/450,510 4 3. Claims 9–11, 15, and 18 are rejected under 35 U.S.C. § 103 as being unpatentable over Moon, Baym, Kato, Kroll, and Evans. 4. Claim 12 is rejected under 35 U.S.C. § 103 as being unpatentable over Moon, Baym, Kato, Kroll, Evans, Fumuro, and Bridger. 5. Claim 14 is rejected under 35 U.S.C. § 103 as being unpatentable over Moon, Baym, Kato, Kroll, Evans, Fumuro, and Banet. 6. Claims 16 and 17 are rejected under 35 U.S.C. § 103 as being unpatentable over Moon, Baym, Kato, Kroll, Evans, Fumuro, and Tenzer. 7. Claims 21 and 22 are rejected under 35 U.S.C. § 103 as being unpatentable over Moon, Baym, Kato, Kroll, Fumuro, and Kiani. OPINION Unpatentability of Claims 1 and 3–6 over Moon, Baym, Kato, Kroll, and Fumuro Appellant argues claims 1 and 3–6 as a group. Appeal Br. 17–20. Claim 1 is representative. See 37 C.F.R. § 41.37(c)(1)(iv). The Examiner finds that Moon discloses the invention substantially as claimed except for an air port and first altitude sensor positioned as claimed with a processing unit that determines a height difference. Final Act. 4–5. The Examiner relies on Baym as teaching an altitude sensor coupled with a blood pressure cuff to determine an adjusted measurement based on cuff height. Id. at 5. The Examiner relies on Kato as generating an adjusted blood pressure measurement using first and second height determinations. Id. at 6. The Examiner relies on Kroll as detecting orthostatic hypotension by analyzing blood pressure signals and different height measurements. Id. at 9. The Examiner relies on Fumuro for an air port on an inflation Appeal 2020-004536 Application 14/450,510 5 component with a coupling element rotatably coupled thereto and a tubular element coupled with the coupling element. Id. The Examiner concludes that it would have been obvious to a person of ordinary skill in the art at the time of the invention to combine the teachings of the prior art to achieve the claimed invention. Id. at 5–11. According to the Examiner, a person of ordinary skill in the art would have done this to compensate for hydrostatic forces based on the location of a blood pressure cuff, to adjust a blood pressure measurement based on height differentials, to protect against fall risk from posture changes, and to provide a detachable connection for ease of maintenance. Id. Finally, the Examiner finds that positioning the altitude sensor on the coupling element of the blood pressure cuff such that a center of the first altitude sensor is at a same location as the center of the air port in a y-axis direction of the x-y plane of the inflation component is merely a design choice for the placement of the sensor in Moon. Id. at 11. Appellant concedes that Baym discloses an altitude sensing device that determines the altitude of an inflatable cuff as worn by an individual during a blood pressure measurement. Appeal Br. 19. Nevertheless, Appellant argues that the prior art, including Baym, fails to disclose positioning the first altitude sensor along the y-axis of the x-y plane of the inflation component. Id. Appellant further argues that such placement is not merely a matter of “design choice.” Id. The claimed position of the first sensor is not “mere design choice”. The claimed position of the first sensor directly impacts the measurements taken by the system. Specifically, positioning the first sensor at the center of the air port in a y-axis direction of the x-y plane of the inflation component (as shown in Figure 4) provides an accurate measurement of the Appeal 2020-004536 Application 14/450,510 6 relative height of the inflation component when generating an adjusted blood pressure measurement. If the first sensor were positioned differently, this would impact the measurement. Id. at 19–20. In response, the Examiner observes that Appellant’s own Specification fails to indicate or suggest that there is any criticality with respect to placement of an altitude sensor in a particular location on the cuff. Ans. 3–4 (citing Spec. ¶¶ 35–36, 41). The Examiner remarks that “it seems the altitude sensor must merely be on the cuff.” Id. at 4. Specifically with respect to Appellant’s argument that positioning the sensor differently would impact the measurement, the Examiner observes that “Appellant only provides criticality to placement of an altitude sensor at a cuff location.” Id. at 5. Appellant’s Specification teaches that adjusted blood pressure measurements can be used to diagnose orthostatic hypotension. Spec. ¶ 8. In this regard, Appellant’s device receives first and second height measurements from each of a first altitude sensor and a second altitude sensor. Id. ¶ 7. The first and second measurements are recorded at different patient positions, such as laying down, sitting, and standing. Id. The second altitude sensor is positioned at the heart level of the patient. Id. at 8. Figure 3 from Appellant’s disclosure depicts an unrolled example cuff 202 that includes air port 204 and altitude sensor 102. Spec. ¶ 33, Fig. 3. Cuff 202 is disposed in an x-y plane that coincides with the plane of the page on which Figure 3 appears, said figure being annotated with x-y coordinate arrows. Id. Spec. ¶ 35, Fig. 3. The example cuff 202 has an x-y-plane that substantially conforms to one side of the cuff. In embodiments, the altimeter 102 is positioned on the cuff 202 such that the center Appeal 2020-004536 Application 14/450,510 7 of the altimeter 102 is at the same as the center of the air port 204 in the y-axis direction. In some embodiments, the altimeter 102 is positioned on the cuff 202 such that the center of the altimeter 102 is aligned with the center of the air port 204 in the x-axis direction. In other embodiments, the center of the altimeter 102 is positioned on the cuff 202 such that it is not in alignment in either the x- or y-directions with the center of the air port 204. Id. ¶ 35. Stated differently, in various embodiments, the altitude sensor can be aligned with: (1) the x-axis, (2) the y-axis, or (3) anywhere else on the x-y plane defined by the cuff. Id. The y-axis/x-y plane claim language that Appellant now relies on to distinguish over the prior art was added to claim 1 by amendment. Compare Claims App. claim 1, with Spec. (as filed) claim 1. Indeed the terms “y-axis” and “x-y plane” do not appear anywhere in Appellant’s claims as originally filed. Spec. (as filed) claims 1–20. Furthermore, conspicuously absent from Appellant’s Specification is any teaching that placing the altitude sensor along the y-axis results in any difference in operation or accuracy of the device when compared with placing the altitude sensor along the x-axis or anywhere else within the x-y plane. Furthermore, it bears mention that Appellant’s cuff may be worn by the user on the arm, wrist, finger, thigh, or lower leg. Spec. ¶¶ 30, 33, 41. Measurements from Appellant’s device may be made at different patient positions such as laying down, sitting, and standing. Id. ¶ 7. We understand that the term “altitude” as used with respect to Appellant’s invention relates to some height measured in a vertical direction above a plane that is parallel to sea level. Such orientation is fixed in space. The x-y plane of Appellant’s device, on the other hand, will vary depending on where and how it is worn by the patient as well as by the posture of the patient and the positioning of Appeal 2020-004536 Application 14/450,510 8 the patients’ appendages. In other words, there may be times when the y-axis of Appellant’s device is more-or-less aligned with the vertical/altitude dimension and there may be other times when, due to the positioning or posture of the patient, the x-axis is more-or-less aligned with the vertical/altitude dimension. There is no teaching or other discussion in Appellant’s Specification that accounts for the aforementioned variability in patient positioning relative to the vertical/altitude dimension. Appellant’s argument against the Examiner’s determination regarding design choice is unpersuasive. Appellant’s position that positioning of the first sensor “directly impacts” the measurements taken by the system is not supported by any evidence or persuasive technical reasoning. Thus, Appellant’s entire opposition to the Examiner’s determination amounts to unsubstantiated attorney argument that is entitled to little weight. See In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (explaining that attorney arguments and conclusory statements that are unsupported by factual evidence are entitled to little probative value). Where there is an entire failure on the part of Appellant to present any reason that the difference between the claimed invention and the prior art results in a different function or produces unexpected results, it may be appropriate to sustain an Examiner’s design choice determination. See In re Rice, 341 F.2d 309, 314 (CCPA 1965) (“Appellants have failed to show that the change [in the claimed invention] as compared to [the reference], result in a difference in function or give unexpected results.”). In the instant case, Appellant makes much of the fact that Baym does not specifically state where the altitude sensor is located relative to the inflatable cuff. Appeal Br. 19. However, Appellant’s own Specification Appeal 2020-004536 Application 14/450,510 9 essentially informs the reader that it matters naught whether the sensor is placed on the x-axis, the y-axis, or anywhere else on the x-y plane. Spec. ¶ 35. Appellant presents neither evidence nor persuasive technical reasoning that location of the sensor on the cuff is critical to operation of the claimed device. The Examiner’s findings of fact are supported by a preponderance of the evidence and the Examiner’s legal conclusion of unpatentability is well- founded. In view thereof, we sustain the Examiner’s unpatentability rejection of claims 1 and 3–6. Unpatentability of Claims 9–11, 15, and 18 over Moon, Baym, Kato, Kroll, and Evans Appellant argues claims 9–11, 15, and 18 as a group. Appeal Br. 21–22. Claim 9 is representative. 37 C.F.R. § 41.37(c)(1)(iv). Claim 9 is an independent method claim and includes limitations directed to receiving and analyzing third and fourth height measurements, respectively, from the first and second altimeters. Claims App. Appellant argues that the cited art fails to teach or suggest a method. Appeal Br. 21. In response, the Examiner states: The references of Moon and Kato teach that a single corrected blood pressure measurement can be output by the use of two heights measurements for correction and a blood pressure measurement. Then Evans and Kroll note that hypotension is evaluated by changes in blood pressure between postures. So based on given teachings, one of ordinary skill in the art would want to create an accurate blood pressure measurement at two different heights, and one of ordinary skill in the art would recognize that an accurate blood pressure measurement requires two altitude values for each of the blood pressure measurements. Thus, one would be motivated to perform corrected blood pressure measurements at sitting position Appeal 2020-004536 Application 14/450,510 10 (using first blood pressure and first heart height and first cuff height) and then at the standing position (using second pressure and second heart height and second cuff height). Ans. 6. As explicitly found by the Examiner in the Final Rejection, Evans teaches having a patient change positions from lying down to sitting or standing to diagnose orthostatic hypotension risk. Final Act. 18 (citing Evans ¶ 30). Thus, as we understand the Examiner proposed combination, Moon and Kato teach receiving and analyzing information from a first height measurement from a first altimeter and a second height measurement from a second altimeter. Evans and Kroll evaluate hypotension by comparing changes in blood pressure from a laying down or sitting position to a standing position. Combining the teachings of the prior art would satisfy the claim limitations at issue. In other words, the device of Moon/Kato would first take blood pressure measurements at first and second altitude sensors when the patient is in a laying down or sitting position and, then, in accordance with the teachings of Evans and Kroll, the Mood/Kato device would take two more measurements, one from each sensor, after the patient assumes a standing position. Appellant’s argument in traverse of the rejection is abbreviated and conclusory, comprising a single, six-line paragraph. Appeal Br. 21. There is no detailed analysis or discussion that tends to undermine or rebut the Examiner reasoning. Id. Having considered the competing positions of Appellant and the Examiner, we find the Examiner’s position more persuasive. We sustain the Examiner’s rejection of claims 9–11, 15, and 18. Appeal 2020-004536 Application 14/450,510 11 Unpatentability of Claims 7, 12, 14, 16, 17, 21, and 22 over Combinations base on Moon, Baym, Kato, and Kroll These claims depend, directly or indirectly, from either of independent claims 1 or 9. Claims App. Appellant does not argue for their separate patentability apart from arguments presented with respect to claims 1 and 9, which we have previously considered. Consequently, for reasons previously expressed with respect to claims 1 and 9, we sustain the Examiner’s rejection of claims 7, 12, 14, 16, 17, 21, and 22. CONCLUSION Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 3-6 103 Moon, Baym, Kato, Kroll, Fumuro 1, 3-6 7 103 Moon, Baym, Kato, Kroll, Fumuro, Banet 7 9–11, 15, 18 103 Moon, Baym, Kato, Kroll, Evans 9–11, 15, 18 12 103 Moon, Baym, Kato, Kroll, Evans, Fumuro, Bridger 12 14 103 Moon, Baym, Kato, Kroll, Evans, Fumuro, Banet 14 16, 17 103 Moon, Baym, Kato, Kroll, Evans, Fumuro, Tenzer 16, 17 21, 22 103 Moon, Baym, Kato, Kroll, Fumuro, Kiani 21, 22 Overall Outcome 1, 3-7, 9- 12, 14-18, 21, 22 Appeal 2020-004536 Application 14/450,510 12 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation