Butterfly Network, Inc.

Patent Trials and Appeals Board

Mar 22, 2022

2021002891 (P.T.A.B. Mar. 22, 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. 15/626,954 06/19/2017 Daniel Nouri B1348.70035US06 7886 129830 7590 03/22/2022 BFLY Operations, Inc. c/o WOLF, GREENFIELD & SACKS, P.C. 600 Atlantic Avenue Boston, MA 02210-2206 EXAMINER BRUTUS, JOEL F ART UNIT PAPER NUMBER 3793 NOTIFICATION DATE DELIVERY MODE 03/22/2022 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): B1348_eOfficeAction@WolfGreenfield.com Patents_eOfficeAction@WolfGreenfield.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte DANIEL NOURI, ALEX ROTHBERG, MATTHEW DE JONGE, JIMMY JIA, JONATHAN M. ROTHBERG, MICHAL SOFKA, DAVID ELGENA, MARK MICHALSKI, TOMER GAFNER, and ABRAHAM NEBEN Appeal 2021-002891 Application 15/626,954 Technology Center 3700 Before JILL D. HILL, CARL M. DeFRANCO, and LEE L. STEPINA, Administrative Patent Judges. STEPINA, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1-3, 5, 7-10, and 23-30. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE and enter a NEW GROUND OF REJECTION pursuant to 37 C.F.R. § 41.50(b). 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as Butterfly Network, Inc. Appeal Br. 3. Appeal 2021-002891 Application 15/626,954 2 CLAIMED SUBJECT MATTER Appellant’s invention relates to automated image analysis for diagnosing a medical condition. Claims 1, 23, and 30 are independent. Claims 1 and 23, reproduced below with emphasis added, are illustrative of the claimed subject matter: 1. A method, comprising: obtaining, by at least one processor, an ultrasound image of an operator of an ultrasound device at least in part by guiding the operator of the ultrasound device to obtain the ultrasound image; and generating, by the at least one processor, a diagnosis of a medical condition of the operator at least in part by analyzing the ultrasound image using a deep learning technique. 23. A system, comprising: an ultrasound device configured to capture ultrasound images; and a computing device communicatively coupled to the ultrasound device, the computing device being configured to: receive medical information about a subject, wherein the medical information about the subject is selected from a group consisting of: a heart rate, a blood pressure, a body surface area, an age, a weight, a height, and a medication being taken by the subject; identify, based on the medical information, a target anatomical view of the subject to be imaged by the ultrasound device; obtain an ultrasound image containing the target anatomical view captured by the ultrasound device; and generate a diagnosis of a medical condition of the subject using the ultrasound image containing the target anatomical view. Appeal Br. 19-20 (Claims App.). Appeal 2021-002891 Application 15/626,954 3 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Min US 2010/0069987 A1 Mar. 18, 2010 Tupin, Jr. US 2011/0060215 A1 Mar. 10, 2011 Stuebe US 2013/0345563 A1 Dec. 26, 2013 Macoviak US 2014/0058755 A1 Feb. 27, 2014 Seo US 2014/0207001 A1 July 24, 2014 Sharma US 2015/0112182 A1 Apr. 23, 2015 Cho US 2016/0066893 A1 Mar. 10, 2016 Pelissier US 2017/0105701 A1 Apr. 20, 2017 REJECTIONS I. Claims 1-3, 5, 7, and 8 are rejected under 35 U.S.C. § 103 as unpatentable over Stuebe, Sharma, and Pelissier. II. Claims 23, 29, and 30 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Stuebe. III. Claim 9 is rejected under 35 U.S.C. § 103 as unpatentable over Stuebe, Sharma, Pelissier, and Tupin, Jr. IV. Claim 10 is rejected under 35 U.S.C. § 103 as unpatentable over Stuebe, Sharma, Pelissier, and Macoviak. V. Claims 24 and 25 are rejected under 35 U.S.C. § 103 as unpatentable over Stuebe and Seo. VI. Claim 26 is rejected under 35 U.S.C. § 103 as unpatentable over Stuebe and Cho. VII. Claim 27 is rejected under 35 U.S.C. § 103 as unpatentable over Stuebe and Tupin, Jr. Appeal 2021-002891 Application 15/626,954 4 VIII. Claim 28 is rejected under 35 U.S.C. § 103 as unpatentable over Stuebe and Min. OPINION Rejection I; Stuebe, Sharma, and Pelissier The Examiner finds that Stuebe discloses most of the limitations of the method of claim 1, but does not disclose using a deep learning technique, and does not disclose obtaining an ultrasound image of an operator of the ultrasound device. Final Act. 2-3. The Examiner finds that Sharma uses a deep learning technique and that Pelissier obtains an ultrasound image of an operator. Id. at 3-4, 12-13. The Examiner considers that it would have been obvious to one of ordinary skill in the art to combine the teachings of Stuebe and Sharma to identify features of a subject “using a deep learning technique; because large numbers (even millions) of collected samples of various physiological data can be used.” Id. at 4. The Examiner also considers that it would have been obvious to one of ordinary skill in the art to combine the teachings of Stuebe and Pelissier to obtain an ultrasound image of an operator of the ultrasound device “to help improve their scanning technique.” Id. (citing Pelissier, Abstract). Appellant argues that Pelissier discloses that a user performs an ultrasound scan on a patient, but does not disclose that the operator and patient are the same person. Appeal Br. 15. Thus, according to Appellant, the Examiner mischaracterizes Pelissier, because “the cited portions of Pelissier do not disclose guiding the operator of the ultrasound device to obtain an ultrasound image of the operator, when the operator is also the subject,” as required by claim 1. Id. Appeal 2021-002891 Application 15/626,954 5 In the Answer, the Examiner takes the position that because Pelissier does not disclose that the operator must be different than the subject, “the same subject can be the operator as well, unless it is disclosed.” Ans.6. In reply, Appellant argues that “[t]here is nothing in Pelissier explicitly or inherently disclosing that the subject can be the operator as well, as alleged in the Examiner’s Answer.” Reply Br. 7. Pelissier discloses either “a user performs an ultrasound scan on a patient,” or an “operator places a probe against the patient.” Pelissier ¶¶ 61, 68, 75, 77, 160. This is also depicted in Figure 3 of Pelissier wherein an “operator is holding probe 103 against the abdomen of patient P.” Id. ¶ 77. We do not discern, nor has the Examiner identified any teaching in Pelissier, that a user or operator is the patient. An object of Pelissier is to “provide visual feedback to help the inexperienced operator to modify and improve his or her ultrasound scanning technique.” Id. ¶ 12. This is achieved by providing remote feedback, to “help[] inexperienced ultrasound users to capture accurate images in less time, ultimately leading to improved patient care and reduced costs.” Id. ¶ 32. Although we find no explicit exclusion in Pelissier of the use of the disclosed ultrasound device on one’s self, this lack of explicit exclusion is insufficient to support the Examiner’s finding that Pelissier discloses obtaining an ultrasound image of an operator as recited in claim 1. See Final Act. 3, 12-13. Accordingly, we reverse Rejection I. Rejection II; Anticipation - Stuebe In rejecting independent claims 23, 29, and 30 as being anticipated by Stuebe, the Examiner finds, inter alia, that Stuebe receives medical information about a subject by obtaining “one or more measurements (e.g., Appeal 2021-002891 Application 15/626,954 6 dimensions of anatomical structures, ECG recordings) from a patient.” Final Act. 6. Appellant argues that the claims recite more than just any type of medical information, and require one of “a heart rate, a blood pressure, a body surface area, an age, a weight, a height, or a medication being taken by the subject.” Appeal Br. 10. In the Answer, the Examiner changes the analysis and “interprets the heart (as a body surface area) that is used to identify (and also by adjusting) a target anatomical view of the subject to be imaged by the ultrasound device.” Ans. 4. Appellant replies that the Examiner’s interpretation is being articulated for the first time in the Answer, and in any event, it is not consistent with the broadest reasonable interpretation of the claims. Reply Br. 5. According to Appellant, the Specification uses the term “body surface area” to mean the surface area of the body, which is its ordinary use in the art. Id. at 6. Appellant has the better position. As to the Examiner’s findings set forth in the Final Action, the Examiner does not explain sufficiently why Stuebe’s medical information corresponds to any of the information recited in claims 23, 29, and 30. As to the Examiner’s position set forth in the Answer, although we appreciate that the heart has a surface area, neither the abstract nor any other portion of Stuebe upon which the Examiner relies discloses measuring or determining the surface area of the heart. Rather, Stuebe discloses that “measurements [are] (e.g., values of different dimensions) of anatomical structures 458, 460 shown in the measurement frame.” Stuebe ¶ 60. Moreover, we agree with Appellant that the broadest Appeal 2021-002891 Application 15/626,954 7 reasonable interpretation of the term “body” in claims 23 and 30, consistent with the Specification, is the entire human body. In particular, Appellant’s Specification discloses moving the ultrasound device “along the patient’s body” to capture an ultrasound image of a “portion of the patient’s body,” and depicts the entire human body. Spec. ¶¶ 109-111, 335, Fig. 2. The Specification also appears to distinguish between organs, such as the heart, and the body. See Spec. ¶ 280. Further, Appellant has provided evidence that the term “body surface area” is known in the art to be the total area of a human’s skin. See Reply Br. 6. Based on the record before us, the Examiner has not established by a preponderance of the evidence that medical information disclosed by Stuebe is selected from a group consisting of: a heart rate, a blood pressure, a body surface area, an age, a weight, a height, and a medication being taken by the subject, as required by claims 23 and 30. Accordingly, we do not sustain the rejection of claim 23 and claim 29 depending therefrom, as well as the rejection of claim 30 as anticipated by Stuebe. Rejections III and IV - Claims 9 and 10 Claims 9 and 10 depend directly or indirectly from claim 1 and further define the invention. Appeal Br. 20. The Examiner does not rely on the disclosures of Tupin, Jr. or Macoviak in any manner that would remedy the deficiency in the combination of Stuebe, Sharma, and Pelissier discussed above in Rejection I. For the same reasons, we do not sustain Rejections III and IV. Appeal 2021-002891 Application 15/626,954 8 Rejections V-VIII; Claims 24-28 Claims 24-28 depend directly or indirectly from claim 23 and further define the invention. Appeal Br. 21. The Examiner does not rely on the disclosures of Seo, Cho, Tupin, Jr., or Min in any manner that would remedy the deficiency in the anticipation rejection based on Stuebe discussed above in Rejection II. For the same reasons, we do not sustain Rejections V-VIII. NEW GROUND OF REJECTION Claim 1 We enter a new ground of rejection of claim 1 as unpatentable over Stuebe, Sharma, and Pelissier. We adopt the Examiner’s findings as to claim 1 as outlined in the Final Action with respect to Stuebe and Sharma, which Appellant does not appear to dispute. See Final Act. 2-3; Appeal Br. 5-17. We also adopt the Examiner’s reason for combining Stuebe and Sharma. Id. at 4. In addition, we also adopt the Examiner’s finding as to Pelissier that Pelissier “guid[es] the operator of the ultrasound device to obtain the ultrasound image.” Id. at 3. As noted above, Pelissier does not exclude the operator from being the subject, but fails to explicitly disclose that the operator is the subject. Nonetheless, one of ordinary skill in the art would have understood that the operator is capable of being the subject of an ultrasound device, as evidenced by the following teachings of Pellissier. As Pelissier discloses, “existing ultrasound systems enable a remote expert to provide communications to an inexperienced operator regarding ultrasound images.” Pelissier ¶ 8 (emphasis added). Pelissier further states, “[t]here remains a need for practical and cost effective systems that can help an inexperienced operator to capture ultrasound images and/or learn better Appeal 2021-002891 Application 15/626,954 9 imaging techniques” (id. ¶ 12) and “System 100 may be configured to facilitate training a technician to make such measurements or to assist an inexperienced user to achieve acceptable measurements” (id. ¶ 155); see also id. ¶¶ 32, 117. Thus, Pelissier discloses that even inexperienced operators may operate an ultrasound system. In any event, we note that claim 1 does not limit the practice of the claimed method to any particular location or to operators of any particularly high (or low) level of skill in using an ultrasound device. See Appeal Br. 19 (Claims App.). Thus, claim 1 does not preclude a medical professional from practicing the recited method (including self-applying the ultrasound system) in a conventional medical facility.2 For various reasons, a person of ordinary skill in the art would have found it obvious to self-apply the ultrasound system as an alternative to applying the ultrasound system to a different individual. This is similar to what occurs when people take their own pulse, blood pressure, or even their own weight. One of ordinary skill in the art of ultrasound imagine would have found it obvious to substitute oneself as the subject of the imaging process. A person of ordinary skill in the art would have recognized that the results of this process would have been predictable inasmuch as the status of a person as a medical professional who uses ultrasound equipment is not associated with any pertinent physical difference from a person who typically undergoes ultrasound imaging. Here, the technique is not beyond the abilities of a person of ordinary skill in the art because, as evidenced by Pelissier, a user “may request remote 2 One might also characterize a medical professional using an ultrasound machine on oneself as a form of taking a selfie. Appeal 2021-002891 Application 15/626,954 10 assistance from an expert … when a user [of ultrasound apparatus 100A] is ready to begin imaging and requires assistance.” Pelissier ¶ 69. Accordingly, it would have been obvious to further modify the Examiner’s proposed combination of the teachings of Stuebe, Sharma, and Pelissier to have the ultrasound imaging technique applied to the operator as a mere combination of known methods to yield predictable results or as a simple substitution of one patient for another (the operator). For the reasons discussed above, we enter a new ground of rejection of claim 1 under 35 U.S.C. § 103 as unpatentable over Stuebe, Sharma, and Pelissier. Claims 2, 3, 5, and 7-10 We leave it to the Examiner to determine the propriety of any rejections of claims 2, 3, 5, and 7-10 based upon the prior art and rationales set forth above. Although we decline to reject every claim under our discretionary authority under 37 C.F.R. § 41.50(b), we emphasize that our decision does not mean the remaining claims are patentable. Rather, we merely leave the patentability determination of these claims to the Examiner. See MPEP § 1213.02. CONCLUSION The Examiner’s rejections are reversed, and we enter a new ground of rejection of claim 1. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed New Ground Appeal 2021-002891 Application 15/626,954 11 1-3, 5, 7, 8 103 Stuebe, Sharma, Pelissier 1-3, 5, 7, 8 23, 29, 30 102 Stuebe 23, 29, 30 9 103 Stuebe, Sharma, Pelissier, Tupin, Jr. 9 10 103 Stuebe, Sharma, Pelissier, Macoviak 10 24, 25 103 Stuebe, Seo 24, 25 26 103 Stuebe, Cho 26 27 103 Stuebe, Tupin, Jr. 27 28 103 Stuebe, Min 28 1 103 Stuebe, Sharma, Pelissier 1 Overall Outcome 1-3, 5, 7-10, 23-30 1 TIME PERIOD FOR RESPONSE This decision contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” 37 C.F.R. §41.50(b) also provides that the Appellant, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new Evidence relating to the claims so rejected, or Appeal 2021-002891 Application 15/626,954 12 both, and have the matter reconsidered by the examiner, in which event the proceeding will be remanded to the examiner. . . . (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same Record. . . . Further guidance on responding to a new ground of rejection can be found in the Manual of Patent Examining Procedure § 1214.01. 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). REVERSED; 37 C.F.R. § 41.50(b)