Ex Parte Gal et alDownload PDFPatent Trials and Appeals BoardMay 30, 201913540656 - (D) (P.T.A.B. May. 30, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/540,656 07/03/2012 Avner Gal 76808 7590 06/03/2019 Leason Ellis LLP One Barker A venue Fifth Floor 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 10516/006005-US 1 9674 EXAMINER TOTH, KAREN E White Plains, NY 10601-1526 ART UNIT PAPER NUMBER 3791 NOTIFICATION DATE DELIVERY MODE 06/03/2019 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@leasonellis.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte AVNER GAL, ALEXANDER M. RA YKHMAN, EUGENE NAIDIS, YULIA MA YZEL, ALEXANDER KLIONSKY, and ANATOL Y DIBER1 Appeal2019-000056 Application 13/540,656 Technology Center 3700 Before EDWARD A. BROWN, JILL D. HILL, and GEORGE R. HOSKINS, Administrative Patent Judges. HILL, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Avner Gal et al. ("Appellants") appeal under 35 U.S.C. § 134(a) from the Examiner's final decision rejecting claims 2-4, 6, 9-12, and 28. We have jurisdiction under 35 U.S.C. § 6(b). 1 Appellants identify the real party in interest as A.D. INTEGRITY APPLICATIONS LTD. Appeal Br. 2. Appeal2019-000056 Application 13/540,656 We REVERSE and enter NEW GROUNDS of rejection pursuant to 37 C.F.R. § 41.50(b). BACKGROUND Sole independent claim 28, reproduced below, represents the claimed invention, with a key limitation italicized. 28. A self-contained system for determining an accurate measurement of a blood glucose concentration, the system comprising: a hardware platform that includes at least one processor and a communications module, wherein the at least one processor is configured by executing software; a plurality of distinct measuring channels that are collectively disposed in a single housing, wherein each distinct measuring channel is configured to obtain a respective measurement of blood glucose concentration in a technologically different way, and further wherein each of the distinct measuring channels is specially configured for performing a non-invasive measurement of a respective and unique physiological response to a respective glucose concentration of a subject, and wherein each single non- invasive measurement represents a respective measurement of the blood glucose concentration, wherein the hardware platform, when executing the software, is configured to: operatively connect to the respective measuring channels via the communications module; for each of the respective measuring channels: drive the respective measuring channel to perform its single non-invasive measurement of the respective and unique physiological response; and receive, from the respective measuring channel, the measuring channel's measurement of the blood glucose concentration; and 2 Appeal2019-000056 Application 13/540,656 determine, as a function of processing the measurements respectively received from the plurality of respective measuring channels, a measurement of the blood glucose concentration, wherein the determined measurement of the blood glucose concentration more accurately represents the blood glucose concentration than any one of the measurements respectively received from the measuring channels. REJECTI0NS2 I. Claim 28 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Freger (US 6,954,662 B2, iss. Oct. 11, 2005) and Dorogusker (US 2008/0076972 Al, pub. Mar. 27, 2008), or, in the alternative, over Freger, Dorogusker, Oraevsky (US 6,405,069 Bl, iss. June 11, 2002), Elden (US 6,517,482 Bl, iss. Feb. 11, 2003), and Cho (US 5,795,305, iss. Aug. 18, 1998). Final Act. 6. II. Claims 2-4 and 6 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Freger, Dorogusker, Oraevsky, and Sullivan (US 7,666,151 B2, iss. Feb. 23, 2010). Final Act. 8. III. Claims 9 and 10 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Freger, Dorogusker, Oraevsky, Sullivan, and Byrne (US 5,395,033, iss. Mar. 7, 1995). Final Act. 10. IV. Claim 11 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Freger, Dorogusker, Oraevsky, Sullivan, Byrne, and Uenishi (US 2010/0298667 Al, pub. Nov. 25, 2010). Final Act. 10. 2 The Examiner withdrew rejections under 35 U.S.C. § 112, ,-J,-J 1 and 2 (Advisory Action dated May 2, 2018), and the rejection of claim 13 after its cancellation (Ans. 3). 3 Appeal2019-000056 Application 13/540,656 V. Claim 12 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Freger, Dorogusker, Oraevsky, Sullivan, and Cho. Final Act. 11. ANALYSIS Sole independent claim 28 recites, inter alia, "the determined measurement of the blood glucose concentration more accurately represent[ing] the blood glucose concentration than any one of the measurements respectively received from the measuring channels." Appeal Br. 27-28 (Claims App'x ( emphasis added)). In the Final Office Action dated October 4, 2017, the Examiner rejected claim 28 under 35 U.S.C. § 112, first paragraph (as failing to comply with both the enablement requirement and the written description requirement) and second paragraph ( as being indefinite) for multiple reasons (Final Act. 2-5). For example, the Examiner determined that claim 28 is indefinite, because: The term "more accurately" ... is a relative term which renders the claim indefinite. The term "more accurately" is not defined by the claim, the [S]pecification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how much improvement is needed to qualify as a "more accurate" measurement. Further, [the Specification does not] call for comparing the measurements to determine whether one is "more accurate" than another, or how this might be validated. Id. at 5. Each of the rejections under 35 U.S.C. § 112, first and second paragraphs, was withdrawn following entry of an amendment. See Advisory Action of May 2, 2018. 4 Appeal2019-000056 Application 13/540,656 Written Description under 35 U.S.C. § 112, first paragraph 35 U.S.C. § 112, first paragraph, requires that: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same. To satisfy the written description requirement, Appellants must convey with reasonable clarity to those skilled in the art that, as of the filing date, they were in possession of the claimed invention. See Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir. 1991). An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). Claim 28 recites the determined glucose measurement more accurately representing the glucose "than any one of the measurements respectively received from the [plural distinct] measuring channels." Appellants state that support for this limitation can be found in paragraphs 31 3 and 73 of their Specification. Appeal Br. 4. The Examiner found support for this limitation in paragraph 131 of the Specification. Final Act. 3. Paragraph 31 of Appellants' Specification does not describe measurement accuracy. Paragraph 73 of the Specification relevantly states that "to increase the accuracy of ... glucose measurement, the device ... 3 Appellants' reference to paragraph 31 may have been a typographical error, intending to refer instead to paragraph 131. 5 Appeal2019-000056 Application 13/540,656 preferably uses a combination of ... three non-invasive methods: ultrasonic, electromagnetic and thermal." Paragraph 131 states that glucose values are received from each measurement channel, and "are checked for correlation. Subsequently, weights are assigned to each of the three values, according to the degree of correlation. Finally, a weighted combination of the three technologies outputs produces a more accurate glucose reading." Appellants' Specification provides no explicit discussion of determining a glucose measurement that more accurately represents glucose "than any one of the measurements respectively received from the [plural distinct] measuring channels," as recited in claim 28. Thus, while Appellants' Specification certainly discusses determining a more accurate measurement, it never states or implies that the determined measurement is more accurate than any one of the individual measurements, that is, every one of the individual measurements. We discern no basis for finding that one skilled in the art would derive an understanding of the specifically claimed "more accurate[] ... than any one of' from Appellants' limited disclosure in paragraphs 31, 73, and 131, or any other disclosure in the Specification identified by Appellants, and thus would not have understood Appellants to have possession of the claimed invention. Appellants' Specification, therefore, does not convey with reasonable clarity to those skilled in the art that they were in possession of the claimed invention. For this reason, we reject claim 28 under 35 U.S.C. § 112, first paragraph, as lacking written description. Claims 2-4, 6, and 9-12 depend from claim 28, and are therefore rejected for the same reason. To provide Appellants with a full and fair opportunity to respond, we designate this as a NEW GROUND of rejection. 6 Appeal2019-000056 Application 13/540,656 Indefiniteness under 35 U.S.C. § 112, second paragraph 35 U.S.C. § 112, second paragraph, requires that a specification conclude with one or more claims particularly pointing out and distinctly claiming the subject matter that the applicant regards as their invention. A decision on whether a claim is indefinite under 35 U.S.C. § 112, second paragraph, requires a determination of whether those skilled in the art would understand what is claimed when the claim is read in light of the specification. See Power-One, Inc. v. Artesyn Techs., Inc., 599 F.3d 1343, 1350 (Fed. Cir. 2010); Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F.2d 1565 (Fed. Cir. 1986). While relative terminology (e.g., "more than") can be definite, limitations containing such terminology must be understandable by a skilled artisan and allow the public to determine the scope of the claim. Regarding the "more accurately ... than" limitation discussed above, we determine that the limitation renders the claim indefinite for the following reason. Claim 28, considered in light of Appellants' Specification, requires that the blood glucose value determined by weighting plural sensor values is somehow made more accurate than any one of the plural individual sensor values. Appellants' Specification discloses only one way to increase accuracy of the sensor values: "The received glucose values from each measurement channel are checked for correlation. Subsequently, weights are assigned to each of the three values, according to the degree of correlation. Finally, a weighted combination of the three technologies outputs produces a more accurate glucose reading." Spec. ,-J 131. Thus, Appellants appear to be using a weighted combination value, where 7 Appeal2019-000056 Application 13/540,656 individual values with more "correlation" count more than others (i.e., carry more weight). Appellants, however, do not explain what the measurements are "checked for correlation" with respect to, for example: other concurrently- sensed glucose values; previously sensed glucose values; some type of relative importance; or a change in blood glucose level. Further, even if a skilled artisan would understand how to use the "correlation" and "weighting" referred to, without specificity, in Appellants' Specification, we are unable to discern how such correlation and subsequent weighting would accomplish determining a blood glucose value that is more accurate than any one of the sensed values. We understand "any one of' to be synonymous with "each of," and question how a weighted combination of the three technology outputs is guaranteed to produce a more accurate glucose reading than each of the three technology outputs. For example, if a patient's actual blood glucose level is 90 mg/dL, and a glucose concentration is determined from each of an ultrasonic, an electromagnetic and a thermal sensor at values of 88 mg/dL, 90 mg/dL, and 92 mg/dL, respectively, it is not apparent from the limited disclosure how would Appellants' weighted combination value ever be "more accurate than" the completely accurate electromagnetic reading of 90 mg/ dL? Appellants' Specification is completely silent on this. For this reason, we reject claim 28 under 35 U.S.C. § 112, second paragraph, as indefinite. Claims 2-4, 6, 9-12 depend from claim 28, and are therefore rejected for the same reason. To provide Appellants with a full and fair opportunity to respond, we designate this as a NEW GROUND of rejection. Rejections I-V: Obviousness 8 Appeal2019-000056 Application 13/540,656 The Examiner finds that Freger discloses, inter alia, a system comprising plural "distinct measuring channels (column 2, lines 37-52) ... non-invasively measuring glucose level ... using at least two sensors, each sensor independently non-invasively measuring a different value" via "a different technological measurement channel," the system making a composite measurement that "'more accurately' represents the [ medical] parameter than any of the individual measurements (figure 1, weighting is applied to increase the accuracy of the composite value)." Final Act. 6-7. Appellants argue, inter alia, that the Examiner erred in finding that the prior art discloses determining, "'as a function of processing the measurements respectively received from the plurality of respective measuring channels, a measurement of the blood glucose concentration' that 'more accurately represents the blood glucose concentration than any one of the measurements respectively received from the measuring channels."' Appeal Br. 5. According to Appellants, Freger does not disclose a weighted average that more accurately represents the blood glucose concentration than any one of the measurements received from the measuring channels. Appeal Br. 11. Appellants further contend that Freger teaches away from the claimed process by stating that, in "'situations where the three measurement procedures are all equally reliable, then the weighted factors would be identical,' thereby producing a final result that is not more accurate than any one of the measurements, in counter-distinction to ... claim 28." Id. ( citing Freger 4:61-5:9). The Examiner finds this disclosure in Freger' s composite measurement that is weighted to "'more accurately' represent[] the parameter than any of the individual measurements." Final Act. 7, Freger 9 Appeal2019-000056 Application 13/540,656 1 : 54-57 ("The instant invention uses measurements of three distinct parameters to determine the blood glucose level, thereby substantially increasing the accuracy of the measurement."); 4:61-62 ("The weight for each measurement depends on the reliability of the specific measurement procedure."); 4:66-5:3 ("The purpose of the 'relative weight' variable is to take into consideration the fact that in some situations one measurement may be more accurate than another due to the specific measurement procedure being used."). Further, the Examiner finds that Freger uses "the exact same procedure for generating a 'more accurate measurement' - by applying weights to the sensed values reflective of their correlation," the only difference being that Freger provides actual details of how weighting takes place, whereas Appellants "merely generally describe[] the desired outcome without providing any details of how it is achieved." Ans. 6. We have considered the Examiner's position and Appellants' arguments, and we determine that, for the reasons discussed above regarding indefiniteness, the scope of claim 28 is too uncertain, because we are unable to properly interpret the "more accurately represents ... than any one of' limitation. Consequently, we do not sustain the obviousness rejection of claim 28, because to do so would require speculation as to the scope of the claims. See In re Steele, 305 F.2d 859, 862-63 (CCPA 1962) (holding that the Board erred in affirming a rejection of indefinite claims under 35 U.S.C. § 103(a), because the rejection was based on speculative assumptions as to the meaning of the claims). The rejections of dependent claims 2-4, 6, and 9-12 are not sustained for the same reason. It should be understood, however, that our decision in this regard is proforma, and based solely on 10 Appeal2019-000056 Application 13/540,656 the indefiniteness of the claimed subject matter, and does not reflect on the adequacy of the prior art evidence applied in support of the rejection. DECISION We REVERSE,proforma, the Examiner's obviousness rejections. We ENTER A NEW GROUND OF REJECTION of claims 2-4, 6, 9- 12, and 28 under 35 U.S.C. § 112, first paragraph, as lacking written description. We ENTER A NEW GROUND OF REJECTION of claims 2-4, 6, 9- 12, and 28 under 35 U.S.C. § 112, second paragraph, as indefinite for failing to particularly point out and distinctly claim the subject matter Appellants regard as the invention. This decision contains new grounds of rejection pursuant to 37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides that "[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 Appellants, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new grounds 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 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 .... 11 Appeal2019-000056 Application 13/540,656 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § l .136(a). See 37 C.F.R. § l.136(a)(l )(iv). REVERSED; 37 C.F.R. § 41.50(b) 12 Copy with citationCopy as parenthetical citation