Ex Parte Gal et alDownload PDFPatent Trial and Appeal BoardJun 11, 201513540656 (P.T.A.B. Jun. 11, 2015) 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. 13/540,656 07/03/2012 Avner Gal 103437-1-300 9674 27267 7590 06/11/2015 WIGGIN AND DANA LLP ATTENTION: PATENT DOCKETING ONE CENTURY TOWER, P.O. BOX 1832 NEW HAVEN, CT 06508-1832 EXAMINER TOTH, KAREN E ART UNIT PAPER NUMBER 3735 MAIL DATE DELIVERY MODE 06/11/2015 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte AVNER GAL, ANATOLY DIBER, ALEXANDER KLIONSKY, YULIA MAYZEL, EUGENE NAIDIS, and ALEXANDER M. RAYKHMAN1 ____________ Appeal 2014-009028 Application 13/540,656 Technology Center 3700 ____________ Before EDWARD A. BROWN, JILL D. HILL, and MARK A. GEIER, Administrative Patent Judges. GEIER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE This is a decision on appeal, under 35 U.S.C. § 134(a), from the Examiner’s rejection of claims 1–4, 6, 9–13, 15–22, and 26–28.2 App. Br. 6. An Oral Hearing occurred on May 19, 2015. We have jurisdiction under 35 U.S.C. § 6(b). 1 Appellants indicate that the real party in interest is A.D. Integrity Applications Ltd. App. Br. 4. 2 The Appellants cancelled claims 5, 7, 8, 14, and 23–25, and these cancelled claims are not before us on this Appeal. See App. Br. 6. Appeal 2014-009028 Application 13/540,656 2 We AFFIRM. THE CLAIMED SUBJECT MATTER The claimed subject matter relates to “a device for non-invasive measurement of the blood glucose level of a subject patient.” Spec. ¶ 2. Claims 1 and 13 are representative and recite: 1. A device for non-invasively measuring glucose level in a subject comprising: a unitary external unit having a first portion and an opposing second portion configured to receive a part of the subject's body therebetween; at least two sensors attached to said unitary external unit, each sensor independently noninvasively measuring a different value indicative of said glucose level; and a processor receiving a value from each sensor and calculating a combination of each said value to produce a glucose level reading. 13. A device for non-invasively measuring glucose level in a subject comprising: a housing having a first portion and an opposing second portion configured to receive a part of the subject's body therebetween; a first capacitor plate positioned on said first portion and a second capacitor plate positioned on said opposing second portion of said housing and configured to receive a part of the subject's body to which said device is attachable with said first capacitor plate spaced from said second capacitor plate by a calibrated distance; an auto-oscillating circuit connected to said first and second capacitor plates; a processing means for calculating glucose level based on a tissue impedance signal, an ambient temperature and an earlobe temperature; and Appeal 2014-009028 Application 13/540,656 3 a means to communicate said tissue impedance signal, said ambient temperature and said earlobe temperature to said processing means. THE REJECTIONS ON APPEAL The Examiner rejected claims 1–4, 6, and 9–12 under 35 U.S.C. § 112, ¶ 2, as being indefinite. The Examiner rejected claim 1 under 35 U.S.C. § 102(b) as anticipated by or, in the alternative, under 35 U.S.C. § 103(a) as obvious over Freger (US 6,954,662 B2; iss. Oct. 11, 2005). The Examiner rejected claims 2–4 and 6 under 35 U.S.C. § 103(a) as obvious over Freger in view of Oraevsky (US 6,405,069 B1; iss. June 11, 2002) and Sullivan (US 7,666,151 B2; iss. Feb. 23, 2010). The Examiner rejected claims 9 and 10 under 35 U.S.C § 103(a) as obvious over Freger in view of Oraevsky, Sullivan, and Byrne (US 5,395,033; iss. Mar. 7, 1995). The Examiner rejected claim 11 under 35 U.S.C § 103(a) as obvious over Freger in view of Uenishi (US 2010/0298667 A1; pub. Nov. 25, 2010).3 3 The precise scope of this rejection is ambiguous, in that the Examiner’s rejection refers to “Freger, as modified, above . . ..” Final Act. 6. Thus, it is not clear whether Oraevsky, Sullivan, and Byrne are part of this rejection. See App. Br. 9 and 17–18 (referring to these additional references as part of the rejection). We find that it is not necessary to resolve the Appellants’ appeal of this rejection. Appeal 2014-009028 Application 13/540,656 4 The Examiner rejected claim 12 under 35 U.S.C § 103(a) as obvious over Freger in view of Oraevsky, Sullivan, and Cho (US 5,795,305; iss. Aug. 18, 1998).4 The Examiner rejected claim 13 under 35 U.S.C. § 103(a) as obvious over Elden (US 6,517,482 B1; iss. Feb. 11, 2003) in view of Sterling (US 2010/0049007 A1; pub. Feb. 25, 2010), Cho, and Freger. The Examiner rejected claim 15 as obvious over Elden in view of Sterling, Cho, Freger, and Sullivan. The Examiner rejected claim 16 under 35 U.S.C. § 103(a) as obvious over Elden in view of Sterling, Cho, Freger, and Oraevsky. The Examiner rejected claims 17 and 18 under 35 U.S.C. § 103(a) as obvious over Elden in view of Sterling, Cho, Freger, Oraevsky, and Sullivan. The Examiner rejected claim 19 under 35 U.S.C. § 103(a) as obvious over Elden in view of Sterling, Cho, Freger, Oraevsky, and Shih (US 2010/0007330 A1; pub. Jan. 14, 2010).5 The Examiner rejected claims 20 and 21 as obvious over Elden, Sterling, Cho, Freger, and Zheng (Zheng et. Al., Noninvasive glucose Determination by Oscillating Thermal Gradient Spectrometry, Diabetes Technology & Therapeutics, vol. 12, no. 1 (2000)). 4 Appellants do not present arguments directed to this rejection. 5 Appellants do not present arguments directed to this rejection. Appeal 2014-009028 Application 13/540,656 5 The Examiner rejected claim 22 under 35 U.S.C. § 103(a) as obvious over Elden in view of Sterling, Cho, Freger, Oraevsky, Shih, and Zheng. The Examiner rejected claims 26 and 28 under 35 U.S.C. § 103(a) as obvious over Freger. The Examiner rejected claim 27 under 35 U.S.C. § 103(a) as obvious over Freger in view of Oraevsky and Shih.6 ANALYSIS Rejection of Claims 1–4, 6, and 9–12 as Indefinite The Examiner found that claim 1 was indefinite in its recitation of “calculating a combination of each said value.” Final Act. 2. Specifically, the Examiner found that “[i]t is not clear how one could calculate a combination of each of the two values, since each value is a single value and there [sic] – one could calculate a combination using each value, or, less awkwardly, produce a glucose level reading that is calculated by combining each of the glucose level values into a single reading.” Final Act. 2.7 Appellants argue that when viewed in light of the Specification — in particular, paragraphs 18, 19, and 76 — the claim language is clear. App. Br. 12. For the reasons elaborated below, we agree with the Examiner. The Examiner presented a well-grounded rejection under Section 112, ¶2. Final Act. 2. Once the Examiner has done so, the burden is on the applicant to amend or to adequately explain that the claim is not indefinite. 6 Appellants do not present arguments directed to this rejection. 7 Appellants submitted an Amendment After Final to amend the language, but the Examiner did not enter the amendment. See App. Br. 12; Ans. 3. Appeal 2014-009028 Application 13/540,656 6 In re Packard, 751 F.3d 1307, 1311 (Fed. Cir. 2014) (“We conclude that, when the USPTO has initially issued a well-grounded rejection that identifies ways in which language in a claim is ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention, and thereafter the applicant fails to provide a satisfactory response, the USPTO can properly reject the claim as failing to meet the statutory requirements of § 112(b).”). Appellants do not argue that the Examiner’s grammatical reading of the claim is incorrect. See App. Br. 12; Reply Br. 11. Instead, Appellants argue that the general principles of the invention are clear. See id. We agree with the Examiner that even if the general principle of the invention is clear, Appellants have not provided an explanation by way of argument or by citations to the Specification that clarifies the claim language. Ans. 3 (“The Examiner does not disagree with Appellant’s characterization of the claimed invention in the remarks; however, the language currently found in the claims is unclear and does not accurately reflect the intended invention.”). For these reasons, we affirm the Examiner’s rejection of claim 1 as indefinite. Moreover, as Appellants state claims 2–4, 6, and 9–12 stand or fall with claim 1, we also affirm the Examiner’s rejection of claims 2–4, 6, and 9–12. Rejection of Claim 1 as Anticipated by, or Obvious over, Freger The Examiner rejected claim 1 as anticipated by or, in the alternative, obvious over Freger. Final Act. 3. Appellants challenge the Examiner’s obviousness rejection on several grounds.8 See App. Br. 12–15; Reply Br. 8 We note that the Appellants initially argued that the Examiner had not adequately articulated an obviousness rejection separate from its novelty Appeal 2014-009028 Application 13/540,656 7 12–16. The crux of these arguments is that Freger discloses a method, and does not disclose, teach, or suggest the structures recited in claim 1. See, e.g., App. Br. 13. In particular, Appellants argue that nothing in Freger would teach or suggest using a “unitary external unit” as required by claim 1. App Br. 13–14; Reply Br. 12–14. A key issue with respect to the “unitary external unit” limitation is the proper construction of that limitation. During examination, we give claim language “the broadest reasonable meaning of the words in their ordinary usage as they would be understood by one of ordinary skill in the art, taking into account whatever enlightenment by way of definitions or otherwise that may be afforded by the written description contained in the applicant’s specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). “Absent claim language carrying a narrow meaning, the PTO should only limit the claim based on the specification or prosecution history when those sources expressly disclaim the broader definition.” In re Bigio, 381 F.3d 1320, 1325 (Fed Cir. 2004). The key disagreement between the Examiner and Appellants is whether a “unitary external unit” must be within a single housing. The Examiner concluded that “any device as a whole may be considered a ‘unitary’ device absent any specific definition of the term.” Ans. 4. The Examiner further stated that “the claim merely calls for a device housing two glucose sensors . . ..” Id. Appellants do not provide a claim construction, rejection. App. Br. 14. However, following the Examiner’s further elaboration of the rejection in the Answer, the Appellants addressed that rejection in their Reply Brief. Reply Br. 13–16. Appeal 2014-009028 Application 13/540,656 8 but their arguments rely upon a construction that a “unitary external unit” must be within a single housing. See, e.g., Reply Br. 13, 16; see also id. 12 (“However, the pending claims themselves define unitary as meaning ‘at least two sensors attached to said unitary external unit.’”).9 Neither Appellants, nor the Examiner, provide us with a dictionary definition or any concrete basis upon which to decide the plain meaning of the disputed claim terms. Our review of applicable dictionary definitions does not resolve this issue. For example, per Merriam-Webster, “unitary” means “having the character of a unit” and “unit,” in turn, means “a single thing . . . that is a constituent of a whole” or “a piece or complex of apparatus serving to perform one particular function.” MERRIAM-WEBSTER ONLINE DICTIONARY, http://www.merriam-webster.com/dictionary/unitary and http://www.merriam-webster.com/dictionary/unit (last visited June 3, 2015). In our view, it is not clear from these definitions that a “unit” must be within a single housing in the context of the claims at issue. The Specification is more helpful. While the Specification does not provide a specific definition, it states that “at least three different elements to effect three separate and distinct non-invasive measurements of glucose are provided within a single, unitary external device, e.g., within a single housing.” Spec. ¶ 18 (emphasis added). While this sentence does not use the claim language verbatim, we think it is sufficiently clear to instruct one of skill in the art that a “unitary” device or unit may be a device that is contained within a single housing, but that it does not have to be. See id. 9 Appellants confirmed this construction at the hearing for this Appeal. Hearing Transcript 4–8. Appeal 2014-009028 Application 13/540,656 9 Indeed, we determine that in light of this statement, one of skill in the art would not conclude that Appellants have disavowed any claim scope involving a “unitary external unit” that is not within a single housing. Furthermore, the Specification’s other uses of the term “unitary” are consistent with a broader construction. See, e.g., Spec. ¶ 73 (describing the device of Figure 1 as a “unitary non-invasive device”); Fig. 1 (depicting a “unitary device” as having two components connected by a cable). For the foregoing reasons, we conclude that the claim limitation “unitary external unit” does not require a single housing within which the associated components must be disposed. See Bigio, 381 F.3d at 1325. The language merely requires that the external unit be configured such that one of skill in the art would consider it to be part of the same whole, whether it is within a single housing or in multiple housings associated in some other manner. Based upon this construction, we agree with the Examiner’s finding that Freger teaches or suggests “a unitary external unit.” The Examiner found that “Freger clearly discloses a single device having multiple sensors, and is merely silent as to the exact structure of each of the various sensors that may be included in the device.” Ans. 5. Freger discloses “using a non- invasive technique” to take “simultaneous measurements using two, three or more different technologies.” Freger 2:2–4. Freger further discloses that preferably, such measurements are taken “through the ear-lobe.” Id. at 2:14–15. Freger teaches taking these measurements through “the device” (Freger 2:53–54, 58–59, 62–64), and provides details regarding measurements using acoustics, conductivity, and heat capacity (id. at 3:14– 43). Even in light of Appellants’ arguments to the contrary, we agree with Appeal 2014-009028 Application 13/540,656 10 the Examiner that these disclosures would teach or suggest the use of “unitary external unit” to make these simultaneous measurements through the earlobe. Appellants also argue that “[p]utting multiple sensors on one ‘unitary external unit’ is no easy feat” and refer to various details from the Specification regarding a device having multiple sensors within a single housing. Reply Br. 13; see also id. 9, 13–16; App. Br. 11 (“In other words, the novelty of the invention and the length of time it took to build the prototype demonstrates [sic] that the creation of the device was not obvious.”). At a starting point, the nature of these arguments is not clear from Appellants’ briefing.10 Whatever the intended legal grounding of these arguments, these disclosures are only relevant to the obviousness inquiry to the extent they are commensurate with the scope of the claims. These arguments all depend on a construction of “unitary external unit” that requires all elements to be within a single housing. As noted supra, we have rejected that construction. In addition, Appellants argue that In re Gianelli, 739 F.3d 1375 (Fed. Cir. 2014) compels reversal because it stands for the proposition that “the 10 All of Appellants’ arguments are directed toward the Examiner’s establishment of a prima facie case. See Reply Br. 9 (“As such, the Answer similarly fails to carry the Examiner's burden of showing a prima facie case of obviousness.”) Appellants do not argue secondary considerations in either of their briefs. Appellants also do not present arguments regarding any reasonable expectation of success in the Examiner’s combination. To the extent any of their arguments could be construed in this respect, we note that the arguments are not tied to claim language and include nothing beyond anecdotal evidence and attorney argument. Appeal 2014-009028 Application 13/540,656 11 Examiner cannot, in hindsight, merely assume that an asserted combination is a simple task when the complexity and needed size of such unitary external unit are considered.” App. Br. 15. Gianelli is not relevant to this Appeal. Gianelli involved an obviousness rejection based upon an Examiner’s proposed usage of a “chest press machine” as a “rowing machine.” Gianelli, 739 F.3d at 1380. The Federal Circuit reversed that rejection, noting that “[p]hysical capability alone does not render obvious that which is contraindicated.” Id.11 In the present appeal, we do not see any instance of the Examiner proposing such a mere capability of the prior art. Freger, as does the present invention, relates to non-invasive measurement of multiple parameters related to glucose content in the blood. See Freger; Spec. As such, we are not persuaded by Appellants’ arguments regarding Gianelli. For all the foregoing reasons, we affirm the Examiner’s rejection of claim 1 as obvious over Freger. See Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299, 1307 (Fed. Cir. 2006) (quoting SIBIA Neurosciences, Inc. v. Cadus Pharm. Corp., 225 F.3d 1349, 1356 (Fed. Cir. 2000)) (“A claim can be obvious even where all of the claimed features are not found in specific prior art references, where ‘there is a showing of a suggestion or motivation to modify the teachings of [the prior art] to the claimed invention.’”). We do not reach the Examiner’s anticipation rejection. 11 See also id. (“And, on this record, it is not obvious to modify a machine with handles designed to be pushed to one with handles adapted to be pulled. A chest press machine is not a rowing machine, nor has evidence been shown that it is. In fact, anyone who has used exercise machines knows that a sure-fire way to cause injury is to use a machine in a manner not intended by the manufacturer.”). Appeal 2014-009028 Application 13/540,656 12 Rejection of Claims 2–4 and 6 as Obvious over Freger, Oraevsky, and Sullivan Appellants challenge the Examiner’s rejection based only upon the limitations present in claim 2 (see App. Br. 16). As such, we select claim 2 as representative and claims 3, 4, and 6 stand or fall with claim 2. Some of Appellants’ arguments here reiterate arguments made with respect to Freger or rely on a construction of “unitary external unit” that requires all the components to be disposed within a single housing. See, e.g., App. Br. 15. For the reasons explained with respect to claim 1 supra, we reject those arguments here as well. Appellants argue that the Examiner improperly combined Freger with Oraevsky and Sullivan. Specifically, Appellants argue that: (1) because Freger does not explicitly disclose a device, it “provides no criteria from which to direct one of ordinary skill in the art what structures should be used” (App. Br. 15); (2) “Oraevsky discloses what is apparently a complete method for glucose measurement” (id. at 16); and (3) “Sullivan does not discuss or have anything to do with measuring glucose levels, much less in doing so in a non-invasive manner” (id.). We do not find Appellants’ arguments persuasive. The Examiner provided a rationale explaining why one of skill in the art would have used Freger as a primary reference and would have looked to Oraevsky and Sullivan. Ans. 6; Final Act. 4. With respect to Freger, the Examiner found that Freger disclosed various sensors, but no specifics as to their structure. Ans. 5. Accordingly, the Examiner found, “[o]ne would naturally look to the art to find disclosures of those sensors that include their Appeal 2014-009028 Application 13/540,656 13 specific design in order to make the device of Freger and have it include the sensors that it calls for.” Id. The Examiner found that one of skill in the art would have looked to Oraevsky because “Freger discloses a device with an assortment of measurement modalities; Orarevsky [sic] provides specifics as to one of these modalities.” Id. at 6. With respect to Sullivan, the Examiner found that “Sullivan teaches a protective membrane for piezoelectronic sensors; Orarevsky [sic] teaches piezoelectronic sensors. . . It would be obvious to provide protection for Orarevsky’s [sic] sensors in order to extend their lifetime.” Id. Appellants have not persuaded us that the Examiner erred in any of the foregoing findings or conclusions. Appellants also argue that even if combined, the combination of references does not teach or suggest claim 2. Specifically, Appellants argue that Oraevsky does not disclose certain limitations of claim 2 for two reasons. First, it discloses “[t]he use of a pulse laser to create acoustic pressure pulses is not one of the three methods of measuring glucose recited in claim 2.” App. Br. 16. Second, it fails to disclose the “details of piezo electric elements used for ultrasonic measurements and the thermal sensor for thermal measurements.” Reply Br. 17. We do not find Appellants’ arguments persuasive of Examiner error. Appellants have not pointed to any specific claim language or limitations they believe Oraevsky does not disclose. To the extent Appellants argue that Oraevsky does not disclose the claimed “ultrasonic piezo element[s],” the Examiner made the following finding: Oraevsky teaches a device for non-invasively measuring a glucose level in a subject comprising ultrasonic piezo elements Appeal 2014-009028 Application 13/540,656 14 positioned on opposing portions of a device configured to surround a part of the subject's body to which the device is attachable (column 4, lines 62-63; column 5, lines 16-18; column 6, lines 24-26 and 66-67; column 7, lines 2-10). Final Act. 4.12 Appellants’ arguments do not inform us of error in the Examiner’s findings regarding Oraevsky. For the foregoing reasons, Appellants have not apprised of us any reversible error committed by the Examiner. We therefore affirm the Examiner’s rejection of claims 2–4 and 6. In addition, Appellants state that claim 12 stands or falls with claims 2–4 and 6. App. Br. 9.13 Therefore, we also affirm the Examiner’s rejection of claim 12 on this basis. Rejection of Claims 9 and 10 as Obvious over Freger, Oraevsky, Sullivan, and Byrne Although argued under a separate heading, Appellants base their arguments on the dependency of claims 9 and 10 from claim 3, which, in turn, depends from claim 2. See App. Br. 17. To the extent the arguments rely on that dependency, we reject those for the same reasons stated with respect to the rejection of claims 2–4 and 6, supra. 12 See also Ans. 5 (“[T]he claims merely call for a piezo element that measures ultrasonic signals. Orarevsky [sic] explicitly teaches a piezoelectric transducer that monitors ultrasonic frequencies (column 6, lines 24-26) that are used to obtain information about glucose concentration (column 6, lines 55-57).”). 13 Appellants state that claim 12 stands or falls with the Examiner’s rejections of claim 1 and the Examiner’s rejections of claims 2–4 and 6. App. Br. 9. Appellants further state that claims 9–11 also stand or fall on these issues, but present separate arguments regarding those claims. See id. Appeal 2014-009028 Application 13/540,656 15 In addition, Appellants state that “[t]he inclusion of Byrne presents four disparate references that, firstly would not be combined by one skilled in the art, and second, even if combined, do not suggest the combination of elements recited in Applicant’s claims 9 and 10.” App. Br. 17. We find that this conclusory argument unpersuasive of any error committed by the Examiner.14 Rejection of Claim 11 as Obvious over Freger and Uenishi Although argued under a separate heading, Appellants base their arguments on the dependency of the claim on claim 3, which, in turn, depends from claim 2. See App. Br. 18. To the extent the arguments rely on that dependency, we reject those for the same reasons stated with respect to the rejection of claims 2–4 and 6, supra. In addition, Appellants state that “[t]he inclusion of Uenishi presents five disparate references that, firstly would not be combined by one skilled in the art, and second, even if combined, do not suggest the combination of elements recited in Applicant's claim 11.” App. Br. 18. We find this 14 We note that the Examiner provided a reason why one of skill in the art would have combined the relevant references. Final Act. 5; see also KSR Int’l. Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007). To the very limited extent Appellants elaborated their argument in the Reply Brief (see Reply Br. 17), we do not consider this new argument because Appellants have not presented a showing of good cause explaining why the argument could not have been presented in the Appeal Brief. 37 C.F.R. § 41.41(b)(2); see Ex parte Borden, 93 USPQ2d 1473, 1476–77 (BPAI 2010) (informative). Appeal 2014-009028 Application 13/540,656 16 conclusory argument unpersuasive of any error committed by the Examiner.15 Rejection of Claim 13 as Obvious over Elden, Sterling, Cho, and Freger Appellants first argue that the Examiner has not provided a sufficient motivation to combine the references. In particular, Appellants argue that: (1) “[Freger] is not an appropriate base from which to argue that particular combinations of structure are obvious” because it “is devoid of the specific structures” and “does not suggest adjusting an impedance measurement for determining glucose by looking to the ambient temperatures” (Reply Br. 18); (2) Cho teaches collection of the claimed temperature information “for a different purpose and does so to support an entirely different method of monitoring glucose” thereby teaching away from the “claim as a whole” and because Cho states its method is highly accurate also “tends to teach away from the use of additional components and methodologies to measure glucose by implying such additional features are unnecessary” (App. Br. 19); (3) Elden teaches away from the combination because it (a) “discloses comparing the measured impedance with a predetermined (i.e., not variable) relationship between impedance and blood glucose level” in contrast to the claimed invention and (b) “discloses spacing electrodes between 0.2 mm and about 2 cm apart, suggesting a range ill-suited for use with affixing the 15 We note that the Examiner provided a reason why one of skill in the art would have combined the relevant references. Final Act. 6; see also KSR, 550 U.S. at 418. To the very limited extent Appellants elaborated their argument in the Reply Brief (see Reply Br. 17), we do not consider this new argument because Appellants have not presented a showing of good cause explaining why the argument could not have been presented in the Appeal Brief. 37 C.F.R. § 41.41(b)(2); see Borden, 93 USPQ2d at 1476–77. Appeal 2014-009028 Application 13/540,656 17 device over an earlobe” (App. Br. 19); and (4) “[a]s both Sterling and Elden are already directed to non-invasive measurements, there is no apparent motivation to combine the disclosures” (id.). The Examiner addressed each argument made by Appellants as to each reference. With respect to Freger, the Examiner found that Freger was an appropriate base because “Freger clearly teaches combining a plurality of modalities in a single device to improve the accuracy of glucose measurement.” Ans. 7. With respect to Cho, the Examiner found Cho was suggested by Freger as “a singular component of the device.” Ans. 7. With respect to Elden, the Examiner found: (1) Elden’s method of measuring glucose is not relevant because “[t]he claim merely calls for using capacitor plates and an auto-oscillating circuit, and obtaining an impedance signal - the claim does not even call for the plates and circuit to be remotely related to the impedance signal” (Ans. 8); and (2) Elden’s disclosed dimensions of a device compatible with an earlobe “which is generally about 5mm thick” (id.). Finally, with respect to Sterling, the Examiner found that since both Sterling and Elden disclose non-invasive techniques to measure glucose, “it would be easier to incorporate teachings of Sterling into Elden.” Id. With respect to the teach away arguments, we also note that “[a] reference does not teach away . . . if it merely expresses a general preference for an alternative invention but does not ‘criticize, discredit, or otherwise discourage’ investigation into the invention claimed.” DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009) (quoting In re Fulton, 391 F.3d 1195, 1201 (Fed Cir. 2004)). Appellants have not apprised us of any disclosures that criticize, discredit or otherwise Appeal 2014-009028 Application 13/540,656 18 discourage investigation into the claimed invention. In particular with respect to Cho, we are not persuaded that Cho’s mention of “high accuracy” would have discouraged one of skill in the art from combining that technique with other non-invasive techniques in light of Freger’s disclosures. See Ans. 7. In sum, Appellants have not persuaded us the Examiner erred in combining the cited references. Indeed, the Examiner provided a detailed rationale explaining why one of skill in the art would have combined the references: It would have been obvious to one of ordinary skill in the art at the time the invention was made to have made the device of Elden, as modified, with processing means for calculating glucose level from an impedance signal, an ambient temperature, and an earlobe temperature, as taught by Cho and Freger, in order to allow comparison between different modes of measurement to increase accuracy. Final Act. 8. As to Sterling, the Examiner determined: It would have been obvious to one of ordinary skill in the art at the time the invention was made to have made the device of Elden and located the plates on opposing portions of a housing, as taught by Sterling, in order to increase convenience for the subject and because Elden does not disclose details of how to configure the components of the device. Final Act. 7. Appellants also argue that, even if combined, the references do not render the claimed invention obvious. Appellants’ arguments in this respect focus on the following limitation of claim 13: “a processing means for calculating glucose level based on a tissue impedance signal, an ambient Appeal 2014-009028 Application 13/540,656 19 temperature and an earlobe temperature.” Specifically, Appellants note that “Elden and Sterling lack any mention of temperature and Cho does not mention impedance” and argue that “[w]ithout the recognition that an impedance measurement of glucose might need to be corrected for ambient and skin temperatures, the obviousness rejection fails.” Reply Br. 18; see also App. Br. 18 (arguing that no reference discloses “obtaining measurements of the ambient temperature and earlobe temperature and communicating these to a processor”). Critically, Appellants’ arguments rely on the claim requiring that the ambient temperature must be used to correct an impedance measure of glucose. See Reply Br. 18. Per the claim language, the claimed means must only calculate a glucose level “based on a tissue impedance signal, an ambient temperature and an earlobe temperature.” App. Br., Claims App. That language does not require the claimed means to use the ambient temperature to correct a tissue impedance signal. In our view, the claim merely requires that the means uses ambient temperature in some manner in the calculation of a glucose measurement. See Final Act. 8; Ans. 8. Appellants point to their Specification for this requirement, but do not articulate any reasoning why this limitation should be incorporated into the claims. See App. Br. 18 (citing paragraph 110 of the Specification). Under the broadest reasonable interpretation, it is not appropriate for us to import a limitation from the Specification into the claims absent the Appellants’ express disavowal of claim scope. Bigio, 381 F.3d at 1325.16 In our view, 16 We note also that the Appellants did not make any arguments based upon the interpretation of the claim under 112, ¶6. Appeal 2014-009028 Application 13/540,656 20 Appellants’ citation of a single paragraph within the description of the preferred embodiments section of the written description does not constitute their disavowal of claim scope in light of the broad claim language. We note also that other portions of the Specification refer to the use of ambient temperature for correction of a thermal measurement of glucose level. See Spec. ¶ 88. The Examiner also shared our view of the claims, and relied upon the Cho reference for the disclosure of the disputed limitation. Final Act. 8 (“Cho teaches a device for monitoring glucose using an ambient temperature and skin temperature (column 4, lines 13–20)”). Appellants assert that “Cho teaches the collection of these conditions for a different purpose and does so to support an entirely different method of monitoring glucose.” App. Br. 19. We do not find Appellants’ arguments persuasive, as Cho discloses the noninvasive measurement of glucose levels and specifically discloses the use of ambient temperature to correct a thermal measurement of glucose levels. Final Act. 8 (citing Cho, 4:13–20). In light of our construction of the claim and our view of the Examiner’s valid reasons for combining Cho with the other cited references, claim 13 requires no more. For the foregoing reasons, we affirm the Examiner’s rejection of claim 13. In addition, Appellants state that claim 19 stands or falls on this issue. App. Br. 10.17 As such, we also affirm the Examiner’s rejection of claim 19. 17 We note that Appellants state claims “15–22 stand or fall on this issue.” App. Br. 10. Appellants go on to separately argue some of these claims and Appeal 2014-009028 Application 13/540,656 21 Rejection of Claim 15 as Obvious over Elden, Sterling, Cho, Freger, and Sullivan Appellants argue that one of skill in the art would not have combined Sullivan with the other references because “Sullivan is primarily directed to piezoelectric sensors as included in objects such as bedding, and specifically teaches away from devices that are attached to a user by means other than the positioning of the patient (such as laying on a bed).” App. Br. 19. The Appellants’ arguments do not demonstrate Examiner error. The Examiner articulated a rational basis for including Sullivan. Specifically, the Examiner noted that “Sullivan teaches a device with multiple sensors with membranes covering the sensors (column 6, lines 11- 19), in order to protect the sensing elements.” Final Act. 8. Thus, one of skill in the art would have looked to Sullivan “in order to protect the components” recited in the other references. Id. The Examiner also acknowledged that Sullivan discussed piezoelectronic sensors in a context that differed from the claimed invention, but stated that “the structure of the membrane is unaffected by where the piezoelectronic sensors are used.” Ans. 9. Moreover, we note that Appellants have not apprised us of any statements in Sullivan that would rise to the level of teaching away from the use of Sullivan’s membranes in a context different from that discussed in Sullivan. See DePuy Spine, 567 F.3d at 1327. Appellants also argue that the Examiner erred in finding that the prior art teaches or suggests the particular configuration claim 16 recites. App. we therefore address them separately. Appellants do not mention claim 19 anywhere else in their briefing. Appeal 2014-009028 Application 13/540,656 22 Br. 20. In particular, Appellants take issue with the Examiner’s finding that although Sullivan does not disclose the particular configuration: it would have been a mere matter of design choice for one of ordinary skill in the art at the time the invention was made to have used a flat membrane and a convex membrane, since Applicant has not disclosed use of these particular membrane shapes as providing a particular advantage, solving a stated problem, or serving a different purpose than that of the membranes taught by Sullivan. Moreover, it appears that using membranes of an unspecified shape, as taught by Sullivan, or flat and convex membranes, as taught by the Applicant, would perform equally well to measure capacitance. Final Act. 8–9. Appellants note that paragraph ninety-eight of their Specification does recite a specific advantage: “it has been found that it is advantageous if one membrane 40 is flat and the other 38 is convex. This ‘hybrid’ combination provides the best solution from a fitting point of view, and securely holds the device on the subject’s ear lobe.” See App. Br. 20. While the Appellants are correct regarding the teachings of their Specification, our inquiry does not end there. Where the Examiner has found that a design choice is within the skill of one of the art and would have been obvious, the applicant must show that the choice “result[s] in a difference in function or give[s] unexpected results.” In re Rice, 341 F.2d 309, 314 (CCPA 1965); see also In re Kuhle, 526 F.2d 553, 554–55 (CCPA 1975) (holding that the particular placement of a battery contact was an obvious matter of design choice within the skill of the art where the placement provided “no novel or unexpected result”). Here, the Examiner determined: Appeal 2014-009028 Application 13/540,656 23 One of ordinary skill in the art would seek to find the best design to securely hold the device of Elden, as modified, to an ear lobe, since that is where it is designed to be used. The exact shape of the sensors and membranes would be chosen by one of ordinary skill in the art to be a shape that securely holds the device in place – that is, providing the same advantage as the flat and convex shapes of the claimed invention – because such a motivation is inherent to successful operation of the device when attached to the ear lobe. Ans. 9–10. As the Appellants have not come forward with a novel or improved functionality or an unexpected result of the design choice, we affirm the Examiner’s rejection of claim 15. See Rice, 341 F.2d at 314; Kuhle, 526 F.2d at 554–55. Rejection of Claim 16 as Obvious over Elden, Sterling, Cho, Freger, and Oraevsky Appellants make two arguments regarding claim 16. First, that “Oraevsky discloses a device that only determines glucose content utilizing a pulsed laser, which as previously stated, is not one of the methods recited by the claims of the present application.” App. Br. 20. Second, that “Sullivan only discloses that piezoelectric sensors may be disposed throughout a hospital room to monitor patient movement.” Id. Each argument repeats arguments made for prior claims and neither specifically references a limitation of claim 16. As such we reject both arguments for the reasons stated supra. Rejection of Claims 17 and 18 as Obvious over Elden, Sterling, Cho, Freger, Oraevsky, and Sullivan Appellants merely reiterate their arguments presented with respect to claim 15. App. Br. 20. In addition, Appellants state that the rejection of Appeal 2014-009028 Application 13/540,656 24 claim 17 stands or falls with the Examiner’s rejection of claim 18. App. Br. at 10. As such, we also affirm the Examiner’s rejection of claims 17 and 18 for the same reasons stated above with respect to claim 15, supra. Rejection of Claims 20 and 21 as Obvious over Elden, Sterling, Cho, Freger, and Zheng Appellants merely reiterate their arguments presented with respect to claim 13. App. Br. 21. As such, we also affirm the Examiner’s rejection of claims 20 and 21 for the same reasons stated above with respect to claim 13, supra. Rejection of Claim 22 as Obvious over Elden, Sterling, Cho, Freger, Oraevsky, Shih, and Zheng Appellants simply state that none of the cited references teach the device as recited in claim 13. App. Br. 21. As such, we also affirm the Examiner’s rejection of claim 22 for the same reasons stated above with respect to claim 13, supra. Rejection of Claims 26 and 28 as Obvious over Freger and Claim 27 as Obvious over Freger, Oraevsky, and Shih Appellants’ arguments regarding claim 26 are similar to those they made regarding claim 1. Reply Br. 19 (“The issues for claim 26 are identical to claim 1.”). For the reasons stated regarding claim 1, supra, we also affirm the Examiner’s rejection of claim 26. Appellants state that the rejections of claims 27 and 28 stand or fall with claim 26. App. Br. 10. As such, we affirm the Examiner’s rejection of claims 27 and 28 for the same reasons identified with respect to claim 26. Appeal 2014-009028 Application 13/540,656 25 CONCLUSION We have reviewed each of Appellants’ arguments and have determined that the arguments fail to demonstrate that the Examiner committed reversible error in its findings and conclusions regarding the rejections at issue in this Appeal. With respect to any arguments not recited or addressed in this decision, we adopt as our own (1) the findings and reasons set forth by the Examiner in the action from which the Appellants have appealed and (2) the reasons set forth by the Examiner in the Examiner’s Answer. We concur with the conclusions reached by the Examiner. We affirm the Examiner’s rejections of claims 1–4, 6, and 9–12 under 35 U.S.C. § 112, ¶ 2 and of claims 1–4, 6, 9–13, 15–22, and 26–28 under 35 U.S.C. § 103(a). We do not reach the Examiner’s rejection of claim 1 under 35 U.S.C. § 102(b). 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 mls Copy with citationCopy as parenthetical citation