Bin He et al.Download PDFPatent Trials and Appeals BoardFeb 23, 20212020004325 (P.T.A.B. Feb. 23, 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. 14/947,326 11/20/2015 Bin He 920171.00085 4455 26710 7590 02/23/2021 QUARLES & BRADY LLP ATTN: IP DOCKET 411 E. WISCONSIN AVENUE SUITE 2350 MILWAUKEE, WI 53202-4426 EXAMINER TURCHEN, ROCHELLE DEANNA ART UNIT PAPER NUMBER 3793 NOTIFICATION DATE DELIVERY MODE 02/23/2021 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): pat-dept@quarles.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte BIN HE and KAI YU ____________________ Appeal 2020-004325 Application 14/947,326 Technology Center 3700 ____________________ Before JOHN C. KERINS, EDWARD A. BROWN, and BENJAMIN D. M. WOOD, Administrative Patent Judges. KERINS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1 seeks our review under 35 U.S.C. § 134(a) of the Examiner’s Decision rejecting claims 1–23, 27, and 28. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM and enter a NEW GROUND OF REJECTION under 37 C.F.R. § 41.50(b). 1 The term “Appellant” is used herein to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies Regents of the University of Minnesota as the real party in interest. Appeal Br. 1. Appeal 2020-004325 Application 14/947,326 2 CLAIMED SUBJECT MATTER Appellant’s invention relates to a method for determining electrical activity in a subject using ultrasound and electromagnetics. Independent claim 1 is illustrative, and is reproduced below: 1. A method for determining electrical activity in a subject using ultrasound and electromagnetics, the method comprising: directing ultrasound energy to a portion of a subject's anatomy using an ultrasound system, the ultrasound energy inducing a perturbation to locations in the subject's anatomy; sensing, using sensors arranged about the subject, a plurality of electromagnetic signals representing an electrical activity of the subject; identifying electromagnetic signals that are modulated by the perturbation; and generating a report of the electrical activity using the identified electromagnetic signals. REJECTIONS The Examiner rejects: (i) claims 13–23 under 35 U.S.C. § 112(a) as failing to comply with the written description requirement; (ii) claims 27 and 28 under 35 U.S.C. § 112(b) as being indefinite; (iii) claims 1–6, 8–14, and 17–22 under 35 U.S.C. § 102(a)(1) as being anticipated by Tyler (US 2011/0178441 A1, published July 21, 2011); (iv) claim 7 under 35 U.S.C. § 103 as being unpatentable over Tyler in view of Ko (WO 2012/068493 A1, published May 24, 2012); (v) claims 15 and 16 under 35 U.S.C. § 103 as being unpatentable over Tyler in view of John (US 2006/0265022 A1, published Nov. 23, 2006); Appeal 2020-004325 Application 14/947,326 3 (vi) claim 23 under 35 U.S.C. § 103 as being unpatentable over Tyler in view of Zeien (US 2014/0276093 A1, published Sept. 18, 2014); and (vii) claims 27 and 28 under 35 U.S.C. § 103 as being unpatentable over Tyler in view of Mishelevich (US 2014/0088462 A1, published Mar. 27, 2014). The Examiner additionally indicates, under the heading “Double Patenting,” that should claim 27 be found allowable, claim 28 would be subject to an objection as being a substantial duplicate of claim 27. Final Act. 2. Because no actual rejection has been lodged in this respect, the issue is not within our jurisdiction, and is deemed to not be an issue on appeal. ANALYSIS Claims 13–23--35 U.S.C. § 112(a)--Written Description The Examiner takes the position that the application as filed fails to show that Appellant was in possession of an algorithm by which the claimed computer can perform the steps or activities required of it in claim 13. Final Act. 3. In particular, the Examiner clarifies in the Answer that there is no indication in the Specification as to what processing is performed by the claimed computer to “identify, from the electromagnetic signal data, signals modified by the perturbation.” Ans. 11. Appellant maintains that the Examiner has not identified any particular concept or portion of the invention that lacks written descriptive support, and that the rejection appears to be based on the absence in the Specification of computer code allowing the claimed functions to be performed. Appeal Br. 4. Although the Final Action admittedly references all functions which the claimed computer is to be programmed to perform, the Answer highlights the above-noted identification step or function. No Appeal 2020-004325 Application 14/947,326 4 Reply Brief was filed to point out where the Specification as filed provides support for this specific limitation. Appellant relies on “Figs. 2, 3, and 4 and the accompanying description” as providing “extensive discussion of all the claimed concepts.” Id. Our review of the Specification and accompanying drawings leads us to conclude that the Examiner has the better position. Claim 13 requires the provision of a computer that is programmed to receive electromagnetic signal data from sensors, and to identify, from that electromagnetic signal data, signals that are modulated by an ultrasound-induced perturbation in a subject’s anatomy. Appeal Br., Claims Appendix. We interpret this to mean that, from among the electromagnetic signal data that are received from sensors, some subset of the signals are to be identified as having been modulated by the ultrasound-induced perturbation. Otherwise, if the entirety of the signals in the received set of electromagnetic data is exactly the same as the signals that are modulated by the perturbation in every instance, the identifying step would be redundant of the receiving step. Appellant’s Specification includes several mentions of a computer being programmed to receive signal data from sensors, and to identify from that data signals modulated by an ultrasound-induced perturbation, essentially in the same terms as recited in claim 13. See, e.g., Fig. 3; ¶¶ 33, 41, 42, 69; original claim 13. As pointed out by the Examiner, however, the Specification does not appear to provide any disclosure as to what differentiates the signals modulated by the ultrasound-induced perturbation from other signals received in the electromagnetic signal data, in order for the former to be identified from within the latter. Figure 3, as noted by the Examiner, is merely a series of black boxes reciting steps in flowchart form, Appeal 2020-004325 Application 14/947,326 5 including the “identification” step at 306, and the accompanying disclosure parrots the claim language without providing any explanation as to how the steps are accomplished. Ans. 11. Appellant has not identified specific disclosure detailing what is involved in the “identification” of modulated signals, and we are unable to find such disclosure. We regard the Examiner’s reference to the absence of an algorithm by which the claimed computer can be programmed to perform the identification step or function to be founded in the lack of disclosure as to what differentiates the modulated signals from the set of signals, and of any particular technique that might be used by the claimed computer to make such differentiation. Thus, although the Specification and claims as originally filed contain generic language that is substantially identical to the claimed step or function of identifying, from among all received signals, those that are modulated by the perturbation, they fail to evidence that Appellant was in possession of any manner (species) of doing so. cf., Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349 (Fed. Cir. 2010) (en banc) (“[T]he specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus”). The Examiner additionally notes that “one of ordinary skill would not be apprised of how to make or use the invention in light of the referenced portion of the specification,” in terms of how the modulated electromagnetic signals are identified. Ans. 11. This suggests that the rejection could well have been made on the ground that the application as filed fails to meet the enablement standard of § 112(a), as well. The rejection based on lack of Appeal 2020-004325 Application 14/947,326 6 adequate written description is, nonetheless, appropriate based on the record before us. The rejection of claims 13–23 as failing to comply with the written description requirement is sustained. Claims 27 and 28--35 U.S.C. § 112(b)--Indefiniteness Claims 27 and 28, which depend from claim 1, are rejected as being indefinite due to the recitation that the ultrasound energy that induces a perturbation according to claim 1, is “at least a medium-intensity ultrasound energy.” Final Act. 3. The Examiner takes the position that the term is a relative term not defined in the claims, and that the Specification does not provide a standard, such as a statement of upper and lower limits of what constitutes “medium-intensity,” by which a person of ordinary skill in the art could determine what subject matter is encompassed by the term. Id. at 3–4. The Examiner additionally asserts that “medium-intensity ultrasound” does not have a known definition in the art. Id. Appellant cites to the voltage maps illustrated in Figure 6 and paragraph 48 of the application as evidencing that “medium intensity sonification . . . can ‘initiate significant neural activities in response to the tFUS stimulation.’” Appeal Br. 5. Appellant avers that this description would allow a person of ordinary skill in the art to “understand the degree that a ‘medium-intensity ultrasound energy’ entails.” Id. Appellant’s argument appears to be that a determination as to whether the intensity rises to a level to be considered “medium-intensity,” as compared to “low intensity,” is made based on the presence or absence of “significant neural activit[y]” responsive to the stimulation. This amounts to Appeal 2020-004325 Application 14/947,326 7 explaining that the relative term “medium-intensity” is determined by having reference to another relative term, “significant,” which is equally not meaningfully described or defined in the Specification. Indeed, the “butterfly plot” portions of Figure 6, which we understand to represent measured levels of neural activity at so-called low and medium intensities of sonication, do not even employ a scale so as to allow one to have any chance of determining what is significant versus what is not, in terms of neural activity. Appellant’s argument thus does not apprise us of error in the rejection of claims 27 and 28 as being indefinite. The rejection is sustained. Claims 1–6, 8–14, and 17–22--35 U.S.C. § 102(a)(1)--Tyler Appellant presents arguments for independent method claim 1, and, under a separate heading, presents essentially the same arguments for independent system claim 13. See Appeal Br. 6, 10. Appellant does not separately argue any of the rejected dependent claims. We address the arguments advanced for claims 1 and 13 below, and claims 2–6, 8–12, 14, and 17–22 stand or fall with claims 1 and 13. The Examiner finds that Tyler discloses all limitations set forth in claims 1 and 13. Final Act. 4. Appellant contests the findings as to the claim limitations requiring inducing a perturbation to a location in a subject’s anatomy, and using sensors arranged about the subject. Appeal Br. 6. Appellant additionally argues that Tyler teaches away from using sensors arranged about the subject. Id. Appellant maintains that Tyler employs low-intensity, low frequency ultrasound, and has, as a goal, “avoiding any perturbation.” Appeal Br. 7. Appeal 2020-004325 Application 14/947,326 8 In response to the Examiner’s position (see, e.g., Final Act. 10) that Tyler’s use of ultrasound is intended to affect and/or alter neural activity, fitting within the meaning of inducing perturbations, Appellant asserts that claims 1 and 13 require that the inducing of a perturbation must be done in a manner to allow for the identification of electromagnetic signals that are modulated by the perturbation. Appeal Br. 8. Appellant further maintains that Tyler does not teach or suggest identifying affected or altered neural activity, “as electromagnetic signals that are modulated by the perturbation.” Id. Appellant reiterates that Tyler involves the use of low intensity ultrasound to modulate neuronal activity, and “does not consider the implications of ultrasound energy that is not a low-intensity ultrasound energy.” Id. The Examiner responds that paragraph 10 of Tyler explicitly describes that its methods include modulating cellular activity by providing ultrasound waves at an effective intensity and time range to alter the cell activity. Ans. 13–14. The Examiner further notes that claims 1 and 13 do not provide a particular limit as to the intensity of the ultrasound employed. Id. at 13. The Examiner has the better position here. Appellant appears to argue, as we best understand, that its claims require the inducing of a perturbation of a particular magnitude in order to meet the claim limitations that include identifying electromagnetic signals modulated by the perturbation. As suggested by the analysis above regarding the absence of written descriptive support for the identification step or function, there is no indication in Appellant’s Specification as to any particular threshold level of a magnitude of a perturbation. Tyler indicates that it is possible to detect effects on neural activity caused by directing ultrasonic energy into a subject, by electroencephalogram (EEG) and magnetoencephalography Appeal 2020-004325 Application 14/947,326 9 (MEG) techniques. Tyler ¶ 91; Ans. 14. These also happen to be two approaches identified by Appellant as being suitable for use in its method. Spec. ¶ 34. As such, we are not apprised of any shortcomings in Tyler as to the claim limitations involving inducing of a perturbation and sensing and identifying electromagnetic signals resulting from the perturbation. Appellant additionally argues that the claim limitation requiring sensors to be arranged “about the subject” is not met by Tyler, because “Tyler only describes sensors disposed ‘in’ the subject, rather than sensors disposed about the subject.” Appeal Br. 8–9. Appellant relies on an unspecified version of the Merriam-Webster Dictionary as defining “about” as “on or near the person of,” which, according to Appellant, excludes “in” the person. Id. at 9. Appellant cites to paragraph 254 of Tyler as disclosing the use of fine-wire electromyogram (EMG) recordings, which require needles being invasively extended into the subject/person. Id. The Examiner provides a claim construction position to the effect that “about” is inclusive of “in or on,” and therefore does not limit the claim to the use of sensors arranged on the surface of the subject’s skin. Ans. 14. We need not explicitly decide this issue, however, in that the Examiner additionally points out that Tyler does not disclose only the fine-wire EMG technique, but also discloses, as noted above, that EEG and MEG techniques may be used that do not involve insertion of needles, similarly to Appellant’s disclosure of using EEG and MEG. Id. As such, we are not apprised of Examiner error in finding that Tyler discloses the use of sensors arranged about a subject. Appeal 2020-004325 Application 14/947,326 10 Appellant’s “teaching away” argument is not only based on the incorrect premise that Tyler discloses only invasive fine-wire EMG sensing, the rejection is one based on anticipation, to which a teaching away argument is not germane. All told, we are not apprised of error in the Examiner’s rejection of claims 1 and 13 as being anticipated by Tyler. The rejection is sustained as to these claims, as well as to claims 2–6, 8–12, 14, and 17–22, which fall with claims 1 and 13. Claim 7--35 U.S.C. § 103--Tyler/Ko Appellant does not provide any arguments specific to claim 7 or to the proposed combination of the teachings of Ko with Tyler. For the reasons presented above, the rejection is sustained. Claims 15 and 16--35 U.S.C. § 103--Tyler/John Appellant does not provide any arguments specific to claims 15 and 16 or to the proposed combination of the teachings of John with Tyler. For the reasons presented above, the rejection is sustained. Claim 23--35 U.S.C. § 103--Tyler/Zeien Appellant does not provide any arguments specific to claim 23 or to the proposed combination of the teachings of Zeien with Tyler. For the reasons presented above, the rejection is sustained. Appeal 2020-004325 Application 14/947,326 11 Claims 27 and 28--35 U.S.C. § 103--Tyler/Mishelevich Having determined, supra, that claims 27 and 28 are indefinite, we cannot sustain the rejection of these claims under 35 U.S.C. § 103, because to do so would require speculation as to the scope of the claims. See In re Aoyama, 656 F.3d 1293, 1300 (Fed. Cir. 2011) (holding that the Board erred in affirming an anticipation rejection of indefinite claims); 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). It should be understood that our decision in this regard is based solely on 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. NEW GROUND OF REJECTION--37 C.F.R. § 41.50(b) Claims 1–12, 27, and 28--35 U.S.C. § 112(a)--Written Description Independent claim 1 includes the step of “identifying electromagnetic signals that are modulated by the perturbation,” in a manner similar to the recitation in independent claim 13 of a computer being programmed to “identify, from the electromagnetic signal data, signals modulated by the perturbation.” For the reasons discussed above in affirming the written description rejection of claim 13, claim 1 and claims 2–12, 27, and 28 depending therefrom, are rejected as failing to comply with the written description requirement of 35 U.S.C. § 112(a). DECISION The rejection of claims 13–23 under 35 U.S.C. § 112(a) as failing to comply with the written description requirement is affirmed. Appeal 2020-004325 Application 14/947,326 12 The rejection of claims 27 and 28 under 35 U.S.C. § 112(b) as being indefinite is affirmed. The rejection of claims 1–6, 8–14, and 17–22 under 35 U.S.C. § 102(a)(1) as being anticipated by Tyler is affirmed. The rejection of claim 7 under 35 U.S.C. § 103 as being unpatentable over Tyler in view of Ko is affirmed. The rejection of claims 15 and 16 under 35 U.S.C. § 103 as being unpatentable over Tyler in view of John is affirmed. The rejection of claim 23 under 35 U.S.C. § 103 as being unpatentable over Tyler in view of Zeien is affirmed. The rejection of claims 27 and 28 under 35 U.S.C. § 103 as being unpatentable over Tyler in view of Mishelevich is reversed, pro forma. Claims 1–12, 27, and 28 are rejected, in a NEW GROUND OF REJECTION, under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/ Basis Affirmed Reversed New Ground 13–23 112(a) Written Description 13–23 1–12, 27, 28 27, 28 112(b) Indefiniteness 27, 28 1–6, 8– 14, 17–22 102(a)(1) Tyler 1–6, 8–14, 17–22 7 103 Tyler, Ko 7 15, 16 103 Tyler, John 15, 16 23 103 Tyler, Zeien 23 Appeal 2020-004325 Application 14/947,326 13 27, 28 103 Tyler, Mishelevich 27, 28 Overall Outcome 1–23, 27, 28 1–12, 27, 28 This decision contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b). Section 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” Section 41.50(b) also provides: When the Board enters such a non-final decision, 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 both, and have the matter reconsidered by the examiner, in which event the prosecution will be remanded to the examiner. The new ground of rejection is binding upon the examiner unless an amendment or new Evidence not previously of Record is made which, in the opinion of the examiner, overcomes the new ground of rejection designated in the decision. Should the examiner reject the claims, appellant may again appeal to the Board pursuant to this subpart. (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same Record. The request for rehearing must address any new ground of rejection and state with particularity the points believed to have been misapprehended or overlooked in entering the new ground of rejection and also state all other grounds upon which rehearing is sought. Further guidance on responding to a new ground of rejection can be found in the Manual of Patent Examining Procedure § 1214.01. Appeal 2020-004325 Application 14/947,326 14 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED; 37 C.F.R. § 41.50(b) Copy with citationCopy as parenthetical citation