LifeLens Technologies, LLCDownload PDFPatent Trials and Appeals BoardFeb 25, 20222021003191 (P.T.A.B. Feb. 25, 2022) 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. 14/815,251 07/31/2015 Landy Toth 1156-2 CIP 5654 31825 7590 02/25/2022 RYAN, MASON & LEWIS, LLP 48 South Service Road Suite 100 Melville, NY 11747 EXAMINER ARCHER, MARIE ART UNIT PAPER NUMBER 1631 NOTIFICATION DATE DELIVERY MODE 02/25/2022 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): jbr@rml-law.com nyoffice@rml-law.com wel@rml-law.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte LANDY TOTH and ROBERT SCHWARTZ Appeal 2021-003191 Application 14/815,251 Technology Center 1600 BEFORE DONALD E. ADAMS, ERIC B. GRIMES, and JOHN E. SCHNEIDER, Administrative Patent Judges. SCHNEIDER, 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, 2, 4-9, and 12-33. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as LifeLens Technologies, LLC. Appeal Br. 1. Appeal 2021-003191 Application 14/815,251 2 CLAIMED SUBJECT MATTER The claims are directed to systems and methods for reliable measurement of one or more physiologic parameters of a subject. Spec. ¶ 2. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A patch interface, comprising: a substrate with a surface; an adhesive coupled to the substrate, the adhesive being formulated for attachment to the skin of a subject; an interconnect embedded into or coupled to the substrate, the interconnect being configured for attachment of the patch interface to a microcircuit; and a plurality of microelectrodes attached to or embedded into the surface of the substrate and electrically coupled with the microcircuit via the interconnect; and one or more macroelectrodes electrically coupled with the microcircuit via the interconnect; wherein the patch interface is configured to monitor neural activity from the skin of the subject; wherein the microcircuit comprises two or more processing banks, a first one of the two or more processing banks being coupled to: at least a first one of the one or more macroelectrodes; and a first subset of the plurality of microelectrodes; wherein the first processing bank comprises a first preamplifier bank and a first switch bank, the first switch bank being configured to selectively connect one or more of the microelectrodes in the first subset of the plurality of microelectrodes and the first macroelectrode to the first preamplifier bank, the first preamplifier bank comprising one or more conditioning circuits configured to utilize signals measured by the first macroelectrode to remove at least one of one or more stretch artifacts and one or more movement artifacts from signals measured by the connected one or more microelectrodes in the first subset of the plurality of microelectrodes; and Appeal 2021-003191 Application 14/815,251 3 wherein the signals measured by the first macroelectrode comprise macroelectrophysiological signals from the subject and the signals measured by the connected one or more microelectrodes comprise neural activity signals from the subject. REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Sessions US 3,805,769 Apr. 23, 1974 Hamilton et al. US 5,978,693 Nov. 2, 1999 Del Mar US 6,605,046 B1 Aug. 12, 2003 John et al. US 2005/0043775 A1 Feb. 24, 2005 Van Herk US 2009/0118790 A1 May 7, 2009 Fahey US 2010/0004715 A1 Jan. 7, 2010 Ghaffari et al. US 2010/0298895 A1 Nov. 25, 2010 Jehan WO 97/20549 June 12, 1997 REJECTIONS The Examiner has rejected the claims as follows: Claims 1, 2, 4-9, and 12-33 have been rejected under 35 U.S.C. § 112(a) for failure to comply with the written description requirement. Claims 1, 2, 4-9, and 12-33 have been rejected under 35 U.S.C. § 112(b) as indefinite. Claims 1, 2, 4-9, 12-17, 21, 26, and 27 have been rejected under 35 U.S.C. § 103 as unpatentable over Van Herk in view of John and Hamilton. Claims 18, 19, and 28 have been rejected under 35 U.S.C. § 103 as unpatentable over Van Herk in view of John, Hamilton, and Fahey. Appeal 2021-003191 Application 14/815,251 4 Claims 20, 23, and 24 have been rejected under 35 U.S.C. § 103 as unpatentable over Van Herk in view of John, Hamilton, and Ghaffari. Claim 22 has been rejected under 35 U.S.C. § 103 as unpatentable over Van Herk in view of John, Hamilton, and Sessions. Claim 25 has been rejected under 35 U.S.C. § 103 as unpatentable over Van Herk in view of John, Hamilton, and Jehan. Claims 29 and 30 have been rejected under 35 U.S.C. § 103 as unpatentable over Van Herk in view of John, Hamilton, and Del Mar. OPINION Written Description The issue before us is whether the Examiner properly concluded that the claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the art that the inventor had, at the time of the invention, possession of the claimed invention. Means-Plus-Function Before we can resolve the issue of whether the written description requirement has been satisfied, we must first address whether the Examiner properly concluded that the term “conditioning circuit configured to use signals” should be construed to be a mean-plus-function term.2 The Examiner finds the term “conditioning circuit configured to utilize signals” to be a generic place holder coupled with functional language 2 Appellant contends that the Examiner has improperly construed several other terms as mean-plus-function terms. See Appeal Br. 6. As those terms are not at issue in this Appeal, we need not address whether the terms should be construed as means-plus-function terms. Appeal 2021-003191 Application 14/815,251 5 without reciting significant structure to perform the recited function. Non- Final Act. 4-5. Appellant traverses the Examiner’s interpretation of the term as a mean-plus-function limitation but does not offer any argument or explanation why the Examiner’s interpretation is in error. Appeal Br. 6. We agree with the Examiner that the term “conditioning circuit configure to utilize signals” should be construed to be a mean-plus-function limitation. As the Examiner points out, while the absence of the term “means” creates a rebuttable presumption that the claim term should not be interpreted as a “means-plus-function” limitation, the presumption can be overcome if the claim recites a function “without reciting sufficient structure, material or acts to entirely perform the recited function.” Non- Final Act. 4; see MPEP § 2181. We agree with the Examiner’s finding that The “conditioning circuit” in claims 1, 26 and 31 is recited as comprised in a microcircuit. The microcircuit is disclosed as including at least a processor (see specification at paragraph 294). As such, the broadest most reasonable interpretation of the “conditioning circuit” in claims 1, 26 and 31 is that it includes a general purpose processor for performing a specialized function (utilize signals measured by the first macroelectrode to remove at least one of one or more stretch artifacts and one or more movement artifacts from signals measured by the connected one or more microelectrodes) and therefore, is interpreted under 35 U.S.C[.] 112(f) as including computer-implemented means-plus function limitations. Non-Final Act. 5-6. Appeal 2021-003191 Application 14/815,251 6 Written Description Having determined that the term “conditioning circuit” is a means- plus-function limitation, we now turn to the issue of whether there is sufficient support for the term in the Specification. The Examiner states MPEP section 2181 (II)(B) sets forth that for a computer- implemented means-plus-function claim limitation invoking 35 U.S.C. 112(f) or pre-AIA[ ]35 U.S.C. 112, sixth paragraph, a general purpose computer is usually only sufficient as the corresponding structure for performing a general computing function (e.g., “means for storing data”), but the corresponding structure for performing a specific function is required to be more than simply a general purpose computer or microprocessor. Non-Final Act. 6. The Examiner goes on to find that in the present application, the computer-implemented function must include an algorithm which transformed the general purpose computer or processor. Id. The Examiner finds the present Specification fails to disclose an algorithm which transforms a general purpose processor into a special purpose computer programmed to perform the claimed function. Id. at 9. Appellant contends that even if the term “conditioning circuit” were interpreted as a means-plus-function limitation involving a general purpose computer, the Specification, including the drawings, provides the necessary “algorithm.” Appeal Br. 6-11. Appellant points to Figures 20j, 21, and 30 as well as Paragraphs 401, 515, 518, 519, 521, 523, 531, 532, 537, and 574 as presenting algorithms that transform a generic microprocessor into a special purpose computer. Id. Appeal 2021-003191 Application 14/815,251 7 We have considered the arguments presented by the Examiner and Appellant as well as the drawings and paragraphs cited by Appellant and find the Examiner has the better position. While the sections of the Specification cited by Appellant disclose how the data is acquired by the processor and what the expected result is, we discern nothing in the Specification to show how the processor manipulates the data to achieve the desired results. For example, Figure 30 and accompanying paragraph 574 disclose how to distinguish between a physiological signal and an artifact, but Appellant does not point to nor do we discern any disclosure as to how the conditioning circuit removes the artifact from the physiological signal. See Spec. ¶ 574. Based on the foregoing we affirm the rejection under 35 U.S.C. § 112(a) for lack of adequate written description. Indefiniteness The issue before us in whether the Examiner properly concluded that the claims fail to particularly point out and distinctly claim the subject matter the inventors regards as their invention. The Examiner finds the term “conditioning circuit configured to utilize signals” to be indefinite for essentially the same reasons stated above with respect to the rejection for failure to comply with the written description requirement. Non-Final Act. 9-10. Appellant presents essentially the same arguments as Appellant presented with respect to the written description rejection. Appeal Br. 11-12. For the reasons stated above, we affirm the rejection for indefiniteness. Appeal 2021-003191 Application 14/815,251 8 Obviousness Based on Van Herk, John, and Hamilton The issue with respect to this rejection is whether a preponderance of the evidence supports the Examiner’s conclusion that the subject matter of claims 1, 2, 4-9, 12-17, 21, 26, and 27 would have been obvious to one of ordinary skill in the art at the time the invention was made over Van Herk combined with John and Hamilton. The Examiner finds Van Herk teaches all of the elements of the claims with the exception of “an adhesive coupled to the substrate, the adhesive being formulated for attachment to the skin of a subject” and conditioning circuits that are “configured to utilize signals measured by the first microelectrode to remove at least one of one or more stretch artifacts and one or more movement artifacts from signals measured by the connected one or more microelectrodes in the first subset of the plurality of microelectrodes.” Non-Final Act. 13-16. With respect to the limitation calling for “an adhesive coupled to the substrate, the adhesive being formulated for attachment to the skin of a subject” the Examiner finds this limitation is taught by John. Id. at 15. The Examiner finds John teaches the use of an adhesion layer constructed for contact with the skin. Id. The Examiner finds It would have been prima facie obvious to one with ordinary skill in the art before the effective filling date of the claimed invention to modify the electrode system by Van Herk with an[] adhesive for attachment to the skin of a subject as taught by John. One would have been motivated to do so and had a reasonable expectation of success in doing so because all elements were known in the prior art and John teaches that electrode arrays for placement on the skin can be modified with an adhesive (John at ¶ 77). The skilled artisan would recognize that this modification would facilitate the electrodes and the Appeal 2021-003191 Application 14/815,251 9 counter electrode to make electrical contact with the skin which is Van Herk’s objective (Van Herk at ¶ 33). Id. at 16. Turning to the conditioning circuit, the Examiner finds Hamilton teaches a patient monitoring system which uses the electrode assemblies to remove motion artifacts from a contaminated signal received from the electrodes which arises from skin deformation. Id. The Examiner finds It would have been prima facie obvious to one with ordinary skill in the art before the effective filling date of the claimed invention to have combined the teachings of Van Herk with Hamilton. One would have been motivated to do so and had a reasonable expectation of success in doing so because it is known in the art that motion artifact resulting from electrode and patient movement is a significant source of noise in making physiological recordings such as electromyograms (EMG) which results in a contaminated signal being received from the electrode, and is particularly a problem in cases where it is necessary to make such recordings while the patient is engaged in activity (Hamilton at col. 1, lines 15-20). The skilled artisan would recognize that Van Herk is directed to measuring EMG signals during the performance of a physical activity (Van Herk at ¶ 48) and modifying Van Herk with Hamilton’s teachings would prevent the acquisition of contaminated signals. Id. at 17. Appellant contends The cited portions of Hamilton, and Van Herk, John and Hamilton generally, do not disclose a preamplifier bank which comprises one or more conditioning circuits configured to utilize signals measured by a first macroelectrode to remove at least one of one or more stretch artifacts and one or more movement artifacts from signals measured by connected one or more microelectrodes in a first subset of a plurality of microelectrodes, where the signals measured by the first Appeal 2021-003191 Application 14/815,251 10 macroelectrode comprise macro-electrophysiological signals from a subject and the signals measured by the connected one or more microelectrodes comprise neural activity signals from the subject. Appeal Br. 15. Appellant goes on to contend that Hamilton is silent about measuring neural activity but is instead directed to measuring macrophysiological signals. Id. Appellant contends that Van Herk and John are similarly deficient. Id. We have considered the arguments presented by the Examiner and Appellant and conclude that the Examiner has not demonstrated that the subject matter of claim 1 and its dependent claims would have been obvious over Van Herk combined with John and Hamilton, but that the Examiner has shown that the subject matter of claims 26 and 27 would have been obvious over Van Herk combined with John and Hamilton. As Appellant points out, claim 1 calls for the patch interface to monitor neural activity of the skin. Appeal Br. 15. The Examiner relies on Van Herk as teaching this claim element. Non-Final Act. 14. Van Herk, however, teaches measuring muscle activity such as an electromyogram (“EMG”) measurement. See Van Herk ¶ 38. As the present Specification makes clear, measuring muscle activity is distinct from measuring neural activity. See Spec. ¶ 193 (“Some non-limiting examples of such sensors include electrophysiological sensors (e.g. EKG, EMG, . . . ), temperature sensor . . . , neural activity (e.g. skin sympathetic activity).”). The Examiner does not point to nor do we discern any teaching in Van Herk or in John or Hamilton, of measuring neural activity. See, e.g., Hamilton, col. 9, ll. 41-52. Thus, the combination of references fails to teach all of the elements of claim 1. Appeal 2021-003191 Application 14/815,251 11 The analysis of claim 26 yields a different result. Claim 26 calls for a module configured to monitor one or more of “physiologic signals, physical signals, skin based neural activity, and electrophysiological signals from the subject.” Appeal Br. 27 (Claims Appx.). The present Specification teaches that an EMG detects an electrophysiological signal. Spec. ¶ 193. Van Herk teaches using an EMG measurement, thus Van Herk teaches this claim limitation. Van Herk ¶ 38. Based on the foregoing we conclude that a preponderance of the evidence does not support the Examiner’s conclusion that the subject matter of claims 1, 2, 4-9, 12-17, and 21 would have been obvious over Van Herk combined with John and Hamilton. We also conclude that a preponderance of the evidence does support the conclusion that the subject matter of claims 26 and 27 would have been obvious over Van Herk combined with John and Hamilton. Obviousness Based on Van Herk, John, Hamilton, and Fahey. In response to this rejection, Appellant argues that Fahey does not remedy the deficiencies of Van Herk, John, and Hamilton. Appeal Br. 17. The Examiner does not offer any additional argument to support the finding of obviousness. See Ans. 42-43. Claims 18 and 19 depend from claim 1. For the reasons stated above, we reverse the rejection of these claims. Claim 28 depends from claim 26. For the reasons stated above, we affirm this rejection as it applies to claim 28. Appeal 2021-003191 Application 14/815,251 12 Obviousness Based on Van Herk, John, Hamilton, and Ghaffari, Sessions or Jehan In response to each of these rejections, Appellant has argued that the additional references do not remedy the deficiencies of Van Herk, John or Hamilton. Appeal Br. 17. The Examiner does not offer any additional arguments to address the deficiencies of Van Herk, John or Hamilton with respect to measuring neural activity. Ans. 43-44. All of the claims at issue in the rejections depend from claim 1. For the reasons stated above, we reverse these rejections. Obviousness based on Van Herk, John, Hamilton, and Del Mar Claims 29 and 30 have been rejected as obvious over Van Herk, John, Hamilton, and Del Mar. Claim 29 depends from claim 26 and adds the limitation that the module is hermetically sealed. Appeal Br. 28. Claim 30 also depends from claim 26 and adds the limitation that the module further comprises a gasket “shaped to isolate a region formed by the module interconnect and the patch interface from a surrounding environment when the module is coupled with the patch interface.” Id. The Examiner reiterates the findings with respect to the teaching of Van Herk, John, and Hamilton. Non-Final Act. 25. The Examiner finds that Van Herk, John, and Hamilton do not teach the additional limitations of claims 29 and 30. Id. The Examiner finds Del Mar teaches an EMG monitoring system where the hardware and firmware components are “totally encapsulated in the environmentally sealed and water proofed monitor-housing.” Id. The Examiner finds Del Mar teaches a monitor housing consisting of Appeal 2021-003191 Application 14/815,251 13 a plastic molded, rectangular base 74 covered by a plastic molded lid 76 and is sealed to the base via a rubber grommet 80 that circumvents the periphery of lid 76. Input/output interface 64 is configured to snugly fit within a cutout 82 of base 74, and is environmentally sealed watertight by an input interface seal 84 circumventing the periphery of interface 64 and attached to the inside wall of base 74. The plastic or hard rubber input/output interface 64 is configured with four cylindrical, sealed, “male contact” receptacles, input receptacles 66, 68, 70, and 72 for insertion therein of four cylindrical “female” electrical input contacts 67, 69, 71, and 73 for leads 32, 34, 36, and 38, respectively, illustrated in FIG. 2. All electronic components contained within housing 22 are assembled on a first and second dual sided and parallel printed circuit boards (PCB) 86 and are configured to fit snugly within housing 22 base 74 and is environmentally enclosed therein by lid 76 and seal 80 (col. 7 lines 35-65, col. 8 lines 10-20; Figures 1, 4-6). Id. at 25-26. The Examiner concludes It would have been prima facie obvious to one with ordinary skill in the art before the effective filling dat[e] of the invention to have combined the teachings of Van Herk with Del Mar. One would have been motivated to do so and had a reasonable expectation of success in doing so because all elements were known in the prior art and Del Mar teaches that systems for monitoring EMG comprising a module can be modified with a hermetically sealed housing and electrode interface connection (Del Mar, Figures 4-6). The skilled artisan would also recognize that an [sic] hermetically sealed ho[u]sing would prevent the electronic components from degrading due to environmental exposure. Id. at 26. With respect to claim 29, Appellant contends that while Del Mar teaches the module is “environmentally sealed and water proofed”, Del Mar does not teach a hermetic seal. Appeal Br. 20. Appeal 2021-003191 Application 14/815,251 14 With respect to claim 30, Appellant contends the rubber grommet of Del Mar is not equivalent to the recited gasket. Id. Appellant argues the grommet of Del Mar is used to seal the lid to the base of the module which is not the same as isolating the region formed by the module interconnect and the patch interface. Id. at 21. We have considered the arguments presented by the Examiner and Appellant and find the Examiner has the better position. With respect to claim 29, Del Mar teaches “[a]ll the hardware and firmware components of the recording elements of the monitor, excepting, of course, electrodes and electrical leads are totally encapsulated in the environmentally sealed and water proofed monitor-housing.” Del Mar, col. 7, ll. 37-41. The present Specification teaches “In such usage cases, the module may be hermetically sealed, such that fluid ingress into the module is limited.” Spec. ¶ 299. We agree with the Examiner that Del Mar’s teaching that the module is environmentally sealed and water proofed is the same as a hermetic seal as the term is used in the present claims. See Ans. 45-46. Turning to claim 30, we agree with the Examiner that Del Mar teaches the limitation calling for a gasket shaped to isolate the region formed by the module interconnect and the patch interface. Ans. 46. As the Examiner points out, Del Mar teaches a gasket (Figure 4, interface seal 84) shaped to isolate a region formed by the module interconnect and the patch (Figure 4, interface seal 84 circumvents the periphery of plastic input/output interface 64 which includes sealed contacts for connecting patch electrodes). Del Mar teaches that upon assembly, the PCB leads (92, 94) couple the PCB 88 to the input/output interface 64 (col. 8, lines 10-15). As Appeal 2021-003191 Application 14/815,251 15 such, the gasket (interface seal 84) is coupled to the circuit board (PCB 88). Id. Based on the foregoing we affirm the rejection of claims 29 and 30. CONCLUSION The rejection of claims 1, 2, 4-9, and 12-33 under 35 U.S.C. § 112(a) for failure to comply with the written description requirement is affirmed. The rejection of claims 1, 2, 4-9, and 12-33 under 35 U.S.C. § 112(b) as indefinite is affirmed. The rejection of claims 1, 2, 4-9, 12-17, and 21 under 35 U.S.C. § 103 as unpatentable over Van Herk in view of John and Hamilton is reversed; however, the rejection of claims 26 and 27 is affirmed. The rejection of claims 18 and 19 under 35 U.S.C. § 103 as unpatentable over Van Herk in view of John, Hamilton, and Fahey is reversed; however, the rejection of claim 28 is affirmed. The rejection of claims 20, 23, and 24 under 35 U.S.C. § 103 as unpatentable over Van Herk in view of John, Hamilton, and Ghaffari is reversed. The rejection of claim 22 under 35 U.S.C. § 103 as unpatentable over Van Herk in view of John, Hamilton, and Sessions is reversed. The rejection of claim 25 under 35 U.S.C. § 103 as unpatentable over Van Herk in view of John, Hamilton, and Jehan is reversed. The rejection of claims 29 and 30 under 35 U.S.C. § 103 as unpatentable over Van Herk in view of John, Hamilton, and Del Mar is affirmed. Appeal 2021-003191 Application 14/815,251 16 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 2, 4-9, 12-33 112(a) Written Description 1, 2, 4-9, 12-33 1, 2, 4-9, 12-33 112(b) Indefiniteness 1, 2, 4-9, 12-33 1, 2, 4-9, 12-17, 21, 26, 27 103 Van Herk, John, Hamilton 26, 27 1, 2, 4-9, 12-17, 21 18, 19, 28 103 Van Herk, John, Hamilton, Fahey 28 18, 19 20, 23, 24 103 Van Herk, John, Hamilton, Ghaffari 20, 23, 24 22 103 Van Herk, John, Hamilton, Sessions 22 25 103 Van Herk, John, Hamilton, Jehan 25 29, 30 103 Van Herk, John, Hamilton, Del Mar 29, 30 Overall Outcome 1, 2, 4-9, 12-33 TIME PERIOD FOR RESPONSE 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). AFFIRMED Copy with citationCopy as parenthetical citation