Palo Alto Research Center Incorporated

Patent Trials and Appeals Board

Mar 3, 2022

2021001536 (P.T.A.B. Mar. 3, 2022)

UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 14/984,719 12/30/2015 Michael I. Recht 20150179US01/0600.178US01 1004 99064 7590 03/03/2022 MRG/HD - PARC c/o Mueting Raasch Group 111 Washington Ave. S., Suite 700 Minneapolis, MN 55401 EXAMINER HURST, JONATHAN M ART UNIT PAPER NUMBER 1799 NOTIFICATION DATE DELIVERY MODE 03/03/2022 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): ptodocketing@mrgs.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte MICHAEL I. RECHT, JOERG MARTINI, and PETER KIESEL ____________ Appeal 2021-001536 Application 14/984,719 Technology Center 1700 ____________ Before ADRIENE LEPIANE HANLON, CHRISTOPHER C. KENNEDY, and JANE E. INGLESE, Administrative Patent Judges. INGLESE, Administrative Patent Judge. DECISION ON APPEAL The Appellant1 requests review under 35 U.S.C. § 134(a) of the Examiner’s non-final rejection of claims 1-20.2 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM IN PART. 1 “Appellant” refers to the “applicant” as defined in 37 C.F.R. § 1.42 (2022). The Appellant identifies the real party in interest as Palo Alto Research Center Incorporated. Appeal Brief filed July 28, 2020 (“Appeal Br.”), 3. 2 Non-Final Office Action entered February 13, 2020 (“Non-Final Act.”), 1. Appeal 2021-001536 Application 14/984,719 2 CLAIMED SUBJECT MATTER Claim 1 illustrates the subject matter on appeal, and reads as follows: 1. A device comprising: a test vessel comprising a base material of low heat conductivity material and having one or more test locations, each test location being thermally isolated from transferring heat into the test vessel and configured to contain a medium suitable for culturing a live substance; and a thermochromic material thermally coupled to the one or more test locations, the thermochromic material configured to exhibit a spectral shift in light emanating from the thermochromic material in response to a sub-Kelvin change in temperature of the thermochromic material. Appeal Br. 13 (Claims Appendix) (emphasis added). REJECTIONS The Examiner maintains the following rejections in the Examiner’s Answer entered November 19, 2020 (“Ans.”): I. claims 1-20 under 35 U.S.C. § 112(a) as failing to comply with the written description requirement; and II. claims 1-20 under 35 U.S.C. § 103 as unpatentable over Tipgunlakant3 in view of Bedingham4 and Coates.5 FACTUAL FINDINGS AND ANALYSIS Upon consideration of the evidence relied upon in this appeal and each of the Appellant’s contentions, we affirm the Examiner’s rejection of claims 1-10 and 12-20 under 35 U.S.C. § 103 for reasons set forth in the 3 Tipgunlakant et al., US 2014/0273191 A1; Sept. 18, 2014. 4 Bedingham et al., US 2002/00447003 A1; Apr. 25, 2002. 5 Coates et al., US 2003/0052305 A1; Mar. 20, 2003. Appeal 2021-001536 Application 14/984,719 3 Non-Final Action, the Answer, and below, and we reverse the Examiner’s rejection of claims 1-20 under 35 U.S.C. § 112(a), and rejection of claim 11 under 35 U.S.C. § 103, for reasons set forth in the Appeal and Reply Briefs, and below. We review appealed rejections for reversible error based on the arguments and evidence the Appellant provides for each issue the Appellant identifies. 37 C.F.R. § 41.37(c)(1)(iv) (2022); Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential) (cited with approval in In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011) (explaining that even if the Examiner had failed to make a prima facie case, “it has long been the Board’s practice to require an applicant to identify the alleged error in the examiner’s rejections”)). Rejection I We turn first to the Examiner’s rejection of claims 1-20 under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. Independent claims 1, 15, and 18 recite a device or kit comprising, in part, a test vessel having one or more test locations that are configured to contain a medium suitable for culturing a live substance, and are each “thermally isolated from transferring heat into the test vessel.” The Examiner finds that the Specification does not provide written description support for “each test location being thermally isolated from transferring heat into the test vessel,” as recited in each of independent claims 1, 15, and 18. Non-Final Act. 3. The Examiner finds that the Specification includes only “one reference to thermal isolation,” which states that “the heat generated by metabolism is isolated from transfer into Appeal 2021-001536 Application 14/984,719 4 the vessel.” Id. The Examiner finds that although “this does teach heat generated by metabolism is isolated from the test vessel[,] this does not teach that the test locations are thermally isolated from the rest of the vessel.” Id. According to the Examiner, “heat generated by metabolism may [] be isolated from transfer into the vessel[,] while the test location which hold[s] medium may not be so isolated.” Id. As the Appellant argues (Appeal Br. 8-9), however, the disclosures of the Appellant’s Specification as a whole reasonably would convey to one of ordinary skill in the art that the Appellant was in possession of the subject matter at issue at the time the present application was filed. Specifically, the Specification discloses that the Appellant’s invention relates to a device used to detect and/or monitor the growth of live substances, such as cells, to determine, for example, the efficacy of anti- microbial, anti-viral, and/or anti-fungal pharmaceutical agents against such cells. Spec. 4, l. 27-5, l. 24; see also Appeal Br. 5. The Specification explains that the device includes a thermochromic material that optically indicates a temperature increase caused by growth of cells being cultured in the vessel due to energy conversion by the cells, such as when the cells convert chemical energy to heat. Spec. 4, l. 37-5, l. 12. The Specification explains that such a temperature increase in the cells causes a temperature increase in material surrounding the cells, including the growth medium in which the cells are cultured, the material in which the growth medium is contained (the wells or “test locations” in the test vessel), and the thermochromic material. Id. The Specification indicates that the amount of heat transfer from one material to the next “is dominated by material properties,” and the Specification explains that, “[t]herefore, it is possible to Appeal 2021-001536 Application 14/984,719 5 control the heat transfer by material choice” such as by isolating the heat generated by metabolism from transfer into the test vessel material and instead thermally connecting or coupling the heat to the thermochromic material. Spec. 5, ll. 12-16. The Specification describes thermally coupling the thermochromic material to the test locations-or test wells-of the test vessel, such as by disposing a layer or coating of the thermochromic material along the walls and bottom of each individual test well (“test location”). Spec. 7, ll. 16-18; 8, ll. 19-21. The Specification further describes thermally coupling the thermochromic material to one or both of the medium and the live substance (cells) contained within the test wells (“test locations”), and the Specification explains that the thermochromic material “is positioned to be sufficiently close and thermally coupled to the live substance [] so as to be sensitive to changes in temperature due to energy conversion of the live substance.” Spec. 7, ll. 18-25 (reference numerals omitted). The Specification discloses that “energy conversion of the live substance results in a temperature increase of the thermochromic material at the test location. These temperature increases are sub-Kelvin, and may be less than about 1 milliKelvin (mK). . . [and] depend on a variety of factors,” including “thermal insulation of [the] test volume.” Spec. 10, ll. 14-18. To this end, the Specification describes thermally insulating the test volume (culture medium) in the test wells (test location) by disposing a heat insulation layer between the thermochromic material and the “base material of the test vessel structure,” which, the Specification explains, “can enhance sensitivity of the thermochromic sensing due to reduced heat conductivity Appeal 2021-001536 Application 14/984,719 6 from the thermochromic material.” Spec. 12, ll. 23-27; see also Spec. 14, ll. 12-15 (“[t]he heat insulating layer can be designed to enhance sensitivity of the thermochromic sensing due to the reduced heat transfer from the test location 401 to the sacrificial material of the test vessel 400 or the surrounding”); Spec. 15, l. 23-16, l. 8 (describing a process for making a thermochromic test vessel by disposing a thermal insulation layer on the test wells (test locations) before disposing the thermochromic material at the test locations). Contrary to the Examiner’s findings, when considered together, these disclosures in the Appellant’s Specification reasonably would indicate to one of ordinary skill in the art that the Appellant was in possession at the time of filing of a test vessel including test locations (test wells) in which heat generated by cells contained in a medium within the test locations is isolated from transfer into the test vessel, and in which the test locations themselves are thermally isolated from transferring heat into the test vessel, as recited in independent claims 1, 15, and 18. In re Kaslow, 707 F.2d 1366, 1375 (Fed. Cir. 1983) (citations omitted) (explaining that the test for determining compliance with the written description requirement is whether the disclosure of the application as originally filed reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter, rather than the presence or absence of literal support in the specification for the claim language). We, accordingly, reverse the Examiner’s rejection of claims 1-20 as failing to comply with the written description requirement. Appeal 2021-001536 Application 14/984,719 7 Rejection II Claims 1-10 and 12-20 We turn now to the Examiner’s rejection of claims 1-10 and 12-20 under 35 U.S.C. § 103 as unpatentable over Tipgunlakant in view of Bedingham and Coates. To address this rejection, the Appellant presents arguments directed to independent claims 1, 15, and 18, which the Appellant argues together. Appeal Br. 9-11. We, therefore, select claim 1 as representative, and limit our discussion accordingly. 37 C.F.R. § 41.37(c)(1)(iv) (2022). The Appellant argues that “[n]one of the asserted references has been shown to teach, or suggest, 1) a vessel comprising low heat conductivity material, and 2) that each test location is thermally isolated from transferring heat into the vessel.” Appeal Br. 9. The Appellant argues that although Tipgunlakant discloses forming a microplate (test vessel) of “some type of polymer or plastic,” Tipgunlakant does not disclose, and would not have suggested, “that such polymer or plastic would be low heat conductivity material.” Id. The Appellant argues that Tipgunlakant actually would have suggested otherwise because although Tipgunlakant discloses thermally controlling a microplate from within the microplate, Tipgunlakant discloses using means outside the microplate wells for thermal control of the wells, such as thermoelectric devices, fluidics, and/or a cap. Id. at 9-10 (citing Tipgunlakant ¶¶ 192-199). The Appellant argues that, therefore, “Tipgunlakant would utilize a test vessel comprising high heat conductivity material to more efficiently, externally adjust the well temperatures,” and use of a “low heat conductivity material for the microplate would undermine Tipgunlakant’s external thermal control.” Id. at 10. The Appellant argues Appeal 2021-001536 Application 14/984,719 8 that Tipgunlakant’s disclosure of external thermal control of microplate wells also “demonstrates that each of Tipgunlakant’s microplate wells is not thermally isolated.” Id. The Appellant’s arguments do not identify reversible error in the Examiner’s rejection, for reasons that follow. We point out initially, as the Examiner finds (Ans. 5), that one of ordinary skill in the art would have understood polymers and plastics as disclosed in Tipgunlakant to be low heat conductivity materials, and we find no objective evidence to the contrary on the record before us. In re Paulsen, 30 F.3d 1475, 1480, 31 USPQ2d 1671, 1675 (Fed. Cir. 1994) (“[A] prior art reference must be ‘considered together with the knowledge of one of ordinary skill in the pertinent art.’”) (quoting In re Samour, 571 F.2d 559, 562 (CCPA 1978)). Therefore, contrary to the Appellant’s arguments, one of ordinary skill in the art reasonably would have understood Tipgunlakant’s microplate (test vessel) to be formed of a low heat conductivity material. Furthermore, Tipgunlakant discloses that the microplate described in the reference includes numerous cell culture wells, and Tipgunlakant indicates that “[v]arious methods can be used to control the temperature of group[s] of cell culture wells and individual cell culture wells,” through control of the temperature of the “gas environment” surrounding the wells, the temperature of culture media in the wells, the temperature of the individual well walls, and the temperature of the microplate material. Tipgunlakant ¶¶ 112, 192- 197; Fig. 1. Tipgunlakant discloses that such temperature control can be accomplished using, “controlled thermoelectric devices (providing cooling and/or heating),” “electrical resistive heating elements,” and “fluidic heating and cooling methods employing associated fluidics throughout a Appeal 2021-001536 Application 14/984,719 9 microplate.” Id. ¶¶ 198, 199. Tipgunlakant’s description of temperature control is not limited to this disclosure, however, as the Appellant’s arguments imply. Rather, Tipgunlakant goes on to explain that “[h]igher precision in temperature control can be obtained by employing thermal insulation among wells, on microplate surfaces, etc.” Id. ¶ 200. Contrary to the Appellant’s arguments, Tipgunlakant thus explicitly discloses using thermal insulation among cell culture wells and on the microplate surfaces to provide high precision temperature control of individual cell culture wells and groups of cell culture wells. One of ordinary skill in the art reasonably would have understood this disclosure to teach, or at the very least to have suggested, that the cell culture wells thermally insulated in this manner would be thermally isolated from transferring heat into the microplate (test vessel), as recited in claim 1. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (An obviousness analysis “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for [an examiner] can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.”); see also In re Preda, 401 F. 2d 825, 826 (CCPA 1968) (“[I]t is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom.”). Moreover, contrary to the Appellant’s further arguments, one of ordinary skill in the art would have understood that use of a low heat conductivity material to form Tipgunlakant’s microplate would facilitate- rather than undermine-Tipgunlakant’s high precision thermal control of the cell culture wells (achieved using thermal insulation among the cell culture Appeal 2021-001536 Application 14/984,719 10 wells and on the microplate surfaces), by further reducing heat transfer from the cell culture wells into the microplate. Tipgunlakant’s disclosures, therefore, reasonably would not have led one of ordinary skill in the art away from using a low heat conductivity material to form Tipgunlakant’s microplate, as the Appellant argues. The Appellant argues that “Bedingham explicitly teaches that uniform temperature control is desired across the process chambers including the use of a metallic sublayer . . . thereby teaching away from the claimed thermal isolation and low heat conductivity material.” Appeal Br. 10 (citing Bedingham ¶¶ 19-21, 114). Although Bedingham does disclose uniform temperature control across process chambers (test locations) of a substrate (test vessel) (see, e.g., ¶¶ 114, 116), the Examiner’s rejection relies on Bedingham’s disclosure of thermochromic temperature sensors disposed in thermal connection with the process chambers (test locations). Non-Final Act. 5. The Examiner proposes modifying Tipgunlakant’s microplate to substitute such sensors for the colorimetric indicators disposed in Tipgunlakant’s individual cell culture wells. Id. The Appellant does not identify any disclosure in Bedingham that criticizes, discredits, or otherwise would have discouraged one of ordinary skill in the art from thermally isolating process chambers (test locations) from transferring heat into a substrate (test vessel), and forming the substrate (test vessel) from a low heat conductivity base material, as recited in claim 1, and we find no such disclosure in Bedingham. Likewise, the Appellant does not direct us to any disclosure in Bedingham that would have led one of ordinary skill in the art away from substituting Bedingham’s thermochromic Appeal 2021-001536 Application 14/984,719 11 temperature sensors for the colorimetric indicators disclosed in Tipgunlakant. Contrary to the Appellant’s arguments, Bedingham, therefore, does not teach away from the device of claim 1. Meiresonne v. Google, Inc., 849 F.3d 1379, 1382 (Fed. Cir. 2017) (“A reference that ‘merely expresses a general preference for an alternative invention but does not criticize, discredit, or otherwise discourage investigation into’ the claimed invention does not teach away.” (quoting Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d 731, 738 (Fed. Cir. 2013)). We, accordingly, sustain the Examiner’s rejection of claims 1-10 and 12-20 under 35 U.S.C. § 103. Claim 11 Claim 11 depends from claim 1 and recites that the device further comprises a layer within a test location and between the thermochromic material and the medium that comprises one or more of parylene, indium- tin-oxide (ITO), metal, polyethylene glycol (PEG), diamond, zinc oxide, graphene, graphite, and indium phosphide. The Examiner finds that Tipgunlakant does not disclose that Tipgunlakant’s device includes such a layer, but finds that Bedingham discloses a biological testing device that includes thermal structure 484’ formed as a metal layer provided between liquid crystal film 454’ (thermochromic material), and process chamber 450’ (medium), which the Examiner finds corresponds to the arrangement recited in claim 11. Non-Final Act. 19 (citing Bedingham ¶¶ 163, 169); see also Bedingham ¶¶ 152, 160. The Appellant argues that Bedingham’s thermal structure 484’ “is explicitly taught as being located below the process chamber 450’,” and, Appeal 2021-001536 Application 14/984,719 12 therefore, is not positioned within a test location and between the thermochromic material and the medium as required by claim 11. Appeal Br. 11. The Examiner responds to the Appellant’s argument by indicating that the Examiner interprets the “test locations” recited in claim 11 “to include the thermochromic material and portions of the device surrounding wells of the device vessel and . . . not just the empty space taken up by the medium . . . in light of the [S]pecification which describes test locations as being ‘in, on, or about the wells.’” Ans. 6 (citing Spec. 7, ll. 16-18). The Examiner finds that Bedingham’s Figure 10A shows that thermal structure 484’ (formed of metal) “is a separating layer between the thermochromic material 454’ and the medium in well area 450’” and, therefore, “is clearly ‘in, on, or about the wells,’” and thus “is within the test locations.” Ans. 6. As the Appellant points out in the Reply Brief (Reply Br. 10), however, the Examiner’s interpretation of a “test location” as recited in claim 11 is inconsistent with the description of “test locations” provided in the Appellant’s Specification, and the Examiner’s interpretation of this term, therefore, is unduly broad. See, e.g., Spec. 1, ll. 25-26 (describing “test locations configured to contain a medium suitable for culturing a live substance,” and indicating that “[a] thermochromic material is thermally coupled to the one or more test locations.”); Spec. 6, l. 25 (indicating that “the test locations may be test wells which are recessed locations on a test plate”); Spec. 7, ll. 16-18 (indicating that a thermochromic material “is thermally coupled to the one or more test locations,” and “the thermochromic material may be disposed at the test locations, e.g., in, on, and/or about the test wells.”). Appeal 2021-001536 Application 14/984,719 13 On the record before us, the Examiner does not provide a sufficient factual basis to establish that Bedingham discloses or would have suggested a layer within a test location and between the thermochromic material and the medium, under a broadest reasonable interpretation of “test location” that is consistent with the Appellant’s Specification. In re Smith Int’l, Inc., 871 F.3d 1375, 1382-83 (Fed. Cir. 2017) (“The correct inquiry in giving a claim term its broadest reasonable interpretation in light of the specification is not whether the specification proscribes or precludes some broad reading of the claim term adopted by the examiner. And it is not simply an interpretation that is not inconsistent with the specification. It is an interpretation that corresponds with what and how the inventor describes his invention in the specification, i.e., an interpretation that is ‘consistent with the specification.’” (quoting In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997)). Therefore, because the Examiner’s rejection of claim 11 is premised on an unreasonably broad interpretation of “test locations” that is inconsistent with the Appellant’s Specification, we do not sustain the Examiner’s rejection of claim 11 under 35 U.S.C. § 103. Morris, 127 F.3d at 1054-55 (“While the Board must give the terms their broadest reasonable construction, the construction cannot be divorced from the specification and the record evidence.”). DECISION SUMMARY Claims Rejected 35 U.S.C. § Reference(s)/ Basis Affirmed Reversed 1-20 112(a) Written Description 1-20 Appeal 2021-001536 Application 14/984,719 14 Claims Rejected 35 U.S.C. § Reference(s)/ Basis Affirmed Reversed 1-20 103 Tipgunlakant, Bedingham, Coates 1-10, 12-20 11 Overall Outcome 1-10, 12-20 11 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) (2022). AFFIRMED IN PART