Theranos, Inc.Download PDFPatent Trials and Appeals BoardNov 25, 20202020000078 (P.T.A.B. Nov. 25, 2020) 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. 14/598,625 01/16/2015 Elizabeth A. Holmes 2001.501A 1839 107075 7590 11/25/2020 Labrador Diagnostics LLC 160 Foss Creek Cir #2369 Healdsburg, CA 95448 EXAMINER LIU, SHUYI S ART UNIT PAPER NUMBER 1774 NOTIFICATION DATE DELIVERY MODE 11/25/2020 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): docketing@labradordiagnostics.com eofficeaction@appcoll.com patents@labradordiagnostics.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte ELIZABETH A. HOLMES, DANIEL L. YOUNG, TIMOTHY SMITH, SCOTT RIDEL, JOHN KENT FRANKOVICH, and MICHAEL SIEGEL Appeal 2020-000078 Application 14/598,625 Technology Center 1700 ____________ Before TERRY J. OWENS, JEFFREY T. SMITH, and MERRELL C. CASHION, JR., Administrative Patent Judges. Opinion for the Board filed by Administrative Patent Judge SMITH. Opinion Dissenting filed by Administrative Patent Judge OWENS. SMITH, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 50–62 are pending in the application.2 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. Appellant identifies the real party in interest as Theranos IP Company, Inc. Appeal Br. 2. 2 The claims on appeal appear in the corrected claims appendix submitted July 1, 2019. Appeal 2020-000078 Application 14/598,625 2 STATEMENT OF THE CASE Appellant’s invention is generally directed to a compact high speed centrifuge for use with sample containers. (Spec. ¶ 5.) Independent claim 50 is representative of the appealed subject matter and is reproduced below: 50. A system comprising: a centrifuge comprising: a centrifuge body; at least one sample vessel holder coupled to the centrifuge body; a drive mechanism for rotating said centrifuge body at a rotational speed of at least 1000 rpm; and a detector for use in determining at least a rotational position of the centrifuge body; a centrifuge housing shaped to enclose at least a circumferential perimeter of the centrifuge body; a first air bearing configured to operably support an underside surface of the centrifuge body, wherein at least a portion of the first air bearing is defined by the centrifuge housing; and a second air bearing configured to operably support an lateral surface of the centrifuge body, wherein at least a portion of the second air bearing is defined by the centrifuge housing; a fluid handling system comprising at least one pipette head configured to provide overhead access to the centrifuge and movable X-Y and Z directions; and a programmable processor configured to align the at least one pipette head of the fluid handling system with a holder. Claims Appendix. The following rejections are presented for our review: 3 3 The complete statement of the rejections on appeal appears in the April 10, 2018 Final Action. (Final Act. 6–11.) Appeal 2020-000078 Application 14/598,625 3 I. Claim 50 and 51 are rejected under 35 U.S.C. § 103(a) as unpatentable over Pang (US 7,141,213 B1, iss. Nov. 28, 2006) in view of Krumme (US 2010/0034492 A1; pub. Feb. 11, 2010) and Ingber (US 2011/0008825 A1; pub. Jan 13, 2011). II. Claim 52 is rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Pang, Krumme, Ingber and further in view of Noguchi (US 7,667,184 B2; Feb 23. 2010). III. Claims 53, 54, and 58 are rejected under 35 U.S.C. § 103(a) as unpatentable over the combination Pang, Krumme, Ingber and further in view of Gordon (EP 1129783 A2; pub Sep. 5, 2001) and Meeks (US 2006/0013733 A1; Jan. 19, 2006). IV. Claims 55–57 and 59–62 are rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Pang, Krumme, Ingber, and Ryu (US 2010/0009831 A1; pub. Jan. 14, 2010). OPINION We review the appealed rejections for error based upon the issues Appellant identifies, and in light of the arguments and evidence produced thereon. See In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011) (“[I]t has long been the Board’s practice to require an applicant to identify the alleged error in the examiner’s rejections” (citing Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential))). Having considered the respective positions the Examiner and Appellant advance in light of this appeal record, we affirm the Examiner’s rejections based on the fact-finding and reasoning set forth in the Answer Appeal 2020-000078 Application 14/598,625 4 and Final Office Action, which we adopt as our own. We add the following primarily for emphasis. Rejection I Claims 50 and 51 are rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Pang, Krumme, and Ingber. We limit our discussion to the independent claim 50 as argued by Appellant. (Appeal Br. 4–10). Appellant argues Krumme fails to describe a housing that provides an air bearing feature as required by independent claim 50. (Appeal Br. 4–6.) Appellant argues Krumme instead uses pressurized gas at discrete structures that are not part of the centrifuge housing to provide the air bearings. (Appeal Br. 5 citing Krumme ¶ 36.) Appellant’s arguments are not persuasive of reversible error for reasons the Examiner presents. (Ans. 8–9.) Appellant has not refuted the Examiner’s determination that Krumme’s axial air bearings 10, 11, and 12 as well as Krumme’s radial air bearings 13, 14, and 15 are all structures supported by or attached to the housing 2.4 (Final Act. 6–7; Krumme ¶ 18.) Appellant has not established that Krumme’s attachment configuration is patently distinct from the claimed invention. Appellant points to Specification paragraphs 238, 245, and 246 and Figures 19–20 as descriptive of the air bearings required by the claimed invention. (Appeal Br. 3.) Specification paragraph 236 specifically discloses that air bearing 724 is configured to opposite side walls of the centrifuge rotor. This description 4 Appellant has not refuted the Examiner's determination that Krumme stator 2 is a housing structure. (Final Act. 4.) Appeal 2020-000078 Application 14/598,625 5 does not require the air bearing to be an integral portion of the housing but rather is inclusive of an attachment (configuration) to the housing. Thus, Appellant has not directed us to evidence that establishes a patentable distinction between an air bearing that is attached to the housing versus an air bearing configured to the housing. Appellant argues the Examiner relies on impermissible hindsight to combine the teachings of the cited art. Appellant specifically state: [T]hat ABSENT the impermissible use of HINDSIGHT, there is NO technical benefit cited by the Examiner for making the proposed combination of using a very SLOW 300 RPM design of a CT scanner (Krumme) to “improve”" the bearing function of a 3,600 to 100,000 RPM centrifuge (Pang). (Appeal Br. 7, emphasis original.) We are unpersuaded by this argument. As the Examiner explains in the Answer, one of ordinary skill in the art would have been capable of applying Krumme’s teaching of a known method of enhancement to a “base” device to Pang’s centrifuge with the expectation that the modified device would be suitable to perform Pang’s centrifuging operation. Ans. 10–11. Therefore, the Examiner has provided a reasonable basis for combining the teachings of the cited art. Further, Appellant has not directed us to evidence that air bearings were recognized to be unsuitable for operation at high speeds. The prior art cited by the Examiner establishes that bearing functions can be achieved utilizing air bearings as an alternative to mechanical bearings. (See Krumme ¶ 5.) A person of ordinary skill in the art would have recognized the suitable adjustments that would have been necessary for operating air bearings Appeal 2020-000078 Application 14/598,625 6 dependent upon the speed of rotation. See KSR Int’l. Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (In making an obviousness determination one “can take account of the inferences and creative steps that a person of ordinary skill in the art would employ”). Appellant further argues the Examiner has failed to establish a reasonable expectation of success for utilizing Krumme’s bearings configured for a vertical device given the horizontal configuration ascribed by Pang. (Appeal Br. 9–11.) Appellant’s arguments lack persuasive merit. It is not necessary to physically incorporate the air bearings described by Krumme into the device described by Pang to render obvious the claimed invention. See In re Etter, 756 F.2d 852, 859 (Fed. Cir. 1985) (en banc) (“Etter’s assertions that Azure cannot be incorporated in Ambrosio are basically irrelevant, the criterion being not whether the references could be physically combined but whether the claimed inventions are rendered obvious by the teachings of the prior art as a whole.”); see also In re Sneed, 710 F.2d 1544, 1550 (Fed. Cir. 1983) (“[I]t is not necessary that the inventions of the references be physically combinable to render obvious the invention under review.”) and In re Nievelt, 482 F.2d 965, 968 (CCPA 1973) (“Combining the teachings of references does not involve an ability to combine their specific structures.”). “The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.... Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art.” In re Keller, 642 F.2d 413, 425 (CCPA 1981). Appellant has not directed us to evidence that air bearings were Appeal 2020-000078 Application 14/598,625 7 recognized to be unsuitable for use at various angles. Given that Krumme establishes that bearing functions can be achieved utilizing air bearings as an alternative to mechanical bearings (see Krumme ¶ 5), Appellant has not explained adequately why one skilled in the art would not have been capable of adjusting Krumme’s air bearings to perform at a desired angle of operation. See KSR. 550 U.S. at 418. For the foregoing reasons and those the Examiner presents, we sustain the rejection of claim 50. Rejections II–IV Claims 52–62 are rejected under 35 U.S.C. § 103(a) as unpatentable over Pang, Krumme and Ingber in combination with additional references stated in the rejections. Appellant relies on the arguments presented for claim 50 to address the rejections of claims 52–62. (Appeal Br. 11–12.) Appellant does not assert non-obviousness based on the additional features set forth in claims 52–62 by explaining how the additional references cited by the Examiner fail to establish the obviousness of these additional features. Because we do not find Appellant’s arguments persuasive as to independent claim 50, it follows that these arguments are unpersuasive as to claims 52–62. CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 50, 51 103(a) Pang, Krumme, Ingber 50, 51 Appeal 2020-000078 Application 14/598,625 8 Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 52 103(a) Pang, Krumme, Ingber, Noguchi 52 53, 54, 58 103(a) Pang, Krumme, Ingber, Gordon, Meeks 53, 54, 58 55–57, 59–62 103(a) Pang, Krumme, Ingber, Ryu 55–57, 59–62 Overall Outcome 50–62 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 Appeal 2020-000078 Application 14/598,625 9 OWENS, Administrative Patent Judge, dissenting. Setting forth a prima facie case of obviousness requires establishing that the applied prior art would have provided one of ordinary skill in the art with an apparent reason to modify the prior art to arrive at the claimed invention. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Pang discloses a laboratory centrifuge of the type having a spindle driven at a speed as high as about 3,600 to about 100,000 rpm (col. 2, ll. 9– 18; col. 5, ll. 26–30). Pang is silent regarding centrifuge bearings. Krumme discloses a computer tomograph (CT scanner) (¶ 3). Krumme teaches (¶ 5): In modem computer tomographs of high resolution, the rotating part of the gantry rotates at high rotation numbers, for example 300 r.p.m. Simultaneously a very high positional tolerance of the gantry in ranges distinctly below 1 mm is required. With this, mechanical bearings frequently approach limits of what is technologically possible. Here, an elegant way of providing a bearing function is by means of an aerodynamic bearing, also known as an air bearing. Krumme’s CT scanner comprises “a rotatable device having aerostatic bearing facilities and a direct drive in the form of a segmented ring motor so that it can be equipped with a simpler and thus also less costly bearing means” (¶ 8). The Examiner finds (Ans. 10): [O]ne of ordinary skill in the art would be well aware that what would be considered a "high" rotational speed for a larger rotational device, such as the gantry of a CT scanner, would not necessarily be considered a "high" rotational speed for a smaller rotational device, since the RPM of a rotational device is a function of the radius of the rotor. Given such understanding, however, one of ordinary skill in the art would still be able to glean from the teachings of Krumme that air bearings can Appeal 2020-000078 Application 14/598,625 10 provide improved bearing performance at high rotational speeds for a rotatable device of any give size, including a centrifuge of any size. The rationale to support a conclusion that the claim would have been obvious is that a method of enhancing a particular class of devices (methods, or products) has been made part of the ordinary capabilities of one skilled in the art based upon the teaching of such improvement in other situations. One of ordinary skill in the art would have been capable of applying this known method of enhancement to a "base" device (method, or product) in the prior art and the results would have been predictable to one of ordinary skill in the art. The Examiner concludes that [i]t would have been obvious for one having ordinary skill in the art at the time of the invention to have provided the system of Pang et al. with the air bearings of Krumme for the purpose of providing improved bearing function for a rotatable device at high rotation numbers (paragraph [0003], [0005], [0023]) (Final Rej. 7). The Examiner does not provide evidence supporting the finding that “one of ordinary skill in the art would still be able to glean from the teachings of Krumme that air bearings can provide improved bearing performance at high rotational speeds for a rotatable device of any give size, including a centrifuge of any size.” See In re Warner, 379 F.2d 1011, 1017 (CCPA 1967) (“A rejection based on section 103 clearly must rest on a factual basis, and these facts must be interpreted without hindsight reconstruction of the invention from the prior art”). Also, the Examiner’s finding that one of ordinary skill in the art would have been capable of making the proposed modification to Pang’s centrifuge does not establish that Krumme would have provided one of ordinary skill in the art with an apparent reason to make that modification. Appeal 2020-000078 Application 14/598,625 11 Accordingly, I dissent from the affirmance of the Examiner’s rejection. Copy with citationCopy as parenthetical citation