Ex Parte PIRON et al

Patent Trials and Appeals BoardMar 29, 2019

14855054 - (D) (P.T.A.B. Mar. 29, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/855,054 09/15/2015 293 7590 04/02/2019 DOWELL & DOWELL, P.C. 2560 HUNTINGTON A VE, SUITE 203 ALEXANDRIA, VA 22303 FIRST NAMED INVENTOR Cameron PIRON 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 19395CON 6326 EXAMINER PAULSON, SHEETAL R. ART UNIT PAPER NUMBER 3626 NOTIFICATION DATE DELIVERY MODE 04/02/2019 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): DOWELL@DOWELLPC.COM DVejerano@dowellpc.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte CAMERON PIRON, GAL SELA, MONROE M. THOMAS, SIMON ALEXANDER, MURUGATHAS YUWARAJ, MICHAEL WOOD, ALEX PANTHER, JOSHUA RICHMOND, WES HODGES, and DAVID GALLOP Appeal2017-009742 Application 14/855,054 1 Technology Center 3600 Before JOHN A. EVANS, CATHERINE SHIANG, and MATTHEW J. McNEILL, Administrative Patent Judges. McNEILL, Administrative Patent Judge. DECISION ON APPEAL Appellants appeal under 35 U.S.C. Â§ 134(a) from the Examiner's rejection of claims 1-7, 11, and 14-22, which are all the claims pending in this application. Claims 8-10, 12, and 13 are canceled. Br. 5. We have jurisdiction under 35 U.S.C. Â§ 6(b). We affirm. 1 Appellants identify the Applicant, Synaptive Medical (Barbados) Inc., as the real party in interest. Br. 3. Appeal2017-009742 Application 14/855,054 STATEMENT OF THE CASE Introduction Appellants' application relates to image guided medical procedures involving tissue excision, identification, and pathology analysis. Spec. 2: 11-13. Claim 1 illustrates the appealed subject matter and reads as follows: 1. A method of generating one or more steps of a surgical plan based on archival surgical plan data from one or more prior medical procedures, the method comprising: during a medical procedure, employing a diagnostic device to perform an in-vivo local tissue measurement associated with a region of interest of a subject, thereby obtaining tissue analysis data; obtaining archival tissue analysis data associated with one or more prior medical procedures; obtaining surgical plan data associated with the one or more prior medical procedures; comparing, according to pre-selected similarity criteria, the tissue analysis data and the archival tissue analysis data associated with the one or more prior medical procedures; identifying, using the processor, one or more similar prior medical procedures having archival tissue analysis data satisfying the pre-selected similarity criteria; and processing, using the processor, the surgical plan data associated with the one or more similar prior medical procedures to generate one or more steps of a suggested surgical plan. The Examiner's Rejection Claims 1-7, 11, and 14-22 stand rejected under 35 U.S.C. Â§ 101 as being directed to patent-ineligible subject matter. Final Act. 2-6. 2 Appeal2017-009742 Application 14/855,054 ANALYSIS An invention is patent-eligible if it claims a "new and useful process, machine, manufacture, or composition of matter." 35 U.S.C. Â§ 101. However, the Supreme Court has long interpreted 35 U.S.C. Â§ 101 to include implicit exceptions: "[l]aws of nature, natural phenomena, and abstract ideas" are not patentable. E.g., Alice Corp. v. CLS Bank Int 'l, 573 U.S. 208, 216 (2014). In determining whether a claim falls within an excluded category, we are guided by the Supreme Court's two-step framework, described in Mayo and Alice. Id. at 217-18 ( citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 75-77 (2012)). In accordance with that framework, we first determine what concept the claim is "directed to." See Alice, 573 U.S. at 219 ("On their face, the claims before us are drawn to the concept of intermediated settlement, i.e., the use of a third party to mitigate settlement risk."); see also Bilski v. Kappas, 561 U.S. 593, 611 (2010) ("Claims 1 and 4 in petitioners' application explain the basic concept of hedging, or protecting against risk."). Concepts determined to be abstract ideas, and thus patent ineligible, include certain methods of organizing human activity, such as fundamental economic practices (Alice, 573 U.S. at 219-20; Bilski, 561 U.S. at 611 ); mathematical formulas (Parker v. Flook, 437 U.S. 584, 594--95 (1978)); and mental processes (Gottschalkv. Benson, 409 U.S. 63, 69 (1972)). Concepts determined to be patent eligible include physical and chemical processes, such as "molding rubber products" (Diamond v. Diehr, 450 U.S. 175, 191 (1981) ); "tanning, dyeing, making water-proof cloth, vulcanizing India rubber, smelting ores" (id. at 184 n.7 (quoting Corning v. Burden, 56 U.S. 3 Appeal2017-009742 Application 14/855,054 252, 267---68 (1854))); and manufacturing flour (Benson, 409 U.S. at 69 (citing Cochrane v. Deener, 94 U.S. 780, 785 (1876))). In Diehr, the claim at issue recited a mathematical formula, but the Supreme Court held that "[a] claim drawn to subject matter otherwise statutory does not become nonstatutory simply because it uses a mathematical formula." Diehr, 450 U.S. at 176; see also id. at 192 ("We view respondents' claims as nothing more than a process for molding rubber products and not as an attempt to patent a mathematical formula."). Having said that, the Supreme Court also indicated that a claim "seeking patent protection for that formula in the abstract ... is not accorded the protection of our patent laws, ... and this principle cannot be circumvented by attempting to limit the use of the formula to a particular technological environment." Id. ( citing Benson and Flook); see, e.g., id. at 187 ("It is now commonplace that an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection."). If the claim is "directed to" an abstract idea, we tum to the second step of the Alice and Mayo framework, where "we must examine the elements of the claim to determine whether it contains an 'inventive concept' sufficient to 'transform' the claimed abstract idea into a patent- eligible application." Alice, 573 U.S. at 221 ( quotation marks omitted). "A claim that recites an abstract idea must include 'additional features' to ensure 'that the [claim] is more than a drafting effort designed to monopolize the [abstract idea]."' Id. ( quoting Mayo, 566 U.S. at 77). "[M]erely requir[ing] generic computer implementation[] fail[ s] to transform that abstract idea into a patent-eligible invention." Id. 4 Appeal2017-009742 Application 14/855,054 The PTO recently published revised guidance on the application of Â§ 101. USPTO's January 7, 2019 Memorandum, 2019 Revised Patent Subject Matter Eligibility Guidance ("Revised Guidance"). Under that guidance, we first look to whether the claim recites: ( 1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes); and (2) additional elements that integrate the judicial exception into a practical application (see MPEP Â§ 2106.05(a}-(c), (e}-(h)). Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim: (3) adds a specific limitation beyond the judicial exception that are not "well-understood, routine, conventional" in the field (see MPEP Â§ 2106.05(d)); or ( 4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. See Revised Guidance. Revised Guidance Step 1 Step 1 of the Revised Guidance asks whether the claimed subject matter falls within the four statutory categories of patentable subject matter identified by 35 U.S.C. Â§ 101: process, machine, manufacture, or composition of matter. See Revised Guidance. Claim 1 recites "[a] method of generating one or more steps of a surgical plan." Appellants do not argue the Examiner erred in concluding claim 1 falls within the four statutory 5 Appeal2017-009742 Application 14/855,054 categories of patentable subject matter. We agree with the Examiner's conclusion because claim 1 falls within the process category. Revised Guidance Step 2A, Prong 1 Under Step 2A, Prong 1 of the Revised Guidance, we determine whether the claims recite any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes). See Revised Guidance. Appellants argue claim 1 is not directed to an abstract idea. Br. 14- 16. In particular, Appellants argue the Examiner's analysis is insufficient because the Examiner does not clearly explain why the abstract idea corresponds to a concept that courts have identified as an abstract idea. Br. 14. Appellants argue merely stating there is not a meaningful difference between the abstract idea and other cases is insufficient in providing an explanation. Id. at 15. Appellants also argue the claimed method goes well beyond a simple rule-based method, such as found to be abstract in SmartGene. Id. at 15-16 ( citing SmartGene, Inc. v. Advanced Biological Laboratories, SA, 555 F.App'x. 950 (Fed. Cir. 2014)). Appellants argue the claims in SmartGene involved providing a set of rules for correlating a medical condition with treatment regimens and associated advisory information, which the court characterized as "comparing new and stored information using rules to identify options." Br. 15. According to Appellants, claim 1 involves significantly more, because the claimed method provides an indirect and multi-step method that is not rule-based, and directly associates tissue analysis data with surgical plans based on rules. Id. at 16. 6 Appeal2017-009742 Application 14/855,054 Claim 1 recites the following limitations: (1) "obtaining archival tissue analysis data associated with one or more prior medical procedures;" (2) "obtaining surgical plan data associated with the one or more prior medical procedures;" (3) "comparing, according to pre-selected similarity criteria, the tissue analysis data and the archival tissue analysis data associated with the one or more prior medical procedures;" (4) "identifying ... one or more similar prior medical procedures having archival tissue analysis data satisfying the pre-selected similarity criteria;" and (5) "processing ... the surgical plan data associated with the one or more similar prior medical procedures to generate one or more steps of a suggested surgical plan." These limitations, under their broadest reasonable interpretation, recite a method of generating a surgical plan based on comparison of archival tissue analysis data and the current patient's tissue analysis data because the limitations all recite operations that a doctor would ordinarily take to generate a surgical plan based on tissue analysis data. For example, limitations (1) and (2) recite obtaining "archival tissue analysis data" and "surgical plan data" for prior medical procedures, which is characteristic of the steps a doctor would take in comparing a current medical procedure to prior medical procedures. Limitations (3) and ( 4) recite "comparing" current tissue analysis data with archival tissue analysis data and "identifying" prior medical procedures as "similar," which are characteristic of the steps a doctor would take in identifying the similar prior medical procedures. Finally, limitation (5) recites generating a suggested surgical plan, which is characteristic of the steps a doctor would take in using information gleaned from the prior medical procedures to generate a current surgical plan. These steps are a collection of observations, 7 Appeal2017-009742 Application 14/855,054 evaluations, and judgments that constitute concepts performed in the human mind. These claims are similar to the claims in SmartGene, where the court held claims comparing new and stored information using rules to identify options in a medical setting were directed to a mental process. See SmartGene, 555 F.App'x. at 950. Accordingly, we conclude the claims recite a collection of observations, evaluations, and judgments that constitute concepts performed in the human mind, which are a mental process as identified in the Revised Guidance, and thus an abstract idea. Revised Guidance Step 2A, Prong 2 Under Step 2A, Prong 2 of the Revised Guidance, we next determine whether the claims recite additional elements that integrate the judicial exception into a practical application (see MPEP Â§ 2106.05(a}-(c), (e}-(h)). We conclude that claim 1 does not integrate the judicial exception into a practical application. As explained above, claim 1 recites a collection of observations, evaluations, and judgments that constitute concepts performed in the human mind. The "identifying" and "processing" steps recite that these operations are performed "using a processor." However, the mere fact that these limitations require a computer is not enough to integrate the recited abstract idea into a practical application. Claims that amount to mere instructions to implement an abstract idea on a computer do not integrate an abstract idea into a practical application. See MPEP Â§ 2106.05([). Claim 1 also recites "during a medical procedure, employing a diagnostic device to perform an in-vivo local tissue measurement associated with a region of interest of a subject, thereby obtaining tissue analysis data." This limitation is also insufficient to integrate the abstract idea into a 8 Appeal2017-009742 Application 14/855,054 practical application because claims that link the use of an abstract idea to a particular technological environment are insufficient to integrate an abstract idea into a practical application. See MPEP Â§ 2106.05(h). Moreover, this "obtaining" of "tissue analysis data" is also insignificant extra-solution activity, which does not integrate the abstract idea into a practical application. See MPEP Â§ 2106.05(g); see also Mayo, 566 U.S. at 79 ( concluding that additional element of measuring metabolites of a drug administered to a patient was insignificant extra-solution activity, which was insufficient to confer patent eligibility). Notably, Appellants have not persuasively explained how claim 1 recites improvements to any technology or technical field (see MPEP Â§ 2106.05(a)), improves a particular machine (see MPEP Â§ 2106.05(b)), transforms or reduces a particular article to a different state or thing (see MPEP Â§ 2106.05(c)), or describes a process or product that applies the exception in a meaningful way, such that it is more than a drafting effort designed to monopolize the exception (see MPEP Â§ 2106.05(e)). See App. Br. 5-9. Appellants' argument that the claim goes well beyond the simple rule based claim at issue in SmartGene is unavailing for the reasons discussed above with respect to Step 2A, Prong 1. Like the claims at issue in SmartGene, claim 1 recites a method for obtaining and comparing stored and input data and rules using basic computer functionality to perform a process that could be performed mentally by a doctor. Accordingly, we conclude that claim 1 does not integrate the judicial exception into a practical application because claim 1 does no more than call on a processor with basic functionality to perform a method that doctors 9 Appeal2017-009742 Application 14/855,054 routinely perform mentally. Thus, Appellants have not persuaded us the Examiner erred in concluding claim 1 is directed to an abstract idea. Revised Guidance Step 2B Under Step 2B of the Revised Guidance, we next determine whether the claims recite an "inventive concept" that "must be significantly more than the abstract idea itself, and cannot simply be an instruction to implement or apply the abstract idea on a computer." BASCOM Global Internet Servs., Inc. v. AT&T Mobility LLC, 827 F.3d 1341, 1349 (Fed. Cir. 2016). There must be more than "computer functions [that] are 'well- understood, routine, conventional activit[ies]' previously known to the industry." Alice, 573 U.S. at 225 (second alteration in original) (quoting Mayo, 566 U.S. at 73). Appellants argue claim 1 recites significantly more than merely describing and applying the abstract idea. Br. 17-20. In particular, Appellants argue claim 1 recites performing in-vivo tissue measurements to provide input to automated surgical planning, which represents a significant departure from current clinical practice. Id. at 19. According to Appellants, local tissue measurements are conventionally performed in an ex-vivo manner, prior to or after a surgical procedure. Id. at 19-20. Appellants argue these in-vivo measurements represent "significantly more" than the claimed abstract idea. Appellants have not persuaded us of Examiner error. Appellants' argument that in-vivo tissue measurements represent a significant departure from current clinical practice are unsupported by factual evidence and, therefore, entitled to little probative value. See In re Geisler, 116 F.3d 1465, 10 Appeal2017-009742 Application 14/855,054 1470 (Fed. Cir. 1997); see also In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984). The Specification also appears to contradict this argument, noting that "during a neurosurgical resection procedure, a surgeon typically needs to decide, at various stages during the procedure, whether or not an exposed tissue region should be excised." Spec. 53:3-5. "There are several diagnostic modalities that the surgeon can use to attempt to make such a determination." Id. at 53: 5-7. The Specification explains that examining the cells under a microscope is the "gold standard in tumor identification." Id. at 53:10-11. The Specification explains that it is not feasible to perform this method on every excised piece of tissue and often cannot be performed intraoperatively, but explains that an iterative approach may be possible, although complex and uncertain in its effectiveness. Id. at 53: 10-18. The Specification explains that this "gold standard" technique may be used in combination with imaging, tissue analysis, and the claimed computerization of the methods to greater effect. See id. at 5 3: 19-55: 21. In other words, the Specification explains that in-vivo measurements are a conventional technique that may be used more efficiently in combination with the recited computer limitations. While the claimed method purports to accelerate the process of analyzing tissue analysis data, the speed increase comes from the capabilities of a general-purpose computer, rather than the patented method itself. See Bancorp Servs., L.L. C. v. Sun Life Assur. Co. of Can. (U.S.), 687 F.3d 1266, 1278 (Fed. Cir. 2012) ("[T]he fact that the required calculations could be performed more efficiently via a computer does not materially alter the patent eligibility of the claimed subject matter."). 11 Appeal2017-009742 Application 14/855,054 For these reasons, we agree with the Examiner that the claims do not recite an "inventive concept" sufficient to transform the claims from an abstract idea to a patent eligible application. We, therefore, sustain the patent-ineligible subject matter rejection of claim 1. We also sustain the rejection of independent claims 11 and 22, for which Appellants provide similar arguments. See Br. 14-20. Dependent Claims Appellants argue the Examiner erred in rejecting dependent claims 2- 7 and 14-21 because these claims provide field-specific limitations pertaining to specific types of tissue analysis involving tumors and specific types of diagnostic devices. Br. 21. Appellants argue these field-specific limitations are directed to a practical application of particular types of tissue analyses and the Examiner failed to address these limitations. Id. The Examiner finds dependent claims 2-7 and 14-21 do not add meaningful limitations because these claims merely use the claimed computer or device as a tool to carry out the abstract idea. Ans. 8. The Examiner finds claims 2-7 are directed to comparing analyzed data to determine tumor characteristics. Id. The Examiner finds claims 14-21 recite diagnostic devices that are well-known in the industry and used in a generic manner to perform in-vivo local tissue analysis. Id. The Examiner further finds the Specification provides no teachings that these diagnostic devices provide any benefits over conventional diagnostic devices. Id. Appellants did not file a Reply Brief to respond to these findings. Appellants have not persuaded us of Examiner error. Claim 2 recites "[t]he method according to claim 1 wherein the tissue analysis data associated with the subject comprises an identification of one or more tumor 12 Appeal2017-009742 Application 14/855,054 types." Appellants have not persuasively explained how the tissue analysis being an identification of tumor types is a practical application that changes the nature of the claim compared to independent claim 1. Instead, we find claim 2 merely recites limitations generally linking the use of the judicial exception to a particular technological environment. See MPEP Â§ 2106.05( e ); see also Classen Immunotherapies Inc. v. Biogen IDEC, 659 F.3d 1057, 1066-68 (Fed. Cir. 2011). Appellants argue claims 2-7 as a group, and Appellants' arguments for claims 3-7 are similarly unpersuasive. Claim 14 recites "[t]he method according to claim 1 wherein the diagnostic device is an imaging diagnostic device." Appellants have not persuasively explained how an imaging diagnostic device is a practical application that changes the nature of the claim compared to the diagnostic device recited in claim 1. Instead, we find this limitation merely links the use of the judicial exception to a particular technological environment. See id. Appellants argue claims 14-21 as a group, and Appellants' arguments for claims 15-21 are similarly unpersuasive. We, therefore, sustain the rejection of dependent claims 2-7 and 14-21. DECISION We affirm the decision of the Examiner rejecting claims 1-7, 11, and 14-22. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a)(l)(iv). See 37 C.F.R. Â§ 41.50(Â±). AFFIRMED 13