Ex Parte Lundback

Patent Trial and Appeal BoardApr 26, 2016

11795945 (P.T.A.B. Apr. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 111795,945 09/18/2007 466 7590 YOUNG & THOMPSON 209 Madison Street Suite 500 Alexandria, VA 22314 04/28/2016 FIRST NAMED INVENTOR Stig Lundback 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. 1505-1116 8365 EXAMINER HARWARD, SOREN T ART UNIT PAPER NUMBER 1631 NOTIFICATION DATE DELIVERY MODE 04/28/2016 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): DocketingDept@young-thompson.com yandtpair@firs ttofile. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte STIG LUNDBACK Appeal2014-002539 Application 11/795,945 Technology Center 1600 Before DEMETRA J. MILLS, ERIC B. GRIMES, and MELANIE L. McCOLLUM, Administrative Patent Judges. MILLS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. Â§ 134. The Examiner has rejected the claims for obviousness and indefiniteness. We have jurisdiction under 35 U.S.C. Â§ 6(b). We affirm the indefiniteness rejection. STATEMENT OF CASE According to the Specification, page 3, 11. 15-18, the invention relates to a system related to dynamic boundary conditions stored in preferably relational databases for the heart being a cluster state machine. This cluster state machine is a result of a fusion of dynamic boundary conditions of finite heart muscle cell state machines and dynamic boundary conditions of a ~ V-pump state machine. The newly created machine is a 1 Appeal2014-002539 Application 11/795,945 cluster state machine that . . . will be referred to as the heart cluster state machine or as the L1 V-heart pump. The system may be used for educational purposes and for medical diagnosis, prognosis, and surgery treatments, among others. Id., at 11. 1-7. The following claim is representative. 21. A system adapted to realize a heart cluster state machine simulating the heart of an individual, comprising: a heart cluster state machine achieved by fusions of finite heart muscle cell state machines forming a L1 V-pump state machine, said finite heart muscle cell state machines defined by boundary conditions of said heart muscle cell state machines and of said L1 V-pump state machine, said heart cluster state machine adapted to work in accordance with boundary conditions of surrounding tissue, and inlet and outlet vessels, to the heart, said heart cluster state machine serving one or two closed circulatory systems having boundary conditions generated in those systems; and input means (2) adapted to receive a set of heart and circulatory system input values ( 4 ), said input values ( 4) comprising at least input values selected from the group consisting of single imaging data of the heart, mixed imaging data of the heart, and physiological data of the heart, and a processing means ( 6), said set of values applied to said processing means ( 6) i) to generate and handle dynamic boundary conditions of said heart cluster state machine, and ii) to determine, based on said set of input values, a relational database system satisfying both a working regimen of the heart muscle cell state machine and a working regimen of the L1 V-pump state machine of said heart cluster state machine. 2 Appeal2014-002539 Application 11/795,945 Cited References Kamm et al. Lundback et al. US 6, 117,087 Sept. 12, 2000 (hereinafter, "Kamm") WO 01/88642 Al Nov. 22, 2001 (hereinafter, "Lundback") Nash and Hunter, Computational Mechanics of the Heart, 61 J. Elasticity 113-141 (2000) (hereinafter, "Nash"). Grounds of Rejection 1. Claims 21-23 and 30-33 are rejected under 35 U.S.C. Â§ 103(a) as being unpatentable over Nash in view ofLundback. 2. Claims 25-29 and 34--40 are rejected under 35 U.S.C. Â§ 103(a) as being unpatentable over Nash, in view ofLundback and Kamm. 3. Claims 21--40 are rejected under 35 U.S.C. Â§ l 12(b) or 35 U.S.C. Â§ 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter vvhich the applicant regards as the invention. FINDINGS OF FACT The Examiner's findings of fact are set forth in the Answer at pages 3-6 and Final Action pages 2-18. PRINCIPLES OF LAW In making our determination, we apply the preponderance of the evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427 3 Appeal2014-002539 Application 11/795,945 (Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings before the Office). "In rejecting claims under 35 U.S.C. Â§ 103, the examiner bears the initial burden of presenting a primafacie case of obviousness." In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993) (citations omitted). UnderÂ§ 103, "there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness." KSR Int'! Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007). See also In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). Rejections 1 and 2 We do not find that the Examiner has provided evidence to support a prima facie case of obviousness. Based on the cited references, the Examiner concludes that .LA~n invention \'1/ould have been obvious to one of ordinaf'J skill in the art if it simply combines known prior art elements using known methods and yields predictable results. At the time of invention, said practitioner could have combined the myocardium mechanical model and the tissue model of Nash with the ~ V pump model and the circulatory model of Lundback using known mathematical modeling techniques, such as would be necessary to implement either of these inventions in the first place. This interpretation that the invention is merely a combination of known mathematical models is consistent with the description of the invention given in the specification (p. 3, 11. 16-19). Since the model ofNash simulates the mechanical and material effects of heart pumping, whereas the model of Lundback simulates the fluid effects of heart pumping, the two models simulate independent characteristics of heart behavior and therefore perform the same in combination as they do separately. Given that the model of 4 Appeal2014-002539 Application 11/795,945 Nash calculates muscle forces, fluid pressures, and stroke volumes for a given heart geometry (pp. 132-137, passim.), and that these quantities are free parameters in the model of Lundback (p. 10, 11. 12-21; p. 12, 11. 9-16); given that all of these models are directed to aspects of heart behavior, are based on compatible mathematical principles (i.e. optimization of systems of parameterized, bounded equations); and given that Nash explicitly teaches that the model ... be adapted to include other characteristics (pp. 137-138 Â§ 8), said practitioner would have readily predicted that the combination would result in a system that simulates the behavior of the heart using a bounded state machine model of finite elements of the myocardium, a ~ V pump, surrounding tissue, and a circulatory system. The invention is therefore prima facie obvious. Final Act. 9-10. Appellant contends that, "given that the two models [of Nash and Lundback] are based on unrelated different theories and LUNDBACK explicitly teaches away from the very basis of the model in NASH, one of ordinary skill in the art would not have discouraged [sic] from combining their elements." Br. 9. The Examiner responds, arguing, Though the examiner agrees that Nash and Liindback [sic] model the heart according to different theories, it does not follow that the two are incompatible. As explained above, the finite-element myocyte model of Nash allows calculation of parameters such as forces, pressures, and volumes, from imaging data, and that these parameters can be used as inputs can [sic] to the model of Liindback [sic]. The assertion, made without any evidence or reasoned explanation, that a finite-element myocyte model of heart pumping and a fluid model of heart pumping "are not compatible" simply cannot be resolved with the statement in the Specification that the invention is "a fusion of dynamic boundary conditions of finite heart 5 Appeal2014-002539 Application 11/795,945 muscle cell state machines and dynamic boundary conditions of a ~ V- pump state machine" (p. 3, 11. 17-19). Final Act. 17. The Examiner further states that The examiner did not argue that features in the model of Nash should be modified by the teachings of Lundback. Rather, the examiner stated that the two models could be used together in an overall method of modeling the biomechanical behavior of the heart and circulatory system: Nash models the behavior of the cardiac muscle, and Lundback models the behavior of the blood and circulatory system. Lundback teaches that the fluid model must be parameterized with pump cavity volumes, muscle forces, and piston velocities (see description of TF- and C-elements on pp. 5-6, and of model parameterization on p. 12, 11. 1-23); these values can be obtained from the biomechanical model of Nash. Thus, the only modification needed to combine the models is that the data created by the model of Nash are used to parameterize the model of Lundback; the models themselves do not need to be modified in any way. Ans. 4; emphasis added. We conclude that Appellant has the better argument. UnderÂ§ 103, "there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness." KSR, 550 U.S. at 418. See also Kahn, 441 F .3d at 988. That is, the showing of obviousness must be clear and particular. Broad conclusory statements regarding the teaching of multiple references, standing alone, are not evidence. In re Dembiczak, 175 F.3d 994, 999 (Fed. Cir. 1999) (citations omitted). In the present case, we do not find that the Examiner has articulated a specific reason, suggestion or motivation stemming from the prior art to combine the cited references to arrive at the claimed invention. The Examiner essentially relies on general disclosure in Nash that the Nash 6 Appeal2014-002539 Application 11/795,945 model can be adapted to include other characteristics (pp. 137-138 Â§ 8). Final Act. 9-10. The Examiner does not explain why, from the disclosure at Nash, pages 137 and 138, one of ordinary skill in the art would have been motivated to select the characteristics of the system of Lundback to combine them with the heart computational studies of Nash. The Examiner does not explain with specificity why one of ordinary skill in the art would have combined the two heart model theories, or used the parameters of Nash in the system of Lundback, to develop a system adapted to realize a heart cluster state machine simulating the heart of an individual. In other words, what "could have been done" with Nash's data parameters is not the legal obviousness standard. Rather, the legal standard is what would have been obvious or suggested to one of ordinary skill in the art concerning use of the Nash parameters upon reading Nash. The "examiner must present a convincing line of reasoning as to why the artisan would have found the claimed invention to have been obvious in light of the teachings of the references." Ex parte Clapp, 227 USPQ 972, 973 (BPAI 1985). Furthermore, the Examiner appears to implicitly rely on Appellant's disclosure as motivation to combine the cited references, e.g, "[t]his interpretation that the invention is merely a combination of known mathematical models is consistent with the description of the invention given in the specification (p. 3, 11. 16-19)." Final Act. 9. The Examiner may not rely on knowledge gleaned only from applicant's disclosure. In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). "We must ... be careful not to allow hindsight reconstruction of references to reach the claimed invention without any explanation as to how or why the references would be 7 Appeal2014-002539 Application 11/795,945 combined to produce the claimed invention." Innogenetics, N. V. v. Abbott Labs., 512 F.3d 1363, 1374 n.3 (Fed. Cir. 2008). In view of the above, obviousness rejections 1 and 2 are reversed. Rejection 3 - Indefiniteness The Examiner found that, " [ t ]he rejection of claims 21-40 under 3 5 U.S.C. Â§ 112, second paragraph, is not being reviewed on appeal as Appellant made no argument in the Brief regarding this rejection." Ans. 2. Because Appellant provides no rebuttal to this rejection on the merits, it is summary affirmed. CONCLUSION OF LAW The cited references do not support the Examiner's obviousness rejections 1 and 2, which are reversed. The indefiniteness rejection 3, which covers all the claims, is affirmed. Therefore, all claims remain rejected. TIME PERIOD No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ l.136(a). AFFIRMED 8