Ex Parte Kucharczyk et alDownload PDFPatent Trial and Appeal BoardAug 25, 201512321139 (P.T.A.B. Aug. 25, 2015) 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. 12/321,139 01/15/2009 John Kucharczyk 500.003US2 6211 97462 7590 08/26/2015 Mark A. Litman & Associates, P.A. 7001 Cahill Road, Ste. 15A Edina, MN 55439 EXAMINER ROY, BAISAKHI ART UNIT PAPER NUMBER 3777 MAIL DATE DELIVERY MODE 08/26/2015 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte JOHN KUCHARCZYK and MARK A. LITMAN1 __________ Appeal 2012-012316 Application 12/321,139 Technology Center 3700 __________ Before DONALD E. ADAMS, ROBERT A. POLLOCK, and ELIZABETH A. LaVIER, Administrative Patent Judges. POLLOCK, Administrative Patent Judge. DECISION ON APPEAL Appellants appeal under 35 U.S.C. § 134(a) from the final rejection of claims 1–14 and 17–20. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. STATEMENT OF THE CASE The Specification states that “[a]s cells are introduced into a tissue for purposes of effecting therapy to a patient, it becomes critical to monitor the status of the cells and their assimilation and integration into the environment.” Spec. 16:3–5. Further, certain “hallmarks of cell growth and proliferation . . . can be assessed according to the present invention (as by 1 Appellants identify the Real Party in Interest as NEXGEN MEDICAL SYSTEMS, INCORPORATED. App. Br. 3. Appeal 2012-012316 Application 12/321,139 2 MRI),” such as indications of increased metabolism as the cells replicate or the presence of or increase in blood flow. Id. at 16:5–21. Claims 1, 2, and 10 are independent. Illustrative claim 1 recites: 1. A method for indicating viability of transplanted progenitor or stem cells in an organ engineering environment, the method being performed with a medical device that supports at least one sensing function, the method comprising: non-destructively observing a region of the growing tissue or organ where cells have been placed; sensing a property within said region of the organ that is indicative of cell viability or nonviability of the cells; and using data from sensing said property within said region to indicate cell viability from the cells on tissue cytoarchitecture within the organ wherein said cell viability is indicated by a property in cell chemistry resulting from an event selected from the group consisting of cell activity, cell inactivity, cell growth, cell death, specific cell function, specific cell dysfunction, volumetric expansion of cell population, and volumetric decrease of cell population. Claim 2 specifies that the “non-destructively observing” step is carried out “with a medical imaging system.” In Claim 10, the “non- destructive[] observing” step is directed to indicating the viability of cells grown on a scaffold as a complete transplantable organ, wherein the sensed property “comprises blood flow or changes in blood flow as vascular supply is developed.” I. Claims 1–14 and 17–20 stand provisionally rejected under 35 U.S.C. § 101 as claiming the same invention as that of claims 5, 6, 7, 9, 11– Appeal 2012-012316 Application 12/321,139 3 15, 17, 18–21, 29, and 54–56 of copending Parent Application No. 09/606,137.2 II. Claims 1, 2, 7, 8, 10, 11, 14–16, 18, and 19 stand rejected under 35 U.S.C. § 102(b) as anticipated by Major.3 III. Claims 3, 4, 5, 6, 9, 12, 13, 17, and 20 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Major in view of Morcos.4 ANALYSIS Statutory Double Patenting Rejection In response to the rejection under 35 U.S.C. § 101 over claims 5, 6, 7, 9, 11–15, 17, 18–21, 29, and 54–56 of copending Parent Application No. 09/606,137, Appellants contend that “[a]s this rejection is provisional, Applicants will address this issue upon allowance of any claims asserted to be overlapping in either pending application.” App. Br. 10. Appellants further indicate that their Reply Brief “includes herewith a Terminal Disclaimer with respect to that copending application.” Reply Br. 2. The Board finds no evidence that a terminal disclaimer has been filed in either application. More to the point, a statutory double patenting rejection under 35 U.S.C. § 101 cannot be cured by terminal disclaimer. See In re Vogel, 422 F.2d 438, 441 (CCPA 1970). Thus, absent any substantive argument on this issue, we summarily affirm the rejection. See MPEP 2 The instant application is a continuation-in-part of Application No. 09/606,137 (“the Parent Application”). The Parent Application is currently pending and subject to a Notice of Appeal filed October 16, 2014. 3 Major et al., US 5,869,463, issued Feb. 9, 1999. 4 Morcos et al., US 5,497,770, issued Mar. 12, 1996. Appeal 2012-012316 Application 12/321,139 4 § 1205.02 (Rev. 8, July 2010) (“If a ground of rejection stated by the examiner is not addressed in the appellant’s brief, that ground of rejection will be summarily sustained by the Board.”). The failure to appeal is a waiver under Ex parte Frye, 2010 WL 889747, at *4 (BPAI Feb. 26, 2010) (precedential) (“If an appellant fails to present arguments on a particular issue – or, more broadly, on a particular rejection – the Board will not, as a general matter, unilaterally review those uncontested aspects of the rejection.”). Rejections under 35 U.S.C. § 102(b) and 35 U.S.C. § 103(a) All claims stand rejected as anticipated by Major or obvious based on Major in view of Morcos. Appellants direct us to the Board Decision of April 16, 2012, in the Parent Application (Appeal No. 2010-009722), which also involved rejections over Major alone or in combination with Morcos. App. Br. 4, 10–11. For claims 1, 2, and claims dependent therefrom, the dispositive issue for the 35 U.S.C. § 102(b) and 35 U.S.C. § 103(a) rejections is the same as decided in the appeal involving the Parent Application. We provide additional analysis with respect to claim 10 and its dependent claims. The Examiner finds that Major discloses a method of indicating the viability of transplanted cells that involves nondestructively observing a region of a patient to where progenitor or stem cells grown in a culture have been transplanted (col. 7 lines 33-41). The method involves sensing a property within the region of a patient or tissue cytoarchitecture that is indicative of cell viability or inviability of the transplanted progenitor or stem cells using magnetic resonance imaging (col. 11 lines 28-36) where cell viability is indicated by a property in cell chemistry resulting Appeal 2012-012316 Application 12/321,139 5 from an event such as cell activity/inactivity, cell growth/death, specific cell function/dysfunction, volumetric expansion of cell population, and volumetric decrease of cell population (col. 4 lines 7-14). Ans. 3–4. With respect to independent claim 10, the Examiner finds that Major “would necessarily involve monitoring tissue blood flow or changes in blood flow as vascular supply is developed and where T1 and T2 weighted images with and without contrast agent are generated (col. 11 lines 32-36).” Id. at 4; see id. at 5, 6, 10. Appellants argue that Major does not disclose non-destructively observing a region containing transplanted cells and sensing a property in cell chemistry or blood flow that indicates cell viability, as required by the claims. App. Br. 11–16, 19–20; Reply Br. 6–9. Specifically, Appellants argue that Major tests cells in vitro for viability before implantation (App. Br. 11–16; Reply Br. 6–9), but monitors successful engraftment of cells only by post-mortem histological methods, and not the claimed method of non- destructively observing a tissue region (App. Br. 14–16; Reply Br. 9). Appellants argue that Major only uses MRI to initially position the transplanted tissue in the subjects (App. Br. 16; Reply Br. 9) and to assess tumor formation (App. Br. 14–15; Reply Br. 8–9), not to sense a property indicative of cell viability. Appellants also argue Morcos does not make up for the deficiency of Major. Id. at 17–19. We agree with Appellants that the Examiner has not adequately shown that Major discloses a method that includes all of the limitations of the claims on appeal, or that Major in combination with Morcos would have made obvious a method meeting the limitations of the rejected claims. “[T]he examiner bears the initial burden, on review of the prior art or on any Appeal 2012-012316 Application 12/321,139 6 other ground, of presenting a prima facie case of unpatentability.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). All of the claims on appeal require “non-destructively observing a region of a patient” where cells have been transplanted, sensing a property that is indicative of cell viability, and using the sensed property to indicate cell viability, where cell viability is indicated by a property in cell chemistry (independent claims 1 and 2), “blood flow or changes in blood flow” (independent claim 10). As specified in claim 2, one method of non- destructively observing a tissue region is by magnetic resonance imaging (MRI). The Examiner points to Major’s disclosure at column 7, lines 33–41 and column 11, lines 28–36, as meeting the “non-destructively observing” and “sensing” limitations of the claims. Ans. 3–4. These passages, however, do not describe the required claim steps. At column 7, lines 33– 41, Major describes performing “pre-implantation MRI to determine target coordinates for the later implantation of cells in the subject’s brain.” This disclosure therefore does not describe “non-destructively observing a region of the growing tissue or organ where cells have been placed.” See claim 1 (emphasis added). At column 11, lines 28–36, Major describes using MRI to evaluate tumor or nodule formation in monkeys following implantation of cells. Major discloses that the “scans revealed no evidence of tumor or nodule formation” (Major, 11:35–36) but does not describe the results as indicating anything about the viability of the transplanted cells. As we concluded in the appeal in the Parent Application, the Examiner has not provided evidence that detecting “[n]o evidence of tumor formation” (i.e., at column 11, line 30) is the same thing as “sensing a Appeal 2012-012316 Application 12/321,139 7 property . . . that is indicative of cell viability or nonviability,” as recited in the claims. That is, the lack of tumor evidence described in Major does not indicate either viability or nonviability of the transplanted cells. Similarly, with respect to claim 10, the Examiner has not explained why Major’s teaching of “MR evaluation and obtaining T1 and T2 weighted images . . . shows blood flow changes in the cells and necessarily provides a quantitative assessment of the transplanted cells.” See Ans. 5, 10. To the contrary, we do not discern where Major suggests sensing blood flow or changes in blood flow, or how such data is indicative of viability or nonviability of transplanted cells on an organ scaffold, in accord with claim 10. Thus, the Examiner has not shown that Major discloses a method meeting the limitations of the claims on appeal. The Examiner has not pointed to any disclosure in Morcos that would have made obvious the limitations that are not expressly disclosed by Major, and has, therefore, failed to establish a prima facie case of obviousness. SUMMARY I. We summarily affirm the provisional rejection of claims 1–14 and 17– 20 under 35 U.S.C. § 101 as claiming the same invention as that of claims 5, 6, 7, 9, 11–15, 17, 18–21, 29, and 54–56 of copending Application No. 09/606,137. II. We reverse the rejection of claims 1, 2, 7, 8, 10, 11, 14–16, 18, and 19 under 35 U.S.C. § 102(b) as anticipated by Major. III. We reverse the rejection of claims 3, 4, 5, 6, 9, 12, 13, 17, and 20 under 35 U.S.C. § 103(a) as unpatentable over Major in view of Morcos. Appeal 2012-012316 Application 12/321,139 8 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). AFFIRMED cdc Copy with citationCopy as parenthetical citation