Ex Parte Knize et alDownload PDFBoard of Patent Appeals and InterferencesDec 1, 201011378853 - (D) (B.P.A.I. Dec. 1, 2010) 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. 11/378,853 03/16/2006 Mark G. Knize IL-11466 7536 24981 7590 12/01/2010 Lawrence Livermore National Security, LLC LAWRENCE LIVERMORE NATIONAL LABORATORY PO BOX 808, L-703 LIVERMORE, CA 94551-0808 EXAMINER MARTIN, PAUL C ART UNIT PAPER NUMBER 1657 MAIL DATE DELIVERY MODE 12/01/2010 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 BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte MARK G. KNIZE, KRISTEN S. KULP, and KUANG JEN J. WU __________ Appeal 2010-008412 Application 11/378,853 Technology Center 1600 __________ Before CAROL A. SPIEGEL, TONI R. SCHEINER, and JEFFREY N. FREDMAN, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL1 This is an appeal under 35 U.S.C. § 134 involving claims to an apparatus for analyzing cells. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 The two-month time period for filing an appeal or commencing a civil action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing, as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE” (paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery mode) shown on the PTOL-90A cover letter attached to this decision. Appeal 2010-008412 Application 11/378,853 2 Statement of the Case The Specification teaches that the “invention relates to sample preparation and more particularly to sample preparation of biological cells for use with imaging mass spectrometry” (Spec. 1 ¶ 0002). The Claims Claims 1, 3, 5, and 6 are on appeal. Claim 1 is representative of the argued claims. The remaining claims have not been argued separately and therefore stand or fall together. 37 C.F.R. § 41.37(c)(1)(vii). Claim 1 reads as follows: 1. An apparatus for reliably and reproducibly exposing the contents of a biological cell to an analysis instrument, wherein said biological cell has intracellular contents, comprising: a sample handling unit, said sample handling unit including a first solid substrate with first substrate face and a second solid substrate with second substrate face, wherein said first substrate face and said second substrate face are opposed with an unobstructed open space between said first substrate face and said second substrate face and wherein the biological cell is positioned between said first substrate face and said second substrate face in said open space, and a framework with a mechanism for applying a range of pressures to said first substrate face and said second substrate face that can force said first substrate face directly against said second substrate face to entirely close said unobstructed open space, said mechanism for applying a range of pressures to said first substrate face and said second substrate face operable to apply a release pressure to the biological cell to release the Appeal 2010-008412 Application 11/378,853 3 intracellular contents of the biological cell and reliably and reproducibly expose the intracellular contents of the biological cell to the analysis instrument, and a pressure measuring device connected to said sample handling unit for enabling said framework to apply said release pressure to the biological cell to release the intracellular contents of the biological cell and reliably and reproducibly expose the intracellular contents of the biological cell to the analysis instrument. The issues A. The Examiner rejected claims 1, 3, and 5 under 35 U.S.C. § 103(a) as obvious over Takamatsu2 and Malone3 (Ans. 4-6). B. The Examiner rejected claims 1, 3, 5, and 6 under 35 U.S.C. § 103(a) as obvious over Takamatsu, Malone, and Roddy4 (Ans. 6-7). A. 35 U.S.C. § 103(a) over Takamatsu and Malone The Examiner finds it obvious “to modify the apparatus of Takamatsu et al. to include a pressure measuring device as taught by Malone et al. because this would provide important data as to what pressures are required 2 Takamatsu et al., On the mechanism of cell lysis by deformation, 38 J. BIOMECHANICS 117-124 (2005). 3 Malone et al., Effects of High Pressure on the Viability, Morphology, Lysis, and Cell Wall Hydrolase Activity of Lactococcus lactis subsp. cremoris, 68 APPLIED ENVIRONMENTAL MICROBIOLOGY 4357-4363 (2002). 4 Roddy et al., Identification of Cellular Sections with Imaging Mass Spectrometry Following Freeze Fracture, 74 ANALYTICAL CHEMISTRY 4020-4026 (2002). Appeal 2010-008412 Application 11/378,853 4 to lyse the cells and at what pressures the appearance and degree of certain morphologies occur” (Ans. 5). Appellants note that “claim 1 includes the following claim limitations . . . a mechanism for applying a range of pressures to said first substrate face and said second substrate face that can force said first substrate face directly against said second substrate face to entirely close said unobstructed open space” (App. Br. 12-13). Appellants contend that in “the Takamatsu reference a cell suspension is only deformed. Two glass beads are shown positioned between the microslide and the cover glass. The two glass beads prevent the microslide and the cover glass from contacting each other” (id. at 13). Appellants also contend that the Final Rejection does not establish a reasonable expectation of success with the proposed combination. There could be no combination of the Primary Takamatsu reference and the Secondary Malone reference that would provide a reasonable expectation of success or that would show Appellants’ invention of claims 1, 3, and 5. The Takamatsu reference has no need to include Applicants’ claim element, “a pressure measuring device . . . ” (id. at 15). Appellants contend that the “Final Rejection does not provide an explanation of how or why the Primary Takamatsu reference and the Secondary Malone reference would or could be combined to produce the missing claim limitations” (id.). Appeal 2010-008412 Application 11/378,853 5 The issue with respect to this rejection is: Does the preponderance of the evidence of record support the Examiner’s conclusion that Takamatsu and Malone render obvious the apparatus of claim 1? Findings of Fact 1. Takamatsu teaches that a “mechanical device with two parallel temperature-controlled stages was used to keep the two glass surfaces parallel during the compression process and to ensure that the procedure was performed at a precisely controlled temperature (Fig. 1)” (Takamatsu 118, col. 2). 2. Figure 1 of Takamatsu is reproduced below: “Fig. 1 Experimental technique for observation of deformed cells” (Takamatsu 119, col. 1). Appeal 2010-008412 Application 11/378,853 6 3. Takamatsu teaches that the “cells became deformed between the two flat surfaces and the distance between these surfaces was determined from the known diameter of the glass beads. The glass plates with the compressed cells were then placed under a microscope” (Takamatsu 118, col. 2). 4. Takamatsu teaches that the “stage of the microscope was also maintained at a controlled temperature. The phase-contrast and fluorescence images observed using a 10x objective at the same position were recorded using a digital camera” (Takamatsu 118, col. 2). 5. Malone teaches a study which “investigated the effects of high pressure on the viability, structure, lysis, and cell wall hydrolase activity of two L. lactis subsp. cremoris strains (MG1363 and SK11) in buffer suspensions. This will provide a better understanding of the biochemical and microbiological basis for changes that occur in pressure-treated cheeses” (Malone 4357, col. 2). 6. Malone teaches that “the sample was pressure treated to a pressure in the range of 100 to 800 MPa for 5 min at 25°C in a Quintus high- pressure food processor” (Malone 4358, col. 1). Principles of Law “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” Id. at 417. Moreover, an “[e]xpress suggestion to substitute one equivalent for another need not be present to render such substitution Appeal 2010-008412 Application 11/378,853 7 obvious.” In re Fout, 675 F.2d 297, 301 (CCPA 1982). As noted by the Court in KSR, “[a] person of ordinary skill is also a person of ordinary creativity, not an automaton.” 550 U.S. at 421. Analysis Takamatsu teaches an apparatus with a sample handling unit, first and second solid substrates with unobstructed faces opposed to one another, and a framework for applying a range of pressures to the substrate faces (FF 1- 4). Malone teaches investigating the effects of pressure on cell lysis (FF 5). Malone teaches that “the sample was pressure treated to a pressure in the range of 100 to 800 MPa for 5 min at 25°C in a Quintus high-pressure food processor” (Malone 4358, col. 1). Applying the KSR standard of obviousness to the findings of fact, we agree with the Examiner that it would have been obvious to include a pressure sensor in the device of Takamatsu “as taught by Malone et al. because this would provide important data as to what pressures are required to lyse the cells and at what pressures the appearance and degree of certain morphologies occur” (Ans. 5). Such a combination is merely a “predictable use of prior art elements according to their established functions.” KSR, 550 U.S. at 417. Appellants note that “claim 1 includes the following claim limitations . . . a mechanism for applying a range of pressures to said first substrate face and said second substrate face that can force said first substrate face directly against said second substrate face to entirely close said unobstructed open space” (App. Br. 12-13). Appellants contend that in “the Takamatsu reference a cell suspension is only deformed. Two glass beads are shown Appeal 2010-008412 Application 11/378,853 8 positioned between the microslide and the cover glass. The two glass beads prevent the microslide and the cover glass from contacting each other” (App. Br. 13; also see Reply Br. 5-6). We are not persuaded. Claim 1 is drawn to an apparatus, and not a method of using that apparatus. The glass beads are added with Takamatsu’s sample, and are not part of the device itself (FF 3). Use of a different sample without the glass beads would permit the first and second substrate faces of Takamatsu’s apparatus to close entirely, as required by claim 1. See Catalina Marketing International, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 810 (Fed. Cir. 2002) (“[D]isputed preamble language does not limit Claim 1-an apparatus claim. To hold otherwise would effectively impose a method limitation on an apparatus claim without justification”). Appellants also contend that the Final Rejection does not establish a reasonable expectation of success with the proposed combination. There could be no combination of the Primary Takamatsu reference and the Secondary Malone reference that would provide a reasonable expectation of success or that would show Appellants’ invention of claims 1, 3, and 5. The Takamatsu reference has no need to include Applicants’ claim element, “a pressure measuring device . . .” (App. Br. 15). We are not persuaded. Takamatsu teaches a device which permits increasing the pressure and Malone teaches devices in which pressure is measured. We agree with the Examiner that it would have been obvious to include a means for measuring the pressure applied by Takamatsu’s device Appeal 2010-008412 Application 11/378,853 9 “because this would provide important data as to what pressures are required to lyse the cells and at what pressures the appearance and degree of certain morphologies occur” (Ans. 5), and there would have been a reasonable expectation of success in adapting known pressure measuring devices of Malone to known devices which apply pressure as in Takamatsu. Kubin stated that “[r]esponding to concerns about uncertainty in the prior art influencing the purported success of the claimed combination, this court [in O’Farrell] stated: ‘[o]bviousness does not require absolute predictability of success … all that is required is a reasonable expectation of success.”’ In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009) (citing In re O’Farrell, 853 F.2d 894, 903-904 (Fed. Cir. 1988)). Appellants contend that the “Final Rejection does not provide an explanation of how or why the Primary Takamatsu reference and the Secondary Malone reference would or could be combined to produce the missing claim limitations” (App. Br. 15). We are not persuaded. The Examiner provides a specific combination which addresses the limitations of claim 1 (FF 1-6). Again, the Examiner reasons it would have been obvious “to modify the apparatus of Takamatsu et al. to include a pressure measuring device as taught by Malone et al. because this would provide important data as to what pressures are required to lyse the cells and at what pressures the appearance and degree of certain morphologies occur” (Ans. 5). We agree with the reasoning of the Examiner. The Examiner's reasoning for combining the references need not disclose the same purpose as Appellants in order to establish obviousness under 35 U.S.C. § 103. In re Dillon, 919 F.2d 688, 692-93 (Fed. Cir. 1990). Appeal 2010-008412 Application 11/378,853 10 Conclusion of Law The preponderance of the evidence of record supports the Examiner’s conclusion that Takamatsu and Malone render obvious the apparatus of claim 1. B. 35 U.S.C. § 103(a) over Takamatsu, Malone, and Roddy The Examiner finds that the “teachings of Takamatsu et al. and Malone et al. were discussed above. Neither Takamatsu et al. nor Malone et al. taught an apparatus wherein the first solid and second solid substrates are silicon or stainless steel” (Ans. 6). The Examiner finds that “Roddy et al. teaches the use of two solid silicon wafers in a device for wherein an aqueous solution of cells is positioned between the two wafers” (id.). The Examiner finds it obvious to modify mechanism for cell lysis by deformation comprising a sample handling unit including a cover glass and a slide glass as taught by Takamatsu et al. to use two solid silicon substrates as taught by Roddy et al. because both references teach the use of solid silicon and glass substrates in cell compression techniques to expose the contents of biological cells to analysis. (Ans. 7.) Appellants reiterate the argument that in “the Takamatsu reference a cell suspension is only deformed. Two glass beads are shown positioned between the microslide and the cover glass. The two glass beads prevent the microslide and the cover glass from contacting each other” (App. Br. 18). Appellants also reiterate the argument that the “Takamatsu reference has no need to include Applicants' claim element, ‘a pressure measuring device connected to said sample handling unit . . .’” (App. Br. 21). Appeal 2010-008412 Application 11/378,853 11 We are not persuaded. As we have already noted, the claims are drawn to an apparatus, not a method. The glass beads in Takamatsu are not part of the apparatus, but rather are included in the sample which Takamatsu analyzes. The apparatus itself does not include glass beads and would therefore satisfy the claim limitation for two substrate faces which “entirely close said unobstructed space” (see Claim 1). It is only in Takamatsu’s application of the apparatus to a particular sample, not the apparatus itself, that the glass beads are introduced (FF 1-4). As we noted, we agree with the Examiner’s reason to incorporate a pressure measuring device (see Ans. 5). SUMMARY In summary, we affirm the rejection of claim 1 under 35 U.S.C. § 103(a) as obvious over Takamatsu and Malone. Pursuant to 37 C.F.R. § 41.37(c)(1)(vii)(2006), we also affirm the rejection of claims 3 and 5, as these claims were not argued separately. We affirm the rejection of claim 6 under 35 U.S.C. § 103(a) as obvious over Takamatsu, Malone, and Roddy. 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)(2006). AFFIRMED Appeal 2010-008412 Application 11/378,853 12 cdc Lawrence Livermore National Security, LLC LAWRENCE LIVERMORE NATIONAL LABORATORY PO BOX 808, L-703 LIVERMORE, CA 94551-0808 Copy with citationCopy as parenthetical citation