Ex Parte Kshirsagar

Patent Trials and Appeals BoardMar 6, 2019

14254236 - (D) (P.T.A.B. Mar. 6, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/254,236 04/16/2014 32692 7590 03/08/2019 3M INNOVATIVE PROPERTIES COMPANY PO BOX 33427 ST. PAUL, MN 55133-3427 FIRST NAMED INVENTOR Manjiri T. Kshirsagar 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. 65742US010 3218 EXAMINER ARIAN!, KADE ART UNIT PAPER NUMBER 1651 NOTIFICATION DATE DELIVERY MODE 03/08/2019 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): LegalUSDocketing@mmm.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MANJIRI T. KSHIRSAGAR 1 Appeal2018-005944 Application 14/254,236 Technology Center 1600 Before JEFFREY N. FREDMAN, DEBORAH KATZ, and JOHN G. NEW, Administrative Patent Judges. NEW, Administrative Patent Judge. DECISION ON APPEAL 1 According to Appellant, the real party in interest is 3M Company (Appeal Br. 2). Appeal2018-005944 Application 14/254,236 SUMMARY Appellant files this appeal under 35 U.S.C. Â§ 134(a) from the Examiner's Final Rejection of claims 1-14 and 16 as unpatentable under 35 U.S.C. Â§ 103(a) as obvious over the combination ofN.Y. Lee et al., Microfluidic Immunoassay Plaiform Using Antibody-immobilized Glass Beads and Its Application for Detection of Escherichia coli 0157:H7, 27 BULL. KOREAN CHEM. Soc. 479--483 (2006) ("Lee"); Plumb et al. (US 7,298,886 B2, November 20, 2007) ("Plumb"); and D.V. Volodkin et al., Protein Encapsulation via Porous CaC03 Microparticles Templating, 5 BIOMACROMOLECULES 1962-72 (2004) ("Volodkin"). 2 We have jurisdiction under 35 U.S.C. Â§ 6(b). We affirm. NATURE OF THE CLAIMED INVENTION Appellant's invention is directed to a process for optically detecting the presence of coliform strains in a sample by using a particulate concentration agent to bind or capture a variety of coliform strains and contacting the coliform-bound particulate concentration agent with a culture medium in a culture device. Spec.; Abstr. 2 We note that the Examiner inadvertently erred in omitting Volodkin from the statement of the obviousness rejection, but relies on Volodkin in the body of the rejection. See Final Act. 7. Because the Examiner previously cited Volodkin during prosecution and put the Appellant on notice of the reference, we hold this error harmless. 2 Appeal2018-005944 Application 14/254,236 REPRESENTATIVE CLAIM Claim 1 is representative of the claims on appeal and recites: 1. A process comprising (a) providing at least one sample suspected of comprising at least one coliform strain; (b) providing at least one culture device comprising at least one culture medium that is hydrated or hydratable; ( c) providing at least one particulate concentration agent that is substantially optically transparent when in contact with said culture medium in said culture device when said culture medium is hydrated, wherein each of said at least one particulate concentration agent can concentrate a variety of coliform strains, wherein said particulate concentration agent comprises inorganic microparticles selected from metal silicates; silica; metal carbonates; metal phosphates; metal oxide-, gold-, or platinum-modified diatomaceous earth; and combinations thereof; ( d) placing said particulate concentration agent in contact with said sample such that at least a portion of said coliform strain is bound to or captured by said particulate concentration agent to form coliform-bound particulate concentration agent; ( e) placing said coliform-bound particulate concentration agent in contact with said culture medium of said culture device; (f) incubating said culture device comprising said coliform-bound particulate concentration agent in contact with said culture medium, said culture medium being hydrated; and (g) optically detecting the presence of said coliform strain without separating said coliform strain from said particulate concentration agent, wherein said optically detecting is performed in the culture device. App. Br. 24. 3 Appeal2018-005944 Application 14/254,236 ISSUES AND ANALYSIS We adopt the Examiner's findings, reasoning, and conclusion establishing that Appellant's claims 1-14 and 16 are primafacie obvious over the combined prior art. We address the arguments raised by Appellant below. Issue 1 Appellant argues that the Examiner erred because the cited prior art does not disclose a microparticle that can concentrate a variety of coliform strains. App. Br. 15. Analysis The Examiner finds that Lee teaches the simultaneous detection of multiple bacterial pathogens by using glass beads attaching different antibodies in a single microfluidic device. See Final Act. 6; see also Ans. 6- 7 (citing Lee 479,483). The Examiner finds Lee teaches a specific example of a process of detecting the presence of at least one coliform strain (E. coli) by: (1) providing a sample of E. coli in a hydrated growth medium, providing at least one glass bead with surface antibodies specific to E. coli; (2) contacting the E. coli and growth medium with the glass beads to bind the E. coli in a microfluidic chamber; and (3) optically detecting the E. coli without separating the E. coli from the glass bead. Final Act. 6 ( citing Lee 482--483). The Examiner finds that Lee "do[ es] not teach the particulate concentrating agent comprises metal carbonate microparticles." Final Act. 7. However, the Examiner finds Volodkin teaches metal carbonate 4 Appeal2018-005944 Application 14/254,236 microparticles capable of absorbing macromolecules. Id. ( citing Volodkin Abstr., 1963). The Examiner determines a person of ordinary skill in the art would have combined Volodkin's metal carbonate microparticles with Lee's detection process, in order to reduce non-specific binding with a reasonable expectation of success in capturing coliform strains. See id. The Examiner finds Lee does "not teach optically detecting a color change in the presence of [a] gas bubble proximate to at least [an] E. coli colony with the flat film." Final Act. 7. However, the Examiner finds that Plumb teaches a flat film culture medium for optically detecting a color change and the presence of a gas bubble proximate to an E. coli colony. See id. at 7-8 (citing Plumb col. 1, 11. 52-56; col. 13, 11. 33-50). The Examiner determines that a person of ordinary skill in the art would have been motivated to combine the growth medium for optically detecting a color change and the presence of a gas bubble from an E. coli colony in a culture device with Lee to reduce errors as taught by Plumb. See id. Appellant argues that "the silica microparticles of Lee are not structurally the same as the inorganic microparticles disclosed in the present application." App. Br. 15 ( emphasis in original). Specifically, Appellant argues that application discloses amine-functionalized glass beads and unmodified silica micro spheres, as opposed to Lee's glass beads, which are surface modified with antibodies and L-lysine blocking the remaining surface. See id. at 16-17. Appellant further argues that "surface functionalization of the concentration agent is critical to its total structure, because the surface functionalization affects the ability of the concentration agent to selectively or non-selectively capture a material." Reply Br. 5. Appellant argues that this limitation is recited in the claims as "wherein each 5 Appeal2018-005944 Application 14/254,236 of said at least one particulate concentration agent can concentrate a variety of coliform strains." See id. Furthermore, Appellant argues that "Lee does not explicitly disclose glass beads having more than one antibody attached such that each microparticle could concentrate a variety of coliform strains." App. Br. 17 ( emphasis in original). Rather, Appellant contends that Lee "discloses the use of multiple different beads of different sizes having different attached antibodies to detect multiple analytes in one device using discrete microchambers for the different beads. Nowhere does Lee disclose that each of the beads can concentrate a variety of coliform strains." Id. at 18. We are not persuaded by Appellant's arguments. We begin with the interpretation of the claims on appeal. We interpret the claims in light of Appellant's Specification and with the knowledge of one of ordinary skill in the art. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Appellant contends that "wherein each of said at least one particulate concentration agent can concentrate a variety of coliform strains" requires a specific surface functionalization of the concentration agent. See Reply Br. 4---6. However, the Specification states that "[ s ]uitable particulate concentration agents include ... particles comprising biomolecules ... (for example, beads with surface-bound antibodies)." Spec. 13. Absent an express recitation of a specific surface functionalization, we conclude that the broadest reasonable interpretation of the particulate concentration agent includes beads with surface-bound antibodies, as taught by Lee. We agree with Appellant that Lee does not expressly disclose beads including more than one antibody immobilized on each bead. However, "[i]n determining whether the subject matter of a patent claim is obvious, 6 Appeal2018-005944 Application 14/254,236 neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid underÂ§ 103." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,419 (2007). Here the claims recite "at least one particulate concentration agent ... wherein each of said at least one particulate concentration agent can concentrate a variety of coliform strains, wherein said particulate concentration agent comprises inorganic microparticles selected from ... silica." The Specification defines "concentration agent" as "a material or composition that binds microorganisms including coliforms ... ," which, as discussed above, may comprise surface-bound antibodies. Spec. 7, 13. Therefore, we conclude that the broadest reasonable interpretation of the claims includes at least one particulate concentration agent being a material, e.g., silica microparticles, wherein the each of the material (silica microparticles) can concentrate a variety of coliform species. Because Lee teaches glass beads attaching several different antibodies for simultaneous binding and detection of multiple bacterial pathogens, we agree with the Examiner that Lee teaches or suggests the recited limitation that each of at least one particulate concentration agent can concentrate a variety of coliform strains. 7 Appeal2018-005944 Application 14/254,236 Issue 2 Appellant argues that the Examiner erred because the cited prior art does not disclose a culture device comprising a culture medium and thus does not teach or suggest the required steps of the claimed process. App. Br. 19-21. Analysis Appellant argues that Lee teaches a microfluidic device, not a culture device with a culture medium or a flat film. App. Br. 20. Appellant argues that Lee teaches adding E. coli and growth medium at the same time to a microfluidic device packed with anti-body coated glass beads. See id. at 21. Thus, Appellant argues that "Lee fails to disclose ... 'providing at least one culture device comprising at least one culture medium that is hydrated or hydratable' and 'placing said coliform-bound particulate concentration agent in contact with said culture medium of said culture device."' Id. In other words, Appellant argues that the prior art does not teach steps (b) and ( e) of the claimed process. See Reply Br. 9. Appellant further argues that Lee teaches optically detecting microorganism strains using fluorescence, which does not require incubating prior to optical detection. App. Br. 21. Thus, Appellant argues there would have been no motivation to modify the microfluidic device of Lee with the culture device of Plumb, "at least because incubation of microorganisms is more time consuming than fluorescence detection and requires either including a growth medium in the microfluidic device or transferring the beads to a (e.g., flat film) culture device." Id. 8 Appeal2018-005944 Application 14/254,236 We are not persuaded by Appellant's arguments. Again, we begin with claim interpretation, where the Specification defines "culture device" as "a device that can be used to propagate microorganisms including coliforms under conditions that will permit at least one cell division to occur." Spec. 7. Applying the broadest reasonable interpretation, we conclude the definition of culture device includes Lee's microfluidic device as well as Plumb's flat film. As to the steps of the process, we conclude that the broadest reasonable interpretation of the claims allows for overlap between the steps. The plain meaning of the claims does not preclude combining the "providing" and "placing steps." Moreover, the Specification provides: The sample contacting step of the process of the invention can be carried out by any of various known or hereafter-developed methods of providing contact between two materials. For example, the particulate concentration agent can be added to the sample, or the sample can be added to the particulate concentration agent. Spec. 24 ( emphasis added). The Specification also states: "the particulate concentration agent and the sample are combined (using any order of addition) in any of a variety of containers." Id. As to contacting with a culture medium, the Specification provides: A preferred contacting method includes both mixing . . . and preliminarily incubating ... a microorganism-containing sample (preferably, a fluid) with particulate concentration agent. If desired, one or more additives (for example ... microbial growth media . . . can be included in the combination of particulate concentration agent and sample. Id. at 25-26. Furthermore, the Specification states that "[h]ydration of the culture medium ... can be effected either prior to or after ... the culture 9 Appeal2018-005944 Application 14/254,236 medium and the coliform-bound particulate concentration agent are brought into contact (or simultaneously therewith)." Spec. 27. In other words, the Specification allows for simultaneously mixing of a sample and concentration agent with a hydrated growth medium. Because we determine that the broadest reasonable interpretation of the claims allows for the overlap between process steps, we find Lee's method of combining a glass bead (concentration agent), diluted growth medium containing E. coli (hydrated culture medium and coliform sample), and a microfluidic device ( culture device), teaches the limitations of steps (b ),( d), and ( e) of the claimed process. Moreover, as to the combination with Plumb for teaching incubating an E. coli colony on a flat film culture medium for optical detection, we are similarly not persuaded that the references cannot be combined. As discussed above, Appellant argues the combination requires incorporating "a growth medium in the microfluidic device" or "the beads to a ( e.g., flat film) culture device." However, "[t]he 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 the references would have suggested to those of ordinary skill in the art." In re Keller, 642 F.2d 413,425 (C.C.P.A. 1981). Instead, we agree with the Examiner that the combined teaching suggests a process using an optically transparent particulate concentration agent that can concentrate a variety of coliform strains with a flat film culture medium for optically detecting coliform foodbome pathogens. 10 Appeal2018-005944 Application 14/254,236 Issue 3 Appellant argues the Examiner's proposed modification to the prior art would render it inoperable for its intended purpose. Analysis Appellant contends the Examiner "proposed supplementing the glass beads coated with antibody specific to one microorganism strain with metal carbonate particles." App. Br. 22. Appellant argues that "to include a concentration agent such as a metal carbonate as proposed by the Examiner, would destroy the sensitivity ... of the method of Lee, rendering it unsatisfactory for its intended purpose." Reply Br. 10. We are not persuaded that the Examiner erred in determining that there would be a reasonable expectation of success to employ metal carbonate as a particulate concentrating agent to bond coliform strains. See Ans. 12-13. Appellant adduces no evidence that modifying the multiparticulate material in Lee would prevent "multiple-analyte detection with a single operation" which is the end goal of the reference. See Lee 483. Therefore, we conclude that it would have been obvious to a person of ordinary skill in the art to modify the detection process of Lee with the metal carbonate particles of Volodkin. 11 Appeal2018-005944 Application 14/254,236 DECISION The Examiner's rejection of claims 1-14 and 16 as unpatentable under 35 U.S.C. Â§ 103(a) is affirmed. 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). AFFIRMED 12