James Nial. Hynes et al.Download PDFPatent Trials and Appeals BoardMay 28, 202014233602 - (D) (P.T.A.B. May. 28, 2020) 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. 14/233,602 01/17/2014 James Nial Hynes LUXCL005USPT01 6117 22878 7590 05/28/2020 Agilent Technologies, Inc. Global IP Operations 5301 Stevens Creek Blvd Santa Clara, CA 95051 EXAMINER PATURY, SRIKANTH ART UNIT PAPER NUMBER 1657 NOTIFICATION DATE DELIVERY MODE 05/28/2020 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): Agilentdocketing@cpaglobal.com ipopsadmin@agilent.foundationip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte JAMES NIAL HYNES and DMITRI BORIS PAPKOVSKY Appeal 2019-000485 Application 14/233,602 Technology Center 1600 ____________ Before DONALD E. ADAMS, FRANCISCO C. PRATS, and ULRIKE W. JENKS, Administrative Patent Judges. JENKS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 files this appeal from Examiner’s decision to reject the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 Appellant identifies the real party in interest as Luxcel Biosciences, Ltd. Appeal Br. 2. We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appeal 2019-000485 Application 14/233,602 2 STATEMENT OF THE CASE Claims 1–4, 6–9, 11, 14, 15 and 19 are on appeal, and can be found in the Claims Appendix of the Appeal Brief. Claim 1 is representative of the claims on appeal, and reads as follows: 1. A method of detecting the presence of thermoduric microorganisms in a product, comprising the steps of: (a) placing an aliquot of the product into a vessel equipped with an optical probe sensitive to a thermoduric microorganism metabolite, wherein the thermoduric microorganism metabolite is oxygen, and wherein the optical probe is an oxygen sensitive photoluminescent dye, (b) hermetically sealing the aliquot and the optical probe within the vessel, (c) pasteurizing the hermetically sealed aliquot within the vessel, (d) incubating the pasteurized and hermetically sealed aliquot within the vessel for an incubation period, and (e) periodically interrogating the probe during the incubation period, wherein the interrogations measure changes in the probe reflective of changes in concentration of a thermoduric microorganism metabolite within the aliquot, with such changes in concentration indicative of the presence of viable thermoduric microorganisms in the aliquot, having survived pasteurization of the hermetically sealed aliquot. Appeal Br., Claims Appendix. REFERENCES The prior art relied upon by Examiner is: Name Reference Date Kleinerman US 6,607,300 B1 Aug. 19, 2003 Belhumeur et al. (“Belhumeur”) US 7,851,178 B1 Dec. 14, 2010 Papkovsky et al. (“Papkovsky”) US 2006/0002822 A1 Jan. 5, 2006 G.L. Pettipher & Ubaldina M. Rodrigues, Rapid Enumeration of Bacteria in Heat-treated Milk and Milk Products Using a Membrane Filtration- Appeal 2019-000485 Application 14/233,602 3 Name Reference Date Epifluorescent Microscopy Technique, 50 J. Applied Bacteriology 157–66 (1981) (“Pettipher”) Milk Facts, Heat Treatments and Pasteurization, http://milkfacts.info/Milk%20Processing/Heat%20Treatments%20and%20 Pasteurization.htm, last accessed March 2, 2017 (“Milk Facts”) REJECTION Claims 1–4, 6–9, 11, 14, 15, and 19 are rejected under pre-AIA 35 U.S.C. §103(a) as being unpatentable over Papkovsky in view of Pettipher, Belhumeur, and Milk Facts as further evidenced by Kleinerman. OBVIOUSNESS The issue is whether the preponderance of evidence of record supports Examiner’s conclusion that the method of detecting the presence of thermoduric microorganisms is obvious. A. Findings of Fact (FF) FF1. Pettipher teaches that “[q]uality control in the dairy industry would benefit from the use of a rapid, inexpensive, sensitive, direct method for enumerating bacteria in milk and milk products.” Pettipher 157. Pettipher teaches using “[a] rapid direct epifluorescent filter technique (DEFT) . . . to enumerate bacteria in heat-treated milk and milk products.” Id., Abstract. Pettipher teaches collecting samples from collection tankers and pasteurizing the sample in the laboratory at 63°C for 30 minutes, storing the sample in the refrigerator, and examining the product daily over a 5 day period. Id. at 157. FF2. Milk Facts teaches that the commercial implementation of pasteurization eliminated the common milkborne illnesses such as “typhoid fever, scarlet fever, septic sore throat, diptheria, and diarrheal diseases.” Milk Facts 3. Milk Facts teaches that Appeal 2019-000485 Application 14/233,602 4 “pasteurization conditions of 145°F (62.8°C) for 30 minutes for a batch process, or 161°F (71.7°C) for 15 sec for a continuous process, were adopted in order to inactivate Coxiella burnetii, and these conditions are still in use today.” Id. FF3. Papkovsky teaches that “solid-state luminescent oxygen probes and systems based thereon have been used in various assays and applications in particular in blood gas analysis, monitoring biological activity, presence of microorganisms, cellular respiration, . . . or sterility for example.” Papkovsky ¶ 5. Papkovsky teaches using an improved oxygen sensitive probe to monitor oxygen uptake by chemical or biological samples comprising the step of adding an oxygen sensitive probe to a test sample and measuring changes in the probe emission which reflect changes in the dissolved oxygen concentration, [] wherein the probe comprises a monofunctional derivative of an oxygen-sensitive photoluminescent dye covalently attached to a water- soluble hydrophilic macromolecular carrier. Id. ¶ 34. FF4. The biological test samples contemplated by Papkovsky include “microorganisms, subcellular organell[e]s, animal tissue or aquatic animals.” Id. ¶ 35. FF5. Papkovsky teaches: Monofunctional derivatives of water-soluble Pt- coproporphyrins are preferred dyes[, because they are easily conjugated to macromolecules]. . . . [These o]xygen probes based on Pt-coproporphyrins have emission at about 650 nm and they are suitable for time- resolved fluorescence measurements and lifetime-based oxygen sensing with relatively simple instrumentation. . . . [T]he probes can be used in trace amounts even in Appeal 2019-000485 Application 14/233,602 5 complex biological samples with high scattering and autofluorescence. Id. ¶ 65. Papkovsky teaches conjugating the oxygen-sensitive luminescent dyes to hydrophilic macromolecular carriers. Id. ¶ 67. The preferred conjugates are: Pt-porphyrins with poly(ethyleneglycols), (PEGs), such as PEG-5,000, PEG-10,000 and PEG-20,000 (numbers correspond to different molecular weights). PEG molecules normally contain terminal OH-group(s), and no other reactive functionality within the chain. These terminal OH-groups are suitable for chemical modification and/or for site-directed conjugation with the oxygen-sensitive dyes. Id. ¶ 68. FF6. Papkovsky teaches a method of monitoring cellular respiration using a cell viability assay. Id. ¶¶ 112–114, see Fig. 3. The steps include adding “PtCP-BSA 2:1 or PtCP-PEG-20, 000 (1:1) conjugate . . . at a concentration 10.6 to 10-9 M” to a well containing 150 µl of cells at a concentration range of 105-107 cells/ml. Id. ¶ 112. To this cell:dye mixture the method adds “100 ul of heavy mineral oil . . . on top of each sample to reduce the effect of atmospheric oxygen and phosphorescence intensity readings were taken at regular time intervals (1-3 minutes) for a for a period of 30-120 min.” Id. ¶ 112, see also id. ¶ 47 (“Mineral oil reduces diffusion of ambient air oxygen into the sample thus acting as a seal.”). In addition, Papkovsky teaches that the dye can be either added directly to the sample or it can be pre- coated onto the walls of the sample well before adding the sample. Id. ¶ 114. FF7. Belhumeur teaches a method of evaluating the efficiency of a Appeal 2019-000485 Application 14/233,602 6 sterilization process. Belhumeur 2:18–20. The method includes subjecting a prion protein degradation indicator in a container to a sterilization process followed by determining the degradation of the indicator. Id. at 2:21–24. “The indicator may be a biological indicator, biochemical indicator, or chemical indicator.” Id. at 2:36–37. FF8. Kleinerman teaches photoluminescent material such as platinum(I) porphyrin among others. Kleinerman 4:13–16. Kleinerman teaches that it is only “[i]n the high temperature region (above 500°C.) within which the luminescence decay time τ decreases appreciably,” resulting in a decrease of luminescent efficiency. Id. at 6:18–20. FF9. The Specification describes hermetically sealing as any “sealing techniques capable of withstanding the thermal treatment, including specifically but not exclusively a screw cap 20, a heat or adhesive sealing foil (not shown), layer of mineral oil (not shown), etc.” Spec. ¶ 40. B. 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. C. Analysis Examiner finds that Papkovsky teaches a method for measuring oxygen concentration/uptake in biological samples comprising microorganisms using photoluminescent dyes. Final Act. 3; see also Ans. 6 (Papkovsky “teaches the use of porphyrin based photo luminescent oxygen Appeal 2019-000485 Application 14/233,602 7 probes (the same dyes used in the instant application) to monitor microorganism levels in samples.”); FF3–FF6. Examiner finds that Papkovsky’s method “can measure/monitor any microorganism based on oxygen consumption/levels in its methods.” Ans. 6. Examiner finds that Papkovsky correlates the oxygen concentration to cell number. Final Act. 3; FF6. Examiner acknowledges that Papkovsky “does not teach pasteurization of the biological sample to be a food sample and monitoring thermoduric microorganisms in the sample.” Final Act. 4. Examiner relies on Pettipher and Milk Facts for teaching that pasteurization conditions for milk product are optimizable. Ans. 6; FF1, FF2. Examiner relies on Pettipher for teaching a method of monitoring thermoduric bacteria in pasteurized milk. Ans. 6; FF1. Examiner finds that Kleinerman teaches that “that the porphyrin oxygen probes can withstand high temperatures.” Ans. 7; FF8. Belhumeur teaches measuring the sufficiency of a sterilization process using an indicator. FF7. Examiner cites Belhumeur “to teach that sterilization (autoclaving) of probes to monitor contamination was known in the art.” Ans. 7. Based on these disclosures, Examiner concludes that it would have been obvious to one of ordinary skill at the time the invention was made to substitute one known biological sample having the potential for containing viable bacteria for another. Ans. 5; FF1, FF6. Examiner further concludes that it would have been obvious to add an oxygen sensitive probe into a sample before pasteurizing the sample in order to prevent contamination of the sample after pasteurization. Ans. 5. Appellant contends that none of the references teach all the limitations of the present claims. Appeal Br. 5–6. Appellant contends that Pettipher Appeal 2019-000485 Application 14/233,602 8 “says nothing about use of the technique to specifically measure only thermoduric bacteria in the milk and milk products.” Appeal Br. 6 (emphasis added). Appellant contends that Belhumeur “does not disclose a probe to monitor contamination” because it only measures degradation of the indicator. Reply Br. 2; see Appeal Br. 6–7. We have reviewed Appellant’s contentions in light of Examiner’s cited art and find that the preponderance of the evidence supports Examiner’s conclusion that the claims are obvious. We address Appellant’s contentions below. We are not persuaded by Appellant’s contention that the references do not disclose all the claimed elements. We note that Appellant’s arguments attacking the Papkovsky, Pettipher, Belhumeur, Milk Facts, and Kleinerman references individually (see, e.g., Appeal Br. 5–6), where the rejection is based on their combination, is improper. “Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. . . . [The reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Papkovsky teaches that oxygen sensitive probes were known to be used to test for sterility. FF3. Papkovsky teaches using oxygen sensitive probes for monitoring cellular respiration using a cell viability assay. FF6. The assay takes cells and exposes them to an oxygen-sensitive luminescent dye before taking phosphorescence intensity readings at intervals over a two-hour period. FF6. Papkovsky teaches that oxygen-sensitive luminescent dye and test sample are mixed and then sealed with mineral oil in order to Appeal 2019-000485 Application 14/233,602 9 reduce the diffusion of ambient oxygen into the test sample. FF6, see FF9 (hermetically sealing encompasses using a layer of mineral oil). Thus, as acknowledged by Examiner, Papkovsky teaches all the steps but for the pasteurizing step. See Final Act. 4. Examiner relies on Pettipher and Milk Facts for teaching pasteurization of milk to make it safe for consumption, and for teaching that the process can be optimized. Ans. 6; FF1, FF2. Pettipher teaches that there is a need for better “[q]uality control in the dairy industry” and that the industry “would benefit from the use of a rapid, inexpensive, sensitive, direct method for enumerating bacteria in milk and milk products.” FF1. Thus, Pettipher teaches that milk even after pasteurization needs to be checked for the presence of viable bacteria to ensure that the pasteurization process was effective. Examiner finds that “[t]he artisan would be motivated to add the oxygen probe in the sample wells with the sample before pasteurizing so as to not contaminate the samples after pasteurizing.” Ans. 5. We find no error with Examiner’s conclusion that it would have been obvious to include an oxygen sensitive probe before sealing and pasteurizing the sample. We are not persuaded by Appellant’s contention that Pettipher “says nothing about use of the technique to specifically measure only thermoduric bacteria in the milk and milk products.” Appeal Br. 6 (emphasis added). One of skill in the art would understand that thermoduric bacteria are bacteria that can survive, to varying extents, the pasteurization process. FF1, FF2; see Spec. ¶ 3 (“The standard test for detecting and enumerating thermoduric bacteria is the Laboratory Pasteurization Count (LPC), which serves as an indicator of the effectiveness of farm sanitation and hygiene procedures.”). Appeal 2019-000485 Application 14/233,602 10 Thermoduric bacteria does not pertain to a particular strain of bacteria but is generally understood as any bacteria that survives the pasteurization process. Pettipher teaches the need for improved quality control in the dairy industry to ensure the efficacy of the pasteurization process in order to make sure the milk product is safe for consumption. FF1. Because Pettipher detects bacteria after pasteurization, we agree with Examiner that pasteurized milk has the potential to contain thermoduric bacteria. See Ans. 6 (“[I]t would be obvious to an artisan to use the pasteurized milk comprising thermoduric bacteria.”). We are not persuaded by Appellant’s contention that Belhumeur “does not disclose a probe to monitor contamination.” Reply Br. 2; see Appeal Br. 7. Belhumeur teaches adding an indicator before applying a sterilization process. FF8. We agree with Examiner that Belhumeur teaches using an indicator for determining that the sterilization condition applied to a sample was sufficient to decontaminate the sample. See Ans. 7 (Examiner explains that “Bellhumeur was cited to teach that sterilization (autoclaving) of probes to monitor contamination was known in the art.”). Papkovsky teaches that oxygen probes were known to be used to test sample sterility. FF1. Papkovsky’s oxygen sensitive probe can measure viable bacteria and the probe can be added either before or after applying a pasteurization process. Picking one of a finite number of known solutions to a known problem is obvious. KSR, 550 U.S. at 421: When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that Appeal 2019-000485 Application 14/233,602 11 instance the fact that a combination was obvious to try might show that it was obvious under § 103. Here, Examiner finds that “[t]he artisan would be motivated to add the oxygen probe in the sample wells with the sample before pasteurizing and seal the samples during the testing so as to not contaminate the samples after pasteurizing.” Ans. 7. We find no error with Examiner’s conclusion that based on the combination of references one of ordinary skill in the art would have been motivated to use an oxygen sensitive probe to measure the efficiency of the pasteurization process. See FF1–FF6. We agree with Examiner’s rationale that the choice of adding the probe to the sample before the pasteurization process ensures that any viable bacteria in the sample is not a product of post-pasteurization contamination but instead is a product of insufficient pasteurization. D. Conclusion We conclude, considering the totality of the cited evidence and arguments, that the preponderance of the evidence supports Examiner’s conclusion of obviousness with respect to claim 1, and Appellant has not provided sufficient rebuttal evidence or evidence of secondary considerations that outweighs the evidence supporting Examiner’s conclusion. As Appellant does not argue the claims separately, claims 2–4, 6–9, 11, 14, 15 and 19 fall with claim 1. 37 C.F.R. § 41.37 (c)(1)(iv). Appeal 2019-000485 Application 14/233,602 12 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–4, 6–9, 11, 14, 15, 19 103(a) Papkovsky, Pettipher, Belhumeur, Milk Facts, Kleinerman 1–4, 6–9, 11, 14, 15, 19 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 Copy with citationCopy as parenthetical citation