MERCK PATENT GMBHDownload PDFPatent Trials and Appeals BoardMay 19, 20212020004819 (P.T.A.B. May. 19, 2021) 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. 15/121,944 08/26/2016 Wolfgang SCHMIDT MERCK-4499 2109 23599 7590 05/19/2021 MILLEN, WHITE, ZELANO & BRANIGAN, P.C. 2200 CLARENDON BLVD. SUITE 1400 ARLINGTON, VA 22201 EXAMINER PAGUIO FRISING, MICHELLE F ART UNIT PAPER NUMBER 1651 NOTIFICATION DATE DELIVERY MODE 05/19/2021 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): docketing@mwzb.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte WOLFGANG SCHMIDT and TIM CSER Appeal 2020-004819 Application 15/121,944 Technology Center 1600 Before ERIC B. GRIMES, ROBERT A. POLLOCK, and JOHN E. SCHNEIDER, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1–20. See Final Act. 1. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Merck Patent GmbH. Appeal Br. 1. Appeal 2020-004819 Application 15/121,944 2 CLAIMED SUBJECT MATTER The claims are directed to a method of detecting microbes carried in a non-liquid sample such as food (vegetables, meats, dairy, etc.), environmental samples (sponges, swabs, soil, etc.), cosmetic or pharmaceutical preparations (creams, ointments, etc.), and various systems for doing so. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A method, comprising a. providing a single test sample to be tested, b. providing a sample of from 1 g to 500 g of dehydrated growth medium, c. providing heated pure water from a water system with a heater located upstream or downstream of a source of pure water, which heater heats water to a temperature of about 30-45 °C, and which heater is selected from the group consisting of tankless water heaters and heat exchangers, wherein the total amount of water provided in the heater for heating is sufficient to dissolve the sample of dehydrated growth medium but insufficient to dissolve multiple samples of dehydrated growth medium, d. homogenizing the test sample, e. reconstituting the sample of dehydrated growth medium into a liquid form with the heated pure water from c) by i. adding the heated pure water to the sample of dehydrated growth medium and reconstituting the sample of dehydrated growth medium and then adding the reconstituted liquid medium to the homogenized test sample in a container, or ii. adding the heated pure water, sample of dehydrated growth medium and the test homogenized sample into a container together, f. mixing the reconstituted liquid medium and homogenized test sample to a homogenous consistency and g. incubating the container containing the pure water, reconstituted liquid medium and homogenized test sample for a period of time sufficient to allow growth of microbes to form an incubated sample. Appeal 2020-004819 Application 15/121,944 3 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Novotny US 2003/0185548 A1 Oct. 2, 2003 Croteau WO 97/18455 May 22, 1997 De La Rosa Fraile EP 1,098,002 A1 May 9, 2001 Chandrapati WO 2009/052137 A1. April 23, 2009 Food Poultry Breeder Improves Environmental Monitoring with Innovative Dry-Bags, FOOD SAFETY MAGAZINE, August/September 2007 Sept. 2007 de Boer Methodology for detection and typing of foodborne microorganisms, 50 INT'L J. FOOD MICROBIOL. 119–130 1999 REJECTIONS Claims 1–12, 14, and 16–20 are rejected under 35 U.S.C. § 103 as being unpatentable over Croteau and De la Rosa Fraile, in view of Food and Novotny.2 Claims 1–20 are rejected under 35 U.S.C. § 103 as being unpatentable over Croteau and De la Rosa Fraile in view of Food and Novotny, and in further in view of Chandrapati and de Boer. 2 Claims 1–19 were also rejected under 35 U.S.C. § 112(a) for failure to satisfy the written description requirement. Final Act. 5. That rejection was withdrawn. Ans. 9. Appeal 2020-004819 Application 15/121,944 4 Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis 1–12, 14, 16–20 103 Croteau, De La Rosa Fraile, Food, Novotny 1–20 103 Croteau, De La Rosa Fraile, Food, Novotny, Chandrapati, de Boer, OPINION Croteau Combined with De La Rosa Fraile, Food, and Novotny Issue The issue with respect to this rejection is whether a preponderance of the evidence supports the Examiner’s conclusion that the subject matter of claims 1–12, 14, and 16–20 would have been obvious to one of ordinary skill in the art at the time the invention was made over Croteau combined with De La Rosa Fraile, Food, and Novotny. The Examiner finds that Croteau teaches a method for performing microbiological tests on a sample comprising “liquefying the sample, and then mixing it with water and medium to a homogeneous consistency.” Final Act. 9. The Examiner finds that Croteau teaches that the mixture is then incubated at 37°C to allow bacterial growth. Id. The Examiner finds that Croteau teaches that the process can be performed on a unit dose basis. Id. The Examiner finds that while Croteau does not teach the specific amounts of dehydrated growth medium recited in the claims, “a person with ordinary skill in the art would have determined the appropriate amount through routine experimentation and optimization especially since it would depend on the amount and type of sample being tested.” Id. at 10. The Examiner finds that De La Rosa Fraile “teaches a method of performing microbiological tests by homogenizing a semi-solid and/or solid Appeal 2020-004819 Application 15/121,944 5 sample through shaking and suspending the powdered media in sterile distilled water, which is provided at room temperature or about 25°C and can also be ‘about 30°C’.” Id. The Examiner finds that Food teaches the use of a tankless water heater upstream with a source of pure water. Id. at 10–11. The Examiner concludes Given the convenience of preheating pure water with the aid of an instant heater and employing it for reconstitution of dehydrated medium in a bag, a person with ordinary skill in the art before the effective filing date of the claimed invention would have modified the process of Croteau et al. and De la Rosa Fraile by using a water deionizer and instant heater such that deionized water is provided to an instant water heater, heated to 42°C, and then filtered through a filter prior to mixing with dehydrated medium in a bag as taught by Food Safety Insider and Novotny et al.. [sic] It can be predicted that such modification would allow easy preparation of reconstituted medium and make microbial testing of a sample more efficient and less labor-intensive. The water deionizer is a device that yields pure water for the instant water heater to heat, which fulfills “providing heated pure water from a water system with a heater located upstream or downstream of a source of pure water”. And since the instant water heater provides hot water on demand, it can be expected that only the water needed to dissolve the dehydrated medium is instantaneously heated, thereby satisfying the limitation “wherein the total amount of heated water provided in the heater is sufficient to dissolve the sample of dehydrated growth medium but insufficient to dissolve multiple samples of dehydrated growth medium”. Furthermore, use of a bag containing sterile medium such as the one shown by Food Safety Insider would advantageously keep the dehydrated medium sterile. The obviousness of the instant claim is based on some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. See MPEP § Appeal 2020-004819 Application 15/121,944 6 2143.01 and KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007). Thus, the claimed invention is obvious over Croteau et al. and De la Rosa Fraile, in view of Food Safety Insider and Novotny et al. Id. at 11–12. Appellant contends that the references fail to teach all of the elements of the claims. Appeal Br. 5. Specifically, Appellant contends that the references do not teach or suggest a system where the total amount of water in the heater is sufficient to dissolve a sample of dehydrated growth medium, but insufficient to dissolve multiple samples. Id. Appellant contends that the Examiner has improperly pieced together teachings from various references without considering the teachings of the references as a whole. Id. Appellant contends that Croteau is silent as to the relation of the water in the heater and the sample size and that the remaining references teach the use of heaters designed to heat bulk amounts of water. Id. at 6. Appellant also contends that modifying the heater taught in Food would render the system unsatisfactory for its intended purpose. Id. at 7–8.3 Principles of Law “[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability. If 3 In its reply brief Appellant presents additional arguments distinguishing Croteau and De La Rosa Fraile. Reply Br. 5–8. These arguments do not respond to arguments made by the Examiner in the Answer but respond to the original Final Rejection. As such they should have been raised in the Appeal Brief. See 37 C.F.R. § 41.41 (B)(2). As Appellant has not advanced any argument demonstrating good cause why we should consider these arguments now, we decline to consider them. Id. Appeal 2020-004819 Application 15/121,944 7 that burden is met, the burden of coming forward with evidence or argument shifts to the applicant.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). A proper § 103 analysis requires “a searching comparison of the claimed invention—including all its limitations—with the teaching of the prior art.” In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995). Analysis We adopt the Examiner’s findings of fact, reasoning on scope and content of the prior art, and conclusions set out in the Final Action and Answer regarding this rejection. We find the Examiner has established a prima facie showing that the subject matter of the claims would have been obvious over Croteau combined with De La Rosa Fraile, Food, and Novotny to a person of ordinary skill in the art at the time the invention was made. Appellant has not produced evidence showing, or persuasively argued, that the Examiner’s determinations on obviousness are incorrect. Only those arguments made by Appellant in the Briefs have been considered in this Decision. Arguments not presented in the Briefs are waived. See 37 C.F.R. § 41.37(c)(1)(iv) (2015). We have identified claim 1 as representative; therefore, all claims fall with claim 1. We address Appellant’s arguments below. Appellant contends that the references fail to teach the claim element calling for the total amount of water provided in the heater to be sufficient to dissolve the sample but insufficient to dissolve multiple samples of the dehydrated growth medium. Appeal Br. 5. Appellant argues that the claim requires that the water heater be sized to produce a single unit amount of heated water and the references do not teach resizing the water heater. Id. at 5–6. Appellant argues that while Croteau may teach unit dosing, this is not the same as limiting the heated water to a single dose. Id. at 6. Appellant Appeal 2020-004819 Application 15/121,944 8 contends that Food teaches heating bulk amounts of water not a single unit amount of water. Id. at 6–7. Appellant argues that when read as a whole, Croteau is also directed to bulk amounts of water to reconstitute the dehydrated medium. Id. We have considered Appellant’s arguments and are not persuaded that the rejection is in error. While Croteau teaches the bulk preparation of the growth medium to prepare a number of samples, Example 2 of Croteau is clearly limited to single unit preparation and teaches the use of only enough water to rehydrate the growth medium. Croteau, 13. While Food discloses the preparation of a bulk amount of growth medium, Food is only relied upon for the teaching of using heated water to reconstitute the medium and the use of a tankless water heater to heat the water. See Final Act. 10–11. We agree with the Examiner that Croteau’s teaching of using only an amount of water to reconstitute the dehydrated growth medium combined with Food’s teaching to use heated water and the use of a tankless water heater would have led one skilled in the art to the present invention. Final Act. 11–12. Appellant argues that modification of Food would render the system disclosed in Food unfit for its intended purpose, negating the combination proposed by the Examiner. Appeal Br. 7–8. Appellant contends that Food is directed to bulk sample preparation and that modifying the heater in Food to produce only sufficient water for one sample would defeat that purpose. Id. Once again we are not persuaded by Appellant’s argument. As noted above, Food is cited only for the teaching of using heated water to reconstitute the dehydrated growth medium and to use a tankless hot water heater. Final Act. 10–11. The Examiner did not propose modifying Food but Appeal 2020-004819 Application 15/121,944 9 instead argues that it would have been obvious to modify Croteau to use heated water produced by a tankless water heater. Id. at 11–12. Appellant also contends that the claims require that water be provided in the water heater and that the water heater of Food “provides no water in its heater.” Appeal Br. 8. We remain unpersuaded. As the Examiner points out, Novotny teaches that water is always present in a tankless water heater and that a tankless system delivers heated water in the amount needed. Ans. 11. The Examiner goes on to point out [N]ot having a tank for storing heated water does not mean that water is not being provided in the heater. According to Novotny et al., a typical instant water heater has a water inlet that introduces water into chambers and also a water outlet through which heated water exits (Figure 1; par. [0041]- [0043]). When a faucet is opened during use, water flows through the chambers and is heated upon contact with the heater coils present therein (par. [0044]). What a user collects from the water outlet is therefore water that was just heated. Instant water heaters are called tankless, not because there is no water provided in the heater, but because it does not have a tank for storing water that is already heated. Thus contrary to Appellants’ argument, use of Food Safety Insider’s instant water heater necessitates having water in the water heater (specifically in the chambers). More importantly, an instant water heater is capable of providing a single unit of heated water sufficient for reconstituting a single amount of water [sic, medium] since only the amount of water needed is heated and dispensed. Id. at 12. Thus, we agree with the Examiner that the combined teachings of the references render the present invention obvious. Appeal 2020-004819 Application 15/121,944 10 Conclusion Based on the foregoing we conclude that a preponderance of the evidence supports the Examiner’s conclusion that the subject matter of claim 1 would have been obvious to one of ordinary skill in the art at the time the invention was made over Croteau combined with De La Rosa Fraile, Food, and Novotny. Claims 2–12, 14, and 16–20 have not been argued separately and therefore fall with claim 1. Croteau combined with De La Rosa Fraile, Food, Novotny, Chandrapati, and de Boer Issue The issue with respect to this rejection is whether a preponderance of the evidence supports the Examiner’s conclusion that the subject matter of claims 1–20 would have been obvious to one of ordinary skill in the art at the time the invention was made over Croteau combined with De La Rosa Fraile, Novotny, Food, Chandrapati, and De Boer. The Examiner reiterates the findings with respect to the teachings of Croteau, De La Rosa Fraile, Food, and Novotny. Final Act. 13. The Examiner finds that Chandrapati teaches the use of paddles to homogenize samples for microbiological testing. Id. The Examiner also finds that de Boer taches the use of a StomacherTM to homogenize samples. Id. at 13–14. With respect to claim 13, the Examiner concludes One with ordinary skill in the art before the effective filing date of the claimed invention would have liquefied the sample using a stomaching device and have reasonable expectation that microbes in the sample would be released. This would ensure that accurate results regarding the presence and/or amount of microbes in the sample being tested would be obtained. Id. at 14. Appeal 2020-004819 Application 15/121,944 11 Turning to claim 15, the Examiner finds that the combination of references teach a method that uses a water deionizer and instant water heater to generate heated deionized water, which are the same as “a system for producing pure water, a system for heating water”, respectively. The bag containing sterile dehydrated medium is analogous to “a bag of sterile granular growth medium”. The stomaching device is analogous to “a blender for homogenizing”. The incubator that provides an environment conducive for growth of bacteria in the sample reads on “an incubator for growing microbes contained within the test sample”. Id. Appellant contends that the teachings of Chandrapati and de Boer conflict with each other and that it would not be obvious to combine the references. Appeal Br. 9. Appellant contends that Chandrapati teaches mixing with paddles inside a bag whereas de Boer eliminates the use of paddles. Id. at 10. Appellant also contend that the claims require several homogenization steps and Chandrapati and de Boer only teach one homogenization step. Id. Analysis We have considered the arguments presented by the Examiner and Appellant as well as the evidence of record and conclude that the Examiner has the better position. As discussed above, the combination of Croteau, De La Rosa Fraile, Food, and Novotny teach the elements of claim 1. Appellant has only presented arguments regarding claims 13 and 15, which we will now address. Appeal 2020-004819 Application 15/121,944 12 Depending from claim 1, claim 13 requires that “the test sample is homogenized by a blender selected from the group consisting of a stationary blender and a paddle blender.” Claim 15 recites that the method of claim 1 is performed by a system for detecting microbes in a sample, said system comprising: a bag of sterile granular growth medium, a system for producing pure water, a system for heating water, a blender for homogenizing the test sample and the combined sample, medium and water and an incubator for growing microbes contained within the test sample. Appellant contends that the disclosures of Chandrapati and de Boer contradict each other making a combination of the references improper. Appeal Br. 9. We are unpersuaded by this argument. The Examiner cited Chandrapati and de Boer as teaching homogenization of samples for microbiological samples and did not suggest combining the teachings of the references. See Final Act. 13–14. Moreover, as admitted by Appellant, Chandrapati teaches the use of a paddle mixer to homogenize a sample. Chandrapati, 5. This is one of the two homogenization methods recited in claim 13. Thus Chandrapati combined with Croteau, De La Rosa Fraile, Food and Novotny renders claim 13 obvious. Appellant argues that the present claims call for at least two homogenization steps, namely homogenization of the sample to be tested and then homogenization of the mixture of the test sample and the growth medium. See Appeal Br. 10–11. Appellant argues that Chandrapati and de Boer only teach a single homogenization step. Id. We remain unpersuaded by Appellant’s argument. While Chandrapati and de Boer may teach only one homogenization step, Croteau teaches both steps. Croteau teaches that the method may include liquefying the sample. Croteau 3. Croteau also teaches that the tube containing the food sample and Appeal 2020-004819 Application 15/121,944 13 the growth medium is shaken to completely mix the two components. Id. at 13. We agree with the Examiner that these two steps are the equivalent to the homogenization steps recited in the claims. Ans. 14. Conclusion Based on the foregoing we conclude that a preponderance of the evidence supports the Examiner’s conclusion that the subject matter of claims 1, 13, and 15 would have been obvious over Croteau combined with De La Rosa Fraile, Novotny, Food, Chandrapati, and De Boer. Claims 2–12, 14, and 16–20 have not been argued separately and, therefore, fall with claim 1. CONCLUSION The Examiner’s rejections are affirmed. More specifically, DECISION SUMMARY Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–12, 14, 16–20 103 Croteau, De La Rosa Fraile, Food, Novotny 1–12, 14, 16–20 1–20 103 Croteau, De La Rosa Fraile, Food, Novotny, Chandrapati, de Boer, 1–20 Overall Outcome 1–20 Appeal 2020-004819 Application 15/121,944 14 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