Ex Parte Bitterly et alDownload PDFPatent Trial and Appeal BoardJan 3, 201813415702 (P.T.A.B. Jan. 3, 2018) 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. 13/415,702 03/08/2012 Steve Bitterly I022-P12116US 5277 33356 7590 01/05/2018 SoCAL IP LAW GROUP LLP 310 N. WESTLAKE BLVD. STE 120 WESTLAKE VILLAGE, CA 91362 EXAMINER CLARKE, TRENT R ART UNIT PAPER NUMBER 1651 NOTIFICATION DATE DELIVERY MODE 01/05/2018 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): USPTO@socalip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte STEVE BITTERLY and JACK BITTERLY Appeal 2016-007216 Application 13/415,7021 Technology Center 1600 Before FRANCISCO C. PRATS, JEFFREY N. FREDMAN and DAVID COTTA, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134(a) involves claims to a sensor for determining the presence of microbes. The Examiner rejected the claims as failing to comply with the written description requirement, lacking enablement, as being indefinite, and for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We reverse the Examiner’s rejection asserting lack of written description, but affirm the remaining rejections. 1 Appellants state that the “real parties in interest are the first named inventor, Steven Bitterly, and Jean Bitterly, the trustee or administrator of the estate of Jack Bitterly, the deceased second inventor.” Appeal Br. 1. Appeal 2016-007216 Application 13/415,702 STATEMENT OF THE CASE The Specification discloses that, “[conventional biological or microbial fuel cells convert biochemical energy directly into electricity. The driving force ... is the redox reaction of a carbohydrate substrate such as glucose and methanol using a microorganism or an enzyme as the catalyst.” Spec. 128. The Specification discloses that “[mjicrobial fuel cells also can act as a sensor to test wastewater for organic materials.” Id. 129. Appellants’ invention is directed to a sensor that “uses the metabolic reactions of bacteria or other microbes to produce a quantifiable and measurable voltage signal. An electronic processor, recorder or other device reads and records such signals.” Id. 130. The Specification explains that “[e]ach bacterium has its own specific growth rate under controlled fuel-cell conditions and temperatures. Therefore, each produces its own specific voltage versus time growth-plot.” Id. 133. Thus, “[b]y knowing the voltage versus growth-time versus temperature for the more common bacteria, a system including the sensors may use algorithms to analyze outputs from an array of micro-sensors. The results can be used to narrow unknown bacteria down to one or more probable candidates.” Id. Claim 1 is representative and read as follows (Appeal Br. 28): 1. A sensor for determining the presence of microbes comprising: a. a first chamber formed of at least one outside wall, the first chamber containing a food source for microbes, b. an anode in the first chamber capable of being connected to a first electrical terminal, 2 Appeal 2016-007216 Application 13/415,702 c. at least a portion of the outside wall of the first chamber comprising a semipermeable membrane, the semipermeable membrane having a pore size large enough for microbes to pass into the first chamber but small enough to prevent the passage of particals [sic] particles substantially larger than the micorbes [sic] microbes, d. a second chamber formed of at least one outside wall, the second chamber containing a cathode capable of being connected to a second electrical terminal, and e. a membrane between the first and second chambers capable of allowing ions to pass between the chambers. The following rejections are before us for review: (1) Claims 1—9, 20, and 21, under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement (Final Act. 13— 14;2 Ans. 2-3); (2) Claims 20 and 21, under 35 U.S.C. § 112, first paragraph, as failing to comply with the enablement requirement (Final Act. 14—18; Ans. 3-6); (3) Claims 1—9, 20, and 21, under 35 U.S.C. § 112, second paragraph, as being indefinite (Final Act. 18—19; Ans. 6—7); (4) Claims 1, 3—5, 7, and 8, under 35 U.S.C. § 103(a), as being unpatentable over Nam3 (Final Act. 19-22; Ans. 8—10); (5) Claims 1—5 and 7, under 35 U.S.C. § 103(a), as being unpatentable over Pu4 and Winger5 (Final Act. 22—24; Ans. 10-12); 2 Final Office Action entered April 16, 2015. 3 WO 2004/024633 A2 (published March 25, 2004). 3 Appeal 2016-007216 Application 13/415,702 (6) Claims 1 and 3—8, under 35 U.S.C. § 103(a), as being unpatentable over Nam and Ivnitski4 5 6 (Final Act. 24—25; Ans. 12—13); (7) Claims 1 and 3—8, under 35 U.S.C. § 103(a), as being unpatentable over Nam, Cho,7 and Topas Product Brochure8 (Final Act. 25—26; Ans. 13— 14); and (8) Claims 1, 3—5, and 7—9, under 35 U.S.C. § 103(a), as being unpatentable over Nam and Nakamura9 (Final Act. 26—27; Ans. 14—15). STANDARD OF REVIEW As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): [T]he examiner bears the initial burden ... of presenting a prima facie case of unpatentability. . . . After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. WRITTEN DESCRIPTION To meet the initial burden of establishing a prima facie case of unpatentability based on a lack of written description, the Examiner must 4 CN 101975809 A (published February 16, 2011) (as translated). 5 Alvin G. Winger et al., Some Electrochemical Properties of New Synthetic Ion Exchange Membranes, 100 J. Electrochem. Soc. 178—184 (1953). 6 Dmitri Ivnitski et al., Biosensors for detection ofpathogenic bacteria, 14 Biosensors & Bioelectronics 599-624 (1999). 7 US 7,666,285 B1 (issued Feb. 23, 2010). 8 http://www.topas.com/sites/defaulVfiles/files/topas_product- brochure_english.pdf (accessed Nov. 25, 2013). 9 Noriyuki Nakamura et al., Electrochemical detection of viable bacteria in urine and antibiotic selection, 6 Biosensors & Bioelectronics 575—580 (1991)(ab stract only). 4 Appeal 2016-007216 Application 13/415,702 “present[] evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims.” In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996). The Examiner determines that the recitation in clause c of claim 1, requiring the claimed semipermeable membrane to have a pore size large enough for microbes to pass into the first chamber, but small enough to prevent the passage of particles substantially larger than the microbes, lacks descriptive support in the disclosure as filed. Ans. 2—3. In particular, the Examiner contends that the term “particle” is not in the Specification, and the Specification does not included “a recitation of the prevention of the passage of any item, through the semipermeable membrane or otherwise.” Id. at 3. As support for the limitation at issue, Appellants direct us to Tflf 46, 72, and 73 of the Specification, as well as Figure 5. Appeal Br. 9—10. Having carefully reviewed the contentions and evidence advanced by both the Examiner and Appellants, we find that the preponderance of the evidence does not support the Examiner’s position. The test for determining whether a specification is sufficient to support a particular claim “is whether the disclosure of the application relied upon ‘reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter.’” Ralston Purina Co. v. Far- Mar-Co, Inc., 772 F.2d 1570, 1575 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375 (Fed. Cir. 1983)). Thus, “[i]t is not necessary that the application describe the claim limitations exactly, but only so clearly that persons of ordinary skill in the art will recognize from the disclosure that appellants invented processes 5 Appeal 2016-007216 Application 13/415,702 including those limitations.” In re Wertheim, 541 F.2d 257, 262 (CCPA 1976) (citation omitted); see also Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000) (“In order to satisfy the written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue.”). In the present case, as Appellants contend, 146 of the Specification discloses that the inventive sensor’s semipermeable membrane may have pores which are slightly larger than the size of the average bacterial cell: The porous material could be Gore-Tex®, an expanded and porous polytetrafluoroethylene (ePTFE), or a similar material. Typically, Gore-Tex has about 9 billion pores/in2 or around 1.4 billion pores/cm2. Thus, the average pore has a length of about 11 g-in or 27 g-cm (0.27 g-m). Typical bacteria have dimensions of about 8 g-in or 20 g-cm, so ePTFE could be a suitable option as the outside semipermeable membrane. Spec. 146. The Specification, thus, might not provide word-for-word support for the limitation at issue. Paragraph 46 of the Specification might also be erroneous as to the average size of bacteria, as the Examiner contends. See Ans. 18—19. Nonetheless, the disclosure in the Specification cited by Appellants supports their contention that a skilled artisan would recognize the sensor of the proposed invention as having a semipermeable membrane which would allow microbes to pass through, but which would exclude substances, including particles, significantly larger than the microbes. Accordingly, because Appellants persuade us, for the reasons discussed, that a preponderance of the evidence does not support the Examiner’s rejection under the written description requirement, we reverse that rejection. 6 Appeal 2016-007216 Application 13/415,702 ENABLEMENT—CLAIM 20 Claim 20 recites, “[t]he sensor of claim 1 wherein the semipermeable membrane is formed of stretched polytetrafhioroethylene.” Appeal Br. 29. In determining that claim 20 is not supported by an enabling disclosure, the Examiner finds initially that the “level of predictability in the biomedical arts is low, thus the amount of direction needed from the inventor is high.” Ans. 4. The Examiner then determines that the Specification “provides no working examples of any working sensor meeting the limitations of claim[] 20 . . . nor any working example of any sensor at all.” Id. The Examiner cites Gore10 as evidence that stretched polytetrafhioroethylene, recited in claim 20, would not allow an aqueous solution to pass through, “and, hence, would not allow the passage of microbes into the first chamber wherein the semipermeable membrane comprises Gore-Tex or polytetrafhioroethylene, absent evidence to the contrary.” Id. Appellants contend initially that the enablement requirement does not require the disclosure of a perfected commercially viable embodiment. Appeal Br. 15 (citing M.P.E.P § 2164, quoting, CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333, 1338 (Fed. Cir. 2003)). Appellants contend that the Examiner has not met the burden of showing non-enablement. Appeal Br. 15—16 (M.P.E.P § 2164.04; In re Wright, 999 F.2d 1557, 1562 (Fed. Cir. 1993); In re Marzocchi, 439 F.2d 220, 224 (CCPA 1971)). 10 US 3,953,566 (issued April 27, 1976). 7 Appeal 2016-007216 Application 13/415,702 In addition, Appellants contend: The specification explains that Brownian motion causes microbes to pass through the pores of the semipermeable membrane because the microbes are smaller than the pores. However, surface tension blocks water from passing through the semipermeable membrane’s pores. Applicants do not assert that all microbes in every drop of water will pass through the semipermeable membrane. As long as some pass, applicants’ device generates electrical signals. Amplifying tiny signals if necessary generates readable signals. Appeal Br. 16. Appellants contend further: GoreTex ePTFE material is known to have pores, and nothing explains why microbes smaller than the pores could not pass through the pores. Gore-Tex’s use in human surgery grafting is well known. There, body cells embed all throughout the Gore-Tex matrix, yet the typical size of human cells is much larger than the average bacteria size. . . . While true [that an aqueous solution would not pass through Gore-Tex at ambient pressure], it is irrelevant. Applicants are not causing water to flow through Gore-Tex, just to have microbes on one side of the semipermeable membrane pass through the pores to reach another aqueous solution. The microbes are not static. Besides Brownian motion, it is well known that many bacteria move by their own self-propelled motion by flagella, spiral rotation of the entire cell and pilli. No movement of bacteria through the semipermeable membrane requires water flow. Reply Br. 6—7. Having carefully reviewed the contentions and evidence advanced by both the Examiner and Appellants, we find that the preponderance of the evidence supports the Examiner’s position. As the Examiner found, the Specification does not disclose any working examples of a functioning microbial sensor. See Spec., generally. 8 Appeal 2016-007216 Application 13/415,702 As noted above, moreover, the Examiner advances evidence (the Gore patent) acknowledged as accurate by Appellants, that an aqueous microbe- containing solution cannot pass through the stretched polytetrafluoroethylene (PTFE) semipermeable membrane recited in claim 20. Appellants, in contrast, do not identify, nor do we discern, any specific disclosure in the Specification demonstrating, or even explaining, that Brownian motion allows microbes to pass through claim 20’s stretched PTFE membrane. Nor do Appellants identify any specific evidence in the Specification, or elsewhere in the record, supporting their assertion that natural bacterial modes of propulsion would be sufficient to allow bacteria to pass through claim 20’s stretched PTFE membrane, despite the fact that the aqueous milieu containing the bacteria cannot pass through the membrane. Given the lack of any working examples using claim 20’s stretched PTFE membrane, and given total the absence of persuasive evidence rebutting the evidence supporting the Examiner’s prima facie case, we are not persuaded that Appellants have shown error in the Examiner’s conclusion of lack of enablement. Even assuming that Appellants’ contentions in this regard might be plausible, our reviewing court has instructed that mere plausibility of a proposed theory of operability is insufficient to establish enablement: If mere plausibility were the test for enablement under section 112, applicants could obtain patent rights to ‘inventions’ consisting of little more than respectable guesses as to the likelihood of their success. When one of the guesses later proved true, the ‘inventor’ would be rewarded the spoils instead of the party who demonstrated that the method actually worked. That scenario is not consistent with the statutory requirement 9 Appeal 2016-007216 Application 13/415,702 that the inventor enable an invention rather than merely proposing an unproved hypothesis. In re ’318 Patent Infringement Litigation, 583 F.3d 1317, 1327 (Fed. Cir. 2009) (quoting Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1325 (Fed. Cir. 2005)). In sum, because Appellants do not persuade us, for the reasons discussed, that a preponderance of the evidence fails to support the Examiner’s enablement rejection as to claim 20, we affirm that rejection. ENABLEMENT—CLAIM 21 Claim 21 recites, “[t]he sensor of claim 1 wherein the semipermeable membrane has an outer surface facing outward from the sensor and an inside surface facing inside of the sensor, the semipermeable member being formed of a woven fabric treated with a hydrophilic substance on the outer surface and a hydrophobic substance on the inside surface.” Appeal Br. 29. In determining that claim 21 is not supported by an enabling disclosure, the Examiner finds initially that the “level of predictability in the biomedical arts is low, thus the amount of direction needed from the inventor is high.” Ans. 4. The Examiner then determines that the Specification “provides no working examples of any working sensor meeting the limitations of claim[] ...21... nor any working example of any sensor at all.” Id. The Examiner acknowledges the disclosure in 173 of the Specification that hydrophobic/hydrophilic coated woven fabrics may be used as the disclosed sensor’s semipermeable membrane, but contends 10 Appeal 2016-007216 Application 13/415,702 nonetheless that Appellants’ Specification is inadequate to enable the subject matter recited in claim 21: Because there are literally millions of hydrophobic and hydrophilic substances which could be used to treat a woven fabric, yet not a single example of an acceptable treatment to generate a semipermeable membrane suitable for use in the invention is given, the claimed invention would require an undue level of experimentation to determine which of the millions of possible hydrophobic and hydrophilic treatments would produce a semipermeable membrane suitable for use in the claimed invention and is therefore rejected under 35 U.S.C. § H2(a). Id. at 5. The Examiner contends, in particular, that Appellants’ Specification fails to provide sufficient details to enable a skilled artisan to practice the claimed invention. Id. at 6. In their Appeal Brief, Appellants do not specifically address the Examiner’s conclusion of lack of enablement as to claim 21. See Appeal Br. 15-16. In their Reply Brief, Appellants newly argue that “neither the examiner’s answer nor the final rejection cites evidence to the (1) millions of substances and (2) that only a few found after undue experimentation might work.” Reply Br. 7. Having carefully reviewed the contentions and evidence advanced by both the Examiner and Appellants, we find that the preponderance of the evidence supports the Examiner’s position. We first note that Appellants’ failure to specifically address the Examiner’s rejection as to claim 21 constitutes waiver of any argument to that rejection. See 37 C.F.R. § 41.37(c)(l)(iv) (except in certain circumstances not applicable here, “any arguments or authorities not 11 Appeal 2016-007216 Application 13/415,702 included in the appeal brief will be refused consideration by the Board for purposes of the present appeal”); see also MPEP § 1205.02 (“If a ground of rejection stated by the examiner is not addressed in the appellant’s brief, appellant has waived any challenge to that ground of rejection and the Board may summarily sustain it, unless the examiner subsequently withdrew the rejection in the examiner’s answer.”). We are not persuaded, therefore, that Appellants’ new argument is properly presented for the first time in the Reply Brief, such that we should consider it. See also 37 CFR § 41.41(b)(2) (“Any argument raised in the reply brief which was not raised in the appeal brief, or is not responsive to an argument raised in the examiner’s answer, including any designated new ground of rejection, will not be considered by the Board for purposes of the present appeal, unless good cause is shown.”); Ex parte Borden, 93 USPQ2d 1473, 1477 (BPAI 2010) (The reply brief is not “an opportunity to make arguments that could have been made in the principal brief on appeal to rebut the Examiner’s rejections, but were not.”) (“Informative”). In any event, on the current record, it is undisputed that the Specification fails to provide any working examples of microbial sensors, and fails to include any description of specific exemplary materials for use in the embodiment described in 173 of the Specification and recited in claim 21. Appellants, moreover, do not direct us to any specific evidence that, despite these deficiencies in the Specification identified by the Examiner, a skilled artisan nonetheless would have been able to make and use a microbial sensor encompassed by claim 21 without undue experimentation. Our reviewing court has explained, in a similar situation, that 12 Appeal 2016-007216 Application 13/415,702 when there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required; there is a failure to meet the enablement requirement that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. It is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement. This specification provides only a starting point, a direction for further research. Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366, (Fed. Cir. 1997) (citation omitted). Moreover, even acknowledging Appellants’ status as independent inventors (see Reply Br. 8), Appellants do not direct us to any authority suggesting that the enablement standard may be applied differently to an independent inventor, as opposed to a university or corporation (see id.). In sum, for the reasons discussed, we affirm the Examiner’s rejection of claim 21 for lack of enablement. INDEFINITENESS In rejecting claims 1—9, 20, and 21 for indefmiteness, the Examiner determines that the phrase in claim 1, ‘“particles substantially larger than the microbes’ . . . renders the claim indefinite because it is unclear what the metes and bounds of the phrase are, i.e. what size of particle is being recited and what constitutes a particle.” Ans. 7. In particular, the Examiner finds that, because the term “particle” is not present in the Specification, “it is not clear what constitutes a particle - any solid object?” Id. The Examiner contends, moreover that microbes “are 13 Appeal 2016-007216 Application 13/415,702 not all of uniform size,” as evidenced by the “Microbial size”11 web article. Id. The Examiner determines, moreover that “the term ‘substantially’ is a relative term which also renders the claim indefinite” because the term “is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.” Id. In their Appeal Brief, Appellants do not specifically address the Examiner’s conclusion of indefmiteness as to claim 1. See Appeal Br. generally. In their Reply Brief, Appellants contend that the Appeal Brief “did not break-up the indefmiteness response as a separate section, but it showed why the claims were definite. See the two paragraphs at the bottom of page 13.” Reply Br. 4. In addition, Appellants newly argue that the Examiner erred in determining that the term “substantially” is indefinite. Id. at 4—5 (citing Deere & Co. v. Bush Hog, LLC, 703 F.3d 1349, 1359 (Fed. Cir. 2012)). Having carefully reviewed the contentions and evidence advanced by both the Examiner and Appellants, we find that the preponderance of the evidence supports the Examiner’s position. Contrary to Appellants’ assertion, the final two paragraphs of page 13 of the Appeal Brief, discussing how a semipermeable membrane may block a “particle,” make no mention of indefmiteness, nor do they present any argument as to how or why claim 1 ’s term “substantially” is definite under §112, second paragraph. See Appeal Br. 13. 11 https://sizes.com/natural/bacteria.html (accessed May 5, 2016). 14 Appeal 2016-007216 Application 13/415,702 Thus, Appellants’ failure to specifically address the indefiniteness rejection, in particular the Examiner’s determination as to the claim term “substantially,” constitutes waiver of any argument to in that regard. See 37 C.F.R. § 41.37(c)(l)(iv); MPEP § 1205.02. We are not persuaded, therefore, that Appellants’ new argument is properly presented for the first time in the Reply Brief, such that we should consider it. See 37 CFR § 41.41(b)(2); Ex parte Borden, 93 USPQ2d at 1477 (“Informative”). In any event, we are not persuaded that our reviewing court has held that the term “substantially” is, as a matter of course, definite under § 112, second paragraph. To the contrary, the Federal Circuit has placed express conditions on the definiteness of terms of degree: The criticized words [‘approach each other,’ ‘close to,’ ‘substantially equal,’ and ‘closely approximate’] are ubiquitous in patent claims. Such usages, when serving reasonably to describe the claimed subject matter to those of skill in the field of the invention, and to distinguish the claimed subject matter from the prior art, have been accepted in patent examination and upheld by the courts. Deere v. Bush Hog, 703 F.3d at 1359 {quoting Andrew Corp. v. Gabriel Elecs., Inc., 847 F.2d 819, 821 (Fed. Cir. 1988) (internal quotations and brackets in original; emphasis added)); see also Seattle Box Co. v. Indus. Crating & Packaging, Inc., 731 F.2d 818, 826 (Fed. Cir. 1984) (When assessing whether a term of degree like “substantially” is definite, one must determine whether the Specification “provides some standard for measuring that degree.”). On the current record, Appellants do not explain adequately how or why claim 1 ’s recitation of a semipermeable membrane, that prevents the passage of particles “substantially larger” than the microbes permitted to 15 Appeal 2016-007216 Application 13/415,702 pass through membrane, serves reasonably to explain to a skilled artisan the actual size of the particles that may pass through the membrane, and the size of the particles that are necessarily excluded. Nor do Appellants direct us to any disclosure in the Specification that might provide that explanation. Thus, even if it were proper to consider Appellants’ newly presented arguments in the Reply Brief (which it is not), we are not persuaded that Appellants have shown error in the Examiner’s determination that claim 1 is indefinite under § 112, second paragraph. We, therefore, affirm the Examiner’s rejection of claim 1, and its dependent claims, for indefmiteness. OBVIOUSNESS—NAM In rejecting claims 1, 3—5, 7, and 8 over Nam, the Examiner finds that Nam describes a sensor having all of the claimed features, except for claim 1 ’s semipermeable membrane, which allows microbes to pass through, but which excludes particles substantially larger than the microbes. Ans. 8—10. The Examiner notes, however, that Nam “teaches filtering suspended substances from the water entering the anode chamber.” Id. at 10. The Examiner reasons, therefore, that an ordinary artisan would have considered a filtration membrane encompassed by claim 1 an obvious substitute to use in place of the pretreatment unit [disclosed in Nam], because it is necessary to the operation of the sensor for it to obtain microbes from the sampled water to metabolize (oxidize) organic material to operate the sensor and Nam teaches the value of filtering suspended substances in the sample to prevent clogging of the anode chamber (p 6, lines 13- lb)... . Id. In particular, the Examiner reasons, an ordinary artisan would have found it obvious “to use a membrane which is permeable to microbes but prevents the passage of macroscopic objects to filter the incoming water to 16 Appeal 2016-007216 Application 13/415,702 prevent suspended substances from entering and clogging the anode chamber.” Id. Appellants contend, for a number of reasons, that Nam is not analogous art to the claimed invention. Appeal Br. 16—21; Reply Br. 14—15. Appellants contend, moreover, that Nam does not teach or suggest a number of features required by the rejected claims, except through hindsight. Appeal Br. 21—22; 9-11. Having carefully reviewed the contentions and evidence advanced by both the Examiner and Appellants, we find that the preponderance of the evidence supports the Examiner’s position. Regarding the use of analogous art in obviousness rejections, our reviewing court has stated: Two separate tests define the scope of analogous prior art: (1) whether the art is from the same field of endeavor, regardless of the problem addressed and, (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved. In reBigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). In the present case, we determine that Nam satisfies both criteria. In particular, because the background section of Appellants’ Specification discusses the use of microbial fuel cells as sensors (see Spec. Tflf 27—29), Appellants do not persuade us that Nam, which describes using a microbial fuel cell as a sensor (see, e.g., Nam 3), is outside Appellants’ field of endeavor. Moreover, because Nam is directed to using microbial metabolic activity to create a redox potential sufficient to generate a detectable electrical signal (see id.), the same problem Appellants’ sensor addresses 17 Appeal 2016-007216 Application 13/415,702 (see Spec. 130), we are not persuaded that Nam is not reasonably pertinent to Appellants’ technical problem. Appellants also do not persuade us that hindsight is required to modify Nam’s device in the manner posited by the Examiner. Nam is directed to a biofuel cell useful for measuring “the water quality of rivers, such as biochemical oxygen demand (BOD),” which is “an important index of the level of water contamination, and is expressed as the amount of dissolved oxygen required for the biochemical oxidation of organic compounds for 5 days.” Nam 1 (citation omitted). As required by Appellants’ claim 1, and is undisputed by Appellants, Nam’s device includes anode and cathode chambers which are separated by a membrane that allows ions to pass through. See Nam 3 (describing “a biofuel cell consisting of an anode where organic substances are oxidized by enriched electrochemically active microorganisms, and a cathode to which electrons generated from the anode are transferred” in which the “cathode and the anode are divided by an ion exchange membrane”). As required by claim 1, both the anode and cathode are connected to electrical terminals, and ultimately to a voltmeter that measures the voltage generated in the cell, which in turn is connected to a data collection transmission unit provided on the biofuel cell, so as to transmit data detected by the biofuel cell to a remote data receiving unit. Id. at 7. As the Examiner found, in one example Nam describes testing its device by introducing glucose into the microorganism-containing anode chamber to verify that the current generated by the biofuel cell corresponded to the amount of organic material present in the cell. Id. at 8—9. Thus, as 18 Appeal 2016-007216 Application 13/415,702 required by Appellants’ claim 1, Nam’s anode-containing chamber may also contain food for microbes. As to claim 1 ’s semipermeable membrane, we note, as the Examiner found, that Nam’s device includes “a pretreatment unit for preventing suspended substances from being introduced into the anode of the biofuel cell.” Nam 3; see also id. at 6 (“The pretreatment unit 11 can prevent the clogging of the anode 10a due to the suspended substances present in the sample.”) Given Nam’s disclosure of the desirability of preventing clogging of its device by suspended solids, taken alongside its disclosure that the device’s ultimate purpose was to use the metabolic activity of microorganisms to generate a current to measure organic contaminants in river water, we discern no error in the Examiner’s determination that an ordinary artisan would have considered it obvious to include on Nam’s device a filter that prevented objects larger than microorganisms from entering the device, but that allowed the microorganisms to enter. Because this rationale is based solely on teachings in the prior art, Appellants do not persuade us that the Examiner’s rejection of claim 1 is based on improper hindsight. In addition, we agree with the Examiner that Appellants’ arguments regarding the differences between claim 1 ’s device and Nam’s device are not directed to features present in the claims. In particular, claim 1 recites none of the structural differences (“bulky, rigid structure”) or functional differences (“measur[ing] signals from moderately dry substances (e.g., food or skin)” “holding water back,” “prevent[ing] the loss of the carbohydrates from within the sensor”) asserted by Appellants as distinguishing Nam’s 19 Appeal 2016-007216 Application 13/415,702 device from the claimed device. Appeal Br. 21—22; see also Reply Br. 10- 11 (similar arguments). In sum, for the reasons discussed, Appellants do not persuade us that the preponderance of the evidence fails to support the Examiner’s conclusion that the sensor recited in claim 1 would have been obvious to an ordinary artisan in view of Nam. We, therefore, affirm the Examiner’s rejection of that claim over that reference. Because claim 3 “stands or falls with claim 1” (Appeal Br. 22), we affirm the Examiner’s rejection as to that claim as well. We note that Appellants have presented separate argument as to claims 4, 5, 7, and 8. See id. Technically, however, to present separate argument regarding claims, “[ujnder each heading identifying the ground of rejection being contested, any claim(s) argued separately or as a subgroup shall be argued under a separate subheading that identifies the claim(s) by number.” 37 C.F.R. 41.37(c)(l)(iv). Appellants have not provided separate subheadings as required by rule and, therefore, have not properly presented argument as to separate claims. In any event, contrary to Appellants’ contention that “Nam lacks a signal processor or anything that reads the signal” as recited in claims 4 and 5 (Appeal Br. 22), Nam, as noted above, describes its device as including a voltmeter that measures the voltage generated in the cell, which in turn is connected to a data collection transmission unit provided on the biofuel cell, so as to transmit data detected by the biofuel cell to a remote data receiving unit. See Nam 7. Appellants’ claim 7 recites “[t]he sensor of claim 1 wherein the outside wall of the first chamber and the outside wall of the second chamber 20 Appeal 2016-007216 Application 13/415,702 are attached to each other.” Appeal Br. 29. The Examiner contends that Nam teaches this feature based on Nam’s teaching of screws that hold the entire device together. Ans. 9, 35 (citing Nam Fig. 2). Appellants contend that Figure 2 of Nam does not teach the arrangement required by claim 7 because “Fig. 2 of Nam shows the rigid chambers to be separated by internal structure.” Appeal Br. 22. As the Examiner contends, however (Ans. 34), claim 7 does not include any limitation that excludes an internal structure between the attached outside walls of the first and second chambers. Indeed, we note that, as to this embodiment, Appellants’ Specification expressly encompasses the presence of an internal structure between the attached walls. See Spec. 1 68 (“By ‘attached,’ applicants mean that the ends attach directly to each other or that the ends of semipermeable membrane 150 may be intermediate the ends.'” (emphasis added)). Thus, even acknowledging that the screwed-together outside walls of Nam’s anode and cathode chambers are separated by an internal structure (see Nam Fig. 2), Appellants do not persuade us that claim 7 excludes the arrangement shown in Nam, particularly when the claim is viewed in light of the Specification. Fastly, as to claim 8’s requirement for carbohydrate to be in the first chamber (see Appeal Br. 29), Nam describes testing its device by introducing glucose into the microorganism-containing anode chamber to verily that the current generated by the biofuel cell corresponded to the amount of organic material present in the cell, as noted above. See Nam 8— 9. Appellants, therefore, do not persuade us that Nam fails to teach or suggest a sensor encompassed by claim 8. 21 Appeal 2016-007216 Application 13/415,702 In sum, for the reasons discussed, Appellants do not persuade us that the preponderance of the evidence fails to support the Examiner’s conclusion that the sensors recited in claims 1, 3—5, 7, and 8 would have been obvious to an ordinary artisan in view of Nam. We, therefore, affirm the Examiner’s rejection of those claims over that reference. OBVIOUSNESS—PU AND WINGER In rejecting claims 1—5 and 7 over Pu and Winger, the Examiner finds that Pu describes a sensor having all of the claimed features, including the ion-permeable membrane between the first and second chambers recited in claim 1. Ans. 10—11. The Examiner cites Winger as evidence that the material constituting Pu’s ion-permeable, “Amberplex[,] is an ion-exchange membrane.” Id. at 11. The Examiner finds that Pu differs from the rejected claims in that Pu’s device does not include claim 1 ’s semipermeable membrane, which allows microbes to pass through, but which excludes particles substantially larger than the microbes. Id. The Examiner determines, however, that an ordinary artisan would have known that “a membrane permeable to microbes would be a suitable material to use for a least a portion of the outside of the first chamber, because the anode chamber in Pu’s device must necessarily be permeable to blue-green algae for the device to be an algae sensor.” Id. In addition, the Examiner reasons: The walls of chamber 5 in Fig. 1 are depicted with a dashed line which suggests permeability; hence, a person of ordinary skill in the art would find it obvious to construct the anode of Pu’s device with at least a portion of the outside wall being constructed of a membrane through which blue-green algae can pass so that the algae detector can detect them. 22 Appeal 2016-007216 Application 13/415,702 A person of ordinary skill in the art would find it obvious that, in order to prevent the anode chamber getting clogged with debris, the filter, or semipermeable membrane, which is permeable to blue-green algae should be impermeable to macroscopic debris .... Id. at 11—12. Appellants contend that the Examiner erred in finding that Pu suggests including on its device the semipermeable membrane required by claim 1. Appeal Br. 22—24; Reply Br. 11—13. Appellants contend, in addition, that Pu is not analogous art. Reply Br. 15. Having carefully reviewed the contentions and evidence advanced by both the Examiner and Appellants, we find that the preponderance of the evidence supports the Examiner’s position. As the Supreme Court has explained, in determining whether the prior art supplies a reason for practicing the claimed subject matter, the analysis “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007); see also id. at 421 (“A person of ordinary skill is ... a person of ordinary creativity, not an automaton.”). In the present case, in addition to the dashed line in Pu’s Figure 5, the Examiner also contends that an ordinary artisan would have been prompted to include a semipermeable membrane on the outer wall of Pu’s device “in order to prevent the anode chamber getting clogged with debris, [and] the filter, or semipermeable membrane, which is permeable to blue-green algae should be impermeable to macroscopic debris.” Ans. 12; see also id. at 36 (“the sensor is designed to sense the concentration of blue-green algae; thus, 23 Appeal 2016-007216 Application 13/415,702 the anode chamber in Pu’s device must necessarily be permeable to the liquid (e.g. lake water) to be surveyed along with the algae contained within the liquid for the device to function as an algae sensor”). Appellants do not directly address this portion of the rejection, nor do Appellants identify specific error in the Examiner’s finding that it would have been desirable to exclude macroscopic debris from the sensor while allowing the sensed algae to enter the sensor. See Appeal Br. 22—24; Reply Br. 11—13. We are not persuaded, moreover, that the Examiner’s conclusion of obviousness is based on improper hindsight. Specifically, Pu discloses “a blue-green algae concentration sensor” (Pu, abstract) that undisputedly has each of the features required by Appellants’ claim 1, except for a semipermeable membrane on the outside wall of the anode-containing chamber that allows microbes to pass through, but which excludes particles substantially larger than the microbes. Even acknowledging the less than optimal grammar in the machine translation, it is evident that Pu’s objective is monitoring contamination of potential drinking water by algae. Pu 1 (disclosing that “eutrophication of water, cause the economic loss to reach 37,700,000,000 yuan, and the most obvious characteristic of eutrophication is exactly the excessive reproduction of alga”); see id. (disclosing “[djesire to monitor the effect of contaminative situation of water algae and evaluation improvement”).12 As the Examiner found (Ans. 36), Pu discloses that raw lake water is among the samples which may be tested using its sensor. See id. at 2 12 In citing to the machine translation of Pu, we cite as page 1 the first page following the translation’s abstract, and the remaining pages as if numbered consecutively. 24 Appeal 2016-007216 Application 13/415,702 (disclosing that the electrical conductivity of tested samples may not be “more than 10 by blue alga concentration behind the NaCl solution that is greater than 2.0mol[/]L or the filtering blue alga2 individual/ liter the lake raw water constitute”); id. at 4 (same). Given Pu’s disclosure that raw lake water is among the samples intended for testing by its sensor, we discern no error in the Examiner’s finding that an ordinary artisan would have reasonably inferred that it would be desirable to filter out macroscopic debris from the tested raw lake water sample, while also allowing the sensed organism, algae, to pass into the sensor. Because the Examiner’s conclusion of obviousness as to claim 1 is, therefore, based on the teachings in the prior art, we are not persuaded that, the Examiner’s rejection is based on improper hindsight. Moreover, contrary to Appellants’ contentions (Appeal Br. 23; Reply Br. 13), claim 1 does not recite that the sensor allows microbes through the semipermeable membrane without the water medium As to the issue of analogous art, the Appeal Brief did not include any specific argument explaining why Pu is not analogous art to Appellants’ invention. See Appeal Br., generally. Appellants, therefore, waived any argument to in that regard. See 37 C.F.R. § 41.37(c)(l)(iv); MPEP § 1205.02. We are not persuaded, moreover, that Appellants’ new argument in that regard (see Reply Br. 15) is properly presented for the first time in the Reply Brief. See 37 CFR § 41.41(b)(2); Ex parte Borden, 93 USPQ2d at 1477 (“Informative”). In any event, given that Pu is directed to microbial fuel cells, the same field as Appellants’ invention, and given that Pu involves using microbial metabolic activity to create a redox potential sufficient to generate a 25 Appeal 2016-007216 Application 13/415,702 detectable electrical signal, the same problem with which Appellants are involved, we are not persuaded Pu is not analogous art. In sum, for the reasons discussed, Appellants do not persuade us that the preponderance of the evidence fails to support the Examiner’s conclusion that the sensor recited in claim 1 would have been obvious to an ordinary artisan in view of Pu. We, therefore, affirm the Examiner’s rejection of that claim over that reference. As to Appellants’ arguments regarding claims 5 and 7 (see Appeal Br. 24), we again note that Appellants did not include a separate heading for those arguments, contrary to the requirement of 37 C.F.R. 41.37(c)(l)(iv). In any event, contrary to Appellants’ contention that Pu’s voltmeter is not a signal processor encompassed by claim 5 (Appeal Br. 24), Appellants’ Specification states expressly that the “anode and cathode connect to signal processor 140, which may be a computer, special electronics or another device for indicating current or voltage between the anode and cathode.'1'’ Spec. 1 69 (emphasis added). Also, contrary to Appellants’ argument regarding claim 7 that the outer wall of the first and second wall of Pu’s device are not attached, we note that the Pu’s Figure shows that the outer walls of the two chamber intersect at the point at which they join the ion-passing membrane 4. As noted above, the attachment of the two walls recited in claim 7 does not exclude a situation in which the membrane intercedes between the two walls. Spec. 168. In sum, for the reasons discussed, Appellants do not persuade us that the preponderance of the evidence fails to support the Examiner’s conclusion that the sensors recited in claims 1—5 and 7 would have been 26 Appeal 2016-007216 Application 13/415,702 obvious to an ordinary artisan in view of Pu. We, therefore, affirm the Examiner’s rejection of those claims over that reference. OBVIOUSNESS—NAM AND IVNITSKI In rejecting claims 1 and 3—8 over Nam and Ivnitski, the Examiner relies on the rationale based on Nam, discussed above, as to claims 1, 3—5, 7, and 8, but concedes that Nam does not disclose that the outside wall of the first chamber of its sensor is made of flexible material, as recited in claim 6. Ans. 12-13. The Examiner cites Ivnitski as evidence that it was known in the art that it was suitable to construct sensors of the type described in Nam using flexible materials, and that the sensor recited in Appellants’ claim 6, therefore, would have been obvious to an ordinary artisan. Id. Appellants do not assert error in the Examiner’s characterization of Ivnitski. Rather, Appellants contend that Ivnitski fails to remedy Nam’s alleged failure to teach or suggest the semipermeable membrane recited in claim 1, discussed above. See Appeal Br. 24—25; Reply Br. 13. For the reasons discussed above as to the rejection of claim 1 over Nam, we do not find these arguments persuasive. We, therefore, affirm the Examiner’s rejection of claims 1 and 3—8 over Nam and Ivnitski. OBVIOUSNESS— NAM, CHO, AND THE TOP AS PRODUCT BROCHURE In rejecting claims 1 and 3—8 over Nam, Cho, and the Topas Product Brochure, the Examiner relies on the rationale based on Nam, discussed above, as to claims 1, 3—5, 7, and 8, but concedes that Nam does not disclose that the outside wall of the first chamber of its sensor is made of flexible material, as recited in claim 6. See Ans. 13—14. 27 Appeal 2016-007216 Application 13/415,702 The Examiner cites Cho as evidence that it was known in the art that it was desirable to construct sensors of the type described in Nam using films composed of cyclic olefin polymer, a type of plastic, and cites the Topas Product Brochure as evidence that films composed of cyclic olefin polymer are flexible. See id. The Examiner determined, therefore, that the sensor recited in Appellants’ claim 6 would have been obvious to an ordinary artisan. See id. Appellants contend that Cho and the Topas Product Brochure fail to remedy Nam’s alleged failure to teach or suggest the semipermeable membrane recited in claim 1, discussed above. See Appeal Br. 25; Reply Br. 13. For the reasons discussed above as to the rejection of claim 1 over Nam, we do not find these arguments persuasive. Appellants contend that “neither secondary reference teaches that flexibility is desirable characteristic for Nam’s pond-floating device or for its pre-treatment unit.” Appeal Br. 25. Cho, however, discloses that cyclic olefin copolymer, which on this record is an undisputedly flexible material, possesses a number of properties that make it desirable for use in a BOD sensor (the type of sensor described in Nam): Cyclic Olefin Copolymer (COC) was used as the sensor substrate as well as the material to create the microfluidic layer. It is a rugged, transparent polymer with inertness towards chemicals like acetone, unlike many other plastic materials. Use of the cost-effective COC and batch fabrication techniques allow these sensors to be disposable. Cho 11:39-45. 28 Appeal 2016-007216 Application 13/415,702 Appellants do not persuade us, therefore, that Cho fails to suggest forming the outside wall of Nam’s device from a flexible material, as recited in claim 6. Thus, because Appellants do not persuade us that preponderance of the evidence fails to support the Examiner’s conclusion that a sensor encompassed by claims 1 and 3—8 would have been obvious in view of Nam, Cho, and the Topas Product Brochure, we affirm the Examiner’s rejection of those claims over those references. OBVIOUSNESS—NAM AND NAKAMURA In rejecting claims 1, 3—5, and 7—9 over Nam and Nakamura, the Examiner relies on the rationale based on Nam, discussed above, as to claims 1, 3—5, 7, and 8, but concedes that Nam does not disclose including a microbial growth inhibitor in the first chamber of its sensor, as recited in claim 9. Ans. 14—15. The Examiner cites Nakamura as evidence that it was desirable to include antibiotics in sensors of the type described in Nam, in order to determine inhibitory concentrations of the antibiotics. Id. at 14. The Examiner determines, therefore, that it would have been obvious to include an antibiotic in Nam’s sensor for that purpose, that the sensor recited in Appellants’ claim 9, accordingly, would have been obvious to an ordinary artisan. Id. at 14—15. Appellants contend that “Nakamura uses carbon nanotubes that indirectly detect an analyte in a solution based format by measuring the difference in conductance of the nanotube during oxidation. This is not how applicants’ sensor works.” Appeal Br. 26. 29 Appeal 2016-007216 Application 13/415,702 Therefore, Appellants contend, “the assertion that Nakamura uses its sensor for detecting the viability of antibiotics in the presence of E-coli bacteria in urine is unrelated to applicants’ ‘selectively’ regulating which bacteria are present in any given biosensor cell.” Id.', see also Reply Br. 14. Having carefully reviewed the contentions and evidence advanced by both the Examiner and Appellants, we find that the preponderance of the evidence supports the Examiner’s position. Claim 9 recites “[t]he sensor of claim 1, further comprising an inhibitor in the first chamber for inhibiting the growth of particular microbes.” Appeal Br. 29. As is evident, claim 9 does not include any recitation of selectively regulating which bacteria are present in the claimed sensor. Thus, because Appellants’ arguments are not directed to a claimed feature, we do not find them persuasive. As the Examiner found, Nakamura discloses that, in a sensor similar to that described in Nam, microorganisms can be tested for susceptibility to antibiotics by measuring the reduction in current that occurs when the antibiotic is introduced into the sensor. See Nakamura, abstract (“The susceptibility of bacteria to various antibiotics was also determined from the peak current. The minimum inhibitory concentration values obtained by the electrochemical method were in good agreement with those obtained by the conventional method.”). It might be true that Nakamura’s reason for including an antibiotic in a sensor of the type taught in Nam is different than Appellants’ reason for including the antibiotic. As the Supreme Court has explained, however, that fact does not demonstrate that the claimed subject matter would have been unobvious. See KSR v. Teleflex, 550 U.S. at 419 (“[I]n determining whether 30 Appeal 2016-007216 Application 13/415,702 the subject matter of a patent claim is obvious, 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 under § 103.”). Thus, because Appellants do not persuade us that a preponderance of the evidence fails to support the Examiner’s conclusion that a sensor encompassed by claims 1, 3—5, and 7—9 would have been obvious in view of Nam and Nakamura, we affirm the Examiner’s rejection of those claims over those references. SUMMARY For the reasons discussed, we reverse the Examiner’s rejection of claims 1—9, 20, and 21, under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. For the reasons discussed, however, we affirm the Examiner’s rejection of claims 20 and 21, under 35 U.S.C. § 112, first paragraph, as failing to comply with the enablement requirement. For the reasons discussed, we also affirm the Examiner’s rejection of claims 1—9, 20, and 21, under 35 U.S.C. § 112, second paragraph, as being indefinite. For the reasons discussed, we also affirm the Examiner’s rejection of claims 1, 3—5, 7, and 8, under 35 U.S.C. § 103(a), as being unpatentable over Nam. For the reasons discussed, we also affirm the Examiner’s rejection of claims 1—5 and 7, under 35 U.S.C. § 103(a), as being unpatentable over Pu and Winger. 31 Appeal 2016-007216 Application 13/415,702 For the reasons discussed, we also affirm the Examiner’s rejection of claims 1 and 3—8, under 35 U.S.C. § 103(a), as being unpatentable over Nam and Ivnitski. For the reasons discussed, we also affirm the Examiner’s rejection of claims 1 and 3—8, under 35 U.S.C. § 103(a), as being unpatentable over Nam, Cho, and the Topas Product Brochure. For the reasons discussed, we also affirm the Examiner’s rejection of claims 1, 3—5, and 7—9, under 35 U.S.C. § 103(a), as being unpatentable over Nam and Nakamura. TIME PERIOD 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 32 Copy with citationCopy as parenthetical citation