G. WhitemanDownload PDFPatent Trials and Appeals BoardJun 29, 20212020005943 (P.T.A.B. Jun. 29, 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. 12/640,861 12/17/2009 G. Robert Whiteman 19864.00025 (ABS-7) 9526 112619 7590 06/29/2021 Belvis Law P.O. Box 11317 Chicago, IL 60611 EXAMINER XU, QING ART UNIT PAPER NUMBER 1653 NOTIFICATION DATE DELIVERY MODE 06/29/2021 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): docket@belvislaw.com gbelvis@belvislaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte G. ROBERT WHITEMAN ____________ Appeal 2020-005943 Application 12/640,861 Technology Center 1600 ____________ Before DONALD E. ADAMS, ERIC B. GRIMES, and TAWEN CHANG, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals2 from Examiner’s decision to reject claims 105–108 and 110. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as “Dr. G. Robert Whiteman and Advanced Biological Services, Inc.” (Appellant’s March 19, 2020, Appeal Brief (Appeal Br.) 2). 2 This Appeal is related to Appeal 2010-001533 (Application 10/395,424, now US 7,879,593), Appeal 2019-006725 (Application 12/640,913, now US 10,995,024), and Appeal 2020-000188 (Application 12/044,293, now abandoned). Appeal 2020-005943 Application 12/640,861 2 STATEMENT OF THE CASE Appellant’s disclosure “relates to apparatus, methods, and applications for treating wastewater, and more particularly to biological processes for removing pollutants from wastewater” (Spec.,3 Abstr.). Appellant’s disclosure “further relates to apparatus and methods for growing microbes on-site at a wastewater treatment facility, and for economically inoculating sufficient microbes to solve various treatment problems rapidly” (id.). Claim 105 is reproduced below: 105. A method of reducing a time to bring an effluent stream having pollutants from a wastewater treatment plant into compliance by reducing the pollutants in the effluent stream, within 1 to 3 days, to an amount within a permit requirement, the method comprising: a) determining a first BOD[4] amount in an effluent stream from a wastewater treatment plant, wherein the effluent stream has a pollutant, whereby the first BOD amount is in excess of a permit requirement for the wastewater treatment plant and wherein the effluent stream has a flow comprising 14 million gallons per day and the first BOD amount is 7,000 - 15,000 lbs./day BOD; b) providing an on-site system for growing of microbes at the wastewater treatment plant; c) depositing inoculum, nutrient, and water into the on-site system, wherein the inoculum comprises microbes selected to degrade the pollutant; wherein the microbes in the inoculum are not isolated or freeze dried; d) growing the inoculum in the on-site system to provide a treatment batch comprising an increased number of the microbes, the growing comprising heating and mixing the 3 Appellant’s December 17, 2009, Specification. 4 Appellant defines the acronym “BOD” as “biochemical oxygen demand” (Spec. ¶ 60). Appeal 2020-005943 Application 12/640,861 3 inoculum in the on-site system; whereby the treatment batch has a concentration of microbes that is at least 100 times larger than the concentration of microbes in the inoculum; and, directly applying at least a portion of the treatment batch to a waste water in the wastewater treatment plant; thereby degrading the pollutant; whereby, within 1 to 3 days the first BOD amount in the effluent stream is reduced to a second BOD amount, wherein the second BOD amount is within the permit requirement. (Claims App.5 2.) Grounds of rejection before this Panel for review: Claims 105–108 and 110 stand rejected under 35 U.S.C. § 112, second paragraph. Claims 105–108 and 110 stand rejected under the written description provision of 35 U.S.C. § 112, first paragraph. Claims 105–108 and 110 stand rejected under the enablement provision of 35 U.S.C. § 112, first paragraph. Claims 105 and 110 stand rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1–19 of Whiteman ’956.6 Claims 105–108 and 110 stand rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1–19 of Whiteman ’956 in view of Mehta.7 5 Appellant’s “APPENDIX OF CLAIMS” filed with Appellant’s March 29, 2020, “Response to Notice of Non-Compliant Appeal Brief.” 6 Whiteman, US 10,322,956 B2, issued June 18, 2019. 7 Mehta, US 5,877,113, issued Mar. 2, 1999. Appeal 2020-005943 Application 12/640,861 4 Claims 105–108 and 110 stand rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1–8 of Whiteman ’0248 in view of Dale.9,10 DEFINITENESS: ISSUE Does the preponderance of evidence support Examiner’s conclusion that Appellant’s claim 105 is indefinite? ANALYSIS “A claim is indefinite if, when read in light of the specification, it does not reasonably apprise those skilled in the art of the scope of the invention.” Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1342 (Fed. Cir. 2003). Appellant’s claim 105, reproduced above, is drawn to a method of reducing a time to bring an effluent stream having pollutants from a wastewater treatment plant into compliance by reducing the pollutants in the effluent stream, within 1 to 3 days, to an amount within a permit requirement. Examiner finds that Appellant’s claim 105, when read in light of Appellant’s Specification, fails to provide a standard against which a person of ordinary skill in this art would compare the claimed method to determine whether the time required to bring an effluent stream into compliance with a permit requirement is reduced (see Ans. 3 (Examiner 8 Whiteman, US 10,995,024 B2, issued May 4, 2021. 9 Dale et al., US 5,879,928, Mar. 9, 1999. 10 Whiteman ’024 issued May 4, 2021, therefore, this rejection is no longer provisional (cf. Examiner’s June 12, 2020 Answer (Ans.) 18–22). Appeal 2020-005943 Application 12/640,861 5 finds “no point of comparison for the comparative term ‘reducing a time’”)). We agree. Because the foregoing discussion is not based on a hypothetical, we are not persuaded by Appellant’s contentions regarding hypothetical interpretations of its claim 105 (see Appeal Br. 22–23; see also Reply Br. 7). Appellant contends that the phrase at issue is in the preamble of its claim 105 (see Appeal Br. 21–22; see also Reply Br. 6–7) and, thus, does not render the claim indefinite. However, the mere fact that a term is in the preamble is not a sufficient basis for concluding that the term is not a limitation of the claim. See Storage Tech. Corp. v. Cisco. Sys., Inc., 329 F.3d 823, 831 (Fed. Cir. 2003) (“Whether to treat a preamble as a claim limitation is determined on the facts of each case in light of the claim as a whole and the invention described in the patent.”). On this record, Appellant discloses: In another aspect of the present invention, there is provided a method of reducing the time required for coming into compliance with an environmental discharge regulation comprising fermenting an inoculum comprising microbes to provide a treatment batch; and administering at least a portion of the treatment batch to a wastewater treatment system. (Spec. ¶ 23 (emphasis added)). In addition, Appellant relies on the foregoing indefinite language as a limitation in order to distinguish its claim 105 from the claims of both Whiteman ’024 and Whiteman ’956 (see Appeal Br. 32–33 (Appellant contends that “[t]he claims of . . . [Whiteman ’024 and Appeal 2020-005943 Application 12/640,861 6 Whiteman ’956] do not relate to . . . reducing the time to come into compliance”) (emphasis added)).11 Thus, we find that Examiner issued a well-grounded rejection that identifies the way in which the language of Appellant’s claim 105 is unclear, and Appellant failed to provide a satisfactory response to Examiner’s rejection. Therefore, we sustain the indefiniteness rejection of claim 105. [W]hen the USPTO has initially issued a well-grounded rejection that identifies ways in which language in a claim is ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention, and thereafter the applicant fails to provide a satisfactory response, the USPTO can properly reject the claim as failing to meet the statutory requirements of § 112[, second paragraph]. In re Packard, 751 F.3d 1307, 1311 (Fed. Cir. 2014). CONCLUSION The preponderance of evidence supports Examiner’s conclusion that Appellant’s claim 105 is indefinite. The rejection of claims 105 under 35 U.S.C. § 112, second paragraph is affirmed. Claims 106–108 and 110 are not separately argued and fall with claim 105. 11 We acknowledge Appellant’s reproduction its claim 105 with bolding to highlight claim elements that Appellant contends “are not disclosed or suggested by the claims of [Whiteman ’956]” (see Appeal Br. 34–36). Appellant later contends, however, that the “highlight[ing of] the preamble on page 35 of the Appeal Brief” was a “formatting error” and that “[i]t is clear that given the body of the claim, and in particular, the highlighted section of the body of the claim . . ., that the preamble is duplicative, and not necessary, to avoid the double patenting rejection” (Reply Br. 8). Appellant’s contention, however, fails to account for the statement made on pages 32–33 of Appellant’s Brief, wherein Appellant explicitly relies on the limitation at issue, regarding reducing the time to come into compliance, in distinguishing claim 105 from Whiteman ’024 and Whiteman ’956. Appeal 2020-005943 Application 12/640,861 7 Claim Interpretation: In view of the foregoing rejection under 35 U.S.C. § 112, second paragraph, we apply Examiner’s interpretation of the preamble of Appellant’s claim 105 to address the remaining rejections on this record. For clarity, Examiner states that “the preamble is interpreted as: ‘A method of bringing an effluent stream having pollutants from a wastewater treatment plant into compliance with an environmental discharge regulation by reducing the pollutants in the effluent stream, within 1 to 3 days, to an amount within a permit requirement’” (Ans. 4). Written Description: ISSUE Does the preponderance of evidence on this record support Examiner’s finding that Appellant’s Specification fails to provide written descriptive support for the claimed invention? ANALYSIS “[T]he test for sufficiency [of the written description] is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). A “sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350. “[A]n adequate written description requires a precise definition, such as by structure, formula, chemical name, Appeal 2020-005943 Application 12/640,861 8 physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials.” Id. Although “functional claim language can meet the written description requirement when the art has established a correlation between structure and function,” “merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.” Id. In addition, although Appellant’s claim 105 is directed to a method rather than a product, we note that the same standard applies with regard to the written description requirement. As the Rochester Court made clear: Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods. University of Rochester v. G.D. Searle & Co., 358 F.3d 916, 926 (Fed. Cir. 2004). For the following reasons, we find that Appellant’s Specification fails to provide written descriptive support commensurate with the scope of Appellant’s claimed invention. The method of Appellant’s claim 105, reproduced above, requires, inter alia, the application of microbes to waste water in a wastewater treatment plant to degrade a pollutant, such that within 1 to 3 days a first BOD amount in an effluent stream is reduced to a second BOD amount that is within a permit requirement. Examiner finds that Appellant’s Specification: Appeal 2020-005943 Application 12/640,861 9 [D]oes not provide[] any guidance for treating the wastewater by using any amounts of any microbes for complying with environmental discharge regulations, thereby within 1-3 days, reducing any pollutants at any high amount to an amount within a permit requirement and bringing the BOD of discharged wastewater in compliance with a permit requirement, as the claims required. (Ans. 5 (emphasis added).) Examiner acknowledges that Appellant’s Specification discloses that “[t]he types of microbe or microbes present in the inoculum depend on the type of wastewater to be treated” (Spec. ¶ 44; see also id. ¶ 53 (“The type of microbe or microbes, which will be most effective for a particular application will depend upon the application, the wastewater characteristics, and the characteristics that are required to solve the particular problem.”)), but finds that Appellant’s disclosure fails to identify the “criteria . . . for identifying and selecting microorganisms necessary to reduce within a period of 1 to 3 days pollutants or BOD from amounts in excess of a permit requirements to amounts within the permit requirement” (Ans. 6; see id. (Examiner finds that “[p]aragraph 44 [of Appellant’s Specification] generally asserts that the appropriate microbes ‘depend on the type of wastewater to be treated,’ but the nature of this ‘dependence’ is not pointed out.”); see also id. (citing Spec. ¶ 54: Table 1) (Examiner finds that although Appellant’s Specification “generally lists some example microbes known in the prior art, . . . there is no [disclosure] that these microbes could work in the claimed method, for bringing the effluent stream into [compliance] with a permit requirement”)). Examiner further finds that “the Case Studies submitted by applicant on 2/26/07 in parent application 10/395424 and listed on the 12/17/09 IDS in the instant application . . . detail four instances in which some embodiment Appeal 2020-005943 Application 12/640,861 10 of applicant’s invention was presumably carried out on various wastewater sites,” but “are wholly silent as to which bacterial species were applied to the wastewater, and how any microbes introduced into wastewater could compete with native microbes and . . ., thus be[] active at degrading pollutants” (Ans. 7). In addition, Examiner finds that these “Case Studies do not include any relevant details of time reduction and bringing, within 1 to 3 days, an effluent stream into compliance with environmental regulations” (id.; see also id. at 6 (Examiner finds that “[n]one of the examples in [Appellant’s] [S]pecification provide guidance regarding how to use any amount of microbes in bioaugmentation for treating wastewater, thus to reach the goal within a period of 1 to 3 days as” set forth in Appellant’s claim 105)). In addition, Examiner finds that Appellant’s “[S]pecification includes no specific protocols providing guidance for removing all possible contaminants from wastewater” (Ans. 6). There can be no doubt that Appellant’s claim 105 fails to identify a specific microbe or pollutant. Thus, those of ordinary skill in this art would reasonably interpret Appellant’s use of the term microbe or pollutant to represent any microbe or pollutant from a genera of microbes and pollutants (see, e.g., Ans. 24). Therefore, we are not persuaded by Appellant’s contention that “[a]t no point does [Examiner’s] rejection specify the claim elements, or claim terms that form the basis of the rejection,” but instead “Examiner appears to be basing the rejection on the terms ‘any pollutant’ or ‘any kinds of microbes,’” which are “terms . . . not found in the claims” (Appeal Br. 10). Appeal 2020-005943 Application 12/640,861 11 For the foregoing reasons, we are also not persuaded by Appellant’s contention that the essence of the invention is providing an on-site system to grow a treatment batch from an inoculum, wherein the microbes in the inoculum are not isolated or freeze dried, and then directly applying that treatment batch to the waste water. (claim 105, elements b, c, d). It is these steps that provides the results of the claimed method. It is these steps, as well as the claimed method as a whole, that have never been done or suggested by others. (Appeal Br. 11.) We do not find, and Appellant does not identify, an evidentiary basis on this record to support a finding that the full scope of: “pollutants in waste water treatment plants [are] well known to those of skill in the art” and “[t]he type of microbes that can be used to treat waste water are well known to those of skill in the art” (id.). See In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (“Attorney’s argument in a brief cannot take the place of evidence.”). Appellant also fails to identify an evidentiary basis on this record to support a finding that the amount of microbe present in an inoculum was known. Thus, Appellant’s contention that “[t]he claims specifically require that ‘the treatment batch has a concentration of microbes that is at least 100 times larger than the concentration of microbes in the inoculum’” fails to identify the amount of microbe necessary to achieve the result set forth in Appellant’s claimed method (see Appeal Br. 13; see also id. at 14). Simply stated, at least 100 times larger than an unknown amount is still an unknown amount. As discussed above, Examiner finds that Appellant’s Specification: [D]oes not provide[] any guidance for treating the wastewater by using any amounts of any microbes for complying with Appeal 2020-005943 Application 12/640,861 12 environmental discharge regulations, thereby within 1-3 days, reducing any pollutants at any high amount to an amount within a permit requirement and bringing the BOD of discharged wastewater in compliance with a permit requirement, as the claims required. (Ans. 5 (emphasis added).) Appellant contends that its Specification “provides detailed [disclosure] regarding the types of microbes that can be used to grow a treatment batch,” according to Appellant’s claimed invention (Appeal Br. 15–16 (citing Spec. ¶¶ 53–59)). Appellant discloses that microbes within the scope of its claimed invention include, but are not limited to those microbes able to degrade pollutants on the list of Federal Priority pollutants (see Spec. ¶ 53 (Appellant discloses that “[f]or example, microbes may be selected based on their ability to degrade pollutants on the list of Federal Priority pollutants, which is incorporated herein by reference”)). In addition, Appellant’s claim 105, reproduced above, requires microbes that are “not isolated or freeze dried” (see generally Appeal Br. 20–21; Ans. 36–37). For the foregoing reasons, we find that although Appellant’s Specification discloses various techniques for isolating and identifying bacteria (see Spec. ¶¶ 57–59), these types of bacteria are excluded from Appellant’s claimed invention. In addition, although Appellant’s Specification discloses that a microbe may be available from commercial sources (see Spec. ¶ 56), we find that Appellant’s claimed invention excludes freeze-dried microbes, including commercially available freeze- dried microbes. Appellant discloses: “The type of microbe or microbes, which will be most effective for a particular application will depend upon the application, Appeal 2020-005943 Application 12/640,861 13 the wastewater characteristics, and the characteristics that are required to solve the particular problem” (Spec. ¶ 53). Appellant also discloses “examples of microbes with particular biodegradation characteristics” (Spec. 54; see also id. ¶¶ 55–56). Appellant fails, however, to identify an evidentiary basis on this record to support a finding that microbes capable of degrading the full scope of pollutants encompassed by Appellant’s claimed invention within the time period required by Appellant’s claims, were known to those of ordinary skill in this art at the time of Appellant’s claimed invention. For the foregoing reasons, we are not persuaded by Appellant’s contentions that “the long establish[ed] rule that the [S]pecification ‘need not teach and preferably omits, what is well known in the art’,” applies to the invention claimed on this record (Appeal Br. 10). As the Capon court explained: Precedent illustrates that the determination of what is needed to support generic claims to biological subject matter depends on a variety of factors, such as the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, the predictability of the aspect at issue, and other considerations appropriate to the subject matter. Capon v. Eshhar, 418 F.3d 1349, 1359 (Fed. Cir. 2005). Appellant contends that its “Specification provides teachings about testing, evaluating and selecting a suitable, and the best, microbe for any particular wastewater application” (Appeal Br. 13; see also id. at 13–18; id. at 16 (citing Spec. ¶¶ 60–62) (Appellant contends that its Specification discloses “techniques used to determine most effective microbe for a particular wastewater treatment”)). Stated differently, Appellant contends that a person of ordinary skill in this art would have found it prima facie Appeal 2020-005943 Application 12/640,861 14 obvious to identify the appropriate microbe for a particular need through trial and error testing (see Ans. 6 (Examiner find that Appellant’s Specification “only implies that a person seeking to carry out the method on a given wastewater site should conduct trial-and-error with microbes and combinations of microbes at various amounts until an operative embodiment is found.”)). We are not persuaded. Although “the description requirement does not demand any particular form of disclosure, . . . or that the specification recite the claimed invention in haec verba, a description that merely renders the invention obvious does not satisfy the requirement.” Ariad, 598 F.3d at 1352. In sum, we are not persuaded by Appellant’s contention that its disclosure provides written descriptive support for the full scope of its claimed invention (see Ans. 6 (Examiner finds that Appellant’s Specification “does not permit the skilled artisan to visualize all of the members of the genus of microbes being administered in the claimed methods.”)). For the foregoing reasons, we are not persuaded by Appellant’s contention that the type of pollutants and microbes “do not relate to the essences of the present invention[]” (Appeal Br. 11). For the foregoing reasons, we are not persuaded by Appellant’s contention that its “claims are directed to a method, and do not claim any . . . new pollutant or a new microbe” (Appeal Br. 12). As discussed above, although Appellant’s claim 105 is directed to a method rather than a product, we note that the same standard applies with regard to the written description requirement. See University of Rochester v. G.D. Searle & Co., 358 F.3d at 926. Appeal 2020-005943 Application 12/640,861 15 CONCLUSION The preponderance of evidence on this record supports Examiner’s finding that Appellant’s Specification fails to provide written descriptive support for the claimed invention. The rejection of claim 105 under the written description provision of 35 U.S.C. § 112, first paragraph, is affirmed. Claims 106–108 and 110 are not separately argued and fall with claim 105. Enablement: ISSUE Does the evidence of record support Examiner’s conclusion that undue experimentation would be required to practice the claimed invention? ANALYSIS Factors to be considered in determining whether a disclosure would require undue experimentation . . . include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). The analytical framework for determining whether claims fail to satisfy the enablement requirement balances the Wands factors to determine if undue experimentation would have been required to perform the reasonable scope of the claimed method at the time of filing of the Specification. Appeal 2020-005943 Application 12/640,861 16 Nature and Breadth of Appellant’s Claims: As Examiner explains, the method of Appellant’s claim 105 requires: [R]educing within a period of 1 to 3 days pollutants and BOD from amounts in excess of a permit requirement to amounts within the permit requirement. The “permit requirement” recited in the claim is an undefined variable and it can be any permit requirement including those in the past, at present, and in the future. The “pollutants” in the wastewater can be any kinds of pollutants at any high amounts, including those not biologically degradable. The claimed method comprises a step of applying any amounts of microbes from the treatment batch to a wastewater in the wastewater treatment plant, thereby reducing amounts of BOD/pollutants (7000 - 15000 lbs /day) in excess of a permit requirement to amounts within the permit requirement. The “microbes” . . . can be any microbes [that are not isolated or freeze-dried]. (Ans. 8.) Direction, Guidance, Working Examples: Examiner finds that the eleven examples disclosed in Appellant’s Specification fail to provide “any information, data, results, or evidence to demonstrate that pollutants and BOD that are in excess of a permit requirement could be brought into compliance with the permit requirement within a period of 1 to 3 days, as required by [Appellant’s] claim [105]” (Ans. 9 (citing Spec. 24–45)). Examiner further finds that Appellant’s Specification fails “to provide any data, results, or evidence” to establish that microbes introduced into wastewater according to Appellant’s claim 105 are capable of competing “with native microbes” already present in the wastewater (Ans. 9). Thus, Examiner finds that Appellant’s Specification failed to establish that native microbes present in wastewater would not outcompete microbes introduced Appeal 2020-005943 Application 12/640,861 17 into wastewater according to Appellant’s claim 105 and, thus, prevent the introduced microbes from “bringing the pollutants and BOD of discharged wastewater [into] . . . compliance [with permit requirements] within 1-3 days” (Ans. 10). Appellant’s Specification discloses: A typical example of a selective nutrient supplement for Pseudomonas putida would be phenol, which assists in selecting and favoring the growth of the Pseudomonas which has phenol degradation capability. Thus Pseudomonas putida could outgrow any background contamination and reversion is minimized. Reversion being where the plasmid coding for phenol degradation is lost by the microbe due to a competitive disadvantage by retaining unnecessary genetic material. A typical example of a selective inhibitor for Pseudomonas is Pseudomonas Isolation Broth (PIB), which contains the chemical called cetrimide that selectively inhibits the growth of other microbes, and, therefore, favors the growth of Pseudomonas, hence the term selective inhibitor. (Spec. ¶ 68.) Examiner acknowledges Appellant’s disclosure that the Pseudomonas putida could outgrow any background contamination if phenol is added to wastewater, but finds this disclosure speculative and unsupported by evidence on this record (see Ans. 10 (citing Spec. ¶ 68) (Examiner finds that “the assumed ‘could outgrow’ is not supported by any factual evidence” and Appellant’s Specification “failed to provide any data to support such an approach could work in the claimed method to bring the effluent stream into complying with a permit requirement”)). In addition, Examiner finds that phenol is a toxic pollutant and cetrimide is ammonium pollutants, which need to be removed from wastewater. Given the claims require that the effluent stream has a flow of 14 million gallons per day, addition of significant amounts of phenol and cetrimide would be needed, which consequently Appeal 2020-005943 Application 12/640,861 18 conflicts with the intended purpose of the claimed method for reducing the pollutants in the effluent stream. (Ans. 10.) Skill in, and predictability of, the art: Examiner finds that the state of this art, at the time of Appellant’s claimed invention, was unpredictable (Ans. 10). Examiner finds that King “suggests that skilled artisans did not generally expect success in carrying out bioremediation around the time of the invention” (id. (citing King12 4 (King discloses “‘[e]ven if there is only an even (50-50) chance of success when using bioremediation, it is usually worth a try. A bioremediation approach may not be right for every site, but when it's right, it’s wonderful.’”)). Thus, Examiner finds that “King’s statement clearly indicates that at the time of the invention, predicting the success of bioremediation was, at best, a coin toss” (Ans. 10–11). In addition, Examiner finds: King goes on to cast further doubt on the success of bioaugmentation (i.e., addition of non-native microorganisms to a waste site) in particular, teaching that while biodegradation may be achieved in the controlled conditions of a laboratory, “very often there is no realistic correlation between lab findings and the multitude of parameters that dictate the efficiency and rates of degradation that may be expected in a field bioremediation project.” . . . King teaches that added non- native microorganisms are typically overwhelmed and eliminated by the needs of the native microbes, which have adapted to the pollutants in the wastewater and gained a “competitive edge over introduced species that found the environment strange” and that “[a]fter addition, these 12 King et al., Practical Environmental Bioremediation, The Field Guide, 4, 7–9 (CRC Press LLC) (1998). Appeal 2020-005943 Application 12/640,861 19 introduced microbes often rapidly decrease in number and can become undetectable within a few days”. (Ans. 11 (citing King 8).) Thus, Examiner finds: King’s teachings clearly imply that at the time of the invention, skilled artisans would have viewed applicant’s claimed method as having limited chance of succeeding in any given bioremediation project in the field and that the time to comply with government regulations would increase, not decrease, under bioaugmentation because the non-native bacteria are usually quickly removed from the wastewater. (Ans. 11.) State of the Prior Art: Examiner finds that “[w]ater can be contaminated in diverse and numerous ways, as evidenced by . . . [Drinking Water Contaminants13], which shows that the Environmental Protection Agency (EPA) recognized dozens of water contaminants” (Ans. 11). Examiner also finds that “[i]n addition to the federal regulations set forth by the EPA, states have their own regulations, and these are constantly changing, as evidenced by . . . [Radiation14], which describes New York State’s regulations for radioactive contaminants in discharged wastewater and indicates that these regulations are currently being updated” (Ans. 11–12; see also id. at 12 (citing Toshikuni,15 Abstr.) (Examiner finds that Toshikuni discloses “that wastewater may be contaminated by radioactive isotopes, which can 13 EPA Ground Water & Drinking Water, available at http://www.epa.gov/ogwdwOOO/hfacts.html, last accessed Feb. 10, 2010. 14 Radiation – NYS Dept. of Environmental Conservation, available at http://www.dec.ny.gov/chemical/296.htrnl, last accessed Oct. 4, 2010. 15 Toshikuni et al., US 4,693,833, issued Sept. 15, 1987. Appeal 2020-005943 Application 12/640,861 20 sometimes be removed chemically using complexing agents and the like”)). Examiner finds “[n]o prior art [that] reveals any protocols for using microbes to reduce radioactive contaminants from wastewater” (Ans. 12). Examiner finds that the art, both contemporaneous with, and years after, Appellant’s claimed invention, established that “numerous organic chemical contaminants cannot be removed by any known microbes” (id. (citing Hiraishi,16 Abstract (Examiner finds that Hiraishi discloses “that years after the instant filing, skilled artisans considered the field of dioxin bioremediation to be nascent”); Goodell17 ¶ 14 (Examiner finds that Goodell discloses “that some resistant dyes in textile and paper finishing plant wastewater cannot be removed by bacteria”); Dale18 1:44–60 (Examiner finds that Dale discloses that in those “situation[s] where microbes are capable of degrading [pollutants], each of the[] microbes is directed at only a specific pollutant, they do not address variety of pollutants”)). Examiner further finds that “the EPA considers some living organisms to be water contaminants, including Cryptosporidium parvum, a parasite; neither the prior art nor the contemporaneous art includes any teachings of microbes that can remove Cryptosporidium from wastewater” (Ans. 12.) 16 Hiraishi et al., Toward the bioremediation of dioxin-polluted soil: structural and functional analyses of in situ microbial populations by quinone profiling and culture-dependent methods, 57 Appl. Microbiol. Biotechnol. 248–56 (2001). Abstract only. 17 Goodell et al., US 2003/0186036 A1, published Oct. 2, 2003. 18 Dale et al., US 5,879,928, issued Mar. 9, 1999. Appeal 2020-005943 Application 12/640,861 21 Quantity of Experimentation Necessary: Examiner finds: It is not routine in the art to apply any amounts of microbes for reducing within a period of 1 to 3 days any pollutants and BOD in excess of a permit requirement to amounts within the requirement. Neither the prior art no[r] the disclosure of [Appellant’s] [S]pecification show that the claimed method can be performed to reaching the goal, as defined in the claims. Therefore, in absence of some guidance as to how to use the claimed method for bringing an effluent stream into compl[iance] with an environmental discharge regulation, [in 1 to 3 days] one of skill in the art would have to carry out a large amount of experimentation to find which additional steps or additional compounds need to be included in the method of [Appellant’s] [c]laim[] 105. (Ans. 13.) For the foregoing reasons, we find that Examiner set forth a reasonable basis for finding that the scope of the appealed claims is not enabled by Appellant’s Specification. Thus, the burden was properly shifted to Appellant to present persuasive evidence or arguments to support the enablement of Appellant’s claimed invention. See In re Wright, 999 F.2d 1557, 1562 (Fed. Cir. 1993). For the foregoing reasons, we are not persuaded by Appellant’s contentions that Examiner’s enablement rejection appears to be nothing more than a re-argument of the prior written [description] rejection[]” (Appeal Br. 23). In addition, for the reasons set forth above, we are not persuaded by Appellant’s “incorporation and reassert[ion]” of its contentions made with respect to the written description rejection (id.). Even if Appellant enabled one microbe capable of reducing one pollutant in an effluent stream to an amount within a permit requirement Appeal 2020-005943 Application 12/640,861 22 within 1 to 3 days, as required by Appellant’s claimed invention, the enablement requirement of 35 U.S.C. § 112, first paragraph requires Appellant’s disclosure to enable “those skilled in the art to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech, Inc. v. Novo Nordisk. A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d at 1561). As discussed above, Examiner established that Appellant failed to provide an enabling disclosure of the full scope of its claimed invention. Thus, we are not persuaded by Appellant’s intimation that it provided at least one method for making and using its claimed invention that bears a reasonable correlation to the entire scope of claim 105 (see Appeal Br. 27; see generally id. at 28). Appellant discloses that “[t]he terms ‘environmental discharge regulation’ and ‘discharge permit’ are used to describe such permits and regulations including, but not limited to, NPDES Permits, other discharge permit requirements, or other environmental regulations regarding limits on effluent materials that can be introduced into the environment” (Spec. ¶ 34 (emphasis added)). In addition, Appellant acknowledges that “[s]uch regulations vary from state to state, and from country to country” (id.). In sum, although Appellant identifies various types of regulations, Appellant does not limit the scope of its disclosure, or claims, to any particular regulation, which may vary from state to state, and from country to country (see id.). Thus, we are not persuaded by Appellant’s contention that Examiner’s finding that “the ‘permit requirement’ is an undefined variable” “ignores the claims as [a] whole and ignores the Specification” (Appeal Br. 29). Appeal 2020-005943 Application 12/640,861 23 Appellant’s claim 105 requires, inter alia, the addition of microbes to wastewater that those of ordinary skill in the art would understand to comprise native microbes. Those of ordinary skill in this art would understand that these native microbes, present in wastewater, would compete with non-native microbes added to the wastewater (see, e.g., King 8 (King discloses that “native [microbial] populations . . . naturally have a competitive edge over introduced [microbial] species that find the environment strange and available food resources unwanted”)). Thus, we are not persuaded by Appellant’s contention that its “claims do not require, [that its microbes] ‘compete with native microbes’ or [possess] ‘a competitive edge’” (Appeal Br. 30). Appellant discloses that “[o]ne aspect of the present invention is the sufficient, repeated inoculation of the functional microbes (whether an exogenous or indigenous source) that allows a microbial population to be established quickly and out-compete an undesirable indigenous population, such as filamentous or Zoogloeal type microbes, which cause bulking” (Spec. ¶ 37). Appellant’s Specification fails to disclose the quantity of microbes necessary to out-compete an undesirable indigenous population and, thereby, reduce a pollutant in an effluent stream to an amount within a permit requirement within 1 to 3 days, as required by Appellant’s claimed invention. Therefore, we are not persuaded by Appellant’s contention that its claims are enabled because its “Specification specifically and repeatedly teaches that the microbes that are introduced as a treatment batch out compete the undesirable indigenous microbes in the waste water” (Appeal Br. 31 (citing ¶ 37)). Appeal 2020-005943 Application 12/640,861 24 We recognize Appellant’s contention that Examiner’s discussion of the addition of “phenol or the PIB broth containing [the] inhibitor cetrimide to the wastewater . . . are not claim terms,” “are not required by the claims,” and, thus, “cannot form the basis for an enablement rejection of the claims” (Appeal Br. 31). We find, however, no requirement in Appellant’s claimed invention that excludes this subject matter and thus, we find that Appellant’s claimed invention encompasses this subject matter, as disclosed in Appellant’s Specification (see generally Spec. ¶ 68). For the reasons set forth above, we are not persuaded by Appellant’s contention that the prior art relied upon by Examiner fails to support the enablement rejection on this record (see Appeal Br. 31; see also Reply Br. 7–8). In sum, we find that Appellant failed to provide persuasive argument or evidence that rebuts Examiner’s prima facie case of non-enablement on this record. CONCLUSION The evidence of record supports Examiner’s conclusion that undue experimentation would be required to practice the claimed invention. The rejection of claim 105 under the enablement provision of 35 U.S.C. § 112, first paragraph, is affirmed. Claims 106–108 and 110 are not separately argued and fall with claim 105. Obviousness-type Double Patenting: ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness-type double patenting? Appeal 2020-005943 Application 12/640,861 25 ANALYSIS In an obviousness-type double patenting rejection, Examiner must establish, in an analysis comparable to that under 35 U.S.C. § 103, that one of ordinary skill would have considered the rejected claims obvious over the conflicting claims. See, e.g., In re Braat, 937 F.2d 589, 592–93 (Fed. Cir. 1991). Because the same analysis applies to all of the obviousness-type double patenting rejections, on this record, we consider the rejections together. Claims 1–2 of Whiteman ’956 are reproduced below: 1. A method of treating wastewater in a wastewater treatment plant using microbes, while minimizing the growth phase of the microbes in the wastewater treatment plant, the method comprising: a. providing an on-site fermentation system at a wastewater treatment plant for treating a wastewater, wherein the wastewater contains pollutants, the wastewater treatment plant having an influent stream and an effluent stream of the wastewater; the fermentation system comprising: a main tank comprising a mixing apparatus and a heater; a transfer pump and line for transferring a treatment batch for application to wastewater in the wastewater treatment plant; b. adding an inoculum, nutrients and water to the main tank; wherein the inoculum contains a first concentration of microbes; c. growing the microbes in the main tank to provide a treatment batch; whereby the treatment batch contains a second concentration of microbes; wherein the first concentration is at least 100 time smaller than the second concentration; d. applying an amount of the treatment batch to the wastewater; whereby sufficient numbers of microbes are Appeal 2020-005943 Application 12/640,861 26 introduced into the wastewater to avoid the need for a growth phase of a biomass in the wastewater; e. whereby the treatment batch reduces the pollutants in the wastewater, without the need for a growth phase of a biomass in the wastewater; wherein the effluent stream has lower pollutants than the influent stream and, f. thereby avoiding a need for addition of supplemental nutrients to the wastewater. 2. The method of claim 1, wherein the level of pollutants is reduced to at or below the NPDES permit requirements for the wastewater treatment plant. (Whiteman ’956, 31:66–32:34.) Whiteman ’956 discloses that “NPDES permits for wastewater are generally in units of maximum allowed pounds per day (lbs./day) of BOD and a maximum monthly average” (id. at 17:49– 51; see generally Ans. 15). Claim 1 of Whiteman ’024 is reproduced below: 1. A method of reducing an amount of treatment chemicals required to maintain an effluent stream from a wastewater treatment plant at a predetermined level of a pollutant within permit requirements, the method comprising: a) determining an amount of a treatment chemical used to treat wastewater in a wastewater treatment plant to remove a pollutant from the wastewater, whereby the amount of the pollutant is reduced to a predetermined level of the pollutant in an effluent stream leaving the wastewater treatment plant; b) providing an on-site system for growing of microbes at the wastewater treatment plant; c) depositing inoculum, nutrient, and water into the onsite system, wherein the inoculum comprises microbes selected to degrade the pollutant; wherein the microbes in the inoculum are not isolated, concentrated or freeze dried; Appeal 2020-005943 Application 12/640,861 27 d) growing the inoculum in the on-site system to provide a treatment batch comprising an increased number of the microbes, the growing comprising heating and mixing the inoculum in the on-site system; whereby the treatment batch has a concentration of microbes that is at least 100 times larger than a concentration of microbes in the inoculum; and, directly applying at least a portion of the treatment batch to the waste water in the wastewater treatment plant; thereby degrading the pollutant; e) wherein, the determined amount of the treatment chemical can be reduced by 25% without increasing the predetermined level of the pollutant in the effluent stream leaving the wastewater treatment plant. (Whiteman ’024.) Appellant contends that Examiner failed to establish that a number of claim elements set forth in Appellant’s claim 105 are “disclosed or suggest[ed] by the claims of” Whiteman ’956 (see Appeal Br. 34–36). Specifically, Appellant contends that Whiteman ’956 fails to make obvious a method as set forth in Appellant’s claim 105, which comprises: a) determining a first BOD amount in an effluent stream from a wastewater treatment plant, . . . whereby the first BOD amount is in excess of a permit requirement for the wastewater treatment plant and wherein the effluent stream has a flow comprising 14 million gallons per day and wherein the first BOD amount is 7,000 - 15,000 lbs./day BOD; [and] d) . . . whereby, within 1 to 3 days the first BOD amount in the effluent stream is reduced to a second BOD amount, wherein the second BOD amount is within the permit requirement. (see Appeal Br. 35–36.)19 We are not persuaded. 19 We recognize that although Appellant’s brief cited the preamble of its claim 105, Appellant contends that citation of the preamble of its claim 105 was in error (see Reply Br. 8). Appeal 2020-005943 Application 12/640,861 28 As Examiner explains, “[i]n the absence of evidence to the contrary, it is presumed that a method having substantially [the] same steps generates or yield substantially the same outcomes, effects, or functions” and “[a]s evidenced by the disclosures of [Whiteman ’956’s] [S]pecification[] . . ., the method of the ’956 patent is capable of yielding all of the effects recited in the instant claim” (id.). In this regard, we note that Whiteman ’956 discloses that “NPDES permits for wastewater are generally in units of maximum allowed pounds per day (lbs./day) of BOD and a maximum monthly average” (Whiteman ’956, 17:49–52). Whiteman ’956 further discloses: In a plant with a 14 [million gallons per day] . . . flow, a single pass lagoon system is inoculated from a 1000 gallon tank containing a concentration of 1.4x109 cfu/ml microorganisms. . . . With the single pass lagoon system currently in place, the plant is releasing wastewater with 7,000- 15,000 lbs./day [first] BOD, and is not in compliance with the NPDES permit. When treatment is implemented with the fermentation system of the current invention, the effluent is down to 3,000 lbs./day [second] BOD in 3 days. (Whiteman ’956, 17:35–37, 58–64; see also Whiteman ’024, 17:35–37, 49– 52, 58–64 (Whiteman ’024’s Specification contains the same disclosure)). Examiner concludes that the scope of Whiteman ’956’s claims encompass the method of Appellant’s claim 105 (see Ans. 15–16). For the foregoing reasons, we are not persuaded by Appellant’s contention that Examiner “failed to ‘provide objective evidence or cogent technical reasoning to support [a] conclusion of inherency’” (Appeal Br. 34 (alteration in original)). In the context of an obviousness-type double-patenting rejection, a patent’s disclosure may be used to determine whether a claim “merely define[s] an obvious variation of what is earlier disclosed and claimed,” “to Appeal 2020-005943 Application 12/640,861 29 learn the meaning of [claim] terms,” and to “interpret [] the coverage of [a] claim.” In re Basell Poliolefine Italia S.P.A., 547 F.3d 1371, 1375 (Fed. Cir. 2008). Therefore, we are not persuaded by Appellant’s contentions regarding Examiner’s reliance on Whiteman ‘956’s Specification (Appeal Br. 33). As discussed above, the Specification of Whiteman ’024 is the same as Whiteman ’956, thus we find no error in Examiner’s conclusion that the scope of Whiteman ’956’s claims encompass the method of Appellant’s claim 105 (see Ans. 15–16). To the extent that Appellant’s contentions relating to Whiteman ’956 apply to Whiteman ’024, we are not persuaded for the same reasons as set forth above with respect to Whiteman ’956. Having found no deficiency in Examiner’s rejection of Appellant’s claim 105 over Whiteman ’956 and Whiteman ’024, we are not persuaded by Appellant’s contention regarding Dale (see Appeal Br. 36). To the extent that Appellant’s contention regarding Dale also applies to Examiner’s reliance on Mehta, we are not persuaded for the same reason as set forth above, with respect to Dale. CONCLUSION The preponderance of evidence relied upon by Examiner supports a conclusion of obviousness-type double patenting. The rejection of claim 105 under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1–19 of Whiteman ’956 is affirmed. Claim 110 is not separately argued and falls with claim 105. The rejection of claim 105 under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1–19 Appeal 2020-005943 Application 12/640,861 30 of Whiteman ’956 in view of Mehta is affirmed. Claims 106–108 and 110 are not separately argued and fall with claim 105. The rejection of claim 105 under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1–8 of Whiteman ’024 in view of Dale is affirmed. Claims 106–108 and 110 are not separately argued and fall with claim 105. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 105–108, 110 112 Definiteness 105–108, 110 105–108, 110 112 Written Description 105–108, 110 105–108, 110 112 Enablement 105–108, 110 105, 110 Obviousness-type Double Patenting, Whiteman ’956 105, 110 105–108, 110 Obviousness-type Double Patenting, Whiteman ’956, Mehta 105–108, 110 105–108, 110 Obviousness-type Double Patenting, Whiteman ’024, Dale 105–108, 110 Overall Outcome 105–108, 110 Appeal 2020-005943 Application 12/640,861 31 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). See 37 C.F.R. § 1.136(a)(1)(iv) (2019). AFFIRMED Copy with citationCopy as parenthetical citation