R.J. REYNOLDS TOBACCO COMPANYDownload PDFPatent Trials and Appeals BoardOct 1, 20212020006035 (P.T.A.B. Oct. 1, 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. 13/647,670 10/09/2012 Anthony Richard Gerardi R60999 2940US.1 (0421.4) 4129 26158 7590 10/01/2021 WOMBLE BOND DICKINSON (US) LLP ATTN: IP DOCKETING P.O. BOX 7037 ATLANTA, GA 30357-0037 EXAMINER NGUYEN, PHU HOANG ART UNIT PAPER NUMBER 1747 NOTIFICATION DATE DELIVERY MODE 10/01/2021 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): BostonDocket@wbd-us.com IPDocketing@wbd-us.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ANTHONY RICHARD GERARDI Appeal 2020-006035 Application 13/647,670 Technology Center 1700 Before MICHAEL P. COLAIANNI, DEBRA L. DENNETT, and SHELDON M. MCGEE, Administrative Patent Judges. MCGEE, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1–18, 28, and 29. We have jurisdiction. 35 U.S.C. § 6(b). We affirm-in-part. 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 is R.J. Reynolds Tobacco Company. Appeal Br. 1. Appeal 2020-006035 Application 13/647,670 2 CLAIMED SUBJECT MATTER The claims are directed to methods of extracting and isolating one or more o-methylated flavonoids from Nicotiana plant material. Claim 1; Spec. 1:3–4. Sole independent claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A method of extracting and isolating one or more o- methylated flavonoids from plants of the Nicotiana species, comprising: receiving a plant material of the [Nicotiana] species; contacting the plant material with a solvent for a time and under conditions sufficient to extract one or more o- methylated flavonoids from the plant material into the solvent; separating the solvent containing the one or more o- methylated flavonoids from the extracted plant material, wherein the solvent containing the one or more o-methylated flavonoids contains at least about 0.1% of the o-methylated flavonoids on a dry weight basis; and purifying the solvent containing the one or more o- methylated flavonoids to provide an isolate comprising at least about 50% by weight of the one or more o-methylated flavonoids on a dry weight basis. REJECTIONS I. Claims 1, 5–18, 28, and 29 under 35 U.S.C. § 103(a) as unpatentable over Watanabe2; II. Claims 2 and 3 under 35 U.S.C. § 103(a) as unpatentable over Watanabe in view of Murphy3; and 2 Watanabe et al., “Flavonoid and Certain Related Phenolic Compounds in Parts of the Tobacco Flower,” Arch. Biochem. Biophys., 112(1):111– 14, Oct. 1965. 3 Murphy et al., “Methyl Ethers of Quercetin in Tobacco Flowers,” J. Org. Chem., 25(11):2063–64, Nov. 1960. Appeal 2020-006035 Application 13/647,670 3 III. Claim 4 under 35 U.S.C. § 103(a) as unpatentable over Watanabe in view of Murphy, and further in view of ACTT.4 Final Act. 2–5. OPINION We review the appealed rejections for reversible error based on the arguments and evidence presented by Appellant. 37 C.F.R. § 41.37(c)(1)(iv); Cf. Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential) cited with approval in In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011) (explaining that even if the Examiner had failed to make a prima facie case, “it has long been the Board’s practice to require an applicant to identify the alleged error in the examiner’s rejections”). Herein, we address the claims separately to the extent they are so argued by Appellant. Claim 1 In rejecting claim 1, the Examiner finds that Watanabe discloses contacting a plant material of the Nicotiana species under conditions sufficient to extract o-methylated flavonoids from the plant material into the solvent. Id. at 2. Because “Watanabe discloses . . . the same starting material as the claimed []plant material of the [Nicotiana] species and solvent conditions to extract the claimed flavonoids,” the Examiner determines that “it would have been obvious to one of ordinary skill in the art that the solvent as taught by Watanabe would have at least about 0.1% of the o-methylated flavonoids on a dry weight basis.” Id. The Examiner also finds that Watanabe describes purification of the o-methylated flavonoids. 4 Arrangement and Classification of Tobacco Types, Nov. 2006, pp. 18, 129; available at http://legacy.library.ucsf.edu/tid/uux76a99/pdf. Appeal 2020-006035 Application 13/647,670 4 Id. Based on this finding, the Examiner concludes that it also would have been obvious to one of ordinary skill in the art “to purify[] the solvent containing the one or more o-methylated flavonoids to provide an isolate comprising at least about 50% by weight of the one or more o-methylated flavonoids on a dry weight basis.” Id. Appellant argues that the Examiner has failed to produce sufficient evidence that the claimed amounts of o-methylated flavonoids can be obtained by Watanabe’s method. Appeal Br. 5. Appellant points to its Specification to evince the art’s understanding that “minimal amounts of o- methylated flavonoids [are] commonly found in plants,” i.e., are typically present in quantities of “less than 0.01% by weight.” Id. Appellant asserts the claimed method has a “unique capability to obtain [the claimed] amounts of o-methylated flavonoids.” Id. Appellant contends that “Watanabe does not indicate the amount of o- methylated flavonoid obtained from the extraction therein.” Id. at 6. Rather, according to Appellant, Table 1 of Watanabe only evinces that o-methylated flavonoids were present in each extract, but “gives no indication as to [their] relative amount . . . in the extract with respect to any other component present therein.” Id.; see also id. at 9 (arguing that the Examiner “has failed to provide any evidence regarding the amount of o-methylated flavonoids that . . . could be obtained from [Watanabe’s] extraction processes.”). Appellant’s arguments are not persuasive of reversible error. The facts of this case fall squarely within well-established case law regarding burdens of proof before the Office. Where, as here, the claimed and prior art products are . . . produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products Appeal 2020-006035 Application 13/647,670 5 do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. § 102, on ‘prima facie obviousness’ under 35 U.S.C. § 103 . . . the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Here, the Examiner undisputedly finds that Watanabe’s method uses the same starting material, solvent, and extraction conditions as those claimed. Final Act. 2. Thus, it is Appellant’s burden––not the Examiner’s– –to show that Watanabe’s extract does not contain the claimed level of o- methylated flavonoids, i.e., “at least about 0.1% of the o-methylated flavonoids on a dry weight basis.” On this record, Appellant has failed to do so. Moreover, the Examiner undisputedly finds that Watanabe also discloses purifying the extract and that purifying the solvent containing the extract to the claimed concentration––i.e., “at least about 50% by weight . . . on a dry weight basis”––would have been obvious. Id. at 2–3. Although Appellant alludes to the claimed purity on several occasions (Appeal Br. 4, 5), Appellant does not appear to advance any specific substantive argument regarding the Examiner’s findings and conclusion regarding purification. Rather, Appellant’s arguments are focused on the “minimal amounts” or “very low quantities” expected to be extracted by Watanabe’s method vis-à- vis the amounts extracted by the claimed method. See Appeal Br. 5–7. Thus, to the extent Appellant’s arguments could be understood to apply to the claimed purification step, we are unpersuaded by such contentions because they amount to no more than bare assertions devoid of evidence. See In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011) (“[T]he Appeal 2020-006035 Application 13/647,670 6 Board [has] reasonably interpreted Rule 41.37 to require more substantive arguments in an appeal brief than a mere recitation of the claim elements and a naked assertion that the corresponding elements were not found in the prior art.”). Moreover, we note that “the mere purity of a product, by itself, does not render the product unobvious.” MPEP 2144.04 VII. Even further, the claims are broad as to purification methods, and Watanabe and the instant application each disclose purification by chromatography. Watanabe 112; Spec. 17:1–31; Best, 562 F.2d at 1255. Appellant also contends that “the method recited in the pending claims represents unexpected results for the same reasons” discussed in the Appeal Brief with respect to the expectations in the art. Appeal Br. 8. This argument lacks persuasive merit for several reasons. First, Appellant has not established sufficiently that such results would truly have been unexpected. See Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007) (“[B]y definition, any superior property must be unexpected to be considered as evidence of non-obviousness.”). Also, Appellant does not support its assertion with factual evidence. See In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984) (“[I]t is well settled that unexpected results must be established by factual evidence. Mere argument or conclusory statements in the specification does not suffice.”). Moreover, Appellant has not produced evidence commensurate in scope with the claims. “[O]bjective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support.” In re Tiffin, 448 F.2d 791, 792 (CCPA 1971). Appeal 2020-006035 Application 13/647,670 7 Because Appellant has not shown reversible error in the Examiner’s rejection of claim 1, we sustain it, along with the rejection of claims 2, 3, 5, and 9–18 not separately argued.5 Claim 4 Claim 4 depends from claim 1 and requires that “the plant material . . . is obtained from a Galpao communs plant.” Appeal Br. 17. The Examiner relies on the combination of Watanabe, Murphy, and ACTT to reject this claim. Final Act. 4–5. Appellant first argues that claim 4 is patentable for the same reasons articulated with respect to claim 1. Id. at 10. We reject that argument for the same reasons we have already expressed supra. Appellant next contends that the Examiner’s motivation to combine Watanabe, Murphy and ACTT is lacking. Appeal Br. 11. We disagree for the reasons expressed by the Examiner––i.e., the skilled artisan would have been motivated to use the claimed tobacco variety because it has larger leaves and has a lower relative price than the one sucker variety. Final Act. 5; Ans. 8. Finally, Appellant argues that [t]he ACTT reference does not disclose that the use of any particular type of tobacco material (much less the Galpao commun[s] variety tobacco specifically recited in claim 4) could lead to an extract containing a high percentage of o-methylated flavonoids when subjected to the processes of Watanabe and/or Murphy, let alone that it would lead to an extract with the surprisingly high amount . . . recited. 5 Although Appellant addresses claims 2 and 3 under a separate subheading, Appellant makes no separate substantive arguments with respect to these claims. Appeal Br. 9–10. Rather, Appellant merely relies on the same arguments as presented for claim 1. Id. at 10. Appeal 2020-006035 Application 13/647,670 8 Appeal Br. 12. This argument is unpersuasive because the Examiner need not point to an express teaching in ACTT or the other relied upon prior art regarding a “high” o-methylated flavonoid concentration. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007) (explaining that the “obviousness analysis cannot be confined by a formalistic conception of the words teaching, suggestion, and motivation, or by overemphasis on the importance of published articles and the explicit content of issued patents.”). Here, the Examiner has made the requisite fact findings and has provided a suitable reason to combine the Watanabe, Murphy and ACTT references. Final Act. 4–5. As with claim 1, the burden lies with Appellant to show that the prior art process would not inherently impart the claimed characteristics to the prior art purified extract. Best, 562 F2d. at 1255. On this record, Appellant has failed to meet that burden. Claims 6–8 and 28 These claims depend from claim 1, and require higher solvent concentrations of o-methylated flavonoids. Appeal Br. 18, 20. As with claim 1, the Examiner finds that Watanabe discloses the same starting material and solvent conditions to extract the flavonoids. Final Act. 3. The Examiner furthermore finds that the skilled artisan could optimize Watanabe’s solvent to arrive at the ranges recited in these claims. Id. In addressing this rejection, Appellant largely repeats an argument made with respect to claim 1––i.e., that Watanabe does not teach or suggest the claimed amounts. Appeal Br. 13. This argument lacks persuasive merit for these claims as it did for claim 1 because Appellant has not met its Appeal 2020-006035 Application 13/647,670 9 burden to show that Watanabe’s method does not yield the claimed amounts of flavonoids. Best, 562 F2d. at 1255. Appellant’s arguments also do not address the Examiner’s optimization rationale, so no reversible error has been shown for this additional reason. Final Act. 3. Claim 29 Claim 29 depends from claim 1 and requires that “the solvent is methanol.” Appeal Br. 20. The Examiner finds that Watanabe discloses the solvent is methanol. Final Act. 3 (citing Watanabe, p. 111). Appellant argues, inter alia, “that the claim language ‘wherein the solvent is methanol’ explicitly limits the extraction solvent to only methanol.” Appeal Br. 14. On this record, we agree with Appellant and reverse the rejection of claim 29. Here, the Specification distinguishes between using individual solvents and solvent mixtures. See Spec. 14:18–20 (listing individual solvents such as methanol, hydrocarbons, methylene chloride and combinations thereof); id. at 15:30–16:2 (“In certain embodiments, the o- methylated flavonoid-containing extract is a methanol extract, although other solvents (e.g., other alcohol solvents) could be used.”). Moreover, the doctrine of claim differentiation supports a narrow reading of claim 29. Claim 5 depends from claim 1 and recites that the solvent comprises methanol, whereas claim 29 requires that the solvent “is methanol.” “‘There is presumed to be a difference in meaning and scope when different words or phrases are used in separate claims. To the extent that the Appeal 2020-006035 Application 13/647,670 10 absence of such difference in meaning and scope would make a claim superfluous, the doctrine of claim differentiation states the presumption that the difference between claims is significant.’” U.S. v. Telectronics, Inc., 857 F.2d 778, 783–84 (Fed. Cir. 1988) (quoting Tandon Corp. v. U.S. Int’l Trade Comm’n, 831 F.2d 1017 (Fed. Cir. 1987)). For these reasons, we determine that the broadest reasonable interpretation of claim 29 is that the solvent is limited to methanol. The relied-upon disclosure of Watanabe does not limit its solvent choice to methanol. Watanabe, 111 (disclosing that “[t]he material was finally extracted with a water-saturated solvent mixture containing equal volumes of isopropyl alcohol, n-butyl alcohol, benzene, chloroform, ethyl acetate, and methyl alcohol.”). Because the Examiner’s rejection of claim 29 relies on an unreasonably broad interpretation of the scope of this claim, we do not sustain this rejection. CONCLUSION The Examiner’s rejections are affirmed-in-part. DECISION SUMMARY Claim(s) Rejected 35 U.S.C. § Reference(s) / Basis Affirmed Reversed 1, 5–18, 28, 29 103(a) Watanabe 1, 5–18, 28 29 2, 3 103(a) Watanabe, Murphy 2, 3 4 103(a) Watanabe, Murphy, ACTT 4 Overall Outcome 1–18, 28 29 Appeal 2020-006035 Application 13/647,670 11 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). AFFIRMED-IN-PART Copy with citationCopy as parenthetical citation