Mark Deem et al.

Patent Trials and Appeals BoardOct 29, 2020

13081406 - (D) (P.T.A.B. Oct. 29, 2020)

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. 13/081,406 04/06/2011 Mark Deem 4680.06US02 3875 24113 7590 10/29/2020 PATTERSON THUENTE PEDERSEN, P.A. 80 SOUTH 8TH STREET 4800 IDS CENTER MINNEAPOLIS, MN 55402-2100 EXAMINER CLARK, RYAN T ART UNIT PAPER NUMBER 3794 NOTIFICATION DATE DELIVERY MODE 10/29/2020 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): efsuspto@ptslaw.com johnson@ptslaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte MARK DEEM, VIVEK SHENOY, and MARTIN L. MAYSE Appeal 2020-002382 Application 13/081,406 Technology Center 3700 ____________ Before MICHAEL J. FITZPATRICK, MICHELLE R. OSINSKI, and CARL M. DEFRANCO, Administrative Patent Judges. FITZPATRICK, Administrative Patent Judge. DECISION ON APPEAL Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s final decision rejecting claims 1–5, 7–16, 18, 112–114, and 116–121. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 “Appellant” refers to the applicant as defined in 37 C.F.R. § 1.42. Appellant identifies Nuvaira, Inc. as the sole real party in interest. Appeal Br. 2. Appeal 2020-002382 Application 13/081,406 2 STATEMENT OF THE CASE The Specification The Specification “generally relates to the field of pulmonary treatments.” Spec. 1:8. The Claims Claims 1–5, 7–16, 18, 112–114, and 116–121 are rejected. Final Act. 1. Claims 6, 17, 19–111, and 115 are cancelled. Id. at 2. No other claims are pending. Id.; see also Appeal Br. 18–24. Claim 1 is illustrative and reproduced below. 1. A system for pulmonary treatment, comprising: a pulmonary treatment device having a first elongate member and an energy delivery element, the energy delivery element being positionable through at least a portion of a trachea and within a first airway via a pharynx, the energy delivery element being monopolar and configured to deliver energy radially outward from within the first airway to a wall of the first airway to alter nerve tissue of a nerve trunk located along an outer wall of the first airway, wherein the pulmonary treatment device comprises an expandable member configured to move between a contracted configuration and an expanded configuration, and an energy emitter assembly, the energy emitter assembly including the energy delivery element disposed on a conduit configured for receiving media therethrough to cool the energy delivery element, the energy emitter assembly being configured to extend circumferentially about the expandable member when in the expanded configuration; and a protection device having a second elongate member and a protection member, the protection portion being positionable in an esophagus via the pharynx while the pulmonary treatment device is positioned in the first airway, the protection device being free of energy delivery elements, and being configured to absorb heat from a wall of the esophagus to inhibit damage to non-target tissue, Appeal 2020-002382 Application 13/081,406 3 wherein the first and second elongate members are configured to simultaneously extend through the pharynx when the energy delivery element is positioned within the first airway and the protection device is positioned within the esophagus. Appeal Br. 18. The Examiner’s Rejections The rejections before us, all under 35 U.S.C. § 103(a), are as follows: 1. claims 1–5, 7, 8, 10, 11, 14–16, 18, 112–114, and 116–121 as unpatentable over Mayse2 and Lafontaine3 (Final Act. 2); 2. claim 9 as unpatentable over Mayse, Lafontaine, and Fishel4 (id. at 6); and 3. claims 12 and 13 as unpatentable over Mayse, Lafontaine, and Ingle5 (id. at 7). DISCUSSION Rejection 1 Appellant argues the rejection of all claims together. Appeal Br. 12– 15. We choose claim 1 as representative. See 37 C.F.R. § 41.37(c)(1)(iv). Mayse is directed to pulmonary treatments systems. Mayse, Abstract (“Systems, assemblies, and methods to treat pulmonary diseases”). The Examiner found that Mayse teaches most of the subject matter of claim 1 but “fails to disclose a protection device having a second elongate member and a protection member, the protection portion being positionable in an esophagus via the pharynx while the pulmonary treatment device is 2 US 2009/0306644 A1, published Dec. 10, 2009 (“Mayse”). 3 US 2008/0161890 A1, published July 3, 2008 (“Lafontaine”). 4 US 2009/0069875 A1, published Mar. 12, 2009 (“Fishel”). 5 US 6,216,704 B1, issued Apr. 17, 2001 (“Ingle”). Appeal 2020-002382 Application 13/081,406 4 positioned in the first airway, the protection device being free of energy delivery elements, and being configured to absorb heat from a wall of the esophagus to inhibit damage to non-target tissue.” Final Act. 2–3 (citing Mayse ¶¶141, 142, and 152 and Figs. 2A, 15A, 15B, and 17). Lafontaine “is directed towards methods, systems, and apparatus for protecting esophageal tissue during ablation.” Lafontaine, Abstract. The Examiner found that Lafontaine teaches “a protection device (Fig. 4 esophageal catheter 400) having an elongate member (Fig. 4 elongate member 404) with a protective member (Fig. 4 balloon 402) positionable in the esophagus to absorb heat (acts as a heat sink, paragraph [0065]) from a wall of the esophagus and inhibit damage to non-target-tissue during ablation.” Final Act. 3. The Examiner concluded: It would have been obvious to one of ordinary skill in the art at the time of the invention to have included the device of Lafontaine together with the device of Mayse in order to protect non-target tissue from ablation energy so that tissue not meant to be treated can be kept at normal body temperatures (Lafontaine par. [0065]); further, Mayse recognizes the need to cool adjacent tissues to prevent injury thereto (par. [0144]). The combination of Mayse with Lafontaine teaches wherein the first and second elongate members are configured to simultaneously extend through the pharynx when the energy delivery element is positioned within the first airway and the protection device is positioned within the esophagus since this is a functional limitation that the device of Mayse and Lafontaine would be capable of preforming. Id. at 3–4. Appellant first argues that Mayse “teaches cooling of non-target tissue between the energy emitter and the target nerve tissue, and not beyond the nerve tissue[.] . . . Mayse does not disclose or suggest specifically Appeal 2020-002382 Application 13/081,406 5 protecting the esophagus and tissue proximate the esophagus, and is silent with respect to positioning a protection member in the esophagus to protect the esophagus and surrounding tissue.” Appeal Br. 13–14 (citing Mayse ¶144). This argument is not persuasive of error because the Examiner does not rely on Mayse for teaching the protection of esophageal tissue specifically. Rather, the Examiner cites Mayse for generally teaching “the need to cool adjacent tissue to prevent injury thereto.” Final Act. 4 (citing Mayse ¶144). The Examiner relies on a different reference, Lafontaine, for teaching the protection of esophageal tissue specifically. Id. at 3; see also In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (“Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. . . . [The reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole.”). Appellant argues that “Lafontaine is directed to methods of treating cardiac arrhythmias with catheter ablation therapy via ablation of cardiac tissues, in which the ablation catheter is inserted into the heart,” and “the skilled person would have no reason to believe that Lafontaine teaches anything relevant to lung treatment, which is the focus of Mayse.” Appeal Br. 14. As the Examiner notes (see Ans. 5), this appears to be an argument that Lafontaine is non-analogous art. A prior art reference is analogous art if it meets either of the following criteria: “(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 re Clay, 966 Appeal 2020-002382 Application 13/081,406 6 F.2d 656, 658–59 (Fed. Cir. 1992). The Examiner finds that Lafontaine meets both criteria. Ans. 5 (“Lafontaine is in the same field of endeavor because Lafontaine pertains to an in vivo ablation device. Lafontaine is also reasonably pertinent to the particular problem because it is using a balloon to cool the esophagus to prevent damage to the esophagus.”). We see no error in the Examiner’s finding that Lafontaine is analogous art. Appellant replies, however, that it was not challenging Lafontaine’s status as analogous art and was “instead highlighting that Mayse and Lafontaine are directed at solving two very different problems.” Reply Br. 3. However, there is no legal requirement for references to be directed to solving the same or similar problems in order for their teachings to be combined. Appellant argues that Lafontaine teaches an “ablation catheter is inserted into the heart, and not into the airway.” Appeal Br. 14. Thus, according to Appellant, “one of skill in the art, having a device already positioned in the airway via the pharynx [i.e., Mayse’s first elongate member carrying electrode 2004], would not be motivated, absent the present disclosure, to introduce yet another device into the esophagus [i.e., Lafontaine’s protective device] also via the already substantially occluded pharynx.” Id. The Examiner answers this argument, in part, by pointing out that there are no limitations in the claim directed to the size of the pulmonary treatment device and protection device or their corresponding elongate members. Ans. 4. The Examiner adds that Appellant “has not presented any supporting reasons that the structures of Mayse and Lafontaine would not be capable of fitting in the pharynx at the same time.” Id. Finally, the Appeal 2020-002382 Application 13/081,406 7 Examiner cites evidence showing that it is possible, and was known prior to Appellant’s claimed invention, to have “multi-balloon configurations inserted in the pharynx at the same time.” Id. (citing US 4,231,365, issued Nov. 4, 1980 to Scarberry, Fig. 1; US 6,374,827, issued Apr. 23, 2002 to Bowden et al., Fig. 3).6 In reply, Appellant “maintain[s] that one of skill in the art would not be motivated to introduce two devices, i.e. the cooled ablation catheter of Mayse and the esophageal cooling device of Lafontaine, through the same lumen, i.e. the pharynx, absent the present disclosure.” Reply Br. 2. Appellant relies on the fact that neither Mayse nor Lafontaine teaches two devices “configured to be simultaneously introduced via the pharynx and into the trachea and esophagus.” Id. However, as explained in the rejection and above, each of those references provide a reason for introducing a unique device through the pharynx—Mayse introducing an ablation device through the pharynx for use in the trachea/bronchi and Lafontaine introducing a protection device through the pharynx for use in the esophagus. The prior art provides a reason to combine these teachings. See Final Act. 3–4. Appellant does not rebut adequately that reason. Nor does Appellant substantiate its own argument that a person of ordinary skill in the art would not, or could not, introduce both devices through the pharynx simultaneously. Lastly, Appellant does not dispute the Examiner’s finding that it is possible, and was known, to insert multiple medical devices into the 6 These references were listed in a May 19, 2015, Notice of References Cited. Appeal 2020-002382 Application 13/081,406 8 pharynx at the same time. See Ans. 4 (citing US 4,231,365, Fig. 1; US 6,374,827, Fig. 3); see generally Reply Br. None of Appellant’s arguments apprises us of error in the Examiner’s rejection of claim 1. Accordingly, we affirm the rejection of claim 1, as well as that of claims 2–5, 7, 8, 10, 11, 14–16, 18, 112–114, and 116–121, which fall therewith. 37 C.F.R. § 41.37(c)(1)(iv). Rejections 2 and 3 Appellant argues the patentability of claims 9, 12, and 13 solely on the basis that the additional cited teachings from Fishel and Ingle do not remedy the alleged deficiency in the rejection of claim 1 from which they ultimately depend. Appeal Br. 16. Thus, for similar reasons, we affirm the rejection of claims 9 as unpatentable over Mayse, Lafontaine, and Fishel, and the rejection of claims 12 and 13 as unpatentable over Mayse, Lafontaine, and Ingle. SUMMARY Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–5, 7, 8, 10, 11, 14–16, 18, 112–114, 116–121 103(a) Mayse, Lafontaine 1–5, 7, 8, 10, 11, 14–16, 18, 112–114, 116–121 9 103(a) Mayse, Lafontaine, Fishel 9 12, 13 103(a) Mayse, Lafontaine, Ingle 12, 13 Overall Outcome 1–5, 7–16, 18, 112– 114, 116– 121 Appeal 2020-002382 Application 13/081,406 9 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