IP MED, INC. et al.

Patent Trials and Appeals BoardNov 29, 2021

2021004118 (P.T.A.B. Nov. 29, 2021)

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. 16/071,648 07/20/2018 Ari ISAACS INOV25749(100650-00180) 8104 26304 7590 11/29/2021 KATTEN MUCHIN ROSENMAN LLP 575 MADISON AVENUE NEW YORK, NY 10022-2585 EXAMINER MOON, MATTHEW RYAN ART UNIT PAPER NUMBER 3785 NOTIFICATION DATE DELIVERY MODE 11/29/2021 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): doreen.devito@katten.com nycuspto@katten.com samson.helfgott@katten.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte ARI ISAACS ____________ Appeal 2021-004118 Application 16/071,648 Technology Center 3700 ____________ Before DANIEL S. SONG, STEFAN STAICOVICI, and BRETT C. MARTIN, Administrative Patent Judges. STAICOVICI, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE. Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s decision in the Final Office Action (dated Sept. 18, 2020, hereinafter “Final Act.”) rejecting claims 1–6 and 10–16. We have jurisdiction over this appeal under 35 U.S.C. § 6(b). 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. IP MED, INC. is identified as the real party in interest in Appellant’s Appeal Brief (filed Mar. 15, 2021, hereinafter “Appeal Br.”). Appeal Br. 2. Appeal 2021-004118 Application 16/071,648 2 SUMMARY OF DECISION We AFFIRM. INVENTION Appellant’s invention is directed to a medicament delivery device including “an oral tubular section for placement in the mouth of a user and a nasal tubular section for placement in the naris of a user.” Spec. 1, ll. 8–10. Claim 1, the sole independent claim, is representative of the claimed invention and reads as follows: 1. A medicament delivery device comprising: a first tubular section; a second tubular section; a bendable section including corrugations connecting the first tubular section to the second tubular section; a one way valve having a widened body in line with the first tubular section, wherein the widened body has a greater cross- sectional diameter than the first tubular section, and wherein the one way valve allows airflow from the first tubular section to the second tubular section and restricts airflow from the second tubular section to the first tubular section; a removable cap having a compartment holding a medicament including a sealable opening, wherein a proximal end of the second tubular section is located within the removable cap and abuts the sealable opening, and wherein a proximal end of the first tubular section is located within the cap and does not abut the sealable opening, wherein removal of a sealing medium for sealing the sealable opening causes the medicament to flow through the second tubular section in a first direction and into the corrugations of the bendable section, and Appeal 2021-004118 Application 16/071,648 3 wherein the medicament exits the second tubular section in a second opposite direction during use of the medicament delivery device after removal of the removable cap from the proximal end of the first tubular section and the proximal end of the second tubular section. Appeal Br. 8 (Claims App). REJECTIONS I. The Examiner rejects claims 14 and 15 under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. II. The Examiner rejects claims 1, 10, and 14–16 under 35 U.S.C. § 103 as being unpatentable over Keldmann ’482,2 Gray,3 Keldmann ’423,4 and Faram.5 III. The Examiner rejects claim 2 under 35 U.S.C. § 103 as being unpatentable over Keldmann ’482, Gray, Keldmann ’423, Faram, and Gengar.6 IV. The Examiner rejects claim 3 under 35 U.S.C. § 103 as being unpatentable over Keldmann ’482, Gray, Keldmann ’423, Faram, Gengar, and Denton.7 2 Keldmann et al., US 2002/0165482 Al, published Nov. 7, 2002. 3 Gray et al., US 4,579,114, issued Apr. 1, 1986. 4 Keldmann et al., US 2008/0190423 Al, published Aug. 14, 2008. 5 Faram, US 9,566,397 B2, issued Feb.14, 2017. 6 Gengar et al., US 9,078,989 B2, issued July 14, 2015. 7 Denton et al., US 2013/0298902 A1, published Nov. 14, 2013. Appeal 2021-004118 Application 16/071,648 4 V. The Examiner rejects claims 4–6 under 35 U.S.C. § 103 as being unpatentable over Keldmann ’482, Gray, Keldmann ’423, Faram, Gengar, and Chintakis.8 VI. The Examiner rejects claim 11 under 35 U.S.C. § 103 as being unpatentable over Keldmann ’482, Gray, Keldmann ’423, Faram, and Moller.9 VII. The Examiner rejects claims 12 and 13 under 35 U.S.C. § 103 as being unpatentable over Keldmann ’482, Gray, Keldmann ’423, Faram, and Tsutsui.10 ANALYSIS Rejection I The Examiner finds that the limitation “the first tubular section is positioned at 80° relative to the second tubular section” in claim 14 is not supported by Appellant’s original disclosure. Final Act. 3–4. As Appellant does not address the rejection, Appellant has waived any argument of error. See Appeal Br. 3–6. Accordingly, we summarily sustain the rejection under 35 U.S.C. § 112(a) of claim 14, and its dependent claim 15, as failing to comply with the written description requirement. See In re Berger, 279 F.3d 975, 984, 985 (Fed. Cir. 2002) (holding that the Board did not err in sustaining a rejection under 35 U.S.C. § 112, second paragraph, when the applicant failed to contest the rejection on appeal). 8 Chintakis et al., US 2016/0271352 A1, published Sept. 22, 2016. 9 Moller, US 2011/0066136 A1, published Mar. 17, 2011. 10 Tsutsui et al., US 8,827,946 B2, issued Sept 9, 2014. Appeal 2021-004118 Application 16/071,648 5 Rejection II Appellant has not presented arguments for the patentability of claims 10 and 14–16 apart from independent claim 1. See Appeal Br. 4–6. Therefore, in accordance with 37 C.F.R. § 41.37(c)(1)(iv), we select claim 1 as the representative claim to decide the appeal of the rejection of these claims, with claims 10 and 14–16 standing or falling with independent claim 1. The Examiner finds that Keldmann ’482 discloses a medicament delivery device 10 including, inter alia, first tubular section 11 (oral section), second tubular section 12 (nasal section), bendable section 13 with corrugations, medicament dose 14, and one-way valve 28 in line with first tubular section 11, wherein one-valve 28 allows air to flow from first tubular section 11 (oral section) to second tubular section 12 (nasal section) and restricts air flow in the opposite direction. Final Act. 4–5 (citing Keldmann ’482, paras. 46, 56, Figs. 6, 16). However, the Examiner further finds that Keldmann ’482 “does not disclose a removable cap having a compartment holding a medicament including a sealable opening,” as called for by independent claim 1. Id. at 5. Nonetheless, the Examiner finds that Keldmann ’423 discloses a medicament delivery device including, inter alia, first and second tubular sections (right and left tubes) and removable cap 2 having compartment 4, with sealable opening 7 sealed by film 11, for holding a medicament. Id. at 5–6 (citing Keldmann ’423, Figs. 1, 2). The Examiner further finds that the proximal end of the first tubular section (right tube) is located within cap 2, but does not abut sealable opening 7, whereas the proximal end of the Appeal 2021-004118 Application 16/071,648 6 second tubular section (left tube) is located within cap 2 and abuts sealable opening 7. Id. at 6 (citing Keldmann ’423, Figs. 2–4). Thus, in a first instance, the Examiner concludes that because the one- way valve 28 of Keldmann ’482, associated with the first tubular section (oral section), prevents airflow from the second tubular section (nasal section) to the first tubular section (oral section), it would have been obvious to a person of ordinary skill in the art: to position the proximal end of the second [nasal] tubular section [12] of . . . Keldmann ’482 reference within the cap [of Keldmann ’423] and abut the sealable opening [7] (instead of the first [oral] tubular section [11]) in order to prevent inhalation of the medicament (Keldmann ’482 already discloses that the purpose of including a one-way valve in the first tubular [oral] section [11] is to prevent inhalation of the medicament). Id (citing Keldmann ’482, para. 56). In a second instance, the Examiner further determines that it would have been obvious to a skilled artisan: to modify the removable cap and medicament of Keldmann ’482 such that the removable cap has a compartment holding a medicament including a sealable opening, wherein a proximal end of the second [nasal] tubular section [12] is located within the removable cap and abuts the sealable opening, and wherein a proximal end of the first [oral] tubular section [11] is located within the cap and does not abut the sealable opening, as taught by Keldmann ’423, because pre-filling the medicament in a cap instead of prefilling the medicament in the tube allows for higher production speed and lower handling costs. Id (citing Keldmann ’423, para. 67). Furthermore, the Examiner also relies on Gray to disclose a one-way valve having a widened body and on Faram to disclose removal of a sealing medium covering a sealing opening of a tubular section to cause medicament Appeal 2021-004118 Application 16/071,648 7 to flow in a first direction, and, during use, to flow in a second opposite direction. Id. at 5, 7 (citing Gray, col. 3, ll. 26–27, Figs. 1–5; Faram, col. 7, ll. 47–50, Fig. 3). The Examiner determines that modifying the one-way valve of Keldmann ’482 to have a widened body, as per Gray, would have been obvious to a skilled artisan “for the purpose of improving control of air flow due to the inclusion of a biasing spring.” Id. at 5. The Examiner further determines that it would have been obvious to a person of ordinary skill in the art to remove the sealing medium covering the sealing opening in the device of Keldmann ’482, as modified by Keldmann ’423 and Gray, to cause medicament to flow in a first direction, and, during use, to flow in a second opposite direction, as per Faram, “for the purpose of reducing risk of improper dosing events.” Id. at 8. The Examiner explains that: because the direction of inhalation flow is opposite to that of the flow of the medicament depositing within the tubular sections, one of ordinary skill in the art would recognize that the likelihood of more medicament from the medicament compartment reaching the patient is increased due to the medicament being released into the medicament delivery device closer to the user, therefore having less area to travel when being inhaled. Id. at 8–9. In response, Appellant argues “that the Examiner’s combination of references relies on conclusory statements and a hindsight construction not supported by the teachings of the prior art references.” Appeal Br. 4; see also Reply Brief (filed June 17, 2021, hereinafter “Reply Br.”) 1. Appellant contends that both Keldmann ’482 and Keldmann ’423 disclose that the medicament must “pass over all the corrugations,” that is, “flow[] over the entire length of the corrugations,” whereas in the Examiner’s rejection, Appeal 2021-004118 Application 16/071,648 8 medicament is released into the second tubular section 12 of Keldmann ’482, as modified by Keldmann ’423, Gray, and Faram, that is, at a location after (downstream) of the corrugations in the intake direction (the direction in which medicament flows to exit the device and be delivered to the patient). See id. at 5–6 (citing Keldmann ’482, para. 11; Keldmann ’423, paras. 5, 38, 57, Figs. 27a, 27b, 27c) (emphasis omitted). Thus, according to Appellant, the Examiner’s position that a skilled artisan would recognize that more medicament would reach the patient in the device of Keldmann ’482, as modified by Keldmann ’423, Gray, and Faram, because the medicament is released into the medicament delivery device closer to the user, contradicts the express teachings of both Keldmann ’482 and Keldmann ’423. Id. at 6 (citing to Final Act. 8). We are not persuaded by Appellant’s argument that the Examiner’s determination of obviousness is based on impermissible hindsight reconstruction. “[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). In this case, the Examiner’s modification is an improvement to the medicament delivery device of Keldmann ’482 to include a removable cap having a compartment holding a medicament and a sealable opening in the same manner as taught by Keldmann ’423 to lead to the predictable results of “higher production speed and lower handling costs” and “reduce[d] mechanical agitation of the medicament during transport of the device.” See Examiner’s Answer (dated Apr. 22, 2021, hereinafter “Ans.”) 21 (citing Keldmann ’423, paras. 38, 67). Thus, the Appeal 2021-004118 Application 16/071,648 9 Examiner has provided a sufficient reasoning with rational underpinnings to combine the teachings of Keldmann ’482 and Keldmann ’423. See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[R]ejections on obviousness grounds [require] some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness”) (cited with approval in KSR, 550 U.S. at 418). Furthermore, we appreciate that Keldmann ’482 discloses medicament passing over corrugations. See Keldmann ’482, para. 11. However, the Examiner is correct that Keldmann ’482 does not state “that the medicament must pass through all the corrugations of the corrugated section.” Ans. 25. Moreover, claim 1 does not require that the medicament pass over all corrugations. See Appeal Br. 8 (Claims App.) (“wherein removal of a sealing medium . . . causes the medicament to flow through the second tubular section in a first direction and into the corrugations of the bendable section”). Limitations not appearing in the claims cannot be relied upon for patentability. In re Self, 671 F.2d 1344, 1348 (CCPA 1982). We also appreciate that Keldmann ’423 discloses that the medicament should be located at the beginning of the corrugations before inhalation in the intake direction (the direction in which medicament flows to exit the device and be delivered to the patient). See Keldmann ’423, paras. 5, 38, 57. However, the Examiner is correct that the rejection employs Keldmann ’423 as a secondary reference “to teach that the medicament is housed within a cap as opposed to being housed within the medicament delivery device prior to use, and . . . not . . . to teach operation of the medicament delivery device.” Id (emphasis added). Obviousness does not require that all of the features of the secondary reference be bodily incorporated into the primary Appeal 2021-004118 Application 16/071,648 10 reference. In re Keller, 642 F.2d 413, 425 (CCPA 1981). We must attribute skill to the hypothetical person described in 35 U.S.C. § 103(a). In re Sovish, 769 F.2d 738, 742 (Fed. Cir. 1985). The fact that some judgment and mechanical skill may be required for “maneuvering/tilting the [medicament delivery] device” (see Ans. 26) to allow the medicament to flow through the second tubular (nasal) section 12 and into the corrugations of the bendable section 13 of the device of Keldmann ’482, as modified by Keldmann ’423, Gray, and Faram, does not necessarily mean that such combination constitutes a nonobvious invention. Graham v. John Deere Co. of Kansas City, 383 US 1, 10–12 (1966) (discussing Hotchkiss v. Greenwood, 11 How. 248 (1851)). Lastly, Appellant argues that neither Keldmann ’482 nor Keldmann ’423 discloses positioning a proximal end of a second (nasal) tubular section, rather than a proximal end of a first (oral) tubular section, within a removable cap with a medicament compartment to abut a sealable opening. See Appeal Br. 4. Appellant’s contention is not persuasive because an artisan must be presumed to know something about the art apart from what the references disclose. In re Jacoby, 309 F.2d 513, 516 (CCPA 1962). In this case, a skilled artisan would have known that positioning the proximal end of the first (oral) tubular section 11 of Keldmann ’482 to abut the sealable opening of the removable cap of Keldmann ’423 would have obviated the purpose of one-way valve 28, namely, to prevent inhalation of medicament “exiting the opening of the first tubular section [11].” See Final Act. 6 (citing Keldmann ’482, para. 56); Ans. 26. The Examiner is correct “that the medicament must be [located] downstream of the valve [28] prior to user exhalation in the tubular structure in order to prevent user inhalation Appeal 2021-004118 Application 16/071,648 11 of the medicament, and therefore the sealed opening must be placed on the second [nasal] tubular section.” Ans. 23 (emphasis added). In conclusion, for the foregoing reasons, we sustain the rejection under 35 U.S.C. § 103 of independent claim 1 as unpatentable over Keldmann ’482, Gray, Keldmann ’423, and Faram. Claims 10 and 14–16 fall with claim 1. Rejections III–VII Appellant does not separately argue the rejections under 35 U.S.C. § 103 of claims 2–6 and 11–13. See Appeal Br. 3–7. Therefore, for the same reasons discussed supra, we likewise sustain Rejections III–VII. CONCLUSION Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 14, 15 112(a) Written description 14, 15 1, 10, 14–16 103 Keldmann ’482, Gray, Keldmann ’423, Faram 1, 10, 14–16 2 103 Keldmann ’482, Gray, Keldmann ’423, Faram, Gengar 2 3 103 Keldmann ’482, Gray, Keldmann ’423, Faram, Gengar, Denton 3 4–6 103 Keldmann ’482, Gray, Keldmann ’423, Faram, Gengar, Chintakis 4–6 Appeal 2021-004118 Application 16/071,648 12 11 103 Keldmann ’482, Gray, Keldmann ’423, Faram, Moller 11 12, 13 103 Keldmann ’482, Gray, Keldmann ’423, Faram, Tsutsui 12, 13 Overall outcome 1–6, 10–16 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