Hospi Corporation

Patent Trials and Appeals BoardSep 27, 2021

2021000284 (P.T.A.B. Sep. 27, 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. 14/074,613 11/07/2013 Bradford MACY JR. 12142-700.301 2977 66854 7590 09/27/2021 SHAY GLENN LLP 2929 CAMPUS DRIVE SUITE 225 SAN MATEO, CA 94403 EXAMINER WILSON, LARRY ROSS ART UNIT PAPER NUMBER 3783 NOTIFICATION DATE DELIVERY MODE 09/27/2021 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): info@shayglenn.com shayglenn_pair@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte BRADFORD MACY JR. Appeal 2021-000284 Application 14/074,613 Technology Center 3700 Before STEFAN STAICOVICI, WILLIAM A. CAPP, and JEREMY M. PLENZLER, Administrative Patent Judges. PLENZLER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1–13 and 23–27. 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(a). Appellant identifies the real party in interest as Hospi Corporation. Appeal Br. 2. Appeal 2021-000284 Application 14/074,613 2 CLAIMED SUBJECT MATTER The claims are directed to a rectal medication administration device. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A rectal medication administration device comprising: a tube comprising a first lumen, a second lumen and a plurality of holes extending from the first lumen through a wall of the tube; a balloon proximal to the plurality of holes and having a cavity therein in communication with the second lumen, wherein the balloon is configured to be inflated to hold the tube in place within a patient’s rectum; a first valved port in communication with the first lumen, wherein the first valved port is configured to open when connected to a first syringe or infusion set to provide medication transmission therethrough and to close when the first syringe or infusion set is withdrawn; and a second valved port in communication with the second lumen, wherein the second valved port is configured to open when connected with a second syringe to provide fluid to inflate the balloon and to close when the second syringe is withdrawn; wherein the device is configured to be expelled through a rectal sphincter during defecation. Appeal 2021-000284 Application 14/074,613 3 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Swanson US 3,409,015 Nov. 5, 1968 Todd US 3,926,705 Dec. 16, 1975 Gonzales US 5,830,186 Nov. 3, 1998 Rutner US 6,254,570 B1 July 3, 2001 Macy US 8,603,029 B2 Dec. 10, 2013 Deniega US 2002/0082547 A1 June 27, 2002 Kim US 2004/0039348 A1 Feb. 26, 2004 Phillips US 2004/0124389 A1 July 1, 2004 REJECTIONS Claims 23–27 are rejected under 35 U.S.C. § 112, second paragraph, as being indefinite. Claims 1–3, 7, 12, 13, 23, 24, and 27 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Swanson, Phillips, and Todd. Claims 4, 9, 10, and 25 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Swanson, Phillips, Todd, and Gonzalez. Claims 5 and 6 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Swanson, Phillips, Todd, and Rutner. Claim 8 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Swanson, Phillips, Todd, and Deniega. Claims 11 and 26 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Swanson, Phillips, Todd, and Kim. Claims 1–13 and 23–27 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1–8 of Macy. Appeal 2021-000284 Application 14/074,613 4 OPINION Indefiniteness Independent claim 23 recites, among other things, that “the balloon ha[s] a pliability sufficient to allow the inflated balloon to pass through a rectal sphincter during defecation.” The Examiner determines that this limitation “is a relative term which renders the claim indefinite” because “[t]he term ‘a pliability sufficient’ is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.” Non-Final Act. 2. Appellant responds, citing paragraph 42 of its Specification, for example, and explaining that “[t]he degree of pliability can thus be measured, based upon Appellant’s specification, based upon whether the inflated balloon can pass through the rectal sphincter during defecation.” Appeal Br. 6. Appellant contends that “even if the specification did not provide the standard for measuring ‘pliability sufficient,’ Appellant submits that one of ordinary skill in the art, in view of the status of the art, would be nevertheless reasonably apprised of the scope of the invention.” Id. Based on the record before us, Appellant has the better position. Consistent with Appellant’s contentions, we have no reason to believe that one skilled in the art would not readily appreciate the standard for the recited compliance. The references cited by the Examiner in the obviousness rejection provide further evidence that design considerations for rectal catheter balloons were well known in the art at the time of the invention. See, e.g., Gonzales, 10:41–45 (“The dispenser head 14 is further pliable enough to deform to a compressed state and a smaller effective diameter Appeal 2021-000284 Application 14/074,613 5 when it is removed from the body cavity, such as by being pulled through the anal sphincter (not shown) of the anus 56.”); Kim ¶ 54 (explaining sizing considerations for balloon retention), ¶ 55 (describing balloon materials). Although the claim may be broad, the Examiner fails to establish that it is indefinite. It is clear that the claim requires a level of pliability for allowing “the inflated balloon to pass through a rectal sphincter during defecation.” The Examiner fails to establish that further detail is necessary to know the metes and bounds of the claim. Obviousness For claim 1, the Examiner finds that Swanson teaches its device being “configured to be expelled through a rectal sphincter during defecation.” Non-Final Act. 4 (citing “col. 4, lines 20-25 describ[ing] deflating the balloon” and “col. 2, lines 22-22 describ[ing] the balloon’s purpose is for retention thus when the balloon is deflated the device is then configured to be expelled through the rectal sphincter during defecation”). With respect to claim 23, the Examiner finds that Swanson’s “balloon ha[s] a pliability sufficient to allow the inflated balloon to pass through a rectal sphincter during defecation.” Non-Final Act. 7 (citing “col. 2, lines 16-20 describ[ing] the balloon 28 as distending,” which “shows the inflated balloon has sufficient pliability to be capable of passing through the rectal sphincter during defecation”). Appellant is correct that Swanson provides no teaching regarding its balloon being configured to pass through a rectal sphincter during defecation or having a pliability sufficient for the same. See Appeal Br. 7–9, 11–13. Indeed, based on the disclosure of Swanson, we know nothing as to how the balloon could meet the limitations noted above. Rather, Swanson appears to Appeal 2021-000284 Application 14/074,613 6 require deflation for removal from its implanted location. See Swanson, 4:20–25. For at least these reasons, we do not sustain the Examiner’s decision to reject claims 1–13 and 23–27 under 35 U.S.C. § 103(a). Double Patenting Our rules state that Appellant’s “arguments shall explain why the examiner erred as to each ground of rejection contested by appellant.” See 37 C.F.R. § 41.37(c)(1)(iv). “When the appellant fails to contest a ground of rejection to the Board . . . the PTO may affirm the rejection of the group of claims that the examiner rejected on that ground without considering the merits of those rejections.” Hyatt v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008). Accordingly, because there is no assertion of error by Appellant, we summarily affirm the Examiner’s double patenting rejection. CONCLUSION The Examiner’s rejections under 35 U.S.C. §§ 112 and 103 are reversed. The Examiner’s double patenting rejection is affirmed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 23–27 112, second paragraph Indefiniteness 23–27 1–3, 7, 12, 13, 23, 24, 27 103(a) Swanson, Phillips, Todd 1–3, 7, 12, 13, 23, 24, 27 Appeal 2021-000284 Application 14/074,613 7 4, 9, 10, 25 103(a) Swanson, Phillips, Todd, Gonzalez 4, 9, 10, 25 5, 6 103(a) Swanson, Phillips, Todd, Rutner 5, 6 8 103(a) Swanson, Phillips, Todd, Deniega 8 11, 26 103(a) Swanson, Phillips, Todd, Kim 11, 26 1–13, 23–27 Nonstatutory Double Patenting (Macy) 1–13, 23– 27 Overall Outcome 1–13, 23– 27 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). AFFIRMED