Ex Parte HardingDownload PDFPatent Trials and Appeals BoardMay 30, 201914326072 - (D) (P.T.A.B. May. 30, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/326,072 07/08/2014 71562 7590 06/03/2019 Kirton McConkie Craig Metcalf 36 S. State Street, Suite 1900 Salt Lake City, UT 84111 FIRST NAMED INVENTOR Weston F. Harding 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 ATTORNEY DOCKET NO. CONFIRMATION NO. P-10233 1057 EXAMINER LEGETTE-THOMPSON, TIFFANY ART UNIT PAPER NUMBER 3783 NOTIFICATION DATE DELIVERY MODE 06/03/2019 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): aturner@kmclaw.com KMC-docketing@clairvolex.com IP _docket@bd.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte WESTON F. HARDING Appeal2018-007487 Application 14/326,072 1 Technology Center 3700 Before STEFAN STAICOVICI, MICHAEL J. FITZPATRICK, and WILLIAM A. CAPP, Administrative Patent Judges. ST AI CO VICI, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE- Appellant appeals under 35 U.S.C. § 134(a) from the Examiner's decision in the Final Office Action (dated Nov. 15, 2017, hereinafter "Final Act.") rejecting claims 1, 3-10, 12-20, 22, and 23. 2 We have jurisdiction over this appeal under 35 U.S.C. § 6(b). SUMMARY OF DECISION We AFFIRM. 1 Becton, Dickinson and Company is the applicant and is identified as the real party in interest in Appellant's Appeal Brief (filed Jan. 30, 2018, hereinafter "Appeal Br."). Appeal Br. 2. 2 Claim 2, 11, and 21 are canceled. Appeal Br. 19, 20, 22. Appeal2018-007487 Application 14/326,072 INVENTION Appellant's invention is directed to "an actuator for a side port of a ported catheter ... configured to elute an antimicrobial agent." Spec. para. 1. Claims 1, 14, and 19 are independent. Claim 14 is illustrative of the claimed invention and reads as follows: 14. A ported catheter comprising: a catheter adapter having a distal opening, a proximal opening, and an inner lumen that extends between the distal and proximal openings; a side port comprising a plurality of ridges, wherein the plurality of ridges form a sidewall opening into the inner lumen; a tubing contained within the inner lumen and forming a seal over the sidewall opening, wherein an external diameter of the tubing is constant along an entire length of the tubing; and an actuator contained within the side port, wherein the actuator includes a symmetric, T-shaped cross-section, wherein the actuator comprises a top portion and a bottom portion, wherein the top portion has a larger outer diameter than the bottom portion, wherein the bottom portion is configured to extend through the plurality of ridges to contact the external diameter of the tubing to compress the tubing to open a fluid pathway through the sidewall opening. REJECTIONS I. The Examiner rejects claims 14 and 22 under 35 U.S.C. § 103 as being unpatentable over Lopez (US 5,810,768, iss. Sept. 22, 1998), and Schmidt et al. (US 5,613,663, iss. Mar. 25, 1997, hereinafter "Schmidt"). II. The Examiner rejects claims 1, 3, 5, 7, 10, 12, 13, 15-18, and 23 under 35 U.S.C. § 103 as being unpatentable over Lopez, 2 Appeal2018-007487 Application 14/326,072 Schmidt, and Harding et al. (US 2008/0161763 Al, pub. July 3, 2008, hereinafter "Harding"). III. The Examiner rejects claims 4, 6, 8, and 9 under 35 U.S.C. § 103 as being unpatentable over Lopez, Schmidt, Harding, and Ou-Yang et al. (US 8,512,294 B2, iss. Aug. 20, 2013, hereinafter "Ou-Yang"). IV. The Examiner rejects claims 15-18 under 35 U.S.C. § 103 as being unpatentable over Lopez, Schmidt, and Burkholz et al. (US 2011/0009831 Al, pub. Jan. 13, 2011, hereinafter "Burkholz"). V. The Examiner rejects claims 19 and 20 under 35 U.S.C. § 103 as being unpatentable over Lopez, Schmidt, Burkholz, and Stout et al. (US 2011/0160662, pub. June 30, 2011, hereinafter "Stout"). ANALYSIS Rejection I Appellant does not present arguments for the patentability of claim 22 apart from claim 14. Therefore, we select claim 14 as the representative claim to decide the appeal of the rejection of these claims, with claim 22 standing or falling with claim 14. See 37 C.F.R. § 4I.37(c)(l)(iv). The Examiner finds that Figure 7 a of Lopez discloses a ported catheter including, inter alia, a catheter adapter 10, a side port 12 having ridges and a sidewall opening 16, a tubing 20 that forms a seal over sidewall opening 16, and an actuator 21. Final Act. 3 (citing Lopez, Fig. 7a). As shown below, the Examiner provides an annotated Figure 7a of Lopez: 3 Appeal2018-007487 Application 14/326,072 A.mwiatNI Fig. 7u The Examiner's annotated Figure 7 a of Lopez illustrates the location of the ridges and the sidewall opening. Id. The Examiner further finds Lopez does not disclose that actuator 21 has a T-shaped cross section, has a diameter at the top portion larger than at its bottom portion, and extends through the plurality of ridges to contact and compress the external diameter of tubing 20, which is constant along its length. Id. at 3--4. Nonetheless, the Examiner finds that Lopez discloses in Figures 4 and 5, in an embodiment different from the embodiment of Figure 7 a, tubing 44 that has a constant diameter along its length and actuator 25 that has a bottom portion configured to contact and compress the external diameter of tubing 44 to open a fluid pathway. Id. at 4 (citing Lopez, col 7, 11. 27-30). The Examiner further finds that Schmidt discloses an actuator 625 having a T- shaped cross-section with a diameter at the top portion larger than at its bottom portion. Id. at 4--5 (citing Schmidt, col. 5, 11. 65----67, col. 6, 11. 1-5, Fig. 3). Thus, in a first instance, the Examiner determines that it would have been obvious to a person of ordinary skill in the art, to modify the tab and tube configuration of the embodiment of Figs. 7a-7b taught by Lopez such that the tab and tube are configured like the tab and tube of Figs. 4-5 taught by Lopez because Lopez teaches that both tabs and tubes are used to open a side port to allow fluid to enter the lumen of the device; hence, the modification would yield the same predictable results. 4 Appeal2018-007487 Application 14/326,072 Id. According to the Examiner "combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art." Id. Second, the Examiner further determines that: it would have been obvious to a skilled artisan to modify the device taught by Lopez by adding the catheter taught by Schmidt ... to the distal end of the device taught by Lopez and to substitute element 25 for element 625 as taught by Schmidt ... because Lopez teaches that the device is used to transfer medication intravenously ... and Schmidt . . . teaches that element 616 is an artery cannula; hence, it is used to transfer fluid intravenously. Id. at 5 (citing Lopez, col. 1, 11. 5-8; Schmidt, col. 5, 11. 47-52) (emphasis added). According to the Examiner, because element 25 of Lopez collapses element 44 and Schmidt's element 625 opens and closes valve 20, "the tubular body of Schmidt [625] is capable of compressing element 44 [of Lopez] located inside the lumen for the purposes of injecting another fluid inside the lumen via the side port." Id. (citing Lopez, col. 6, 11. 1-7, col. 7, 11. 30-31; Schmidt, col. 5, 11. 30-34, 64---67, col. 6, 11. 1-5). Appellant argues that tab 25 of Lopez "is incompatible with the embodiment shown in Figure 7 A of Lopez and would be incapable of extending through the alleged ridges of Figure 7 A." Appeal Br. 13. According to Appellant, because "tab 25 is attached to the inner wall of conduit 12 ... it appears that tab 25 would not be permitted to extend through the alleged ridges of Figure 7 A." Id. ( citing Lopez, col. 7, 11. 2 7- 29). Appellant further asserts that because tab 25 of Lopez is not connected directly to tube 40, in the Examiner's combination, tab 21 would likewise not be directly connected to tube 20, and, thus, "it is unclear how tab 21 5 Appeal2018-007487 Application 14/326,072 would be supported." Id. Hence, according to Appellant, "tab 21 would appear to render the medical connector in Figure 7 A [ of Lopez] inoperable or unsatisfactory for its intended purpose." Id. We are not persuaded by Appellant's arguments because they are not responsive to the Examiner's rejection. The Examiner is not substituting tab 25 of Figure 4 for tab 21 of Figure 7a of Lopez, but rather, is modifying the embodiment of Figure 7 a "such that tab 21 is formed to be a separate component from tube 24 just as tab 25 and ... valve 40 of Fig. 4 ... are formed as separate components." Examiner Answer (dated May 17, 2018, hereinafter "Ans."), 4 ( emphasis added). Below, an annotated Figure 7a of Lopez is shown, representing our understanding of the Examiner's modification of Lopez: !0-"' ' Figure 7 a of Lopez, as annotated by us, illustrates tab 21 in contact with, but separate from tube 24, and also in contact with the inner wall of secondary conduit 12 along the vertical portion of the ridge. 3 3 As illustrated above in the Examiner's annotated Figure 7 a of Lopez, the inner sidewall of secondary conduit 12 includes a ridge having a horizontal portion and a vertical portion. 6 Appeal2018-007487 Application 14/326,072 As tab 25 of Lopez is a "movable tab" that is "attached to the inner wall of the secondary conduit [12]," tab 25 of Lopez is both attached and movable with respect to the inner wall of secondary conduit 12. Lopez, col. 3, 11. 64---65. In a similar manner, in light of the Examiner's modification, and as illustrated above, tab 21 is both attached and movable with respect to the inner wall of secondary conduit 12 along the vertical portion of the ridge. Accordingly, we do not agree with Appellant that the Examiner's technical reasoning is insufficient to evidence that tab 21 of Lopez, as modified, is separate from tube 24 and would be positioned in contact with the inner wall of secondary conduit 12 to move downward through the ridges to contact and compress tube 24 when forced by medical implement 30. Reply Brief (filed July 17, 2018, hereinafter "Reply Br."), 2 (citing Ans. 4). As such, the plurality of ridges of Figure 7 A of Lopez would not prevent tab 21 of Lopez, as modified, from contacting tube 24, as Appellant contends. Therefore, the Examiner is correct that "forming the tab 21 and the tube 24 to be separate structures [like tab 25 and valve 40] would not render the medical connector of Fig. 7 A [ of Lopez] inoperable." Ans. 5. We, thus, do not agree with Appellant that the Examiner's position is "conclusory and grounded in speculation" and, more specifically, that tab 21 of Lopez, as modified, is "unattached," such that it "would tilt or fall over within the secondary conduit 12," and, thus, render the medical connector of Lopez inoperable. Reply Br. 3. Furthermore, we are not persuaded by Appellant's position that Lopez does not teach a tab that "is not attached to the valve 20" and "is not attached to the inner wall of the secondary conduit 12." Id. As discussed supra, tab 25 of Lopez is both attached and movable with respect to the inner wall of secondary conduit 12, and, furthermore, the 7 Appeal2018-007487 Application 14/326,072 Examiner's rejection is based on a modification of tab 21 of Lopez in light of tab 25. Appellant further argues that "substitution of the tab 25 of Lopez with the tubular body 625 of Schmidt would change the principle of operation of Lopez." Appeal Br. 13. Appellant notes that tab 25 of Lopez is attached to the inner wall of conduit 12, whereas tubular body 625 of Schmidt is "'displaceable' within a cylindrical guide section 615b, which does not appear to be attached to the connection piece 610." Id. at 13-14. Thus, according to Appellant, the Examiner's substitution "would appear to change the principle of operation of the device in Lopez, which appears to operate via the tab attached to the inner wall of the conduit 12." Id. at 14. We are not persuaded by Appellant's arguments for the following reasons. First, as noted supra, tab 25 of Lopez is both attached and movable, i.e., displaceable, with respect to the inner wall of secondary conduit 12. See Ans. 8; see also Lopez, col. 3, 11. 64--65. In other words, like tubular body 625 of Schmidt, tab 25 of Lopez is displaceable. Second, we agree with the Examiner's finding that tab 25 of Lopez "serve[s] as an actuation mechanism for deforming the tube [24] and opening the valve" when medical implement 30 exerts a force on tab 25. Id. We further agree with the Examiner that Schmidt's tubular body 625 "serves as an actuation mechanism for opening the valve flap 20" using outer cone 40 of a syringe to exert a force on tubular body 625. Id. Hence, the Examiner is correct that because both tab 25 of Lopez and tubular body 625 of Schmidt are movable ( displaceable) by a medical instrument to open a valve, substituting Schmidt's tubular body 625 for tab 25 of Lopez would not change the principle of operation of Lopez's device. Id. at 8-9. Appellant does not persuasively argue the Examiner's findings and reasoning. 8 Appeal2018-007487 Application 14/326,072 In conclusion, for the foregoing reasons, we sustain the rejection under 35 U.S.C. § 103 of independent claim 14 as unpatentable over Lopez and Schmidt. Claim 22 falls with claim 14. Rejection II Appellant does not present arguments for the patentability of claims 5, 7, 10, 12, 13, and 23 apart from claim 1. See Appeal Br. 14--16. Therefore, we select claim 1 as the representative claim to decide the appeal of the rejection of these claims, with claims 5, 7, 10, 12, 13, and 23 standing or falling with claim 1. In view of Appellant's arguments, we will address the rejection of claim 3 separately. In addition to the arguments discussed supra that we did not find persuasive (see Appeal Br. 14--15), Appellant further argues that "Harding does not appear to disclose an actuator or more specifically an actuator that "comprises an antimicrobial agent,' as required by claim 1." Id. at 15 ( citing Harding, para. 28). We are not persuaded by Appellant's argument because Appellant cannot show nonobviousness by attacking Harding individually when the rejection as articulated by the Examiner is based on a combination of Lopez, Schmidt, and Harding. See In re Merck & Co. Inc., 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 .... [Each reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole."). In this case, the Examiner relies on the combination of Lopez and Schmidt to disclose a T-shaped actuator, as called for by independent claim 9 Appeal2018-007487 Application 14/326,072 1, and on Harding to disclose an antimicrobial agent. Ans. 13-14; see also Final Act. 9 (citing Harding, paras. 28, 36). Appellant does not persuasively argue the Examiner's findings and reasoning to combine the teachings of Lopez, Schmidt, and Harding. As to the rejection of claim 3, Appellant sets forth a similar argument as discussed supra, that is, "Harding does not appear to make any mention of an actuator or more specifically an actuator formed from a material that contains the antimicrobial agent." Appeal Br. 15-16 ( citing Harding, para. 28). Once more, we note that the Examiner relies on the combination of Lopez and Schmidt to disclose a T-shaped actuator, as called for by independent claim 1, and on Harding to disclose an "antimicrobial agent ... integrated directly into the material of the body of' a medical device. Ans. 14; see also Final Act. 10 (citing Harding, paras. 28, 36). Here, as well, Appellant does not persuasively argue the Examiner's findings and reasoning to combine the teachings of Lopez, Schmidt, and Harding. In conclusion, for the foregoing reasons, we sustain the rejection of claims 1 and 3 as unpatentable over the combined teachings of Lopez, Schmidt, and Harding. Claims 5, 7, 10, 12, 13, and 23 fall with claim 1. As Appellant does not set forth any other substantive arguments regarding the rejection of claims 15-18, for the reasons discussed above, we also sustain the rejection of these claims as unpatentable over Lopez, Schmidt, and Harding. Rejections III and IV Appellant does not present any substantive arguments with respect to Rejections III and IV. See Appeal Br. 12-18. Therefore, for the same reasons discussed supra, we also sustain Rejections III and IV. 10 Appeal2018-007487 Application 14/326,072 Rejection V Appellant does not present arguments for the patentability of claim 20 apart from claim 19. See Appeal Br. 16-18. Therefore, we select claim 19 as the representative claim to decide the appeal of the rejection of these claims, with claim 20 standing or falling with claim 19. In addition to the arguments discussed supra that we did not find persuasive (see Appeal Br. 16-17), Appellant further argues that the top portion 4b of Stout's pusher 4, which Appellant considers to be the actuator of claim 19, "does not appear to be disposed in a side port, nor is it capable of contacting residual fluid disposed along the plurality of ridges." Id. at 17. Furthermore, Appellant contends that "the opening near element 1 in Fig. 2 of Stout," does not constitute a side port, as called for by claim 19. Id. at 17-18 (emphasis added). We are not persuaded by Appellant's arguments as they are not responsive to the Examiner's rejection. The Examiner is not considering pusher 4 and opening 1 of Stout as the actuator and side port, respectively, of independent claim 19. Rather, in light of Stout's teachings, the Examiner is modifying the size of tubular element 625 of Lopez, as modified by Schmidt and Berkholz, "such that it extends across a majority of the inner diameter of the [lumen of] side port [12]." Final Act. 23 (citing Stout para. 50). We, thus, agree with the Examiner's determination that such a modification would "ensure that the tubular body [625] is stable while positioned within the lumen of the secondary conduit 12 [of Lopez, as modified by Schmidt and Burkholz] and to ensure that the tubular body [ 625] maintains a coaxial position within the lumen of the secondary conduit 12." Ans. 21. Appellant does not persuasively argue the Examiner's 11 Appeal2018-007487 Application 14/326,072 findings and reasoning to combine the teachings of Lopez, Schmidt, Berkholz, and Stout. Lastly, Appellant argues that "Burkholz does not appear to disclose an actuator or more specifically an actuator that 'comprises one or more antimicrobial agents,' as required by claim 19. Appeal Br. 18 ( citing Berkholz, para. 2). We are not persuaded by Appellant's argument because Appellant cannot show nonobviousness by attacking Burkholz individually when the rejection as articulated by the Examiner is based on a combination of Lopez, Schmidt, and Berkholz, and Stout. Specifically, the Examiner relies on the combination of Lopez, Schmidt, and Stout to disclose a T-shaped actuator, as called for by independent claim 19 (see Final Act. 19--22), and on Berkholz to disclose an antimicrobial coating on the surface of a medical device (see id. at 22). Appellant does not persuasively argue the Examiner's findings and reasoning to combine the teachings of Lopez, Schmidt, Burkholz, and Stout. As such, for the foregoing reasons, we also sustain the rejection under 35 U.S.C. § 103 of independent claim 19 as unpatentable over Lopez, Schmidt, Berkholz, and Stout. Claim 20 falls with claim 19. SUMMARY The Examiner's decision to reject claims 1, 3-10, 12-20, 22, and 23 under 35 U.S.C. § 103 is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv). AFFIRMED 12 Copy with citationCopy as parenthetical citation