Medtronic, Inc.

Patent Trials and Appeals Board

Jan 5, 2022

2021002138 (P.T.A.B. Jan. 5, 2022)

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. 15/962,644 04/25/2018 James M. Haase P0027359USC2/13405390102 5035 64619 7590 01/05/2022 MEDTRONIC, INC. (NEURO/MRG) 710 MEDTRONIC PARKWAY NE MS-LC340 MINNEAPOLIS, MN 55432-5604 EXAMINER WILSON, LARRY ROSS ART UNIT PAPER NUMBER 3783 NOTIFICATION DATE DELIVERY MODE 01/05/2022 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): ptodocketing@mrgs.com rs.patents.five@medtronic.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JAMES M. HAASE, NICHOLAS R. WHITEHEAD, and RONALD L. MEZERA Appeal 2021-002138 Application 15/962,644 Technology Center 3700 Before JEREMY M. PLENZLER, BRANDON J. WARNER, and LISA M. GUIJT, Administrative Patent Judges. GUIJT, 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 24-36, 38, and 39. 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 Medtronic, Inc. Appeal Br. 2. Appeal 2021-002138 Application 15/962,644 2 CLAIMED SUBJECT MATTER Appellant’s invention relates to “implantable infusion devices.” Spec. ¶ 2. Claim 24, reproduced below as the sole independent claim on appeal, is illustrative of the claimed subject matter: 24. An implantable infusion device, comprising: a reservoir for housing an infusion medium; a drive mechanism having an inlet chamber, a piston and a piston channel, wherein the inlet chamber is in fluid communication with the reservoir, wherein the piston channel is in fluid communication with the inlet chamber, the piston channel having a distal end and a proximal end, the proximal end being closer to the inlet chamber than the distal end, wherein the piston is axially moveable within the piston channel to drive infusion medium out of the distal end of the piston channel, wherein the piston is positioned and moveable within the piston channel such that a clearance between the piston and the piston channel is sufficiently small to prevent undissolved gas in the inlet chamber from passing through the clearance; a filter disposed between the inlet chamber and the reservoir, wherein the filter is hydrophilic and is configured to prevent microorganisms from entering the inlet chamber from the reservoir, wherein the filter is configured to allow dissolved gas to pass from the reservoir to the inlet chamber such that over time, the dissolved gas comes out of solution as undissolved gas in the inlet chamber, and wherein the filter is configured to prevent the undissolved gas from passing from the inlet chamber to the reservoir; an outlet in fluid communication with the piston channel, the outlet being closer to the distal end of the piston channel than the proximal end of the piston channel; and a valve in fluid communication with, and disposed between, the outlet and the piston channel. Appeal 2021-002138 Application 15/962,644 3 THE REJECTIONS2 The prior art relied upon by the Examiner is: Name Reference Date Lorenzen US 2003/0050625 A1 Mar. 13, 2003 Flaherty US 6,740,059 B2 May 25, 2004 Falk US 2006/0276744 A1 Dec. 7, 2006 Kamen US 2007/0219480 A1 Sept. 20, 2007 Haase US 2007/0255227 A1 Nov. 1, 2007 The following rejections are before us on appeal: I. Claims 24-27 and 35 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Lorenzen and Haase. II. Claim 28 stands rejected under 35 U.S.C. § 103(a) as being unpatentable over Lorenzen, Haase, and Flaherty. III. Claims 29-31, 36, 38, and 39 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Lorenzen, Haase, and Falk. IV. Claims 32-34 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Lorenzen, Haase, and Kamen. OPINION Rejection I Appellant argues claims 24-27 and 35 as a group. Appeal Br. 6-17. We select claim 24 as representative. See 37 C.F.R. § 41.37(c)(1)(iv). Regarding independent claim 24, the Examiner finds that Lorenzen’s implantable infusion device comprises a drive mechanism having an inlet 2 The Examiner’s rejection of claims 24-36, 38, and 39 on the grounds of nonstatutory double patenting has been withdrawn, in view of Appellant’s filing of a termination disclaimer. Ans. 8-9; Final Act. 9. Appeal 2021-002138 Application 15/962,644 4 chamber (i.e., inlet chamber 56), a piston (i.e., piston portion 44), and a piston channel (i.e., channel 35), wherein piston portion 44 is moveable within channel 35 and the clearance between piston portion 44 and channel 35 is sufficiently small so as to prevent the passage of undissolved gas (i.e., gas bubbles) from passing through the clearance, as required by claim 24. Final Act. 2-3 (citing, e.g., Lorenzen ¶¶ 77, 108, Fig. 3; Spec. ¶ 8). The Examiner also finds that Lorenzen discloses that filter 58 is disposed between inlet chamber 56 and (an upstream) reservoir 13, as required by claim 24. Id. (citing, e.g., Lorenzen ¶ 49, Fig. 3). The Examiner determines that Lorenzen fails to disclose a hydrophilic filter or that the filter is configured, inter alia, to prevent undissolved gas from passing from the inlet chamber to the reservoir, as required by claim 24, and the Examiner relies on Haase for teaching a hydrophilic filter configured as claimed. Final Act. 3-4 (citing Haase ¶¶ 48, 49). In particular, the Examiner finds that “the hydrophilicity of the filter prevents [undissolved] gases from passing in either direction.” Id. at 4. The Examiner reasons that it would have been obvious to have included Haase’s filter in Lorenzen’s infusion device “to substantially reduce or eliminate the gas bubbles [from] passing into the pump,” as taught by Haase. Id. (citing Haase ¶ 48). Appellant argues that “[t]aken as a whole, one would not include a filter of Haase in an implantable infusion device of Lorenzen,” because “one would be concerned that dissolved gases would enter the inlet chamber, come out of solution, and not be able to diffuse back to the reservoir, thereby causing a buildup of air in the inlet.” Appeal Br. 6-7 (citing Spec. ¶¶ 12, 47); see id. at 10. Appellant explains that, in the prior art, “a great deal of Appeal 2021-002138 Application 15/962,644 5 care is taken to remove air from the reservoir and pump inlet chamber” and that “[i]f . . . a hydrophilic microbial filter [is included] between the reservoir and the inlet chamber, one would not be able to remove air from the inlet chamber during a refill procedure due to the high bubble point of such filters.” Id. at 7; see also Reply Br. 3. Appellant also argues that “Lorenzen recognizes and teaches problems associated with the presence of gas downstream of the reservoir[],” and therefore, Haase’s filter would not have been incorporated into Lorenzen’s device, as proposed by the Examiner, because “one would understand that doing so would exacerbate the problems associated with gas buildup described by Lorenzen.” Appeal Br. 7 (citing Lorenzen ¶ 108); see Lorenzen ¶ 108 (disclosing that contact between piston portion 44 and valve member 66 within piston chamber 65 at the end of the forward piston stroke makes it “less likely” that gas present in the infusion medium accumulates within piston chamber 65); Appeal Br. 8 (arguing that gas buildup in Lorenzen’s inlet chamber “would interfere with the operation of the piston pump”); Reply Br. 2 (“[G]as introduced at the most upstream portion of the infusion device, the reservoir, is cause for concern at or downstream of the piston channel because such gas may cause the pump to malfunction. To correct such a malfunction, if it occurs, would require surgery to explant the device from the patient in which it is implanted.”). Appellant further submits that Haase, too, “recognizes that it is important to reduce gas bubbles in implantable infusion systems and suggests that great measures had been taken to prevent introduction of gas.” Id. at 7 (citing Haase ¶ 7); see also id. at 7-8 (citing Haase ¶¶ 9, 41, 48). Appellant concludes that “the teachings of Lorenzen and Haase, when viewed as a whole would lead one Appeal 2021-002138 Application 15/962,644 6 away from the proposed arrangement” and also that the Examiner improperly relies on hindsight. Appeal Br. 10. Appellant further concludes that the Examiner’s reliance on Lorenzen’s piston channel clearance as preventing undissolved gas in the inlet chamber from passing through the piston channel is hindsight. Id. at 9. It is undisputed that Lorenzen discloses a filter disposed in the position claimed, however, Lorenzen is silent regarding the specific type of, or particular purpose for, the filter: “a filter may be disposed between the reservoir and the drive mechanism (or as part of the inlet of the drive mechanism)” (Lorenzen ¶ 12) and “[a] filter or screen member, such as a porous or screen material 58, may be disposed within the inlet chamber 56” (id. ¶ 75). Notably, Lorenzen discloses that “cover member 50 may be provided with an inlet cover 62 that, when removed, allows access to the inlet chamber 56 to, for example, install, replace or service a filter 58 . . . , or to service or clean the inlet 27.” Id. Appellant’s Specification discloses that known piston-drive implantable infusion devices “avoided” placement of a hydrophilic filter3 between the reservoir and the inlet chamber because the bubbles “cannot be removed by aspiration when the reservoir is replenished with infusion medium” (due to the filter). Spec. ¶ 12. The Specification discloses, with respect to the claimed invention: Yet, it has been found, as described herein, that when the piston to channel clearance is sufficiently small to prevent undissolved free gas bubbles from passing through the clearance, 70% or more of the inlet chamber volume can be occupied by 3 See, e.g., Appeal Br. 7 (acknowledging that “hydrophilic microbial filter[s]” have “[a] high bubble point”). Appeal 2021-002138 Application 15/962,644 7 undissolved gas. Accordingly, infusion devices as described herein can include the beneficial effects of preventing contaminated infusion medium from reaching the inlet chamber and thus being delivered to the patient. Id. Thus, on the record before us, undissolved gas (or gas bubbles) accumulating in the inlet chamber is not a problem identified by the Specification; rather, the passage of such undissolved gas through the piston channel clearance creates problems. Indeed, the Specification discloses that when the piston channel clearance prevents the passage of undissolved gas through the piston, 70% or more (i.e., up to 100%) of the inlet chamber volume can be occupied by undissolved gas. We are not persuaded by Appellant’s argument that because Lorenzen recognizes a problem with, and provides a solution for, undissolved gas accumulating in the piston chamber (forward of the piston stroke), Lorenzen teaches away from using a filter that appears to promote the accumulation of undissolved gas in the inlet chamber. The “mere disclosure of alternative designs does not teach away.” In re Mouttet, 686 F.3d 1322, 1334 (Fed. Cir. 2012). Rather, teaching away requires “clear discouragement” from implementing a technical feature. In re Ethicon, Inc., 844 F.3d 1344, 1351 (Fed. Cir. 2017). Here, as discussed supra, rather than teaching that undissolved gas in the inlet chamber should be avoided, for example, to prevent the build-up of undissolved gas in the inlet chamber or dosing problems downstream, Lorenzen (i) provides a solution to address undissolved gas when undissolved gas does become present in the piston chamber; (ii) provides access to the inlet chamber via a cover member to service or clean the inlet; and (iii) similar to Appellant’s solution, includes a piston channel clearance that does not allow undissolved gas to pass from Appeal 2021-002138 Application 15/962,644 8 the inlet chamber to the piston chamber. In other words, the Examiner correctly finds that “Lorenzen does not discuss gas in the inlet chamber being a problem” (Ans. 10), which is consistent with Appellant’s disclosure allowing for up to 100% of the inlet chamber volume to be occupied by undissolved gas. See Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) (“a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine”). In addition, the Examiner’s finding that Lorenzen’s disclosed clearance between the piston and piston channel, which is undisputed by Appellant, results in the prevention of undissolved gas from passing from the inlet chamber to the piston chamber is also not hindsight, but rather, a finding based on inherency from structure disclosed in Lorenzen. See Ans. 13-17. Accordingly, we sustain the Examiner’s rejection of claim 24 and claims 25-27 and 35 fall therewith. Rejections II-IV Appellant chose not to present arguments for the patentability of claims 28-31, 36, 38, and 39 apart from the arguments presented for claim 24 supra. Accordingly, for essentially the same reasons as stated supra, we also sustain the Examiner’s rejection of claims 28-31, 36, 38, and 39. CONCLUSION The Examiner’s rejections are affirmed. Appeal 2021-002138 Application 15/962,644 9 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 24-27, 35 103(a) Lorenzen, Haase 24-27, 35 28 103(a) Lorenzen, Haase, Flaherty 28 29-31, 36, 38, 39 103(a) Lorenzen, Haase, Falk 29-31, 36, 38, 39 32-34 103(a) Lorenzen, Haase, Kamen 32-34 Overall Outcome 24-36, 38, 39 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