Ex Parte Miesel et alDownload PDFPatent Trial and Appeal BoardMar 22, 201712793457 (P.T.A.B. Mar. 22, 2017) Copy Citation 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. 12/793,457 06/03/2010 Keith A. Miesel 1023-907US01/P0035143.00 6722 71996 7590 03/24/2017 SHUMAKER & SIEFFERT , P.A 1625 RADIO DRIVE , SUITE 100 WOODBURY, MN 55125 EXAMINER VU, QUYNH-NHU HOANG ART UNIT PAPER NUMBER 3763 NOTIFICATION DATE DELIVERY MODE 03/24/2017 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): pairdocketing @ ssiplaw.com medtronic_neuro_docketing @ cardinal-ip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte KEITH A. MIESEL, JAMES M. HAASE, CHRIS J. PAIDOSH, DARREN A. JANZIG, and TIMOTHY J. DENISON Appeal 2015-005985 Application 12/793,4571 Technology Center 3700 Before JOHN C. KERINS, STEFAN STAICOVICI, and LEE L. STEPINA, Administrative Patent Judges. STAICOVICI, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Keith A. Miesel et al. (Appellants) appeal under 35 U.S.C. § 134(a) from the Examiner’s final decision rejecting claims 1—16, 25, and 44—52.2 We have jurisdiction over this appeal under 35 U.S.C. § 6(b). 1 According to Appellants, Medtronic, Inc. is the real party in interest. Appeal Br. 3 (filed Jan. 13, 2015). 2 Claims 17—24, 26—31, 34, 36, and 37 are withdrawn from consideration and claims 32, 33, 35, and 38—43 are canceled. Final Act. 2 (transmitted Aug. 13, 2014). Appeal 2015-005985 Application 12/793,457 SUMMARY OF DECISION We REVERSE. INVENTION Appellants’ invention relates “to pressure sensors for use within implantable medical devices including medical pumps.” Spec. 11. Claims 1, 25, and 44 are independent. Claims 1 and 25 are illustrative of the claimed invention and read as follows: 1. An implantable medical device (IMD) comprising: one or more electrical components within the IMD; a fluid enclosure wall partially defining a fluid enclosure configured to accommodate a fluid within the IMD, wherein: the fluid enclosure wall defines a channel opening, and the IMD is configured to deliver the fluid out of the IMD; and a pressure sensor comprising an operative surface that comprises a sensor housing configured to mate to the fluid enclosure wall, wherein: the operative surface is configured to partially define the fluid enclosure and occlude the channel opening when the sensor housing is mated to the fluid enclosure wall, and occlusion of the channel opening by the pressure sensor separates the fluid from the one or more electrical components. 25. A device comprising: a bulkhead that defines a first portion of a fluid enclosure configured to accommodate a fluid; and a pressure sensor configured of a size and a shape to self- align in a predetermined rotational orientation within a channel opening defined by the bulkhead and occlude the channel opening. 2 Appeal 2015-005985 Application 12/793,457 REJECTIONS The following rejections are before us for review: I. The Examiner rejected claims 25 and 49 under 35 U.S.C. § 102(b) as being anticipated by Jonsson (US 2007/0261496 Al, published Nov. 15,2007). II. The Examiner rejected claims 1—10, 14—16, 25, 44, 45, 49, and 52 under 35 U.S.C. § 103(a) as being unpatentable over Ginggen (US 2006/0089619 Al, published Apr. 27, 2006) and Jonsson. III. The Examiner rejected claims 11—13 under 35 U.S.C. § 103(a) as being unpatentable over Ginggen, Jonsson, and Hirata (US 2007/0168150 Al, published July 19, 2007). IV. The Examiner rejected claims 46 and 47 under 35 U.S.C. § 103(a) as being unpatentable over Ginggen, Jonsson, and Robb (US 2008/0000531 Al, published Jan. 3, 2008). V. The Examiner rejected claims 5, 44, 48, and 49 under 35 U.S.C. § 103(a) as being unpatentable over Ginggen, Jonsson, and Miesel (US 7,320,676 B2, issued Jan. 22, 2008). VI. The Examiner rejected claim 50 under 35 U.S.C. § 103(a) as being unpatentable over Jonsson and Robb. VII. The Examiner rejected claim 51 under 35 U.S.C. § 103(a) as being unpatentable over Jonsson and Miesel. 3 Appeal 2015-005985 Application 12/793,457 ANALYSIS Rejection I Based on a passage taken from Appellants’ previously filed Appeal Brief (filed Jan. 27, 2014, hereinafter “January 2014 Brief’), the Examiner finds that the limitation ‘“the pressure sensor is sized and shaped to self- align[] in a predetermined rotational orientation to the channel opening’ refers [to a] pressure sensor [that] is positioned within a channel opening.” Final Act. 2 (citing January Brief, p. 7, para. 2). The Examiner considers the limitation of independent claim 25, which reads, “to self-align in a predetermined rotational orientation within a channel opening” to be a “functional limitation which only requires the capability of performing the claimed function.” Id. Thus, according to the Examiner, as Jonsson’s pressure sensor 6013 is located within channel 612, Jonsson’s pressure sensor is capable of performing the above mentioned functional limitation. Id. at 2—3. Appellants argue that the Examiner “relies upon an erroneous characterization of Appellants[’] remarks to support an unreasonable interpretation of the claim language.” Appeal Br. 6. According to Appellants, in the Examiner’s view, “the limitation of claim 25 merely ‘refers that the pressure sensor is positioned within a channel opening.’” However, Appellants assert that the January 2014 Brief “clarifies that claim 25 requires that ‘the pressure sensor is sized and shaped to self-align in this predetermined rotational orientation within a channel opening.” Id. at 7 3 Although the Examiner uses reference number “604,” we note this to be a typographical error as Jonsson refers to sensor 601. See e.g., Jonsson para. 52. 4 Appeal 2015-005985 Application 12/793,457 (citing January 2014 Brief, p. 7). Appellants contend that even if the limitation “self-align in a predetermined rotational orientation” is considered a functional limitation, “the Examiner has failed to explain why sensor 601 of Jonsson, or any other device, would have the capability of being configured of a size and a shape to self-align in a predetermined rotational orientation within a channel opening ... as set forth in claim 25.” Id. at 9. The Examiner responds that Appellants’ Specification does not define “the term ‘a size and shape to self-align [in a] predetermined rotational orientation within a channel opening.’” Ans. 3. As Appellants’ Figure 5A shows pressure sensor 112 fitted in a channel opening, the Examiner takes the position that “[t]he term ‘self-align rotational orientation’ is interpreted as ‘to fit in a slot or opening.’” Id. at 4. Appellants reply that at least based on paragraph 82 of the Specification, “one of ordinary skill would have understood that each pressure sensor can only be placed into bulkhead 104 in one particular orientation, i.e., the orientation in which the shape of the pressure sensor matches the shape of the opening in the bulkhead.” Reply Br. 3.4 Hence, Appellants assert that “the limitations of claim 25 require more than merely a pressure sensor ‘to fit in a slot or opening.’” Id. at 4. It is well established that claims are construed with an eye toward giving effect to all terms in the claim. See Stumbo v. Eastman Outdoors, Inc., 508 F.3d 1358, 1362 (Fed. Cir. 2007) (denouncing claim constructions which render phrases in claims superfluous). Furthermore, claim language 4 Paragraph 82 of Appellants’ Specification states that the “channel opening [of bulkhead 104] may be sized and/or shaped to only accept pressure sensor 112 in a predetermined orientation.” 5 Appeal 2015-005985 Application 12/793,457 should be read in light of the Specification, as it would be interpreted by one of ordinary skill in the art. In re Suitco Surface, Inc., 603 F.3d 1255, 1260 (Fed. Cir. 2010). In this case, we agree with Appellants’ position that claim 25 requires more than a pressure sensor fitting in a slot or opening. Each of Appellants’ disclosed embodiments describes a pressure sensor housing having an eccentric shape, which is defined as “any structure that can only be matched to a similarly shaped opening in one position when rotated 360 degrees” and generally is a non-circular shape. Spec. 191. In addition, Appellants’ Specification describes a technique for orienting pressure sensor 112 within bulkhead 104 of IMD 16 and states that because “pressure sensor 112 is configured as a shape that is self-aligning to the opening, there is only one way that pressure sensor 112 will fit within the opening of bulkhead 104.” Id. 1130; Fig. 16. As such, in light of Appellants’ Specification, a person of ordinary skill in the art would understand that the limitation of “a pressure sensor configured of a size and a shape to self-align in a predetermined rotational orientation within a channel opening,” as recited in claim 25, requires that the pressure sensor must be in a specific, predetermined rotational orientation in order to fit in the opening. In contrast, Jonsson’s circular sensor 601 (see Jonsson, Fig. 6a) does not require a specific, predetermined rotational orientation because it would fit in any rotational position when rotated 360 degrees merely by placing it in the opening. The Examiner’s interpretation would in effect render meaningless, or superfluous, the term “predetermined.” 6 Appeal 2015-005985 Application 12/793,457 In conclusion, although Jonsson’s pressure sensor 601 fits in an opening of housing 610, the Examiner does not point to any disclosure or provide any technical reasoning that establishes that Jonsson’s pressure sensor 601 has a shape that is self-aligning to the opening (in housing 610), in a predetermined rotational orientation, or is capable of fitting within the opening in a predetermined rotational orientation, as called for by independent claim 25. Accordingly, for these reasons, we do not sustain the rejection under 35 U.S.C. § 102(b) of claims 25 and 49 as anticipated by Jonsson. Rejection II Claims 1—10, 14—16, 45, and 52 The Examiner finds that Ginggen discloses most of the limitations of independent claim 1 including, inter alia, a pressure sensor, but that “Ginggen does not disclose the location of the pressure sensor ... at a channel opening . . . formed in the fluid enclosure wall as required in claim 1.” Final Act. 4. Nonetheless, the Examiner finds that Jonsson discloses “a pressure sensor 601 comprising an operative surface that comprises a sensor housing configured to mate to the fluid enclosure wall (including elements 602 and 610).” Id. The Examiner concludes that it would have been obvious to modify the device of Ginggen so that the pressure sensor is “mated to the fluid enclosure wall, as taught by Jonsson, for the benefit of sensing the pressure of the fluid at the outlet channel of the pump outlet and the pressure of the fluid in the drug chamber, since the fluid in the drug chamber is in communication with the outlet channel.” Id. According to the 7 Appeal 2015-005985 Application 12/793,457 Examiner, Jonsson’s pressure sensor 601 would be located in the wall of Ginggen’s pump outlet 24. See Ans. 4—5. Appellants argue that, “the Examiner has failed to explain why one of ordinary skill in the art would have arrived at the Examiner-proposed modification of ‘sensing the pressure of the fluid at the outlet channel of the pump.’” Appeal Br. 14—15. Appellants assert that because Ginggen discloses “a pressure sensor for sensing the pressure of the drug in drug chamber 14 and/or refill port chamber 44,” “it seems that one of ordinary skill in the art would have positioned the Jonsson pressure sensor for sensing pressure of drug in drug chamber 14 or refill port chamber 44.” Id. at 15 (citing Ginggen para. 33). Appellants thus contend, The Examiner has not articulated any rationale for why one of ordinary skill in the art would have deviated from positioning a pressure sensor within drug chamber 14 or refill port chamber 44, as disclosed by Ginggen, or why one of ordinary skill in the art would have positioned a pressure sensor for sensing the pressure of the fluid at the outlet channel of the pump. Id.', see also Reply Br. 6—7. The Examiner responds that, “one skilled in the art would recognize that more than one pressure sensor[s] can be provided in the pump system for measuring the pressure of fluid in different locations.” Ans. 7. The Examiner notes that Jonsson teaches “a pressure sensor 601 located within an opening within the wall tube 602 to measure the pressure of blood or other fluid passing through the tube. Id. Based on this teaching, the Examiner takes the position that a person having ordinary skill in the art would have easily recognize [d] that modifying the device of Ginggen with 8 Appeal 2015-005985 Application 12/793,457 providing/adding the pressure sensor mated to the opening of the fluid enclosure wall, as taught by Jonsson, would provide the benefits of measuring the pressur[]e of the fluid to prevent air bubble or reduce leaking or occlusion. Id. at 7—8. We do not agree with the Examiner’s position because Ginggen specifically discloses that “[cjontrol electronics 28 can also include a pressure sensor for sensing the pressure of the drug in drug chamber 14 and/or refill port chamber 44.” Ginggen 133. Therefore, we agree with Appellants that in view of Ginggen’s explicit teachings, the logical location at which to position Jonsson’s pressure sensor would be in drug chamber 14 or refill port chamber 44 of Ginggen’s device. See Reply Br. 6—7. Although the Examiner reasons that providing Jonsson’s pressure sensor 601 in the wall of Ginggen’s pump outlet 24 “would provide the benefits of measuring the pressure of the fluid to prevent air bubble or reduce leaking or occlusion,” the Examiner has not provided adequate findings that the prior art recognized a problem with air bubbles, leaking, or occlusion in devices such as Ginggen’s implantable pump. Rather, Ginggen discloses the use of capillary chip and filter 20 to release a constant flow of drug from drug chamber 14 into fluidic connection channel 22 toward pump outlet 24, which would appear to preclude these issues from arising. See Ginggen | 20; Fig. 1. Without an adequate articulated reasoning based on rational underpinnings for providing Jonsonn’s pressure sensor for sensing the pressure of the fluid at the outlet channel 24 of the Ginggen pump, the Examiner’s rejection appears to be the result of hindsight analysis. See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). 9 Appeal 2015-005985 Application 12/793,457 Accordingly, for the foregoing reasons, we do not sustain the rejection under 35 U.S.C. § 103(a) of independent claim 1, and claims 2—10, 14—16, 45, and 52 depending therefrom, as unpatentable over Ginggen and Jonsson. See In re Fine, 837 F.2d 1071, 1073 (Fed. Cir. 1988). Claims 25 and 49 The Examiner finds that Ginggen discloses most of the limitations of independent claim 25, but fails to disclose “a pressure sensor configured of a size and shape to self-align in a predetermined rotational orientation within a channel opening.” See Final Act. 7—8. The Examiner relies on Jonsson to disclose such a pressure sensor. See id. at 7. However, as discussed supra in Rejection I, Jonsson’s pressure sensor 601 does not self-align in a predetermined rotational orientation within a channel opening 612, as called for by claim 25. Therefore, the Examiner’s legal conclusion of obviousness is not supported by sufficient factual findings. See In re Warner, 379 F.2d 1011, 1017 (CCPA 1967) (holding that “[t]he legal conclusion of obviousness must be supported by facts. Where the legal conclusion is not supported by facts it cannot stand.”). Thus, for the same reasons as discussed supra in Rejection I, we do not sustain the rejection of independent claim 25, and claim 49 depending therefrom, as unpatentable over the combined teachings of Ginggen and Jonsson. 10 Appeal 2015-005985 Application 12/793,457 Claim 44 Similar to independent claim 25, independent claim 44 recites, in relevant part, a “pressure sensor [that] is sized and shaped to self-align to the channel opening defined by the fluid enclosure wall.” See Appeal Br. 40 (Claims App.). However, for the same reasons as discussed supra in the rejection of claim 25, Jonsson’s pressure sensor 601 does not self-align in a predetermined rotational orientation within a channel opening 612, as called for by independent claim 44. Accordingly, for the same reasons as discussed above in the rejection of claim 25, we do not sustain the rejection of independent claim 44 as unpatentable over the combined teachings of Ginggen and Jonsson. Rejections III—V The Examiner does not rely on Hirata, Robb, and Miesel in any manner that would remedy the deficiencies in the rejection based upon Ginggen and Jonsson discussed supra in Rejection II. See Final Act. 8—10. Thus, for the same reasons as discussed above in Rejection II, we do not sustain the rejections under 35 U.S.C. § 103(a) of claims 11—13 as unpatentable over Ginggen, Jonsson, and Hirata; of claims 46 and 47 as unpatentable over Jonsson, Ginggen, and Robb; and of claims 5, 44, 48, and 49 as unpatentable over Jonsson, Ginggen, and Miesel. 11 Appeal 2015-005985 Application 12/793,457 Rejections VI and VII The Examiner does not rely on Robb and Miesel in any manner that would remedy the deficiencies in the rejection based upon Jonsson discussed supra in Rejection I. See Final Act. 11. Thus, for the same reasons as discussed above in rejection I, we do not sustain the rejections under 35 U.S.C. § 103(a) of claim 50 as unpatentable over Jonsson and Robb and of claim 51 as unpatentable over Jonsson and Miesel. DECISION The Examiner’s decision to reject claims 1—16, 25, and 44—52 is reversed. REVERSED 12 Copy with citationCopy as parenthetical citation