Lior Sobe

Patent Trials and Appeals BoardOct 30, 2019

11945828 - (D) (P.T.A.B. Oct. 30, 2019)

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. 11/945,828 11/27/2007 Lior Sobe 0K-0413USO6/065513-000399 8054 67337 7590 10/30/2019 DYKEMA GOSSETT PLLC (STJ) 4000 Wells Fargo Center 90 South Seventh Street Minneapolis, MN 55402 EXAMINER COOK, CHRISTOPHER L ART UNIT PAPER NUMBER 3793 NOTIFICATION DATE DELIVERY MODE 10/30/2019 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): ASJM_Patents@abbott.com MN-IPMail@dykema.com Patents@dykema.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte LIOR SOBE Appeal 2019-002421 Application 11/945,828 Technology Center 3700 ____________ Before LINDA E. HORNER, MICHAEL L. WOODS, and JASON W. MELVIN, Administrative Patent Judges. HORNER, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1‒4, 6, 7, 10, 12‒16, and 19‒26.2 We have jurisdiction under 35 U.S.C. § 6(b). The Examiner rejected the claims on appeal as failing to comply with the written description requirement, as being indefinite, and as obvious over 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Mediguide Ltd. Appeal Brief 1 (September 14, 2018) (“Appeal Br.”). 2 Claims 5, 8, 9, 11, 17, 18, 27, and 28 are canceled. Appeal Br. 21‒23, 27 (Claims Appendix). Appeal 2019-002421 Application 11/945,828 2 the combination of various prior art references. Appellant argues that the claim language finds adequate support in the original disclosure and is sufficiently clear to one having ordinary skill in the art. Appellant further argues that the prior art does not render obvious the subject matter of the claims. For the reasons explained below, we agree with Appellant that the Examiner erred in finding that the claims lack adequate written descriptive support and in rejecting the claims as indefinite. We find, however, that Appellant has not identified error in the Examiner’s rejections of the claims for obviousness. Because we sustain at least one ground of rejection of each claim on appeal, we affirm. CLAIMED SUBJECT MATTER The claimed subject matter relates to “methods and systems for withdrawal of a fluid sample from the body of a patient.” Spec. 1:8‒9. The method and system allow for navigating a surgical needle toward a target organ of the body of a patient using a medical positioning system (MPS), a MPS sensor, a removable mandrel, and an electromagnetic field generator. Id. at 5:5‒10. The MPS sensor is located at the tip of the removable mandrel, which can be moved in and out of the surgical needle. Id. at 5:10‒ 12. The electromagnetic field generator generates an electromagnetic field and the MPS sensor produces an output according to the electromagnetic field. Id. at 5:13‒16. The MPS determines the position of the tip of the removable mandrel according to the output of the MPS sensor to enable navigation of the surgical needle toward the target organ. Id. at 5:16‒20. Claims 1, 19, and 23 are the independent claims on appeal. Claim 1 is illustrative of the subject matter on appeal and is reproduced below. Appeal 2019-002421 Application 11/945,828 3 1. System for navigating a surgical needle toward a target organ of the body of a patient, the system comprising: a surgical needle; a removable mandrel having a distal tip; a medical positioning system (MPS) sensor unit located proximate said distal tip of said removable mandrel, the MPS sensor unit including an MPS sensor located within MPS housing; an electromagnetic field generator for generating an electromagnetic field; and an MPS coupled with said MPS sensor and with said electromagnetic field generator, said MPS sensor producing an output according to said electromagnetic field, said MPS determining the position of said tip of said removable mandrel in a coordinate system respective of said MPS, according to said output of said MPS sensor, said MPS producing an indication respective of said position, to enable navigation of said surgical needle toward the target organ; wherein each of an outer diameter of said removable mandrel and an outer diameter of said MPS sensor unit is of such a value that said removable mandrel and said MPS sensor unit seal against an inner wall of a lumen of said surgical needle; and wherein said removable mandrel and said MPS sensor unit are configured i) to be moved, in unison, in and out of said surgical needle, and ii) to block entrance of undesired bodily substances of the body of the patient into said surgical needle while said surgical needle is being advanced toward the target organ and while said removable mandrel and said MPS sensor unit are located within said surgical needle. Appeal Br. 19‒20 (Claims Appendix). EVIDENCE Manwaring US 5,711,299 Jan. 27, 1998 Glossop US 2002/0143317 A1 Oct. 3, 2002 Zohmann US 2005/0004521 A1 Jan. 6, 2005 Appeal 2019-002421 Application 11/945,828 4 Strommer US 2006/0058647 A1 Mar. 16, 2006 Makower US 2007/0208252 A1 Sept. 6, 2007 REJECTIONS The following rejections are on appeal: 1. Claims 1‒4, 6, 7, 10, 12‒16, and 19‒26 are rejected under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. 2. Claim 2 is rejected under 35 U.S.C. § 112, second paragraph, as being indefinite. 3. Claims 1‒4, 7, 10, 12‒16, and 19‒26 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Zohmann, Glossop, Strommer, and Manwaring. 4. Claim 6 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Zohmann, Glossop, Strommer, Manwaring, and Makower. PRIOR APPEAL This application was the subject of a prior appeal. Appeal 2013-006628 (PTAB October 30, 2015) (“prior appeal”). In the prior appeal, the Board affirmed the rejection of then-pending claims 1‒25 as being unpatentable under 35 U.S.C. § 103(a) over various combinations of prior art. Appellant thereafter reopened prosecution and amended the claims. The Examiner made new grounds of rejection of the amended claims that resulted in the present appeal.3 3 Of the prior art used in the rejections in the present appeal, only the Makower reference previously was before us. Appeal 2019-002421 Application 11/945,828 5 ANALYSIS Written Description Rejection of Claims 1‒4, 6, 7, 10, 12‒16, and 19‒26 Independent Claims 1, 19, and 23 The Examiner rejected independent claims 1, 19, and 23 because the original disclosure fails to provide support for the MPS sensor unit located “proximate” (i.e., not at) the distal tip of the removable mandrel and configured to block entrance of undesired bodily fluid. Final Act. 4‒5 (addressing claim 1); id. at 5 (explaining that claims 19 and 23 have the same issue as claim 1). Appellant adopts the Examiner’s interpretation of “proximate” as meaning “at or near.” Appeal Br. 10 (citing Final Act. 7). Appellant contends that “the term ‘proximate’ correctly and clearly describes the position of the MPS sensor unit 172 with respect to the distal tip of the removable mandrel 170, as disclosed both in the originally filed application and in the Examiner’s . . . annotated version of Fig[ure] 2.” Id. (referring to annotated Figure 2 on page 5 of the Final Office Action). Neither the Examiner nor Appellant provided us with a dictionary definition of “proximate” as evidence of the term’s plain and ordinary meaning. Further, Appellant’s Specification does not use this term to describe the relative locations of the MPS sensor unit and the distal tip of the removable mandrel, or otherwise provide a definition of the term. Because the meaning of this term is a basis for the written description rejection, we provide a dictionary definition for the record. Specifically, “proximate” is defined as “very near or next, as in space, time, or order.” The American Heritage Dictionary of the English Language, Fifth Ed., Houghton Mifflin Harcourt Publishing Company (2019), definition 2, available at Appeal 2019-002421 Application 11/945,828 6 https://www.ahdictionary.com/word/search.html?q=proximate (last accessed October 17, 2019) (copy of entry attached as Appendix A to this Decision). Appellant’s Specification describes that in Figure 1, “MPS sensor unit 110 is firmly coupled with the tip of removable mandrel 108 by methods known in the art, such as welding, brazing, employing an adhesive, pressure fit (e.g., MPS sensor unit 110 having a conical shape), and the like.” Spec. 9:13–16. Figure 1, which is a schematic illustration of a first embodiment, shows MPS sensor unit 110 next to the distal tip of removable mandrel 108. Thus, the Specification shows, with reference to the Figure 1 embodiment, sufficient written description support for the MPS sensor unit located “proximate,” or next to, the distal tip of the removable mandrel. Figure 2 is a schematic illustration of a second embodiment. Spec. 7:8–11. The schematic illustration depicts transmitter 168 between the distal tip of removable mandrel 170 and MPS sensor unit 172. With reference to Figure 2, the Specification describes, “MPS sensor unit 172 is coupled with the tip of removable mandrel 170 in a similar manner of coupling of MPS sensor unit 110 with removable mandrel 108, as described herein above in connection with Figure 1.” Spec. 13:24–27. Specifically, with regard to the location of transmitter 168, the Specification describes: Transmitter 168 is physically coupled with removable mandrel 170 and with MPS sensor unit 172 . . . . Transmitter 168 is located at the tip of removable mandrel 170. . . . Alternatively, transmitter 168 is located at a proximal end of the removable mandrel, in which case the transmitter is coupled with the MPS sensor by a pair of wires which pass through a bore of the removable mandrel. Further alternatively, transmitter 168 can be integrated with MPS sensor unit 172. Spec. 13:30‒14:7. Thus, in the Figure 2 embodiment, the Specification describes that transmitter 168 can be part of MPS sensor unit 172 and that Appeal 2019-002421 Application 11/945,828 7 sensor unit 172 can be coupled to the tip of removable mandrel 170 in a manner similar to the embodiment of Figure 1, i.e., by welding, brazing, employing an adhesive, pressure fit, and the like. Thus, the Specification shows, with reference to the Figure 2 embodiment, sufficient written description support for the MPS sensor unit located “proximate,” or next to, the distal tip of the removable mandrel. The Examiner further rejected the claims for insufficient written description because, although Appellant asserts the claims are directed to the embodiment disclosed in Figure 2, the only recitation of both the mandrel and sensor sealing against the inner wall is described with respect to Figure 3. Final Act. 5. Appellant contests this finding. Appeal Br. 12. Appellant argues that the original disclosure describes, with reference to Figure 2, that “MPS sensor unit 172 includes an MPS sensor (not shown) and an MPS housing (not shown), similar to the MPS sensor and the MPS housing of sensor unit 110, as described herein above in connection with F[igure] 1.” Id. (quoting Spec. 13:15‒18). Appellant notes that the Specification describes, with reference to Figure 1: The outer diameter of removable mandrel 108 and of MPS sensor unit 110 is of such a value that MPS sensor unit 110 and removable mandrel 108 can be moved in unison…. In this manner, MPS sensor unit 110 seals against an inner wall 136 on lumen 126, and thereby, fluids and solid materials which are located at distal portion 132, cannot reach proximal portion 134. Id. (quoting Spec. 10:9‒16 (underlining omitted)). It appears that the Examiner’s rejection is based on the erroneous finding that the only recitation of both the mandrel and sensor sealing against the inner wall is described with respect to Figure 3. Final Act. 5. Appeal 2019-002421 Application 11/945,828 8 Based on the descriptions from the Specification noted by Appellant and discussed above, we agree with Appellant that this disclosure provides adequate written description support for the claimed outer diameter of the removable mandrel and outer diameter of the MPS sensor unit being of a value so that the mandrel and sensor unit seal against an inner wall of a lumen of the surgical needle. We are not persuaded otherwise by the fact that the schematic illustration of Figure 2, as originally filed, appears to show a gap between the outer surface of the mandrel and sensor unit and the inner wall of the needle lumen, because the description makes clear that Appellant had possession of the claimed subject matter. For these reasons, we do not sustain the rejection under 35 U.S.C. § 112, first paragraph, of independent claims 1, 19, and 23, and their dependent claims 2‒4, 6, 7, 10, 12‒16, 20‒22, and 24‒26. Dependent claim 2 The Examiner additionally separately rejected claim 2 because the original disclosure fails to disclose an embodiment as claimed “where all the limitations of claim 1 are met and the MPS sensor is firmly coupled to the tip.” Final Act. 6. For the reasons discussed above, we find that under the plain and ordinary meaning of “proximate,” the MPS sensor unit can be located both next to the distal tip of the removable mandrel and be firmly coupled to it. Thus, we likewise find that the original disclosure provides adequate written descriptive support for the subject matter of dependent claim 2. Appeal 2019-002421 Application 11/945,828 9 Indefiniteness Rejection of Claim 2 The Examiner appears to have maintained the rejection of claim 2 as being indefinite based on the Examiner’s finding that “[i]t is unclear how the MPS sensor can be ‘proximal’ said distal tip and firmly coupled with the tip and blocking entrance of undesired bodily substances.” Final Act. 7; Ans. 2 (withdrawing 35 U.S.C. § 112(b) rejection of “specifically Claim 1 and the limitation of the MPS sensor unit located ‘proximal said distal tip’” but not explicitly withdrawing the separate basis for the rejection of dependent claim 2). Appellant does not address claim 2 explicitly, but Appellant argues that “proximate” should be interpreted to mean “at or near.” Appeal Br. 13. For the reasons discussed above, we find that under the plain and ordinary meaning of “proximate,” the MPS sensor unit can be located both next to the distal tip of the removable mandrel and be firmly coupled to it. Thus, we do not sustain the rejection of dependent claim 2 under 35 U.S.C. § 112, second paragraph, as being indefinite. Obviousness Rejections Claims 1‒4, 7, 10, 12‒16, and 19‒26 The Examiner found that Zohmann discloses a hollow surgical needle having a removable stylet (mandrel) that is sufficient to occlude the hollow needle. Final Act. 8. The Examiner found that Glossop teaches an MPS sensor provided proximate to the distal end of a stylet configured to provide position and orientation information to a medical positioning system, and Strommer teaches using MPS sensors fixed to the tip of an instrument to provide coordinates of the tip sensor that are superimposed on a display and used as navigation feedback. Id. at 9. The Examiner determined it would have been obvious to modify Zohmann’s stylet to be equipped with an MPS Appeal 2019-002421 Application 11/945,828 10 sensor near or at its distal end, as taught by Glossop and Strommer, to accurately navigate the needle to an intended target within the body. Id. at 9‒10. The Examiner further found that Manwaring teaches sensors integral with a surgical instrument or part of a separate housing that removably couples to the surgical instrument, and that it would have been obvious to further modify Zohmann to provide a housing for the MPS sensor components to protect the sensor components and improve patient safety. Id. at 10. The Examiner found that “it would appear Glossop’s MPS sensor diameter matches the size of the stylet and therefore would also seal against the inner wall in the modified system and method described above.” Id. (emphasis omitted). Alternatively, the Examiner found it would have been obvious to size the MPS sensor housing to match the diameter of Zohmann’s stylet to maintain the pressure fit on the inner wall. Id. at 10‒11. Appellant contests the Examiner’s finding as to Glossop’s sensor diameter.4 Appeal Br. 15. Appellant argues that Figures 8a and 8b of Glossop show a gap between sensor coil 21/position sensor 20 and the inner wall of needle 702, which gap would suggest that sensor coil 21/position sensor 20 (as well as stylet 790 with a similar diameter) does not seal against the inner wall of the lumen of needle 702. Id. at 15‒16. This argument does not identify error in the Examiner’s rejection, because, as explained above, the Examiner relied on Zohmann to disclose a stylet having a diameter sufficient to seal against the inner wall of the lumen 4 Appellant argues the claims subject to this ground of rejection as a group. Appeal Br. 14‒18. We select claim 1 as representative of the group, and claims 2‒4, 7, 10, 12‒16, and 19‒26 stand or fall with claim 1. See 37 C.F.R. § 41.37(c)(1)(iv). Appeal 2019-002421 Application 11/945,828 11 needle. Final Act. 8 (citing Zohmann ¶ 29). We agree with this finding. Zohmann teaches a needle and stylet for administering local anesthetic to a peripheral nerve during a nerve block procedure. Zohmann ¶ 9. The Examiner relied on Glossop to teach a sensor and stylet having the same outer diameter. Final Act. 9. The Examiner reasoned, and we agree, that a person having ordinary skill in the art, would have been led by Glossop to add a sensor unit to the distal tip of Zohmann’s stylet and to make the sensor unit of the same outer diameter as Zohmann’s stylet so as to occlude the needle lumen, as taught in Zohmann. Final Act. 9‒10; Ans. 6‒8. In other words, the Examiner’s rejection does not rely on Glossop to disclose the claimed seal, but only for its disclosure of a coil sized to match the stylet’s diameter. Ans. 8‒9 (asserting that the modification of Zohmann to add Glossop’s sensor would retain the sealing properties of Zohmann’s stylet and size the sensor diameter to match the stylet’s diameter). As noted by the Examiner, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. Ans. 8‒9 (citing In re Keller, 642 F.2d 413 (CCPA 1981); In re Merck & Co., 800 F.2d 1091 (Fed. Cir. 1986)). In response to these arguments, the Examiner stated that, “a person skilled in the art would have found it obvious to size the MPS sensor housing to match the diameter of Zohmann’s mandrel (e.g. stylet) in order to preserve Zohmann’s principle of operation (e.g. occluding needle opening . . .).” Ans. 6 (emphasis omitted). Appellant contests the Examiner’s finding that occluding the needle is a principle of operation of Zohmann. Reply Br. 6. Appellant argues that Zohmann teaches away from occlusion because Zohmann teaches that selectively withdrawing the stylet Appeal 2019-002421 Application 11/945,828 12 enables backflow of fluid into the needle hub. Id. (citing Zohmann, Abstract). We find no teaching away from occlusion in Zohmann. In fact, we agree with the Examiner’s determination that the purpose of Zohmann’s stylet is to occlude the needle lumen. Final Act. 8 (citing Zohmann ¶ 29); see also Zohmann ¶ 29 (describing that the length and diameter of the stylet are sufficient to occlude the hollow needle and its fenestrations when the stylet is inserted). The ultimate use of the needle is to deliver the nerve blocking agent via the fenestrations. Zohmann ¶ 27 (describing fenestrations 20 used to distribute local anesthetic to fascial compartment 30). Thus, of course, when the stylet is removed in order to deliver a drug, then the needle is no longer occluded. Zohmann makes clear that occlusion of the needle is important during delivery and placement of the needle at the target site. Id. ¶ 31 (“Occlusion of fenestrations 20 is particularly necessary in cases where the needle 12 must be repositioned during a procedure.”). Zohmann teaches withdrawing the stylet momentarily to determine if the needle is in the correct location. Id. ¶ 32. Thus, contrary to Appellant’s argument, we find that Zohmann teaches that the stylet occludes the hollow needle when it is inserted therein. Appellant also argues, for the first time in the Reply Brief, that Zohmann teaches away from the proposed modification to add a sensor to Zohmann’s stylet because Zohmann teaches that a precise location of a peripheral nerve need not be pinpointed in order to effectively anesthetize the nerve. Reply Br. 5 (citing Zohmann ¶ 28); see also Ans. 6 (Examiner stating that “Appellant does not appear to argue Examiner’s initial modification to equip the stylet of Zohmann with an MPS sensor described by Glossop and Strommer in order to accurately navigate the needle to an Appeal 2019-002421 Application 11/945,828 13 intended target within the body”). We disagree. Although Zohmann teaches that the use of fenestrations 20 obviates the need to precisely locate the peripheral nerve (Zohmann ¶ 28), Zohmann also teaches that needle must pass through the fascial compartment, which is only a few millimeters in width (id. ¶¶ 28‒29). Thus, we find that location of the needle is important in Zohmann, as evidenced by the discussion elsewhere in Zohmann of the need to reposition the needle if it is not placed in the proper location. Id. ¶¶ 31‒32. Appellant further contests the Examiner’s alternate reasoning that it would have been obvious to size the sensor housing to match the stylet diameter to maintain a pressure fit on the inner wall. Appeal Br. 16. Because, as discussed above, we find that the Examiner provided under the primary reasoning an adequate explanation based on rational underpinnings for the proposed modification of Zohmann with the sensor unit of Glossop and Strommer, as further modified by Manwaring, we do not reach the Examiner’s alternate explanation. For the reasons provided above, we sustain the rejection of claims 1‒ 4, 7, 10, 12‒16, and 19‒26 under 35 U.S.C. § 103(a) as unpatentable over Zohmann, Glossop, Strommer, and Manwaring. Claim 6 Appellant relies on the arguments presented above against the rejection of claim 1 and does not present any additional arguments against the rejection of dependent claim 6. Appeal Br. 14‒18. For the reasons discussed above, we likewise sustain the rejection of claim 6 under 35 U.S.C. § 103(a). Appeal 2019-002421 Application 11/945,828 14 DECISION The decision of the Examiner rejecting the claims under 35 U.S.C. § 112, first and second paragraphs, is reversed. The decision of the Examiner rejecting the claims under 35 U.S.C. § 103(a) 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). See 37 C.F.R. § 1.136(a)(1)(iv). CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/ Basis Affirmed Reversed 1‒4, 6, 7, 10, 12‒16, 19‒26 112, first paragraph Written Description 1‒4, 6, 7, 10, 12‒16, 19‒26 2 112, second paragraph Indefiniteness 2 1‒4, 7, 10, 12‒16, 19‒26 103(a) Zohmann, Glossop, Strommer, Manwaring 1‒4, 7, 10, 12‒16, 19‒26 6 103(a) Zohmann, Glossop, Strommer, Manwaring, Makower 6 Overall Outcome 1‒4, 6, 7, 10, 12‒16, 19‒26 AFFIRMED Notice of References Cited Application/Control No. Applicant(s)/Patent Under Patent Appeal No. Examiner Art Unit Page 1 of 1 U.S. PATENT DOCUMENTS * Document Number Country Code-Number-Kind Code Date MM-YYYY Name Classification A US- B US- C US- D US- E US- F US- G US- H US- I US- J US- K US- L US- M US- FOREIGN PATENT DOCUMENTS * Document Number Country Code-Number-Kind Code Date MM-YYYY Country Name Classification N O P Q R S T NON-PATENT DOCUMENTS * Include as applicable: Author, Title Date, Publisher, Edition or Volume, Pertinent Pages) U V W X *A copy of this reference is not being furnished with this Office action. (See MPEP § 707.05(a).) Dates in MM-YYYY format are publication dates. Classifications may be US or foreign. U.S. Patent and Trademark Office PTO-892 (Rev. 01-2001) Notice of References Cited Part of Paper No.