Ex Parte Hartmann et alDownload PDFPatent Trial and Appeal BoardJul 28, 201713016765 (P.T.A.B. Jul. 28, 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. 13/016,765 01/28/2011 Steven L. Hartmann 5074A-000123/US 5214 132492 7590 08/01/2017 Harness, Dickey, & Pierce, PLLC (Medtronic Surgical Technologies) 5445 Corporate Drive Suite 200 Troy, MI 48098 EXAMINER SIRIPURAPU, RAJEEV P ART UNIT PAPER NUMBER 3786 NOTIFICATION DATE DELIVERY MODE 08/01/2017 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): troymailroom @hdp. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte STEVEN L. HARTMANN, BRUCE M. BURG, ANDREW BZOSTEK, BRAD JACOBSEN, and MATTHEW W. KOENIG Appeal 2016-000302 Application 13/016,765 Technology Center 3700 Before CHARLES N. GREENHUT, MICHAEL L. HOELTER, and ANNETTE R. REIMERS, Administrative Patent Judges. GREENHUT, Administrative Patent Judge. DECISION ON APPEAL Appeal 2016-000302 Application 13/016,765 STATEMENT OF THE CASE Appellants appeal under 35 U.S.C. § 134 from a rejection of claims 1— 22 and 24—30. Claim 23 has been cancelled. App. Br. 5. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part and enter a new ground of rejection. THE CLAIMED SUBJECT MATTER The claims are directed to a surgical instrument with a tracking device for use in surgical procedures that are navigated or that use computer assistance. Spec. 11. Claims 1, 8, and 14 are independent. App. Br. 28—34. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A navigation system, comprising: an instrument that is operable to be moved relative to a subject and having an exterior wall that defines an instrument axis; a holding portion defined by the instrument within a surface of the exterior wall having a holding portion diameter, the holding portion defining a cavity having a pair of tapered surfaces and a first pair of opposed flat surfaces extending from the pair of tapered surfaces and angled with respect to the instrument axis; and a tracking device formed of at least a first portion having a first conductive wire wound around a first core to form a first coil defining a first navigation vector angled with respect to the instrument axis, wherein the first coil has a first central portion having a first coil diameter larger than the holding portion diameter of the exterior wall, the central portion being tapered to a first pair of ends, the tracking device being configured to be aligned by the pair of tapered surfaces and the first pair of opposed flat surfaces, wherein the first coil comprises a second pair of opposed surfaces configured to engage the first pair of opposed flat 2 Appeal 2016-000302 Application 13/016,765 surfaces and is positioned in the holding portion of the instrument. REFERENCES Acker US 6,253,770 B1 July 3, 2001 Ben-Haim US 2002/0165448 A1 Nov. 7, 2002 Gilboa US 6,833,814 B2 Dec. 21,2004 Martinelli US 2006/0036189 A1 Feb. 16, 2006 Ritter US 2007/0197899 A1 Aug. 23, 2007 Gerhart US 2009/0171187 A1 July 2, 2009 REJECTIONS Claims 1—7 and 25—27 stand rejected under 35 U.S.C. § 112(b) as indefinite. Final Act. 2. Claim 25 stands rejected under 35 U.S.C. § 112(a) as failing to comply with the written-description requirement. Id. Claims 1—7, 14—22, and 25—27 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Ben-Haim, Acker, Martinelli, Ritter, and Gilboa. Id. at 4. Claims 8—10, 12, 13, 24, and 30 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Ben-Haim, Acker, Martinelli, and Gilboa. Id. at 17. Claim 11 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Ben-Haim, Acker, Martinelli and Gerhart. Id. at 22. Claims 28 and 29 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Ben-Haim, Acker, Gilboa, Martinelli, and Ritter. Id. at 22. 3 Appeal 2016-000302 Application 13/016,765 ANALYSIS NEW GROUNDS OF REJECTION UNDER 37 C.F.R. § 41.50(b) Claims 2, 3, 10, 11, and 14—22—Lacking Adequate Written Description We enter a new ground of rejection for claims 2, 3, 10, 11, and 14—22 under 35 U.S.C. § 112(a) for failing to comply with the written-description requirement. To satisfy the written description requirement, a disclosure must reasonably convey to one skilled in the art that the applicant had possession of the subject matter in question when the application was filed. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). The claims are generally drawn to a surgical instrument with a “tracking device”; essentially, one or more wire coils embedded into a “holding portion,” or cavity, in the instrument. App. Br. 28 (Claims App’x.). The Specification discloses and depicts a single coil positioned per single holding portion. Spec 175, Figs. 7, 8. In fact, the holding portion appears to be shaped to accommodate the recited diameter of the single coil as well as engage the coil’s opposed (and tapered) ends. Id. Independent claims 1 and 8 claim this structure as well. Claim 1 recites a “first coil” positioned in a holding portion, with the first coil’s pair of opposed surfaces “engag[ing]” the holding portion’s pair of opposed flat surfaces. App. Br. 28. Similarily, claim 8 recites “a first holding portion” to hold the “first coil” of the tracking device, the first holding portion having a “first pair of opposed planar surfaces” to which the first coil’s “second pair of opposed planar surfaces” engage. Id. at 31. 4 Appeal 2016-000302 Application 13/016,765 However, some of the claims require multiple coils to be placed into a single holding portion. Claim 14 recites a tracking device having a second coil also positioned in “the” holding portion. App. Br. 32—33. Claims 15— 22 ultimately depend from claim 14. Likewise, claims 2 and 3, which depend from claim 1, recite a tracking device with additional coils, the additional coils positioned in “the” holding portion defined in claim 1. App. Br. 29. Since the holding portion seems to be shaped to “engage” a single coil (Spec. 175), it is unclear how additional coils would also fit in the holding portion. Further, claim 10, which depends from claim 8, recites “wherein each of the first coil, the second coil, and the third coil are spaced apart a distance along the instrument axis of the instrument within the holding portion.” App. Br. 32. Because the Specification does not describe or depict an instrument with a single holding portion that holds multiple coils, but instead describes a holding portion shaped to accommodate only a single coil, claims 2, 3, 10, and 14—22 lack adequate written description. Accordingly, we reject these claims under 35 U.S.C. § 112(a). Claims 14—22, Rejected Under 35 U.S.C. § 112(b) as Indefinite Claim 14 (and its dependent claims) are rejected under 35 U.S.C. § 112(b) as indefinite. Claim 14 recites a method of forming and using a navigation system comprising, providing an instrument having a tracking device with a first and a second “tracking portion,” corresponding, respectively, to a first and a second coil, the first and second coils formed by winding a wire around a first core and a second core. Id. App. Br. 32—34 (Claims App’x.). Claim 14 requires the first coil to have a “coil central 5 Appeal 2016-000302 Application 13/016,765 portion diameter” greater than the instrument diameter. Id. at 33. But for the second coil, claim 14 requires that “second core central portion diameter” be greater than the instrument diameter. Id. (emphasis added). This inconsistency makes little sense, for two reasons. First, there is no apparent reason for the first tracking portion/first coil to be described differently than the second tracking portion/second coil. Second, the core central portion diameter is necessarily smaller than the coil central portion diameter (as the coil is wound around the core), and thus it is not clear how the core central portion diameter can be “greater than the instrument diameter,” as recited. See Spec., Figs. 7, 8. Thus, we suspect that the inconsistency is the result of a claim drafting error, and, accordingly, we reject the claim, and its dependent claims under 35 U.S.C. § 112(b) as indefinite. GROUNDS OF REJECTION ON APPEAL Claims 1—7 and 25—27, 29—Indefiniteness Claims 1—7, 25—27, 29: Lack of Antecedent Basis In the Final Office Action, the Examiner rejected claim 1 as indefinite because the term “extended wall” lacks antecedent basis. Clams 2—7 and 25—27 ultimately depend from claim 1. Appellants tried to amend the claim after the Notice of Appeal by changing “extended” to “exterior,” but the amendment was not entered (Mar. 20, 2015 Advisory Action). Appellants did not otherwise respond to this rejection. Claim 29 ultimately depends from claim 8 and additionally recites “wherein the first coil has a length along the coil axis less than the first diameter along the first axis.” The Examiner rejected claim 29 as indefinite because the term “the coil axis” 6 Appeal 2016-000302 Application 13/016,765 lacks antecedent basis. Again, Appellants tried to amend this claim to change “the” to “a,” but the amendment was not entered. Appellants did not otherwise respond to this rejection. Because Appellants’ amendment was not entered, claims 1—7, 25—27, and 29 contain typographical errors that should be fixed prior to issue. Given that, and that Appellants did not substantively respond to these rejections, they are sustained. See, e.g., In re Berger, 279 F.3d 975 (Fed. Cir. 2002) (in which the Board affirmed an uncontested rejection of claims under 35U.S.C. § 112, second paragraph, and on appeal the Federal Circuit affirmed the Board’s decision and found that the appellant had waived his right to contest the indefmiteness rejection by not presenting arguments as to error in the rejection on appeal to the Board). Claim 25: Indefiniteness of Term “generally parallel ” Claim 25 depends from claim 1 and additionally recites “wherein the first coil defines a surface generally parallel to an instrument external surface.” App. Br. 36 (Claims App’x.). In the Final Office Action the Examiner rejected claim 25 as indefinite because “it is unclear what is meant by generally parallel.” Final Act. 2. Appellants respond that “those skilled artisan[s] would know the bounds of the term generally parallel, and that the term generally parallel has the same meaning is [sic] used in the English language.” App. Br. 24. Appellants apparently rely on Figures 7 and 8 as depicting an embodiment of this “generally parallel” arrangement. See App. Br. 25 (“The coil forms a surface near the reference number 302 which discloses a coil which defines a surface generally parallel to an instrument external surface.”). In the Answer, the Examiner responds that figures 7 and 7 Appeal 2016-000302 Application 13/016,765 8 “show several uneven cured surfaces with gaps interspersed,” apparently referring to the shape of the coil windings. Ans. 12. The Examiner also asserts that Appellants do not provide evidence supporting their opinion that “substantially parallel” is definite. Id. We understand the Examiner’s position to be that the Specification does not provide sufficient disclosure to determine what first-coil “surface” is supposed to be parallel to “an instrument external surface” and hence claim 25 is “unclear.” Final Act. 2. Having reviewed the Specification, and Figures 7 and 8 in particular, we agree with the Examiner. The term is unclear, and Appellants do not substantively respond to the Examiner’s description of Figures 7 and 8. Accordingly, we sustain this rejection. Claim 25—Written Description The Examiner rejects claim 25 for lacking an adequate written description because “[t]he specification and drawings fail to show a surface generally parallel to an instrument external surface and rather show an uneven surface with curved surfaces and gaps formed by coils.” Final Act. 3. Appellants respond that “[t]he coil forms a surface near the reference number 302 which discloses a coil which defines a surface generally parallel to an instrument external surface.” App. Br. 25. Appellants are referring to Figures 7—8. For the reasons discussed above regarding the indefmiteness of claim 25, we also sustain the Examiner’s written-description rejection of claim 25. 8 Appeal 2016-000302 Application 13/016,765 Claims 1—7, 14—22, and25—27—Unpatentability— Ben-Haim, Acker, Martinelli, Ritter, and Gilboa For independent claim 1,1 the Examiner relies on Ben-Haim to teach a “barrel-shaped” coil. Final Act. 5. The Examiner asserts that a barrel shaped coil has a central diameter that is larger than the end diameters, as claimed. Id. But Ben-Haim does not teach a holding portion having any particular shape or size, or a tracking device configured to be aligned in (or to engage with) surfaces of the holding portion. See Ben-Haim, Figs. 3,14. The Examiner cites Acker as disclosing a similar instrument having a “holding portion,” but, like Ben-Haim, Acker does not depict a holding portion having any particular shape. Final Act. 5. The Examiner relies on Martinelli to teach a tracking device having a holding portion with a pair of opposed flat surfaces that engage a coil tracking device. Final Act. 5—6. Martinelli’s “holding portion” is cube shaped (Martinelli, Figs. 1A, IB), so it does not have the claimed “pair of tapered surfaces” from which the pair of opposed flat surfaces extend. The Examiner therefore relies on Gilboa, specifically apertures 510 and 512 in the device depicted in Figure 15, to teach a holding portion that is “tapered in shape.” Final Act. 6. The Examiner asserts that it would have been obvious to combine Ben-Haim, Martinelli, and Gilboa to ensure that the coils stay fixed in a specific orientation and location. Id. The Examiner also argues that it would have been “an obvious matter of design choice” to change the shape of the coils and holding portions. Id. Appellants’ primary argument is that the proposed combination does not teach a “holding portion defining a cavity having a pair of tapered 1 The issues are similar for independent claim 14. 9 Appeal 2016-000302 Application 13/016,765 surfaces and a first pair of opposed flat surfaces extending from the pair of tapered surfaces,” and a “tracking device . . . configured to be aligned by the pair of tapered surfaces and the first pair of opposed flat surfaces.” App. Br. 15—16. Appellants dispute that Gilboa’s apertures 510 and 512 are tapered surfaces, arguing instead that they are “curved lines” that support cylindrical posts rather than tapered surfaces of a coil. Reply Br. 3. Appellants also dispute the Examiner’s design-choice rationale, because “the claimed structure functions differently than the cited structure as it allows alignment of the tracking device while allowing for maximum coil size.” App. Br. 17. Finally, Appellants challenge the Examiner’s reasons to combine the references, asserting that the rejections are improperly based on hindsight. Id. at 18—22. None of the cited references teaches “a first pair of opposed flat surfaces extending from [a] pair of tapered surfaces,” as recited in claim 1 (claim 14 contains similar language). The Examiner relies on the combination of Martinelli and Gilboa as teaching this shape. Final Act. 5—6. But the Examiner does not sufficiently explain how a person of ordinary skill in the art would have combined Gilboa’s semi-circular apertures with Martinelli’s cube-shaped opening to produce a cavity having a pair of opposed flat surfaces extending from a pair of tapered surfaces. Accordingly, we find this rational unpersuasive. We are also not persuaded that the shape of the holding portion is merely a matter of design choice. A “design choice” rationale may be appropriate in cases where the choice of one structural detail over another would not affect the function or purpose of the claimed device. See In re Gal, 980 F.2d 717, 719 (Fed. Cir. 1992) (finding of obvious design choice 10 Appeal 2016-000302 Application 13/016,765 precluded when claimed structure and the function it performs are different from the prior art). Here, the Specification supports Appellants’ contention that the shape of the holding portion performs a specific function: permitting the alignment of a specifically shaped coil. See Spec. 175, Figs. 7, 8. Accordingly, we do not sustain the Examiner’s rejection of claims 1 and 14, as well as dependent claims 2—7, 15—22, and 25—27, as obvious over Ben-Haim, Acker, Martinelli, Ritter, and Gilboa. Claims 8—10, 12, 13, 24, and 30— Unpatentable over Ben-Haim, Acker, Martinelli, and Gilboa Unlike claims 1 and 14, claim 8 recites specific relative dimensions of the core of the coil, not the coil itself. That is, claim 8 requires the core of each of the claimed three coils to have a “center portion core diameter” that is larger than the “end core diameter.” App. Br. 30—31 (Claims App’x.). Claims 9, 10, 12, 13, 24, and 30 depend from claim 8. Id. at 31—37. The Examiner asserts that “Ben-Haim discloses a barrel[-]shaped core and a barrel[-]shaped core has a larger central diameter tapered to narrower outer diameters as currently claimed.” Final Act. 18. Appellants dispute this. App. Br. 23-24. Ben-Haim discloses, as an alternative embodiment, using barrel shaped coils. Ben-Haim 1113. Ben-Haim does not disclose barrel-shaped cores, per se. While it may make sense that the core of a coil would have the same shape as the coil itself, the Examiner has not provided evidence or persuasive argument supporting this notion. Because we disagree with the Examiner that Ben-Haim teaches a barrel-shaped core, the Examiner’s rejection of claim 8, and its dependent claims, is not sustained. 11 Appeal 2016-000302 Application 13/016,765 Claim 11—unpatentable over Ben-Haim, Acker, Gilboa, Martinelli, and Gerhart Claim 11 ultimately depends from claim 8. App. Br. 32 (Claims App ’x.). The Examiner’s rejection of claim 11 relies on the erroneous finding that Ben-Haim teaches a barrel-shaped core. Final Act. 22—23. Gerhart is not relied upon to cure this deficiency. Id. Therefore, for the reasons discussed above, we do not sustain this rejection. Claims 28 and 29—unpatentable over Ben-Haim, Acker, Gilboa, Martinelli, and Ritter Claims 28 and 29 ultimately depend from claim 8. The Examiner’s rejection of claims 28 and 29 relies on the erroneous finding that Ben-Haim teaches a barrel-shaped core. Final Act. 23—24. Ritter is not relied upon to cure this deficiency. Id. Therefore, we do not sustain this rejection. DECISION For the above reasons, we (1) affirm the Examiner’s rejection of claims 1—7 and 25—27 as indefinite; (2) affirm the Examiner’s rejection of claim 25 as failing to comply with the written-description requirement; and (3) reverse the Examiner’s rejections of claims 1—22 and 24—30 as unpatentable under 35 U.S.C. § 103(a). We also enter new grounds of rejection for claims 2, 3, 10, 11, and 14—22. FINALITY OF DECISION This decision contains new grounds of rejection under 37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” 12 Appeal 2016-000302 Application 13/016,765 37 C.F.R. § 41.50(b) also provides that Appellant, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new grounds of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the proceeding will be remanded to the examiner .... (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same record .... Further guidance on responding to a new ground of rejection can be found in the Manual of Patent Examining Procedure § 1214.01. 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-IN-PART; 37 C.F.R, $ 41.50(b) 13 Copy with citationCopy as parenthetical citation