Matthew W. Bown et al.Download PDFPatent Trials and Appeals BoardOct 31, 201914309782 - (D) (P.T.A.B. Oct. 31, 2019) 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. 14/309,782 06/19/2014 Matthew W. Bown 101672.0069P3 1563 158673 7590 10/31/2019 BD/Rutan & Tucker, LLP 611 ANTON BLVD SUITE 1400 COSTA MESA, CA 92626 EXAMINER KREMER, MATTHEW ART UNIT PAPER NUMBER 3791 NOTIFICATION DATE DELIVERY MODE 10/31/2019 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): ip.docket@bd.com patents@rutan.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte MATTHEW W. BOWN and DAVID M. BUTTS1 ____________________ Appeal 2018-008021 Application 14/309,782 Technology Center 3700 ____________________ Before JAMES P. CALVE, MICHELLE R. OSINSKI, and NATHAN A. ENGELS, Administrative Patent Judges. OSINSKI, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant appeals under 35 U.S.C. § 134(a) from the Examiner’s decision rejecting claims 1–4, 8, 17, and 18.2 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as C. R. Bard, Inc. Appeal Br. 3. 2 After this rejection, Appellant filed an amendment to cancel claims 8 and 18. Amdt Under 37 CFR § 41.33, filed Apr. 12, 2018. The amendment was entered. Adv. Action (mailed May 14, 2018). Appellant now appeals the rejection of pending claims 1–4 and 7. See Appeal Br. 3. Claims 5 and 7 are withdrawn from consideration, and claims 6, 8–16, and 18 are cancelled. Appeal Br. 23–24 (Claims App.). Appeal 2018-008021 Application 14/309,782 2 THE CLAIMED SUBJECT MATTER Claims 1 and 17 are the independent claims. Claim 1 is reproduced below. 1. A guidewire system, comprising: a shaped guidewire, a portion thereof including a shape memory material, comprising: an elongate body with a proximal end and a distal end defining a longitudinal axis; and a shaped portion, the shaped portion having a first configuration, deflected from the longitudinal axis, and designed to be malleable from the first configuration to a second deflected configuration, the shaped portion having a diameter the same as a diameter of the elongate body; and an apparatus for positioning at an incision site on a corpus of a patient, the apparatus having a proximal end and a distal end, the apparatus interacting with the shaped portion of the shaped guidewire to prevent the shaped portion from advancing distally of the proximal end of the apparatus. Appeal Br. 23 (Claims App.) EVIDENCE The Examiner relied on the following evidence in rejecting the claims on appeal: THE REJECTIONS3 I. Claims 1–4 and 17 stand rejected under 35 U.S.C. § 102(b) as anticipated by, or alternatively under 35 U.S.C. § 103(a) as unpatentable over, Douk. Final Act. 6–9. 3 A rejection of claims 8 and 18 under 35 U.S.C. § 112, second paragraph, as being indefinite (Final Act. 5) has been withdrawn (Ans. 13) and is not Wilson Ressemann Douk McNamara US 5,211,183 US 5,281,203 US 5,827,241 US 6,254,550 B1 May 18, 1993 Jan. 25, 1994 Oct. 27, 1998 July 3, 2001 Appeal 2018-008021 Application 14/309,782 3 II. Claims 1–4 and 17 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Ressemann, Wilson or Douk, and McNamara. Id. at 9–13. III. Claims 1–4 and 17 stand rejected on the ground of nonstatutory double patenting over claims 1–4 and 20 of U.S. Patent No. 8,758,268 in view of Wilson or Douk. Id. at 14–17. OPINION Rejection I With respect to independent claim 1, the Examiner finds that Douk discloses, among other things, a guidewire comprising a “shaped portion having a first configuration (the non-linear segment of FIG. 23 of Douk), deflected from the longitudinal axis, and designed to be malleable from the first configuration to a second deflected configuration.” Final Act. 6. The Examiner asserts that the guidewire has some flexibility which includes the non-linear segment of FIG. 23 of Douk such that the non-linear segment of FIG. 23 of Douk is designed to be malleable from the configuration in FIG. 23 to a second configuration of a flexed state since the nitinol material is described as being able to behave that way. Id. at 6–7 (citing Douk 14:61–15:47, Fig. 23); Ans. 16 (citing Douk 14:61– 15:47, Fig. 23) (asserting virtually identical language). The Examiner explains further that “the material nitinol is malleable from the first configuration of FIG. 23 to a second deflected configuration since nitinol is flexible by its very nature which is discussed in col. 14, line before us on appeal. The rejections of claims 8 and 18 in each of Rejections I–III (Final Act. 6–17) are moot in view of Appellant’s cancellation of these claims and have been expressly withdrawn by the Examiner (Ans. 13). Appeal 2018-008021 Application 14/309,782 4 61 to col. 15, line 47 of Douk.” Final Act. 19. The Examiner takes the position that “[u]sing the broadest reasonable interpretation, the term ‘malleable’ can mean ‘capable of being altered or controlled by outside forces or influences.’” Id. at 20 (quoting Merriam-Webster Dictionary, available at www.merriam-webster.com); see also Ans. 14–16 (citing same definition). According to the Examiner, “there is nothing inherent in the term ‘malleable’ or explicit in the [S]pecification that requires the term ‘malleable’ to mean that the guidewire loses its superelastic characteristics.” Final Act. 20. Moreover, according to the Examiner, “[t]he fact that the guidewire changes shape with the removal of the rollers is not precluded by the claim language” and “[i]ndeed, the fact that the guidewire will change shape shows that it is designed to be malleable, as is consistent with the broadest reasonable interpretation of the term ‘malleable.’” Id.; see also Ans. 15 (“[T]here is nothing inherent in the term ‘malleable’ or explicit in the [S]pecification that requires the term ‘malleable’ to mean that the guidewire undergoes significant plastic deformation before rupture and will not return to its original shape after the load is removed.”) and Ans. 16 (“[T]he very nature of guidewires demands that all guidewires are capable of being altered or controlled by outside forces or influences so as to be able to be snaked through the tortuous pathways of the cardiovascular system without causing harm to the patient.”).4 4 The Examiner’s alternative obviousness position is based on a determination that “to the extent the guide catheter 36 and/or the adaptor 30 of FIGS. 3–9 is not shown in the embodiment of FIG. 23, it would have been obvious to include such a catheter and/or adaptor to the embodiment of Appeal 2018-008021 Application 14/309,782 5 Appellant argues that the Examiner’s proposed interpretation of the term “malleable” is unreasonably broad. Appeal Br. 11–12. Appellant points to its Specification in which Appellant (i) “defines malleable ‘as to be shaped into a shape and remain in the shape until reshaped’”; (ii) states that “‘[i]n another embodiment, a proximal portion of the nitinol guidewire can be treated to impart malleability and enable deflection by a clinician’”; and (iii) states that “‘[b]y treating it in this manner at a desired temperature, the guidewire portion loses its superelastic characteristics and becomes malleable.’” Id. at 12 (quoting Spec. ¶¶ 8, 32, Abstr.) (emphasis omitted). Appellant elaborates that “the malleable properties are clearly differentiated from the elastic (kink-resistant) properties as remaining in the deformed shape, and not returning to its original shape, after the load is removed.” Reply Br. 5 (emphasis omitted) (citing Spec. ¶ 32, which states“[T]he distal portion of the guidewire retains its kink-resistant qualities while the heat- treated portion is malleable. This allows the clinician to bend the guidewire portion, such as the proximal portion, to form a hook or other angled member.”). In short, Appellant argues that “the Examiner’s assertions that the flexible characteristics of Douk are commensurate with the malleable requirements of the claim, as defined in the Instant Specification, are without merit.” Appeal Br. 13. Appellant also points out that “the Examiner overlooks the interpretation [of the term “malleable”] directed to properties [i.e., the first definition set forth in Merriam-Webster Dictionary of “capable of being extended or shaped by beating with a hammer or by the pressure of rollers”], FIG. 23.” Final Act. 7. The alterative obviousness position relies on the same construction of the term “malleable.” Id. Appeal 2018-008021 Application 14/309,782 6 and instead selectively utilizes the interpretation directed to human behavior, which is not contextually relevant to the Instant Application as a whole.” Reply Br. 6. Appellant also argues that the Examiner’s proposed interpretation “is so excessively broad as to render the term meaningless.” Id. at 4 (citing MPEP § 2111.01(I), (III). More particularly, Appellant argues that the Examiner’s proposed construction is “so broad as to be effectively useless in defining the concept for a person having ordinary skill in the art” and “does not provide for what occurs after the outside forces are removed, so as to differentiate between ‘elastic’ and ‘malleable.’” Id. at 8 (emphasis omitted). As described above, the Examiner indicates that all guidewires “are capable of being altered or controlled by outside forces or influences” (Ans. 16), thereby suggesting that all guidewires are necessarily “malleable.” To construe the limitation of “malleable” as simply being able to be controlled by outside forces or influences would effectively render the claim limitation superfluous, and thus would be improper. See Stumbo v. Eastman Outdoors, Inc., 508 F.3d 1358, 1362 (Fed. Cir. 2007). That is, under the Examiner’s interpretation, the claim limitation is construed so broadly that every guidewire would be “malleable” by virtue of it having to be sufficiently flexible so as to be able to be snaked through the tortuous pathways of the cardiovascular system without causing harm to the patient, whereas Appellant takes the position that this would be unreasonable. Reply Br. 4. The term “malleable” must be construed in a way that gives the term effect and is consistent with the Specification. Merely equating flexibility with malleability fails to give the term any effect, because every guidewire would have to have at least some degree of flexibility in order to perform its Appeal 2018-008021 Application 14/309,782 7 function in a cardiovascular system, but every guidewire is not necessarily “designed to be malleable from the first configuration to a second deflected configuration” as claimed. The Specification discloses that the malleable guidewire retains a deflected configuration so the clinician can form a hook or other angled member to prevent migration of the guidewire into the vasculature of the patient. Spec. ¶ 32. Therefore, the Examiner’s position fails to give proper weight to the limitation of claim 1 interpreted in light of the Specification. We agree with Appellant that the Examiner’s rejection relies on an unreasonably broad interpretation of the term “malleable.” That is, the Examiner’s rejection relies on a finding that the embodiment of Figure 23 of Douk is a malleable guidewire simply because it is flexible enough to be constrained in a non-linear path defined by a number of rollers. Douk, 15:8– 36. In accordance with the Examiner’s interpretation of the term “malleable,” the Examiner determines it to be of no importance that the guidewire of Figure 23 of Douk will return to its previous shape after the rollers are removed. Ans. 15. However, when the term “malleable” is given its broadest reasonable interpretation consistent with the Specification— namely, the ability to be shaped into a shape and remain in the shape until reshaped—the Examiner does not explain sufficiently how the embodiment of Figure 23 of Douk teaches or suggests a malleable guidewire (i.e., a guidewire that will remain in its shaped configuration until reshaped). Because the Examiner’s rejection of claim 1 relies on an erroneous claim construction for the term “malleable,” we do not sustain the Examiner’s rejection of claim 1, and claims 2–4 which depend therefrom. We also do not sustain the Examiner’s rejection of independent claim 17 Appeal 2018-008021 Application 14/309,782 8 which recites a substantially similar limitation to that of independent claim 1 (i.e., “the shaped portion composed of a shape memory material and configured to be malleable from a first configuration to a second configuration”) (Appeal Br. 24 (Claims App.)) and for which the Examiner relies on the same erroneous claim construction for the term “malleable” (Final Act. 8–9). Rejection II The Examiner relies on Ressemann to teach “a shaped guidewire (the guide wire 20 of Ressemann) comprising: an elongate body (the straight portion of 20 to the right of the retaining means 72 of Ressemann) . . . and a shaped portion (the retaining means 72 of Ressemann).” Final Act. 10. As to a portion of the shaped guidewire including a shape memory material, the Examiner turns to the teaching of Wilson or Douk that “nitinol is a suitable material for the guidewire.” Id. (citing Wilson Abstr., cols. 1–2, 6:10–30; Douk cols. 14–15). The Examiner concludes that it would have been obvious to one of ordinary skill in the art “to use nitinol as the material for the guidewire since a material is required and Wilson or Douk teaches a suitable material and/or it is a simple substitution of one known element for another to obtain predictable results.” Id. The Examiner acknowledges that “[t]he combination does not teach how a shaped guidewire made of nitinol can be formed,” and states that “McNamara teaches how such a nitinol guidewire may be shaped.” Id. (citing McNamara cols. 4–6). The Examiner concludes that it would have been obvious to one of ordinary skill in the art “to use the method of shaping a nitinol guidewire of McNamara in the combination since a method of forming is required and McNamara teaches one such method.” Id. Appeal 2018-008021 Application 14/309,782 9 The Examiner finds that “Ressemann as modified according to the above 103 analysis” would result in a shaped portion “designed to be malleable from the first configuration to a second deflected configuration.” Id. at 11; see also id. at 12 (the Examiner similarly finding in connection with independent claim 17 that “the guide wire 20 of Ressemann as modified according to the above 103 analysis has this ability [i.e., to be malleable from a first configuration to a second configuration]”). Appellant argues that the combination fails to teach a shaped portion that is “designed to be malleable from the first configuration to a second deflected configuration,” as claimed. Appeal Br. 19–20. More particularly, Appellant argues that “Douk and Wilson only provide a generic recitation of nitinol,” but this is “insufficient to provide any teaching of malleability as required.” Id. Appellant also argues that “McNamara [also] fails to teach imparting or designing the nitinol guidewire to be malleable, as defined by the Instant Specification.” Id. at 20. The Examiner responds first by indicating that a “shaped Nitinol guidewire is . . . capable [of being altered or controlled by outside forces or influences]” in accordance with the Examiner’s interpretation of malleable. Ans. 35. For the same reasons described above in connection with Rejection I, this response by the Examiner relies on an erroneous construction of “malleable.” The Examiner next responds by indicating that “the shaped portion can be made by the same process of annealing as the present invention” and “[i]f the shaped Nitinol guidewire has the same size, shape, material, and function and made by the same annealing process as the present invention, it is presumed to have the same properties as the present invention.” Id. (underlining omitted). Appeal 2018-008021 Application 14/309,782 10 Appellant replies that although McNamara teaches a method of treating Nitinol involving annealing, McNamara’s method “produce[s] a device with nitinol’s superelastic properties.” Reply Br. 15–16 (quoting McNamara 5:55–57). More particularly, Appellant argues that McNamara’s “‘shape-set annealing’ method” merely refers to the shape-set annealing process set forth in Appellant’s Specification that is used to “maintain[] the superelastic and shape memory properties” and “impart to the guidewire portion a desired shape.” Id. at 16 (quoting Spec. ¶ 30) (emphasis omitted). Appellant distinguishes McNamara’s shape-set annealing method from another annealing process described in Appellant’s Specification which utilizes a lower temperature heat treatment in order to cause “the guidewire portion [to] lose[] its superelastic characteristics and become[] malleable” and which “allows the clinician to bend the guidewire portion.” Id. (citing Spec. ¶¶ 32–33) (emphasis omitted). According to Appellant, “[t]he Examiner’s presumption that the asserted combination would inherently meet all the requirements of the claims is unfounded” and “information has been provided in the Instant Specification to show a difference between the claimed processes, which results in a guidewire being ‘designed to be malleable,’ and that of the ‘shape-set annealing’ process described in the asserted art.” Id. at 17 (emphasis omitted). We are persuaded by Appellant that the Examiner has not provided a sufficient basis to support the Examiner’s determination that the claimed malleable characteristic of independent claims 1 and 17 necessarily flows from the combined teachings of Ressemann, Wilson or Douk, and McNamara. See In re Oelrich, 666 F.2d 578, 581 (CCPA 1981). In particular, the Examiner’s technical reasoning to support that Ressemann, as Appeal 2018-008021 Application 14/309,782 11 modified by the teachings of (i) Wilson or Douk and (ii) McNamara, is inherently designed to be malleable from a first configuration to a second configuration relies on McNamara treating its nitinol wire with “the same annealing process as the present invention” (Ans. 35 (emphasis omitted)), but Appellant has shown that McNamara’s annealing process (McNamara 2:27–29, 3:12–16, 5:16–19) is not the same as Appellant’s heat treatment process for imparting malleability to a shape memory material (id. ¶¶ 32– 33). Instead, McNamara’s annealing process is akin to Appellant’s “shape set annealing process” (Spec. ¶ 30) that does not impart malleability and instead maintains superelasticity. Reply Br. 16. In particular, McNamara describes that “Nitinol can be permanently shaped by annealing with extreme heat.” McNamara 2:27–28. McNamara further describes that “[b]ecause of the superelasticity of nitinol, permanently deforming the material to produce the desired bend in the wire requires special manufacturing techniques” and “[t]he basic procedure involves maintaining the device in the desired final shape while subjecting it to extreme heat for a prescribed period of time.” Id. at 5:9–18. McNamara describes that the process “produce[s] a device with nitinol’s superelastic properties.” Id. at 5:55–57. As explained above, the Examiner lacks sufficient technical reasoning to support a determination of inherency of the claimed feature, and, the Examiner has not otherwise explained how retaining means 72 of Ressemann, as modified by the teachings of (i) Wilson or Douk and (ii) McNamara, is comprised of a shape memory material that is designed to be malleable from a first configuration to a second configuration (i.e., has Appeal 2018-008021 Application 14/309,782 12 the ability to be shaped into a shape and remain in that shape until reshaped in connection with both a first configuration and a second configuration). For the foregoing reasons, Appellant has apprised us of error in the Examiner’s finding that the subject matter of independent claims 1 and 17 is rendered obvious by the combination of Ressemann, Wilson or Douk, and McNamara. We do not sustain the rejection of claims 1 and 17, and claims 2–4 which depend from claim 1. Rejection III Appellant does not present any substantive arguments contesting the Examiner’s rejection of claims 1–4 and 17 on the ground of nonstatutory double patenting as being unpatentable over claims 1–4 and 20 of U.S. Patent No. 8,758,268 in view of Wilson or Douk. See Appeal Br. 6–22 (presenting arguments only as to the anticipation and obviousness rejections). Consequently, Appellant has waived any argument of error, and we summarily sustain the rejection of claims 1–4 and 17 on the ground of nonstatutory double patenting. See, e.g., Hyatt v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008) (explaining that summary affirmance without consideration of the substantive merits is appropriate where an appellant fails to contest a ground of rejection); Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential) (“If an appellant fails to present arguments on a particular issue—or more broadly, on a particular rejection—the Board will not, as a general matter, unilaterally review those uncontested aspects of the rejection”); 37 C.F.R. § 41.37(c)(1)(iv); MPEP § 1205.02 (“If a ground of rejection stated by the examiner is not addressed in the appellant’s brief, appellant has waived any challenge to that ground of rejection and the Board Appeal 2018-008021 Application 14/309,782 13 may summarily sustain it, unless the examiner subsequently withdrew the rejection in the examiner’s answer.”). CONCLUSION The Examiner’s decision to reject claims 1–4 and 17 under 35 U.S.C. § 102(b) as anticipated by, or alternatively under 35 U.S.C. § 103(a) as unpatentable over, Douk is reversed. The Examiner’s decision to reject claims 1–4 and 17 under 35 U.S.C. § 103(a) as unpatentable over Ressemann, Wilson or Douk, and McNamara is reversed. The Examiner’s decision to reject claims 1–4 and 17 on the ground of nonstatutory double patenting is affirmed. In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–4, 17 102(b) Douk 1–4, 17 1–4, 17 103(a) Douk 1–4, 17 1–4, 17 103(a) Ressemann, Douk or Wilson, McNamara 1–4, 17 1–4, 17 Nonstatutory Double Patenting in view of Wilson or Douk 1–4, 17 Overall Outcome 1–4, 17 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 Copy with citationCopy as parenthetical citation