Ex Parte FeiglDownload PDFPatent Trial and Appeal BoardJul 18, 201712177694 (P.T.A.B. Jul. 18, 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. 12/177,694 07/22/2008 Alexander J. Feigl AFEI:002USD1 4892 32425 7590 07/20/2017 NORTON ROSE FULBRIGHT US LLP 98 SAN JACINTO BOULEVARD SUITE 1100 AUSTIN, TX 78701-4255 EXAMINER ORKIN, ALEXANDER J ART UNIT PAPER NUMBER 3731 NOTIFICATION DATE DELIVERY MODE 07/20/2017 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): aoipdocket @ nortonrosefulbright .com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ALEXANDER J. FEIGL1 Appeal 2016-004814 Application 12/177,694 Technology Center 3700 Before ERIC B. GRIMES, RYAN H. FLAX, and TIMOTHY G. MAJORS, Administrative Patent Judges. MAJORS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to needle placement methods. The Examiner rejected the claims for lack of written description, as anticipated, and for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. STATEMENT OF THE CASE Appellant explains that “[traditional needle advancement and positioning instruments almost exclusively use a hemostat-like tool that allows a needle to be gripped by the tool and then advanced into the tissue being sutured.” (Spec. 2:11—13.) Appellant’s invention “relates to an 1 Appellant identifies the Real Party in Interest as A&P Feigl Family Limited Partnership. (Br. 1.) Appeal 2016-004814 Application 12/177,694 instrument that may be used to position one or more needles in locations that are difficult to suture using conventional methods.” {Id. at 2:6—7.) The Specification’s drawings better illustrate Appellant’s invention. Figures 1 and 6 are reproduced below and show a device usable for practicing the claimed methods. Figure 1 is a cross-sectional view of a suture-placement device including, inter alia, body (10), and lumen (15) with respective first (16) and second (17) lumen openings. {Id. at 11:26—28.) Figure 1 also shows an arcuate shaped needle guide channel (12) formed in the body, which is configured to receive an arcuate-shaped needle (not depicted in Fig. 1) within the channel. {Id. at 10:24—30.) The device may further include a handle (19) connected via shaft (20) to the body (10). {Id. at 12:18—19.) FIG. 1 2 Appeal 2016-004814 Application 12/177,694 FIG, 6 Figure 6 is a cross-sectional view of the suture-placement device, and shows a needle (60) attached at one end to suture (62) and being advanced out of the needle guide channel (61) by pulling suture (62) outward from opening (63) of the lumen in the direction of arrow (64). {Id. at 14:1—4.) As the Specification explains, “the needle has at least one directional component, represented by arrow 65a, that is opposite in direction to one of the directional components, represented by arrow 64, of the second end of the suture.” {Id. at 14:5—7; see also id. at 13:3—20.) Claims 53—57, 59—61, and 64—76 are on appeal. The independent claims (claims 53, 64, and 71) are reproduced below. 53. A needle placement method comprising: using a medical device to position a first needle to which a first length of suture is attached, the first needle being 3 Appeal 2016-004814 Application 12/177,694 positioned at least partially within a first needle guide channel of the medical device; and advancing the first needle completely out of the first needle guide channel and the medical device by pulling the first length of suture, wherein the pulling includes moving the first length of suture in a first direction having a positive longitudinal component, and the advancing includes the first needle moving in a second direction having a negative longitudinal component. 64. A needle placement method comprising: using a medical device to position a first needle to which a first length of suture is attached, the first needle being positioned at least partially within a first needle guide channel of the medical device, the first needle having a length and being curved along at least a portion of the length when the first needle is in an unconstrained position', and advancing the first needle by pulling the first length of suture, wherein the pulling includes moving the first length of suture in a first direction having a positive longitudinal component, and the advancing includes the first needle moving in a second direction having a negative longitudinal component. 71. A needle placement method comprising: using a medical device to position a first needle to which a first length of suture is attached, the first needle being positioned at least partially within a first needle guide channel of the medical device, the first length of suture not being attached to another needle', and advancing the first needle by pulling the first length of suture, wherein the pulling includes moving the first length of suture in a first direction having a positive longitudinal component, and the advancing includes the first needle moving in a second direction having a negative longitudinal component. (Br. 8—9, 11 (Claims App.) (emphases added).) 4 Appeal 2016-004814 Application 12/177,694 The claims stand rejected as follows: I. Claims 71—76 under 35 U.S.C. § 112, first paragraph (pre- AIA), for failure to satisfy the written description requirement. II. Claims 53 and 54 under 35 U.S.C. § 102(b) by Kontos ’539.2 III. Claims 55, 57, 71—73, and 75 under 35 U.S.C. § 103(a) over Kontos ’539. IV. Claims 56 and 74 under 35 U.S.C. § 103(a) over Kontos ’539 and Kontos ’849.3 V. Claims 59, 61, and 76 under 35 U.S.C. § 103(a) over Kontos ’539 and Pilling.4 VI. Claim 60 under 35 U.S.C. § 103(a) over Kontos ’539, Kontos ’849, and Pilling. VII. Claims 64—69 under 35 U.S.C. § 103(a) over Kontos ’539, Kontos ’849, and Stalker.5 VIII. Claim 70 under 35 U.S.C. § 103(a) over Kontos ’539, Kontos ’849, Stalker, and Pilling. I - WRITTEN DESCRIPTION The Examiner rejected claim 71, and dependent claims 72—76, for failing to comply with the written description requirement. According to the Examiner, the limitation of claim 71 that “the first length of suture not being 2 Kontos, US 5,980,539, issued Nov. 9, 1999. 3 Kontos, US 5,810,849, issued Sept. 22, 1998. 4 Pilling et al., US 1,815,725, issued July 21, 1931. 5 Stalker et al., US 5,972,005, issued Oct. 26, 1999. 5 Appeal 2016-004814 Application 12/177,694 attached to another needle” is a negative limitation that lacks support in Appellant’s disclosure. (Final Act. 2—3.) “[T]he test for sufficiency [of the written description] is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” AriadPharms., Inc. v. EliLilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). Thus, the issue before us is whether Appellant’s disclosure reasonably conveys to the skilled artisan possession of a method using a one-to-one arrangement between the suture and the needle. We are unpersuaded the Examiner met the burden to show that claim 71 lacks adequate descriptive support. As Appellant points out, in haec verba support is not required.6 (Br. 2.) Hence, contrary to the Examiner’s suggestion, the Specification need not literally recite that the suture is not attached to more than one needle. (Ans. 4 (“the specification needs to disclose that not only the suture may be attached to a needle, BUT it is not attached to more than one needle.”).) In any event, Appellant’s disclosure does adequately describe “the first length of suture not being attached to another needle.” As Appellant contends, all the relevant figures show a one- to-one relationship between the suture and the needle. (Br. 3.) And the Specification elsewhere describes a single needle attached to a single suture. For example, the Specification describes “a first needle, and a length of suture attachable to the first needle” (Spec. 4:24—25), “[e]ach additional 6 “[T]he disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue.” Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). 6 Appeal 2016-004814 Application 12/177,694 needle may have its own additional length of suture” and “[e]ach additional length of suture may be attached to its own additional needle.” {Id. at 5:15— 17.) From this, we disagree the skilled person would read Appellant’s disclosure and conclude the inventor did not have possession of a method where the suture is connected to one needle — and one needle alone — as required in claim 71. The Examiner further responds that Appellant’s description “would not rule out the possibility of the suture attached to another needle.” (Ans. 4.) We assume for the moment that is true. Indeed, in describing that any additional needle “may” have its own length of suture (Spec. 5:15—17), the Specification reasonably discloses that additional needles may be connected to the first suture to which a first needle is attached. That does not, however, change our conclusion because it would mean Appellant described alternative embodiments (e.g., additional needles may or may not be connected to a common suture), and opted to claim one of them in claim 71. Cf. Inphi Corp. v. Netlist, Inc., 805 F.3d 1350, 1357 (Fed. Cir. 2015) (holding that “[prior precedent] did not create a heightened written description standard for negative claim limitations and that properly described, alternative features are sufficient to satisfy the written description standard of § 112, paragraph 1 for negative claim limitations.”) For these reasons, we conclude the preponderance of the evidence does not support the Examiner’s rejection for lack of written description. II-ANTICIPATION The Examiner rejected method claims 53 and 54 as anticipated by Kontos ’539. (Final Act. 3—5.) As to the key disputed step of claim 53, the 7 Appeal 2016-004814 Application 12/177,694 Examiner finds Kontos ’539 teaches “advancing the first needle completely out of the first needle guide channel and the medical device by pulling the first length of suture (col. 6,11. 55-59).” (Id. at 3.) Appellant argues Kontos ’539 does not disclose the method of claim 53 because, in Kontos ’539, the needle is only partially advanced out of the alleged needle guide channel by pulling the suture. (Br. 3 4.) Appellant contends “Kontos [’539] state[s] that it is the doctor grasping needle 14 itself and pulling on it that gets it completely out of lumen 10.” (Id. at 4 (quoting Kontos ’539 6:55-7:7).) Appellant’s argument is persuasive. “Anticipation requires that all of the claim elements and their limitations are shown in a single prior art reference.” In re Skvorecz, 580 F.3d 1262, 1266 (Fed. Cir. 2009). As Appellant points out (Br. 4), Kontos ’539 discloses: The first needle 14 is drawn proximally by means of the first suture portion 20' until the pointed end 14' of the first needle protrudes from the skin. The first needle 14 is then grasped by the doctor and withdrawn from the needle retention lumen 10, thereby drawing the first suture portion 20' out through the skin. (Kontos ’539 6:62—66; see also id. Fig. 10.) The method described in Kontos ’539 thus requires the doctor to physically grasp and pull the needle to advance the needle completely out of the lumen. This differs from the method of claim 53, where the needle is advanced completely out of the needle guide channel and device by pulling the suture. The Examiner responds that “one can read that the pulling step of the suture helps or aids or starts the step of advancing the first needle completely out of the first needle guide channel” and that even if the doctor “pulls the 8 Appeal 2016-004814 Application 12/177,694 needle out as well, there is still ‘a pull’ being applied to the suture.” (Ans. 5.) We are unpersuaded the Examiner is applying a reasonable interpretation of claim 53. The pulling of the suture (with the directionality claimed) is responsible for advancing the needle completely out of the needle guide channel and device. (See, e.g., Spec. 13:28—29 (“it is the suture itself that advances the needle out of the needle guide channel”).) In sum, the preponderance of the evidence does not support the Examiner’s finding that claims 53 and 54 are anticipated. Ill & VII - OBVIOUSNESS The Examiner rejected claims 55, 57, 71—73, and 75 over Kontos ’539 (Rejection III), and claims 64—69 over Kontos ’539, Kontos ’849, and Stalker (Rejection VII). Rejection III Claims 55 and 57 depend from claim 53. The Examiner reprises the findings about Kontos ’539 and claim 53 (Final Act. 6) that we concluded were unpersuasive as discussed above concerning Rejection II. For claim 71, from which claims 72, 73, and 75 depend, the Examiner finds “modification to include an additional needle guide channel will have the first length of suture not attached to another needle as shown in Fig. 15 of Kontos.” (Id. at 7.) We disagree. Kontos ’539’s related description and drawings make clear that Figure 15 does not disclose a length of suture that is attached to only one needle. (See Kontos ’539 7:40-60 (describing how each needle withdrawal lumen includes two needles coupled to a suture); see also id. Figs. 15 and 17—21 (showing the operation of the device shown in Fig. 15).) 9 Appeal 2016-004814 Application 12/177,694 As correctly noted by Appellant, “each disclosed length of suture (20 and 85) [as depicted in Figure 15] are attached to two needles.” (Br. 5.) Kontos ’539 does not, therefore, teach or suggest all the limitations of claim 71. For these reasons, the preponderance of the evidence does not support the Examiner’s conclusion that claims 55, 57, 71—73, and 75 would have been obvious over Kontos ’539. Rejection VII The Examiner rejected claim 64, and dependent claims 65—69, based on the combination of Kontos ’539, Kontos ’849, and Stalker. (Final Act. 9— 10.) The key limitation of claim 64 is “the first needle having a length and being curved along at least a portion of the length when the needle is in an unconstrained position.” In other words, the needle is at least partially curved in its natural (unconstrained) state. The Examiner reasons it would have been obvious to modify Kontos ’539 with the flexible distal section of Kontos ’849 (which provides the arcuate-shaped needle guide channel), in order to “prevent the device from penetrating or damaging the lining of the blood vessel.” {Id. at 9.) The Examiner, finding that the device modified according to Kontos ’539 and ’849 fails to disclose the curved needle of claim 64, turns to Stalker. {Id.) According to the Examiner, Stalker teaches a needle that “resiliently maintain[s] a linear configuration when positioned in the delivery device and elastically assume[s] a curved configuration to conform to the guide channel after it pierces tissue.” {Id.) The Examiner then reasons it would have been obvious to use the curved unconstrained needle of Stalker in the modified device of Kontos ’539 and ’849. {Id. at 9-10.) 10 Appeal 2016-004814 Application 12/177,694 Appellant’s only argument is that the Examiner’s reasoning for combining Kontos ’539 and ’849 “makes no sense” because the Examiner references Fig. 6B of Kontos ’849, but then relies on a rationale that concerns Fig. 20 of Kontos ’849. (Br. 6.) Although Appellant’s argument is generally unconvincing,7 neither are we persuaded the Examiner made a threshold showing that claim 64 would have been prima facie obvious and Appellant’s point that the rejection “makes no sense” is correct for other reasons. We do not understand — and the Examiner does not adequately explain — how the curved needle disclosed in Stalker would work in the modified Kontos device. The needle (14) of Kontos ’539 is naturally straight, and the needle (37) of Kontos ’849 appears to take on a slightly curved configuration only when it is disposed in needle retention bore (32) (i.e., when constrained) at the flexible distal end (24). (See Kontos ’539 Fig. 10; Kontos ’849 Figs. 6B and 7.) If, as the Examiner proposes, a needle that assumed a curved position when unconstrained were used in the modified Kontos device, we are unpersuaded the device would work as intended. For example, as shown in Fig. 6B of Kontos ’849 and the related description, “proximal end of the needle 37 is drawn through the wall of the blood vessel, enters opening 10 and extends into the needle withdrawal lumen 26.” (Kontos ’849 6:18—20.) Using a needle that is naturally biased to curve, like 7 The Examiner’s reference to Figs. 6B and 20 of Kontos ’849 together teach that the distal portion of the suturing device should be made flexible (and capable of partially curving) in order to avoid damage to the blood vessel into which the distal portion is inserted. (See Kontos ’849 Figs. 6B and 20.) 11 Appeal 2016-004814 Application 12/177,694 Stalker’s needle (see Stalker 3:16—27 and 6:33 46) in a device with the distal end of Kontos ’849 would appear to prevent the needle from exiting needle retention bore (32), piercing the blood vessel (BV), traversing the gap/void caused by the bend at central arcuate portion (22), and then entering needle withdrawal lumen (26) across the void. (See Kontos ’849 Fig. 6B.) Put succinctly, once the needle exited needle retention bore (32) it would curve and miss opening (10) of needle retention lumen (26). (Id.) The fact that the needles described in Kontos are naturally straight (see, e.g., Kontos ’849 Fig. 7) would seem to allow the needles to exit and enter the relevant bores and lumens, and pierce the tissues as intended. And the Examiner provides no reason with rational underpinning sufficient to explain why the straight needles of Kontos would be modified to Stalker’s needles having a natural curve. For the above reasons, we reverse the rejection of claim 64 and dependent claims 65—69 as obvious. IV, V, VI & VIII These rejections relate to various claims, all of which depend directly or indirectly from one of independent claims 53, 64, or 71. The Examiner has not shown the prior art combinations for these rejections make up for the deficiencies with respect to the cited art and the independent claims. (Final Act. 7—8, 10.) We thus reverse these rejections as well for the reasons explained above. (See discussion regarding Rejections II, III, and VII.) 12 Appeal 2016-004814 Application 12/177,694 SUMMARY We reverse the rejections of the claims on appeal for lack of written description, anticipation, and obviousness. REVERSED 13 Copy with citationCopy as parenthetical citation