Ex Parte LangfordDownload PDFPatent Trial and Appeal BoardFeb 7, 201814021537 (P.T.A.B. Feb. 7, 2018) 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. 14/021,537 09/09/2013 Robert R. Langford 0238(18322) 2604 46909 7590 02/08/2018 TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ATTN: DARRYL NEWELL 6200 JACKSON ROAD ANN ARBOR, MI 48103 EXAMINER SCHERBEL, TODD J ART UNIT PAPER NUMBER 3731 MAIL DATE DELIVERY MODE 02/08/2018 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte ROBERT R. LANGFORD __________ Appeal 2017-001608 Application 14/021,537 Technology Center 3700 __________ Before JEFFREY N. FREDMAN, JOHN G. NEW, and ELIZABETH A. LAVIER, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 involving claims to an apparatus for endoscopic harvesting of a vessel from a body. The Examiner rejected the claims as anticipated and as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Statement of the Case Background “An artery or vein is ‘harvested’ (i.e., removed) from its natural location in a patient’s body and reconnected to provide blood circulation elsewhere in the body” (Spec. 1:22–24). “The known minimally-invasive endoscopic techniques employ a small incision for locating the desired 1 Appellant identifies the Real Party in Interest as Terumo Cardiovascular Systems Corporation (see App. Br. 1). Appeal 2017-001608 Application 14/021,537 2 vessel and for introducing one or more endoscopic devices into the small incision” (id. at 2:4–6). “Existing harvesting devices have required an intricate and physically demanding procedure to isolate a vessel from surrounding tissue and to cut and coagulate side branches” (id. at 2:19–21). “[C]onventional endoscopic devices have not been capable of maintaining a layer of surrounding tissue over the harvested vessel” (id. at 3:5–6). “The present invention provides a user-friendly device and procedure for endoscopically harvesting a vessel with a surrounding pedicle for use in grafting. Patency of the vessel is improved and trauma is reduced as a result of harvesting with no direct contact with the vessel” (Spec. 3:10–13). The Claims Claims 1–5 and 10–14 are on appeal. Independent claim 1 is representative and reads as follows: 1. Apparatus for endoscopic harvesting of a vessel from a body, wherein the vessel has an anterior side closest to the skin, comprising: a sheath extending in a longitudinal direction with a dissector tip for advancing along the vessel substantially along the anterior side to create a flanking tunnel spaced away from the vessel; and a ring-shaped blade mounted to the sheath and disposed in a plane substantially perpendicular to the longitudinal direction and proximal of the dissector tip, wherein the blade forms a lateral loop to encircle the vessel from the flanking tunnel and to make a vasiform cut including a pedicle around the vessel as the sheath advances. Appeal 2017-001608 Application 14/021,537 3 The Issues A. The Examiner rejected claims 1, 4, and 5 under 35 U.S.C. § 102(a)(1) as anticipated by Chin2 (Final Act. 3–4). B. The Examiner rejected claims 2, 3, and 10–13 under 35 U.S.C. § 103(a) as obvious over Chin and Weadock3 (Final Act. 4–6). C. The Examiner rejected claims 10–14 under 35 U.S.C. § 103(a) as obvious over Chin and Parins4 (Final Act. 6–7). A. 35 U.S.C. § 102(a)(1) over Chin The Examiner finds: Chin discloses an apparatus (cannula 900) for endoscopic harvesting of a vessel from a body (col. 1, lns. 13-21) where the vessel has an anterior side closest to the skin including a sheath (sheath of cannula 900) and a ring-shaped blade (dissection probe 907). The sheath extends in a longitudinal direction with a dissector tip for advancing or at least capable of advancing along the vessel substantially along the anterior side to create a flanking tunnel spaced away from the vessel (FIG. 9A-9B and 16; col. 14, lns. 1-20). The ring-shaped blade is mounted to the sheath and disposed in a plane substantially perpendicular to the longitudinal direction and proximal of the dissector tip (FIG. 9A-9B; col. 10, lns. 60-67). The blade forms a lateral loop capable of encircling the vessel from the flanking tunnel and making a vasiform cut including a pedicle around the vessel as the sheath advances (FIG. 9A-9B and 11D-11E; col. 10-11, lns. 60-23). (Final Act. 3). 2 Chin, US 5,980,549, issued Nov. 9, 1999. 3 Weadock et al., US 6,527,771 B1, issued Mar. 4, 2003. 4 Parins et al., US 5,013,312, issued May 7, 1991. Appeal 2017-001608 Application 14/021,537 4 The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that Chin anticipates claim 1? Findings of Fact 1. Chin teaches “a cannula for separating tissue to form an elongated cavity along the course of a small blood vessel and subsequently harvesting the blood vessel, or using the blood vessel as an in-situ graft” (Chin 4:25–28). 2. Figures 9A and 9B of Chin are reproduced below: At the distal end of the body of the cannula 900, a detachable, transparent blunt tip 903 is shown in FIG. 9A retracted onto the distal end of the cannula body, and is shown in FIG. 9B mounted on push rod 906 and extended beyond the distal end of the cannula body 900 to expose the viewing end 905 of an endoscope, and a crescent-shaped dissection probe 907. The probe 907 is mounted on shaft 909 to facilitate selective manipulation of the dissection probe 907 within the field of view of the endoscope 905. (Chin 10:37–45). Appeal 2017-001608 Application 14/021,537 5 3. Chin teaches a surgical procedure involving the cannula 900 shown in FIG. 9A includes making an initial incision and blunt dissection 1601 to form an initial dissected cavity. The cavity may then be sealed 1603 in conventional manner and inflated 1605 to facilitate insertion 1607 of the cannula 900 into the cavity through a conventional gas-tight seal. The cannula 900 is advanced 1609 and a perimeter balloon 901 on the cannula is inflated 1611 to expand the dissected cavity, and is deflated to facilitate further advancement of the cannula, and reinflation of the balloon. This sequence is repeated 1612, 1613 until the dissected cavity of sufficient size or length is formed along the vessel of interest. The dissected cavity is maintained 1615 in a manner as previously described, and the cannula 900 may be retracted 1617 sufficiently within the dissected cavity to facilitate detaching and/or extending 1619 the blunt tip 903 and facilitating extension 1621 of the dissection probe 907. One or more of the steps 1617, 1619, and 1621 may be repeated while dissecting connecting tissue 1623 to harvest the vessel of interest. (Chin 14:1–20). 4. Chin teaches the “surgeon relies upon the visual images obtained through the tip to guide the tip past side branches without injuring them along the length of the vessel, such as a saphenous vein, as it is dissected from surrounding fat” (Chin 5:5–9). 5. Chin teaches: “Selective translational and rotational manipulations may be achieved via similar manipulations of the shaft 909 at the proximal end thereof to dissect connective tissues and lateral branch vessels along the course of the vessel being harvested” (Chin 11:1–5). 6. Chin teaches the “dissection probe 907 (or 1101 and 1103) may be orbited about the axis of shaft 909, and the cannula body 900 may be Appeal 2017-001608 Application 14/021,537 6 rotated on its longitudinal axis to facilitate the dissection of the vessel away from connecting tissue, and the traversal of side-branch vessels” (Chin 11:19–23). 7. The Specification teaches “blade 37 preferably forms an incomplete ring resulting in a gap 43 between terminal end 41 and intermediate section 38. The ring is not complete around the circumference so that the vessel can be loaded within the ring” (Spec. 6:11–13). 8. The Specification teaches: “Preferably, a variety of sizes and shapes are made available to the user in order to adapt an instrument to the size and/or location of a target vessel being harvested from a particular patient” (Spec. 6:20–22). Principles of Law Anticipation under 35 U.S.C. § 102 requires that “each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (quoting Verdegaal Bros., Inc. v. Union Oil Co., 814 F.2d 628, 631 (Fed. Cir. 1987)). “[D]uring patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.” In re Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989). Analysis We begin with claim interpretation because before a claim is properly interpreted, its scope cannot be compared to the prior art. In this case, the dispute centers over the phrases “the blade forms a lateral loop to encircle the vessel” and “a vasiform cut including a pedicle” in claim 1. Appeal 2017-001608 Application 14/021,537 7 We first turn to the Specification to interpret these phrases. Regarding the phrase “the blade forms a lateral loop to encircle the vessel,” the Specification teaches “blade 37 preferably forms an incomplete ring” (FF 7). We therefore find that, in light of the Specification, the reasonable interpretation of the required blade encompasses both complete and incomplete rings. Because a “vasiform cut” simply refers to a cut in the form of a hollow tube,5 and a “pedicle” simply refers to surrounding material left attached to the graft,6 the functional recitation of “a vasiform cut including a pedicle” refers to the size of the cutting blade being used to harvest a vessel. The Specification teaches endoscopic devices in “a variety of sizes and shapes are made available to the user to adapt an instrument to the size and/or location of a target vessel being harvested from a particular patient” (FF 8), thereby recognizing that the amount of pedicle being included in a graft depends on the size of the target vessel and the size of the instrument. We therefore find that the phrase “including a pedicle” represents a functional recitation that relates to the size of the device and the size of the patient’s vessel and imposes no specific structural limitation on the device as recited in claim 1. We adopt the Examiner’s findings of fact and reasoning regarding the scope and content of the prior art (Final Act. 3–4; FF 1–6) and agree that claim 1 is anticipated by Chin. We address Appellants’ arguments below. 5 See https://www.merriam-webster.com/dictionary/vasiform (accessed Jan. 22, 2018). 6 See https://www.merriam-webster.com/dictionary/pedicle (accessed Jan. 22, 2018). Appeal 2017-001608 Application 14/021,537 8 Appellants contend “Chin is adapted to dissecting the vessel from the surrounding fat, instead of cutting a pedicle of fat/connective tissue around the vessel” (App. Br. 3). Appellants also contend in Chin the “side branches are left intact during blunt dissection (whereas the structure of claim 1 would be incapable of leaving side branches intact since it forms a loop encircling the vessel)” (id. at 4). We find this argument unpersuasive because the “vasiform cut including a pedicle” limitation is an intended use recitation, not a structural limitation. That is, whether a pedicle is included in the vasiform cut depends upon the relative size of the device to the vessel being removed (FF 8). As the Examiner notes “vessels in humans and other animals exist in various sizes such that the probe 907 is capable of being used with at least one vessel to make a cut with a pedicle around the vessel” (Ans. 4). Even if we treated this functional recitation as having some structural consequence, Schreiber teaches that writing a claim that mixes structural and functional limitations comes at a price. In re Schreiber, 128 F.3d 1473 (Fed. Cir. 1997). (“[C]hoosing to define an element functionally, i.e., by what it does, carries with it a risk.”). The price is that when the structural limitations are met by a single prior art reference, and when the examiner “has reason to believe” that the prior art reference inherently teaches the functional limitation, the burden shifts to the patent applicant to show that the functional limitation cannot be met by the single prior art reference. Id. See also In re Best, 562 F.2d 1252, 1254–55 (CCPA 1977) (“[W]here the Patent Office has reason to believe that a functional limitation asserted to be critical for establishing novelty in the claimed subject matter may, in fact, be Appeal 2017-001608 Application 14/021,537 9 an inherent characteristic of the prior art, it possesses the authority to require the applicant to prove that the subject matter shown to be in the prior art does not possess the characteristic relied on.”). Appellants have provided no evidence, as opposed to argument, to rebut the Examiner’s position that Chin inherently anticipates (see Ans. 4). Appellants contend: “Since Chin fails to encircle, nothing more is necessary to show that it does not anticipate” (App. Br. 5). Appellants furhter contend that the gap in the dissecting probe of Chin remains open, and has no configuration in which the vessel is encircled from a flanking tunnel or otherwise. The suggestion that Chin can make a vasiform cut by performing multiple cutting steps from opposite sides of the vessel is conclusive proof that it lacks the structure which is required in the present claims. (Reply Br. 2). We find this argument unpersuasive because claim 1, read in light of the Specification, clearly does not require the blade to completely encircle the vessel (FF 7), consistent with the position of the Examiner (see Ans. 2). Indeed, as already noted, the Specification states “blade 37 preferably forms an incomplete ring” (FF 7). Moreover, the claim is drawn to an apparatus, not a method, and does not exclude performing multiple cutting steps such as the rotations disclosed by Chin (FF 5–6) in order to generate a desired vasiform cut. See In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (“[A]ppellant’s arguments fail from the outset because . . . they are not based on limitations appearing in the claims.”). Appeal 2017-001608 Application 14/021,537 10 Conclusion of Law The evidence of record supports the Examiner’s conclusion that Chin anticipates claim 1. B.–C. 35 U.S.C. § 103(a) rejections Appellants do not separately argue these obviousness rejections, instead relying upon their arguments to overcome Chin. The Examiner provides sound fact-based reasoning for combining either Weadock or Parins with Chin (see Final Act. 4–7). Having affirmed the anticipation rejection of claim 1 over Chin for the reasons given above, we also find that the further combination with either Weadock or Parins renders the rejected claims obvious for the reasons given by the Examiner. SUMMARY In summary, we affirm the rejection of claim 1 under 35 U.S.C. § 102(a)(1) as anticipated by Chin. Claims 4 and 5 fall with claim 1. We affirm the rejection of claims 2, 3, and 10–13 under 35 U.S.C. § 103(a) as obvious over Chin and Weadock. We affirm the rejection of claims 10–14 under 35 U.S.C. § 103(a) as obvious over Chin and Parins. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED Copy with citationCopy as parenthetical citation