Ex Parte Carrison

Patent Trial and Appeal BoardDec 27, 2012

10793694 (P.T.A.B. Dec. 27, 2012)

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. 10/793,694 03/03/2004 Harold F. Carrison 03-480 (US01) 5204 41696 7590 12/28/2012 VISTA IP LAW GROUP LLP 12930 Saratoga Avenue Suite D-2 Saratoga, CA 95070 EXAMINER SZPIRA, JULIE ANN ART UNIT PAPER NUMBER 3731 MAIL DATE DELIVERY MODE 12/28/2012 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 HAROLD F. CARRISON ____________ Appeal 2011-013232 Application 10/793,694 Technology Center 3700 ____________ Before TONI R. SCHEINER, DONALD E. ADAMS, and ULRIKE W. JENKS, Administrative Patent Judges. JENKS, Administrative Patent Judge DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a tissue removal probe. The Examiner has rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Appeal 2011-013232 Application 10/793,694 2 STATEMENT OF THE CASE The Specification is directed “to medical devices and methods for removing tissue, and in particular, vertebral bone and intervertebral disc tissue.” (Spec. ¶0002.) Claims 1-44 are on appeal, and can be found in the Claims Appendix of the Appeal Brief (App. Br. 18-23). Claims 1, 5, 17, and 34 are independent claims. Claims 1 and 17 are representative of the claims on appeal, and read as follows: 1. A tissue removal probe, comprising: a laterally flexible and resilient elongated member having a lumen and a precurved distal end; a drive shaft rotatably disposed within the member lumen; a rotatable tissue removal element disposed on the drive shaft adjacent the member distal end, the tissue removal element having an axis of rotation. 17. A method of removing tissue from an anatomical body, comprising: introducing a cannula into the anatomical body at a first location; introducing a tissue removal probe through the cannula, wherein the tissue removal probe comprises an elongated member having a straight portion and a distal end, and a distally located tissue removal element associated with the distal end, the straight member portion having a first axis of rotation, and the tissue removal element having a second axis of rotation; displacing the tissue removal element, wherein the member distal end bends to associate the tissue removal element with a first radius of revolution about the first axis of rotation; App App unpa of th rend 1 Sht 2 Tei eal 2011-0 lication 10 ro rotation, by the fi ro rotation The follo The Exa tentable o The issu e evidence ers obviou FF1. Sh urman, US telbaum et 13232 /793,694 tating the wherein t rst radius o tating the to remove wing grou miner has ver Shturm e is wheth that the c s the tissu turman Fi 5,312,42 al., US 7, straight m he tissue r f revoluti tissue rem tissue at a nd of reje rejected cl an1 in vie er the Exa ombinatio e removal FINDIN g 1 is repr 7, issued M 318,826 B 3 ember por emoval ele on; and oval eleme t least two ction is be aims 1-44 w of Teite ISSUE miner has n of Shturm device and GS OF FA oduced be ay 17, 19 2, issued J tion aroun ment scrib nt about t points alo fore us for under 35 lbaum.2 establishe an in vie methods CT low: 94. an. 15, 20 d the first es a first a he second ng the firs review: U.S.C. § 1 d by a prep w of Teite of using th 08. axis of rc defined axis of t arc. 03(a) as onderanc lbaum e device. e Appeal 2011-013232 Application 10/793,694 4 (Shturman Fig 1.) Figure 1 depicts an atherectomy device having an elongated catheter (20) with at least a pair of lumens (24 and 26); a flexible elongated drive shaft (50) comprised of a helical coil (52) having a central lumen (46); an abrasive burr (40) carried at the distal end of the drive shaft (50); and a motor at the proximal end of the drive shaft for rotating the drive shaft; a positioning wire (70) includes a distal end (74) which is slidably secured about guidewire shaft (96) and a distal burr positioning segment (72) that has a predetermined shape; the guidewire (90) has an elongated shaft (96) a rounded tip (92) and helically wound distal tip portion (94). (See Shturman col. 4, ll. 23-51; col. 8, l. 57 to col. 9, l. 27.) FF2. Shturman disclosed that the entire device is rotational within the artery, this is illustrated in Figures 14 and 15 that are reproduced below: App App (Shtu arter and t to 12 imag abra to co abou eal 2011-0 lication 10 rman Fig y with a le he abrasiv o’clock in es from th sive burr s l. 13, l. 23 FF3. Te t 10º to 15 13232 /793,694 . 14, 15) F sion (12), e burr (40 Fig. 15a. e intravas hows up a .) itlebaum 0º off the igures 14 the device ) is located Fig. 14b cular ultra s a shadow disclosed a central axi 5 and 15 sho has been at 3 o’clo and 15b sh sound cath in the im flexible d s.” (Teitle w the cro positioned ck in Fig ow the ex eter (100) ages. (Sht rill with a baum col ss sections within the 14a and ro pected ult , the locati urman col drilling ti . 2, ll. 36-3 of an lesion tated 90º rasound on of the . 12, l. 54 p angle “o 8.) Fig. 2 f App App repro drilli (Teit pisto moto guid been the c subje shaft eal 2011-0 lication 10 duced bel ng positio lebaum Fi n level 11 r receptac ing tube 13 processed entral axis ct to disto FF4. Te . Fig. 5 is 13232 /793,694 ow shows n. (Teitleb g 2.) Fig.2 2, a guidin le 154. (T 2 . . . [a] to return of the pro rtion.” (T itlebaum reproduce a bone dri aum col. shows a g tube 132 eitlebaum shaped me to a shape ximal seg eitlebaum disclosed a d below: 6 ll with the 10, ll. 24-2 spin luer l , a barrel , col. 12, l tal alloy, f . . . betwe ment when , col. 13, ll flexible d distal dril 7.) ock 106, a knob 134, . 61 to col. or exampl en about 1 the guidi . 52-60.) rilling tip ling end in retainer tu a barrel 13 13, l. 51) e nitinol, t 0° and 150 ng tube 13 attached t the be 108, a 6, and a “The hat has ° off of 2 is not o a flexible App App (Teit 158 and a drilli 13, 4 144. flexi Alter the w eal 2011-0 lication 10 lebaum Fi and proxim flexible s ng tip 130 2-43.) “[ ” (Teitleb ble, solid t natively, “ ire techni 13232 /793,694 g 5.) Figu al segmen haft 144 ( comprise T]he flexib aum, col, ubular stru the flexib que. In th re 5 show t 156 (Te Teitlebaum s a harden le drilling 16, ll. 22-2 cture.” (T le drill 100 is embodim 7 s a guide t itlebaum c col. 14, l ed burr and tip 130 is 3.) “The f eitlebaum can be co ent, the f ube 132 w ol. 13, ll. 5 l. 26-29). a shaft.” soldered lexible sh , col. 14, nfigured t lexible sha ith a distal 2-53). A “The flex (Teitlebau to the flex aft 144 co ll. 43-44.) o be used ft 144 com segment liner 140 ible m, col. ible shaft mprises a in an over prises a - Appeal 2011-013232 Application 10/793,694 8 flexible hollow tubular structure (not shown), that is, [it] has an axial channel for accepting a guide wire.” (Teitlebaum, col. 15, ll. 29-33.) The flexible shaft 144 is inserted into the guiding tube 132, and a “liner 140 is placed between the flexible shaft 144 and the guiding tube 132.” (Teitlebaum, col, 14, ll. 28-29.) PRINCIPLES OF LAW “Obviousness does not require absolute predictability of success .... For obviousness under § 103, all that is required is a reasonable expectation of success.” In re O'Farrell, 853 F.2d 894, 903-904 (Fed. Cir. 1988). A critical step in analyzing these expectations is “casting the mind back to the time of invention, to consider the thinking of one of ordinary skill in the art, guided only by the prior art references and the then-accepted wisdom in the field.” In re Kotzab, 217 F.3d 1365, 1369 (Fed. Cir. 2000). ANALYSIS The Examiner takes the position that Shturman discloses a method of removing tissue from an anatomical body . . . wherein the tissue removal probe comprises an elongated member having a straight portion (please refer to the figure below) and a distal end (figure 1), and a distally located tissue removal element (40) associated with the distal end, the straight member portion having a first axis of rotation, and the tissue removal element having a second axis of rotation. (Ans 7.) App App axis Exam coul Beca (Ans term what that limit wou elon 11.) eal 2011-0 lication 10 (Id.) Ex of rotation iner take d include t use Shtrum . 5), the E ‘pre-curv point on t shows curv ations.” (I Appellan ld look to gated mem Appellant 13232 /793,694 aminer’s a for the ca s the positi he curvatu an “fails xaminer co ed’ has no he length ature, suc d. at 13.) t contend combine S ber having ’s interpre nnotated F nnula/cath on that the re of Shtru to teach th mbines th limits in r of the devi h as Teite s that “ther hturman w a lumen tation of S 9 ig. 1 of Sh eter disclo “pre-curv man’s cat e elongate e referenc egards to t ce the end lbaum, wo e is no rea ith Teitelb and a pre- hturman’s turman sh sed by Sh ed” limita heter. (Ad d member e with Tei he degree is to begi uld meet t son that o aum in or curved dis Fig. 1 rep owing tw turman. (I tion is bro visory Ac being pre telbaum. of curvatu n curving, he claimed ne skilled der to hav tal end.” ( roduced b o possible d.) The ad and tion 2.) -curved” “Since the re, or at any devic in the art e an App. Br. elow: e App App (Id.) App the e eal 2011-0 lication 10 ellant asse el (50) is n drive sha shaft (50 (70) is s these tw (App. Br Appellan lements re 13232 /793,694 rts that ement (50) ot an cann ft (50) of ) is introd imultaneou o elements . 13-14.) t asserts t cited in cl in Shtrur ula as indi Shturman uced into a sly introd are integr hat figure aims 1 and 10 man is a dr cated in th is the ‘can n anatomi uced into t ated as a u 14C and 1 5. ive shaft . e Final Of nula,’ then cal body, he anatom nit. 4E of the S . . Thus, e fice Actio when the the positio ical body, pecificati lement n . . . If the drive ning wire since on depict App App (App indiv 5.” ( Exam inclu (Adv with cathe elon anato the l Shtu repro cathe eal 2011-0 lication 10 . Br. 12.) idually or App. Br. We are n iner’s int de the cur isory Acti positionin ter (20) is gated drive mical bod ocation is rman’s cat duced abo ter, after s 13232 /793,694 Appellant combined 12.) ot persuad erpretation vature of t on 2), or t g guidewi a flexible shaft (50 y at a first a plaque (F heter (50) ve. (Ans. lightly wi s assert th , disclose ed by App that “pre he cathete he curvatu re (70) (An elongated ) (FF1). C location, Fs 1-2). A has two ax 7.) The t thdrawing 11 at “neither all the elem ellants’ a -curved” d r (20) or th re of the f s. 13-14) member, atheter (20 the anatom s explain is of rotat issue remo the cathet Shturman ents recit rguments. istal end c e flexible lexible dri . We find that contai ) is advan ical body ed by the ion see an val probe er (Shturm nor Teite ed by clai We agree an be inter drive shaf ve shaft as that Shtur ns a flexib ced into a is a blood Examiner, notated Fi (40) come an col. 5, lbaum, ms 1 and with the preted to t (50) positione man’s le n vessel and g 1. s out of th l. 65 to d e Appeal 2011-013232 Application 10/793,694 12 col. 6. l. 5; Ans. 8). This tissue removal probe is located at the distal end of the catheter (50) and the distal burr positioning segment (72) that has a predetermined shape that moves the burr into the tissue removal position (FF1). The Examiner explained that the catheter (20) which contains catheter (50) has a first axis of rotation and the tissue removal probe has a second axis of rotation (Ans. 7; see annotated Fig 1 reproduced above). Shtruman disclosed that the entire device is rotational (FF2), thus, when catheter (20) rotates, catheter (50), which is part of catheter (20), rotates at the same time because it is contained within catheter (20) (FF2). Here, rotation by the straight member positions the tissue removal element along an arc, as shown by the positioning of the tissue removal element between 3 o’clock and 12 o’clock (FF2). While the rotation around the tissue removal probe (40) constitutes the other axis of rotation (FF1). We conclude that Shturman meets the claim limitations of having a first and second axis of rotation. The Examiner takes the position that Teitelbaum teaches an “analogous device used to cut intervertebral disc, vertebra, and bone tissue.” (Ans. 10.) The Examiner concludes that it would have been obvious to the ordinary artisan at the time the invention was made “to modify the method of Shturman to cut through intervertebral space or vertebra as taught by Teitelbaum et al. for the predictable result of enabling more efficient cutting of vertebra and intevertebral tissue.” (Ans. 10.) Appeal 2011-013232 Application 10/793,694 13 We are also not persuaded by Appellants’ argument that there is no reason to combine Shtruman and Teitlebaum. (App. Br. 11.) We find that the Examiner has the better position. Teitlebaum is directed to a flexible drill with a dill tip angle between 10º to 150º off the central axis (FF3). The flexible drill tip is positioned using a guide tube (132) that is inserted to the anatomical body through the retainer tube (108). Guide tube (132) is made of flexible metal that returns to the predetermined shape between 10º to 150º off the central axis (FF3) after being discharged from the retainer tube (108). The drilling tip is attached to the flexible shaft (144) that is inserted into the guide tube (132) (FF4). Thus, the drill tip and shaft (144) have an axis of rotation and the guide tube (132) also has an axis of rotation. The Examiner concludes it would have been “be obvious to one of ordinary skill in the art at the time of the invention to provide the invention of Shturman with a pre- curved distal end as taught by Teitelbaum et al. in order to orient the drilling tip to the location of interest.” (Ans. 5.) We agree with the Examiner that Teitlebaum provides a guiding device that is hollow and can receive the catheter of Shturman in order to orient the catheter. “Appellant respectfully submits that the fact that the device of Shturman may be ‘capable of rotation’ is insufficient to establish a prima facie case of obviousness.” (App. Br. 16.) We are not persuaded by this argument. Shtruman disclosed a catheter containing a tissue removal probe, the catheter (20) is an elongated cylindrical (pre-curved) flexible member, that contains a drive shaft within Appeal 2011-013232 Application 10/793,694 14 the member (50) with a tissue removal burr (40) that rotates. (FF1; Ans. 7.) Shtruman disclosed that an abrasive burr (40) is attached to the distal end of the drive shaft (50), and a motor is positioned at the proximal end of the drive shaft for rotating the drive shaft (FF1). In addition, the entire device is rotational as well (FF2). Thus, Shturman device is specifically designed to rotate within an artery in order to remove plaque deposits therein. It is well settled that “anticipation is the epitome of obviousness.” Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983) (quoting In re Fracalossi, 681 F.2d 792, 794 (CCPA 1982)). Appellant contends that withdrawing the catheter to expose the burr is not the same as the claimed element of “displacing the tissue removal element from the cannula to associate the tissue removal element with a first radius of curvature, bending the member distal end, wherein the tissue removal element scribes a first arc defined by the first radius of curvature, and rotating the tissue removal element about the axis of rotation to remove tissue at at least two points along the first arc.” (App. Br. 15-16.) We are not persuaded. Appellant appears to suggest that retracting the catheter to expose the tissue removal burr does not meet the limitation of displacing. To position the burr and positioning wire “the catheter is slightly withdrawn proximally with respect to the positioning wire and the stenosis itself (i.e., positioning wire and burr with the drive shaft appear to be advanced with respect to the catheter) thus freeing the burr positioning segment of the positioning wire allowing it to at least partially regain its Appeal 2011-013232 Application 10/793,694 15 predetermined shape.” (Shturman, col. 5, l. 64 to col. 6, l. 5) The Specification has not provided a specific definition for displacing. The ordinary and customary meaning of displacing, as a person of ordinary skill in the art would interpret it, can be found in a dictionary. Brookhill-Wilk 1, LLC v. Intuitive Surgical, Inc., 334 F.3d 1294, 1298 (Fed. Cir. 2003). To displace3 means to move or shift from the usual place or position, this would encompass exposing the burr by retracting the catheter which moves or shifts the burr from the usual position inside the catheter. Thus, the movement of the catheter that allows the positioning wire to change shape and shift falls within the customary and ordinary meaning of displacing. Finally, Appellant contends that “element (70) in Shturman is the positioning wire (Col. 9, line 3, line 61, Col. 10, lines 26-62), and even if the positioning wire (70) is considered to be the claimed ‘tissue removal probe,’ there is nothing in Shturman that discloses or suggests that the positioning wire (70) can rotate or have first and second axes of rotation, as required by claim 17.” (App. Br. 14.) We are also not persuaded by this argument. Shturman disclosed that the catheter can be rotated within the anatomical body (FF2). Thus, 3 Displace: 1. To move or shift from the usual place or position, especially to force to leave a homeland: millions of refugees who were displaced by the war. 2. To take the place of; supplant. 3. To discharge from an office or position. The Free Dictionary, http://www.thefreedictionary.com/displacing (last accessed December 13, 2012). Appeal 2011-013232 Application 10/793,694 16 positioning wire (70) that holds the burr (40) into position against the plaque can be rotated (FF2) with the rotation of the catheter. We conclude that the preponderance of the evidence of record supports the Examiner’s conclusion that the combination of Shturman in view of Teitelbaum renders obvious the apparatus and methods of claims 1, 5, 17, and 34. We thus, affirm the rejection of claim 1, 5, 17, and 34 under 35 U.S.C. § 103(a) as being obvious, as claims 2-4, 6-16, 18-3, and 35-44 fall with these claims, we affirm the rejection as to those claims as well. SUMMARY We affirm the rejection of claims 1-44 under 35 U.S.C. § 103(a) as unpatentable over Shturman in view of Teitelbaum AFFIRMED lp