Ex Parte Koziczynski et al

Patent Trial and Appeal BoardJul 25, 2016

12762543 (P.T.A.B. Jul. 25, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 121762,543 04/19/2010 Pawel W. Koziczynski 98297 7590 07/27/2016 Walters & Wasylyna, LLC 8193 Avery Road Suite 101 Cleveland, OH 44147 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 016-005 3741 EXAMINER FLICK, JASON E ART UNIT PAPER NUMBER 3763 NOTIFICATION DATE DELIVERY MODE 07/27/2016 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): victor@wwiplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte PA WEL W. KOZICZYNSKI and RICHARD L. GRANT 1 Appeal2013-009265 Application 12/762,543 Technology Center 3700 Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and JACQUELINE T. HARLOW, Administrative Patent Judges. PERCURIAM DECISION ON APPEAL This is an appeal under 35 U.S.C. Â§ 134(a) involving claims to systems and methods for the implantation of filaments. The claims are rejected as anticipated and obvious. We have jurisdiction under 35 U.S.C. Â§ 6(b). We AFFIRM. 1 According to Appellants, the Real Party in Interest is Gold Thread LLC (App. Br. 3). Appeal2013-009265 Application 12/762,543 STATEMENT OF THE CASE Appellants' invention "relates to the implantation of filaments and, more particularly, to systems and methods for intradermally implanting filaments into body tissue, such as mammalian skin" (Spec. i-f 1 ). Claims 1- 20 are on appeal. Claim 1 is illustrative and reads as follows (emphasis added): 1. A filament implant system comprising: an insertion needle including an elongated body defining a longitudinal axis and having a distal end and a proximal end, said distal end of said elongated body including a penetrating tip; and a filament releasably connected to said insertion needle such that said filament is engaged with said insertion needle when said insertion needle is advanced into tissue distally along said longitudinal axis and said filament is automatically disengaged from said insertion needle when said insertion needle is withdrawn from said tissue proximally along said longitudinal axis. The claims stand rejected as follows: I. Claims 1-3, 5, 6, 10, 11, 15, 16, and 18-20 stand rejected under 35 U.S.C. Â§ 102(b) as anticipated by Hussein. 2 II. Claims 1, 7, 8, 13, and 14 stand rejected under 35 U.S.C. Â§ 102(b) as anticipated by Sulamanidze. 3 III. Claim 9 stands rejected under 35 U.S.C. Â§ 103(a) as obvious based on Hussein. 2 Hussein et al., US 6,258,119 Bl, issued July 10, 2001. 3 Sulamanidze et al., US 7,513,904 B2, issued Apr. 7, 2009. 2 Appeal2013-009265 Application 12/762,543 IV. Claim 4 stands rejected under 35 U.S.C. Â§ 103(a) as obvious based on Hussein and Simon. 4 V. Claim 12 stands rejected under 35 U.S.C. Â§ 103(a) as obvious based on Hussein and Quevedo. 5 VI. Claim 17 stands rejected under 35 U.S.C. Â§ 103(a) as obvious based on Hussein and Weiser. 6 I. TheExaminerhasrejectedclaims 1-3, 5, 6, 10, 11, 15, 16, and 18-20 under 35 U.S.C. Â§ 102(b) as being anticipated by Hussein. Because the claims are not separately argued, we focus our attention on independent claim 1, which is representative. Findings of Fact FF 1. Hussein discloses "[a] myocardial implant for insertion into a heart wall for trans myocardial revascularization (TMR) of the heart wall," in which "[t]he TMR implant includes a coaxial anchoring element integrally formed at one end for securing the TMR implant in the heart wall" (Hussein Abstract). FF 2. Hussein depicts in Figure 8B a "TMR implant and a delivery system for insertion of this TMR implant into a heart wall" (id. at 3:10-12). Figure 8B is reproduced below. 4 Simon, US 2003/0229321 Al, published Dec. 11, 2003. 5 Quevedo, US 2011/0046632 Al, published Feb. 24, 2011. 6 Weiser et al., US 6,986,784 Bl, issued Jan. 17, 2006. 3 Appeal2013-009265 Application 12/762,543 (Id. at Fig. 8B.) Figure 8B shows the placement of the implant 45 over an obturator 43 [that has a recess 44]. The pin 40 is then rotated to create a radial stress on the TMR implant 45[]. The pin 40 is locked to the handle[]. Advancement through the heart wall[] of the obturator and TMR device 45 is achieved by pressing the obturator through the heart wall[]. (Id. at 4:28-39; see also Ans. 5.) FF 3. Hussein depicts in Figure 8H releasing the implant 45 in the heart wall 50 (Hussein at 4:39-43). Figure 8H is reproduced below. ---43 F'IGURE 8H (Id. at Fig. 8H.) Figure 8H shows that [ t ]he pin 40 is released from handle [] by withdrawing the locking device[]. This causes the implant 45 to be released from 4 Appeal2013-009265 Application 12/762,543 the obturator 43. The obturator 43 is then pulled back from the heart wall 50 leaving the implant 45 imbedded in the heart wall[]. (Id. at 4:39-43; see also Ans. 5---6.) FF 4. Hussein further discloses that the implant can be a flexible spring (Hussein 2:51-52), and that "[t]he bodies of the myocardial implants are preferably made of a biocompatible material; such as stainless steel" (id. at 5:22-23). FF 5. The Specification teaches that [t]he filament may be any elongated filament, fiber, thread, suture, wire, cable, tube or the like, and may include a distal end and a proximal end. The filament may have various lengths and cross-sectional thicknesses, which may be selected by the user based on the procedure being performed, the target tissue being treated, the type of filament being used, among other factors that will be appreciated by those skilled in the art. (Spec. i-f 51 (reference numbers omitted); see also Ans. 11.) FF 6. The Specification teaches that "the filament may be formed from or may include a metal, such as ... stainless steel" and that "[ t ]he filament may be a monofilament or a multifilament, such as abraded filament or a twisted filament, and may have various cross-sectional profiles, such as round, square or flat" (Spec. i-fi-152, 53 (reference numbers omitted); see also Ans. 11 ). FF 7. The Specification teaches that once the filament is at the desired location in the tissue, the insertion needle may be withdrawn by applying an opposite force to the handle. When the withdrawing force is applied, the force of the tissue closing on the filament implant system engages the filament such that the filament is held in place while the insertion needle is withdrawn relative to the filament and the tissue. (Spec. i-f 59 (reference numbers omitted).) 5 Appeal2013-009265 Application 12/762,543 FF 8. The Specification teaches that when the insertion needle is retracted, the distal end of the filament may catch the surrounding tissue and may pull the filament out of the lumen of the insertion needle, thereby releasing the filament from the insertion needle such that the filament may remain in the tissue at the desired location. (Spec. i-f 62 (reference numbers omitted).) Analysis We begin with claim interpretation, because until a claim is properly interpreted, its scope cannot be compared to the prior art. At issue is the scope of the claim terms "filament," and "said filament is automatically disengaged from said insertion needle when said insertion needle is withdrawn from said tissue" (emphasis added). Appellants contend that because the Specification discloses that "[a] 'filament' is ... any elongated filament, fiber, thread, suture, wire, cable, tube or the like," "[ o ]ne skilled in the art would not interpret a spring to be a filament, as they are neither structural nor functional equivalents" (App. Br. 11 (citing Spec. i-f 51) ). We do not agree. As the Examiner notes, and Appellants do not dispute, the Specification does not narrowly define "filament" (Ans. 11 ). Rather, the Specification exemplifies a broad assortment characteristics that a "filament" may exhibit (Ans. 11 ). Of particular relevance to this appeal, the Specification states that "[t]he filament may be any elongated filament, fiber, thread, suture, wire, cable, tube or the like" (FF 5 (reference numbers omitted)), may be formed from "a metal, such as ... stainless steel" (FF 6), may be "abraded filament or a twisted filament" (id.), and "may have various cross-sectional profiles, such as round, square or flat" (id.). 6 Appeal2013-009265 Application 12/762,543 Accordingly, we determine that the broadest reasonable interpretation of the term "filament," as it is used in the claims on appeal, encompasses a coiled spring. Regarding the interpretation of the claim phrase "said filament is automatically disengaged from said insertion needle when said insertion needle is withdrawn from said tissue proximally along said longitudinal axis" (emphasis added), the Examiner observes that this phrase constitutes functional language for which no corresponding structure is recited, and for which no definition is provided in the Specification (Ans. 11-12). The Examiner concludes, therefore, that the claim phrase "said filament is automatically disengaged from said insertion needle when said insertion needle is withdrawn from said tissue proximally along said longitudinal axis" requires only that "the filament is capable of remaining in the body tissue during the withdrawing step when the needle is withdrawn proximally" (Ans. 11-12). Appellants respond that the Examiner's claim interpretation ignores the plain language of the claim and Appellants' Specification (App. Br. 12). More particularly, Appellants contend that [t ]he claims specify structure: (1) the filament must be releasably connected to the insertion needle, and (2) the releasable connection between the filament and the insertion needle must be such that the filament is automatically disengaged from the insertion needle when the insertion needle is withdrawn from tissue proximally along the longitudinal axis. Therefore, the claimed system and method require a structural connection between the filament and the insertion needle that automatically disengages the filament from the insertion needle when the insertion needle is withdrawn along the longitudinal 7 Appeal2013-009265 Application 12/762,543 axis, not merely a structural connection capable of leaving the filament in the body tissue during the withdrawing step. (Id. at 12-13.) Appellants also assert that "[t]he plain meaning of 'automatically' is an action or operation in a manner that is essentially independent of external influence or control" (id. at 13) and that the Examiner has effectively ignored the "automatically disengaged" limitation (Reply Br. 3). We do not find Appellants' arguments persuasive. As the Examiner observes, and Appellants do not dispute, the Specification does not define "automatically disengaged" (Ans. 11-12). Furthermore, we agree with the Examiner that no corresponding structure is recited for performing the claimed function of automatically disengaging the filament from the insertion needle when the insertion needle is withdrawn from the tissue proximally. That is, in this product claim, the functional result of disengaging the filament from the needle after insertion is to allow the filament to remain in the body, and Hussein teaches this functional result (FF 3) as more extensively discussed below. Accordingly, we agree with the Examiner that the claim phrase "said filament is automatically disengaged from said insertion needle when said insertion needle is withdrawn from said tissue proximally along said longitudinal axis" encompasses a filament that "is capable of remaining in the body tissue during the withdrawing step when the needle is withdrawn proximally" (Ans. 12). In reaching this conclusion, we note that our interpretation is consistent with the Specification, which teaches that "[ w ]hen the withdrawing force is applied, the force of the tissue closing on the filament implant system engages the filament such that the filament is held in place while the insertion needle is withdrawn relative to the filament and the 8 Appeal2013-009265 Application 12/762,543 tissue" (FF 7 (reference numbers omitted)). Our interpretation is likewise consistent with the Specification's disclosure that "when the insertion needle is retracted, ... the filament may catch the surrounding tissue ... such that the filament may remain in the tissue at the desired location" (FF 8 (reference numbers omitted)). See In re Sneed, 710 F.2d 1544, 1548 (Fed. Cir. 1983) ("[C]laims in an application are to be given their broadest reasonable interpretation consistent with the specification and that claim language should be read in light of the specification as it would be interpreted by one of ordinary skill in the art." (citation omitted)). We next address Appellants' contention that "Hussein specifically discloses a myocardial implant 45 formed by a coiled spring-not a filament" because "[a] spring is an elastic object used to store mechanical energy" and a filament and a spring are not structural or functional equivalents (App. Br. 10-11). Appellants argue that Hussein's coil spring is not "threadlike" and therefore fails to satisfy the Examiner's definition of "filament." (See Reply Br. 1-3.) We are not persuaded. Applying the interpretation of "filament" set forth above, we find that the coiled spring implant disclosed by Hussein meets this claim element (FF 1 ). Appellants have not provided any supporting evidence or convincing arguments to show that a filament and a spring are not structural or functional equivalents. "Attorney's argument in a brief cannot take the place of evidence." In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974). Appellants also contend that "Hussein fails to disclose or suggest a filament that is automatically disengaged from the insertion needle when the insertion needle is withdrawn from the body tissue proximally along the 9 Appeal2013-009265 Application 12/762,543 1 . rl" 1 . "h H . ' . 1 r1 1 Â· " . same ~ong1tu_ma~ axis _ecause ~~ussem s imp~ant _e~1very system reqmres the additional active steps of disengaging the locking device 42 from the pin 40 and rotating the pin 40 relative to the handle 41 (and obturator 43) before the implant 45 can be disengaged from the obturator 43" (App. Br. 11-12). Appellants argue that the Examiner's interpretation of "automatically" ignores the structural and functional requirements of Hussein's implant delivery system and the plain language of Appellants' claims and supporting disclosure. (Id. at 12.) Appellants argue that [i]n Hussein, it is clear that disengaging the locking device 42 from the pin 40 is an externally controlled act, which is required to disengage the implant 45 from the obturator 43. Thus, without the required active step of disengaging the locking device 42 from the pin 40, the spring implant 45 would never disengage from the obturator 43. By interpreting the action of withdrawing the locking device 42 from the pin 40 as the cause of the implant 45 to be released from the obturator 43, the Examiner is admitting that disengagement of the implant 45 from the obturator 43 is externally controlled rather than automatic upon \vithdrav,ral of the obturator 43 from the tissue. (Id. at 13; see also Reply Br. 3--4.) We are not persuaded. As set forth above, the claim phrase "said filament is automatically disengaged from said insertion needle when said insertion needle is withdrawn from said tissue" requires only that the filament is capable of remaining in the body tissue during the withdrawing step when the needle is withdrawn. Hussein discloses a system that delivers a TMR implant in which the TMR implant includes an anchoring element and the delivery system includes an obturator and pin with a recess (FF 1-2; see also Ans. 5---6). Hussein discloses that the implant is released and when the obturator is pulled back, the implant is imbedded in the heart wall (FF 3; see also Ans. 5---6). We therefore agree with the Examiner that Hussein 10 Appeal2013-009265 Application 12/762,543 teaches a "filament releasably connected to said insertion needle" and that "said filament is automatically disengaged from said insertion needle when said insertion needle is withdrawn from said tissue," as recited in claim 1. II. The Examiner has rejected claims 1, 7, 8, 13, and 14 under 35 U.S.C. Â§ 102(b) as being anticipated by Sulamanidze. Because the claims are not separately argued, we focus our attention on independent claim 1. Findings of Fact FF 9. Sulamanidze discloses [a] surgical thread [that] is made of a metal, ... in the form of a spiral whose diameter ranges from 0.5 to 5 mm ... and exhibits the properties of a compression or extension spring obtainable by heat treatment. Also a method is disclosed which is characterized in that it consists [of] introducing the spiral-shaped thread into subcutaneous soft tissues in order to tighten and fix said tissues by means of a puncture needle in [the] bore of which a thread=spiral exhibiting the properties of a compression or extension spring is fixed from outside or from inside. When the needle is extracted[,] the thread-spiral remains under [the] skin preserving the compression or extension properties thereof, thereby producing a skin compression or extension effect. (Sulamanidze Abstract; see also Ans. 6-7.) FF 10. Sulamanidze depicts in Figure 2 a "thread wound around a thin injection needle from the outside" (Sulamanidze at 2:49--50). Figure is 2 reproduced below. 11 Appeal2013-009265 Application 12/762,543 i:'JG, 2 (Id. at Fig. 2.) Figure 2 shows a helically shaped surgical thread wound around puncture needle 4 (id. at 2:66-3: 17; see also Ans. 6-7). FF 11. Sulamanidze depicts in Figure 3 a "thread introduced into the opening of a thick injection needle" (Sulamanidze at 2:51-52). Figure 3 is reproduced below. 13 12 .:~ 'i FIS. 3 (Id. at Fig. 3.) Figure 3 shows a helix shaped surgical thread "placed in the opening 12 of the puncture needle 4 with a gap 13 between the diameter of the helix and the inner wall of the needle" (id. at 3 :40-43; see also Ans. 6- 7). FF 12. Sulamanidze depicts in Figure 5 "the needle with the helix thread introduced subcutaneously" (Sulamanidze at 2:55-56). Figure 5 is reproduced below. 12 Appeal2013-009265 Application 12/762,543 9 (Id. at Fig. 5.) Figure 5 shows that "[w]hen using the thread-helix with the properties of an extension spring, it is compressed during the subcutaneous introduction into the soft tissues, while after the extraction of the needle the thread-helixes with the tendency to extend remains in the subcutaneous soft tissues" (id. at 3:47-52; see also Ans. 6-7). Analysis We have considered, but do not find persuasive, Appellants' arguments that the Examiner erred in finding that the claimed filament implant system and method for implanting a filament in body tissue is anticipated by Sulamanidze. We address Appellants' arguments below. Appellants contend that "Sulamanidze fails to disclose or suggest a filament that is automatically disengaged from the insertion needle when the insertion needle is withdrawn from the body tissue proximally along the same longitudinal axis" (App. Br. 15), because the claimed system and method require a structural connection between the filament and the insertion needle that automatically disengages the filament from the insertion needle when the 13 Appeal2013-009265 Application 12/762,543 insertion needle is withdrawn along the longitudinal axis, not merely a structural connection capable of leaving the filament in the body tissue during the withdrawing step. The filament is connected to the insertion needle in such a manner that when the insertion needle is retracted, the body tissue engages the filament such that the distal end of the filament may catch surrounding tissue and the filament is held in place and is to pulled out of (i.e., automatically disengaged from) the insertion needle. Sulamanidze requires the active steps of (1) unfastening the thread 1 from the needle 4 and (2) holding in place the first end 6 of the thread 1 while the needle 4 is withdrawn from the tissue. Therefore, the Examiner's broadest reasonable interpretation of "automatically" requires plainly ignoring the "automatically" limitation. (App. Br. 16-17; see also Reply Br. 4--5.) Appellants also contend that "Sulamanidze' s surgical apparatus requires manually unfastening the ends of the surgical thread from the needle to disengage the surgical thread from the insertion needle" (Reply Br. 4). We are not persuaded. Sulamanidze discloses a system having a puncture needle that delivers a surgical thread that is made of metal and exhibits the properties of a compression or extension spring subcutaneously (FF 9--11; see also Ans. 6-7). Sulamanidze discloses that after extraction of the needle, the thread remains in the tissue (FF 12; see also Ans. 7). We therefore agree with the Examiner that Sulamanidze teaches the "filament releasably connected to said insertion needle" and "said filament is automatically disengaged from said insertion needle when said insertion needle is withdrawn from said tissue" aspects of claim 1. We also agree with the Examiner that there are no claim limitations requiring that body tissue engages the distal end of the filament, or a specified structure or functionality for an automatic disengagement (Ans. 13-14; cf App. Br. 16- 14 Appeal2013-009265 Application 12/762,543 17). "[L ]imitations are not to be read into the claims from the specification." In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993). See also In re Self, 671F.2d1344, 1348 (CCPA 1982) ("[A]ppellant's arguments fail from the outset because ... they are not based on limitations appearing in the claims."). III. The Examiner has rejected claim 9 under 35 U.S.C. Â§ 103(a) as obvious based on Hussein. With respect to claim 9, Appellants present no additional argument based on the teachings of Hussein, and rely on the same arguments addressed above with regard to Hussein (see App. Br. 17; Reply Br. 5). For the reasons discussed above, therefore, we affirm the rejection of claim 9. IV. The Examiner has rejected claim 4 under 35 U.S.C. Â§ 103(a) as being obvious based on Hussein and Simon. With respect to claim 4, Appellants present no additional argument based on the teachings of Simon, and rely on the same arguments addressed above with regard to Hussein (see App. Br. 17; Reply Br. 5). For the reasons discussed above, therefore, we affirm the rejection of claim 4. v. The Examiner has rejected claim 12 under 35 U.S.C. Â§ 103(a) as obvious based on Hussein and Quevedo. With respect to claim 12, Appellants present no additional argument based on the teachings of Quevedo, and rely on the same arguments addressed above with regard to 15 Appeal2013-009265 Application 12/762,543 Hussein (see App. Rr. 17; Reply Rr. 5). For the reasons discussed above, therefore, we affirm the rejection of claim 12. VI. The Examiner has rejected claim 17 under 35 U.S.C. Â§ 103(a) as obvious based on Hussein and Weiser. With respect to claim 17, Appellants present no additional argument based on the teachings of Weiser, and rely on the same arguments addressed above with regard to Hussein (see App. Br. 17; Reply Br. 5). For the reasons discussed above, therefore, we affirm the rejection of claim 17. SUMMARY We affirm the rejection of claims 1, 18, and 20 under 35 U.S.C. Â§ 102(b) based on Hussein. Claims 2, 3, 5, 6, 10, 11, 15, and 16 fall with claim 1, and claim 19 falls with claim 18. We affirm the rejection of claim 1under35 U.S.C. Â§ 102(b) based on Sulamanidze. Claims 7, 8, 13, and 14 fall with claim 1. We affirm the rejection of claim 9 under 35 U.S.C. Â§ 103(a) based on Hussein. We affirm the rejection of claim 4 under 35 U.S.C. Â§ 103(a) based on Hussein and Simon. We affirm the rejection of claim 12 under 35 U.S.C. Â§ 103(a) based on Hussein and Quevedo. We affirm the rejection of claim 17 under 35 U.S.C. Â§ 103(a) based on Hussein and Weiser. 16 Appeal2013-009265 Application 12/762,543 TIME PERJOD FOR RFSPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a)(l )(iv). AFFIRMED 17