Ex Parte Fogarty et alDownload PDFBoard of Patent Appeals and InterferencesMar 25, 200810355429 (B.P.A.I. Mar. 25, 2008) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte THOMAS J. FOGARTY, MICHAEL J. DREWS, NEIL HOLMGREN, and D. BRUCE MODESITT __________ Appeal 2008-0434 Application 10/355,429 Technology Center 3700 __________ Decided: March 25, 2008 __________ Before DONALD E. ADAMS, ERIC GRIMES, and JEFFREY N. FREDMAN, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a biologically implantable system for a heart valve which the Examiner has rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Appeal 2008-0434 Application 10/355,429 Background “Prosthetic heart valves can replace defective human valves in patients” (Spec. 1). The Specification notes that “[i]n a typical prosthetic valve implantation procedure, the heart is incised and the defective valve is removed leaving a surrounding area of locally tougher tissue. Known heart valve replacement techniques include individually passing sutures through the tough tissue to form an array of sutures” (Spec. 2). According to the Specification, “[o]nce all sutures have been run through the ring, all the sutures are pulled up taught and the prosthetic valve is slid or ‘parachuted’ down into place adjacent the tough tissue” (id.). “Thereafter, the prosthetic valve is secured in place by traditional knot tying with the sutures” (id.). Statement of the Case The Claims Claims 10-12, 16, 17, 27, 32, 33, and 35-54 are on appeal. We will focus on claims 10, 27, and 45, which are representative and read as follows: 10. A biologically implantable system for a heart valve, comprising: a first prosthesis comprising an annular ring implantable directly and independently into an annulus of a heart, the first prosthesis comprising a circumference and a fabric covering; a second prosthesis comprising a heart valve crown, the second prosthesis further comprising a circumference including a fabric covering thereon, the circumference defining a shape including a scallop between adjacent lobes; and at least one engagement element disposed on the circumferences of the first and second prostheses that self- engage one another when the second prosthesis is inserted 2 Appeal 2008-0434 Application 10/355,429 into engagement with the first prosthesis after the first prosthesis is implanted within an annulus of a heart. 27. A biologically implantable system for a heart valve, comprising: a first annular prosthesis implantable within an annulus of a heart, the first prosthesis comprising a circumference and a fabric covering; a second prosthesis separate from the first prosthesis and comprising a heart valve crown, the second prosthesis comprising a circumference; a plurality of engagement elements disposed around the circumferences of the first and second prostheses that self-engage one another when the second prosthesis is inserted into engagement with the first prosthesis; and cooperating elements on the first and second prostheses that angularly align the second prosthesis with the first prosthesis and prevent rotation of the second prosthesis with respect to the first prosthesis when the second prosthesis is inserted into engagement with the first prosthesis after the first prosthesis is implanted within an annulus of a heart. 45. A biologically implantable system for a heart valve, comprising: a first annular prosthesis implantable into an annulus within a heart, the first prosthesis including a wall defining a circumference and a central longitudinal axis substantially perpendicular to the circumference, at least a portion of the wall being angled away from the longitudinal axis; a second annular prosthesis comprising a valve; and at least one engagement element on the first and second prostheses that engage one another when the second prosthesis is inserted into engagement with the first prosthesis after the first prosthesis is implanted within an annulus of a heart. 3 Appeal 2008-0434 Application 10/355,429 The prior art The Examiner relies on the following prior art reference to show unpatentability: Alonso US 4,680,031 Jul. 14, 1987 Stobie US 6,143,025 Nov. 7, 2000 Shu US 2004/0015232 A1 Jan. 22, 2004 Berreklouw US 6,790,229 B1 Sep. 14, 2004 The issues The rejections as presented by the Examiner are as follows: A. Claims 10-12, 16, 17, 27, 32, 33, 35-40, 43, and 45-51 stand rejected under 35 U.S.C. § 102(b), as being anticipated by Alonso. B. Claim 54 stands rejected under 35 U.S.C. § 103(a), as being obvious over Alonso and Stobie. C. Claims 41, 42, 44, 52, and 53 stand rejected under 35 U.S.C. § 103(a), as being obvious over Alonso and either Shu or Berreklouw. A. 35 U.S.C. § 102(b) rejection over Alonso The Examiner argues regarding the limitation found in claim 10 of “self engagement” that the “threads of the sewing ring (30) and stent support ring (34), respectively, are the respective engagement elements that self- engage each other” (Ans. 6). The Examiner further contends that “‘self- engage’ does not imply that any particular motion or lack thereof is required. Moreover, upon review of the specification, it is clear that [there] is no special definition for this terminology” (id.). Regarding the limitation in claim 10 requiring a scallop, the Examiner contends that “Alonso illustrates at least one scallop between adjacent lobes 4 Appeal 2008-0434 Application 10/355,429 in element (36) of Figure 1” (Ans. 7). The Examiner supports this point by noting that “[m]oreover, a scallop (i.e. scallop shape) is not a well-defined shape such as that of a geometrical shape; e.g. square or circle. Rather, it has been used to describe many features including decorative ornamental edges or thin slices of meat” (id.). With regard to claim 27, the Examiner argues that “[s]ince Alonso clearly discloses an operative lock of the two elements, the claim language requiring rotation prevention is considered at least read on by Alonso's disclosure” (Ans. 8). Appellants argue that the Alonso reference fails to disclose, teach, or suggest ‘at least one engagement element disposed on the circumferences of the first and second prostheses that self-engage one another when the second prosthesis is inserted into engagement with the first prosthesis after the first prosthesis is implanted within an annulus of a heart’ as recited in claim 10. (App. Br. 8). Appellants further contend that “merely bringing the threaded rings 30, 34 together, without rotation of the stent support ring 34 by a user, will not engage the stent support ring 34 to the sewing ring 30. As such, the threaded rings 30 and 34 cannot be ‘self-engaging’” (Rep. Br. 6). Appellants also argue that it “is also well understood by persons of ordinary skill in the art that ‘engage’ and ‘self-engage’ are not synonymous since ‘self-engage’ is narrower than the term ‘engage’ given the additional word ‘self’” (Rep. Br. 7). In addition, Appellants argue that “Alonso reference fails to disclose, teach, or suggest a second prosthesis having a circumference defining a 5 Appeal 2008-0434 Application 10/355,429 shape including ‘a scallop between adjacent lobes’ as recited in claim 10” (App. Br. 14). Appellants further note that “the components described in the [Alonso] reference must necessarily be circular in order to allow the internally threaded ring 30 and externally threaded stent support ring 34 to threadedly mate together when the externally threaded stent support ring 34 is rotated” (App. Br. 13). Appellants contend regarding claim 27 that Alonso does not teach “that after the first prosthesis or ring is implanted, the second prosthesis cannot be rotated” (App. Br. 14). Appellants argue that Alonso teaches “rotation of the stent support ring 34 after the sewing ring 30 has been implanted and the rings 30 and 34 are threadedly secured together” and that “the Alonso reference notes the particular advantages that post-surgical rotation of the stent support ring 34 can provide” (App. Br. 15). In view of these conflicting positions, we frame the anticipation issues before us as follows: (1) Does Alonso teach heart valve prostheses which are “self engaging”? (2) Does Alonso teach heart valve prostheses which comprise a “scallop between adjacent lobes”? (3) Does Alonso teach prostheses which prevent rotation after the second prosthetic element is inserted into the first prosthetic element as required by claim 27? (4) Does Alonso teach a prosthesis with an angled wall? (5) Does Alonso teach a prosthesis with cooperating elements including a rib and groove? 6 Appeal 2008-0434 Application 10/355,429 Findings of Fact 1. Alonso teaches “an artificial heart valve implant which is designed to maximize the area available for blood flow in the mitral, aortic or tricuspid annulus where the implant is surgically mounted” (Alonso 3:24- 27). 2. Alonso teaches a first prosthestic element that is the sewing ring 30, which “embeds the first cloth tube 38 . . . so that the interior threads 40 of the sewing ring 30 are disposed within the interior 44 of the first cloth tube 38 and the exterior wall 42 of the sewing ring 30 is disposed on the exterior 46 of the first cloth tube 38” (Alonso 5:53-58, fig. 1). 3. Alonso teaches that the “surgeon . . . first implants the sewing ring 30 into the mitral, aortic or tricuspid annulus” (Alonso 7:62-63). 4. Alonso discloses a second prosthestic element that is the stent 32 and stent support 34, and that these have fabric coverings: to assemble the stent 32 to the stent support ring 34 for the heart valve prostheses . . . the second cloth tube 62 is folded over the interior wall 60 of the stent support ring 34. In this manner, the stent support ring 34 is fully enclosed in the second cloth tube 62 and a cloth pocket 67 is formed wherein the stent 32 is mounted by sewing and stitches 50 (Alonso 6:34-41, fig. 1-3). 5. Alonso teaches “three commissural posts 70” which are rounded extensions from the stent 32 (Alonso 7:23-25; Fig. 1). 6. Alonso teaches that the “square threads 40 of the sewing ring 30 readily engage the like threads 58 of the stent support ring 34 within approximately one turn or less” (Alonso 7:66-8:1). 7 Appeal 2008-0434 Application 10/355,429 7. Alonso teaches that the “pressure of the stent support ring 34 on the lip 78 locks the stent support ring 34 into operative position in the sewing ring 30” (Alonso 8:1-3). 8. Appellants’ Specification does not define the term “self engagement”, but states “there is a need for the above prosthesis that can self-engage a second prosthesis to improve implantation time” (Spec. 4:3-4). 9. Appellants’ Specification teaches in figure 52, one embodiment for engagement of the first and second prostheses in which in order for the second prosthesis to be engaged, the “interference beams 198 can be removed, as shown by arrows 200, allowing the latches 188 to contract, as shown by arrows 196, against, for example, the second prosthesis, once the second prosthesis is positioned within the reach of the latches 188” (Spec. 21:5-8, fig. 52). 10. Appellants’ Specification teaches another embodiment for engagement of the first and second prostheses with a “second prosthesis 68 that can have fixation points 286 that align with fixation points 286 on the first prosthesis 2 to allow insertion of sutures, grommets, clips 292 or pins 294 through the aligned fixation points 286 to fix the first prosthesis 2 to the second prosthesis 68” (Spec. 27:23-28:3). 11. Alonso teaches a padded cloth ring 54 which is perpendicular to the circumference and which is angled away from the longitudinal axis (see Alonso, fig. 6-7). Figure 6 of Alonso appears to show the padded cloth ring 54 projection is at a 90 degree angle, while figure 7 appears to show the padded cloth ring 54 at an angle that is greater than 90 degrees and angled away from the longitudinal axis (see Alonso, fig. 6-7). 8 Appeal 2008-0434 Application 10/355,429 Discussion of 35 U.S.C. § 102(b) over Alonso We conclude that the Examiner has set forth a prima facie case that claims 10, 37, and 45 are anticipated by Alonso. Alonso teaches heart valve prostheses with a first prosthetic ring with a fabric covering, a second prosthetic element with fabric which comprises an engagement element to engage the first and second prostheses after implantation into an annulus of a heart (FF 1-10). (1) Self-Engagement The first argued difference between the Alonso prostheses and the prosthesis of claim 10 is whether Alonso teaches elements which “self engage” the first and second prostheses. In analyzing this difference, we first interpret the claim and the term “self engage”. Claim 10 requires that “at least one engagement element disposed on the circumferences of the first and second prostheses . . . self- engage one another when the second prosthesis is inserted into engagement with the first prosthesis after the first prosthesis is implanted within an annulus of a heart” (Claim 10). The Specification does not define the term “self engage” (see Rep. Br. 7). As Appellants note, the term is therefore interpreted using the broadest reasonable interpretation “in view of the specification” (Rep. Br. 7). See, e.g., In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000) (“[D]uring examination proceedings, claims are given their broadest reasonable interpretation consistent with the specification.”). In the current Specification, several alternative modes of engagement are detailed for the first and second prosthetic element (FF 8-10). In the mode of engagement 9 Appeal 2008-0434 Application 10/355,429 depicted in figure 52 and discussed at page 21, the engagement requires the removal of interference beams 198, which “allow[s] the latches 188 to contract, as shown by arrows 196, against, for example, the second prosthesis, once the second prosthesis is positioned within the reach of the latches 188” (Spec. 21:6-8). A different mode of engagement is discussed at page 28 of the Specification, where the engagement comprises the “insertion of sutures, grommets, clips 292 or pins 294 through the aligned fixation points 286 to fix the first prosthesis 2 to the second prosthesis 68” (Spec. 27:23-28:3). Two other modes of engagement, snap fitting and magnet interaction, are found in claims which the Examiner has indicated as allowed (see Claims 20-23). These examples demonstrate that “engagement” in the context of the Specification encompasses initial interactions of the first and second prostheses, whether by positioning as at page 21 or by aligning as at page 28 followed by action by the surgeon to ensure that the prostheses remained in contact with one another. We therefore interpret the phrase “self engagement” as simply requiring the first and second prostheses to interact when they are placed in contact. We conclude that Alonso’s threads are seated and interact when placed in contact with one another and therefore meet the “self engagement” requirement of claim 10. We are not persuaded by Appellants’ argument that “placing threaded components together, without additional manipulation or rotation, will not connect or engage the components to one another” (App. Br. 11). This same argument could be made about most of the modes by which the Specification places two components together. Without pressure by the surgeon on the two components, the snap fit connection will not be 10 Appeal 2008-0434 Application 10/355,429 formed, as the Specification notes “[o]nce seated on the engagement element 148, the second prosthesis 68 can then be engaged by the first prosthesis 2” (Spec. 27:2-3). Similarly, the interactions in which beam 198 is removed or in which pins are inserted into point 286 also require additional manipulation to complete the interaction after the first and second prostheses are “self engaged”. We reject Appellants’ argument that “the term ‘self-engage’ within the context of the present claims does imply, and necessarily requires, lack of a particular motion” (Rep. Br. 6). We think that in light of Appellants’ Specification, which does not define the term “self-engage” and which requires particular motions for most forms of locking engagement, “self- engage” encompasses the interaction shown in Alonso (see FF 8-10). Whether a snap-fit connection or a pin 294 is placed into fixation point 286, the completion of the engagement requires particular motions. Consequently, we conclude that Alonso teaches a mode of engagement which, when read in light of the Specification, is reasonably interpreted as a type of “self engagement”. (2) Scallop “Scallop” is another term which is the subject of dispute between the Examiner and Appellants (see Ans. 7; App. Br. 13). We interpret the term “scallop” using the broadest reasonable interpretation in light of the Specification. See, e.g., In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000) (“[D]uring examination proceedings, claims are given their broadest reasonable interpretation consistent with the specification.”). The Specification discloses two images which are termed “scallops” but no 11 Appeal 2008-0434 Application 10/355,429 definition of this term (see Spec. 29:16, 30:1, 4, fig. 79, 81). However, we do not read limitations from the Specification into the claims. See In re American Academy Science Tech Center, 367 F.3d 1359, 1369 (Fed. Cir. 2004)(“We have cautioned against reading limitations into a claim from the preferred embodiment described in the specification, even if it is the only embodiment described, absent clear disclaimer in the specification.”). Therefore, we must determine whether Alonso’s second prosthesis has any structure which may meet the “scallop” requirement. The “three commissural posts 70” shown in figure 1 of Alonso, are rounded extensions from the stent 32 (see Alonso 7:23-25, fig. 1). Between these posts are rounded edges which are part of the circumference of the second prosthesis (see Alonso, fig. 1). A scallop is defined as “one of a continuous series of circle segments or angular projections forming a border”. Merriam Webster Collegiate Dictionary 1633 (1998). We note that the claim 10 language “the circumference defining a shape including a scallop between adjacent lobes” does not require that the scallop be located in the annular plane. Therefore, the region between the “three comissural posts 70” shown in figure 1 of Alonso reasonably appear to be scallops. (3) Claim 27 rotation lock We agree with the Examiner that Alonso teaches elements which prevent rotation of the second prosthesis relative to the first prosthesis as required by claim 27. Alonso states that the “pressure of the stent support ring 34 on the lip 78 locks the stent support ring 34 into operative position in the sewing ring 30” (Alonso 8:1-3). This statement expressly indicates that the two prosthetic elements are locked together (see FF 7). Appellants argue 12 Appeal 2008-0434 Application 10/355,429 that “the Alonso reference explains that if the heart valve prosthesis must be removed at ‘a later time,’ removal of the stent support ring 34 from the sewing ring 30 is ‘relatively easy because the square threads readily separate from one another’” (App. Br. 15). We do not find this argument persuasive since simply because a later surgeon may remove the valve of Alonso does not detract from Alonso’s express teaching that the pressure locks the elements together (see FF 7). Appellants also conflate the question of whether the prosthetic elements of Alonso are ever able to rotate with the question of whether, when fully implanted into a patient, the prosthetic elements rotate (see Rep. Br. 11). While there is no doubt that during the implantation or during a removal process, the prostheses of Alonso permit rotation, Alonso expressly states that after implantation, the “pressure of the stent support ring 34 on the lip 78 locks the stent support ring 34 into operative position in the sewing ring 30” (Alonso 8:1-3). While Appellants would discount the word “lock”, we agree with the Examiner that the term is reasonably interpreted as preventing movement of the prosthetic parts. As the Examiner noted “[i]f the two elements were not locked than the valve of Alonso would not be operative in that it would screw apart and come apart while implanted. Since US patents are presumed to be operative, this is not a reasonable interpretation of Alonso's disclosure” (Ans. 8). (4) Angled wall Appellants argue that Alonso does not teach the claim 45 limitation of a “first annular prosthesis including a wall defining a circumference and a central longitudinal axis substantially perpendicular to the circumference, ‘at 13 Appeal 2008-0434 Application 10/355,429 least a portion of the wall being angled away from the longitudinal axis’ (App. Br. 16). We reproduce figure 7 of Alonso below. The figure shows a cross-section of the sewing ring 30 shown in Alonso’s figure 4 (Alonso 4:37-38). The longitudinal axis of the prosthetic element shown in Alonso’s Figure 7 is right-to-left. We conclude that Alonso shows at least part of the walls of a first prosthetic element which have an angle that is angled away from the longitudinal axis (see FF 11). Since the angle of padded wall ring 54 is not on the longitudinal axis, it is necessarily angled away from that axis to some degree (see FF 11). We therefore agree with the Examiner that Alonso teaches this element of claim 45. (5) Rib and groove cooperating elements We reject Appellants’ argument that Alonso does not teach features which meet the “cooperating element” and “rib and groove” requirements of claims 11, 12 and 33 because the threads cannot serve both the 14 Appeal 2008-0434 Application 10/355,429 “engagement” and “cooperating element” functions (see App. Br. 17). We agree with the Examiner that the thread components function both as engagement elements and as cooperating elements. The engagement occurs when the threads meet, and the cooperating occurs when the second prosthesis is rotated so that the threads align and lock the second prosthesis into the operative position (see FF 7). We affirm the rejection of claims 10-12, 27, 33, and 45 as anticipated by Alonso. Claims 16, 17, 32, 35-40, 43, and 46-51 fall with claims 10-12, 27, 33, and 45 as they were not separately argued. B. 35 U.S.C. § 103(a) rejection over Alonso and Stobie We have already concluded that Alonso anticipates claims 10-12, 16, 17, 27, 32, 33, 35-40, 43, and 45-51 as discussed above. Since Appellants do not separately argue the limitations of claim 54 which depends from claim 45, we affirm the rejection of claim 54 over Alonso and Stobie. C. 35 U.S.C. § 103(a) rejection over Alonso and either Shu or Berreklouw The Examiner argues that “it would have been obvious to replace the screw thread attachment of Alonso with a removable snap fit attachment for the same reasons that the prior art uses the same and so that the valve could be attached to the ring more quickly” (Ans. 5). The Examiner also contends that “it is clear that Alonso clearly states that the threaded design merely enables better attachment of the cloth to the base material . . . it is clear to the Examiner that it is not required in that the other attachment features apparently can be used at the same time” (Ans. 9). 15 Appeal 2008-0434 Application 10/355,429 Appellants argue that “the Alonso reference repeatedly refers to a sewing ring 30 and stent support ring 34 that are threadedly mountable by rotating the ring and particular advantages that are achieved with these threaded components” (App. Br. 19). Appellants also contend that “the Alonso reference criticizes and teaches away from non-threaded components” (id.). Appellants also argue that “the Alonso reference, as discussed above, makes it even ‘clearer’ that that threaded engagement is in fact required, and that threaded components are particularly advantageous” (Rep. Br. 14). In view of these conflicting positions, we frame the obviousness issue before us as follows: Would it have been obvious to substitute a snap fitting connection of Shu or Berreklouw for the threaded connection of Alonso? Findings of Fact 12. Alonso teaches the use of threaded sewing rings as the means for connecting the stent support ring with the sewing ring (see Alonso 5:52- 60, 7:64-68). 13. Alonso teaches that “prior art valve implants which had relatively complex mounting mechanisms” (Alonso 3:5-6). 14. Shu teaches that a variety of equivalent means can be used to connect the ring and valve body, including “[m]ating male and female screw threads, snaps, fabric hooks, screws, or other interlocking mechanisms” (Shu 2, ¶ 13). 16 Appeal 2008-0434 Application 10/355,429 15. Berreklouw teaches that “[a]ccording to the invention[,] the top closure can comprise a screw ring or snap-fit ring and/or resilient lips” (Berreklouw 7:38-39). Discussion of 35 U.S.C. § 103(a) over Alonso and either Shu or Berreklouw We agree with the Examiner that Alonso when combined with either Shu or Berreklouw teach the snap fit elements (see Ans. 9). We are not persuaded by Appellants’ argument that because Alonso preferred a threaded engagement, it would have been unobvious to use other known equivalent means to connect the ring and valve. In KSR, the Supreme Court indicated that “[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” KSR v. Teleflex Inc., 127 S. Ct. 1727, 1740 (2007). While Alonso teaches threaded engagement mechanisms (FF 12-13), Shu and Berreklouw teach that in the field of heart valve prosthestic elements, the art recognizes the equivalence of threaded engagement and snap fit engagements (see FF 14-15). We conclude that the substitution of the snap fit for its threaded engagement equivalent is a predictable variation, which is obvious. We also reject Appellants’ argument that Alonso teaches away from the invention because Alonso prefers a threaded engagement mechanism. This preference does not “teach away” from alternatives, but simply teaches towards a preferred embodiment (see FF 12-13). Like our appellate reviewing court, “[w]e will not read into a reference a teaching away from a 17 Appeal 2008-0434 Application 10/355,429 process where no such language exists.” DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1364 (Fed. Cir. 2006). We affirm the rejection of claims 41, 42, 44, 52, and 53 as obvious over Alonso with either Shu or Berreklouw. CONCLUSION In summary, we affirm the rejection of claims 10-12, 27, 33, 41, 42, 44, 45, 52, and 53 under 35 U.S.C. § 103(a). Pursuant to 37 C.F.R. § 41.37(c)(1)(vii)(2006), we also affirm the rejections of claims 16, 17, 32, 35- 40, 43, 46-51, and 54 as these claims were not argued separately. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2006). AFFIRMED saj VISTA IP LAW GROUP LLP 2040 MAIN STREET, 9TH FLOOR IRVINE, CA 92614 18 Copy with citationCopy as parenthetical citation