Ex Parte Rao et al

Patent Trials and Appeals BoardFeb 7, 2019

12966852 - (D) (P.T.A.B. Feb. 7, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 12/966,852 12/13/2010 K.T. Venkateswara Rao 128926 7590 02/11/2019 Foley & Lardner LLP 3000 K Street N.W. Suite 600 Washington, DC 20007-5109 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. 109167-0287 9567 EXAMINER TON, MARTIN TRUYEN ART UNIT PAPER NUMBER 3771 NOTIFICATION DATE DELIVERY MODE 02/11/2019 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): ipdocketing@foley.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Exparte K.T. VENKATESWARA RAO, RAJP. GANPATH, AMY LEE, andANUPAMAKARWA Appeal2017-007203 Application 12/966,852 Technology Center 3700 Before ULRIKE W. JENKS, JOHN G. NEW, and CHRISTOPHER G. PAULRAJ, Administrative Patent Judges. JENKS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. Â§ 134(a), Appellants 1 appeals from Examiner's decision to reject claims as obvious and for containing new matter. We have jurisdiction under 35 U.S.C. Â§ 6(b). We AFFIRM. 1 Appellants identify the real party in interest as Endologix, Inc. Br. 3. In addition to the Final Office Action dated Dec. 10, 2015 ("Final Act."), we herein refer to the Appeal Brief, filed Oct. 21, 2016 ("Br."); and Examiner's Answer, mailed Dec. 9, 2016 ("Ans."). No Reply Brief has been filed. Appeal2017-007203 Application 12/966,852 STATEMENT OF THE CASE Claims 1-10, 19, 22, 23, and 26-39 are on appeal, and can be found in the Claims Appendix of the Appeal Brief. Claim 1 is representative of the claims on appeal, and reads as follows: 1. A system for treating an aneurysm in a patient, the system compnsmg: a double-walled filling structure having an outer wall and an inner wall, wherein the filling structure is adapted to be filled with a hardenable fluid filling medium such that when the filling structure is positioned across the aneurysm and filled with the hardenable fluid filling medium, the outer wall expands to conform to an inside surface of the aneurysm and the inner wall forms a tubular lumen to permit blood flow therethrough; and a reinforcing tube surrounding the inner wall, wherein the inner wall is separate from the reinforcing tube and prevents the inner wall from expanding outward beyond the radial dimensions of the reinforcing tube, wherein the reinforcing tube is of a continuous material. Br. 19 (Claims Appendix) Appellants seek review2 of the following rejections made by Examiner: I. Claim 29 under pre-AIA 35 U.S.C. Â§ 112, first paragraph as failing to provide sufficient written description for the elements claimed (new matter). Final Act. 5. 2 In the Final Office Action, Examiner also rejected claim 31 under 35 U.S.C. Â§ 112(d) or pre-AIA 35 U.S.C. Â§ 112, fourth paragraph as failing to further limit the subject matter of claim 1 upon which it depends. Final Act. 6. Appellants do not provide arguments with respect to this rejection, accordingly, we summarily affirm this rejection for the reasons set out by Examiner. 2 Appeal2017-007203 Application 12/966,852 II. Claims 1-8, 10, 19, 22, 23, 26, 27, 29, 31-33, 35, 36, and 38 under pre-AIA 35 U.S.C. Â§ I03(a) as unpatentable over Evans3 in view of Whalen. 4 Id. at 6-12. III. Claims 9 and 34 under pre-AIA 35 U.S.C. Â§ I03(a) as unpatentable over Evans in view of Whalen and further in view ofLee. 5 Id. at 12- 13. IV. Claims 6, 28, 30, 37, and 39 under pre-AIA 35 U.S.C. Â§ I03(a) as unpatentable over Evans in view of Whalen and further in view of Kubo. 6 Id. at 13-14. I. New Matter Examiner finds that claim 3 9: [R ]ecites the limitation "wherein the reinforcing tube is not a coil, spring, stent or scaffold." However, the specification merely states that "The reinforcing tube may be of a continuous material, or it may be a mesh attached to the inner lumen" but it does not at all exclude the device from being a coil spring, stent, or scaffold. Final Act. 5. Examiner directs us to guidance in the MPEP that explains any negative limitation still requires a basis in the original disclosure. Id. ( citing MPEP 2I 73.05(i)). Appellants contend that positively recited elements may be excluded from the claims. Br. 10 (citing In re Johnson, 558 F.2d 1008, 1019 (CCPA 1977)). Appellants contend that the Specification teaches expanded 3 Michael A. Evans et al., US 2006/0025853 Al, published Feb. 2, 2006 ("Evans"). 4 Robert L. Whalen, US 4,130,904, issued Dec. 26, 1978 ("Whalen"). 5 Amy Lee et al., US 2007/0276477 Al, published Nov. 29, 2007 ("Lee"). 6 Yoshihiko Kubo et al., US 5,236,447, issued Aug. 17, 1993 ("Kubo"). 3 Appeal2017-007203 Application 12/966,852 polytetrafluoroethylene ( ePTFE) as a reinforcing material, and the "reinforcing tube or sleeve can reasonably be formed from ePTFE,[however,] it is unreasonable to argue that a coil spring, stent or scaffold can be formed of ePTFE." Id. "To satisfy [the written description] requirement, the specification must describe the invention in sufficient detail so 'that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date sought."' In re Alonzo, 545 F.3d, 1015, 1019 (Fed. Cir. 2008), citingLockwoodv. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed.Cir.1997). It is not necessary that specification provide ipsis verbis support for the claimed subgenus so long as its disclosure reasonably conveys to persons skilled in the art that inventors invented the subgenus claimed, i.e., by adequately directing one skilled in the art to that subgenus. In re Edwards, 568 F.2d 1349, 1351-52 (CCPA 1978). When we consider the disclosure as a whole, in view of the record before us, we are not persuaded by Appellants' contention that the specification's recitation of ePTFE as a material that may form the reinforcing tube or sleeve provides a sufficient description of the subgenus Appellants now seek to exclude from the scope of the claims. As Examiner explains, "[ t ]here is nothing inherent to the structures of a stent, coil spring, or scaffold that would suggest that it cannot be formed of ePTFE." Ans. 2. Citing Johnson, 558 F.2d at 1019, Appellants argue that if an element is positively recited it may be explicitly excluded from the claims. Br. 10. Here, Appellants are adding an embodiment, i.e., "the reinforcing tube is not a coil spring, stent or scaffold." In Johnson the applicant was removing species within a described genus. Further, in Johnson, the Court noted that 4 Appeal2017-007203 Application 12/966,852 the specification contained extensive examples that fully supported the subgenus claimed. See Johnson, 558 F.2d at 1018 (noting that "appellants' grandparent application contains a broad and complete generic disclosure, coupled with extensive examples fully supportive of the limited genus now claimed."). Appellants contend that the Specification teaches "reinforcement of the inner wall is provided by metal rings or compressible and readily expandable rings, each ring forming an undulating or zigzag pattern (Paragraph [0013]), which clearly encompass springs, stents or scaffolds." Br. 10. We are not persuaded that the description of a ring, even an undulating ring, necessarily describes a subgenus comprising a coil spring, stent or scaffold even if they share a common circular shape. We agree with Examiner that the Specification does not recite a coil spring, stent or scaffold. See Final Act. 5. We are not persuaded by Appellants' contention that disclosure of expandable rings including those with zig-zag patterns would necessarily describe coil springs, stent, or scaffolds. See Br. 10. A "description need not recite the claimed invention in haec verba but must do more than merely disclose that which would render the claimed invention obvious." ICU Medical, Inc. v. Alaris Medical Systems, Inc. 558 F.3d 1368, 1377 (Fed. Cir. 2009). In the present situation we find that Examiner has the better position. Here, Appellants disclosure as filed does not provide sufficient examples to describe a genus in order to support the subgenus Appellants now seek to exclude from the claims. Accordingly, we affirm the new matter rejection of claim 39. 5 Appeal2017-007203 Application 12/966,852 II. Obviousness over Evans and Whalen The issue is: Does the preponderance of evidence of record support Examiner's conclusion that the addition of a support structure into the system described in Evans is obvious? Findings of Fact FF 1. Evans teaches a double-walled prosthesis system comprising a filling structure mounted over a delivery catheter for treating an aneurism. Evans Abstract, see also ,r 30. Figure 1, reproduced below, depicts such a prosthesis system. Figure 1 shows system 10 comprising a delivery catheter 14 having an expandable element 16 for delivery of a double-walled filling structure 12 to an aneurysm. Id. ,r 37. The structure contains: a filling tube 20 for delivering a filling medium or material to an internal space 22 of the double-walled filling structure 12. The internal space 22 is defined between an outer wall 24 and inner wall 26 of the filling structure. Upon inflation with the filling material or medium, the outer wall will expand radially outwardly, as shown in broken line, as will the inner wall 26, also shown in broken line. Expansion of the inner wall 26 defines an internal 6 Appeal2017-007203 Application 12/966,852 lumen 28. The expandable balloon or other structure 16 will be expandable to support an inner surface of the lumen 28. Id. "After the double-walled filling structure 12 is properly positioned, a hardenable inflation medium is introduced into the internal space 22 filling of the inner space 22 expands the outer wall 24 of the structure outwardly so that it conforms to the inner surface (S) of the aneurismal space." Id. ,r 44. FF2. Evans teaches that the wall of the double-walled filling structure may be more complex. Figure 3, reproduced below, shows several wall complexes. FIG. 3A 24 tizzz5' FIG.3C 48 ~l 2z ~z 2z zl{ FIG. 3B FIG. 3A shows a multi-layered wall comprising layers 42, 43 and 44 . ... FIG. 3B, a single wall or multiple wall structure can be reinforced by braid, coils, or other metal or non-polymeric reinforcement layers or structures .... FIG. 3C, the external surface 24 of the wall may be covered with drugs, fibers, protrusions, holes, active agents or other substances for a variety of purposes. Id. ,I4I. FF3. Evans teaches: The walls of the filling structures may consist of a single layer or may comprise multiple layers which are laminated or otherwise formed together. Different layers may comprise different materials, including both compliant and/or non-compliant materials. The structure 7 Appeal2017-007203 Application 12/966,852 walls may also be reinforced in various ways, including braid reinforcement layers, filament reinforcement layers, and the like. In some instances, it would be possible to include self-expanding scaffolds within the filling structures so that the structures could be initially delivered and be allowed to self-expand at the treatment site, thus obviating the need for an expansion delivery catheter as described as the preferred embodiment below. Id. ,I 16. FF4. Evans teaches using the system to treat the complex geometry of a transmural abdominal aortic aneurysm (AAA). Id. ,r 43. Figure 5C, reproduced below, shows a tubular lumen flared to different opening sizes across the aneurism. Figure 5C shows the use of "a balloon 16 or other expansible structure which will be shaped to preferentially open the lower proximal end 50 of the tubular lumen to a larger diameter than the upper or distal end 52." Id. ,I 45. 8 Appeal2017-007203 Application 12/966,852 FF5. Whalen teaches prosthetic blood conduit made of two polyester fabric tubes and a coil spring enclosed therebetween. Figure 1, reproduced below, shows such a conduit. Figure 1, shows the blood conduit 10 includes a flexible fabric tube 14 forming an inner surface 12. Id. 1 :48--49. An outer tube 24, encloses both the inner tube 14 and the spring 18. Id. 2: 10-11. A helical reinforcing spring 18 closely surrounds the inner tube 14. Radial strength afforded by the wall structure of the inner tube 14 maintains a close fit between said tube and the spring 18. The spring 18, responsible for most of the radial strength, must be sufficiently flexible to avoid substantial resistance to bending in vivo so the conduit will not interfere with natural organs. One biologically compatible material used for the spring 18 is No. 316 stainless steel. The spring may be entirely of stainless steel or coated therewith. Obviously other biologically compatible spring materials may be used. Id. 1:66-2:9. "The reinforcing spnng 18 is also described as being helical." Id. 2:56-57. "With the spring 18 holding the inner tube 14 in a close fit the sides of the tube 14 cannot expand outwardly and the small but significant radial strength of the tube 14 prevents collapse." Id. 3:19--22. 9 Appeal2017-007203 Application 12/966,852 Analysis Examiner finds that Evans teaches a double-walled filling structure for use in a system to treat an aneurysm. Final Act. 6. The double-walled structure has an outer wall and an inner wall. "[T]he outer wall expands to conform to an inside surface of the aneurysm and the inner wall forms a generally tubular lumen to permit bloodflow therethrough." Id. at 7. (citing Evans ,r 39, Figs 1 and 5C); see FFl, FF4. Examiner finds that Evans teaches that the walls of the filling structure may be reinforced. Final Act. 7 ( citing Evans ,r 16); see FF2-FF3. Examiner acknowledges that Evans "does not specifically teach a reinforcing tube surrounding the inner wall, wherein said inner wall is separate from said reinforcing tube and prevents said inner wall from expanding outward beyond the radial dimension of said reinforcing tube." Final Act. 7. Examiner relies on the teaching of Whalen to incorporate "a reinforcing tube surrounding said wall that prevents the wall from expanding outward beyond the radial dimensions of the tube ... , wherein the tube is made of a stainless steel strand of material formed into a coil spring." Final Act. 7 (citing Whalen 1 :6-2:9); see FF2-FF3. Examiner concludes that it would have been obvious to a person having ordinary skill in the art at the time of invention to utilize the reinforcement tube of the Whalen reference as a means for reinforcing the inner wall of the Evans reference since it is a simple substitution of one known element for reinforcement of a tubular lumen of a prosthesis for another known reinforcement structure. Final Act. 7-8. Appellants contend that "[ t ]he alleged separate reinforcing tube in Whalen is actually a spring 18 that contacts both the inner and outer walls" (Br. 12); that Evans does not suggest a separate reinforcing tube that 10 Appeal2017-007203 Application 12/966,852 surrounds the inner wall (id. at 14); that there is "no apparent reason why one would remove a supporting scaffold, stent or coil spring from an integrated stent-graft and include it as a separate element inside of a filings structure between flexible inner and outer walls" (id. at 15); that interpreting a coil spring to read on a separate reinforcing tube that is made of a continuous material is unreasonable (id. at 13-14 ). We are not persuaded by Appellants contention that Whalen's spring contacting both inner and outer wall of the conduit cannot be incorporated into Evans' s structure. Appellants' arguments attacking the Whalen and Evans references individually (see, e.g., Br. 12), when the rejection is based on their combination, is improper. In re Keller, 642 F.2d 413, 426 (CCPA 1981 ). "[I]t is not necessary that the inventions of the references be physically combinable to render obvious the invention under review." In re Sneed, 710 F.2d 1544, 1550 (Fed. Cir. 1983). Here, Whalen explains that having the spring 18 in close fit with the sides of the tube 14 ensures that tube 14 "cannot expand outwardly and the small but significant radial strength of the tube 14 prevents collapse." FF5. Thus, the role of the spring in Whalen is to provide support for the walls of the inner tube. Furthermore, describing something as being in close fit does not mean that the structures are physically linked together and thereby cannot be separated. Evans teaches that there are numerous ways to reinforce the filling structure. FF2-FF3. Specifically, "including braid reinforcement layers, filament reinforcement layers, and the like."" FF3; see also Ans. 4 ("In fact, using the terms 'reinforced in various ways' and 'and the like' suggests that there are many different ways that can be used to reinforce the walls of the structure, including a reinforcement element as the one taught in Whalen."). 11 Appeal2017-007203 Application 12/966,852 In addition, Evans teaches that the filling space can also incorporate self- expanding scaffolds. FF3. The inclusion of self-expanding scaffold within the filling structure of Evans suggests that the system is flexible in how the components may be arranged, and that such a component would function in the delivery of the system to the intended site of the aneurysm, and also provide some structural reinforcement for the system. Accordingly, we are not persuaded by Appellants contention that Evans does not suggest a reinforcing component. "[W]hen a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007), citing United States v. Adams, 383 U.S. 39, 50-51 (1966). Here, Examiner is relying on substitution of one reinforcement structure for another to reach the conclusion that the combination of references renders the claims obvious. Evans teaches the inclusion of reinforcement structures into the system and also teaches incorporating self-expanding structures, such as a stent, into the filling space of the device. FF3. It is reasonable to interpret that such a self-expanding scaffold not only assists in the placement of the system at the treatment site but that it can simultaneously provide structural support. More importantly, the teaching that a scaffold can be incorporated into filling space reasonably suggests that the inclusion of additional structures within Evans's filling space does not render the system inoperable. We find no error with Examiner's reliance on the combination of Evans and Whalen. We are not persuaded by Appellants' contention that there is no reason to remove a supporting scaffold stent or coil spring from an 12 Appeal2017-007203 Application 12/966,852 integrated stent-graft and use it as a separate structure. See Br. 15. As discussed above, Evans discloses multiple ways to reinforce the system. Evans teaches that the walls may be constructed of single or multiple layers. See FF2-FF3. The walls in Evans can also incorporate braids coils or other metal or non-polymeric reinforcement layers. FF2. We agree with Examiner's interpretation that describing that the system may be "reinforced in various ways" and "and the like" implies that other known structural reinforcements are also acceptable. See Ans. 4. This interpretation is further supported by Evans' s suggestion of incorporating a self-expanding scaffold within the filling space of the endovascular aneurysm treatment system. FF3. As discussed above, such a self-expanding scaffold would reasonably function to provide support for the structure. Accordingly we are not persuaded by Appellants' contention that the teachings in Evans would require rearrangement of the reinforcement structure. We are also not persuaded by Appellants' contention that a coil cannot be interpreted to meet the limitations of a tube that is made out of a continuous material. Br. 13-14. As noted by Examiner, "the definition of a tube as referenced in the Appeal Brief is 'a hollow cylindrical structure' or 'a pipe-like structure.' The overall shape formed by the coils of the spring forms a hollow cylindrical structure that is pipe-like in shape and structure, therein fitting with the definition discussed in the Appeal Brief." Ans. 3; see also Br. 13 ("a 'tube', which is understood as a hollow cylindrical body"). We also agree with Examiner position that because "the coil spring is made of a single continuous wire" it reasonably meets the requirement of a contiguous material. Ans. 3. 13 Appeal2017-007203 Application 12/966,852 We conclude that the evidence cited by Examiner supports a prima facie case of obviousness with respect to claim 1, and Appellants have not provided sufficient rebuttal evidence that outweighs the evidence supporting Examiner's conclusion of obviousness. As Appellants do not argue the claims separately, claims 2-8, 10, 19, 22, 23, 26, 27, 29, 31-33, 35, 36, and 38 fall with claim 1. 37 C.F.R. Â§ 41.37 (c)(l)(iv). III. Obviousness over Evans, Whalen, and Lee Examiner has rejected claims 9 and 34 as obvious based Evans, Whalen, and Lee. Final Act. 12-13. Appellants' only argument with respect to this rejection is that "Lee fails to cure the deficiencies noted in the cited combination of Evans and Whalen." Br. 17. This argument is not persuasive because, as discussed above, we conclude that Evans and Whalen would have made obvious the system recited in claim 1. We affirm the rejection of claims 9 and 34 for the reasons given by Examiner in the Final Office Action and Answer. IV. Obviousness over Evans, Whalen, and Kubo Examiner has rejected claims 6, 28, 30, 37, and 39 as obvious based Evans, Whalen, and Kubo. Final Act. 13-14. Appellants only argument with respect to this rejection is that "Kubo fails to cure the deficiencies noted in the cited combination of Evans and Whalen." Br. 1 7. This argument is not persuasive because, as discussed above, we conclude that Evans and Whalen would have made obvious the system recited in claim 1. We affirm the rejection of claims 6, 28, 30, 37, and 39 for the reasons given by Examiner in the Final Office Action and Answer. 14 Appeal2017-007203 Application 12/966,852 SUMMARY We affirm the new matter rejection of claim 29. We affirm the rejection of claims 1-8, 10, 19, 22, 23, 26, 27, 29, 31- 33, 35, 36, and 38 under pre-AIA 35 U.S.C. Â§ 103(a) over Evans and Whalen. We affirm the rejection of claims 9 and 34 under pre-AIA 35 U.S.C. Â§ 103(a) over Evans, Whalen, and Lee. We affirm the rejection of claims 6, 28, 30, 37, and 39 under pre-AIA 35 U.S.C. Â§ 103(a) over Evans, Whalen, and Kubo. TIME PERIOD FOR RESPONSE 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). AFFIRMED 15