Ex Parte Parker et al

Patent Trial and Appeal BoardSep 19, 2012

11756265 (P.T.A.B. Sep. 19, 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. 11/756,265 05/31/2007 Fred T. Parker 8627/1678 (PA-5965-RFB) 1553 48003 7590 09/19/2012 BRINKS HOFER GILSON & LIONE/CHICAGO/COOK PO BOX 10395 CHICAGO, IL 60610 EXAMINER MILES, JONATHAN WADE ART UNIT PAPER NUMBER 3731 MAIL DATE DELIVERY MODE 09/19/2012 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 FRED T. PARKER and MARK A. MAGNUSON __________ Appeal 2011-011216 Application 11/756,265 Technology Center 3700 __________ Before LORA M. GREEN, JEFFREY N. FREDMAN, and SHERIDAN K. SNEDDEN, Administrative Patent Judges. SNEDDEN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to methods and devices for the treatment of vascular disease. The Examiner has rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Appeal 2011-011216 Application 11/756,265 2 STATEMENT OF THE CASE According to Appellants, the invention relates to methods and devices for shielding the interior surface of an organ in the treatment of vascular disease using an anchor stent and a stiff rod-like cover formed from a bioremodelable collagenous material. (App. Br. 7.) Claims 18-20 and 26-47 are on appeal. The claims have not been argued separately and therefore stand or fall together. 37 C.F.R. § 41.37(c)(1)(vii). Independent claims 18 and 34 are representative and read as follows: 18. A method for shielding at least a portion of the interior surface of an organ, comprising: placing a cover formed from a hydrated bioremodelable material over at least a portion of a first stent, said first stent having a compressed configuration and an expanded configuration, wherein said bioremodelable material is formed from a reconstituted or naturally-derived collagenous material; compressing said hydrated cover into a reduced diameter configuration; attaching said hydrated cover to said first stent by drying said hydrated cover in said reduced diameter configuration to form a stiff rod-like shape, said dried compressed cover thereby compressively holding an external surface of said first stent; advancing said first stent and said attached cover in said dried compressed configuration through a vessel to a specified region thereof; exposing said cover to the flow of blood, thereby wetting said cover and restoring flexibility thereto; expanding said first stent against said wetted flexible cover within said organ; introducing a second stent having said compressed configuration and said expanded configuration into said organ; Appeal 2011-011216 Application 11/756,265 3 advancing said second stent through an interior lumen of said expanded first stent and an interior surface of said wetted cover; and expanding said second stent against said wetted cover. 34. A device for shielding at least a portion of an interior surface of an organ, comprising: an anchor stent assembly, said anchor stent assembly comprising: a first stent having a proximal end, a distal end, an exterior surface, and an interior lumen, said first stent having a compressed configuration and an expanded configuration; a cover formed from a bioremodelable material that is stiff when dried and flexible when wetted, wherein said bioremodelable material is formed from a reconstituted or naturally-derived collagenous material, wherein at least a portion of said cover is disposed around at least a portion of an exterior surface of said stent, said cover being attached to said stent by drying said wetted cover in a compressed reduced diameter configuration having a stiff rod- like shape such that said dried cover compressively holds said external surface of said stent in said compressed configuration. The claims stand rejected as follows: I. Claims 18, 19, 26-32, 34-39, 41, 45, and 46 stand rejected under 35 U.S.C. § 103(a) as obvious over Gifford, III et al. (US 6,712,842 B1, issued Mar. 30, 2004) in view of Euteneuer et al. (US 5,989,280, issued Nov. 23, 1999). II. Claim 20 stands rejected under 35 U.S.C. § 103(a) as obvious over Gifford in view of Euteneuer and further in view of Greenberg et al. (US 7,160,318 B2, issued Jan. 9, 2007). Appeal 2011-011216 Application 11/756,265 4 III. Claims 33 and 40 stand rejected under 35 U.S.C. § 103(a) as obvious over Gifford in view of Euteneuer and further in view of Andreas et al. (US 7,300,456 B2, issued Nov. 27, 2007). IV. Claims 42-44 and 47 stand rejected under 35 U.S.C. § 103(a) as obvious over Gifford in view of Euteneuer and further in view of Kónya et al. (US 6,123,723, issued Sep. 26, 2000). I. Issue The Examiner has rejected claims 18, 19, 26-32, 34-39, 41, 45, and 46 as obvious over the combination of Gifford and Euteneuer. The Examiner finds that Gifford teaches the elements of the claimed device and method except that Gifford “does not disclose wherein said bioremodelable material is formed from a reconstituted or naturally-derived collagenous material, wherein the hydrated cover is attached to said first stent by drying said hydrated cover in said reduced diameter.” (Ans. 7-8: See Ans. 4-8.) For the missing elements, the Examiner relies on Euteneuer. (Ans. 8.) Appellants contend that “Gifford does not disclose a crucial aspect of Applicants’ claimed inventions—that the cover be made of a bioremodelable cover” and that “[t]he Examiner has not established that one of ordinary skill in the art would have been motivated to combine Gifford and Euteneuer in order to achieve Applicants’ claimed inventions.” (Reply Br. 2). The issue with respect to this rejection is: Did the Examiner establish that the teachings of Gifford and Euteneuer are properly combinable to arrive at the claimed invention in each of the grounds of rejection under 35 U.S.C. § 103(a)? Appeal 2011-011216 Application 11/756,265 5 Findings of Fact FF1. Gifford discloses a system “for protecting blood vessels during intravascular procedures” that uses a liner to protect the body passageway. (Gifford at col. 5, ll. 15-16.) FF2. Gifford discloses as follows: The liner 10 is advanced through the vessel in the collapsed condition of FIG. 2 so that the liner 10 can be advanced through small or highly stenosed vessels. After the liner 10 is in position, other devices, such as a stent 26 (FIG. 25) or filter (FIG. 40), may be passed through the liner 10 so that the liner 10 prevents contact between the device and the vessel wall. The liner 10 may also be used to protect the vessel when advancing other devices such as angioplasty balloons, drug delivery catheters, laser catheters or ultrasound catheters. (Gifford at col. 5, ll. 42-51.) FF3. Gifford teaches that the liner is held in a compressed state with heat or other means (Gifford at col. 6, ll. 36-50) and may be “introduced through small and heavily stenosed vessels.” (Gifford at col. 7, ll. 18-20.) FF4. Gifford teaches that the liner may be constructed of silk or polyester. (Gifford at col. 5, ll. 58-63.) FF5. The Examiner finds that Gifford “does not disclose wherein said bioremodelable material is formed from a reconstituted or naturally-derived collagenous material, wherein the hydrated cover is attached to said first stent by drying said hydrated cover in said reduced diameter.” (Ans. 7-8.) FF6. The Examiner finds that Euteneuer “discloses a bioremodelable material formed from a reconstituted or naturally-derived collagenous material (column 12, lines 53-56), and wherein the hydrated cover is Appeal 2011-011216 Application 11/756,265 6 attached to a stent by drying the cover in a reduced diameter (column l3, lines 5-7).” (Ans. 8.) FF7. Euteneuer relates to a “delivery system for implantation of a self-expanding stent in a vessel [that] consists of an elongate flexible catheter for delivering a self-expanding stent to a predetermined location in a vessel.” (Euteneuer, Abstract.) FF8. Euteneuer discloses as follows: The stent can be surrounded by an outer sleeve of water swelling material, which in this embodiment is preferably collagen. The stent can optionally also be held in its reduced delivery configuration by a liner of collagen which is inside the stent. (Euteneuer, col. 12, ll. 36-40.) FF9. Euteneuer discloses as follows: Collagen can be … attached to a fully expanded stent, by for example, wrapping the stent with the collagen and attaching the collagen to itself or by weaving the collagen through the openings in the stent and attaching it to itself. The stent is then mechanically pulled down to its reduced diameter and the collagen is dried, which holds the stent in its reduced diameter. The collagen may also be dried onto the unexpanded stents mentioned above. (Euteneuer, col. 12, l. 64 to col. 13, l. 7.) FF10. Euteneuer discloses that “the water swelling material is formulated so that it is slow to hydrate to allow sufficient time to deliver the stent to the deployment site.” (Euteneuer, col. 12, ll. 30-32.) Appeal 2011-011216 Application 11/756,265 7 FF11. The purpose of the sleeve disclosed in Euteneuer is to protect damage to the vessel wall due to sharp edges of the stent (See Euteneuer, col. 12, ll. 13-20.) by “eliminat[ing] the outward self-expanding force exerted by [a] type of memory metal stent after it has reached its transition temperature” after coming into contact with the heat of the patient’s body. (Euteneuer, col. 12, ll. 13-20.) FF12. Euteneuer discloses that “the collagen material remains in the body, whether as a sleeve surrounding the stent, a liner inside the stent or both, to aid forming of a non-thrombogenic cushion for the stent in the vascular lumen as well as a natural substrate for endotheliazation.” (Euteneuer, col. 14, ll. 14-18.) FF13. The Examiner finds that “it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the bioremodelable material from extracellular matrix, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.” (Ans. 8.) Principles of Law “Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. . . . [The reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole.” In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Appeal 2011-011216 Application 11/756,265 8 In KSR Int’l v. Teleflex Inc., 550 U.S. 398, 415 (2007), the Supreme Court rejected a rigid application of a teaching-suggestion-motivation test in the obviousness determination. The Court emphasized that “the [obviousness] analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 418. Thus, an “[e]xpress suggestion to substitute one equivalent for another need not be present to render such substitution obvious.” In re Fout, 675 F.2d 297, 301 (CCPA 1982). See also KSR, 550 U.S. at 401 (“The Court [in United States v. Adams, 383 U.S. 39, 40 (1966)] recognized that when 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.”) (emphasis added). Analysis We focus our analysis on independent claim 18 since Appellants’ arguments are focused on the limitations of claim 18. (App. Br. 9-13; Reply Br. 2-4.) As they are not argued separately, claims 19, 26-32, 34-39, 41, 45, and 46 fall with claim 18. 37 C.F.R. § 41.37(c)(1)(vii). Appellants argue that Gifford teaches a non-bioremodelable liner that lacks columnar strength to be advanced through small or stenosed blood vessels. (See App. Br. 9-11.) Appellants also argue that “Gifford fails to disclose advancing said first stent and said attached cover in said dried compressed configuration through a vessel to a specified region thereof; Appeal 2011-011216 Application 11/756,265 9 exposing said cover to the flow of blood, thereby wetting said cover and restoring flexibility thereto; and expanding said first stent against said wetted flexible cover within said organ.” (App. Br. 12-13.) Appellants also rely on the Declaration of Mark A. Magnuson to support the finding that the liner in Gifford would have no columnar strength, and thus it could not be advanced through the stenosis as required by the claimed method. (See App. Br. 10 and paragraph bridging pages 12-13.) We are unpersuaded by Appellants’ arguments. Non-obviousness cannot be established by attacking the references individually. In re Merck & Co. Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Appellants’ arguments are primarily directed to the Gifford reference alone. The rejection is based on the combination of references and the Examiner does not dispute that Gifford fails to disclose the use of a cover made from collagenous material that is attached to the stent by drying the cover onto the stent in a reduced diameter. (FF.5) The Examiner’s position is that the device used in Gifford may be substituted with the collagenous sleeve-stent assembly of Euteneuer. (FF13.) In addressing the combination of Gifford and Euteneuer, Appellants argue that “the stent in Euteneuer is not an anchor stent and the cover is not compressed to a stiff rod-like shape,” that “Euteneuer is concerned about minimizing friction between the stent and the catheter,” and thus there would have been “no motivation to attach the collagen sleeve to an anchor stent in a stiff rod-like shape to advance the cover through a stenosis.” (App. Br. 13.) However, as the Examiner explains, Euteneuer discloses an alternative liner for use with an intravascular device for advancing and Appeal 2011-011216 Application 11/756,265 10 placing a stent, where the liner is a collagenous cover used to retain the stent in a reduced diameter, the feature argued by Appellants to be a crucial element of the claims. (See e.g., Ans. 22; Reply Br. 2.) In this regard, Euteneuer teaches an intravascular device having a stent maintained in a reduced diameter (FF8.) by a collagenous material (FF8.) that is dried to the stent (FF8.) and expandable when wetted by the bloodstream (FF9.). The evidence and arguments of record fail to persuade us that the ordinary artisan would not have found it obvious to use the collagenous liner disclosed in Euteneuer in the device and methods of Gifford. We thus find that the Examiner has expressed a proper reason for the combination of Gifford and Euteneuer, namely, the simple substitution of one known element, which is a liner for a stent in Euteneuer, for another liner for a stent in Gifford. (FF13.) We therefore affirm the Examiner’s rejection of claim 18. Claims 19, 26-32, 24-39, 41, 45, and 46 fall with claim 18, over the combination of Gifford and Euteneuer. As to the remaining obviousness rejections, whether Gifford and Euteneuer are properly combined by the Examiner in order to establish a prima facie case of obviousness is the issue in each of the rejections on appeal (App. Br. 14-15). We therefore also affirm the remaining obviousness rejections for the reasons given above. Conclusion of Law The Examiner established that the teachings Gifford and Euteneuer are properly combinable in each of the grounds of rejection under 35 U.S.C. § 103(a). Appeal 2011-011216 Application 11/756,265 11 SUMMARY The rejection of claims 18, 19, 26-32, 34-39, 41, 45, and 46 under 35 U.S.C. § 103(a) as obvious over Gifford and Euteneuer is affirmed. The rejection of claim 20 under 35 U.S.C. § 103(a) obvious over Gifford and Euteneuer in view of Greenberg is affirmed. The rejection of claims 33 and 40 under 35 U.S.C. § 103(a) as obvious over Gifford and Euteneuer in view of Andreas is affirmed. The rejection of claims 42-44 and 47 under 35 U.S.C. § 103(a) as obvious over Gifford and Euteneuer in view of Kónya is affirmed. AFFIRMED alw