Ex Parte Baker et al

Board of Patent Appeals and Interferences

Jun 29, 2012

10373057 (B.P.A.I. Jun. 29, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte WILLIAM R. BAKER, WILLIAM H. HILLS, and ARNOLD E. WILKIE __________ Appeal 2010-001513 Application 10/373,057 Technology Center 3700 ___________ Before BRADLEY W. BAUMEISTER, DENISE M. POTHIER, and JOHN A. EVANS, Administrative Patent Judges. BAUMEISTER, Administrative Patent Judge. DECISION ON APPEAL Appeal 2010-001513 Application 10/373,057 - 2 - REJECTIONS Appellants appeal under 35 U.S.C. § 134(a) from the Examiner’s rejections of claims 1-5, 7-10, 27, and 32: 1. Claims 1-5, 7-10, and 27 stand rejected under 35 U.S.C. § 112, ¶ 1, as lacking written description support; 2. Claims 1-4, 7, 9, 10, and 27 stand rejected under 35 U.S.C. § 102(e) as anticipated by Brown (US 6,071,305); 3. Claim 5 and 8 stand rejected under 35 U.S.C. § 103(a) as obvious over Brown and Kawakami (US 5,141,811) or Hills (US 5,466,410); and 4. Claim 32 stands rejected under 35 U.S.C. § 103(a) as obvious over Wolff (US 5,545,208) and Brown. We affirm in part. See 35 U.S.C. § 6. We also enter a new ground of rejection for claims 1-5, 7-10, and 27 under 35 U.S.C. § 112, ¶ 2, as being indefinite. See 37 C.F.R. § 41.50(b). INVENTION Appellants disclose a synthetic fiber with cavities for holding and releasing medicaments. (Abstract.) Appellants’ Figure 3, reproduced below, shows cross-sectional view of an exemplary fiber 10” having a longitudinal body 12 and exposed longitudinal cavities 16 filled with medicament 18. (Spec., 4:13-15; 6:16 - 7:8.) Multiple fibers 10” can be braided and/or woven to make sutures, textile prostheses (e.g., stents), and epidermal pads. (Spec., 3:16-18; 7:9-11.) Appeal 2010-001513 Application 10/373,057 - 3 - Appellants’ Figure 3 shows a cross-sectional view of an embodiment of the invention. Claims 1 and 32, the only independent claims, read as follows: 1. A flexible and non-rigid synthetic fiber for use in medical applications in which the fiber interacts with living tissue, comprising: a polymer extending in a longitudinal direction and forming a basic structure of the fiber, said polymer including a plurality of longitudinally-extending cavities formed therein; and a medicament disposed in the plurality of longitudinally-extending cavities; wherein said non-rigid and flexible fiber is capable of being combined with other flexible fibers to form a flexible fabric. 32. A synthetic fiber for use in medical applications in which the fiber interacts with living tissue, comprising: a biodegradable polymer extending in a longitudinal direction and forming a basic structure of the fiber, said polymer including a plurality of longitudinally-extending cavities formed therein; and a medicament disposed in the plurality of longitudinally-extending cavities. Appeal 2010-001513 Application 10/373,057 - 4 - APPLIED PRIOR ART 1. BROWN Brown discloses medicament-eluting stent. (Abstract.) Brown’s Figures 2 and 4, reproduced below, respectively show a perspective view of an exemplary helical stent 11 and a cross-sectional view of the fiber 12 forming the stent 11. (Brown, col. 3, ll. 61-62; col. 4, ll. 4-7; col. 5, ll. 39-45.) The fiber 20 includes an exposed, longitudinal cavity that holds and directionally releases the medicament. (Brown, col. 6, ll. 22-58.) Brown’s Figures 2 and 4 respectively show a perspective view of an exemplary stent 11 and a cross-sectional view of the fiber 12 forming the stent 11. 2. WOLFF Wolff also discloses a medicament-eluting stent. (Abstract.) Wolff’s Figure 1, reproduced below, shows a perspective view of an exemplary stent 10 having fibers 12 formed by a homogenous mix of polymer and medicament. (Wolff, col. 2, ll. 26-30 and 43-44; col. 7, ll. 19-23.) Appeal 2010-001513 Application 10/373,057 - 5 - Wolff’s Fig. 1 shows a perspective view of an exemplary stent. § 112, ¶ 1, REJECTION OF CLAIMS 1-5, 7-10, AND 27 Claims 1-5, 7-10, and 27 stand rejected under 35 U.S.C. § 112, ¶ 1, as lacking written description support. The Appellants and Examiner disagree as to whether the Specification describes a “flexible and non-rigid” fiber, as recited by claim 1 (and incorporated by claims 2-5, 7-10, and 27, all depending therefrom). This feature was added to claim 1, by amendment, with the intent of distinguishing the claimed invention over Brown. (See Amdt., Nov. 17, 2004, pp. 2 and 7.) Appellants argue that written description support is provided by the inherent properties of the disclosed products of the fiber (App. Br. 10-11; emphasis in original and citations omitted): The original disclosure of the specification describes a variety of different products that can be formed from the recited synthetic fibers of claim 1, including sutures, fabrics, wound dressings, epidermal pads, patches, bandages, yarns, fabrics, felts, absorbent pads and other fiber masses. . . . In particular, the specification explicitly sets forth that sutures can be made from twisted or braided multifilaments of the invention . . . . The specification further explicitly sets forth that absorbent Appeal 2010-001513 Application 10/373,057 - 6 - pads can be formed with fibers of the invention, where the pads can be soaked, wrung out and then reused. Clearly, the original disclosure of the specification describes synthetic fibers that can be looped, twisted, tangled, etc. about each other to form products such as the above-noted yarns, sutures and absorbent pads. Such fibers inherently have flexible and non-rigid characteristics that enable the fibers to be contorted in such a manner to form these products. In response, the Examiner argues that the disclosed products would not necessarily include a “flexible and non-rigid” fiber (Ans. 11): That particular individual properties must be present in a device that is broadly disclosed as “sutures, fabrics, wound dressings, epidermal pads, patches, bandages, yarns, fabrics, felts, absorbent pads and other fiber masses[”] (see, page 10, 3rd paragraph of the Brief) is a logic that is clearly misplaced by the Appellant. We disagree with the Examiner. The fibers of at least one disclosed product, namely sutures, would necessarily be sufficiently flexible and non-rigid so as to avoid breaking when looped, twisted, braided, and knotted. Accordingly, we do not sustain the written description rejection of claims 1-5, 7-10, and 27. NEW GROUND OF REJECTION UNDER § 112, ¶ 2 However, the lack of written description rejection under 35 U.S.C. § 112, ¶ 1, is based, in part, on the premise that the claim term “flexible and non-rigid” is not objectively clear. See Ans. 9 (“it is not clear if one skilled in the art would necessarily equate non-rigid as being synonymous or equivalent with flexible. Appellant is mistaken that the amended language ‘is clear and definite’ such that the metes and bound of the claimed invention Appeal 2010-001513 Application 10/373,057 - 7 - [are] clearly set forth”). Rather than improperly conflate the written description requirement of 35 U.S.C. § 112, ¶ 1, and the definiteness requirement of 35 U.S.C. § 112, ¶ 2, we address the question of definiteness separately. Pursuant to our authority under 37 C.F.R. § 41.50(b), we reject claims 1-3, 7, 9, 10, and 27 as indefinite under 35 U.S.C. § 112, ¶ 2. When a term of degree is used in a claim, the Specification must provide some standard for measuring the requisite degree. Datamize v. Plumtree Software, Inc., 417 F.3d 1342, 1351 (Fed. Cir. 2005) (citation omitted). Neither claim 1 nor Appellants’ Specification provides any manner of measuring how “flexible and non-rigid” the fiber must be in order to fall within the scope of the claims. Notably, the disclosure does not use the words, “flexible” or “non-rigid.” The only attempted indication is that “said non-rigid and flexible fiber is capable of being combined with other flexible fibers to form a flexible fabric” (claim 1). This further recitation merely begs the question of what is meant by a “flexible” fabric and what are the structural and/or chemical differences between the recited “flexible and non-rigid synthetic fiber” and the recited “other flexible fibers” that “form a flexible fabric.” Appellants’ claimed fiber simply lacks sufficient context to determine the metes and bounds of “flexible and non-rigid,” i.e., the requisite amount of flexibility. The importance of such context when claiming a degree of flexibility is illustrated by a Southern District Court of New York decision addressing a “flexible” stent. In Medinol Ltd. v. Guidant Corp., 417 F.Supp.2d 280, 288 (2005), the court construed a claimed stent’s “flexible cell” as being both “substantially flexible prior to expansion of the stent and substantially rigid after expansion of the stent.” As reflected by Medinol, Appeal 2010-001513 Application 10/373,057 - 8 - the same device can be considered flexible in one context and rigid in another context. Thus, a defined context is imperative for claim terms such as “flexible” and “non-rigid.” See id. at 306 (“The various uses of ‘rigid,’ ‘rigidity,’ or ‘radial rigidity’ cited by the parties cannot be divorced from the contexts in which those statements were made, and thus they shed no particular light on the proper meaning of ‘rigid’ as used in the patents-in- suit.”). Note that we have emphasized the need for such context in Ex Parte Miyazaki, 89 USPQ2d 1207, 1212 (BPAI 2008) (precedential) (quoting Halliburton Energy Servs. v. M-ILLC, 514 F.3d 1244, 1255 (Fed. Cir. 2008)), which states: When a claim limitation is defined in purely functional terms, the task of determining whether that limitation is sufficiently definite is a difficult one that is highly dependent on context (e.g., the disclosure in the specification and the knowledge of a person of ordinary skill in the relevant art area). We note that the patent drafter is in the best position to resolve the ambiguity in the patent claims, and it is highly desirable that patent examiners demand that applicants do so in appropriate circumstances so that the patent can be amended during prosecution rather than attempting to resolve the ambiguity in litigation. Accordingly, given the lack of a context for determining the scope of the “flexible and non-rigid,” we enter a new ground of rejection for claim 1 and dependent claims 2-5, 7-10, and 27 under 35 U.S.C. § 112, ¶ 2, as indefinite. § 102 REJECTION OF CLAIMS 1-4, 7, 9, 10, AND 27 OVER BROWN Claims 1-4, 7, 9, 10, and 27 stand rejected under 35 U.S.C. § 102(e) as anticipated by Brown. Because the claimed fiber has an indefinite Appeal 2010-001513 Application 10/373,057 - 9 - requisite degree of flexibility, we simply cannot evaluate whether the claimed fiber distinguishes over Brown’s teachings. We note that, having no intrinsically disclosed standard, Appellants argue the fiber 12 of Brown’s helical stent must be considered “substantially non-flexible” because it is “capable of physically supporting and preventing the collapse of body lumen walls[.]” (Reply Br. 4; citing Brown, col. 7, ll. 12-24 and 53-67). The argument is impermissibly premised upon mere speculation that a skilled artisan of medical stents would consider a helical stent fiber to be “substantially non-flexible” in view of its supportive function. In addition to being speculative, the argument is not commensurate in scope with the breadth of the claimed invention, i.e., “medical” fibers. Appellants are, therefore, essentially asking the Board to construe claim 1 based on the indefinite phrase, “flexible and non-rigid synthetic fibers.” As explained above, this phrase has no standard in light of the disclosure and thus fails to contain metes or boundaries for what encompasses “[a] flexible and non-rigid fiber,” shedding no assistance in determining whether Brown’s cited fiber 12 could form part of an indescript flexible fabric, as claimed. Accordingly, as evaluating the claimed invention against Brown requires “considerable speculation as to [the] meaning of the terms employed and assumptions as to the scope,” we do not sustain the anticipation rejection of claim 1 over Brown. See In re Steele, 305 F.2d 859, 862, (CCPA 1962) (reversing the Board for speculating as to the claim scope in affirming the prior art rejection). As dependent claims 2-4, 7, 9, 10, and 27 fail to clarify the meaning of “flexible and non-rigid” as claimed, we Appeal 2010-001513 Application 10/373,057 - 10 - likewise do not sustain the anticipation rejection of claims 2-4, 7, 9, 10, and 27 over Brown. § 103 REJECTION OF CLAIM 5 OVER BROWN IN VIEW OF KAWAKAMI OR HILLS Claims 5 and 8 depend directly or indirectly from claim 1. As these dependent claims do not clarify the meaning of “flexible” as claimed, we do not sustain the obviousness rejection of claims 5 and 8. See Steele, 305 F.2d at 862. § 103 REJECTION OF CLAIM 32 OVER WOLFF AND BROWN In rejecting claim 32, the Examiner argues that the claimed fiber is attained by modifying fibers of Wolff’s stent to include medicament-eluting cavities in view of Brown and, further, the modification would have been obvious in view of Brown’s teaching that such cavities provide a directional elution of medicament. (Ans. 8.) Appellants argue that the medicament of Wolff’s biodegradable fibers is “chemically linked to the polymer” and, thus, “clearly different from both the subject invention and from Brown, where drugs or medicaments are disposed within cavities.” (App. Br. 18.) We agree with Appellants’ argument insofar that Wolff’s and Brown’s medicament-eluting structures are different. However, these differences exemplify why it would have been obvious to incorporate one or more of Brown’s medicament-eluting cavities within one or more of Wolff’s fibers. Namely, it would have been obvious because Brown’s cavities provide an alternative medicament-eluting structure that would have been understood as capable of replacing and/or supplementing Wolff’s Appeal 2010-001513 Application 10/373,057 - 11 - compounding of medicament and polymer. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“[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.”). Appellants argue that a “significant leap [is] required to replace the chemically linked drugs as taught in Wolff with drugs disposed in cavities as taught in Brown.” (App. Br. 19.) However, Appellants provide no evidence that such a modification would have been “uniquely challenging or difficult for one of ordinary skill in the art” of medicament-eluting fibers. See Leapfrog Enters., Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007). “[A]rguments of counsel cannot take the place of evidence lacking in the record.” See Estee Lauder Inc. v. L’Oreal, S.A., 129 F.3d 588, 595 (Fed. Cir. 1997) (citation omitted). Appellants also argue that Wolff and Brown are non-analogous art because the “teachings of Wolff (which use a biodegradable material to elute drugs) are so different from the teachings of Brown (which use a non-biodegradable material including cavities containing drugs) that one of ordinary skill in the art would not look to the teachings of Brown to modify the prosthesis of Wolff.” (Reply Br. 6.) Again, Appellants’ argument constitutes mere attorney speculation as to the skill in the art of medicament-eluting fibers. Moreover, Wolff and Brown are directed to the fields of medicament-eluting fibers and drug-delivery stent technology and, thus, clearly analogous art of the claimed invention as required. See In re Kahn, 441 F.3d 977, 986-87 (Fed. Cir. 2006) (“The analogous-art test requires that the Board show that a reference is either in the field of the Appeal 2010-001513 Application 10/373,057 - 12 - applicant’s endeavor or is reasonably pertinent to the problem with which the inventor was concerned in order to rely on that reference as a basis for rejection.”). Accordingly, for the above reasons, the obviousness rejection of claim 32 over Wolff and Brown is sustained. DECISION The Examiner’s decision rejecting claims 1-5, 7-10, and 27 is reversed. The Examiner’s decision rejecting claim 32 is affirmed. Pursuant to our authority under 37 C.F.R. § 41.50(b), we enter a new ground of rejection for claims 1-5, 7-10, and 27 under 35 U.S.C. § 112, ¶ 2. Rule 37 C.F.R. § 41.50(b) states, “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” Furthermore, 37 C.F.R. § 41.50(b) also provides that Appellants, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new grounds of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the proceeding will be remanded to the examiner…. (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same record. (Emphasis added.). Appeal 2010-001513 Application 10/373,057 - 13 - No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED-IN-PART 37 C.F.R. § 41.50(b) rwk