Ex Parte GerberDownload PDFPatent Trial and Appeal BoardOct 29, 201211591447 (P.T.A.B. Oct. 29, 2012) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte MARTIN T. GERBER __________ Appeal 2011-008920 Application 11/591,447 Technology Center 3700 __________ Before LORA M. GREEN, FRANCISCO C. PRATS, and ERICA A. FRANKLIN, Administrative Patent Judges. FRANKLIN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to an implantable elongated member comprising a balloon fixation element composed at lease in part of a biocompatible degradable material, a system comprising the elongated member, and a method of inserting the elongated member into a patient. The Patent Examiner rejected the claims as anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse and enter a New Ground of rejection, pursuant to 37 C.F.R. § 41.50(b). Appeal 2011-008920 Application 11/591,447 2 STATEMENT OF THE CASE Claims 1-28 are on appeal. Independent claims 1, 14, and 21 are representative and read as follows: 1. An implantable elongated member comprising: an elongated body configured to be coupled to a medical device to deliver a therapy from the medical device to a target therapy delivery site in a patient; an inflation lumen; and a balloon fixation element coupled to the elongated body and composed at least in part of a biocompatible degradable material, the balloon fixation element being configured to receive a fluid via the inflation lumen to expand from a first state to a second state. 14. A system comprising: a medical device; and an elongated member comprising: an implantable elongated body configured to be coupled to a medical device to deliver a therapy from the medical device to a target therapy delivery site in a patient; an inflation lumen; and a balloon fixation element coupled to the elongated body and composed at least in part of a biocompatible degradable material, the balloon fixation element being configured to receive a fluid via the inflation lumen to expand from a first state to a second state. 21. A method comprising: inserting an elongated member into the patient, wherein the elongated member includes a balloon fixation element mounted to the elongated member and composed at least in part of a biocompatible degradable material; advancing the elongated member to a target therapy delivery site to deploy the balloon fixation element into tissue of the patient proximate to the target therapy delivery site; and delivering a fluid to the balloon fixation element via an inflation lumen to inflate the balloon fixation element from a first state to a second state, wherein in the second state, the balloon fixation element engages with tissue at the target therapy delivery site. Appeal 2011-008920 Application 11/591,447 3 The Examiner rejected the claims as follows: • claims 1-5, 10-12, 14-16, 18, 19, 21-23, 26-28 under 35 U.S.C. §102(b) as anticipated by Karicherla;1 • claims 6, 7, 9, 17, 24, and 25 under 35 U.S.C. § 103(a) as unpatentable over Karicherla; • claims 8, 13, and 20 under 35 U.S.C. § 103(a) as unpatentable over Karicherla and Kucharczyk.2 ANTICIPATION/OBVIOUSNESS For both the anticipation and obviousness rejections, the Examiner’s position is that Karicherla disclosed an intracardiac lead system with an implantable elongated member comprising a balloon attachment structure or fixation element composed of a biocompatible degradable material. (See, e.g., Ans. 3-4.) Appellant contends that “Karicherla does not disclose or even suggest constructing the balloons 2002, 2004 from a biodegradable material. (App. Br. 9.) Appellant asserts that Karicherla’s disclosure that an attachment structure may be constructed of a biodegradable material that degrades over time referred to an embodiment other than one with balloon-like structures. (Id.) According to Appellant, Karicherla “failed to make any connection between the biodegradable material and the balloons 2002, 2004.” (Id.) 1 Patent No. US 7,448,999 B1 issued to Erica Franklin et al., Nov. 11, 2008. 2 Patent No. US 6,463,317 B1 issued to John Kucharczyk et al., Oct. 8, 2002. Appeal 2011-008920 Application 11/591,447 4 Further, Appellant asserts that a skilled artisan would have recognized that it was “undesirable to form balloons from a biodegradable material when the balloons are filled with a fluid and implanted within the patient’s heart because … use of such a material could lead to the release of the fluid into the heart or the patient’s bloodstream upon the breakdown of the degradable material.” (Id. at 9.) Moreover, Appellant assert that such a fluid release would render the lead 2000 inoperable for its intended purpose, as the fluid used to inflate the balloons is “essential to the lead function.” (Id.) Issue Did Karicherla explicitly or inherently disclose that its balloon-like structures may be composed at least in part of a biocompatible degradable material? Principles of Law “To anticipate a claim, a prior art reference must disclose every limitation of the claimed invention, either explicitly or inherently.” In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). A rejection under 35 U.S.C. § 102 is proper only when the claimed subject matter is identically disclosed or described in the prior art, without any need for picking, choosing and combining various disclosures. In re Arkley, 455 F.2d 586, 587 (CCPA 1972). Findings of Fact 1. Karicherla disclosed an intra-cardiac lead system comprising a lead that is coupled to a medical device capable of providing pacing therapy to the heart chamber, wherein the lead includes an attachment structure that secures the lead to one or both of the septal walls of a patient’s heart. (Karicherla Abstract; col. 2, ll. 10-11; col. 6, ll. 25-67.) Appeal 2011-008920 Application 11/591,447 5 2. Karicherla disclosed that “a variety of different attachment structures may be used in accordance with the teachings herein.” (Id. at col. 17, ll. 61- 62.) 3. Karicherla disclosed that “[a]n attachment structure may be constructed of a variety of materials including, for example, biocompatible materials such as silicone and polyurethane.” (Id. at col. 18, ll. 3-5.) 4. Karicherla disclosed that “[i]n some embodiments the attachment structure may be constructed of a biodegradable material that degrades over time. This type of material may be used, for example, in a case where it may be necessarily to remove the lead sometime in the future.” (Id. at col. 18, ll. 6-10.) 5. Karicherla disclosed that “[i]n some embodiments the attachment structure includes one or more inflatable membranes that expand outwardly from the lead. For example, the lead may include a pair of balloon-like structures,” which Karicherla “referred to as ‘balloons’ for convenience….” (Id. at col. 2, ll. 40-43; col. 25, ll. 26-29.) 6. Karicherla disclosed that “the balloons may be formed in various shapes and constructed of various materials. For example, the balloons may be constructed using biocompatible material such as silicone rubber or polyurethane.” (Id. at col. 28, ll. 2-6.) Analysis When describing its attachment structures in general, Karicherla distinguishes material that is biocompatible and material that is more specifically biodegradable. (Compare FF-3 with FF-4.) Subsequently, when expressly describing the construction of balloon attachment structures, Karicherla only disclosed the material as being biocompatible and not Appeal 2011-008920 Application 11/591,447 6 specifically as biodegradable also. (FF-6.) Thus, we agree with Appellant that Karicherla did not expressly teach that the balloons were composed at least in part of a biocompatible degradable material. Moreover, we agree with Appellant that Karicherla did not disclose that its balloons are necessarily composed of a biodegradable material. Rather, the Examiner’s anticipation rejection involved picking, choosing and combining various disclosures to satisfy this element. See Arkley, 455 F.2d at 587. Accordingly, we reverse the anticipation rejection. Because the anticipation rejection includes the only independent claims on appeal, claims 1, 14, and 21, the obviousness rejections of dependent claims 6-9, 13, 17, 20, and 24-25 must also be reversed for the same reasons. NEW GROUND OF REJECTION Independent claims 1, 14, and 21 are newly rejected under 35 U.S.C. § 103(a) as unpatentable over Karicherla. (37 C.F.R. § 41.50(b)). Principle of Law Picking, choosing and combining various disclosures not directly related to each other by the teachings of the prior art may be entirely proper in the making of a §103 rejection. Arkley, 455 F.2d at 587. Additional Finding of Fact 7. The Specification states that “[a]t least a portion of the balloon fixation element is composed of a biocompatible degradable material, such that once the elongated member is implanted in a patient, at least the portion of the balloon fixation element may degrade in vivo over time.” (Spec. [0007].) Analysis Appeal 2011-008920 Application 11/591,447 7 Karicherla taught an intra-cardiac lead system having an implantable elongated member and a method of using the elongate member in a patient to deliver therapy to a target site. (FF-1.) Karicherla taught that the elongated member comprised an elongated body configured to be coupled to a medical device, i.e., electrical stimulator, to deliver a therapy from the medical device to a target delivery site in a patient (FF- 1); an inflation lumen (FF-5); and a balloon fixation element coupled to the elongated body and configured to receive a fluid via the inflation lumen to expand from a first state to a second state (FF-5,6 ). Karicherla disclosed that the balloon fixation element may be composed of a biocompatible material. (FF-6.) Karicherla did not expressly disclose that the balloon may be composed of a biodegradable material. However, Karicherla generally disclosed that “[i]n some embodiments the attachment structure may be constructed of a biodegradable material that degrades over time. This type of material may be used, for example, in a case where it may be necessary to remove the lead sometime in the future.” (FF-4.) Karicherla also specifically described the balloon as an attachment structure. (FF-5.) Thus, we find that Karicherla would have reasonably suggested to a person of ordinary skill in the art at the time the invention was made to have constructed its balloons using, at least in part, a biocompatible material that was also biodegradable. To the extent that this suggestion is the result of picking, choosing and combining various disclosures not directly related to each other by the teachings of the prior art, such is proper in the making of an obviousness rejection. See Arkley, 455 F.2d at 587. Moreover, we note that Karicherla described a biodegradable material in a similar manner as the instant Specification, i.e., material that “degrades over time.” (See FF-4, 7.) Appeal 2011-008920 Application 11/591,447 8 The amount or duration of time over which the material degrades is not specified, or otherwise limited in either Karicherla or the instant Specification. Thus, a skilled artisan may select a biodegradable material that requires a degradation time that would extend beyond the length of time that the balloon fixation element would be used in and removed from a patient, such that any potential harmful effects of the degradation in vivo may be avoided. Accordingly, we conclude that the inventions of independent claims 1, 14, and 21 would have been obvious to a person of ordinary skill in the art at the time the invention was made over Karicherla. We leave the analysis of whether the pending dependent claims are subject to this rejection based on Karicherla alone or in combination with Kucharczyk, or other available prior art, to the Examiner. SUMMARY We reverse the Examiner’s anticipation and obviousness rejections. A new ground of rejection under 35 U.S.C. § 103(a) as unpatentable over Karicherla is ENTERED for independent claims 1, 14, and 21. 37 C.F.R. § 41.50(b) This decision contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960 (August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)). 37 CFR § 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” Appeal 2011-008920 Application 11/591,447 9 37 C.F.R. § 41.50(b) also provides that the Appellant, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new ground 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.… REVERSED; 37 C.F.R. § 41.50(b) lp Copy with citationCopy as parenthetical citation