Ex Parte Mongeon et alDownload PDFBoard of Patent Appeals and InterferencesJul 20, 201210663570 (B.P.A.I. Jul. 20, 2012) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte LUC R. MONGEON, JESUS CASAS-BEJAR, H. TOBY MARKOWITZ, DAISY P. CROSS, JANELLE BLUM, MICHAEL EBERT, and TIMOTHY G. LASKE __________ Appeal 2011-003497 Application 10/663,570 Technology Center 3700 __________ Before DONALD E. ADAMS, DEMETRA J. MILLS, and LORA M. GREEN, Administrative Patent Judges. GREEN, Administrative Patent Judge. DECISION ON APPEAL This is a decision on appeal under 35 U.S.C. § 134 from the Examiner’s rejection of claims 21-24, 26, 29-33, 35-42, and 46-54. We have jurisdiction under 35 U.S.C. § 6(b). Appeal 2011-003497 Application 10/663,570 2 STATEMENT OF THE CASE Claim 21 is representative of the claims on appeal, and reads as follows: 21. A medical lead comprising: a lead body; a porous electrode mounted on the lead body to deliver electrical stimulation to a stimulation site within a patient; a genetic material that causes expression of at least one of a connexin or a gap-junction by the tissue at the stimulation site, wherein the expression of the at least one of the connexin or the gap-junction by the tissue at the stimulation site increases the conductivity of the tissue; and a chamber body that defines a chamber, the chamber containing a polymeric matrix that absorbs the genetic material and degrades to elute the genetic material to tissue at the stimulation site via the porous electrode. The following ground of rejection is before us for review: Claims 21-24, 26, 29-33, 35-42, and 46-57 stand rejected under 35 U.S.C. § 103(a) as being rendered obvious by the combination of Soykan,1 Heil,2 and Girouard3 (Ans. 5). We affirm. ANALYSIS We adopt the Examiner’s findings and conclusions as our own, and highlight the following: The Examiner relies on Soykan for teaching a system “comprising a lead for delivering electrical stimulation to a tissue . . . and eluting genetic material from a polymeric matrix . . . comprising extracellular collagen” 1 Soykan et al., US 6,151,525, issued Nov. 21, 2000. 2 Heil, Jr. et al., US 4,819,662, issued Apr. 11, 1989. 3 Girouard et al., US 2004/0158289 A1, published Aug. 12, 2004. Appeal 2011-003497 Application 10/663,570 3 (Ans. 5). The Examiner notes that “Soykan does not disclose a separable chamber that elutes material from a porous electrode or that the genetic material causes expression of connexin-43 or a gap-junction” (id. at 6). The Examiner cites Heil for teaching “a lead with a removable chamber that elutes substances through a porous electrode for the purpose of providing controlled release of pharmacological agents at the site of electrical therapy” (id.). The Examiner relies on Girouard for teaching that expression of connein-43 repairs damaged heart tissue (id.). The Examiner concludes: it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Soykan’s invention by providing a lead with a chamber that elutes substances through a porous electrode for the purpose of providing controlled release of pharmacological agents at the site of electrical therapy and providing a cardiac therapy comprising delivering connexin for the purpose of repairing damaged heart tissue. (Id.) Appellants argue claims 21-24, 26, and 29-33 as a group, of which we choose claim 21 as representative. Appellants assert that “the Examiner has failed to establish an apparent reason with a rational underpinning for modifying Soykan in view of Heil and Girouard, and, thus, failed to establish a prima facie case of obviousness of claim 21” (App. Br. 8). Appellants assert that the Examiner’s reasoning that the ordinary artisan “would have looked to Heil to modify Soykan in order to provide ‘controlled release of pharmacological agents at the site of electrical therapy’” ignores Appeal 2011-003497 Application 10/663,570 4 the “fact that the system disclosed by Soykan already provides controlled release of a genetic material at the site of electrical therapy” (id.). Appellants argue further that contrary to the Examiner’s finding that Soykan is silent as to where the polymeric carrier for the genetic material resides on the electrical stimulation device, Soykan teaches “that genetic material may be coated on or otherwise incorporated into a carrier, such as an electrical stimulator capsule or a catheter, and, therefore, Soykan discloses a carrier configuration” (id. at 8-9). Appellants assert that “[a]bsent access to Appellant’s disclosure, one having ordinary skill in the art would not have had any apparent reason to incorporate the electrical stimulator coating disclosed by Soykan into a chamber of the lead disclosed by Heil” (id. at 9). According to Appellants, the “coating disclosed by Soykan differs in operation from the chamber delivery system disclosed by Heil” (id.). Appellants further assert that “Heil does not provide any indication that the porous electrode is advantageous over the coating disclosed by Soykan for releasing a genetic material, or provides some expected beneficial result over the coating disclosed by Soykan,” and thus there is no reason to modify Soykan with Heil (id.). Appellants further assert that Soykan already discloses an electrical stimulation device that carries genetic material as a coating, and thus again there is no reason to modify Soykan with Heil (id. at 9-10). Appellants’ arguments have been carefully considered, but are not found to be convincing. “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield Appeal 2011-003497 Application 10/663,570 5 predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. Id. at 417. While holding that some rationale must be supplied for a conclusion of obviousness, the Supreme Court nonetheless rejected a “rigid approach” to the obviousness question, and instead emphasized that “[t]hroughout this Court’s engagement with the question of obviousness, our cases have set forth an expansive and flexible approach . . . .” Id. at 415. The Court also rejected the use of “rigid and mandatory formulas” as being “incompatible with our precedents.” Id. at 419; see also id. at 421 (“Rigid preventative rules that deny factfinders recourse to common sense, however, are neither necessary under our case law nor consistent with it.”). The Court thus reasoned that the analysis under 35 U.S.C. § 103 “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; see also id. at 421. On this record, both Soykan and Heil deliver a therapeutic material to a patient’s heart tissue using a polymeric carrier (see, e.g., Soykan, col. 11, ll. 15-21; Heil col. 4, ll. 45-51). The polymeric material of Soykan appears Appeal 2011-003497 Application 10/663,570 6 to surround the lead (see, e.g., Soykan, Fig. 1), whereas, as found by the Examiner, the polymeric material of Heil uses a cavity behind a porous electrode (see, e.g., Heil, col. 4, ll. 45-53). But as both allow for the therapeutic material to be delivered to the cardiac tissue, we agree with the Examiner to use a chamber disposed behind a porous lead to place the polymeric material containing the genetic material to be delivered as taught by Soykan as both Soykan and Heil teach the lead allows for delivery of the therapeutic tissue to the cardiac tissue. Appellants also assert that the drug disclosed by Heil and the genetic material taught by Soykan “may have different purposes and different properties,” and thus “there may be different considerations and objectives for elution of a drug versus elution of a genetic material” (App. Br. 10). According to Appellants, “[n]either the Heil nor Soykan disclosures provide reasonable support for asserting that modifying Soykan in view of Heil to include a matrix that elutes a genetic material to tissue at a stimulation site via a porous electrode would reasonably be expected to be successful” (id. at 11). Again, Appellants’ arguments are not convincing. As noted above, both the lead of Soykan and the lead of Heil allow for delivery of a therapeutic material from a polymeric matrix to surrounding cardiac tissue. Thus, the method of delivery of both references is the same—the only thing that differs is the location of the polymeric matrix, in Soykan it surrounds the lead, and in Heil it is located behind a porous electrode. Thus, the ordinary artisan would have had a reasonable expectation that the using the Appeal 2011-003497 Application 10/663,570 7 structure of Heil, wherein the polymeric material is in a chamber behind a porous electrode, would allow for delivery of the genetic material of Soykan. See In re O’Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988) (noting that all that is required is a reasonable expectation of success, not absolute predictability of success). Appellants argue further that the Examiner does not “provide any articulated reasoning for why one having ordinary skill in the art would have looked to Girouard to modify Soykan” (App. Br. 11). Appellants assert that the Examiner’s reasoning that the ordinary artisan would have modified Soykan with Girouard to provide a cardiac therapy to deliver connexin to repair heart tissue is circular and “lacks a rational underpinning” (id.). Specifically, Appellants assert that “Girouard does not provide any indication that connexin is advantageous over the genetic material disclosed by Soykan, or provides some expected beneficial result over the coating disclosed by Soykan” (id.). Appellants assert further that Girouard proposes the use of the genetic material than Soykan, as Girouard conditions donor cells, prior to administration to the area to be treated, whereas Soykan discloses that the cells are converted in vivo (id. at 12). Appellants argue that “[n]either Soykan nor Girouard provides any indication that expression of connexin, which takes place ex vivo in the Girouard reference, may be simply substituted in the in vivo technique disclosed by Soykan, as asserted by the Examiner” (id. at 13). Appellants’ arguments are not convincing. Soykan teaches the delivery of nucleic acids to cardiac tissue, wherein the nucleic acid converts Appeal 2011-003497 Application 10/663,570 8 noncontracting cells to contracting cells (Soykan, col. 7, ll. 53-63). Girouard is drawn to combined cell and electrical therapy of cardiac tissue (Girouard, p. 1, ¶ 8). Girouard teaches that the cells may be conditioned with a transgene, encoding, for example, contractile proteins, or a connexin, such as connexin-43 (id. at p. 12, ¶146). Girouard also teaches that the delivery of the transgene may be accomplished by any means (id. at p. 13, ¶153). Although Girouard teaches in vitro conditioning of the cells, Soykan teaches direct delivery of the genetic material to the cardiac tissue in vivo by means of the polymeric material surrounding the lead. Thus, the ordinary artisan, reading Soykan, Girouard, and Heil, would understand that any desired gene, such as the contractile proteins or connexins of Girouard, may be delivered by the device taught by Soykan and Heil, as Soykan teaches the direct delivery of genetic material to cardiac tissue in vivo. As to claim 46, Appellants argue that the Examiner relies on inherency, reasoning “that ‘[b]ecause Soykan is in effect creating new contractile tissue around the stimulation device, this inherently creates a new arbitrary ‘preferred conduction pathway’’” (App. Br. 17). Appellants argue the fact that a certain characteristic may be present is not sufficient to support a finding of inherency (id.). Appellants assert that “claim 46 recognizes that delivering a genetic material that causes expression of at least one of a connexin or a gap-junction by the tissue at the stimulation site to increase the conductivity of the tissue at the stimulation site can form a preferential conduction pathway to the bundle of His or a Purkinje fiber by increasing the conductivity of the tissue relative to other (e.g., adjacent) tissue through which the stimulation may also traverse” (id. at 18-19). Appeal 2011-003497 Application 10/663,570 9 Claim 46 is drawn to the lead of claim 21, wherein the genetic material is adapted to cause expression of at least one of a connexin or a gap-junction by the tissue at the stimulation site to increase the conductivity of the tissue at the stimulation site and create a preferential conduction pathway between the stimulation site and at least one of a bundle of His or a Purkinje fiber of a heart of the patient. As noted by the Examiner (Ans. 12), claim 46 is thus drawn to an apparatus claim, wherein the function of the genetic material is recited. That is, as found by the Examiner, “[t]here is no method step of applying the genetic material to a certain location to create a preferred pathway, but merely a genetic material adapted to create a preferential conduction pathway” (id.). As Appellants have not explained how the functional limitation limits the structure of the apparatus, we affirm the rejection as to claim 46 as well. As to claims 35-42, Appellants essentially reiterate the arguments made with respect to claim 21, and as to claim 54, Appellants essentially reiterate the arguments made with respect to claim 46 (App. Br. 20). Those arguments are not found to be convincing for the reasons set forth above. SUMMARY We affirm the rejection of claims 21-24, 26, 29-33, 35-42, and 46-57 under 35 U.S.C. § 103(a) as being rendered obvious by the combination of Soykan, Heil, and Girouard. Appeal 2011-003497 Application 10/663,570 10 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. § 1.136(a). AFFIRMED cdc Copy with citationCopy as parenthetical citation