Ex Parte Sirimanne et alDownload PDFBoard of Patent Appeals and InterferencesJun 1, 200910961491 (B.P.A.I. Jun. 1, 2009) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte D. LAKSEN SIRIMANNE, DOUGLAS S. SUTTON, NATALIE V. FAWZI, and GAIL LEBOVIC __________ Appeal 2009-004712 Application 10/961,491 Technology Center 3700 __________ Decided:1 June 1, 2009 __________ Before LORA M. GREEN, RICHARD M. LEBOVITZ, and STEPHEN WALSH, Administrative Patent Judges. WALSH, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a biopsy site marker. The Patent Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 The two-month time period for filing an appeal or commencing a civil action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date shown on this page of the decision. The time period does not run from the Mail Date (paper delivery) or Notification Date (electronic delivery). Appeal 2009-004712 Application 10/961,491 STATEMENT OF THE CASE The invention relates to a subcutaneous cavity marking device. (Spec. 1:11.) The Specification explains that after a biopsy sample is removed from the body, there is a need to determine the location, orientation, and periphery of the subcutaneous cavity from which the lesion was removed. (Id. at 2:2-4.) “[T]he inventive device is a biopsy cavity-marking body made of a resilient, preferably bioabsorbable material having at least one preferably radiopaque or echogenic marker.” (Id. at 4:15-16.) Claim 1 is representative and reads as follows: 1. A biopsy site marker comprising: a body of gelatin, and an X-ray detectable metallic element of specific predetermined non-biological configuration embedded in said body of gelatin. Claims 1 and 3-5, which are all the pending claims, are on appeal. The Examiner rejected the claims under 35 U.S.C. § 103(a) as unpatentable over the combined teachings of Krag2 and Stinson.3 The claims have not been argued separately (App. Br. 5), and therefore stand or fall together. 37 C.F.R. § 41.37(c)(1)(vii). OBVIOUSNESS The Issue The Examiner’s position is that Krag disclosed a biopsy site marker comprising a body of gelatin and an X-ray detectable body embedded in the 2 U.S. Patent No. 6,363,940 B1, issued to David N. Krag, Apr. 2, 2002. 3 U.S. Patent No. 7,083,641 B2, issued to Stinson et al., Aug. 1, 2006. 2 Appeal 2009-004712 Application 10/961,491 gelatin body. (Ans. 3.) The Examiner found that Krag did not explicitly teach a metallic element embedded in the gelatin. (Id.) The Examiner found that Stinson taught a medical marker system comprising metal, steel, gold, platinum or metal oxides. (Id.) The Examiner concluded it would have been obvious to apply Stinson’s teachings to Krag’s marker “for the purpose of enhancing detectability and efficiency.” (Id.) Appellants contend that there would have been no need to look beyond Krag for biocompatible materials because Krag’s dye was already biocompatible. (App. Br. 8-9.) Appellants argue that Krag’s device and Stinson’s device have very different functions, and Krag’s flowable dye serves a very specific purpose crucial to the use of Krag’s device. (Id. at 9.) Thus, if modified as suggested, Krag’s devices could no longer “accomplish their intended function of providing an indicator as to when the boundary of a tissue volume has been encountered.” (Id.) Appellants argue that combining the reference teachings in the way the Examiner did was improper. (Id.) Appellants also contend that Krag did not teach a marker material embedded in gelatin, but rather taught a gelatin capsule containing colored dye. (Id. at 10.) The issue is whether Appellants demonstrated that the Examiner’s combination of the reference teachings was improper. 3 Appeal 2009-004712 Application 10/961,491 Findings of Fact Krag 1. Krag described a method of removing tissue that used markers to define the boundary of tissue to be removed, i.e., a biopsy method. (Col. 3, ll. 35-44.) 2. Krag’s markers were biopsy site markers because they defined a boundary of tissue volume for removal. 3. Krag described a “surgical marker that includes a quantity of colored dye and a capsule encasing the quantity of colored dye. One or both of the dye and capsule are readily imagable by at least one of ultrasonic, magnetic resonance and X-ray energy.” (Col. 3, ll. 1-5.) 4. Krag’s marker 30g comprised “a capsule . . . filled with a colored dye 78, e.g., a vital dye”. (Col. 8, ll. 30-32.) 5. Krag taught that “[t]he capsule is made from gelatin or other suitable material . . . relatively easily cut by the cutting tool used to remove the tissue volume.” (Col. 8, ll. 36-41.) 6. Krag taught that “[m]arker 30g provides a visual guide as to its location by releasing colored dye 78 when severed by a surgical cutting tool.” (Col. 8, ll. 41-43.) Stinson 7. Stinson described a radiopaque marker for use on an implantable endoprosthesis. (Col. 1, ll. 9-11.) 8. According to Stinson, there was “a need for an improved radiopaque marker for use in medical devices, particularly in temporary medical 4 Appeal 2009-004712 Application 10/961,491 devices having low radiopacity,” and the need was “particularly important for surgery . . . performed under fluoroscopy.” (Col. 1, ll. 56-63.) 9. Stinson’s markers could include “an oxide or salt material,” “barium sulfate, bismuth trioxide, iodine, iodide, titanium oxide, zirconium oxide, gold, platinum, silver, tantalum, niobium, stainless steel, or combinations thereof.” (Col. 4, ll. 50-54.) 10. In one Stinson embodiment, a “retrievable radiopaque marker 14 may be loosely incorporated into the implantable endoprosthesis 16.” (Col. 13, ll. 17-19.) 11. Marker 14 could have a radiopaque core 13 within a hollow portion. (Col. 14, ll. 23-26.) 12. “[R]adiopaque core 13 may be solid or include a casing surrounding a solid, gel, powder, or combination thereof and be held in place with a relatively weak bioabsorbable adhesive gelatin . . . .” (Col. 14, ll. 32- 35.) Principles of Law A rejection for obviousness must include “articulated reasoning with some rational underpinning to support the legal conclusion.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007), quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). The proper question to ask is whether a person of ordinary skill in the art would have seen a benefit to combining the prior art teachings. KSR, 550 U.S. at 424; see also In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) 5 Appeal 2009-004712 Application 10/961,491 (the desirability of the combination may arise from the nature of the problem, teachings of references, or the ordinary knowledge of those skilled in the art). “[A] combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. . . . [I]f 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.” KSR, 550 U.S. at 401. “‘A reference is reasonably pertinent if, even though it may be in a different field from that of the inventor’s endeavor, it is one which, because of the matter with which it deals, logically would have commended itself to an inventor’s attention in considering his problem.’ In re Clay, 966 F.2d 656, 659 (Fed. Cir. 1992). In other words, ‘familiar items may have obvious uses beyond their primary purposes.’ KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, [420], 127 S.Ct. 1727, 1742 (2007).” In re Icon Health and Fitness, Inc., 496 F.3d 1374, 1379-80 (Fed. Cir. 2007) (a reference describing a folding bed found analogous to an Appellant’s folding treadmill). References need not be capable of physical combination in order to show obviousness. In re Etter, 756 F.2d 852, 859, 225 USPQ 1, 6 (Fed. Cir. 1985) (in banc); see also, In re Nievelt, 482 F.2d 965, 968, 179 USPQ 224, 226 (CCPA 1976) (“Combining the teachings of references does not involve an ability to combine their specific structures”) (emphasis in original). 6 Appeal 2009-004712 Application 10/961,491 Analysis We agree with the Examiner’s finding that Krag disclosed a biopsy site marker. (FF2.) The Examiner also found that Krag’s marker was an “X-ray detectable body embedded in said body of gelatin,” citing col. 5, ll. 37-53. (Ans. 3.) We do not agree that the cited passage made that disclosure. Krag disclosed a body of gelatin, i.e. a gelatin capsule, containing a vital dye. (FF4 and FF5.) However, the Examiner did not allege, nor produce evidence, that a vital dye is X-ray detectable. We agree with the Examiner’s finding that Krag did not teach a metallic element embedded in the body of gelatin. (Ans. 3.) We agree with the Examiner’s finding that Krag and Stinson are in the same art, detectable medical implants, and therefore pertinent to each other and to Appellants’ claimed subject matter. See Icon Health, 496 F.3d at 1379-80. We agree with the Examiner’s finding that Stinson disclosed a marker system comprising metal, steel, metal oxides, titanium oxide, gold, platinum and other such materials. (FF9.) Based on the findings made, the Examiner concluded: “[i]t would therefore have been obvious to one of ordinary skill in the art to use the teaching by Stinson to modify the teaching by Krag for the purpose of enhancing detectability and efficiency (col. 1 lines 56-65, col. 15 lines 39-43).” (Ans. 3.) The particular modification(s) the Examiner had in mind was not stated.4 The explanation did not identify the modification(s) that would have 4 See MANUAL OF PATENT EXAMINING PROCEDURE § 706.02(j) (“the [E]xaminer should set forth in the Office Action: . . . (C) the proposed modification of the applied reference(s) necessary to arrive at the claimed subject matter . . . .”). 7 Appeal 2009-004712 Application 10/961,491 been obvious, nor did it explain why one of ordinary skill in the art would have thought a particular modification(s) desirable. “Under the correct analysis, any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” KSR, 550 U.S. at 421. The rejection did not indicate a reason. We find that the statements explaining the rejection do not meet the KSR standard of “articulated reasoning with some rational underpinning to support the legal conclusion.” KSR, 550 U.S. at 418. We note that the section of the Examiner’s Answer headed “(10) Response to Argument,” references Stinson, col. 14, ll. 10-39, as supporting a finding that Stinson taught a “gelatin core.” (Ans. 4.) We do not agree. Stinson taught using “adhesive gelatin” to adhere a radiopaque core in a cavity of a marker. (FF12.) The Examiner’s reliance on that disclosure is unclear. To the extent the Examiner may be implying that the Stinson embodiment disclosed at col. 14 reads on a body of gelatin and an X-ray detectable metallic element, Appellants have not been given notice of a clearly stated finding in that regard. CONCLUSIONS OF LAW The explanation of the obviousness rejection did not include “articulated reasoning with some rational underpinning to support the legal conclusion” and therefore failed to state a prima facie case of obviousness. 8 Appeal 2009-004712 Application 10/961,491 SUMMARY We reverse the rejection of claims 1 and 3-5 under 35 U.S.C. § 103(a) as unpatentable over the combined teachings of Krag and Stinson. REVERSED dm WELSH & FLAXMAN LLC 2000 DUKE STREET, SUITE 100 ALEXANDRIA, VA 22314 9 Copy with citationCopy as parenthetical citation