Ex Parte Bogojevic et alDownload PDFPatent Trial and Appeal BoardJun 26, 201311626527 (P.T.A.B. Jun. 26, 2013) Copy Citation 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. 11/626,527 01/24/2007 Aleksander Bogojevic SCHWP0271USA 1366 46140 7590 06/26/2013 DON W. BULSON (BRAI) RENNER, OTTO, BOISSELLE & SKLAR, LLP 1621 EUCLID AVENUE - 19TH FLOOR CLEVELAND, OH 44115 EXAMINER NELSON, KERI JESSICA ART UNIT PAPER NUMBER 3772 MAIL DATE DELIVERY MODE 06/26/2013 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 ALEKSANDER BOGOJEVIC, CHRISTIAN MAIER, GEORG CHRISTIAN, and JORG UHDE __________ Appeal 2011-011623 Application 11/626,527 Technology Center 3700 __________ Before JEFFREY N. FREDMAN, ERICA A. FRANKLIN, and SHERIDAN K. SNEDDEN, Administrative Patent Judges. FRANKLIN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a sterile drape. The Patent Examiner rejected the claims as failing to comply with the written description requirement, anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. STATEMENT OF THE CASE The invention concerns a sterile drape useful to cover objects in a sterile environment and suitable for tracking objects, such as attachments of C-arm x-ray apparatus. (Spec. 1, ll. 9-12.) Appeal 2011-011623 Application 11/626,527 2 Claims 1, 3-15, 17-20, 22 and 24-26 are on appeal. Claims 1 and 26 are representative and read as follows: 1. A sterile drape for a trackable medical device having at least one trackable marker spatially trackable by a medical tracking system, comprising: a draping portion for draping over the trackable medical device; a reinforced film portion having a first portion and a second portion, at least the second portion having a viewing surface configured to view therethrough the at least one trackable marker, the reinforced film portion transparent to electromagnetic radiation in at least one of the visible or infrared spectrum, and the reinforced film portion more resistant to folding than the draping portion; and a holding or tensing device formed in or on the first portion of the reinforced film portion and operative to draw the reinforced film portion taut or smooth on or over a surface of the medical device to enable the medical tracking system to optically track the at least one trackable marker, wherein said holding or tensing device does not impede transmission of electromagnetic radiation through the viewing surface of the second portion when the electromagnetic radiation emitted or reflected by the at least one trackable marker is normal to the viewing surface. 26. The sterile drape according to claim 1, wherein the holding or tensing device is operative to alter a dimension of the sterile drape. The Examiner rejected the claims as follows: • claims 1, 3-15, 17-20, 22 and 24-26 under 35 U.S.C. § 112, first paragraph as failing to comply with the written description requirement; • claims 1, 3, 15, 17-20, 22 and 24 under 35 U.S.C. §102(b) as anticipated by Grier-Idris;1 • claims 1, 3-5, 12, 14, 15, 17-20, 22 and 24 under 35 U.S.C. §102(b) as anticipated by McNeirney;2 1 US Patent No. 5,197,493 issued to Carletta Grier-Idris, Mar. 30, 1993. 2 US Patent No. 6,283,125 B1 issued to John C. McNeirney, Sep. 4, 2001. Appeal 2011-011623 Application 11/626,527 3 • claims 6-11 and 14 under 35 U.S.C. § 103(a) as unpatentable over Grier-Idris; • claims 6-11 under 35 U.S.C. § 103(a) as unpatentable over McNeirney; and • claims 25 and 26 under 35 U.S.C. § 103(a) as unpatentable over Grier-Idris and McCracken.3 WRITTEN DESCRIPTION I. Claims 1, 18 and 24 The Examiner’s position is that the recited claim limitation “when the electromagnetic radiation emitted or reflected by the at least one trackable marker is normal to the viewing surface” is matter which was not described in the Specification in such a way as to reasonably convey to one skilled in the relevant art that the inventors had possession of the claimed invention at the time the application was filed. (Ans. 3-4.) Appellants contend that this claim limitation is adequately described because the Specification “describes the drape as being transparent to electromagnetic radiation, for example, in the infrared and visible spectrums.” (App. Br. 9)(citing Spec. 3, l.31 - 4, l.1.) According to Appellants, one skilled in the art would understand that “[i]f the drape is transparent to electromagnetic radiation, then it is inherent that electromagnetic radiation normal to a viewing surface of the drape will not be impeded by the surface.” (Id. at 9-10.) Appellants assert that 3 US Patent No. 4,614,183 issued to Robert W. McCracken et al., Sep. 30, 1986. Appeal 2011-011623 Application 11/626,527 4 “[m]oreover, a person having ordinary skill in the art would readily recognize that a film portion that is transparent to electromagnetic radiation would not impede electromagnetic radiation that is normal to a viewing surface of the film portion.” (Id. at 10.) The Examiner responds that “the claim language is directed to the condition of use of the trackable marker and the electromagnetic radiation emitted or reflected by the trackable marker[,] which was not discussed explicitly or implicitly in the disclosure as originally filed as being normal to the viewing surface of the second portion of the reinforced film portion.” (Ans. 11.) In the Reply Brief, Appellants note that the Examiner’s position is that the disputed claim limitation is not supported explicitly or implicitly by the Specification, but “fails to address the fact that the limitation is an inherent property of a film drape used in optical navigation,” as Appellants have asserted. (Reply Br. 2.) Specifically, Appellants assert that it was well known in the art that “optical navigation relies on a line-of-sight between an object being tracked (e.g., a marker) and a tracking device (e.g., a camera system).” (Id.) According to Appellants, a skilled artisan would have understood that “a film of material that is transparent to electromagnetic radiation (e.g., infrared light) and being designed for use in optical navigation inherently is transparent to electromagnetic radiation when the emitted electromagnetic radiation is normal to a viewing surface of the film.” (Id.) We agree. Accordingly, we reverse the written description rejection of claims 1, 18 and 24. Appeal 2011-011623 Application 11/626,527 5 II. Claim 26 The Examiner’s position is that the recited claim limitation “wherein the holding or tensing device is operative to alter a dimension of the sterile drape” is matter which was not described in the Specification in such a way as to reasonably convey to one skilled in the relevant art that the inventors had possession of the claimed invention at the time the application was filed. (Ans. 4.) Appellants contend that the claim phrase is supported by both the Specification description of the holding or tensing device (e.g. a belt-hole, a rubber tie, a Velcro fastener, etc.) and Specification Figure 1 illustrating an exemplary holding or tensing device. (App. Br. 10.) Figure 1 is reproduced below: Figure 1 illustrates an exemplary drape formed as a tubular film in accordance with the invention. (Spec. 4, ll. 14-15.) Appellants assert that “[a]s the laces 6 of the belt-hole tie 4 are drawn out, the diameter of the sterile drape 1 is altered, i.e., a dimension of the sterile drape is altered.” (Id. at 11.) The Examiner responds that drawing the laces out alters a diameter encompassed within the reinforced film portion, and subsequently alters the Appeal 2011-011623 Application 11/626,527 6 diameter encompassed within the sterile drape, but does not alter the dimensions of the sterile drape itself. (Ans. 11.) We disagree with the Examiner. While we agree that altering the dimension encompassed within the sterile drape, which is formed as a tubular film (e.g. a bag) does not change the sterile drape itself, such a change may alter a dimension of the drape as it relates to the object being enclosed by the drape, i.e., the diameter of the bag, thereby changing the three dimensional shape of the drape. We agree with Appellants that the Specification description of the holding or tensing device, along with the illustration in Figure 1, would have conveyed with reasonable clarity to those skilled in the art that the inventors were in possession of the invention currently claimed. See In re Alton, 76 F.3d 1168, 1172 (Fed. Cir. 1996). Accordingly, we reverse the written description rejection of claim 26. ANTICIPATION/OBVIOUSNESS I. Grier-Idris The Examiner found that Grier-Idris disclosed a sterile drape, as claimed. (Ans. 4-5.) Appellants contend that in Grier-Idris, “if the electromagnetic radiation is traveling from the top layer 14 toward the bottom layer 25, the electromagnetic radiation will pass through layers 14 and 12 unimpeded until it strikes the adhesive layer 24.” (App. Br. 15-16.) According to Appellants, “one having ordinary skill in the art would not reasonably interpret only the two layers 12 and 14 as a viewing surface.” (Id. at 16.) Further, Appellants assert that such interpretation would not be operable as a sterile drape for optical navigation, as a marker “could not reasonably be Appeal 2011-011623 Application 11/626,527 7 arranged between the adhesive 24 and the layers 12 or 14.” (Id.) According to Appellants, even if one considers only layer 12 or 14 as a viewing surface, the electromagnetic radiation normal to this surface must pass through all of the layers, i.e., layers 12, 14, 24 (the adhesive layer) and 25. (Id.) Appellants assert that “[s]ince Grier-Idris does not specify the use of electromagnetic transparent adhesive, then a conventional adhesive is presumed,” which would “at least partially impede the transmission of electromagnetic radiation,” contrary to the claimed invention. (Id. at 16-17.) In Response, the Examiner explained that “the claim language does not require the transmission of electromagnetic radiation through the holding or tensing device, but merely that the holding or tensing device does not impede transmission of electromagnetic radiation through the viewing surface of the second portion of the reinforced film portion.” (Ans. 11.) Further, the Examiner responded that transparent adhesive used in medical devices were known in the art, as evidenced by Grossman, Sieverding, and Ansell. (Id. at 12.) Therefore, the Examiner reasoned that selecting such a known transparent adhesive as the adhesive in Grier-Idris’ drape “would enable the drape as a whole to be transparent to the transmission of electromagnetic radiation …through both the viewing surface … and the holding or tensing device.” (Id.) In the Reply Brief, Appellants assert that the Examiner’s reference to Grossmann, Sieverding and Ansell are “irrelevant” and reliance on these references in an anticipation rejection is “improper.” (Reply Br. 6.) Moreover, Appellants assert that “there is no reasonable basis to apply such adhesive to the system of Grier-Idris.” (Id. at 7.) Appeal 2011-011623 Application 11/626,527 8 After considering the evidence and arguments, we conclude that the Examiner has established that Grier-Idris anticipates the claimed invention. Appellants assert that the viewing surface of Grier-Idris must comprise the adhesive layer 24, as this layer sits between the upper layers 12 and 14 and the location where a marker would be placed. (See App. Br. 16.) Yet, Appellants assert that there would be no reason for Grier-Idris’ adhesive layer to be transparent in an incise system. (Reply Br. 7.) We disagree. Grier-Idris disclosed that its incise system is applied by removing the release paper 25, exposing the adhesive 24 for adhesion to a patient’s skin in the intended area of the surgical procedure. (Grier-Idris col. 4, ll. 49-52.) Ensuring that the fenestrated area 26 is properly aligned, an incision can be made through the layer 12, the fenestrated area 26 of layer 14 and the patient’s skin within the area defined by the fenestrated area 26. (Id. at ll. 52-58.) As the adhesive is affixed to the patient’s skin through which the incision is made, it is inherently understood that this adhesive would comprise a material that would not impede viewing of this portion of the skin to be incised, e.g., by being transparent. Grier-Idris disclosed that the adhesive layer has a “composition of which is well known to those having ordinary skill in the art.” (Id. at col. 3, ll. 30-32.) In response to Appellants’ argument that this disclosure required a “conventional adhesive” that would impede viewing, (App. Br. 16-17) the Examiner referred to Grossmann,4 Sieverding5 and Ansell6 as evidence that transparent adhesive was a “composition well known to those having ordinary skill in the art,” as taught 4 US Patent No. 4,372,303 issued to Frederic Grossmann et al., Feb. 8, 1983. 5 US Patent No. 4,699,146 issued to David L. Sieverding, Oct. 13, 1987. 6 US Patent No. 5,183,664 issued to Christopher W. G. Ansell, Feb. 2, 1993. Appeal 2011-011623 Application 11/626,527 9 by Grier-Idris. (Ans. 12.) Contrary to Appellants’ position, the Examiner’s citation to these references was not improper, as the Examiner provided the references as evidence that transparent medical adhesive was within the scope of Grier-Idris’ disclosure and not as evidence suggesting a modification of Grier-Idris. See In re Samour, 571 F.2d 559, 563 (CCPA 1978) (“Additional references cited in a rejection under 35 U.S.C. § 102(b) are not relied on for a suggestion or incentive to combine teachings to meet claim limitations (as in a rejection under 35 U.S.C. s 103), but, rather, to show that the claimed subject matter, every material element of which is disclosed in the primary reference, was in possession of the public.”). Accordingly, we affirm the anticipation rejection of claim 1over Grier-Idris. Claims 3, 15, 17, 20, 22 and 24 have not been argued separately and therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii). Regarding the obviousness rejection of dependent claims 6-11 and 14 over Grier-Idris, Appellants assert only that these claims “depend from claim 1 and thus can be distinguished from Grier-Idris for at least the same reasons set forth above [regarding the anticipation rejection over Grier-Idris] with respect to claim 1.” (App. Br. 27.) As we did not find Appellants’ arguments persuasive regarding the anticipation rejection of claim 1, we also do not find those arguments persuasive of nonobviousness regarding claims 6-11 and 14. Accordingly, we affirm the obviousness rejection of claims 6-11 and 14 over Grier-Idris. II. McNeirney The Examiner found that McNeirney disclosed the claimed invention. (Ans. 6.) In particular, the Examiner found that McNeirney disclosed “a Appeal 2011-011623 Application 11/626,527 10 holding or tensing device (ultrasonic welding, heat sealing, solvent welding, gluing, etc. for attaching the window to the sterile drape) … operative to draw the reinforced film portion taut or smooth on or over a surface of the medical device,” as recited by the claimed invention. (Id.) Appellants contend that that “the alleged holding or tensing device of McNeirney attaches the window 14 to the bag12 so as to make the two pieces into a single unit … [and] is not operative to draw the window (i.e., the alleged film portion) taut or smooth as claimed.” (App. Br. 23.) We agree with Appellants. While McNeirney’ s bond (ultrasonic welding, heat sealing, solvent welding, gluing, etc.) between the window and bag/drape is operative to hold the film portion over a surface of the device, there is no disclosure or suggestion that the bond is actually operative to draw the film taut or smooth on or over the surface. Indeed, the Examiner acknowledged that the “the attachment between the window (14) and the drape (12) enables the window to be held taut in place on the surface of a medical device when in use.” (Ans. 13)(emphasis added.) Accordingly, we reverse the anticipation rejection over McNeirney. Regarding the obviousness rejection of dependent claims 6-11 over McNeirney, Appellants assert that these claims “depend from claim 1 and thus can be distinguished from McNeirney for at least the same reasons set forth above [regarding the anticipation rejection over McNeirney] with respect to claim 1.” (App. Br. 27.) We agree, as the Examiner again relied on McNeirney as disclosing the holding or tensing device recited in claim 1 in the obviousness rejection. Accordingly, we reverse the obviousness rejection over McNeirney. Appeal 2011-011623 Application 11/626,527 11 III. Grier-Idris and McCracken The Examiner’s position is that Grier-Idris disclosed the claimed invention substantially as claimed, as described above. (Ans. 10.) However, the Examiner found that Grier-Idris did not teach that its holding or tensing device is (a) operative to alter a position of a first end of the first portion of the reinforced film portion relative to a second end of the first portion, or (b) operative to alter a dimension of the sterile drape. (Id.) The Examiner found that McCracken disclosed an adhesive film dressing useful for surgical incise drape and which comprises an elastic film which may be stretched over the application site. (Id.) According to the Examiner, it would have been obvious for a person of ordinary skill in the art at the time the invention was made to have modified the drape taught by Grier-Idris with an elastomeric polymeric film for the reinforced film portion and draping portion, as taught by McCracken, to more readily conform to the surface on which the drape is secured. (Id.) Appellants contend that McCracken’s adhesive film dressing includes three parts: a film 10, an adhesive 11 that coats the film, and a release paper that covers the adhesive. (App. Br. 29.) Appellants assert that while McCracken’s “adhesive 11 moves with the film 10 as the film 10 is stretched, the adhesive itself is not operative to alter a position of the first and second end of the dressing.” (Id.) Additionally, Appellants assert that the adhesive is not operative to alter a dimension of the film. (Id.) According to Appellants, “the adhesive simply moves as the dimensions of the film 10 are altered, e.g., as a person grasps both ends of the film and pulls them apart.” (Id.)(citing McCracken Fig. 2.) We agree with Appellants for the reasons discussed. Appeal 2011-011623 Application 11/626,527 12 Accordingly, we reverse the obviousness rejection of claims 25 and 26 over Grier-Idris and McCracken. SUMMARY We reverse the rejection of claims 1, 3-15, 17-20, 22 and 24-26 under 35 U.S.C. § 112, first paragraph as failing to comply with the written description requirement; we affirm the rejection of claims 1, 3, 15, 17-20, 22 and 24 under 35 U.S.C. §102(b) as anticipated by Grier-Idris; we reverse the rejection of claims 1, 3-5, 12, 14, 15, 17-20,22 and 24 under 35 U.S.C. §102(b) as anticipated by McNeirney; we affirm the rejection of claims 6-11 and 14 under 35 U.S.C. § 103(a) as unpatentable over Grier-Idris; we reverse the rejection of claims 6-11 under 35 U.S.C. § 103(a) as unpatentable over McNeirney; and we reverse the rejection of claims 25 and 26 under 35 U.S.C. § 103(a) as unpatentable over Grier-Idris and McCracken. 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-IN-PART lp Copy with citationCopy as parenthetical citation