Ex Parte CAPOTE et al

Patent Trials and Appeals BoardFeb 19, 2019

14663034 - (D) (P.T.A.B. Feb. 19, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 14/663,034 03/19/2015 132492 7590 02/21/2019 Harness Dickey (Medtronic Surgical Technologies) 5445 Corporate Drive Suite 200 Troy, MI 48098 Marco CAPOTE 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 507 4A-000163-US 6778 EXAMINER IP,JASONM ART UNIT PAPER NUMBER 3793 NOTIFICATION DATE DELIVERY MODE 02/21/2019 ELECTRONIC 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. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): troymailroom@hdp.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MARCO CAPOTE and MATTHEW F. DICORLETO Appeal2018-001299 Application 14/663,034 Technology Center 3700 Before MICHELLE R. OSINSKI, WILLIAM A. CAPP, and LEE L. STEPINA, Administrative Patent Judges. CAPP, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellants 1 seek our review under 35 U.S.C. Â§ 134(a) of the final rejection of claims 1-8 and 10-13 under 35 U.S.C. Â§ 103(a) as unpatentable over Csavoy (US 8,108,025 B2, iss. Jan. 31, 2012) and Piferi (US 8,195,272 B2, iss. June 5, 2012) and of claims 9 and 14--20 over Csavoy, Piferi, and Glassman (US 4,524,767, iss. June 25, 1985). We have jurisdiction under 35 U.S.C. Â§ 6(b). We AFFIRM-IN-PART. 1 Medtronic Navigation, Inc., is the Applicant and real party in interest. Appeal Br. 2. Appeal2018-001299 Application 14/663,034 THE INVENTION Appellants' invention relates to a patient tracking apparatus for optical surgical navigation. Spec. ,r 1. Claim 1, reproduced below, is illustrative of the subject matter on appeal. 1. A skin-based patient tracking apparatus for surgical navigation comprising: an adhesive layer of adhesive material; a plurality of surgical tracking elements for use in continuously tracking movement of a patient's skin during surgery; a base layer between the adhesive layer and the plurality of surgical tracking elements; and an outer layer covering the plurality of surgical tracking elements; wherein the adhesive material sticks the skin-based patient tracking apparatus to the patient's skin such that movement of the patient's skin results in corresponding movement of the surgical tracking elements to provide the skin-based tracking apparatus as a dynamic reference frame for use in continuously tracking movement of a patient's skin during surgery. Claim 1 OPINION Unpatentability of Claims 1-8 and 10-13 over Csavoy and Piferi The Examiner finds that Csavoy discloses the invention substantially as claimed except for an adhesive layer that sticks to and moves with a patient's skin, for which the Examiner relies on Piferi. Final Action 2-3. The Examiner concludes that it would have been obvious to a person of ordinary skill in the art at the time the invention was made to apply adhesive to Csavoy. Id. at 3. According to the Examiner, a person of ordinary skill would have done this so that markers would move with the skin. Id. 2 Appeal2018-001299 Application 14/663,034 Appellants argue that claims 1 is not unpatentable as anticipated under 35 U.S.C. Â§ 102(b). Appeal Br. 13. This argument is irrelevant as the rejection relies on the teachings of a combination of references under the obviousness provisions of 35 U.S.C. Â§ 103. Final Action 2-3. Next, Appellants argue that the claimed invention provides "numerous advantages." Appeal Br. 8. Such an argument, without more, does not indicate Examiner error. It is well settled that an otherwise obvious improvement or advantage over the individual references found in the prior art, without more, does not confer patentability on an invention. See KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,422 (2007) (explaining that a person of ordinary skill in the art would have seen the benefits of combining the prior art in the manner achieved by the claimed invention). Because the desire to enhance commercial opportunities by improving a product or process is universal-and even common-sensical-we have held that there exists in these situations a motivation to combine prior art references even absent any hint of suggestion in the references themselves. Dystar Textilfarben GmBH & Co., v. CH Patrick Co., 464 F.3d 1356, 1368 (Fed. Cir. 2006). Next, Appellants argue that adding adhesive to the sheets of Csavoy would add mass and so compress or deform the soft tissue of the patent. Appeal Br. 11. Appellants characterize this as an express teaching away from an adhesive layer. Id. In response, the Examiner disputes that combining the adhesive feature of Piferi to the sheet of Csavoy would add mass so as to compress and deform the patient's skin. Ans. 8. An adhesive as taught by Piferi would be made of nothing more than a chemical film and would certainly not compress or 3 Appeal2018-001299 Application 14/663,034 deform any more than placing scotch tape on a person's skin would deform that person's skin. Id. at 8-9. In reply, Appellants assert that even a small amount of compression or deformation of the skin is of great significance during an invasive spinal feature. Reply Br. 4. Csavoy is directed to a tracking system that includes a flexible sheet with one or more trackable devices. Csavoy, Abstract. The sheet is light enough to be placed on the patient without "substantially deforming" the soft tissue around the boney structure. Id. col. 15, 11. 12-17. The sheets 140, 120 can also include a selected weight or mass that does not does substantially compress or deform the soft tissue of the patient 14. For example, a fiducial marker or trackable device can be interconnected with the patient 14 that deforms soft tissue surrounding bone of the patient 14. The deformation of the soft tissue with the tracking device or while positioning the tracking device can introduce certain inaccuracies into the navigation or tracking system 46. Thus, the sheets 120, 140 can be provided with an appropriate mass, density, mass evenness, and the like to substantially remove or eliminate the possibility of an unwanted or undesired deformation. Id. col. 15, 11. 43-54. Csavoy teaches the use of a "selected weight or mass." Id. In modifying Csavoy, a person of ordinary skill in the art would have been able to account for the weight and mass of an adhesive layer in determining the overall weight or mass of the sheet. In an obviousness analysis, "we do not ignore the modifications that one skilled in the art would make to a device borrowed from the prior art." In re Icon Health & Fitness, Inc., 496 F.3d 1374, 1382 (Fed. Cir. 2007). Thus, we are not persuaded by Appellants' argument that merely adding a layer of adhesive to Csavoy would substantially compress or deform the 4 Appeal2018-001299 Application 14/663,034 soft tissue of the patient. Appellants present no evidence as to the amount of weight or mass that an adhesive layer would add to the sheet of Csavoy, much less present evidence that the mass or weight of adhesive would substantially compress or deform the patient's skin. Appellants' position relies entirely on unsubstantiated attorney argument that carries little weight. See Estee Lauder, Inc. v. L 'Orea!, S.A., 129 F.3d 588, 595 (Fed. Cir. 1997) ( explaining that attorney argument cannot take the place of evidence in the record). Furthermore, we disagree with Appellants' position that Csavoy teaches away from using adhesive. The "mere disclosure of alternative designs does not teach away." In re Mouttet, 686 F.3d 1322, 1334 (Fed.Cir. 2012). Rather, teaching away requires "clear discouragement" from implementing a technical feature. In re Ethicon, Inc., 844 F.3d 1344, 1351 (Fed. Cir. 2017). Appellants do not direct us to any language in Csavoy that amounts to a "clear discouragement" from using an adhesive layer. Appellants next argue that the Examiner's proposed combination fails to provide a "dynamic reference frame" as claimed. Appeal Br. 11. In particular, Appellants point out that Piferi's adhesive patch is removed prior to any surgery being performed. Id. In response, the Examiner states that "dynamic reference frame" is broadly interpreted as a reference frame that accounts for activity. Ans. 8. Csavoy does disclose a reference frame since it performs optical tracking of markers in a sheet (14:65-67), but ... can one say that it is "dynamic"? The Examiner believes that one can, because the descriptor, "dynamic", is broad and is not limited in its meaning. Under the combination of Csavoy and Piferi, one arrives at an adhesive sheet with markers embedded within the sheet. If this sheet is adhered to a patient and the 5 Appeal2018-001299 Application 14/663,034 Id. markers move, then the reference frame accounts for activity and can thus be called a "dynamic reference frame". In reply, Appellants argue that the dynamic reference frame of Csavoy does not include the "specific features" claimed by Applicant. Reply Br. 3. Appellants' argument is not persuasive as it amounts to an individual attack on the Csavoy reference without taking into account how the Examiner's rejection modifies Csavoy with the teachings of Piferi. Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986); In re Keller, 642 F.2d 413,425 (CCPA 1981). The Examiner's finding that Csavoy and Piferi, taken in combination, provides a skin-based dynamic reference frame for tracking movement of a patient's skin during surgery is supported by a preponderance of the evidence. Finally, Appellants accuse the Examiner of engaging in an improper hindsight analysis. Appeal Br. 1 7. Appellants further accuse the Examiner of relying on speculation and unfounded assumptions. Id. In response, the Examiner explains that securing the sheet of Csavoy to the patient using adhesive is desirable for reasons found in Csavoy. [O]ne of ordinary skill in the art would understand that you would not want the sheet of markers shifting while it is on the patient's head, or else the tracking would be inaccurate. Thus, the adhesion provided by Piferi would ensure attachment between the marker sheet and the patient's head. The motivation to combine these two elements is to ensure a secure fit of the sheet, which is a clear goal of Csavoy. Ans. 12. The Examiner's explanation is persuasive and sufficient to overcome Appellants' hindsight objection. 6 Appeal2018-001299 Application 14/663,034 In view of the foregoing discussion, we determine the Examiner's findings of fact are supported by a preponderance of the evidence and that the Examiner's legal conclusion of unpatentability is well-founded. Accordingly, we sustain the Examiner's unpatentability rejection of claim 1. Claim 3 Claim 3 depends from claim 1 and adds the limitation: "wherein the adhesive material covers an entirety of the skin-based patient tracking apparatus to stick an entirety of the skin-based patient tracking apparatus to skin." Claims App. The Examiner finds that Piferi discloses adhesive material that covers the entirety of a skin-based tracking patient tracking apparatus. Final Action 3. Appellants argue that it would not have been obvious to include an adhesive on an entirety of the sheets as claimed, because doing so would be unnecessary to anchor the sheets in place, would cause unnecessary discomfort, and compress or deform the patient's soft tissue thereby making it difficult to create an accurate 3D image. Appeal Br. 20-21. In response, the Examiner identifies several reasons why it would have been desirable to secure Csavoy's sheet to the patient. See Ans. 12 (quoted hereinabove). The Examiner states the more persuasive position. Appellants present neither evidence nor persuasive technical reasoning as to why a person of ordinary skill in the art would have been inexorably led to placing adhesive on less than the entire surface of the tracking apparatus. "A person of ordinary skill is also a person of ordinary creativity, not an automaton." KSR, 550 U.S. at 421. It strikes us that applying adhesive to: (1) the entire surface; or (2) less than the entire surface are obvious alternative design choices that are well within the scope of ordinary creativity. 7 Appeal2018-001299 Application 14/663,034 We sustain the Examiner's rejection of claim 3. Claim 10 Claim 10 depends from claim 1 and adds the limitation: "a surgical drape integral with the patient tracking apparatus." Claims App. The Examiner finds that Csavoy' s drape is integral with its patient tracking apparatus. Final Action 4. Appellants argue that a small window is made in Csavoy's sheet to make an incision in the patient. Appeal Br. 23. This argument fails to explain how Csavoy' s sheet is anything other than a surgical drape, as described. See Csavoy, col. 14, 11. 39-40 ("The sheet 140 can include the Steri-Drapeâ„¢ surgical drapes sold by 3Mâ„¢ of St. Paul, Minn."). We sustain the Examiner's rejection of claim 10. Claim 11 Claim 11 depends from claim 1 and adds the limitation: "wherein the base layer includes a surgical drape extending beyond a portion of the patient tracking apparatus including the plurality of surgical tracking elements." Claims App. The Examiner finds that Csavoy discloses a base layer which includes a surgical drape, but does not explicitly disclose an extending portion beyond a patient tracking apparatus. Final Action 4. The Examiner concludes that it would have been obvious to a person of ordinary skill in the art at the time the invention was made to apply an extended covering using the drape. Id. According to the Examiner, a person of ordinary skill in the art would have done this to provide an as-needed extended sterile barrier. Id. Csavoy teaches that sheet 140: 8 Appeal2018-001299 Application 14/663,034 can be formed of a polymer or other substantially non-porous material. The sheet 140 can include the Steri-DrapeTM surgical drapes sold by 3Mâ„¢ of St. Paul, Minn. The surgical drapes allow for maintaining a sterile field around a selected portion of the patient 14. The sheet 140, as mentioned briefly above, can be dimensioned to be positioned on the patient 14. For example the sheet 140 can cover an expanse and be placed to cover an exterior portion of the patient 14. The sheet 140 can also be provided to maintain a sterile field relative to the patient 14. The sheet 140 can, generally, include a top and bottom surface covering an expanse and a relatively thin edge. The sheet 140 can be substantially flexible to drape over and conform to a selected portion of the patient 14. Csavoy, col. 14, 11. 38-50. The foregoing suggests that sheet 140 can extend beyond the patient tracking sensors. Appellants provide a section in their Appeal Brief under a separate heading directed to the rejections of claims 10, 11, 14, 16, and 17. Appeal Br. 22. Having reviewed this section, we are unable to determine that Appellants actually challenge the Examiner's finding and conclusion that it would have been obvious to extend Csavoy's drape. Thus, we are not apprised of error and sustain the Examiner's rejection of claim 11. Claims 2, 4-8, 12, and 13 Appellants do not argue for the patentability of claims 2, 4--8, 12, and 13 apart from arguments presented with respect to claim 1, which we have previously considered. Consequently, we sustain the Examiner's rejection of claims 2, 4--8, 12, and 13. See 37 C.F.R. Â§ 4I.37(c)(l)(iv) (failure to separately argue claims). 9 Appeal2018-001299 Application 14/663,034 Unpatentability of Claims 9 and 14-20 over Csavoy, Piferi, and Glassman Claim 9 Claim 9 depends from claim 1 and adds the limitation: "wherein the outer layer is transparent." Claims App. The Examiner relies on Glassman as teaching a transparent layer on a surgical drape. Final Action 5. The Examiner concludes that it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Csavoy/Piferi with a transparent layer. Id. According to the Examiner, a person of ordinary skill in the art would have done this to provide a way to see through the drape. Id. Appellants do not argue for the separate patentability of claim 9, the rejection of which is hereby sustained. 37 C.F.R. Â§ 4I.37(c)(l)(iv). Claims 14, 16, and 17 Claim 14 is an independent claim that is substantially similar in scope to claim 1 except that it claims additional limitations directed to a transparent outer layer and extension of the surgical drape beyond the tracking elements. Claims App. Claims 16 and 17 depend from claim 14 and are argued under the same heading as claim 14. Appeal Br. 22-24. In traversing the rejection, Appellants merely reprise the same arguments that were unpersuasive with respect to claims 1 and 11 and are equally unpersuasive here. We sustain the rejection of claims 14, 16, and 17. Claim 18 Claim 18 is an independent method claim that is not separately argued. We sustain the Examiner's rejection. 37 C.F.R. Â§ 4I.37(c)(l)(iv). 10 Appeal2018-001299 Application 14/663,034 Claims 15 and 19 Claim 15 depends from claim 14 and claim 19 depends from claim 18. Claims App. These claims are argued under the same heading as claim 3. Appeal Br. 20-22. We sustain the rejection of claims 15 and 19 for essentially the same reasons discussed above in connection with the rejection of claim 3. Claim 20 Claim 20 depends from claim 18 and adds the limitation: "tracking movement of the patient's skin when an incision in the patient's skin is made through the skin-based patient tracking apparatus by determining an average position of the optical surgical tracking elements both before and after making the incision." Claims App. The Examiner finds that Csavoy teaches that the positions of the markers are tracked and that, "since multiple markers are used, it would have been obvious to obtain an average reading from the markers, so as to gain a representative value of any movement that took place." Final Action 7. Appellants argue, among other things, that the underlying reasoning for the Examiner's rejection is conclusory. Appeal Br. 18-19. In response, the Examiner states that calculation of averages is an old and well-known technique of gaining a representative measure of a sampling. Ans. 11. The Examiner states that a person of ordinary skill in the art would have been motivated to calculate an arithmetic mean because such would have been "obviously useful." Id. It is well settled that a claim can be obvious even where all of the claimed features are not found in specific prior art references, where there is a showing of a reason to modify the teachings of the prior art to achieve the 11 Appeal2018-001299 Application 14/663,034 claimed invention. See Randall Mfg. v. Rea, 733 F.3d 1355, 1361---62 (Fed. Cir. 2013). However, the mere fact that the prior art may be modified in the manner suggested by the Examiner does not necessarily make the modification obvious. In re Fritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992). In the instant case, the Examiner's reasoning is insufficient to support the rejection. If calculating an arithmetic mean is "obviously useful," it is incumbent on the Examiner to provide a more detailed explanation and analysis as to how the calculation would have been "useful" and why a person of ordinary skill in the art would have seen the benefit in performing the calculation so as to be motivated to do so. DECISION The decision of the Examiner to reject claims 1-19 is affirmed. The decision of the Examiner to reject claim 20 is reversed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a)(l )(iv). AFFIRMED-IN-PART 12