Ex Parte GillDownload PDFPatent Trial and Appeal BoardJul 25, 201713137071 (P.T.A.B. Jul. 25, 2017) 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. 13/137,071 07/19/2011 Steven Streatfiled Gill 148365.01 4349 27049 7590 07/27 OLIFF PLC P.O. BOX 320850 ALEXANDRIA, VA 22320-4850 EXAMINER DESANTO, MATTHEW F ART UNIT PAPER NUMBER 3649 NOTIFICATION DATE DELIVERY MODE 07/27/2017 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): OfficeAction27049@oliff.com j armstrong @ oliff.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte STEVEN STREATFIELD GILL Appeal 2015-004251 Application 13/137,071 Technology Center 3600 Before NEIL T. POWELL, JASON W. MELVIN, and SEAN P. O’HANLON, Administrative Patent Judges. O’HANLON, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Steven Streatfield Gill (Appellant)1 appeals under 35 U.S.C. § 134 from the Examiner’s final decision rejecting claims 1—20. Appellant’s representative presented oral argument on July 13, 2017. We have jurisdiction over this appeal under 35 U.S.C. § 6(b). We AFFIRM. 1 According to Appellant, the real party in interest is Renishaw (Ireland) Limited. Appeal Br. 1. Appeal 2015-004251 Application 13/137,071 SUMMARY OF THE INVENTION Appellant’s disclosure is directed to “a method of positioning neurosurgical apparatus.” Spec. 11. Claim 1 is the sole independent claim, and is reproduced below from page A-l (Claims Appendix) of the Appeal Brief: 1. A method for delivering a therapeutic agent to a desired target in the brain of patient, the method comprising the steps of: inserting a neurosurgical catheter comprising a fine tube with an external diameter of not more than 1.0mm directly into brain tissue via a hole in a skull of the patient; and intermittently pumping the therapeutic agent through the catheter to the desired target. REFERENCES The Examiner relies on the following prior art references in rejecting the claims on appeal: Rise US 5,752,930 May 19, 1998 Nita US 5,951,539 Sept. 14, 1999 Gill US 2001/0003156 Al June 7, 2001 Hartlaub US 6,348,050 B1 Feb. 19, 2002 Babich US 6,395,299 B1 May 28, 2002 Konya US 6,517,550 B1 Feb. 11,2003 Rezai US 6,609,030 B1 Aug. 19, 2003 Delfani US 2003/0203844 Al Oct. 30, 2003 Whitehurst US 7,013,177 B1 Mar. 14, 2006 Martin R. Turner et al., Clinical Trials in ALS: An Neurology (2001) (hereinafter “Turner”) Overview, Seminars in 2 Appeal 2015-004251 Application 13/137,071 REJECTIONS Claims 1—4, 9-12, 14, and 15—20 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Gill, Hartlaub, Delfani, Konya, and Nita. Claim 5 stands rejected under 35 U.S.C. § 103(a) as being unpatentable over Gill, Hartlaub, Delfani, Konya, Nita, and Turner. Claim 6 stands rejected under 35 U.S.C. § 103(a) as being unpatentable over Gill, Hartlaub, Delfani, Konya, Nita, and Whitehurst. Claim 7 stands rejected under 35 U.S.C. § 103(a) as being unpatentable over Gill, Hartlaub, Delfani, Konya, Nita, and Babich. Claims 12, 13, and 15 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Gill, Hartlaub, Delfani, Konya, Nita, and Rise. Claims 8, 9, 11, and 20 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Gill, Hartlaub, Delfani, Konya, Nita, and Rezai. ANALYSIS Rejection Based on Gill, Hartlaub, Delfani, Konya, and Nita The Examiner finds that Gill discloses a method for delivering a therapeutic agent including, inter alia, inserting a catheter having a diameter less than 1 mm through a hole in patient’s skull. Final Act. 2 (citing, in relevant part, Gill 1 60). The Examiner finds that Gill does not disclose intermittently pumping a drug through the catheter. Id. The Examiner finds that Delfani discloses a method of treating central nervous system disorders by intermittently pumping treatment, and reasons that it would have been obvious to one of ordinary skill to intermittently pump a therapeutic agent through Gill’s catheter. Id. at 3. The Examiner explains that Delfani’s 3 Appeal 2015-004251 Application 13/137,071 intermittent pumping has “several advantages,” including “a larger dose can be administered at a lower concentration per mL than with a continuous method, peak flow concentrations can occur at periodic intervals and the risk of fluid overload is decreased.” Ans. 10. The Examiner relies on Hartlaub, Konya, and Nita to “resolve the level of ordinary skill in the art at the time the invention was made.” Ans. 9; see also Final Act. 2—3 (relying on Hartlaub, Konya, and Nita to teach recitations of certain dependent claims). Appellant traverses, first asserting alleged unexpected results achieved by intermittent pumping of a therapeutic agent through a small catheter and arguing that “Gill fails to discuss intermittent delivery, or a particular diameter for the catheter.” Appeal Br. 5—6 (citing Gill 1 60). Continuing, Appellant argues that “Gill discourages using small catheters.” Id. at 6. Appellant relies on his Declaration submitted during prosecution of the parent patent application to support this argument, asserting that Gill—of which Appellant is the inventor—“does not disclose a catheter with a fine tube having an external diameter of 1 mm or less.” Id. at 7. Appellant acknowledges that “Delfani discloses intermittent delivery of PDGF or the like to treat a nervous system disorder (see paragraph [0014]),” but argues that “Delfani fails to disclose using a diameter of not more than 1.0 mm or identify the disadvantages that can be associated with intermittent delivery.” Id. “[W]hen unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.” In re Baxter TravenolLabs., 952 F.2d 388, 392 (Fed. Cir. 1991) (citing In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984)). The burden of 4 Appeal 2015-004251 Application 13/137,071 demonstrating unexpected results rests on the party asserting them, and “it is not enough to show that results are obtained which differ from those obtained in the prior art; that difference must be shown to be an unexpected difference.” In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972). Moreover, “unexpected results must be established by factual evidence.” De Blauwe, 736 F.2d at 705. Such evidence must be commensurate in scope with the claims which the evidence is offered to support. In re Tiffin, 448 F.2d 791, 792 (CCPA 1971). Appellant has failed to meet these requirements, and, thus, has failed to establish that the claimed invention achieves unexpected results. For example, Appellant presents no factual evidence supporting the assertions and provides no comparison to any prior art. Also, although the Gill Declaration touts the benefits of using a catheter including a stop surface (Gill Dec. 3—4), the arguments are not commensurate in scope with claim 1, which does not require such a stop surface. Furthermore, although the Gill Declaration states that the claimed invention overcomes the problem of reflux {id. at 3), the Specification contradicts this assertion, as the Specification explains that: If, however, the catheter has been inserted into the brain down an indwelling guide tube as in the present invention, then drug exiting the distal port flows back along the tissue/catheter interface until it reaches the guide tube. It then flows preferably along the interface between the guide tube and the catheter and out of the skull into the subgaleal compartment of the scalp. Spec. 1 65 (emphasis added). Appellant’s argument that “Gill fails to discuss intermittent delivery” (Appeal Br. 6) is unpersuasive of error, as the Examiner relies on Delfani to 5 Appeal 2015-004251 Application 13/137,071 teach intermittent pumping. See Final Act. 3. Appellant’s argument that “Delfani fails to disclose using a diameter of not more than 1.0 mm” (Appeal Br. 7) is similarly unpersuasive, as the Examiner relies on Gill to disclose such a catheter diameter. See Final Act. 2. We are also unpersuaded by Appellant’s assertion that “Gill discourages using small catheters.” Appeal Br. 6—7 (discussing Gill 1 60). As indicated in the text reproduced on page 6 of the Appeal Brief, Gill discloses that “when passing . . . catheters to functional targets that are deeply situated in eloquent areas in the brain, it is preferable that they are the smallest diameter possible so as to minimise trauma” and that, to prevent deflection, a guide rod having a diameter larger than 1 millimeter can be inserted through less eloquent areas of the brain to form a tract into which the guide device can be inserted.” Gill 1 60 (emphasis added). A guide device is then inserted into the tract formed by the guide rod, and a fine catheter is inserted through the guide device. Id. However, the guide device “stop[s] short of the desired target in the more eloquent area.” Id. As correctly noted by the Examiner (see Ans. 11), this paragraph goes on to disclose that ‘ fa] fine . . . catheter can now be guided to the desired target through the guide device such that the length emerging from the distal end of the guide device and traversing the eloquent brain tissue will be comparatively short and less likely to deflect from the desired target site.” Gill 160 (emphasis added). Thus, Gill discloses the balancing of benefits—using a fine catheter to minimize trauma to the patient, and using a guide wire having a larger diameter to create a tract through which a guide device is inserted to prevent 6 Appeal 2015-004251 Application 13/137,071 deflection. Rather than discouraging use of a fine catheter, as Appellant asserts, Gill teaches one of ordinary skill to use a fine catheter, first creating a tract into which the guide device is inserted, and then inserting the fine catheter through the positioned guide device. Furthermore, Gill only suggests using a larger diameter guide wire to form a tract “through less eloquent areas of the brain”; fine catheters are used in eloquent areas. Id. Based on the entirety of paragraph 60, including the description of a “small diameter” being “less than 1 millimeter,” we understand the disclosed fine catheter to have an external diameter of not more than 1.0 mm. We note that Appellant acknowledges that a person of ordinary skill would understand a fine tube (and, therefore, a fine catheter) would have such an external diameter. See Reply Br. 5 (“At the time of Appellant’s invention . . ., one skilled in the art believed that a fine tube (with an external diameter of not more than 1.0mm for example)” and “a fine tube with an external diameter of not more than 1.0mm.”). Appellant presents additional arguments in the Reply Brief, asserting that the Examiner’s Answer contained a new ground of rejection because “it . . . asserted that the combination of Gill and Delfani discloses or suggests all of the features in claim 1.” Id.; see also id. at 3—5. In the Final Action, the Examiner identified all of the steps of claim 1 as being disclosed in Gill, except for the intermittently pumping step, which the Examiner found was taught by Delfani. See Final Act. 2-4. Thus, we are not persuaded that the Examiner’s Answer contained a new ground of rejection. That the Examiner stated in the Examiner’s Answer that Hartlaub, Konya, and Nita were used to resolve the level of ordinary skill in the art does not render the Examiner’s 7 Appeal 2015-004251 Application 13/137,071 Answer a new ground of rejection. Thus, the arguments presented for the first time in the Reply Brief are untimely and are not here considered. See 37 C.F.R. § 41.41(b)(2). Appellant next argues that “[t]he claimed external diameter of not more than 1.0 mm is not recognized by any of the references as a result- effective variable” and, therefore, “it is erroneous to summarily conclude that it would have been obvious to adjust the size of the catheter to have the external diameter as recited in claim 1.” Appeal Br. 8—9. Appellant’s argument does not address the Examiner’s determination that Gill discloses inserting a catheter having a diameter less than 1 mm through a hole in patient’s skull (see Final Act. 2), and, therefore, fails to apprise us of error. Appellant next argues that “[i]t would not have been reasonably predictable to combine features from five different references in order to recreate claim 1.” Appeal Br. 9. Continuing, Appellant argues that “the obviousness rejection fails to consider the claimed invention as a whole” because “[i]t appears as if the various features of claim 1 have been carefully picked from the five references in order to construct the obviousness rejection” and “[t]he Office Action does not assert a reason to combine the references.” Id. at 10; see also Reply Br. 8—9. Initially, we note that, as discussed above, the Examiner relies on only Gill and Delfani to reject claim 1. Moreover, reliance on a large number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention. In re Gorman, 933 F.2d 982 (Fed. Cir. 1991) (affirming a rejection of a detailed claim to a candy sucker shaped 8 Appeal 2015-004251 Application 13/137,071 like a thumb on a stick based on thirteen prior art references). We further note that the Examiner set forth “several advantages” of intermittent pumping taught by Delfani (see Ans. 10) and that Appellant admits that “Delfani discloses intermittent delivery of PDGF or the like to treat a nervous system disorder (see paragraph [0014])” (see Appeal Br. 7). Appellant’s arguments, therefore, fail to apprise us of error. Finally, Appellant argues that Delfani does not qualify as prior art because its full disclosure is not entitled to the benefit of its provisional filing date. Reply Br. 7—8. Appellant’s argument is presented for the first time in the Reply Brief and, thus, is untimely and is not here considered. See 37 C.F.R. § 41.41(b)(2). Accordingly, for the foregoing reasons, we sustain the rejection of claim 1 and its dependent claims 2—4, 9—12, 14, and 15—20, which are not argued separately, as being unpatentable over Gill, Hartlaub, Delfani, Konya, and Nita. Rejection Based on Gill, Hartlaub, Delfani, Konya, Nita, and Turner Appellant does not separately address the rejection of dependent claim 5. See Appeal Br. 4—11. Accordingly, for the same reasons as discussed above, we sustain the rejection of this claim as being unpatentable over Gill, Hartlaub, Delfani, Konya, Nita, and Turner. Rejection Based on Gill, Hartlaub, Delfani, Konya, Nita, and Whitehurst Appellant does not separately address the rejection of dependent claim 6. See id. Accordingly, for the same reasons as discussed above, we sustain 9 Appeal 2015-004251 Application 13/137,071 the rejection of this claim as being unpatentable over Gill, Hartlaub, Delfani, Konya, Nita, and Whitehurst. Rejection Based on Gill, Hartlaub, Delfani, Konya, Nita, and Babich Appellant does not separately address the rejection of dependent claim 7. See id. Accordingly, for the same reasons as discussed above, we sustain the rejection of this claim as being unpatentable over Gill, Hartlaub, Delfani, Konya, Nita, and Babich. Rejection Based on Gill, Hartlaub, Delfani, Konya, Nita, and Rise Appellant does not separately address the rejection of dependent claims 12, 13, and 15. See id. Accordingly, for the same reasons as discussed above, we sustain the rejection of these claims as being unpatentable over Gill, Hartlaub, Delfani, Konya, Nita, and Rise. Rejection Based on Gill, Hartlaub, Delfani, Konya, Nita, and Rezai Appellant does not separately address the rejection of dependent claims 8, 9, 11, and 20. See id. Accordingly, for the same reasons as discussed above, we sustain the rejection of these claims as being unpatentable over Gill, Hartlaub, Delfani, Konya, Nita, and Rezai. DECISION The Examiner’s decision to reject claims 1—20 is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv). AFFIRMED 10 Copy with citationCopy as parenthetical citation