Ex Parte Del Priore

Patent Trials and Appeals BoardJan 10, 2019

14197837 - (D) (P.T.A.B. Jan. 10, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/197,837 03/05/2014 26710 7590 01/14/2019 QUARLES & BRADYLLP Attn: IP Docket 411 E. WISCONSIN A VENUE SUITE 2350 MILWAUKEE, WI 53202-4426 UNITED ST A TES OF AMERICA FIRST NAMED INVENTOR Giuseppe Del Priore 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. 144578.00088-11154-55 2117 EXAMINER EISEMAN, ADAM JARED ART UNIT PAPER NUMBER 3791 NOTIFICATION DATE DELIVERY MODE 01/14/2019 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): pat-dept@quarles.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte GIUSEPPE DEL PRIORE 1 Appeal2018-000534 Application 14/197,837 Technology Center 3700 Before JAMES P. CAL VE, MICHELLE R. OSINSKI, and LEE L. STEPINA, Administrative Patent Judges. CAL VE, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant appeals under 35 U.S.C. Â§ 134(a) from the Office Action finally rejecting claims 1-7. We have jurisdiction under 35 U.S.C. Â§ 6(b ). We AFFIRM. 1 Indiana University Research and Technology Corporation is identified as the real party in interest. Appeal Br. 1. Appeal2018-000534 Application 14/197,837 CLAIMED SUBJECT MATTER The claimed device collects cells from the endometrial cavity and the fallopian tubes for subsequent analysis and screening for ovarian cancer and endometrial carcinoma. Spec. ,r 2. A transvaginal probe facilitates insertion of a catheter that delivers fluid through the endometrial cavity and fallopian tubes into the cul-de-sac. Id. ,r 8. A needle positioned on the transvaginal probe collects the fluid delivered by the catheter to the cul-de-sac. Id. Claim 1, the sole independent claim, is reproduced below. 1. A device for screening for detection of gynecological cancers, the device comprising: a transvaginal probe configured to be inserted into a vagina of the patient; a catheter coupled to the transvaginal probe, and a needle coupled to the transvaginal probe and extending past an end of the transvaginal probe, the needle being offset from the catheter a distance selected to simultaneously insert the catheter into an endometrial cavity of the patient and the needle into the cul de sac of the patient when the transvaginal probe is inserted to the vagina. REJECTIONS Claims 1, 5, and 6 are rejected under 35 U.S.C. Â§ I03(a) as unpatentable over Schinkel (US 5,167,222, iss. Dec. 1, 1992) and Brosens (US 6,293,952 Bl, iss. Sept. 25, 2001). Claims 2--4 are rejected under 35 U.S.C. Â§ I03(a) as unpatentable over Schinkel, Brosens, and Dubinsky (US 6,669,643 Bl, iss. Dec. 30, 2003). Claim 7 is rejected under 35 U.S.C. Â§ I03(a) as unpatentable over Schinkel, Brosens, Dubinsky, and Cimber (US 3,580,255, iss. May 25, 1971). 2 Appeal2018-000534 Application 14/197,837 ANALYSIS Claims 1, 5, and 6 Rejected Over Schinkel and Brosens Appellant argues claims 1, 5, and 6 as a group. Appeal Br. 3-8.2 We select claim 1 as representative, with claims 5 and 6 standing or falling with claim 1. 3 7 C.F .R. Â§ 41.3 7 ( c )(1 )(iv). The Examiner finds that Schinkel discloses a screening device as recited in claim 1, including a transvaginal probe (speculum 5), catheter 33, and catheter guide 32, but lacks the claimed needle. Final Act. 3--4. The Examiner finds that Brosens teaches a transvaginal probe (speculum 642 with a coupling member (guide section 644) for coupling needle 674 to the probe. Id. at 4. The Examiner determines it would have been obvious to modify Schinkel' s transvaginal probe to include another guide on the lower spoon of Schinkel's speculum in order to guide a needle to the cul-de-sac of a patient as taught by Brosens. Id. at 4--5. The Examiner also reasons that combining guide elements from different speculums on one speculum would "allow for the guidance of both a catheter to the uterus and a needle to the cul-de-sac." Id. at 5. The Examiner further reasons that the combination would allow a user to guide both a catheter and a needle to their respective locations within the body using a single speculum without having to remove a speculum thereby providing for ease of use for the doctor and increased comfort for a patient. Ans. 12. The Examiner also determines the rejection combines known prior art elements by known methods for their known functions and predictable results. Id.; Final Act. 5. 2 The pages in the Appeal Brief are not numbered. All citations to page numbers in the Appeal Brief are to the pages in the order in which they appear in the Appeal Brief. 3 Appeal2018-000534 Application 14/197,837 Appellant argues that there is no motivation for a skilled artisan to modify Schinkel' s device, which uses a catheter for transvaginal gamete transfer, to include a needle, which Brosens uses to pierce the cul de sac and draw fluids therefrom. Appeal Br. 4--5. Appellant argues that the proposed modifications amount to extra work and greater expense for no objective or apparent reason indicating that the motivation is taken from Appellant's own disclosure. Id. at 5-6; Reply Br. 1-3. Appellant further argues that the new device would needlessly pierce a patient's body and provide a device that never would be used in a medical procedure. Reply Br. 3--4. The Examiner's proposal to modify Schinkel's device by coupling a needle onto lower speculum 8 is based on the teachings of Bro sens that such a configuration would allow a physician to view a patient's body behind the peritoneum wall for visualization of the pelvic organs such as tubo-ovarian structures. Brosens, 1:15-18, 2:13-21, 4:48-51, 6:23-28, 17:12--40, Figs. 18, 20; see KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007) ("[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."); see also DyStar Textilfarben GmbH & Co. Deutsch/and KG v. CH Patrick Co., 464 F.3d 1356, 1368 (Fed. Cir. 2006) (an implicit motivation to combine exists not only when a suggestion may be gleaned from the prior art as whole but also when the combination results in a product that is more desirable because it is stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient). Indeed, Appellant recognizes that the proposed combination provides Schinkel's device with the ability to pierce a part of the patient's body. Reply Br. 2; Appeal Br. 4. 4 Appeal2018-000534 Application 14/197,837 Appellant is correct that Schinkel teaches an instrument to operate on a uterus for a transvaginal gamete transfer. Appeal Br. 4. Schinkel also uses the device for tubal catheterizations. Schinkel, 1:10-14, 4:38-39. However, Appellant's attorney argument that Schinkel provides no reason to pierce the cul de sac during this type of procedure or draw fluids (Appeal Br. 4) is not persuasive in view of Brosens' teaching of a speculum-mounted needle that allows a doctor to view a patient's body (tubo-vascular structures) in a more recognizable position without any orientation confusion as occurs with some laparoscopy. Brosens, 1:27--49, 2:13-21. Brosens teaches that the needle can form a minihydroculdoscopy to overcome problems of other devices used to perform intrafallopian transfer procedures to gametes and embryos. See id. at 1 :55-56. Piercing the peritoneum using the needle allows tubal patency to be tested and cannulation of the Fallopian tube to be inspected along with inspection of ovarian endometriosis, adhesions, and fibromas. Id. at 9:20-35, 10: 1-24. Brosens' needle facilitates procedures for fertility or infertility diagnosis and care (id. at 11 :5-8, 12: 1--4), and Brosens teaches that needle minihydroculdoscopy provides a cost-effective way to obtain a complete exploration of the genital tractus in a painless and safe way (id. at 12: 1--4). It also provides real change in the diagnostic exploration of the internal female genitalia for operative treatment. Id. at 12:35--42. A skilled artisan would appreciate from these teachings that adding Brosens' needle to Schinkel' s device would improve the ability of a doctor to perform intrafallopian transfers and tubal catheterizations by providing a better view of the tubo-ovarian and uterine regions during such procedures to facilitate diagnosis and placement without inserting a separate speculum so the procedure is more efficient, less painful and convenient. Ans. 9-12. 5 Appeal2018-000534 Application 14/197,837 In other words, modifying Schinkel with Brosens' needle allows a doctor to pierce the patient's peritoneum and view the tubo-vascular and uterine regions in which Schinkel' s procedure is being performed with an unimpeded view that is easier to understand as Brosens teaches. Schinkel emphasizes the need for a doctor using Schinkel's instrument to monitor the orientation of the catheter after it is inserted into a patient. Schinkel, 5: 15- 51. Viewing the tubo-vascular and uterine regions using Brosens' needle would improve placement of Schinkel's catheter 33 in uterus 1 and Fallopian tubes 4 to improve gamete transfer and further examination of that region. Modifying Schinkel's instrument according to teachings of Brosens would result in the needle being positioned on lower spoon 8 of Schinkel' s speculum as Brosens teaches (Figs. 18, 20) such that the needle would be spaced from Schinkel's catheter 33 as illustrated in Figure 1 of Schinkel. Such positioning also would place the needle to puncture the peritoneum adjacent to portion 2 of Schinkel (Fig. 1) as Brosens teaches and similar to the position of needle 24 in Appellant's Figure 1. See Appeal Br. 6-7. These teachings of the prior art support the Examiner's determination that the proposed combination would yield a predictable result and would provide more functionality, easier use for a doctor, and increased comfort for a patient. See Ans. 12. These teachings and rational underpinnings address Appellant's assertions regarding the use of improper hindsight. See In re Cree, Inc., 818 F.3d 694, 702 n.3 (Fed. Cir. 2016) (impermissible hindsight argument is of no moment where the Examiner provides a sufficient, non- hindsight reason to combine the references). Accordingly, we sustain the rejection of claim 1 and claims 5 and 6, which fall therewith. 6 Appeal2018-000534 Application 14/197,837 Dependent Claims 2-4 and 7 Rejected Over Schinkel, Brosens, and Dubinsky/Cimber Appellant does not present arguments for the rejections of dependent claims 2--4 and 7. See Appeal Br. 2-8. Therefore, we summarily sustain the rejections of those claims. DECISION We affirm the rejections of claims 1-7. 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 7