Ex Parte Green et alDownload PDFPatent Trial and Appeal BoardAug 19, 201612454805 (P.T.A.B. Aug. 19, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/454,805 0512212009 37468 7590 08/19/2016 STOCKWELL & SMEDLEY, PSC 861 CORPORATE DRIVE, SUITE 200 LEXINGTON, KY 40503 FIRST NAMED INVENTOR Micheal A. Green 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. 123-001 9081 EXAMINER HUMPHREY, LOUISE WANG ZHIYING ART UNIT PAPER NUMBER 1657 MAILDATE DELIVERY MODE 08/19/2016 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 MICHAEL A. GREEN and BRETT THOMAS SPEAR1 Appeal2015-000400 Application 12/454,805 Technology Center 1600 Before ERIC B. GRIMES, MELANIE L. McCOLLUM, and RACHEL H. TOWNSEND, Administrative Patent Judges. TOWNSEND, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method for non-surgical transfer of fluid containing an embryo or sperm into the uterus of a rodent, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b ). We reverse. STATEMENT OF THE CASE Surgical procedures for transferring an embryo into a rodent's uterus involves anesthesia, post-operative care, and the use of analgesics. (Spec. i-f3.) Appellants' specification states "there remains the need for devices and 1 Appellants identify the Real Party in Interest as the named inventors. (Appeal Br. 2.) Appeal2015-000400 Application 12/454,805 methodology that eliminates the need for anesthesia, surgery, and the use of analgesics, and dramatically reduces the time needed for post-operative care and essentially eliminates infection and other post-operative complications." (Spec. i-f5.) Claims 11, 12, 14--18, 20-28, and 32--40 are on appeal. Claim 11 is representative and reads as follows: 11. A method for non-surgical transfer of a fluid into a rodent, comprising the steps of: (a) inserting a speculum into the rodent's vagina, the speculum having a distal end and a proximate end, wherein the speculum is inserted such that the distal end of the speculum is oriented closer to the uterus of the rodent; (b) inserting a transfer device into the speculum, the transfer device including a hub portion and a catheter portion, the hub portion having a first end and a second end, wherein the catheter portion is in fluid communication with the hub portion and terminates at a distal tip; wherein the catheter portion of the transfer device contains the fluid at or near the distal tip of the catheter portion in step (b ), and wherein the fluid comprises at least one embryo, wherein the distal tip of the catheter portion of the transfer device is extended through the cervix and into the uterus of the rodent in step (b ); and wherein the catheter portion of the transfer device is inserted into the speculum in step (b) until the second end of the hub portion contacts the proximate end of the speculum such that the catheter portion is prevented from being further inserted into the speculum. (Appeal Br. 26.) 2 Appeal2015-000400 Application 12/454,805 The following ground of rejection by the Examiner is before us on review: Claims 11, 12, 14--18, 20-28, and 32--40 under 35 U.S.C. § 103 as unpatentable over Marsk,2 Nag,3 and Cecchi.4 DISCUSSION The Examiner finds that Marsk discloses a non-surgical embryo implantation method in mice in which a speculum-a plastic tube-is inserted into the vagina of the mouse, a micrometer syringe connected to a commercially available micropipette with a flexible tubing material that contains fluid and a blastocyst is then inserted into the speculum, and then the blastocyst is expelled by increasing the pressure in the microsyringe. (Non-Final5 5; Ans. 3.) The Examiner notes that the embryo transfer device of Marsk does not include a catheter in fluid communication with a hub as claimed, but Nag teaches such a transfer device with a flexible tapered catheter in a method for human embryo transplant. (Non-Final 7; Ans. 3.) The Examiner further finds that Nag teaches that a shorter and more flexible catheter reduces trauma to the uterine and cervical wall, increasing the likelihood of successful fertilization. (Non-Final 9.) The Examiner finds that it would have been obvious to one of ordinary skill in the art to modify the Marsk method by replacing the Marsk micrometer syringe and 2 Marsk et al., A Simple Method for Non-Surgical Blastocyst Transfer in Mice, 37 J. Reprod. Pert. 393-98 (1974) 3 Nag, US 6,027,443, issued Feb. 22, 2000. 4 Cecchi et al., US 6,156,165, issued Dec. 26, 2000. 5 Non-Final Action dated Sept. 20, 2013. 3 Appeal2015-000400 Application 12/454,805 micropipette transfer device with the Nag transfer device to "avoid irritation or trauma to the uterine and cervical walls and hence increase the likelihood of successful fertilization" as suggested by Nag. (Non-Final 7-8, 10; Ans. 5.) The Examiner notes that neither Marsk nor Nag disclose their transfer devices being prevented from further insertion into a speculum by the hub portion of the transfer device contacting the proximal end of the speculum. (Non-Final 8; Ans. 6.) The Examiner finds that Cecchi fills this gap. According to the Examiner, Cecchi describes an embryo implant catheter assembly that includes an outer guide cannula and an inner catheter that includes a hub, where the inner catheter is longer than the guide cannula. (Non-Final 8; Ans. 6.) The Examiner finds that the inner catheter of Cecchi is placed inside the outer guide cannula and because the hub of the inner catheter is wider than the inner diameter of the proximal end of the guide cannula, the inner catheter would be prevented from further insertion through the guide cannula by the hub's engagement with the guide cannula as seen in Figure 5. (Non-Final 8-9; Ans. 6, 10.) The Examiner further finds that during an embryo implant procedure, when the inner catheter is fully inserted into the outer guide cannula, the inner catheter distal end projects beyond the guide cannula because it is longer than the guide cannula, but that over-insertion of the catheter is prevented. (Non-Final 8; Ans. 6, 13-14.) The Examiner finds that it would have been obvious to further modify the Marsk speculum with Cecchi's hub assembly, such that the speculum of the Marsk reference would have a proximate end like the guide cannula hub described in Cecchi whereby the hub portion of the 4 Appeal2015-000400 Application 12/454,805 transfer device (the Marsk as modified by Nag transfer device) would contact the speculum of Marsk in a manner that prevents further insertion of the transfer device through the speculum upon such contact. (Ans. 6, 10- 15.) According to the Examiner, the pictorial disclosure in Figures 3 and 5 of the Nag patent and in Figures 3-5 of the Cecchi patent, together with the disclosure in the Marsk reference (p. 394 and fig. 2), when combined and viewed as a whole, provides a clear suggestion of inserting the catheter through the guide cannula (speculum) until the catheter hub is contacting the proximate end of the guide cannula (speculum) as a solution to the problem of over-insertion of an embryo/sperm transfer device through the speculum. (Ans. 13.) The Examiner further finds that it would have been obvious to modify the Marsk-Nag-Cecchi device by changing the predetermined distance between the distal tip of the catheter and the distal end of the speculum to adapt Cecchi' s human embryo transfer device for use in the smaller bodies of rodents. (Ans. 10-11.) The Examiner considered the Declaration evidence alleging unexpected and surprising results and satisfaction of long-felt need, but determined that the results were not surprising or unexpected in light of the teachings of Cecchi and, thus, the evidence and arguments as a whole do not overcome the obviousness of the claimed invention. (Ans. 14--15.) It is our opinion that the Examiner failed to meet her burden of establishing a prima facie case of obviousness. Appellants argue that "Cecchi does not teach the contacting feature recited in claim 11" at least because Cecchi discloses that "the inner catheter member 26 is advanced into the uterus until the distal end of the catheter member 26 contacts the uterine wall of the patient." (Appeal Br. 15-16.) 5 Appeal2015-000400 Application 12/454,805 We agree with Appellants. Claim 11 requires that "the catheter portion of the transfer device is inserted into the speculum in step (b) until the second end of the hub portion contacts the proximate end of the speculum such that the catheter portion is prevented from being further inserted into the speculum." (Appeal Br. 26 (emphasis added).) While Cecchi teaches moving the catheter forward into the guide cannula6 after the guide cannula is advanced into the cervical opening, the Examiner has not adequately shown that it teaches a method in which further insertion into the guide catheter is prevented by the second end of the hub portion of the catheter contacting the proximate end of the speculum. It is true, as the Examiner notes, that Figure 5 appears to depict interaction of the catheter hub with the guide cannula hub (Ans. 10). However, the description of "how the assembly of [Cecchi's] invention is used to implant an embryo E in the uterus 40 of an implant recipient" discloses that after the guide cannula is inserted, the catheter insertion continues through the guide cannula until the distal tip of the catheter contacts the inner uterine wall. (Cecchi 6: 16-30.) In short, nothing in this description demonstrates Cecchi teaches or suggests a method in which further insertion of the catheter into the guide cannula is 6 Appellants argue that the guide cannula of Cecchi is not a speculum. (Appeal Br. 15; Reply Br. 5.) We disagree. It is apparent from Marsk that those of ordinary skill in the art consider tubular structures that provide one with the ability to see the area of interest and the possibility to introduce instruments for further intervention to be a speculum. (See, e.g., Marsk Fig. 2.) Appellants do not provide any special definition in the Specification defining the term "speculum." Thus, we agree with the Examiner that the guide cannula of Cecchi could be considered a speculum. 6 Appeal2015-000400 Application 12/454,805 prevented by the second end of the hub portion of the catheter contacting the proximate end of the speculum. The Examiner's conclusion to the contrary appears to rest on the position that "over-insertion of an embryo/sperm transfer device through the speculum" was a recognized problem in the prior art. (Ans. 13.) However, there is insufficient evidence provided by the Examiner or in this record to support the foregoing. A rejection based on § 103 must rest on a factual basis, and these facts must be interpreted without hindsight reconstruction of the invention. In re Warner, 379 F.2d 1011, 1017 (CCPA 1967). Moreover, the Examiner points to nothing in Marsk or Nag to make up for this deficiency. The fact that Nag suggests providing a shortened catheter of flexible material that avoids "trauma to the uterine and cervical walls, increasing the likelihood of successful fertilization" (Ans. 15, citing Nag 4:53-56), does not suggest the transfer device employed in the Marsk procedure should be physically prevented from "being further inserted into the speculum" (Claim 11 ). Thus, the Examiner has not shown that the cited references support a prima facie case of obviousness. Accordingly, for the reasons discussed we reverse the Examiner's rejection of representative claim 11. Claims 36 and 40, the other independent claims, also require that the catheter portion of the transfer device is prevented from further insertion into the speculum by contact between a hub portion of the transfer device and the proximate end of the speculum (Appeal Br. 29, 30). We therefore also reverse the rejection of claims 36 and 40, as well as the dependent claims on appeal. 7 Appeal2015-000400 Application 12/454,805 SUMMARY We reverse the Examiner's rejection of claims 11, 12, 14--18, 20-28, and 32--40 under 35 U.S.C. § 103 as unpatentable over Marsk, Nag, and Cecchi. REVERSED 8 Copy with citationCopy as parenthetical citation