Ex Parte Hoey et alDownload PDFPatent Trial and Appeal BoardMay 31, 201812843581 (P.T.A.B. May. 31, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/843,581 07/26/2010 66854 7590 SHAY GLENN LLP 2755 CAMPUS DRIVE SUITE 210 SAN MATEO, CA 94403 06/04/2018 FIRST NAMED INVENTOR Michael Hoey 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. 10837-705.300 6457 EXAMINER DELLA,JAYMIE ART UNIT PAPER NUMBER 3739 NOTIFICATION DATE DELIVERY MODE 06/04/2018 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): info@shayglenn.com shayglenn_pair@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MICHAEL HOEY and JOHN H. SHADDUCK Appeal2016-000870 Application 12/843,581 Technology Center 3700 Before JOHN C. KERINS, KEVIN F. TURNER, and ARTHUR M. PESLAK, Administrative Patent Judges. KERINS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Michael Hoey and John H. Shadduck ("Appellants") appeal under 35 U.S.C. § 134(a) from a final rejection of claims 1-3, 5-16, 20-24, and 26. Claims 4, 17-19, and 25 are canceled. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM-IN-PART. Appeal2016-000870 Application 12/843,581 THE INVENTION Appellants' invention is directed to a method for treating benign prostatic hyperplasia. Claims 1, 14, 20, and 22 reproduced below, are illustrative: 1. A method for treating benign prostatic hyperplasia (BPH), compnsmg: introducing an energy delivery member transurethrally into a transition zone tissue adjacent a patient's prostatic urethra; and injecting a condensable vapor media from the energy delivery member into the transition zone tissue at a depth of less than 12 mm outward from the patient's prostatic urethra so as to confine the condensable vapor media in the transition zone tissue and to ablate the transition zone tissue adjacent to and less than 12 mm outward from the prostatic urethra. 14. A method for treating benign prostatic hyperplasia (BPH), compnsmg: introducing a probe into a prostatic urethra; extending a vapor delivery member from the probe into a plurality of sites in a transition zone tissue of a prostate; and delivering a condensable vapor media from the vapor delivery member at each of the plurality of sites for 20 seconds or less and confining the condensable vapor media in the transition zone tissue. 20. A method for treating benign prostatic hyperplasia (BPH), compnsmg: introducing an energy delivery member into a transition tissue adjacent a patient's prostatic urethra; and 2 Appeal2016-000870 Application 12/843,581 applying energy into a plurality of transition zone sites in left and right prostate lobes with a condensable vapor media, wherein a rate of energy delivery is between 1 cal/sec and 40 cal/sec. 22. A method for treating benign prostatic hyperplasia (BPH), compnsmg: introducing a probe into a prostatic urethra; extending a vapor delivery member from the probe into a transition zone tissue of a prostate at a depth of less than 12 mm outward from the prostatic urethra; and delivering a condensable vapor media from the vapor delivery member to the transition zone tissue at a delivery pressure ranging from approximately 20 mm Hg to 200 mm Hg. REJECTIONS The Examiner rejects: (i) claims 1-3, 5-8, 11, 12, and 22 under 35 U.S.C. § I03(a) as being unpatentable over Edwards (US 2005/0010203 Al, published Jan. 13, 2005) in view ofMulier (US 2002/0177846 Al, published Nov. 28, 2002); (ii) claims 1-3, 5, 6, 8-12, and 22-24 under 35 U.S.C. § I03(a) as being unpatentable over Edwards and Shadduck (US 2006/0224154 Al, published Oct. 5, 2006); (iii) claims 13 and 26 under 35 U.S.C. § I03(a) as being unpatentable over Edwards in view of Mulier or Shadduck, and further in view of Barry (US 2009/0138001 Al, published May 28, 2009); (iv) claims 14--16 under 35 U.S.C. § I03(a) as being unpatentable over Shadduck in view of Edwards; 3 Appeal2016-000870 Application 12/843,581 (v) claims 20 and 21 under 35 U.S.C. § I03(a) as being unpatentable over Mulier in view of Edwards and Barry, or over Edwards in view of Mulier and Barry; (vi) claim 14 is rejected on the ground of nonstatutory double patenting over claim 5 of Hoey '079 (US 8,273,079 B2, issued Sept. 25, 2012) in view ofMulier or Shadduck; (vii) claims 14 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7, 21, and 31, of Hoey '544 (US Application No. 12/768,544, filed Apr. 27, 2010); and (viii) claims 1 and 2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of Edwards. Rejections of claims 16 and 21 under 35 U.S.C. § I03(a) that relied in part on a printed publication to Hoey '326 (US 2010/0145326 Al, published June 10, 2010) were withdrawn by the Examiner in the Answer. Ans. 4. ANALYSIS Claims 1-3, 5---8, 11, 12, and 22--Edwards/Mulier Appellants present arguments directed to claims 1 and 22, and do not present separate arguments for claims 2, 3, 5-8, 11, and 12. Those claims stand or fall with representative claim 1. Claim 1 The Examiner finds that Edwards teaches a method for treating BPH that involves introducing an energy delivery member transurethrally into a transition zone tissue adjacent a patient's prostatic urethra, and applying energy into the transition zone to ablate transition zone tissue adjacent to the 4 Appeal2016-000870 Application 12/843,581 prostatic urethra. Final Act. 3--4. The Examiner finds that Edwards does not explicitly disclose that the energy is to be delivered to the transition zone tissue at a depth of less than 12 mm outward from the prostatic urethra, so as to confine the vapor media in the transition zone tissue and to ablate only to that depth, nor that the ablating media is a condensable vapor media. Id. at 4--5. The Examiner finds that Mulier discloses the use of a condensable vapor media in treating BPH, and that a vaporous medium can be directed with relative precision to effect ablation of a selected portion of a tissue site. Final Act. 4--5. The Examiner concludes that it would have been obvious to employ a condensable vapor media as the energy source in the Edwards method, to take advantage of the precision in ablating tissue afforded by the vaporous media, so that the ablation can be confined to the regions in which abnormal or diseased tissue is present. Id. The Examiner additionally finds that Edwards includes a teaching that the glandular nodules associated with BPH are found in transition zone tissue, and that transition zone tissue is to be targeted to treat BPH. Ans. 6, citing Edwards, para. 73; Final Act. 29; Edwards, para. 119. The Examiner concludes that it would have been obvious to confine the condensable vapor media to ablate only transition zone tissue, and that, based on the anatomy of the prostate and surrounding tissues, limiting the depth to 12 mm or less would have been obvious as discovering an optimum value of a result- effective variable. Final Act. 4; Ans. 5. Appellants argue that, because Edwards does not mention any needle insertion depth, nor a range of depths, the Examiner's reliance on In re 5 Appeal2016-000870 Application 12/843,581 Boesch 1 for the proposition that discovering an optimum value for a result effective variable involves only routine skill in the art is misplaced. Appeal Br. 4--5. Appellants, however, ignore that Edwards teaches that glandular nodules giving rise to BPH are present in the transition zone tissue, and that it is desired to confine treatment to the transition zone. Edwards, paras. 89, 119, 120, Fig. 38. Appellants also do not address the Examiner's further position that the desired depth of vapor injection is informed by the anatomy of the prostate and surrounding tissues. Further, the language of claim 1 is to the effect that the 12 mm upper limit as to the depth of injection of vapor media is "so as to confine the condensable vapor media in the transition zone tissue" and to limit tissue ablation to that depth. We therefore are not apprised of error in the Examiner's position that the claimed range of vapor injection depth would have been obvious. Appellants also argue that the Examiner's articulated reason to modify Edwards in view of Mulier, namely to obtain greater ablation precision such that only regions containing abnormal or diseased tissue, falls short of establishing a prima facie case of obviousness. Appeal Br. 5; Reply Br. 3. The reason presented is supported by the Mulier disclosure, and Appellants bald assertion does not apprise us of error. According to Appellants, "[t]he Examiner has not provided any rationale at all, ... , for the obviousness of confining Mulier's condensable vapor to prostrate transition zone tissue." Appeal Br. 5. Appellants posit that the question to be answered in the obviousness analysis is, "how, in the absence of any suggestion in either Edwards or Mulier that the ablation effect can or should be limited to the prostate transition zone ... , Mulier's 1 617 F.2d272 (CCPA 1980). 6 Appeal2016-000870 Application 12/843,581 disclosure of general water vapor and tissue principles would have motivated a skilled artisan to confine vapor delivery and the ablation effect to the transition zone." Appeal Br. 5---6. Appellants again tum a blind eye to the Edwards disclosure that glandular nodules that can be the cause of BPH are primarily concentrated in the transition zone, and the further exemplary procedure in Edwards that specifically limits the procedure to treating tissue in the transition zone. Thus, the premise of Appellants' rhetorical question 1s erroneous. Appellants' final Appeal Brief argument is that their showing of unexpected results is evidence of nonobviousness, regardless of the modification proposed by the Examiner. Appeal Br. 6. Appellants note that a Declaration Under 37 C.F.R. § 1.132 of Roger Hastings ("Hastings Declaration" or "Hastings Deel.") avers that a person of ordinary skill in the art would not have expected to be able to confine condensable vapor to the prostate transition zone and to ablate transition zone tissue adjacent to and less than 12 mm outward from the prostatic urethra. Id., citing Hastings Deel., para. 22. This statement lacks any underlying factual support or technical reasoning, and is, indeed, undermined by the Mulier and Edwards disclosures. The Edwards procedure discussed above employs RF energy intended to treat tissue only in the transition zone of the prostate. Edwards, paras. 119--120. Mulier, for its part, recognizes RF ablation as a then- existing ablation technique, that can potentially kill normal surrounding tissue, and, by comparison, notes that the use of vapor in ablation procedures allows for sufficient precision to ablate a selected portion of a tissue site, and can be directed to heat a relatively confined area at the tissue site, thereby 7 Appeal2016-000870 Application 12/843,581 reducing undesired heating of adjacent tissues. See, e.g., Mulier, paras. 7, 49. As such, we afford little weight to the Hastings averment. In the Reply Brief, Appellants again argue that the Examiner has failed to provide a teaching of confining vapor in the transition zone, asserting that Edwards "describes delivering RF energy to the transition zone, but does not describe confining that energy to the transition zone." Reply Br. 2. We again note that Edwards discloses that the transition zone is where the glandular nodules responsible for BPH are principally located, and discloses at least one exemplary procedure in which "[t]he tissues to be treated for the treatment of BPH are located in the transition zone 428 of the prostate." Edwards, paras. 73, 89, 119, Fig. 38. These portions of the Edwards disclosure would inform a person of ordinary skill in the art that the energy (vaporous energy in the modification to Edwards) would be confined to the transition zone. Appellants repeat the allegation that no rationale has been provided to support the position that it would have been obvious to confine the condensable vapor to the transition zone tissue. Reply Br. 2. This assertion is addressed thoroughly above. Appellants take issue with the Examiner's mention that it would have been "obvious to try," or determine through routine experimentation, various parameters associated with the delivery of condensable vapor, such that the vapor ablation is confined to the transition zone, in order to ablate the nodules causing the presence of BPH. Reply Br. 3; Ans. 6-7. Appellants specifically argue that an assertion that such would have been obvious to try is improper, in that "Mulier gives no indication of which parameters would 8 Appeal2016-000870 Application 12/843,581 be critical in confining vapor to a specific zone within the prostate." Reply Br. 3. Contrary to the position advanced by Appellants, Mulier specifically mentions a correlation between the pressure of the vapor spray and depth of ablation. 2 Mulier, para. 52. Mulier notes that if the pressure is insufficient to produce a desired depth of ablation, either the level of heat to produce the vapor may be increased to increase the pressure of the vapor, or a pressure regulator may be adjusted to do the same. Id.; see also id., para. 107 (more pressure may produce a greater ablation depth). Accordingly, Mulier advises the person of ordinary skill in the art that achieving a desired depth of ablation may be accomplished by adjusting a pressure of the vapor as necessary. Appellants' arguments do not apprise us of error in the Examiner's position relative to the unpatentability of claim 1 over Edwards and Mulier. The rejection of claim 1 over Edwards and Mulier is therefore sustained. Claims 2, 3, 5-8, 11, and 12 fall with claim 1. Claim 22 Appellants reference the arguments advanced for claim 1 in arguing against the rejection of claim 22. For the reasons discussed in detail above, the arguments do not apprise us of Examiner error. Claim 22 includes the further limitation that the vapor be delivered to the transition zone tissue at a delivery pressure ranging from approximately 20 mm Hg to 200 mm Hg. The Examiner takes the position that it would have been obvious to operate the Edwards procedure as modified by Mulier 2 This additionally supports the Examiner's position, discussed earlier, that treatement depth is a result effective variable. 9 Appeal2016-000870 Application 12/843,581 to deliver condensable vapor, at a delivery pressure within the claimed range, in that this amounts to discovering an optimum value of a result effective variable that involves only routine skill in the art. Final Act. 9. Appellants cite to the Hastings Declaration as support for the proposition that "the vapor delivery pressure is very important to the effectiveness of the therapy," and that pressures that are too high may extend the vapor ablation effects beyond the target tissue, with pressures that are too low potentially not achieving the desired effect of reducing tissue volume. Appeal Br. 7. We note that this position, not unlike the discussion of the correlation between vapor pressure and ablation depth found in paragraph 52 of Mulier, support the Examiner's position that vapor pressure is, and was known to be, a result-effective variable. Appellants further argue that Mulier does not disclose any value, or range of values, of vapor delivery pressure for treating BPH. Appeal Br. 7. Appellants maintain that Mulier discusses vapor pressure only in the context of a vapor generation system, in which the pressure is 25 pounds per square inch, which translates to 1293 mmHg, well outside the claimed range. Id., citing Mulier, para. 69. That paragraph in Mulier does not appear to be especially pertinent to vapor delivery pressures to perform tissue ablations inside a patient's body. Mulier, however, includes further disclosure pertinent to vapor delivery pressures for ablating tissue. Although admittedly not specific to treatment of BPH, Mulier provides an example, given in the context of calculating a vapor mass required to attain a target temperature, of introducing the steam into tissue at atmospheric pressure, namely, 7 6 mmHg, which is squarely in the claimed range. Mulier, para. 61. A person of ordinary skill in the art, in 10 Appeal2016-000870 Application 12/843,581 view of this disclosure, would regard delivery of vapor pressure at or around atmospheric pressure to be at least a viable starting point for determining, for a particular procedure such as treating for BPH, a particularly desired vapor delivery pressure. As such, arriving at a vapor delivery pressure within the claimed range would have been, according to the Examiner's position, a determination of an optimum value for a result-effective variable. Appellants' arguments do not apprise us of error in the Examiner's position. The rejection of claim 22 as being unpatentable over Edwards and Mulier is sustained. Claims 1-3, 5, 6, 8-12, and 22-24--Edwards/Shadduck Edwards is applied in this rejection in the same manner as in the rejection over Edwards and Mulier addressed above, and Shadduck is relied on much in the same manner as is Mulier. Final Act. 9-15. Appellants present arguments for independent claims 1 and 22, which are substantively the same arguments as presented traversing the rejection over Edwards and Mulier. Appeal Br. 8, 10-11; Reply Br. 4, 6. For the reasons presented in the foregoing section, we do not find that Appellants' arguments apprise us of error in the Examiner's position that claims 1 and 22 are unpatentable over Edwards and Shadduck. Dependent claims 2, 3, 5, 6, 8-12, 23, and 24, are not separately argued, and these claims fall with the independent claim from which they depend. Claims 13 and 26--Edwards/Mulier or Shadduck/Barry 11 Appeal2016-000870 Application 12/843,581 Claim 13 depends from claim 1, and claim 26 depends from claim 22. Each recites that the condensable vapor media is configured to apply energy ranging from 1 to 40 calories per second to the transition zone tissue. The Examiner finds that none of Edwards, Mulier, and Shadduck discloses this limitation directed to the range of energy applied. Final Act. 15. The Examiner cites to Barry as disclosing treating tissue using vaporous energy in the claimed range, and discloses selecting treatment parameters in order to cause a specific degree of injury to the tissue. Id. The Examiner concludes that it would have been obvious to employ the range of energies disclosed by Barry in the method resulting from modifying Edwards in view of Mulier or Shadduck, to provide the benefit of causing a specific degree of injury to tissue to be treated, and as a matter of discovering an optimum value of a result-effective variable involving only routine skill in the art. Id. at 15-16. Appellants argue that Barry is directed to ablating or otherwise injuring lung tissue in the treatment of lung cancer, and does not disclose appropriate values or ranges for energy delivery rates in treating the prostate. Appeal Br. 11. The Examiner has failed to produce evidence or provide adequate reasoning as to why a person of ordinary skill in the art would look to energy rates used in causing specific degrees of damage to cancerous lung cells in determining an appropriate range of energy rates for use in ablating prostate transition zone tissue in the treatment of BPH. Accordingly, the rejection of claims 13 and 26 is not sustained. Claims 14-16--Shadduck/Edwards 12 Appeal2016-000870 Application 12/843,581 Independent claim 14 includes limitations requiring that a vapor delivery member be extended from a probe into a plurality of sites in a transition zone tissue of a prostate, and that a condensable vapor media be delivered from the delivery member for 20 seconds or less at each of the plurality of sites. Appeal Br. 17, Claims Appendix. As to the former limitation, the Examiner takes the position that Shadduck discloses a needle 211 having a plurality of vapor outlets 207 thereon, and that "the needle penetrates 'a plurality of sites' within the prostate, where each site is associated with a respective vapor outlet." Ans. 11-12. As to the latter, the Examiner cites to paragraphs 56, 58, and 61 of Shadduck as together teaching a treatment time of 20 seconds when treating tissue such as prostate tissue. Id. at 12. The Examiner's position that a plurality of vapor outlets on a needle results in the needle being regarded as penetrating a plurality of sites within the prostate falls short of meeting the actual language of claim 14. As pointed out by Appellants (Reply Br. 4--5), the claim requires extending the vapor delivery member into a plurality of sites in the transition zone tissue, not simply having vapor delivered to a plurality of sites as a result of the needle having a plurality of vapor outlets thereon. We also agree with Appellants that the Examiner's reliance on the treatment times disclosed in paragraph 58 of Shadduck as rendering obvious the claim 14 limitation directed to treatment time, is in error. Appeal Br. 9. Appellants point out that paragraph 58 of Shadduck is not directed to treatment times for ablating prostate tissue, whereas mention of treating prostate tissue is discussed in connection with a different embodiment, for which no treatment times are disclosed. Id. 13 Appeal2016-000870 Application 12/843,581 Shadduck discloses that the treatment times of between 1-3 0 seconds and preferably 5-20 seconds are involved in a process for engaging and sealing tissue, with a so-called working end of the apparatus being optimized for performing that function. Shadduck, para. 5 8 ( referring to an instrument disclosed in paragraphs 48-5 8). The Examiner has not pointed to any evidence or provided any viable technical reasoning tending to show that treatment times disclosed as being suitable for a tissue sealing operation, would as well be suitable for ablating prostate transition zone tissue in treating BPH. Accordingly, the rejection of claim 14, and claims 15 and 16 depending therefrom, over Shadduck and Edwards, is not sustained. Claims 20 and 21--Mulier/Edwards/Barry, or Edwards/Mulier/Barry The Examiner relies on Barry in rejecting claims 20 and 21 in the same manner as in the rejection of claims 13 and 26 discussed above. For the same reason noted above, the rejection of claims 20 and 21, which improperly relies on the teachings of Barry, is not sustained. Claim 14--Nonstatutory Double Patenting--Hoey '079/Mulier or Shadduck The Examiner acknowledges that neither claim 5 of Hoey '079, nor the disclosure of Hoey '079, addresses confining a condensable vapor media in the transition zone tissue of the prostate. Final Act. 25. The Examiner cites to Mulier and Shadduck as providing evidence that this aspect of claim 14 on appeal would have been obvious. Id. Appellants argue that neither Mulier nor Shadduck provides a teaching of confining the vapor ablation to the transition zone tissue. Appeal 14 Appeal2016-000870 Application 12/843,581 Br. 14. As noted in the prior discussions of the rejections in view of Edwards in combination with Mulier or Shadduck, it is Edwards that provides a person of ordinary skill in the art with the teaching that confinement of the ablation to the transition zone tissue is desirable. As such, we agree with Appellants that Mulier and Shadduck do not remedy the deficiency in claim 5 of Hoey '079 identified by the Examiner. The rejection of claim 14 on grounds of double patenting over Hoey '079 in view of Mulier or Shadduck is not sustained. Claims 14 and 16--Provisional Nonstatutory Double Patenting--Hoey '544 Because this rejection is provisional in nature, we decline to reach this rejection. See Ex parte Moncla, 95 USPQ2d 1884, 1885 (BP AI 201 O)(Precedential) (panel have flexibility to not reach provisional obviousness-type double patenting rejections). Claims 1 and 2--Provisional Nonstatutory Double Patenting-Edwards Because this rejection is provisional in nature, we decline to reach this rejection. See Ex parte Moncla, 95 USPQ2d 1884, 1885 (BP AI 201 O)(Precedential) (panel have flexibility to not reach provisional obviousness-type double patenting rejections). DECISION The rejection of claims 1-3, 5-8, 11, 12, and 22 under 35 U.S.C. § 103(a) as being unpatentable over Edwards and Mulier is AFFIRMED. 15 Appeal2016-000870 Application 12/843,581 The rejection of claims 1-3, 5, 6, 8-12, and 22-24 under 35 U.S.C. § 103(a) as being unpatentable over Edwards and Shadduck is AFFIRMED. The rejection of claims 13 and 26 under 35 U.S.C. § 103(a) as being unpatentable over Edwards in view of Mulier or Shadduck, and further in view of Barry, is REVERSED. The rejection of claims 14--16 under 35 U.S.C. § 103(a) as being unpatentable over Shadduck in view of Edwards is REVERSED. The rejection of claims 20 and 21 under 35 U.S.C. § 103(a) as being unpatentable over Mulier in view of Edwards and Barry, or over Edwards in view ofMulier and Barry, is REVERSED. The rejection of claim 14 on the ground of nonstatutory double patenting over claim 5 of Hoey '079 in view of Mulier or Shadduck is REVERSED. We do not reach the provisional rejection of claims 14 and 16 on the ground of nonstatutory double patenting as being unpatentable over claims 7, 21, and 31, of Hoey '544. We do not reach the provisional rejection of claims 1 and 2 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of Edwards. 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 16 Copy with citationCopy as parenthetical citation