Ex Parte Hennings et alDownload PDFPatent Trial and Appeal BoardMay 2, 201310699212 (P.T.A.B. May. 2, 2013) 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. 10/699,212 10/30/2003 David R. Hennings C7162.0004 2780 91477 7590 05/03/2013 Dickstein Shapiro LLP 1633 Broadway New York, NY 10019 EXAMINER SHAY, DAVID M ART UNIT PAPER NUMBER 3769 MAIL DATE DELIVERY MODE 05/03/2013 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 DAVID R. HENNINGS, MITCHELL P. GOLDMAN, ROBERT A. WEISS, ERIC B. TAYLOR, and DON JOHNSON ____________ Appeal 2010-009821 Application 10/699,212 Technology Center 3700 ____________ Before PHILLIP J. KAUFFMAN, BARRY L. GROSSMAN, and BART A. GERSTENBLITH, Administrative Patent Judges. GERSTENBLITH, Administrative Patent Judge. DECISION ON APPEAL Appeal 2010-009821 Application 10/699,212 2 STATEMENT OF THE CASE David R. Hennings, Mitchell P. Goldman, Robert A. Weiss, Eric B. Taylor, and Don Johnson (“Appellants”) appeal under 35 U.S.C. § 134 from the Examiner’s decision rejecting claims 1-17, 19-23, 25-35, and 37-46.1 We have jurisdiction under 35 U.S.C. § 6(b). The Claimed Subject Matter Claims 1, 14, 25, and 35 are independent. Claims 1 and 14 are illustrative of the claimed subject matter and are reproduced below. 1. An endovenous method of treating a varicose veins comprising the step of using a laser having a wavelength between about 1.2 and about 1.8 um to heat and shrink collagen in a varicosed vein and to destroy the functionality of the varicose vein. 14. A system for endovenous treatment of varicose veins comprising the following: a laser having a wavelength between about 1.2 and about 1.8 um; and a fiber optic laser delivery device having a proximal end and a distal end, for delivery of laser energy from the distal end of the fiber optic laser delivery device to the inside wall of a varicose vein wherein the functionality of the varicose vein is destroyed and collagen in the varicosed vessel wall can be heated and shrunk. 1 Appellants identify claim 36 amongst the claims pending in the application and on appeal. See App. Br. 2. The Examiner mistakenly includes claim 36 in the heading of the rejection, but correctly notes that claim 36 was cancelled in the Status of Claims. See Ans. 2, 3. The record before us reveals that claim 36 was indeed cancelled. See Amendment (dated Nov. 17, 2006) at 2 (“Please cancel claim 36.”), 6 (identifying claim 36 as “Cancelled”); see also App. Br. 37 (identifying claim 36 as “Cancelled”). Accordingly, claim 36 is not included in the claims on appeal. Appeal 2010-009821 Application 10/699,212 3 References The Examiner relies upon the following prior art references: Dew US 4,854,320 Aug. 8, 1989 Sinofsky US 5,196,004 Mar. 23, 1993 Roth US 5,207,672 May 4, 1993 Goldman US 6,258,084 B1 July 10, 2001 Conn WO 92/17243 Oct. 15, 1992 Makower WO 93/15664 Aug. 19, 1993 Rejections The Examiner makes the following rejections: I. Claims 1, 2, 6, 7, 25-35, 37, 38, 40, 41, and 44-46 are rejected under 35 U.S.C. § 103(a) as unpatentable over Goldman, Sinofsky, and Dew; II. Claims 3-5, 42, and 43 are rejected under 35 U.S.C. § 103(a) as unpatentable over Goldman, Sinofsky, Dew, and Roth; III. Claims 8 and 39 are rejected under 35 U.S.C. § 103(a) as unpatentable over Goldman, Sinofsky, Dew, and Conn; IV. Claims 9-13 are rejected under 35 U.S.C. § 103(a) as unpatentable over Goldman, Sinofsky, Dew, and Makower; V. Claims 14-17 and 20-23 are rejected under 35 U.S.C. § 103(a) as unpatentable over Makower, Roth, and Dew; and VI. Claim 19 is rejected under 35 U.S.C. § 103(a) as unpatentable over Makower, Dew, Roth, and Conn. SUMMARY OF DECISION We AFFIRM. Appeal 2010-009821 Application 10/699,212 4 OPINION Rejection I – Obviousness over Goldman, Sinofsky, and Dew The Examiner concluded that the combination of Goldman, Sinofsky, and Dew renders obvious the subject matter of claims 1, 2, 6, 7, 25-35, 37, 38, 40, 41, and 44-46. Ans. 3-4. The Examiner found that Goldman discloses the elements of the claims with the exception of the claimed wavelength. Id. at 4. The Examiner, however, found that Sinofsky discloses the “notorious nature of the high absorption of infrared wavelengths in the art,” and that Dew teaches “the desirability of using 1.32 micron radiation to treat tissue.” Id. The Examiner determined that it would have been obvious to one of ordinary skill in the art to use the 1.32 um wavelength disclosed by Dew in the method taught by Goldman “since Goldman . . . teach[es] no particular wavelength, and since the wavelength of Dew can destroy (denature) the proteins, but allow near normal tissue to take its place . . . and since this wavelength is highly absorbed by tissue and water, as taught by Sinofsky.” Id. The Examiner also found that it would have been obvious to “employ the venous treatment method of Goldman . . . in the method of Dew . . . since Dew . . . teach[es] the repair of vascular tissue as one of the advantageous uses of their wavelength.” Id. Appellants assert several arguments in response to this rejection. First, Appellants contend that Goldman is not enabling because it is almost entirely directed to RF2 (radio frequency) heating of varicose veins and only contains a single mention of lasers amongst several possible alternatives to 2 Chambers 21st Century Dictionary (2001), available at http://www.credoreference.com/entry/chambdict/rf (last visited Apr. 25, 2013) (indicating that “RF” is an abbreviation for “radio frequency”). Appeal 2010-009821 Application 10/699,212 5 the use of RF energy. App. Br. 12. In particular, Appellants assert that Goldman does not teach “what lasers, with what wavelengths, for what chromophores might be tried in an effort to treat varicose veins” or the duration of treatment. Id. at 16. In support of their argument, Appellants submitted a declaration from Dr. Goldman3 (“Goldman Declaration”), dated December 23, 2009, in which he states that he had no experience or knowledge of the use of lasers, e.g., which laser wavelengths might be useful or power levels might be safe and effective, to treat varicose veins prior to filing the application that issued as the Goldman reference. See id. at 14 (quoting Goldman Decl. ¶ 5). Appellants also note that “[s]ome of the factors to consider in the experimentation required to determine the type of laser, the laser wavelength, the power levels and dose duration for a given use are outlined in Sinofsky.” Id. at 16. Thus, Appellants contend that since Goldman is non-enabling, “the attempt to combine Sinofsky and [Dew] with Goldman is an exercise in futility.” Id. at 17. Second, Appellants assert that even if Goldman were enabling, the rejection is erroneous because Sinofsky and Dew “are completely unrelated to Goldman and to each other and cannot be properly combined.” Id. at 17. Appellants contend that Sinofsky discloses a preferred laser treatment for arterial plaque with laser energy in the 1900-2100 nm range (which is equal to 1.9-2.1 um)4 and tissue removal with laser energy in the 1400-2200 nm 3 Mitchel P. Goldman is a named inventor of the Goldman reference, relied upon by the Examiner, as well as a named inventor of the invention described in the claims before us, although it appears his name is incorrectly spelled with two “l”s (Mitchell) in the present application. See Goldman Declaration at 1. 4 1 um equals 1000 nm. Appeal 2010-009821 Application 10/699,212 6 range (i.e., 1.4-2.2 um). Id. at 18. Appellants assert that Sinofsky discloses several characteristics for using a laser that must be taken into account, but are not recognized by Goldman. Id. Appellants contend that Dew discloses the use of an Nd:YAG laser tuned from its “normal” wavelength of 1.064 um to its “secondary wavelength” of 1.320 um for wound healing and tissue repair by solubilizing collagen. Id. Appellants further note that Dew’s 1.320 um wavelength is outside the lower limit of Sinofsky’s disclosed wavelengths (i.e., it is less than 1.40 um), and thus the “wavelength choices in Sinofsky and [Dew] are antithetical to each other, as are their respective targets,” and thus cannot be combined. Id. Third, Appellants contend that the Examiner picked and chose references simply because they disclosed various aspects of the claims, including the claimed wavelength, without providing a reason with rational underpinning for their combination. Id. at 19. Thus, Appellants assert that the Examiner failed to make a prima facie case of obviousness by relying upon “such disparate references.” Id. We address each of Appellants’ arguments.5 Appellants’ first argument—that Goldman does not enable the use of lasers for the treatment of varicose veins—misses the mark. It is textbook patent law that “[u]nder § 103 . . . a reference need not be enabled; it qualifies as a prior art, regardless, for whatever is disclosed therein.” Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1357 (Fed. Cir. 2003) (citing Symbol 5 Appellants argue the claims subject to Rejection I as a group. See App. Br. 12-20. We select claim 1 as representative. Accordingly, claims 2, 6, 7, 25-35, 37, 38, 40, 41, and 44-46 stand or fall with claim 1. See 37 C.F.R. § 41.37(c)(1)(vii) (2011); see also In re Lovin, 652 F.3d 1349, 1351 (Fed. Cir. 2011). Appeal 2010-009821 Application 10/699,212 7 Techs., Inc. v. Opticon, Inc., 935 F.2d 1569, 1578 (Fed. Cir. 1991); Reading & Bates Constr. Co. v. Baker Energy, 748 F.2d 645, 652 (Fed. Cir. 1984)). Even though Appellants are correct that Goldman discloses lasers in only one instance (see Goldman, col. 7, l. 57), Goldman qualifies as prior art for what is disclosed therein—that lasers can be used in the methods disclosed therein, one use of such methods being the treatment of varicose veins. See Ans. 3-4. The Goldman Declaration attesting to the Goldman inventors’ lack of specificity with respect to enabling the use of lasers in the treatment of varicose veins, see Goldman Decl. (dated Dec. 23, 2008), does not negate the reference’s explicit disclosure that “although the invention will be described as using RF energy from the electrode, it is to be understood that other forms of energy such as . . . lasers can be used.” Goldman, col. 7, ll. 53-59. As the Examiner found, the difference between Goldman’s disclosure and claim 1 resides solely in the claim’s specific recitation of a laser with a wavelength between about 1.2 and about 1.8 um.6 See Ans. 4. The Examiner, however, relied upon Dew as disclosing a wavelength within the claimed range. Id. Accordingly, Appellants’ arguments that Goldman does not enable the use of lasers as called for by claim 1 are inapposite because a prior art reference in the context of a § 103 rejection is not required to enable that which it discloses.7 6 Appellants’ arguments regarding experimentation required to determine the type of laser, power level, and dose duration for a given use of a laser are not commensurate in scope with claim 1 because the claim does not call for specific values for those variables. 7 Appellants’ arguments regarding overcoming a presumption that Goldman is enabled or operable (see, e.g., Reply Br. 5-6), while appropriate in the context of an anticipation rejection under § 102, do not negate the reference’s disclosure to one of ordinary skill in the art in the context of the Appeal 2010-009821 Application 10/699,212 8 With respect to Appellants’ second argument—that Sinofsky and Dew are completely unrelated to each other and to Goldman, and thus cannot be properly combined—we reiterate that “[a] reference qualifies as prior art for an obviousness determination under § 103 only when it is analogous to the claimed invention.” In re Klein, 647 F.3d 1343, 1348 (Fed. Cir. 2011) (citing Innovention Toys, LLC v. MGA Entm’t, Inc., 637 F.3d 1314, 1321 (Fed. Cir. 2011); In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004)). “Two separate tests define the scope of analogous art: (1) whether the art is from the same field of endeavor, regardless of the problem addressed and, (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” Id. (quoting In re Bigio, 381 F.3d at 1325). The “field of endeavor” test “requires the PTO to determine the appropriate field of endeavor by reference to explanations of the invention’s subject matter in the patent application, including the embodiments, function, and structure of the claimed invention.” In re Bigio, 381 F.3d at 1325. If the structure and function of the prior art would have been considered by a person of ordinary skill in the art because of similarity to the structure and function of the claimed invention as disclosed in the application, the prior art is properly considered within the same field of endeavor. See id. at 1325-26. Here, we agree with the Examiner that Sinofsky, Dew, and Goldman constitute analogous art because they are each from the same field of endeavor—laser surgery—as the claimed invention. See Ans. 18. Goldman, discussed above, discloses applying energy, such as that produced by a laser, to shrink a hollow anatomical structure, such as a fallopian tube or a vein, § 103 rejection before us. Appeal 2010-009821 Application 10/699,212 9 for use, inter alia, in the treatment of varicose veins. See, e.g., Goldman, col. 1, ll. 9-13; see also id. at col. 2, ll. 54-56. Sinofsky discloses the use of laser energy, in the range of 1.4 to 2.2 um, to remove biological material, e.g., atherosclerotic plaque, and repair biological material. See, e.g., Sinofsky, col. 2, ll. 49-52, 59-63. Dew discloses the use of optical energy, such as lasers, for closing wounds. See, e.g., Dew, col. 1, ll. 9-14; see also id. at col. 4, ll. 26-31. Accordingly, we disagree with Appellants that Goldman, Sinofsky, and Dew cannot be properly combined. We are similarly not persuaded by Appellants’ third argument in response to this rejection—that the Examiner did not provide a rational reason for combining the references’ disclosures. The Examiner determined that it would have been obvious to one of ordinary skill in the art at the time of invention to employ the wavelengths of Dew and Sinofsky in the method of Goldman since Dew teaches that a wavelength of 1.32 um can denature proteins and allow near normal tissue to take their place,8 and Sinofsky teaches that a wavelength in this range is highly absorbed by tissue and water.9 Ans. 4. Thus, the Examiner provided a reason with rational 8 Claim 1 calls for using a laser to “heat and shrink collagen in a varicosed vein,” and the Examiner correctly recognized that Dew discloses the use of laser energy of wavelength 1.32 um to denature (which can destroy or shrink) collagen. See Ans. 4; see also Dew, col. 5, ll. 32-36 (“Collagen, a major source of protein in the body, is denatured by application of such energy in such a way as to go into solution and form a ‘biological glue’ to seal a lesion, anastomize a severed vessel, or reconstruct damaged tissue.”). 9 The Examiner correctly recognized that Sinofsky discloses that a laser of a wavelength within the claimed range is highly absorbed by water and tissue. See Sinofsky, col. 4, ll. 62-65 (“The absorption of laser energy produced by lasers in this latter group by water is moderately high and, consequently, the absorption by biological tissues of such energy will also be relatively Appeal 2010-009821 Application 10/699,212 10 underpinning as to why one of ordinary skill in the art would have been prompted to employ the wavelengths disclosed in Dew and Sinofsky in the method of Goldman, and Appellants have not persuasively argued why the Examiner’s stated rationale is deficient. Rejection II – Obviousness over Goldman, Sinofsky, Dew, and Roth The Examiner determined that the combination of Goldman, Sinofsky, Dew, and Roth renders obvious the subject matter of claims 3-5, 42, and 43. Ans. 4-5. The Examiner found that Roth teaches “employing [the] pull back rate as claimed,” and “that the desired rate is dependent on the laser energy.” Id. at 4-5. The Examiner determined that it would have been obvious to one of ordinary skill in the art at the time of invention “to employ a pull back as claimed, since [they] are known in the art and provide no unexpected result.” Id. at 5. The Examiner also found that it would have been obvious to “initiate pulling prior to energy application, since the problem of tissue adhesion is notorious in the art.” Id. The Examiner also took Official Notice that the problem of tissue adhesion is notorious in the art. Id. Appellants raise four arguments directed to this rejection. First, Appellants contend that Roth discloses a pullback device in an entirely different context than the claims. App. Br. 20. Second, Appellants assert that Roth does not “cure the deficiencies in the attempted combination of Goldman, Sinofsky and Dew.” Id. Third, Appellants contend that the Examiner failed to provide a reason or rational underpinning for combining Roth with Goldman, Sinofsky, and Drew. Id. Fourth, Appellants assert that each reference is directed to “different fields of use.” Id. high.”). Appeal 2010-009821 Application 10/699,212 11 We do not find Appellants’ arguments persuasive.10 Claim 3 depends from claim 1 and further calls for, inter alia, using “a pullback device to retract the fiber optic laser delivery device through the varicose vein at a rate of between about 0.1 mm/sec and about 10.0 mm/sec while simultaneously delivering laser energy therefrom.” Roth discloses the use of a pullback device as part of a laser delivery device at the claimed rate. See Ans. 5 (citing Roth, col. 15, ll. 24-50 (disclosing pullback rates between 0.01 mm/sec and 50 mm/sec)). Roth is directed to an instrument and method of performing laser surgery to “transluminally open[] any constricted regions of a passageway through a portion of a living body, and in particular, the prostatic urethra of an enlarged prostate.” See, e.g., Roth, col. 1, ll. 11-16. Thus, Roth’s “context” and “field of use” is also laser surgery. Additionally, the Examiner did not rely upon Roth as disclosing the elements of claim 1 taught by Goldman, Sinofsky, and Dew. And as we did not find any of Appellants’ alleged “deficiencies in the attempted combination of Goldman, Sinofsky and Dew” persuasive, Roth need not disclose more. Further, we disagree with Appellants that the Examiner failed to provide a reason with rational underpinning for the proposed combination. The Examiner took Official Notice, which Appellants have not contested, that the problem of tissue adhesion in the art is notorious, and determined that it would have been obvious to one of ordinary skill in the art to employ 10 Appellants argue the claims subject to Rejection II as a group. See App. Br. 20. We select claim 3 as representative. Accordingly, claims 4, 5, 42, and 43 stand or fall with claim 3. See 37 C.F.R. § 41.37(c)(1)(vii); see also In re Lovin, 652 F.3d at 1351. Appeal 2010-009821 Application 10/699,212 12 a pullback device at the rate claimed to address the known problem of tissue adhesion. Ans. 5. Accordingly, Appellants have not persuaded us that the Examiner failed to provide a reason with rational underpinning for the proposed combination. Rejection III – Obviousness over Goldman, Sinofsky, Dew, and Conn The Examiner determined that the combination of Goldman, Sinofsky, Dew, and Conn renders obvious the subject matter of claims 8 and 39. Id. The Examiner found that Conn discloses a diffusing tip as claimed. Id. The Examiner determined that it would have been obvious to one of ordinary skill in the art at the time of invention to “employ a tip as taught by Conn . . . since this would provide a uniform distribution of light and would prevent over or under treatment of tissue [sic] different areas of tissue . . . around the circumference of the vessel.” Id. Appellants acknowledge that Conn discloses a diffusing tip, but raise four arguments in response to this rejection. First, Appellants assert that they do not purport to have invented a diffusing tip for a laser. App. Br. 21. Second, Appellants contend that Conn does not cure the deficiencies of the attempted combination of Goldman with Sinofsky and Drew. Id. Third, Appellants assert that the Examiner has not provided reasoning or rational underpinning for combining Conn with the other references. Id. Fourth, Appellants contend that it was “only an attempt to reconstruct applicants’ invention which inspires reliance on Conn.” Id. We do not find Appellants’ arguments persuasive.11 Claim 8, which depends indirectly from claim 1, calls for the energy to be delivered 11 Appellants argue the claims subject to Rejection III as a group. See App. Br. 21. We select claim 8 as representative. Accordingly, claim 39 stands Appeal 2010-009821 Application 10/699,212 13 “through the fiber optic laser delivery device . . . evenly . . . by using a diffuse radiating-tip mounted to the distal end of the fiber optic laser delivery device.” First, the Examiner did not assert that Appellants invented a diffusing tip for a laser. Second, the Examiner did not rely upon Conn to cure any alleged deficiencies with respect to Goldman, Sinofsky, and Dew. And as we did not find any of Appellants’ alleged deficiencies in the attempted combination of Goldman, Sinofsky and Dew persuasive, Dew need not disclose more. Finally, the Examiner provided a reason with rational underpinning for the proposed combination—since a diffusing tip provides a uniform distribution of light to prevent over or under treatment of different areas of tissue (Ans. 5)—and the Examiner’s analysis does not appear to be any more of an attempt to reconstruct Appellants’ invention than any other inquiry into whether one of ordinary skill in the art would have found a claimed invention obvious. See, e.g., Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 16 (1966) (identifying “the scope and content of the prior art” and the “differences between the prior art and the claims at issue” as two of the inquiries under § 103). Rejection IV – Obviousness over Goldman, Sinofsky, Dew, and Makower The Examiner determined that the combination of Goldman, Sinofsky, Dew, and Makower renders obvious the subject matter of claims 9-13. Ans. 5. The Examiner found that Makower discloses “controlling the heating of tissue using infrared sensing.” Id. The Examiner determined that it would have been obvious to one of ordinary skill in the art at the time of or falls with claim 8. See 37 C.F.R. § 41.37(c)(1)(vii); see also In re Lovin, 652 F.3d at 1351. Appeal 2010-009821 Application 10/699,212 14 invention “to employ the temperature sensor of Makower . . . in the method of Goldman . . . since these are equivalents, as taught by Makower.” Id. Appellants acknowledge that Makower discloses the use of infrared sensing to control heating, but raise three arguments in response to this rejection. First, Appellants contend that Makower does not cure any of the deficiencies of the attempted combination of Goldman with Sinofsky and Dew. App. Br. 21. Second, Appellants assert that “it is only an attempt re [sic] reconstruct applicants’ invention which prompts citation of Makower.” Id. Third, Appellants contend that “[t]here is nothing in the remaining references to suggest that use of a temperature sensor is needed or desirable.” Id. We do not find Appellants’ arguments persuasive.12 Claim 9, which depends indirectly from claim 1, calls for the use of a “non-contact thermal sensor . . . to maintain a desired temperature.” We do not find Appellants’ first and second arguments directed to Makower, which repeat the same arguments noted with respect to Rejections II and III pertaining to Roth and Conn, respectively, persuasive for the reasons we previously explained in addressing Rejections II and III. Further, Appellants’ argument that “[t]here is nothing in the remaining references to suggest that use of a temperature sensor is needed or desirable” is unclear as to which references Appellants refer. See App. Br. 21 (emphasis added). The Examiner provided a reason with rational underpinning as to why one of ordinary skill in the art at the time of invention would have found it obvious to employ a temperature 12 Appellants argue the claims subject to Rejection IV as a group. See App. Br. 21. We select claim 9 as representative. Accordingly, claims 10-13 stand or fall with claim 9. See 37 C.F.R. § 41.37(c)(1)(vii); see also In re Lovin, 652 F.3d at 1351. Appeal 2010-009821 Application 10/699,212 15 sensor. See Ans. 5. While the identification of a teaching, suggestion, or motivation to combine need not be restricted to the references relied upon for a proposed combination in an obviousness inquiry, see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (“the analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ”), the Examiner aptly noted that Goldman “specifically teach[es] providing temperature sensors at the site.” Ans. 21 (citing Goldman, Abstract); see also Ans. 4 (finding that Goldman discloses providing temperature sensors at the site) (citing Goldman, Abstract). Accordingly, we do not find Appellants’ arguments persuasive. Rejection V – Obviousness over Makower, Roth, and Dew The Examiner determined that the combination of Makower, Roth, and Dew renders obvious the subject matter of claims 14-17 and 20-23. Ans. 5-6. The Examiner found that Makower teaches most of the elements claimed, except for the particular laser wavelength and the pull back mechanism. Id. The Examiner found that Dew teaches the claimed wavelength for treating tissue and that Roth teaches a pullback mechanism employing the claimed rate. Id. at 6. The Examiner determined that it would have been obvious to one of ordinary skill in the art at the time of invention to employ the wavelength of [Dew] in the device of [Makower], since [Makower] teach[es] the use of an Nd:YAG laser, which necessarily produces this radiation, as taught by [Dew] and to employ the pull back mechanism of [Roth] since this enables uniform treatment along the surface, as taught by [Roth], thus producing a device such as claimed. Appeal 2010-009821 Application 10/699,212 16 Id. Appellants assert several arguments in response to this rejection. First, Appellants contend that Makower, Roth, and Dew have nothing to do with the treatment of varicose veins. App. Br. 22. Second, Appellants assert that the notion that one of ordinary skill in the art “interested in treating BPH as disclosed in Makower and Roth which explicitly or implicitly disclose the standard wavelength of 1,064 nm [1.064 um] would have any interest in the secondary laser wavelength of Dew . . . which is used for an entirely different purpose is simply untenable.” Id. Third, Appellants contend that Makower and Roth “cannot be combined” because Makower has a locking means to prevent movement of the laser disclosed therein and Roth discloses pulling the laser through the tissue. Id. We do not find Appellants’ arguments persuasive.13 Claim 14 is directed to a system for endovenous treatment of varicose veins comprising (1) “a laser having a wavelength between about 1.2 and about 1.8 um”; and (2) “a fiber optic laser delivery device having a proximal end and a distal end, for delivery of laser energy from the distal end of the fiber optic laser delivery device to the inside wall of a varicose vein.”14 The Examiner considered claim 14 as an apparatus claim, and Appellants have not persuasively explained why such treatment is erroneous. Thus, we agree with the Examiner that one of ordinary skill in the art would find the claimed 13 Appellants argue the claims subject to Rejection V as a group. See App. Br. 22. We select claim 14 as representative. Accordingly, claims 15-17 and 20-23 stand or fall with claim 14. See 37 C.F.R. § 41.37(c)(1)(vii); see also In re Lovin, 652 F.3d at 1351. 14 The claim further recites “wherein the functionality of the varicose vein is destroyed and collagen in the varicosed vessel wall can be heated and shrunk.” Appeal 2010-009821 Application 10/699,212 17 system obvious in light of the disclosure of the claimed structure. See Ans. 21. The Examiner further explained that one of ordinary skill in the art would have found it obvious to use the wavelength of Roth (1.064 um) as well as the wavelength of Dew (1.32 um), which falls within the claimed range, to seal the holes described in Makower. Id. at 21-22. The Examiner also explained that Makower and Roth are not incompatible because Makower’s locking mechanism “only locks the cannula,” but the “fiber can be completely removed and reinserted while the cannula is locked in place.” Id. at 22 (citing Makower at 20, ¶ 1). We discern no error in the Examiner’s interpretation of Makower’s locking mechanism and Appellants have not attempted to rebut this finding. Accordingly, we do not find Appellants’ arguments persuasive. Rejection VI – Obviousness over Makower, Dew, Roth, and Conn The Examiner determined that the combination of Makower, Dew, Roth, and Conn renders obvious the subject matter of claim 19. Ans. 6. The Examiner found that Dew teaches a “diffusing tip on an introducer for a fiber.” Id. The Examiner determined that it would have been obvious to one of ordinary skill in the art to “include the diffuser of [Conn] in the device of [Makower] since this reduces problems due to breakage, as taught by [Conn].” Id. The Examiner also found that at least one embodiment disclosed in Makower involves photodynamic therapy and since Conn discloses that the diffuser taught therein can be used in photodynamic therapy, the teachings were properly combined. Id. at 22 (citing Makower at 20; Conn at 1). Appellants assert that this rejection is erroneous because Makower, Dew, and Roth do not suggest any interest in a diffusing tip, that it would be Appeal 2010-009821 Application 10/699,212 18 useful in any of their devices, or that one skilled in the art would have any inclination to use a diffusing tip in those devices. App. Br. 23. We do not find Appellants’ arguments persuasive. Claim 19, which depends indirectly from claim 14, calls for “a diffusing tip at the distal end of the introducer catheter for providing an even distribution of energy radiating during treatment.” As we explained above, the motivation or suggestion to combine need not be derived from each reference sought to be combined. See KSR, 550 U.S. at 418. The Examiner provided a reason with a rational underpinning as to why it would have been obvious to one of ordinary skill in the art to combine the teachings of the references in the manner claimed. See Ans. 6, 22. Given that Makower and Conn are directed, at least in part, to photodynamic therapy, and that Conn discloses that controlling the diffusion of laser energy from the end of the optical fiber is desirable in photodynamic therapy, this reason has a rationale underpinning. See, e.g., Makower at 20; Conn at 1, ll. 4-7; Ans. 22. Accordingly, we do not find Appellants’ arguments persuasive. Teaching Away/Secondary Considerations Appellants assert that the prior art teaches away from the use of lasers with wavelengths above 1.064 um. App. Br. 25. Rather than base their teaching away arguments on the prior art cited by the Examiner, Appellants base their argument on declarations submitted by Hennings, Geriak, and Goldman, and at least four articles, three of which were attached to the Geriak Declaration (dated Nov. 22, 2005) as Exhibit A (written by Dr. Min), and Exhibits B and C (written by Dr. Proebstle), and one of which was attached to the Declaration of David R. Hennings (dated Dec. 22, 2008) (“Second Hennings Declaration”) as Exhibit 1 (written by Drs. Fan and Rox- Appeal 2010-009821 Application 10/699,212 19 Anderson). Id. at 23-27. Appellants also submitted product literature, attached as Exhibits A-E to the Declaration of David R. Hennings (dated June 30, 2005), from five laser devices for treating varicose veins having wavelengths in the range of 810-980 nm. Id. at 23-24. Additionally, Appellants refer to an article by Luis Navarro, U.S. Patent No. 6,398,777, and U.S. Published Application No. 2005/001523. Id. at 26-27. Appellants contend that the uniform view expressed in the scientific literature at the time of invention was that “there was no consideration of using anything other than blood as a chromophore for laser energy in the 810-980 nm wavelength range, and that a wavelength as high as 1064 nm was undesirable.” Id. at 27. Appellants assert that the present invention was a “substantial and significant departure” from the prior art because the invention targeted water as a chromophore with laser energy in the range of 1200-1800 nm. Id. Appellants also contend that it was error for the Examiner to refuse to consider their evidence of nonobviousness. Id. at 27-32. As noted above, Appellants do not argue that any of the references relied upon by the Examiner discourage a person of ordinary skill in the art from following the path taken by Appellants. Thus, we consider Appellants’ arguments and evidence more akin to secondary considerations of nonobviousness, e.g., skepticism of experts or, on a broad sense, proceeding contrary to accepted wisdom/state of the art. The March 13, 2009, Final Office Action, reflects that the Examiner fully considered the declarations and articles submitted by Appellants. Final Office Action (mailed Mar. 13, 2009) at 2-14. In fact, the Examiner spent thirteen pages explaining his rationale for why the declarations and articles Appeal 2010-009821 Application 10/699,212 20 did not overcome the prima facie case of obviousness based on the combined teachings of the references cited in the various rejections. See id. The Examiner’s Answer, however, does not repeat the rationale provided in the Final Office Action. See Ans. 18-19. Rather, the Examiner states that “[t]here is no assertion whatsoever in any Affidavit of record that the articles or product literature are in any way representative of the prior art with respect to varicose vein treatment.” Id. at 18. It is not entirely clear to us why the Examiner takes this position when the Second Hennings Declaration attests that “[t]he articles from the scientific literature attached as Exhibits A, B and C to the aforesaid Geriak Declaration are fully representative of the prior art with respect to varicose vein treatment and are from highly respected scientific journals.” Second Hennings Decl. ¶ 6; see also Goldman Decl. ¶ 8 (referring to Exhibits A, B, and C of the Geriak Declaration as “representative of the belief held by the prior art prior to the invention claimed in this application”). Thus, we disagree with the Examiner that there was no assertion that the articles are representative of the prior art with respect to varicose vein treatment. Accepting that Exhibits A-C are representative of the prior art with respect to varicose vein treatment, however, does not resolve the issue before us. The Examiner found and we agreed (as discussed supra) that the field of endeavor is more appropriately considered laser surgery, rather than simply the treatment of varicose veins. Thus, while Exhibits A-C are representative of the field of art for varicose vein treatment, they are not fully representative of the laser surgery field. The laser surgery field includes the Sinofsky, Dew, Roth, Conn, and Makower references upon which the Examiner relied. Appeal 2010-009821 Application 10/699,212 21 After fully reviewing and considering Exhibits A-C and Appellants’ arguments directed thereto, we find that they do not persuade us of the nonobviousness of the claimed invention in light of the overwhelming evidence of obviousness when considering the teachings of the references relied upon by the Examiner in the laser surgery field. Of the three exhibits submitted with the Geriak Declaration, Appellants’ focus on Exhibit A (the article by Dr. Min).15 Dr. Min reports that in a study using 1064 nm laser energy, a success rate of 96.8% was reported, but “significant complications were noted, including paresthesias (36.5%) and skin burns (4.8%)” and patients “underwent spinal or general anesthesia rather than strictly local tumescent anesthesia.” Geriak Decl., Ex. A at 995. Treatment with 810 nm diode laser energy, however, was reported to have “no heat related complications despite high temperatures attained at the laser fiber tip.” Id. Three potential reasons were proposed to explain the differences in the results of the two studies: (1) improved delivery and use of sufficient amounts of tumescent fluid; (2) that higher wavelengths, such as 1064 nm, are absorbed less by blood and more by water; and (3) faster rates of withdrawal and shallower depth of penetration of the 810 nm laser energy. Id. While we acknowledge that Exhibit A indicates that some complications occurred with the use of a laser with a longer wavelength, Exhibit A also reports a 98.6% success rate. See id. The claims at issue are directed to methods and a system for treating varicose veins. Neither the 15 Appellants have not asserted and our independent review did not reveal any statements in Exhibits B or C that reflect complications or negative results of using laser energy of longer wavelength. Thus, we focus on Exhibit A. Appeal 2010-009821 Application 10/699,212 22 explicit claim language nor the claims when read in light of the Specification require the exclusion of a certain percentage of complications to constitute “treating varicose veins.” Thus, we are not persuaded that a 98.6% success rate, as reported in Exhibit A, does not constitute successfully treating varicose veins. For the same reasons, we do not find that Dr. Min’s article constitutes sufficient evidence that experts were skeptical as to whether lasers of longer wavelengths could be used to successfully treat varicose veins. Further, Dr. Min proposed three possible explanations to explain the difference in results achieved by the shorter 810 nm wavelength, two of which did not involve the wavelength itself. See Geriak Decl., Ex. A at 995. Accordingly, while Exhibit A may have raised concerns about using a longer wavelength, we find that it does not evidence sufficient skepticism of experts as to whether a longer wavelength could be used to successfully treat varicose veins. Rather, we find it more likely that one of skill in the art would have continued to try various wavelengths while altering the other variables identified by Dr. Min and other variables known in the art, as taught by, inter alia, Sinofsky, Dew, and Roth, to determine if altering those parameters reduced the complications noted by Dr. Min. Appellants also submitted an article by Drs. Fan and Rox-Anderson (Exhibit 1 to the Second Hennings Declaration) and asserted that the article concludes that substantial patient benefit results from the use of laser energy at the claimed wavelength of 1320 nm as compared with wavelengths of 810-1064 nm. See App. Br. 24; Second Hennings Decl., Ex. 1 at 209. Exhibit 1, however, attributes the benefits of reduced pain and bruising to Appeal 2010-009821 Application 10/699,212 23 “higher wavelength and lower energy application.”16 App. Br. 24 (quoting Exhibit 1 at 209). As the Examiner correctly noted when considering this article, the benefits were attributed to two features, while only one feature— longer wavelength—is claimed. Final Office Action (mailed Mar. 13, 2009) at 4. The claims do not recite a specific energy. Thus, the claims are not commensurate in scope with the features attributed to reducing pain and bruising as expressed in Exhibit 1.17 See In re Huai-Hung Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) (“For objective evidence of secondary considerations to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention.”). We have thoroughly considered Appellants’ additional arguments and evidence indicating that lasers of a shorter wavelength were successfully used to treat varicose veins. That evidence, however, does not persuade us that the use of lasers of a wavelength in the claimed range, in and of itself (i.e., the wavelength is the only claim element to which Appellants’ arguments and evidence are directed) reflects such a significant departure from the accepted wisdom/state of the art that a claim directed to such use would not have been obvious to one of ordinary skill in the art in light of the 16 In the context of Exhibit A, we understand the reference to “lower energy application” to refer to the power setting of the laser, which was noted to be 5 W when used with the 1320 nm wavelength as compared to 12-15 W when used with the 810-1064 nm wavelength. Second Hennings Decl., Ex. 1 at 209. 17 While Exhibit A is not prior art (it was published in 2008), we have addressed it because Appellants appear to put substantial reliance upon the statement therein noting the benefits of using a laser of longer wavelength and lower energy. Appeal 2010-009821 Application 10/699,212 24 teachings of the references relied upon by the Examiner. Accordingly, we affirm Rejections I-VI. DECISION We affirm the Examiner’s decision rejecting claims 1-17, 19-23, 25-35, and 37-46. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED mls Copy with citationCopy as parenthetical citation