Ex Parte Knox et alDownload PDFPatent Trial and Appeal BoardFeb 25, 201312146976 (P.T.A.B. Feb. 25, 2013) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte WAYNE H. KNOX, LI DING, KRYSTEL R. HUXLIN, and JAY F. KUNZLER __________ Appeal 2011-002230 Application 12/146,976 Technology Center 3700 __________ Before TONI R. SCHEINER, FRANCISCO C. PRATS, and JEFFREY N. FREDMAN, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method for modifying the refractive index of ocular tissue. The Examiner rejected the claims as anticipated and as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. Appeal 2011-002230 Application 12/146,976 2 Statement of the Case Background “The invention is directed to a method for modifying the refractive index of ocular tissue. The method comprises irradiating select regions of biological tissue with a focused, visible or near-IR laser” (Spec. 3 ¶ 0010). According to the Specification, the “irradiation results in the formation of refractive structures characterized by a change in refractive index, and which exhibit little or no scattering loss. The types of biological tissues that can be modified include ocular tissues such as corneal stromal layer and the lens cortex” (Spec. 3 ¶ 0010). The Claims Claims 13-19, 27-31, and 36-38 are on appeal. Claim 13 is representative and reads as follows: 13. A method for modifying the refractive index of ocular tissue, the method comprising: irradiating select regions of the ocular tissue with a focused, visible or near-IR laser below the optical breakdown threshold of the tissue to provide refractive structures that exhibit a change in refractive index, and exhibit little or no scattering loss; and scanning over the select regions with the laser such that ablation or removal of the tissue is not observed in the irradiated region. The issues 1 A. The Examiner rejected claims 13, 16, 17, and 30 under 35 U.S.C. § 102(b) as anticipated by Hänsel 2 (Ans. 4-6). 1 The Examiner‟s objection to claims 13-19, 27-31, and 36-38 for certain informalities is a petitionable (rather than appealable) matter. Appeal 2011-002230 Application 12/146,976 3 B. The Examiner rejected claims 14, 15, 19, 27, 28, 31, and 36-38 under 35 U.S.C. § 103(a) as obvious over Hänsel (Ans. 6-7). C. The Examiner rejected claims 18 and 29 under 35 U.S.C. § 103(a) as obvious over Hänsel and Seiler 3 (Ans. 7-8). A. 35 U.S.C. § 102(b) over Hänsel The Examiner finds that Hänsel teaches that “[s]elect regions of the ocular tissue are irradiated with a focused, visible or near-IR laser (greater than 600 nm or greater than 1300 nm; Col 5, lines 12-18) below the optical breakdown threshold of the tissue to provide refractive structures” (Ans. 4). The Examiner finds that Hänsel “discloses that the radiation used is therapeutic (Col 3, lines 44-58) and the method avoids the use of high- energy radiation” (id. at 4-5). The Examiner finds that Hänsel “discloses the use of a scanner” (id. at 5). The Examiner also contends that “the mere allegation of non- enablement is insufficient to overcome the presumption of validity afforded a patented claim” (id. at 8). Appellants contend that the “primary issue on Appeal is whether Hansel is an enabling disclosure, that is, whether the complete disclosure of Hansel in combination with the knowledge of an ordinary person in the relevant art has placed in the possession of the public the claimed invention sought by Appellants” (App. Br. 5). Appellants contend that the ordinary artisan “would not know where to begin with respect to the irradiation conditions necessary to modify the refractive index of ocular tissue by 2 Hänsel, H., US 6,478,792 B1, issued Nov. 12, 2002. 3 Seiler et al., US 5,461,212, issued Oct. 24, 1995. Appeal 2011-002230 Application 12/146,976 4 forming refractive structures that exhibit little or no scattering loss and which does not result in the ablation or destruction of the tissue in the irradiated regions” (App. Br. 8). The issue with respect to this rejection is: Does the evidence of record support the Examiner‟s conclusion that Hänsel is an enabled reference which anticipates the claims? Findings of Fact 1. Hänsel teaches that changes “in the refractive index of the various eye lens regions are achieved efficiently and in a simple manner, using a device for irradiation of the eye” (Hänsel, col. 3, ll. 59-61). 2. Hänsel teaches a light source 10 which emits therapeutic radiation 11 for the radiation of the eye lens at any wavelength which is clearly above the operating wavelength of excimer lasers, advantageously greater than 600 nm, and for the radiation of the cornea with a wavelength, which is above a near infra- red wavelength of 1.3 micrometers. (Hänsel, col. 5, ll. 14-18.) 3. The Specification teaches that a “wavelength of 800 nm is useful; preferable ranges include 600-1,000 nm” (Spec. 9 ¶ 0051). 4. Hänsel teaches that the “refractive index variations have to be created in microscopically small dimensions (about 1 micron/micrometer or even less)” (Hänsel, col. 7, ll. 5-7). 5. The Specification teaches that the “laser pulses were focused to a spot size of about 1 µm” (Spec. 9 ¶ 0048). 6. Hänsel teaches that the “time specifications of therapeutic exposure (cw, qcw or pulse mode, pulse duration and repeat frequency) must Appeal 2011-002230 Application 12/146,976 5 be selected in accordance with the examinations to be specified for each individual application” (Hänsel, col. 7, ll. 12-15). 7. Hänsel teaches that “[p]ulse modes with frequencies near the kilohertz range and pulse durations from some microseconds to some milliseconds have been successfully used” (Hänsel, col. 7, ll. 16-18). 8. The Specification teaches a “laser pulse frequency from 1 MHz to 10 GHz” (Spec. 8 ¶ 0045). 9. The Specification teaches that “one can likely operate within a range from 5 fs to 1 ps” (Spec. 9 ¶ 0048). 10. Hänsel teaches that “[s]patial modulation can be performed with electro-optical converters in transmission or reflection mode, or using a scanner” (Hänsel, col. 6, ll. 16-18). 11. Hänsel teaches that the prior art ablation techniques used “energies from 10 µJ to 10 mJ” (Hänsel, col. 2, l. 22). Principles of Law “In patent prosecution the examiner is entitled to reject application claims as anticipated by a prior art patent without conducting an inquiry into whether or not that patent is enabled or whether or not it is the claimed material (as opposed to the unclaimed disclosures) in that patent that are at issue.” Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355 (Fed. Cir. 2003). “The applicant, however, can then overcome that rejection by proving that the relevant disclosures of the prior art patent are not enabled.” Id. Appeal 2011-002230 Application 12/146,976 6 Analysis The Amgen reasoning was recently reaffirmed in Antor, where the Federal Circuit explained that “[e]nablement of prior art requires that the reference teach a skilled artisan to make or carry out what it discloses in relation to the claimed invention.” In re Antor Media Corp., 689 F.3d 1282, 1290 (Fed. Cir. 2012). Antor further teaches that the Appellants must show “that undue experimentation would be required to perform the claimed invention based on the teaching” in the prior art. Id. at 1289. Claim 13 is representative of the rejected claims. See 37 C.F.R. § 41.37(c)(1)(vii). Claim 13 recites a method for modifying the refractive index of ocular tissue by irradiating selected regions of the ocular tissue with a focused, visible or near-IR laser below the optical breakdown threshold of the tissue to provide refractive structures that exhibit a change in refractive index, but which exhibit little or no scattering loss. The selected regions are scanned with the laser such that ablation or removal of the tissue is not observed in the irradiated region. As the Examiner found, Hänsel teaches laser wavelengths and spot sizes which fall within the ranges disclosed as functional in the Specification (FF 2-5). Hänsel also teaches that selection of pulse duration and repeat frequencies are results optimizable variables (FF 6). While Hänsel‟s values for pulse frequency and duration differ somewhat from those in the Specification (FF 7-9), Appellants have made no specific evidentiary showing demonstrating undue experimentation. Instead, Appellants simply criticize the disclosure (see App. Br. 8), and point out how the disclosures of the Specification and Hänsel both relate to the elements of representative Appeal 2011-002230 Application 12/146,976 7 claim 13 (see id. at Evidence Appendix). However Antor and Amgen make it clear that evidence supporting a finding of undue experimentation, not simply attorney argument, is required to demonstrate that a reference, particularly a patent reference claiming similar subject matter, is not enabled. Antor at 1289, Amgen at 1355. Conclusion of Law Appellants have not advanced adequate evidence to undermine the Examiner‟s conclusion that Hänsel is an enabled reference which anticipates representative claim 13. B. 35 U.S.C. § 103(a) over Hänsel The Examiner finds that “[w]hile Hansel is silent with regards to the exact change in refractive index, it is the examiner‟s position that one of ordinary skill in the art would choose the desired change in refractive index to improve the patient‟s vision as much as possible as taught by Hansel” (Ans. 6-7). The Examiner finds that “[o]ne of ordinary skill in the art knows the ablation thresholds of ocular tissue and would choose energy levels below this threshold in order to prevent removal of tissue as ablation is not a desired result of the method taught by Hansel” (Ans. 7). Appellants contend that “[b]ecause the range of change in refractive index is not expressly or implicitly described or suggested in Hansel the assertion of a prima facie case of obviousness as to claims 15, 31 and 36 is legal error” (App. Br. 17). Appellants also contend that “with respect to the asserted statement of knowledge in the art of „ablation thresholds of ocular tissue‟, is the examiner relying upon judicial notice? The ablation thresholds are certainly nowhere to be found in Hansel” (id. at 18). Appeal 2011-002230 Application 12/146,976 8 We find that Appellants have the better position. While Hänsel teaches changing the refractive index (FF 1), the Examiner does not identify, and we do not find, any teaching or suggestion in Hänsel which provides a specific numerical value change in the refractive index. The Examiner has produced no evidence in Hänsel or from any other source which teaches any reason to make a range of change in the refractive index of 0.001 to 0.03, as required by claim 15. There is also no evidence even suggesting that performing the method of Hänsel using the parameters taught by Hänsel would inherently result in the claimed range of the refractive index. Nor is there evidence that the refractive index changes represent a routinely optimizable variable. The pulse energy range is a closer case, since Hänsel teaches that the prior art ablation techniques used “energies from 10 µJ to 10 mJ” (Hänsel, col. 2, l. 22; FF 11), suggesting that this is an optimizable variable. However, the broadest claimed range of energies in the instant claims, found in claim 14, is a range from 0.01 nJ to 10 nJ, which is 1000 fold lower in power than the only disclosed range in the prior art. While Hänsel would certainly suggest to the ordinary artisan that the range for non-ablative techniques must fall below 10 µJ, there is no evidence on record which supports the Examiner‟s position that the ordinary artisan would have recognized that the energy range should fall 1000 fold in order to avoid ablation, rather than 10 fold or 100 fold to ranges of 100 nJ or 1 µJ. Indeed, there is no evidence that even 0.01 nJ would have necessarily been sufficiently low enough in energy to avoid ablation, and it might have been that still lower energies would be required to avoid ablation. “In Appeal 2011-002230 Application 12/146,976 9 proceedings before the Patent and Trademark Office, the Examiner bears the burden of establishing a prima face case of obviousness based upon the prior art.” In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir. 1992). We appreciate that the burden may often be challenging in areas of scant prior art, where the implicit knowledge of the ordinary artisan may not be recorded in the literature. However, where there is no supporting evidence, and the claimed refractive index and pulse energy ranges differ so dramatically from any ranges disclosed in the prior art of record, we conclude that there is not a prima facie case of obviousness. C. 35 U.S.C. § 103(a) over Hänsel and Seiler The Examiner finds it obvious “to perform the method taught by Hansel after cataract surgery as taught by Seiler in order to correct vision problems created by the surgery or afterwards as taught by Seiler” (Ans. 8). The Examiner provides sound fact-based reasoning for combining Hänsel and Seiler. We adopt the fact finding and analysis of the Examiner as our own. Appellants “concede the unpatentability of claims 18 and 29 over Hansel in view of Seiler under section 103(a)” (App. Br. 6), if the anticipation rejection over Hänsel is affirmed. Therefore, consistent with the anticipation rejection, which we affirmed above, we affirm this rejection for the reasons stated by the Examiner. SUMMARY In summary, we affirm the rejection of claim 13 under 35 U.S.C. § 102(b) as anticipated by Hänsel. Pursuant to 37 C.F.R. § 41.37(c)(1), we also affirm the rejection of claims 16, 17, and 30 as these claims were not argued separately. Appeal 2011-002230 Application 12/146,976 10 We reverse the rejection of claims 14, 15, 19, 27, 28, 31, and 36-38 under 35 U.S.C. § 103(a) as obvious over Hänsel. We affirm the rejection of claims 18 and 29 under 35 U.S.C. § 103(a) as obvious over Hänsel and Seiler. 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 cdc Copy with citationCopy as parenthetical citation