10600027 (P.T.A.B. Apr. 11, 2013)

Ex Parte Odrich et al

Patent Trial and Appeal BoardApr 11, 2013

10600027 (P.T.A.B. Apr. 11, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte MARC ODRICH, KENNETH GREENBERG, JEROME A. LEGERTON, CHARLES R. MUNNERLYN, and JOHN K. SHIMMICK __________ Appeal 2011-011985 Application 10/600,027 Technology Center 3700 __________ Before ERIC GRIMES, LORA M. GREEN, and FRANCISCO C. PRATS, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134 involves claims to methods and a system for treating the cornea to mitigate presbyopia. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Appeal 2011-011985 Application 10/600,027 2 STATEMENT OF THE CASE Claims 1-9 and 16-22 stand rejected and appealed (App. Br. 3). 1 Claims 1, 16, and 17, the independent claims, illustrate the appealed subject matter and read as follows (emphasis added): 1. A method of treating a cornea of an eye of a patient to mitigate presbyopia, the eye having a pupil and a cornea, the method comprising: identifying a multifocal ablation shape having a first region providing a near vision correction and a second region providing a far vision correction; adjusting an ablation cut profile of the multifocal ablation shape in response to the size of the pupil so as to provide a balance of the near vision correction provided by the first region and the far vision correction provided by the second region for the patient; ablating the eye with a series of laser beam pulses according to the adjusted ablation cut profile. 16. A method of treating a cornea of an eye of a patient to mitigate presbyopia, the eye having a pupil and a cornea, the method comprising: identifying a multifocal ablation shape having a first region providing a near vision correction and a second region providing a far vision correction; adjusting an ablation cut profile for both the first region and the second region of the multifocal ablation shape in response to the size of the pupil so as to provide a balance of the near vision correction provided by the first region and the far vision correction provided by the second region for the patient; ablating the eye with a series of laser beam pulses according to the adjusted ablation cut profile. 17. A system for treating a cornea of an eye of a patient to mitigate presbyopia with a multifocal ablation shape, the eye having a pupil and a cornea, the system comprising: 1 Appeal Brief entered December 30, 2010. Appeal 2011-011985 Application 10/600,027 3 a laser for making a beam of an ablative light energy; a processor in electrical communication with the laser; and a tangible medium coupled to the processor and having stored instructions that, if executed by the processor, will cause the processor to perform operations comprising: controlling a distribution of a series of laser beam pulses to ablate the multifocal shape on the eye, the multifocal ablation shape producing a first region of the cornea providing a near vision correction and a second region of the cornea providing a far vision correction; and determining the distribution of laser beam pulses to ablate the first and second regions of the multifocal ablation shape, where the distribution of laser beam pulses for ablating both the first and second regions are determined in response to a signal related to a size of the pupil so as to balance the near vision correction and the far vision correction of the multifocal treatment for the patient. The sole rejection before us for review is the Examiner‟s rejection of claims 1-9 and 16-22 as obvious over Frey 2 and Largent 3 (see Ans. 4). 4 Claims 1-9, and this application, have been before us previously in Appeal Number 2008-1260 (see Decision On Appeal (entered May 21, 2008)). In that Decision, we reversed the Examiner‟s rejection of claims 1-9 as lacking written description (see id. at 4-10). The first appeal also included the obviousness rejection over Frey and Largent now before us (see id. at 4). That rejection, which we affirmed, was applied only to claims 10-15 (see id. at 10-21; see also Decision On Request For Rehearing (entered October 30, 2008)). Claims 10-15 have been canceled and replaced by claims 17-22, which are similar to original claims 10-15, except for the insertion of the 2 U.S. Patent No. 6,027,494 (issued Feb. 22, 2000). 3 U.S. Patent No. 6,312,424 B1 (issued Nov. 6, 2001). 4 Examiner‟s Answer entered March 29, 2011. Appeal 2011-011985 Application 10/600,027 4 italicized portion set forth above in claim 17 (see App. Br. 13 (comparison of canceled claim 10 and appealed claim 17)). Upon reconsidering his position, the Examiner extended the obviousness rejection over Frey and Largent to claims 1-9, as well as new claims 16-22 (see Ans. 12 (“[T]he examiner had read the claim to narrowly, and realized this when reviewing the Decision. This lead [sic] the examiner to realize that the art rejection which was applied to claims 10-15 was equally applicable to claims 1-9.”)). For the reasons discussed below, we affirm the Examiner‟s rejection. DISCUSSION The Examiner cited Frey as describing “a laser surgical system including a laser and a processor and scaling the ablation to the pupil size” (Ans. 4). The Examiner cited Largent as “designing a corneal ablation to include multiple zones of ablation . . . that can include both near and far vision corrections . . . which would mitigate presbyopia” (id. (citations omitted)). Based on the references‟ teachings, the Examiner reasoned that an ordinary artisan would have considered it obvious to employ the device of Frey on a subject with presbyopia, since this condition is correctable with laser sculpture as taught by Largent, or to employ the pupil scaling device of Frey in the presbyopia treating system of Largent, since this would reduce the halo effect and improve night vision, as taught by Frey, thus producing a method [and device] such as claimed. (Id.) As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): [T]he examiner bears the initial burden . . . of presenting a prima facie case of unpatentability. . . . Appeal 2011-011985 Application 10/600,027 5 After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. Appellants‟ arguments do not persuade us that a preponderance of the evidence fails to support the Examiner‟s prima facie case of obviousness as to claim 1. Claim 1 recites a method of treating a patient‟s cornea to mitigate presbyopia. In the method‟s first step, one must identify a multifocal ablation shape having a first region providing a near vision correction and a second region providing a far vision correction. In the second step, an ablation cut profile of the multifocal ablation shape is adjusted in response to the size of the pupil so as to provide a balance of the near vision correction provided by the first region and the far vision correction provided by the second region. In the third step, the eye is ablated with a series of laser beam pulses according to the adjusted ablation cut profile. As the Examiner found, and Appellants do not dispute, Largent discloses vision correction methods which mitigate presbyopia. Specifically, in Largent‟s methods, the corneal surface is reshaped to have two differently shaped regions: a first region having “a surface configuration which provides a first vision correction power,” and a second region having “a surface configuration which provides a second vision correction power which is different from the first vision correction power to enhance vision at first and second different distances, respectively. For example, the distances may be near and far distances to thereby provide a bifocal effect” (Largent, col. 1, ll. 34-44). Appeal 2011-011985 Application 10/600,027 6 In one embodiment, Largent‟s process reshapes multiple regions of the cornea, to provide near, far, intermediate, and progressive vision correcting regions (see id. at col. 3, l. 52, through col. 4, l. 16; see also id. at Fig. 2). Largent thus describes the first step in the method of claim 1. As Largent discloses that laser energy is its preferred method of reshaping the cornea for multifocal correction (see Largent, col. 2, ll. 21-28), Largent also describes the third step of claim 1‟s method. As to claim 1‟s second step, by providing both near and far correction zones, Largent‟s multifocal correction profile provides a balance of near and far vision correction. Largent does not, however, describe adjusting the ablation profile of its multifocal ablation shape in response to the size of the pupil. Nonetheless, as the Examiner found, Frey discloses that when reshaping a patient‟s cornea to improve vision, if the portion of the cornea corrected by laser ablation, or “optical zone,” is “smaller than the patient‟s dark adapted[, i.e. substantially dilated,] pupil size, the patient‟s night vision is affected. Typically, the patient‟s vision will be hazy or somewhat blurred, and the patient may perceive halos around bright lights” (Frey, col. 1, ll. 44- 48). Frey thus discloses a corneal ablation vision correction process that “allows for customizing the ablation zone of the patient‟s dark adapted pupil size to eliminate the halo problem” (id. at col. 4, ll. 23-25). We agree with the Examiner that an ordinary artisan practicing Largent‟s method of multifocal correction would have been prompted to adjust Largent‟s multifocal ablation cut profile in response to the patient‟s pupil size as taught by Frey, so as to avoid the halo problem. We therefore Appeal 2011-011985 Application 10/600,027 7 also agree with the Examiner that Largent and Frey would have suggested a process having all of the steps recited in claim 1 to an ordinary artisan. Appellants argue: [F]rom the teachings of Frey/Largent there would be no reason to modify the inner regions of the Largent multi-focal ablation region, as altering the inner ablation region shape would do nothing to address the problem of halos due to a dark adapted pupil size extending beyond the overall optical zone - i.e., the problem with which Frey is concerned. (App. Br. 9.) To illustrate their argument, Appellants present illustrations “B” and “C” reproduced below: Appellants contend that illustration B shows adjustment of a near/far multifocal ablation profile based on pupil size, as suggested by the cited references, whereas illustration C shows the result of adjusting the ablation cut profile required by claims 1, 16, and 17 (see id.). In particular, Appellants argue, the prior art combination (depicted in Illustration B . . .) would not involve adjusting or scaling multiple ablation regions based on pupil size, in contrast to the claimed methods/systems (shown in Illustration C . . .), in which the ablation shape Appeal 2011-011985 Application 10/600,027 8 profile, including inner ablation regions and outer optical zone periphery are adjusted or scaled in response [to] pupil size. (Id.) We are not persuaded. Contrary to Appellants‟ arguments, claim 1 does not recite scaling multiple ablation regions based on pupil size, nor does claim 1 recite scaling inner ablation regions based on pupil size. Rather, claim 1 only requires the practitioner to “adjust[] an ablation cut profile of the multifocal ablation shape in response to the size of the pupil so as to provide a balance of the near vision correction provided by the first region and the far vision correction provided by the second region for the patient” (App. Br. 18 (claim 1)). As Appellants concede, when adjusting the ablation cut profile in response to pupil size according to Frey‟s teachings, at minimum, the practitioner changes the relative diameter and depth of the ablation zone (see App. Br. 8-9). Thus, because the adjustment depicted in illustration B shown above, concededly suggested by Frey and Largent, results in a change in the depth and diameter of the ablation zone, that change is in fact an adjustment of the ablation cut profile of the multifocal ablation shape, as claim 1 requires. Moreover, as the adjustment concededly suggested by Frey and Largent retains both near and far correction, we are not persuaded that Appellants have adequately explained why adjusting the ablation cut profile in the manner depicted in illustration B above would fail to provide a balance of the near and far vision correction regions, as claim 1 also requires. Appellants further argue that “it does not appear that combining Frey/Largent to produce the claimed invention would be technically feasible Appeal 2011-011985 Application 10/600,027 9 without guidance of the present application. Neither reference provides any teachings on how adjustments to the multiple regions might be accomplished even if attempted” (App. Br. 10). In particular, Appellants note, “the present application does provide guidance on how to adjust multiple regions based on pupil size” including providing a cut profile equation (id. (citing Spec. [0026], [0060], [0068]-[0071]). In this regard, Appellants cite the Ruiz patent 5 as support for the proposition that, rather than adjusting the inner ablation region‟s size, “the state of the art presbyopia corrective corneal ablation surgery included ablating only a middle part of the cornea with a central zone strictly defined as between 2 and 3mm in diameter, regardless of the patient‟s individual pupil size” (Reply Br. 4; 6 see also id. at 5-6). As noted above, however, claim 1 does not recite adjustments to multiple regions, nor does claim 1 recite scaling or adjusting inner ablation regions. Rather, claim 1 encompasses the overall size and depth adjustment shown in illustration B above, which Appellants concede is suggested by the cited references. Moreover, while the Specification may provide various approaches for adjusting an ablation cut profile, Appellants have not explained where in claim 1 the Specification-described techniques appear. As our reviewing court has explained, “while „the specification [should be used] to interpret the meaning of a claim,‟ courts must not „import[ ] limitations from the specification into the claim.‟ . . . [I]t is improper to „confin[e] the claims to th[e] embodiments‟ found in the specification . . . .” In re Trans Texas Holdings Corp., 498 F.3d 1290, 1299 (Fed. Cir. 2007) (quoting Phillips v. 5 U.S. Patent No. 5,533,997 (issued Jul. 9, 1996). 6 Reply Brief entered May 27, 2011. Appeal 2011-011985 Application 10/600,027 10 AWH Corp., 415 F.3d 1303, 1323 (Fed. Cir. 2005), citations omitted, bracketed text in internal quotes in original). In sum, for the reasons discussed, Appellants‟ arguments do not persuade us that a preponderance of the evidence fails to support the Examiner‟s prima facie case of obviousness as to claim 1. As Appellants point to no secondary considerations of non-obviousness that might outweigh the evidence of obviousness, we affirm the Examiner‟s rejection of claim 1. As they were not argued separately, claims 2-9 fall with claim 1. See 37 C.F.R. § 41.37(c)(1)(vii). We also conclude that a preponderance of the evidence supports the Examiner‟s prima facie case as to claim 16. Claim 16 recites a process similar to that recited in claim 1, except that, in the adjusting step, the practitioner must adjust an ablation cut profile “for both the first region and the second region of the multifocal ablation shape in response to the size of the pupil so as to provide a balance of the near vision correction provided by the first region and the far vision correction provided by the second region for the patient” (App. Br. 19 (claim 16)). The Examiner contends that an ordinary artisan applying the sizing technique of Frey to Largent‟s multifocal shaping process would have considered it obvious to adjust the inner ablation cut profiles in view of Largent‟s teaching that the “specific configuration of the power curve across the cornea can be tailored to suit the needs of the patient and particular design considerations” (Largent, col. 1, ll. 57-59). In particular, the Examiner reasons, the artisan would have been prompted to adjust the sizes of the inner ablation regions in patients with smaller pupils, so as to avoid Appeal 2011-011985 Application 10/600,027 11 entirely omitting the outer ablation regions taught by Largent as being desirable in its methods (see Ans. 8; see also Largent, Fig. 2). Appellants argue that Largent‟s disclosure regarding tailoring the ablation configuration to a patient‟s needs refers only to the corrective power of the corneal reshaping and would not suggest modifying the inner corrective regions as well as the outer ones (see Reply Br. 5). Appellants argue that the Examiner‟s small pupil hypothesis posits an unrealistic scenario unsupported by evidence (see Reply Br. 7). We are not persuaded. Frey explicitly states that its pupil measuring technique not only allows elimination of the halo problem, but also allows practitioners to avoid removing too much tissue in patients with smaller pupils: This method allows for customizing the ablation zone of the patient‟s dark adapted pupil size to eliminate the halo problem. In turn, this procedure may be done for all of the patients on a customized basis without having to ablate a large volume for patients who only need a smaller volume ablated if they have a smaller dark adapted pupil size. (Frey, col. 4, ll. 23-28.) We agree with the Examiner that an ordinary artisan would have reasonably inferred that, when performing a multifocal ablation procedure as taught in Largent, and when reducing the overall size of the ablation zone in small-pupil patients as described in Frey, it would be desirable to correspondingly reduce the sizes of the inner ablation regions, so as to include all of the desired ablation regions within the overall ablation zone. As the Supreme Court has noted, “the [obviousness] 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 Appeal 2011-011985 Application 10/600,027 12 steps that a person of ordinary skill in the art would employ.” KSR Int’l v. Teleflex Inc., 550 U.S. 398, 418 (2007); see also id. at 421 (“A person of ordinary skill is . . . a person of ordinary creativity, not an automaton.”). As the Supreme Court has also noted, “the mere existence of differences between the prior art and an invention does not establish the invention‟s nonobviousness.” Dann v. Johnston, 425 U.S. 219, 230 (1976). Thus, the fact that none of Frey, Largent, or Ruiz expressly discloses taking into account pupil size when adjusting cornea ablation zones to correct near and far vision does not demonstrate that doing so would have been unobvious. Rather, given the teachings discussed above, we agree with the Examiner that an ordinary artisan would have been prompted to adjust both regions in response to pupil size, as recited in claim 16. While we note Ruiz‟s teaching that the inner ablation region in its presbyopia correction technique must be between 2 and 3 millimeters (see Ruiz, col. 5, ll., 44-45), the express disclosure of “varying” the inner ablation zone within that size range (see id. at col. 3, l. 26) supports the Examiner‟s finding that ordinary artisans would in fact have considered it suitable to adjust the size of an inner ablation region if needed. Moreover, by viewing Ruiz in isolation, without taking into consideration the teachings in Largent and Frey, Appellants violate our reviewing court‟s directive that the prior art must be viewed as a whole. See In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (“Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. . . . [The reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole.”). Appeal 2011-011985 Application 10/600,027 13 Thus, as Appellants‟ arguments do not persuade us, for the reasons discussed, that a preponderance of the evidence fails to support the Examiner‟s prima facie case of obviousness as to claim 16, and as Appellants point to no secondary considerations of non-obviousness that might outweigh the evidence of obviousness, we affirm the Examiner‟s rejection of claim 16. Claim 17 recites, essentially, a system suitable for performing the processes recited in claims 1 and 16, the system having a tangible medium which includes instructions directing a processor to determine the distribution of laser beam pulses to ablate the first and second regions of the multifocal ablation shape “where the distribution of laser beam pulses for ablating both the first and second regions are determined in response to a signal related to a size of the pupil so as to balance the near vision correction and the far vision correction of the multifocal treatment for the patient” (App. Br. 20 (claim 17)). Appellants thus argue that “claim 17 will be allowable for at least a similar rationale” (id. at 11). As discussed above, however, Appellants‟ arguments do not persuade us that a preponderance of the evidence fails to support the Examiner‟s conclusion of obviousness as to either of claims 1 or 16. We therefore also affirm the Examiner‟s rejection as to claim 17 and its dependents. SUMMARY We affirm the Examiner‟s obviousness rejection of claims 1-9 and 16-22 over Frey and Largent. Appeal 2011-011985 Application 10/600,027 14 TIME PERIOD 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 cdc