Ex Parte Duis et alDownload PDFPatent Trial and Appeal BoardAug 19, 201613082427 (P.T.A.B. Aug. 19, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/082,427 04/08/2011 27777 7590 08/23/2016 JOSEPH F. SHIRTZ JOHNSON & JOHNSON ONE JOHNSON & JOHNSON PLAZA NEW BRUNSWICK, NJ 08933-7003 FIRST NAMED INVENTOR Donnie J. Duis 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. VTN5285USNP 6097 EXAMINER TALLMAN, ROBERT E ART UNIT PAPER NUMBER 2872 NOTIFICATION DATE DELIVERY MODE 08/23/2016 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): jnjuspatent@corus.jnj.com lhowd@its.jnj.com pairjnj@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte DONNIE J. DUIS, JOHN R. BUCH, HOLLY L. GRAMMER, and ERIC R. GEORGE Appeal2015-002520 Application 13/082,427 Technology Center 2800 Before JAMES C. HOUSEL, GEORGE C. BEST, and JULIA HEANEY, Administrative Patent Judges. BEST, Administrative Patent Judge. DECISION ON APPEAL The Examiner finally rejected claims 1-23 of Application 13/082,427 under 35 U.S.C. § 112, ,-i 1 as not complying with the written description and enablement requirements, under 35 U.S.C. § 112, ,-i 2 as indefinite, and under 35 U.S.C. § 103(a) as obvious. See generally Final Act. (February 13, 2014). Appellants 1 seek reversal of these rejections pursuant to 35 U.S.C. § 134(a). We have jurisdiction. 35 U.S.C. § 6. For the reasons set forth below, we AFFIRM-IN-PART. 1 Johnson & Johnson Vision Care, Inc. is identified as the real party in interest. Br. 2. Appeal2015-002520 Application 13/082,427 BACKGROUND The '427 Application describes contact lenses that are said to display reduced indoor glare and improve the visual comfort of wearers. Spec. 1. The Specification also describes methods for making and using such contact lenses. Id. In particular, Appellants state that the claimed contact lenses "reduce ocular glare and strain caused by computers and artificially [sic] lighting, but do not otherwise degrade visual acuity at either indoor or reduced lighting (such as night driving) conditions." Id. at 3. Claim 2 is representative of the '427 Application's claims and is reproduced below: 2. A contact lens comprising a central circular area centered at a geometric center of the lens and having a diameter of about 1 to about 9 mm and a peripheral zone, wherein said central circular area has, at body temperature, a percent transmission between 70 to 90% across the region of 450-660nm. Br. 12 (Claims App.). REJECTIONS On appeal, the Examiner maintains the following rejections: 1. Claims 1-23 are rejected under 35 U.S.C. § 112, ii 1 as failing to comply with the written description requirement. Final Act. 2. 2. Claims 1-23 are rejected under 35 U.S.C. § 112, ii 1 as failing to comply with the enablement requirement. Final Act. 4. 3. Claims 1-23 are rejected under 35 U.S.C. § 112, ii 2 as indefinite. Final Act. 5. 2 Appeal2015-002520 Application 13/082,427 4. Claims 1, 2, 6-9, 11-16, 18-20, 22, and 23 are rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Van Gernert '0562 and Van Gernert '767.3 Final Act. 7. 5. Claims 3-5 are rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Van Gernert '056, Van Gernert '767, and Hoffman.4 Final Act. 12. 6. Claim 10 is rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Van Gernert '056, Van Gernert '767, and Haywood. 5 Final Act. 13. 7. Claim 17 is rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Van Gernert '056, Van Gernert '767, and Broderick. 6 Final Act. 14. 8. Claim 21 is rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Van Gernert '056, Van Gernert '767, and Van Gernert '267. 7 Final Act. 15. DISCUSSION Rejection 1. The Examiner rejected claims 1-23 for failing to comply with the written description requirement. Final Act. 2--4. In particular, the Examiner found that claims 1-23 are directed to a genus of all 2 US 7,560,056 B2, issued July 14, 2009. 3 US 5,645,767, issued July 8, 1997. 4 US 5,846,457, issued December 8, 1998. 5 US 7,364,291 B2, issued April 29, 2008. 6 US 2008/0235047 Al, published September 25, 2008. 7 US 2003/0142267 Al, published July 31, 2003. 3 Appeal2015-002520 Application 13/082,427 contact lenses that have the ability to block 10-30% of incident light having wavelengths between 420 and 700 nm. Id. at 3. The Examiner further found that the '427 Application's Specification contains insufficient disclosure to demonstrate that Appellants had possession of the entire claimed genus. Id. at 3--4. For an applicant to comply with the 35 U.S.C. § 112, first paragraph, written description requirement, the applicant's specification must "convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention." Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541F.3d1115, 1122 (Fed. Cir. 2008) (quoting Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir. 1991)). For the reasons set forth in Appellants' Brief, see Br. 4-5, we find that Appellants have demonstrated that they were in possession of the claimed invention as of the '427 Application's filing date. Thus, we reverse the rejection of claims 1-23 for lack of written description. Rejection 2. The Examiner rejected claims 1-23 as failing to comply with the enablement requirement. Final Act. 4-5. In particular, the Examiner found that that each contact lens example described in the '427 Application's Specification described contact lenses containing a photo- chromic material. Id. Based upon this alleged paucity of disclosure, the Examiner concluded that "[t]he claims are directed to contact lenses containing more than just photochromic material and mixtures of various dyes[,] and it would require undue experimentation to produce a contact lens with the functional ability to have transmission between 70 to 90[%] across the region of 420 to 700nm." Id. at 5. 4 Appeal2015-002520 Application 13/082,427 A specification complies with the 35 U.S.C. § 112, first paragraph, enablement requirement if it allows those of ordinary skill in the art to make and use the claimed invention without undue experimentation. See In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993); Atlas Powder Co. v. E.I. du Pont De Nemours & Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984). The Examiner rejected claims 1-23 for lack of enablement because those claims are directed to the genus of all contact lenses comprising various dyes that transmit between 70 to 90% of the incident light. Final Act. 4-5. The Examiner determined that the '427 Application's Specification was not enabling because Id. the three contact lens example shown in the specification Example 1 ... and Example [sic] 3--4 ... are only directed to a contact lenses [sic] with only a photochromic material in it. The claims are directed to contact lenses containing more than just photochromic material and mixtures of various dyes[,] and it would require undue experimentation to produce a contact lens with the functional ability to have transmission between 70 to 90 percent across the region of 420 to 700nm. We begin by noting that the Examiner has not expressly addressed the Wands factors. 8 Although consideration of these factors is not mandatory, see Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1213 (Fed. Cir. 8 Factors to be considered in determining whether a claim is not enabled "include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, ( 4) the nature of the invention, ( 5) the state of the prior art, ( 6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims." In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). 5 Appeal2015-002520 Application 13/082,427 1991 ), they do provide a useful framework for addressing the factual determinations and legal conclusion required to find claims not enabled. Examples 1-7 of the Specification describe the manufacture of various contact lenses comprising reactive photochromic materials and non- reactive dyes. See Br. 5-6. Given the relatively high level of skill in the art of contact lens formulation, the straightforward nature of the claimed property of the contact lenses, and the relatively predictable behavior of the transmission spectra in response to changes in dye concentration, we agree with Appellants that a person having ordinary skill in the art would be able to make and use lenses across the scope of claims 1-23. For these reasons, we reverse the rejection of claims 1-23 pursuant to 35 U.S.C. § 112, iJ 1 for lack of enablement. Rejection 3. The Examiner rejected claims 1-23 as indefinite. Final Act. 5-7. In particular, the Examiner's rejection of claims 1-3, 5-7, 11-17, and 23 are based upon the use of the term "about" to modify numerical limits expressed in each of these claims. Id. at 5-6. Appellants argue that "[t]he use of the word 'about' in this circumstance is well understood by those of skill in the art and does not render the claims indefinite." Br. 7 (citing Andrew Corp. v. Gabriel Elecs., Inc., 847 F.2d 819, 821 (Fed. Cir. 1988)). The Examiner responds that Andrew Corp. does not control this case because Appellants' definition of the word "about" in their Specification renders the term indefinite: As stated in prior office actions[,] it is the special definition of the word about that leads to the indefinite "fuzziness" of the term about in the claims. From Appellants['] specification[:] "As used herein, the word ['about'] includes minor deviations from the recited numerical range, such as 6 Appeal2015-002520 Application 13/082,427 standard deviations which might be observed when measuring multiple samples in a test method." (Page 2, lines 25-27) By the construction of this definition of "about" as relying upon ... the variations in the sample size, experimental set-up, quality of the experimental data, and other factors used in determining the value. [sic] There is no definitive variation in the value that can be ascertained from the above Appellant supplied definition of the term "about". Answer 8. We are not persuaded by the Examiner's argument. Contrary to the Examiner's assertion, Appellants' definition of the term "about" does not incorporate standard deviations. Rather, the definition cites experimental variability, which may be measured as the standard deviation of a sample, as an example of the sort of minor variation intended to be encompassed within the term "about." We conclude that a person having ordinary skill in the art at the time of the invention would have been reasonably apprised of the metes and bounds of the Appellants' claims and that Appellants' definition of the term "about" does not render these claims indefinite. We, therefore, reverse the Examiner's rejection of claims 1-3, 5-7, 11-1 7, and 23 pursuant to 35 U.S.C § 112, ,-i 2. The Examiner identified an additional reason why claims 9, 18, and 19 were rejected as indefinite. These claims depend from claim 1, which is directed to a contact lens "having, at about body temperature, a percent transmission between 70 to 90% across the region of 420-700 nm." Claims 9, 18, and 19 limit the scope of claim 1 by requiring that the contact lens further comprise a photochromic dye. Id. at 6. The Examiner concluded that a person of ordinary skill in the art would not understand whether claims 9, 18, and 19 are directed to contact lenses having the transmission 7 Appeal2015-002520 Application 13/082,427 properties recited in claim 1 when the photochromic dye is in the bleached state or in the unbleached state. Id. Appellants do not present any substantive argument for reversal of the rejection of claims 9, 18, and 19 as indefinite for this reason. See Br. 6-7. We, therefore, summarily affirm the rejection of claims 9, 18, and 19 on this basis. Finally, the Examiner rejected claims 4,9 8, 10, 21, and 22 as depending from rejected base claims. Final Act. 7. As discussed above, we have reversed the rejection of claims 1-3, 5-7, 11-1 7, and 23. Because claims 4, 8, 10, and 22 depend from claims that we have concluded are not indefinite, we also reverse the rejection of these claims. Claim 21, however, depends from claim 9. Because we have affirmed the rejection of claim 9, we also affirm the rejection of claim 21. Rejection 4. The Examiner rejected claims 1, 2, 6-9, 11-16, 18-20, 22, and 23 as unpatentable over the combination of Van Gernert '056 and Van Gernert '767. Final Act. 7-11. In particular, the Examiner found that Van Gernert '056 describes a contact lens having a transmission spectra across the region of 420-700 nm. Id. at 7. The Examiner further found that Van Gernert '056 does not describe a percent transmission between 70-90% across the claimed range. Id. The Examiner also found that Van Gernert '7 67 describes mixing photochromic dyes to produce a desired absorption 9 The Examiner's detailed explanation of this rejection does not mention claim 4. See Final Act. 5-7. We assume that this is an inadvertent oversight and that the Examiner intended to reject claim 4 as depending from a rejected base claim. 8 Appeal2015-002520 Application 13/082,427 spectra across the region between 400-700 nm. Id. Based upon these findings, the Examiner concluded: It would have been obvious to one having ordinary skill in the art at the time of the invention to the included the mixing technique as taught by Van Gernert '7 67 into the contact lens structure as taught by Van Gernert '056 for the benefit of producing a contact lens with any absorption maximum. Id. at 8. We reverse the rejection of claims 1, 2, 6-9, 11-16, 18-20, 22, and 23 as unpatentable over the combination of Van Gernert '056 and Van Gernert '767. The Examiner expressly found that Van Gernert '056 does not "directly teach a percent transmission between 70 to 90%." Id. at 7. Nor does the Examiner explained how Van Gernert '056 and Van Gernert '767- whether considered separately or in combination-suggest a contact lens having the claimed transmission values across the claimed wavelength range. In the absence of such an explanation, we cannot affirm the Examiner's rejection. See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) ("[R ]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness."). Rejections 5--8. In each of these rejections, the Examiner relies upon the combination of Van Gernert '056 and Van Gernert '767 along with an additional reference to reject various dependent claims. In these rejections, the Examiner does not find that any of the additional references describes or suggests the claimed 70-90% transmission across the claimed wavelength range. See Final Act. 12-22. We, therefore, reverse these rejections for the same reasons that we reversed Rejection 4. 9 Appeal2015-002520 Application 13/082,427 CONCLUSION For the reasons set forth above, we reverse the rejection of claims 1- 23 for failure to comply with the written description and enablement requirements set forth in 35 U.S.C. § 112, iJ 1. We reverse the rejection of claims 1-8, 10-17, 20, 22, and 23 as indefinite. We affirm the rejection of claims 9, 18, and 19, and 21 as indefinite. We reverse the rejections of claims 1-23 pursuant to 35 U.S.C. § 103(a). No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § l.136(a). AFFIRMED-IN-PART 10 Copy with citationCopy as parenthetical citation