Ex Parte Tokarski et alDownload PDFPatent Trial and Appeal BoardFeb 22, 201711770778 (P.T.A.B. Feb. 22, 2017) 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. 11/770,778 06/29/2007 Michael Tokarski VTN5127USNP 6931 27777 7590 02/24/2017 JOSEPH F. SHIRTZ JOHNSON & JOHNSON ONE JOHNSON & JOHNSON PLAZA NEW BRUNSWICK, NJ 08933-7003 EXAMINER DESAI, KAUSHIKKUMAR A ART UNIT PAPER NUMBER 3788 NOTIFICATION DATE DELIVERY MODE 02/24/2017 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): j nju spatent @ coru s .j nj. com lhowd@its.jnj.com pair_jnj @ firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MICHAEL TOKARSKI, SHIVKUMAR MAHADEVAN, SCOTT ANSELL, and VINCENT BARRE Appeal 2015-001451 Application 11/770,7781 Technology Center 3700 Before STEFAN STAICOVICI, SUSAN L. C. MITCHELL, and SEAN P. O’HANLON, Administrative Patent Judges. STAICOVICI, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Michael Tokarski et al. (Appellants) appeal under 35 U.S.C. § 134(a) from the Examiner’s decision rejecting claims 45—56.2 We have jurisdiction over this appeal under 35 U.S.C. § 6(b). 1 According to Appellants, the real party in interest is Johnson & Johnson Vision Care, Inc. Br. 1 (filed May. 6, 2014). 2 Claims 1—44 are canceled. See id. at 10. Appeal 2015-001451 Application 11/770,778 SUMMARY OF DECISION We AFFIRM. INVENTION Appellants’ invention relates to a method of packaging “ophthalmic devices that contain pharmaceutical agents.” Spec. 1,11. 5—6. Claims 45 and 51 are independent. Claim 45 (with some paragraphing added) is illustrative of the claimed invention and reads as follows: 45. A method of placing an ophthalmic lens in solution comprising the steps of: providing a blister bowl, an ophthalmic lens and a pharmaceutical agent heated to an elevated temperature above room temperature; treating said blister bowl with said pharmaceutical agent at said elevated temperature; placing said ophthalmic lens in said blister bowl and covering said blister bowl with a cover; wherein said blister bowl comprises a material that absorbs less than about 16 % of said pharmaceutical agent; and wherein the material of the blister bowl is polyetherimide. REJECTIONS The following rejections are before us for review: I. The Examiner rejected claims 45—56 under 35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. 2 Appeal 2015-001451 Application 11/770,778 II. The Examiner rejected claims 45—50 under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA), second paragraph, as being indefinite. III. The Examiner rejected claims 45—47, 49, 51—53, and 55 under 35 U.S.C. § 103(a) as being unpatentable over Brown-Skrobot (US 2005/0205451 Al, pub. Sept. 22, 2005), Schlagel (US 6,695,988 Bl, iss. Feb. 24, 2004), and Martinez (US 4,691,820, iss. Sept. 8, 1987). IV. The Examiner rejected claims 48 and 54 under 35 U.S.C. § 103(a) as being unpatentable over Brown-Skrobot, Schlagel, Martinez, and Kim (US 6,497,969 B2, iss. Dec. 24, 2002). V. The Examiner rejected claims 50 and 56 under 35 U.S.C. § 103(a) as being unpatentable over Brown-Skrobot, Schlagel, Martinez, and Tsuji (US 2004/0034042 Al, pub. Feb. 19, 2004). The Examiner also objected under 35 U.S.C. § 132(a) to Appellants’ Specification as failing to support claimed subject matter in independent claims 45 and 51. The Examiner’s rejection under 35 U.S.C. § 112, first paragraph, for failing to comply with the written description requirement is related to the objection made by the Examiner to Appellants’ Specification. See Final Act. 2—3 (transmitted Nov. 6, 2013). In particular, the Examiner objected under 35 U.S.C. § 132 and rejected under 35 U.S.C. § 112, first paragraph, the same subject matter on the ground that these claimed features are not supported by the original disclosure. 3 Appeal 2015-001451 Application 11/770,778 ANALYSIS Rejection I New or amended claims that introduce elements or limitations not supported by the as-filed disclosure violate the written description requirement. See, e.g., In reLukach, 442 F.2d 967, 968—69 (CCPA 1971). While there is no in haec verba requirement, newly added claim limitations must be supported in the Specification through express, implicit, or inherent disclosure. The fundamental factual inquiry is whether the Specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563—64 (Fed. Cir. 1991). In this case, the Examiner finds that there is no support for “[a] method of placing an ophthalmic lens in solution” that includes “providing” and “treating” steps, as called for by each of independent claims 45 and 51. Final Act. 3^4. Appellants argue that Appellants’ Specification describes “a method for placing an ophthalmic lens in solution” including providing a blister bowl[,] ... an ophthalmic lens[,] . . . and a pharmaceutical agent...[.] The agent is heated to an elevated temperature above room temperature .... The method also includes the step of treating the blister bowl (10) with the pharmaceutical agent at the elevated temperature. Br. 4 (citing Spec. 2, line 1, Spec. 3, line 3 et seq., Spec. 5, line 25 et seq., Spec. 7,11. 22—25, Fig. 1); see also id. at 5. Appellants’ Specification describes a method for measuring “[t]he amount of . . . pharmaceutical agent absorbed by any blister bowl... by 4 Appeal 2015-001451 Application 11/770,778 treating the blister bowl. . . with a solution containing a known amount of a pharmaceutical agent.” Spec. 5,11. 20-23. The Specification further describes”[t]he treatment of the blister bowl. . . [as] allowing a solution of the pharmaceutical agent to contact the blister bowl for a period of time at either room temperature or elevated temperatures.” Id. at 11. 23—26. Hence, the claimed “providing” and “treating” steps of independent claims 45 and 51 are described in Appellants’ Specification as steps of a method for measuring the amount of pharmaceutical agent absorbed by a blister bowl. On page 7 of Appellants’ Specification, Appellants further describe “a method of storing an ophthalmic lens comprising a pharmaceutical agent, wherein the method comprises placing said ophthalmic lens in a blister bowl and covering said blister bowl with a cover.” Spec. 7,11. 22—25. Therefore, the claimed “placing” and “covering” steps of independent claims 45 and 51, are described in Appellants’ Specification as steps of a method of storing an ophthalmic lens. Accordingly, the claimed “method of placing an ophthalmic lens in solution” of independent claims 45 and 51 includes steps from a method for measuring the amount of pharmaceutical agent absorbed by a blister bowl and from a method for storing an ophthalmic lens. Although Appellants’ Specification supports a method for measuring the amount of pharmaceutical agent absorbed by a blister bowl, and separately, supports a method for storing an ophthalmic lens, Appellants’ Specification does not support a method, as now claimed, that arbitrarily combines steps from the described measuring and storing methods. For example, we note that the method for measuring the amount of pharmaceutical agent absorbed by a blister bowl 5 Appeal 2015-001451 Application 11/770,778 also includes a step of measuring the solution for its content of pharmaceutical agent, but such step does not appear in the claimed “method of placing an ophthalmic lens in solution.” See Spec. 5,11. 26—29. We thus agree with the Examiner that Appellants’ Specification does not support the claimed “method of placing an ophthalmic lens in solution” that includes only the steps of “providing” and “treating” the blister bowl from the described method for measuring the amount of pharmaceutical agent absorbed by a blister bowl, and the steps of “placing” and “covering” from the described method of storing an ophthalmic lens. See Ans. 2—3 (transmitted Aug. 7, 2014). We therefore sustain the rejection under 35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA), first paragraph of independent claims 45 and 51 as failing to comply with the written description requirement. As Appellants do not present any other substantive arguments pertaining to the rejection of dependent claims 46—50 and 52—56, we likewise sustain the rejection of these claims. See Br. 4—5. The Examiner also objected under 35 U.S.C. § 132(a) to Appellants’ Specification on the grounds that the Specification does not describe “[a] method of placing an ophthalmic lens in solution” that includes “providing” and “treating” steps, as called for by each of independent claims 45 and 51. Final Act. 2. Ordinarily, an objection is reviewable by petition under 37 C.F.R. § 1.181, and a rejection is appealable to the Patent Trial and Appeal Board. When the issue of new matter presented is the subject of both an objection and a rejection, the issue is appealable. See MPEP § 608.04(c) (providing that “where the alleged new matter is introduced into or affects 6 Appeal 2015-001451 Application 11/770,778 the claims, thus necessitating their rejection on this ground, the question becomes an appealable one, and should not be considered on petition even though that new matter has been introduced into the specification also”). Because the objection to the Specification in the Final Office Action turns on the same issues as the rejection under 35 U.S.C. § 112, first paragraph, our decision with respect to the rejection is dispositive as to the corresponding objection. Rejection II The Examiner finds that Appellants’ “Specification . . . does not provide any standard to ascertain the [claimed] ‘room temperature’” and the limitation “‘elevated above room temperature’ is infinite.” Final Act. 4. According to the Examiner, “‘room temperature’ varies from room to room and location to location and varies under different conditions.” Ans. 4. The test for definiteness under 35 U.S.C. § 112, second paragraph, is whether “those skilled in the art would understand what is claimed when the claim is read in light of the specification.” Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F.2d 1565, 1576 (Fed. Cir. 1986). In this case, we agree with Appellants that “the use of the term ‘room temperature’ is well understood by the public, and can be given its plain and ordinary meaning,” which is “[a]n indoor temperature of from 20 to 25°C (68 to 77°F)” or “[t]he normal temperature of a living room, usually taken as being around 20°C.” Br. 6—7 (citing dictionary definitions). With respect to the limitation “elevated above room temperature,” by not specifying the exact temperature, the claim is merely broad, not 7 Appeal 2015-001451 Application 11/770,778 indefinite. See In re Johnson, 558 F.2d 1008, 1016 n.17 (CCPA 1977) (breadth is not indefiniteness). That is to say, it is clear that the “elevated temperature above room temperature” is a temperature above “20 to 25°C (68 to 77°F)” or above “around 20°C.” For example, Appellants are correct in that independent claim 51 provides an instance of an “elevated temperature above room temperature,” that is, an “elevated temperature at or above 124[°]C.” See Br. 7. In conclusion, for the foregoing reasons, we do not sustain the rejection under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA), second paragraph, of claims 45—50 as being indefinite. Rejection III Each of independent claims 45 and 51 requires, inter alia, that the material of the blister bowl “absorbs less than about 16% of said pharmaceutical agent; and ... is polyetherimide.” See Br. 10—11 (Claims App.). The Examiner finds that the material of the blister bowl 12 of Brown- Skrobot is not polyetherimide, but finds that Schlagel discloses “a blister bowl for ophthalmic lenses which may be made of polyetherimide.” Final Act. 6 (citing Schlagel, col. 1,1. 65—col. 2,1. 5, col. 10,11. 36-48). According to the Examiner, because Appellants describe polyetherimide as absorbing 3—16% of the pharmaceutical agent, then the polyetherimide of Schlagel will likewise have the same absorption property. Id.', see also Spec. 5,11. 29—32 and Spec. 6,11. 14—16. The Examiner concludes that “[i]t would have been obvious to one having ordinary skill in the art... to have made 8 Appeal 2015-001451 Application 11/770,778 the blister bowl of Brown-Skrobot of polyetherimide as taught by Schlagel in order to provide a material which may be used to safely package ophthalmic lenses.” Final Act. 6. According to the Examiner, as “[i]t is known in the art that ULTEM resins are used in medical and chemical instrumentation due to their heat resistance, solvent resistance and flame resistance properties” and ULTEM is a polyetherimide material3, “[t]he selection of a known material based on its suitability for its intended use supports] a prima facie obviousness determination.” Id. (citing MPEP 2144.07). Appellants argue that because Schlagel does not disclose a blister bowl, i.e., lens package, but rather a manufacturing device, i.e., tray, “one would not look to Schlagel for the material for a blister b[owl], and then combine it with Brown-Skrobot.” Br. 8. According to Appellants, “there is no known use even close to a blister bowl” for the polyetherimide material of Schlagel’s device-supporting member. Id. When the materials are all known and a person of ordinary skill in the art would be aware of the stresses to which the various parts would be subjected, the selection of suitable materials is a matter of obvious design choice. See In re Hopkins, 342 F.2d 1010 (CCPA 1965). In other words, the selection of a known material is a design consideration within the skill of the art when the selection is based upon the suitability of the material for its intended use. See In reLeshin, 277 F.2d 197, 199 (CCPA 1960). 3 “Other preferred materials include but are not limited to polyetherimides, sold by General Electric under the tradename Ultem.” Spec. 6,11. 14—16. 9 Appeal 2015-001451 Application 11/770,778 In this case, the Examiner has established that polyetherimide (ULTEM) is a known material having known properties of heat resistance, solvent resistance, and flame resistance. See Final Act. 6. However, the Examiner has not established that a person of ordinary skill in the art would be aware of the stresses to which Brown-Skrobot’s blister bowl 12 is subjected. Therefore, the Examiner has not established that it would have been obvious to the same person of ordinary skill in the art to choose the polyetherimide material from Schlagel’s list of materials4 to replace one of the multiple materials taught by Brown-Skrobot5 that are used for making its blister bowl 12. As such, the Examiner’s selection of SchlageEs known polyetherimide material is not based upon the suitability of the polyetherimide material for making Brown-Skrobot’s blister bowl 12, but rather is an arbitrary selection from a disclosed list of know materials. Although some of the materials disclosed in Schlagel overlap with the materials disclosed in Brown-Skrobot (e.g., polyolefins such as polyethyelene and polypropylene, polycarbonates, nylons), this does not mean that other materials such as polyetherimide can be simply substituted for any of Brown-Skrobot’s materials, as the Examiner contends. Brown- 4 Schlagel discloses using “polystyrenes, polyolefins, acrylics, polycarbonates, polyacetal resins, polyacrylethers, polyacrylether sulfones, polyphenylene oxide, polyphenylene ether . . . PEEK, and nylons.” Schlagel, col. 10,11. 36-41. 5Brown-Skrobot discloses using “polypropylene, polyethylene, nylons, olefin co-polymers, acrylics, rubbers, urethanes, polycarbonates, fluorocarbons, and the like and copolymers and blends of the foregoing.” Brown-Skrobot, para. 12. 10 Appeal 2015-001451 Application 11/770,778 Skrobot discloses a package for storing ophthalmic lenses that requires a material that is “compatible with the chemical and physical properties of. . . the pharmaceutical. . . agent.” Brown-Skrobot, para. 12. In contrast, Schlagel’s materials need to be compatible with a washing solution that includes “de-ionized water and surfactants.” Schlagel, col. 10,11. 41—48. As Schlagel’s material comes into contact with a solution that is different from the solution contacting the material of Brown-Skrobot’s blister bowl, without establishing whether Schlagel’s polyetherimide material is “compatible with the chemical and physical properties” of Brown-Skrobot’s pharmaceutical agent, the Examiner’s substitution is not an obvious selection between known alternatives and, thus, would not have been predictable. See KSR Inti Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). Lastly, we note that the reason proffered by the Examiner to replace the material used to make Brown-Skrobot’s blister bowl 12, i.e., “to provide a material which may be used to safely package ophthalmic lenses,” appears to be performed already by the materials listed in Brown-Skrobot. See Brown-Skrobot, para. 12. The Examiner has not provided any findings that Brown-Skrobot recognized a problem with safely packaging ophthalmic lenses using the materials listed in paragraph 12. Without a persuasive articulated reasoning based on rational underpinnings for modifying the disclosure of Brown-Skrobot, according to Schlagel, the Examiner’s rejection appears to be the result of hindsight analysis. See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). The Examiner’s use of the disclosure of Martinez does not remedy the combination of Brown-Skrobot and Schlagel. See Final Act. 7. Therefore, 11 Appeal 2015-001451 Application 11/770,778 for the foregoing reasons, we do not sustain the rejection under 35 U.S.C. § 103(a) of claims 45^47, 49, 51—53, and 55 as unpatentable over Brown- Skrobot, Schlagel, and Martinez. Rejections IV and V The Examiner’s use of the disclosures of Kim and Tsuji does not remedy the deficiency of the combination of Brown-Skrobot, Schlagel, and Martinez as discussed above. See Final Act. 7—8. Therefore, for the reasons discussed above, we also do not sustain the rejections under 35 U.S.C. § 103(a) of claims 48 and 54 as unpatentable over Brown-Skrobot, Schlagel, Martinez, and Kim, and of claims 50 and 56 as unpatentable over Brown-Skrobot, Schlagel, Martinez, and Tsuji. SUMMARY The Examiner decision to reject claims 45—56 under 35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement is affirmed. The Examiner decision to reject claims 45—50 under 35 U.S.C. § 112(b)or35U.S.C. § 112 (pre-AIA), second paragraph, as being indefinite is reversed. The Examiner decision to reject claims 45^47, 49, 51—53, and 55 under 35 U.S.C. § 103(a) as being unpatentable over Brown-Skrobot, Schlagel, and Martinez is reversed. 12 Appeal 2015-001451 Application 11/770,778 The Examiner decision to reject claims 48 and 54 under 35 U.S.C. § 103(a) as being unpatentable over Brown-Skrobot, Schlagel, Martinez, and Kim is reversed. The Examiner decision to reject claims 50 and 56 under 35 U.S.C. § 103(a) as being unpatentable over Brown-Skrobot, Schlagel, Martinez, and Tsuji is reversed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv). AFFIRMED 13 Copy with citationCopy as parenthetical citation