CooperVision International Holding Company, LPDownload PDFPatent Trials and Appeals BoardMay 7, 202014719341 - (D) (P.T.A.B. May. 7, 2020) 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. 14/719,341 05/22/2015 Inna Maltseva P10093US (3038-115-01) 2120 81693 7590 05/07/2020 Kilyk & Bowersox, P.L.L.C. 400 Holiday Court Suite 102 Warrenton, VA 20186 EXAMINER BUI, LUAN KIM ART UNIT PAPER NUMBER 3736 NOTIFICATION DATE DELIVERY MODE 05/07/2020 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): GHollrigel@coopervision.com docketing@kbpatentlaw.com lkilyk@kbpatentlaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ________________ Ex parte INNA MALTSEVA, CAROL ANN MORRIS, KATHLEEN KHONG, and ANDREW LUK1 ________________ Appeal 2019-004277 Application 14/719,341 Technology Center 3700 ________________ Before FRANCISCO C. PRATS, ULRIKE W. JENKS, and JOHN G. NEW, Administrative Patent Judges. NEW, Administrative Patent Judge. DECISION ON APPEAL 1 We use the term “Appellant” to refer to the “applicant” as defined in 37 C.F.R. § 1.142. Appellant identifies Cooper Vision International Holding Company as the real party-in-interest. App. Br. 3. Appeal 2019-004277 Application 14/719,341 2 SUMMARY Appellant files this appeal under 35 U.S.C. § 134(a) from the Examiner’s Final Rejection of claims 1–12 and 18–20 as unpatentable under 35 U.S.C. § 112(b) as being indefinite. Claims 1–4, 6, and 18–20 also stand rejected as unpatentable under 35 U.S.C. § 103 as being obvious over the combination of Powell et al. (WO 94/13774 A1, June 23, 1994) (“Powell”), the Official Notice taken by the Examiner, and Osawa et al. (US 6,187,264 B1, February 13, 2001) (“Osawa”) or Marlowe et al. (US 2010/0104528 A1, April 29, 2010) (“Marlowe”). Claims 5, 7–10, and 12 stand rejected as unpatentable under 35 U.S.C. § 103 as being obvious over the combination of Powell, the Official Notice taken by the Examiner, Osawa or Marlowe, and Ewart et al. (US 5,375,698, December 27, 1994) (“Ewart”). Claim 11 stands rejected as unpatentable under 35 U.S.C. § 103 as being obvious over the combination of Powell, the Official Notice taken by the Examiner, Osawa or Marlowe, Ewart, and Kadlecik et al. (US 3,977,517, August 31, 1976) (“Kadlecik”). We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. NATURE OF THE CLAIMED INVENTION Appellant’s claimed invention is directed to a sealed contact lens package that contains a sterile, unworn contact lens and a contact lens packaging solution comprising epsilon polylysine (εPLL). Abstr. Appeal 2019-004277 Application 14/719,341 3 REPRESENTATIVE CLAIM Claim 1 is representative of the claims on appeal and recites: 1. An autoclaved, sealed contact lens package comprising a sterile, unworn contact lens and a contact lens packaging solution comprising epsilon polylysine, wherein the unworn contact lens exhibits reduced contamination from Pseudomonas aeruginosa introduced to the lens during removal from the contact lens packaging solution compared to a control contact lens packaged in an identical contact lens packaging solution but without said epsilon polylysine, wherein said reduced contamination is determined by a lens handling assay as described in Example 2, and wherein the unworn contact lens results in less than a two log kill of Pseudomonas aeruginosa when tested after 24 hours incubation with 104 CFU Pseudomonas aeruginosa using an in vitro bioactivity assay as described in Example 4. App. Br. 33. ISSUES AND ANALYSES We adopt the Examiner’s findings, reasoning, and conclusion that the claims on appeal are indefinite and obvious over the combine cited prior art. We address the arguments raised by Appellant below. Appeal 2019-004277 Application 14/719,341 4 A. Rejection of claims 1–12 and 18–20 under 35 U.S.C. § 112(b) as being indefinite2 Issue 1 Appellant argues that the Examiner erred in finding that the limitation of claim 1 reciting “the unworn contact lens exhibits reduced contamination from … bioactivity assay as described in Example 4,” and the limitation of claim 7 reciting “wherein the unworn contact lens exhibits reduce contamination from … as described in Example 2” are indefinite. App. Br. 12. Analysis The Examiner finds that the limitation of claim 1 reciting “the unworn contact lens exhibits reduced contamination … as described in Example 4,” and the limitation of claim 7 reciting “wherein the unworn contact lens exhibits reduce contamination … as described in Example 2” are indefinite because the limitations have no clear meaning. Final Act. 2. The Examiner notes that claims 1 and 7 are both directed to “[a]n autoclaved, sealed contact lens package,” and that methods of testing an autoclaved, sealed contact lens package containing a sterile, unworn contact lens within is not part of the claimed package. Id. 2 The Examiner provided an additional basis for rejecting the claims on this ground, concluding that the limitation of claim 1 reciting: “An autoclaved, sealed contact lens package” was indefinite. Final Act. 2 (emphasis added). The Examiner has withdrawn this basis for the rejection. See Ans. 4. Appeal 2019-004277 Application 14/719,341 5 Appellant argues that the claims are directed to an autoclaved, sealed contact lens package that exhibits reduced contamination when the lens is removed from the package. App. Br. 12. Appellant also argues that paragraph [007] of the Specification discloses that the initial removal of contact lenses from their original sterile packaging can result in significant microbial contamination of the lens, even when handled immediately after hand washing. Id. According to Appellant, the claimed invention, with its required use of epsilon polylysine in the packaging solution, can reduce or eliminate such contamination. Id. Appellant asserts that the lens handling assay of claim 1 is recited for the purpose of providing a standard or level of microbial protection, and that the providing of such a test in claim 1 does not make this claim indefinite. Id. Appellant contends that, to the contrary, the limitation makes the claim more definite, because it clearly defines what the claim means by “reduced contamination.” Id. Appellant contends that, when a feature in a product claim relates to the performance of the product, it is quite common in patent claims to recite how that performance is determined and this is achieved in the claims of the present application. App. Br. 13. Appellant asserts that the usefulness and clarity of this test is even further shown in the examples of the Specification. Id. To that end, Appellant argues, claims 1 and 7 refer to Examples that detail the methods of the tests recited in the claims. Id. We are not persuaded by Appellant’s argument. A claim is invalid as indefinite under 35 U.S.C. § 112(b) when: “its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention.” Nautilus, Inc. v. Biosig Instruments., Inc., 572 U.S. 898, Appeal 2019-004277 Application 14/719,341 6 898–99 (2014). In the appeal before us, claim 1 is directed to: “An autoclaved, sealed contact lens package comprising a sterile, unworn contact lens and a contact lens packaging solution comprising epsilon polylysine.” As such, this defines a structurally complete invention. Claim 1 continues, in relevant part: “wherein the unworn contact lens exhibits reduced contamination from Pseudomonas aeruginosa introduced to the lens during removal from the contact lens packaging solution compared to a control ….” Of course, when the contact lens is removed from the contact lens packaging solution, and purportedly exhibits the claimed reduced bacterial contamination as a result of that removal, the composition is no longer “[a]n autoclaved, sealed contact lens package” because it has been opened (i.e., unsealed) and the contact lens removed. In other words, the limitation of the claim reciting that the lens, after removal from the autoclaved and sealed contact lens package, shows reduced potential for contamination by the removal, is not pertinent to the autoclaved and sealed package, which no longer exists when the seal is broken and the lens removed. The scope of Appellant’s claim is therefore unclear and indefinite, because the metes and bounds of the claim would not be evident to a person of ordinary skill in the art. Is Appellant claiming an autoclaved, sealed package comprising a sterile, unworn contact lens and a contact lens packaging solution comprising epsilon polylysine, as the claim initially recites? Or is Appellant also claiming a resistance to lens contamination after the lens is removed from the now un-sealed packaging? We conclude that, because the metes and bounds of the scope of Appellant’s invention would not be clear to a skilled artisan, the claims are indefinite. Appeal 2019-004277 Application 14/719,341 7 Issue 2 Appellant argues that the Examiner erred in failing to determine whether “those skilled in the art would understand what is claimed when the claim is read in light of the specification.” App. Br. 13 (quoting MPEP § 2173.02). Specifically, Appellant argues that references in claims to testing methods disclosed by Examples of the Specification are permissible. Id. at 14. Analysis Appellant argues that references in claims to testing methods described in Examples, as recited in claims 1 and 7, are permissible. App. Br. 14. By way of example, Appellant points to claim 1 of each of US 9,650,630 B2, 9,492,502 B2, and 9,282,746 B2. Id. Appellant contends that it is axiomatic that a determination of claim scope must be made in light of the specification. App. Br. 14 (see, e.g., Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F.2d 1565, 1576 (Fed. Cir. 1986)). Appellant asserts that claims 1 and 7 expressly refer to Examples found in the Specification, which serve to define the test recited in the claims. Id. Therefore, argues Appellant, the limitations of claims 1 and 7, which explicitly reference Examples disclosed in the Specification, clearly “inform[s] those skilled in the art about the scope of the invention with reasonable certainty.” Id. (quoting Nautilus, 572 U.S. at 898–99). We are not persuaded by Appellant’s reasoning. Appellant is certainly correct that claim scope is interpreted in the light of the disclosures of the Specification. Balanced against this, however, is our reviewing court’s holding that “limitations are not to be read into the claims from the Appeal 2019-004277 Application 14/719,341 8 specification.” In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993). While we acknowledge that the claims of the patents named by Appellant recite, e.g., “when tested under the conditions of Example 1” (see US 9,650,630 B2), the general rule is that the claims should be self-contained; that is, they should not expressly rely upon the description or drawing to give them meaning. See Ex parte Fressola, 27 USPQ2d 1608, 1609 (BPAI 1993) (citing McCrady, PATENT OFFICE PRACTICE, § 90 (3d ed. 1950)). Specifically, the written description and the claims are separate statutory requirements, and modern claim practice requires that the claims stand alone to define the invention. Id. Incorporation into the claims by express reference to the Specification and/or drawings is not permitted except in very limited circumstances. Id.; see MPEP 2173.05(s) (“Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” (citation omitted)). Appellant asserts no exceptional circumstances that compel direct reference to Appellant’s Specification to establish the scope of the claim, or why the claims cannot be amended by Appellant to recite the nature of the test requirements disclosed by the recited examples of the Specification. We therefore agree with the Examiner that the language of the claims in this respect fails to establish the scope of the claim, and we affirm the Examiner’s rejection upon this ground. Appeal 2019-004277 Application 14/719,341 9 B. Rejection of claims 1–4, 6, and 18–20 under 35 U.S.C. § 103 Issue 1 Appellant argues that the Examiner erred by failing to establish that the combined cited references teach or suggest the limitation of claim 1 reciting epsilon polylysine. App. Br. 15. Analysis The Examiner finds that Powell teaches a sealed contact lens package comprising a sterile, unworn hydrophilic contact lens and a contact lens packaging solution including polylysine, in addition to the other limitations of the claims. Final Act. 3–4 (citing Powell 8; Abstr.). However, the Examiner finds, Powell neither teaches nor suggests that the contact lens packaging solution comprises epsilon polylysine in lieu of polylysine. Id. at 4. The Examiner takes Official Notice of the well-established and conventional practice of providing a contact lens packaging solution including epsilon polylysine for better protecting the contact lens. By way of example, the Examiner points to Osawa, which teaches a contact lens solution for preserving and/or disinfecting a contact lens which includes a polylysine such as epsilon polylysine. Final Act. 4 (citing Osawa col. 2, ll. 30–67). The Examiner finds that Osawa further teaches containers containing contact lenses are usually sterilized by autoclaving prior to shipping. Id. (citing Osawa col. 2, ll. 12–27). By way of further example, the Examiner points to Marlowe, which teaches a contact lens solution for disinfecting a soft, silicone, hydrogel contact lens which comprises epsilon polylysine. Final Act. 4 (citing Marlow ¶ 46). Appeal 2019-004277 Application 14/719,341 10 The Examiner therefore concludes that it would have been obvious to a person of ordinary skill in the art to modify the contact lens packaging solution of Powell so the contact lens packaging solution comprises epsilon polylysine for better protecting the contact lens. Final Act. 4. Appellant argues that, contrary to the Examiner’s findings, the cited references do not support modifying the sealed contact lens package of Powell to contain epsilon polylysine, but rather suggest that epsilon polylysine is insufficient for use in Powell. App. Br. 15–16. Appellant contends that Powell teaches “polylysine” as a positively charged chemical agent for inhibiting the uptake of proteins and/or reducing the formation of tear protein deposits on the outer surface and inner bulk matrix of a hydrophilic contact lens. App. Br. 16 (citing Powell 5). According to Appellant, Powell explains that the positively charged chemical agent neutralizes ionic charges in the lens and preferably absorbs more rapidly and/or less reversibly into the lens matrix than tear proteins, such as lysozyme, and removes and/or prevents proteinaceous material from accumulating on and within the contact lens during use. Id. Appellant asserts that Powell teaches that the chemical agent must: (1) be able to be positively charged at physiological pH values; (2) have a steric structure that enables it to enter into pores of the contact lens; and (3) be of a particular molecular weight. Id. (citing Powell 6). Appellant contends that the evidence of record does not show that the claimed epsilon polylysine meets these criteria and thus qualifies for use in the system taught by Powell. App. Br. 16. Appellant notes that Powell teaches simply “polylysine,” which, as Appellant argued during prosecution, likely means alpha polylysine. Id. (citing Response/Argument 9 n.2, filed Appeal 2019-004277 Application 14/719,341 11 April 3, 2018). Appellant therefore contends that Powell suggests only that alpha polylysine meets the steric requirements for the positively charged chemical agent. Id. at 17. Appellant argues further that the cited references show that epsilon polylysine does not have a steric structure that allows for incorporation into a contact lens, i.e., that taught by Powell as being suitable for use in its system. App. Br. 17. In support of this argument, Appellant points to Osawa et al., which Appellant contends expressly teaches that the structure of epsilon polylysine does not allow for it to diffuse into a porous contact lens, as required by Powell. Id. According to Appellant, Osawa characterizes epsilon polylysine as a “high molecular weight compound having a chemical structure composed of polymerized lysine residues,” which in turn promotes “little to no penetrability into the inside of the lens.” Id. (quoting Osawa col. 3, ll. 32–36). Appellant asserts that Osawa further teaches that the use of epsilon polylysine “provides the best countermeasure against low-molecular preservative’s penetration into the inside of a lens.” Id. (quoting Osawa col. 3, ll. 36–38). Appellant contends that Osawa thus teaches away from the incorporation of cleansing components into the lens, which, Appellant argues, is directly contrary to the purpose taught by Powell. Id. We do not find Appellant’s arguments persuasive. As an initial matter, and in the absence of direct evidence, we decline to interpret Powell’s use of “polylysine” as teaching or suggesting either alpha polylysine or epsilon polylysine. Powell expressly teaches the use of “polylysine” in its contact lens solutions: “One method comprises contacting a contact lens with a chemical Appeal 2019-004277 Application 14/719,341 12 agent selected from the group consisting of protamines, polyarginine, polylysine, chitosan and mixtures thereof.” Powell Abstr. Powell teaches, with respect to these chemicals: The positively charged chemical agent of this embodiment is preferably of a size small enough and of optimum steric structure when dissolved in the medium to enter and accumulate in the polymeric pores of the lens bulk matrix such that the ionic charges in the lens will be substantially neutralized at equilibrium as a result of the positively charged agent forming ion pairs with the negatively charged ions of the lens. …. Preferably, the chemical agent possesses a molecular weight ranging from about 100 to about 70,000. More preferably, the chemical agent should have a molecular weight and steric structure that is optimum for penetrating the pores. For example, the chemical agent should have a molecular weight of not less than about 100 in order to penetrate the pores of the lens more easily and neutralize the charges of the lens more quickly. Conversely, if the chemical agent has a molecular weight greater than 70,000, it may be too large to enter the pores of the lens matrix and neutralize the charge of the lens. Powell 6. Osawa teaches that: Polylysine which can be used in the present invention includes α-polylysine resulting from condensation between an α- positioned amino group and a carboxyl group and ε-polylysine resulting from condensation between an ε-positioned amino group and a carboxyl group. The ε-polylysine is preferred. Osawa col. 2, ll. 62–67. Osawa further teaches that: It has turned out that polylysine, the solute of the solution according to the present invention, being a high-molecular weight compound having a chemical structure composed of polymerized lysine residues, has little or no penetrability into the Appeal 2019-004277 Application 14/719,341 13 inside of a lens. That is, the present invention provides the best countermeasure against a low-molecular preservative’s penetration into the inside of a lens as mentioned in the “Background Art” section. Id. at col. 3, ll. 32–38 (emphasis added). In short, Osawa’s teaching of the properties of polylysine, which Appellant characterizes as referring only to epsilon polylysine, in fact applies to both steric forms. Indeed this makes sense, in that the two structures differ principally in their steric structure, rather than in more elementary structural differences. Indeed, Osawa teaches that both forms are usable, but that epsilon polylysine is preferred. That, however, is not dispositive of our analysis. See Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (holding that all disclosures of the prior art, including unpreferred embodiments, must be considered). Rather, we agree with the Examiner that, because Powell teaches the use of polylysine, and Osawa teaches that either steric variant of polylysine may be used in contact lens solutions, but because epsilon polylysine is preferred, we agree with the Examiner that a person of ordinary skill in the art would have found it obvious to use epsilon polylysine in the intervention of Powell. Issue 2 Appellant argues that the Examiner erred in failing to demonstrate that the combined prior art teaches or suggests “a contact lens packaging solution,” as recited in claim 1. App. Br. 18 (emphasis added). Appeal 2019-004277 Application 14/719,341 14 Analysis Appellant argues that the cited references fail to teach or suggest a contact lens packaging solution but, rather, teach only contact lens cleaning or storage solutions. App. Br. 18. Appellant disputes the Examiner’s reasoning that a person of ordinary skill in the art would have modified the packaging solution of Powell by adding epsilon polylysine is “for better protecting the contact lens.” App. Br. 18 (quoting Final Act. 4). Appellant contends that this conclusion is faulty because a newly packaged contact lens is sterilized by autoclaving and thus does not require a disinfectant in the packaging solution for protecting the lens. Id. at 18–19. Appellant contends that it was well-known in the art, at the time of invention, that contact lens packaging solutions and contact lens care solutions (also known as “multipurpose solutions,” “preserving and/or disinfecting solution,” “storage solutions,” and “lens solutions”) are two different types of solutions having different purposes. App. Br. 19. According to Appellant, a packaging solution is included in the blister pack of a newly manufactured hydrogel contact lens to keep the lens hydrated so that it is ready to be put directly on a patient’s eye when it is removed from the packaging. Id. Appellant contends that a packaging solution typically comprises a buffered saline solution, optionally with wettability-enhancing agents. Id. (citing C.W. Sindt, What’s in Your Blister Pack?, REV. CORNEA & CONTACT LENSES (June 2010), available at: https://reviewofcontactlenses.com/ article/whats-in-your-blister-pack (last visited April 23, 2020). Appellant asserts that newly manufactured contact lenses are usually sterilized by autoclaving, and that, as such, there is no risk Appeal 2019-004277 Application 14/719,341 15 of microbial growth, and the addition of a disinfectant to the packaging solution is therefore unnecessary. Id. In contrast, argues Appellant, the purpose of a contact lens care solution is to clean lenses, after they have been worn, to remove protein and lipid deposits originating from tear film and to prevent growth of bacteria on the worn lenses when they are stored during periods of nonuse. App. Br. 19. Appellant contends that contact lens care solutions contain disinfecting agents, including hydrogen peroxide, polyhexamethylene biguanide HCl (PHMB), polyaminopropyl biguanide, polyhexanide hydrochloride, polyquaternium-1 (PQ-1), and myristamidopropyl dimethylamine (MAPD) to achieve this purpose. Id. (citing S.J. Gromacki et al., Understanding Contemporary Contact Lens Care Products, 28 CONTACT LENS SPECTRUM 20–25 (2013). Appellant notes that the Examiner finds that the use of epsilon polylysine as a disinfectant in contact lens solutions is taught by both Osawa and Marlowe. Id. Appellant next points to the Declaration of Dr. Nancy Keir, filed April 3, 2018 (the “Keir Declaration”) as supporting Appellant’s argument that a contact lens packaging solution and a contact lens cleaning solution were known in the art to be two different solutions. Id. (citing Keir Decl. ¶¶ 5–6). Appellant argues that Dr. Keir states that the packaging solution is the medium in which the lens sits when in a new package from the manufacturer that has yet to be opened by a patient, whereas a contact care solution is the solution used to clean a lens that has been used by the patient. Id. at 20. With respect to this argument, Appellant disputes the Examiner’s finding that Osawa teaches that that newly manufactured contact lenses are usually sterilized by autoclaving and that “a single solution is incapable of Appeal 2019-004277 Application 14/719,341 16 handling a contact lens from the shipment through use.” App. Br. 20–21 (citing Osawa cols. 1–2, ll. 63–27). According to Appellant, the cited passage concludes that the invention of Osawa is directed to “a liquid for easy preservation and/or disinfection of a contact lens,” but does not state that the invention is directed to a solution for shipping newly manufactured lenses. Id. at 21. Appellant contends that earlier passages of Osawa’s teachings that the terms “preservation solution” and “storage solution” are used interchangeably, and refer to a solution in which a contact lens is stored after it has been worn and disinfected, and not a solution for newly manufactured lenses. Id. (citing Osawa col. 1, ll. 62–64). Appellant argues that there is nothing in Osawa’s “Disclosure of the Invention” section that describes using epsilon polylysine in an autoclaved contact lens package. Id. Appellant summarizes that both Marlowe and Osawa show contact cleaning solutions, and not the claimed packaging solution. App. Br. 21. Appellant acknowledges that Powell teaches a solution surrounding an unworn contact lens, but argues that the record does not show that epsilon polylysine qualifies as Powell’s positively-charged chemical agent. Id. (citing Powell 8). We are not persuaded by Appellant’s arguments. As an initial matter, we remind Appellant that “one cannot show non-obviousness by attacking references individually where … the rejections are based on combinations of references.” In re Keller, 642 F.2d 413, 426 (C.C.P.A. 1981). Appellant acknowledges that Powell teaches: It is also preferable that the solution of a positively charged protein preventer of the present invention be used to pretreat new contact lenses, that is, lenses that have never been worn before. For example, a contact lens may be prepackaged in the solution. Appeal 2019-004277 Application 14/719,341 17 Pretreating a contact lens in this solution will preferably allow the positively charged chemical agent to be sorbed by the lens, including in the lens matrix, such that the [lens/agent] complex is favored in the environment where the lens is exposed to lysozyme, e.g., in the eye. As a result, when the contact lens is first placed in the eye, the lysozyme in the eye will preferably have fewer sites to which to bind. Powell 8–9; see App. Br. 21. However, Appellant argues that the evidence of record does not suggest that epsilon polylysine qualifies as Powell’s positively-charged chemical agent. We disagree for two reasons. First, the structural diagrams of alpha and epsilon polylysine depicted in Appellant’s Brief (see App. Br. 17) show that both structural variants possess an amino group (-NH2) that is capable of holding a positive charge. In other words, there is nothing about the structure of epsilon polylysine to suggest that it will not have a positive charge similar to that of alpha polylysine. Secondly, as we explained above, Powell teaches that “polylysine” is acceptable for its disclosed compositions, including the prepackaged solutions described in the passage of pages 8–9 quoted supra. Osawa teaches that both alpha and epsilon polylysines are suitable for contact lens solutions, and that epsilon polylysines are preferable. See Osawa col. 2, ll. 62–67. We agree with the Examiner that a person of ordinary skill in the art would have found it obvious to use epsilon polylysine as the “polylysine” in the prepackaged solution disclosed by Powell, because Osawa teaches that epsilon polylysine is preferable to alpha polylysine for lens storage purposes. With respect to the Keir Declaration, and Appellant’s argument that there would be no reason to include polylysine in a sterile, prepackaged Appeal 2019-004277 Application 14/719,341 18 contact lens composition that had been autoclaved, we find Appellant’s arguments similarly not persuasive. Dr. Keir opines that: A packaging solution is included in the blister pack of a newly manufactured hydro gel contact lens to keep the lens hydrated so that it is ready to be put directly on a patient’s eye when it is removed from the packaging. A packaging solution is a buffered saline solution that may include additional ingredients to enhance the wettability of the contact lens. Keir Decl. ¶ 5. Dr. Keir differentiates a packaging solution from a “contact lens care solution” the purpose of which is “to clean lenses after they have been worn by a patient to remove protein and lipid deposits originating from tear film and to prevent growth of bacteria on the lenses when they are stored during periods of nonuse.” Id. at ¶ 6. However, Dr. Keir’s opinion does not overcome the direct teachings of Powell that polylysines can be incorporated into packaging solutions for contact lenses that have never been worn. Moreover, a careful manufacturer might include polylysines (including epsilon polylysine) in such a packaging solution in case the packaging should somehow be compromised prior to a first opening by the wearer. In view of the prior art, therefore, we are not persuaded by Appellant’s arguments. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1370 (Fed. Cir. 2004) (holding that “the Board is entitled to give such weight to declarations as it deems appropriate”). Issue 3 Appellant argues that the Examiner erred in finding that the claimed “reduced contamination” from Pseudomonas aeruginosa is taught or suggested by the cited prior art references. App. Br. 22. Appeal 2019-004277 Application 14/719,341 19 Analysis Appellant argues that evidence disclosed in Appellant’s Specification demonstrates that unworn contact lenses are susceptible to microbial contamination during the brief period of time in which the unworn contact lenses are removed from a freshly opened contact lens package and placed on the wearer’s eye. App. Br. 22. Appellant asserts that this is so even if the user washes their hands with soap and water just prior to removing the lens from the package. Id. (citing Spec. Ex. 1). Appellant argues that, surprisingly, epsilon polylysine in the package solution at a concentration that confers little to no antimicrobial activity to the lens itself (i.e., as determined by testing the lens in the recited in vitro bioactivity assay) can protect the lens from contamination introduced by handling. App. Br. 22. Appellant contends that the evidence of record does not show that the cited references even recognize that lenses are contaminated in this manner upon a first handling of them by a user who has washed their hands. Id. In support of this contention, Appellant again points to the Keir Declaration, which states that: “Newly manufactured contact lenses are sterilized by autoclaving. Thus, there is no risk of microbial growth in the contact lens package, making the addition of a disinfectant to the packaging solution unnecessary for protecting the lens.” Keir Decl. ¶ 7. Appellant contends that, even if the cited art were to have recognized the problem of contaminating unworn (i.e., new) contact lenses by handling them with washed hands, it does not suggest the presence of low concentrations of epsilon polylysine in the packaging solution for solving this problem. App. Br. 23. Appellant argues that Osawa teaches that there Appeal 2019-004277 Application 14/719,341 20 must be prolonged contact between the microbe and epsilon polylysine for the epsilon polylysine to have any effect. Id. (citing Osawa col. 5, ll. 12– 20). However, Appellant asserts, the claimed invention demonstrates that epsilon polylysine in a contact lens packaging solution can provide an immediate protective effect against microbes deposited on a lens during its removal from its packaging. Id. (citing Spec. ¶ 23). Appellant alleges that this immediate protective effect occurs even if the lens material does not bind to the epsilon polylysine to an appreciable extent. Id. Appellant contends that the combined cited prior art references do not recognize a need to prevent contamination of an unworn contact lens obtained for the first time by a patient. Id. We are not persuaded by Appellant’s arguments. As an initial matter, and as we explained in section A, supra, we are unable to determine how the allegedly protective properties of a contact lens package that has been opened and used can read on the claimed “autoclaved, sealed contact lens package.” Leaving that issue aside, however, we are not persuaded that Appellant’s Specification demonstrates surprising or unexpected results when compared with the nearest prior art. See In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991) (holding that “when unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art”). Paragraph [024] and Table 1 of Appellant’s Specification demonstrates that, after soaking contact lenses in various solutions overnight, and after handling the lenses with washed hands and extracting them: Appeal 2019-004277 Application 14/719,341 21 As expected, the ClearCare™ contact lens solution, which does not contain any antimicrobial agents, did not provide protection against handling contamination. However, surprisingly, neither Optifree™ nor AQuify™ brand contact lens care solutions, both of which contain active antimicrobial agents, had any significant effect on bioburden. Only the solution containing εPLL [epsilon polylysine] in the blister resulted in a statistically significant reduction in bacterial count (p=0.00002). Spec. ¶ 24; see also Table 1. However, the tests did not include the polylysine-containing solutions that were disclosed by Powell, Osawa, or Marlowe, and we are therefore unable to discern whether the claimed properties were not also necessarily present in those compositions as well. Appellant has produced no evidence to show that the allegedly unexpected properties of their claimed composition are unexpected in view of the closest prior art, whether or not those properties had been hitherto disclosed: Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product…. Whether the rejection is based on “inherency” under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively,[] the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. In re Best, 562 F.2d 1252, 1255 (C.C.P.A. 1977). Having failed to meet the burden of proof requiring allegedly unexpected or surprising results to be demonstrated in view of the closest prior art, we do not find Appellant’s arguments persuasive, and we affirm the rejection of the claims. Appeal 2019-004277 Application 14/719,341 22 B. Claim 3 Appellant argues claim 3 separately. App. Br. 24. Claim 3 depends from claim 1 and recites: “The package of claim 1, wherein the contact lens is a non-ionic contact lens.” Id. at 33. Appellant argues that the Examiner erred in finding that it would have been obvious to modify the sealed contact lens package of Powell so that the contact lens is non-ionic. Id. at 24. Analysis Appellant asserts that a primary purpose of Powell’s invention is to prevent binding of lysozyme (a positively charged protein found in tears) to anionic contact lenses that contain anionic components, such as methacrylic acid. App. Br. 24. According to Appellant, Powell achieves this by pre- binding a “positively charged protein preventor” to the lens so that lysozyme has fewer available sites to which to bind. Id. (citing Powell 8–9). Appellant argues that there is no teaching or suggestion in Powell that packaging an unworn non-ionic lens in a packaging solution comprising a “positively charged protein preventor” would serve any useful purpose. Id. Appellant argues that the compositions of Powell would not be useful with a non-ionic contact lens because Powell relies upon the electrostatic interaction between the positively charged chemical agent and the anionic sites of the contact lens. Id. at 24–25. Appellant therefore contends that a modification to Powell employing a non-ionic lens would change the principle of operation of the invention. Id. at 25 (citing In re Ratti, 270 F.2d 810, 813 (C.C.P.A. 1959)). The Examiner responds that the combined cited prior art references teach that epsilon polylysine-containing contact lens packaging solutions are Appeal 2019-004277 Application 14/719,341 23 capable of use with various types of contact lenses including hydrophilic contact lenses, as taught by Powell, hard contact lenses and water-containing soft contact lenses, as taught by Osawa, or soft, silicone, hydrogel contact lenses as taught by Marlowe. Ans. 9–10. We are not persuaded by Appellant’s argument. Marlowe teaches solutions containing epsilon polylysine: The contact lens care solutions can also include ε-polylysine, which is a homo-polypeptide of about 25 to 30 l-lysine residues. The ε-polylysine can also provide an additional antimicrobial affect as it has been reported that ε-polylysine is absorbed electrostatically to the cell surface of the bacteria, followed by a stropping of the outer membrane and eventual disruption of the cytoplasm and cell death. Commercial sources of ε-polylysine are obtained from biofermentation of Streptomyces strains. Marlowe ¶ 46. Marlowe thus teaches that epsilon polylysine has an antimicrobial effect independent of any potential binding to the surface of the contact lens. Marlowe further teaches that: The lens care solutions can be used with many different types of contact lenses including: (1) hard lenses formed from materials prepared by polymerization of acrylic esters, such as poly(methyl methacrylate) (PMMA), (2) rigid gas permeable (RGP) lenses formed from silicone acrylates and fluorosilicone methacrylates, (3) soft, hydrogel lenses, and ( 4) non-hydrogel elastomer lenses. Id. at ¶ 61. In addition to the hard and RGP lenses disclosed supra, it is also well known in the art that hydrogel lenses can be non-ionic (FDA Groups 1 and 2). See, e.g., AAlens.com, The FDA has Created the 4 Lens Groups of Hydrogels Materials To Clarify Categories of Similar Polymers for Investigating Solutions Approvals, available at: http://www.aalens.com/ fda.html (last visited April 26, 2020). We consequently agree with the Appeal 2019-004277 Application 14/719,341 24 Examiner that it would have been obvious to a person of ordinary skill to use the epsilon polylysine-containing packaging solution taught by the combined cited prior art with a nonionic lens, and we affirm the Examiner’s rejection of claim 3 upon this ground. C. Claim 18 Issue Appellant argues claim 18 separately. App. Br. 26. Appellant argues that the combined cited prior art neither teaches nor suggests the limitation of dependent claim 18 reciting: “packaging solution comprises from 5 ppm to 500 ppm epsilon polylysine.” Id. Analysis Appellant repeats the argument, presented supra with respect to claim 1, that a “packaging solution,” in the contact lens art is shown to be different from a “care solution,” again arguing that Osawa and Marlowe relate to care solutions. App. Br. 26. With respect to the recited limitation of claim 18, Appellant argues that Osawa teaches that epsilon polylysine can be present in the care solutions in amounts of 10 ppm to 1000 ppm. Id. (citing Osawa col. 3, ll. 25–27). Appellant contends that there is therefore no disclosure in any cited reference of a “packaging solution” as claimed having from 5 ppm to 500 ppm epsilon polylysine as recited in claim 18. We do not find this persuasive. We have explained supra why Appellant’s argument with respect to the “care solutions” of Osawa and Marlowe are unavailing. Furthermore, the claimed range of epsilon Appeal 2019-004277 Application 14/719,341 25 polylysine concentrations is within the range expressly taught by Osawa, as Appellant implicitly acknowledges. The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims…. These cases have consistently held that in such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range. In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). In the appeal presently before us, Appellant adduces no evidence that the claimed range, within the range taught by Osawa, is critical to the properties of their invention, and therefore fails to overcome the Examiner’s prima facie finding of obviousness. We consequently affirm the Examiner’s rejection of claim 18. D. Claim 20 Appellant argues claim 27 separately. App. Br. 27. Appellant repeats the arguments presented separately with respect to claims 3 and 18 supra. We find them no more persuasive upon repetition, and we affirm the Examiner’s rejection of claim 20. E. Rejection of claims 5, 7–10, and 12 over Powell, Osawa or Marlowe, and Ewart Issue Appellant argues that the Examiner erred in finding that Ewart teaches the limitation of claim 7 requiring a sealed contact lens package that contains a plastic base member having a cavity which retains a contact lens Appeal 2019-004277 Application 14/719,341 26 in packaging solution and a resealable cover that forms a liquid-tight seal. App. Br. 27. Analysis The Examiner finds that Ewart teaches a sealed contact lens package (10) comprising a plastic base member (14) having a cavity which retains a contact lens and a contact lens packaging solution and a resealable cover (18) that forms a liquid-tight seal with the plastic base member. Final Act. 6 (citing Ewart col. 3, ll. 49–63; cols. 3–4, ll. 64–10). The Examiner concludes that it would have been obvious to a person of ordinary skill in the art to modify the sealed contact lens package of Powell with the contact lens package of Ewart, so that the sealed contact lens package comprises a plastic base member having a cavity retains the sterile, unworn contact lens, the contact lens packaging solution and a resealable cover that forms a liquid- tight seal with the plastic base member. Id. The Examiner reasons that a skilled artisan would have been motivated to combine the references to better contain the contact lens and the solution, allowing a user to reuse the sealed contact lens package, thus providing more convenience for the user. Id. Appellant argues that that Ewart, like the other cited references, relates to containers for previously worn contact lenses (and not unworn lenses). App. Br. 28 (citing Ewart col. 1, ll. 15–20). Furthermore, contends Appellant, the container of Ewart is not an autoclaved, sealed contact lens package. Id. Appellant argues that there is no teaching or suggestion in Ewart concerning an autoclaved, sealed contact lens package for unworn lenses. Id. Appeal 2019-004277 Application 14/719,341 27 We are not persuaded. As we have explained, Powell teaches an autoclaved, sealed contact lens package for unworn lenses. The Examiner has articulated a reason as to why a person of ordinary skill in the art would have been motivated to combine the package of Powell with the features of the container of Ewart, viz., so that the package can be reused after opening. See Final Act. 6. Appellant does not rebut this reasoning, and we affirm the Examiner’s rejection of the claims. F. Rejection of claim 11 over Powell, Osawa or Marlowe, Ewart, and Kadlecik Issue Appellant argues that the Examiner erred in finding that Kadlecik teaches or suggests the limitation of claim 11 reciting “wherein the plastic base member comprises a plurality of threads for engagement with a compatible set of threads on the resealable cover.” App. Br. 29. Analysis The Examiner finds that Kadlecik teaches a contact lens case (10) comprising a base member having a cavity (12) and a plurality of threads (24) for engagement with a compatible set of threads (26) on a resealable cover (30). Final Act. 7 (see Kadlecik Figs. 1–3). The Examiner concludes that it would have been obvious to a person of ordinary skill in the art to modify the sealed contact lens package of Powell with the teachings of Kadlecik so that the plastic base member comprises a plurality of threads for engagement with a compatible set of Appeal 2019-004277 Application 14/719,341 28 threads on the resealable cover, because the selection of the specific type of contact lens package would have been a matter of obvious design choice, insofar as the resultant structures will work equally well. Final Act. 7. Appellant argues that, as with Ewart, Kadlecik relates to the carrying case for worn contact lenses (not unworn) and there is no teaching or suggestion of the contact lens carrying case being for unworn lenses. App. Br. 29. According to Appellant, there is no teaching or suggestion in Kadlecik of an autoclaved, sealed contact lens package. Id. Appellant argues further that the approaches of Ewart and Kadlecik are divergent from each other. App. Br. 29. Appellant asserts that Ewart achieves its purpose with a contact lens container having adhesive on a perimeter of the container to which a sheet is bound thereto. Id. (citing Ewart Fig. 1). Kadlecik, argues Appellant, teaches storage contact lens containers having a threaded structure, and a cap secured to the container by screwing the cap around the threaded structure. Id. at 30 (citing Kadlecik col. 2, ll. 15–36, Fig. 3). Appellant argues that, for the Examiner’s combination of references to work, Ewart would also have to be capable of closing the contact lens containing area with a cap that is screwed on in the manner described in Kadlecik, but contends that Ewart is not enabled for such a modification. App. Br. 31. Appellant asserts that a skilled artisan would have had no reasonable expectation of success in combining the references. Id. We are not persuaded by Appellant’s arguments. With respect to Appellant’s contention that neither Ewart nor Kadlecik teach a container for contact lenses not previously worn, Powell explicitly teaches a sealed, autoclaved container for such lenses. See Powell 8. Ewart and Kadlecik Appeal 2019-004277 Application 14/719,341 29 each provide alternate means of opening (and, if necessary, reclosing) containers for contact lenses: either via an adhesive film (Ewart) or a screw cap connecting with threads in a plastic base (Kadlecik). We agree with the Examiner that the two methods of opening a sealed lens case taught by Ewart and Kadlecik respectively, represent functions of lens case opening mechanisms that would have been obvious to a person of ordinary skill in the art. With respect to Appellant’s argument that a person of ordinary skill in the art would have had no reasonable expectation of success in combining the teachings of Kadlecik and Ewart: The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. Keller, 642 F.2d at 425. We agree with the Examiner that the alternative contact lens case opening mechanisms taught by the two references present alternate design choices that would have been obvious to the skilled artisan. We consequently affirm the Examiner’s rejection of claim 11. CONCLUSION The Examiner’s rejection of claims 1–12 and 18–20 under 35 U.S.C. § 112(b) is affirmed. The Examiner’s rejection of claims 1–12 and 18–20 under 35 U.S.C. § 103 is affirmed. Appeal 2019-004277 Application 14/719,341 30 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). AFFIRMED Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–12, 18–20 112(b) Indefiniteness 1–12, 18–20 1–4, 6, 18– 20 103 Powell, Osawa, Marlowe 1–4, 6, 18–20 5, 7–10, 12 103 Powell, Osawa, Marlowe, Ewart 5, 7–10, 12 11 103 Powell, Osawa, Marlowe, Ewart, Kadlecik 11 Overall Outcome 1–12, 18–20 Copy with citationCopy as parenthetical citation