CooperVision International Holding Company, LP

Patent Trials and Appeals Board

May 7, 2020

14719341 - (D) (P.T.A.B. May. 7, 2020)

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.
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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.

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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.
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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.
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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,
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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.

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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
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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.

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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).
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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
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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
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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
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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).

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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
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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
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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.
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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
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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.
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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
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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:
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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.

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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
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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
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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
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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
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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.
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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
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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
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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.
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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