Ex Parte Schultz

Board of Patent Appeals and Interferences

Jul 24, 2008

10132843 (B.P.A.I. Jul. 24, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte CLYDE L. SCHULTZ,
Appellant
____________________

Appeal 2008-3731
Application 10/132,8431
Technology Center 1600
____________________

Decided: July 24, 2008
____________________

Before CAROL A. SPIEGEL, DEMETRA J. MILLS, and
MARK NAGUMO, Administrative Patent Judges.

SPIEGEL, Administrative Patent Judge.

DECISION ON APPEAL

1 Application 10/132,843 ("Spec.") was filed 25 April 2002. The real party
in interest is said to be DirectContact LLC (Appellant's Amended Brief on
Appeal Submitted Pursuant to 37 C.F.R. § 41.37 filed on 25 January 2007
("App. Br.") at 3).
Appeal 2008-3731
Application 10/132,843

I. Statement of the Case
Appellant appeals under 35 U.S.C. § 134 from the rejection of all
pending claims, claims 1-3, 5, 6, 8, 11-16, and 34-37. We have jurisdiction
under 35 U.S.C. § 6(b). We AFFIRM.
The subject matter on appeal is directed to soft contact lenses
comprising a hydrogel polymer and 5 to 350 ppb of growth factor. Claims 1
and 35 are illustrative and read:
1. A hydrogel contact lens that comprises (i) a
polymer and (ii) a substantially pure growth factor
at a concentration of between 5 ppb and 350 ppb.
35. The contact lens of claim 1, wherein said
growth factor is passively absorbed in said
polymer.
(App. Br. 28 and 30)
Claim 3 limits the growth factor in the contact lens of claim 1 to epidermal
growth factor ("EGF").
The Examiner finally rejected claims 1-3, 5, 6, 8, 11-16, and 34-37
under 35 U.S.C. § 103(a) as unpatentable over the combined teachings of
Robertson,2 Schultz,3 Cejkova,4 Bawa,5 and El Hage.6 (FR7 2; Ans.8 4) In

2 U.S. Patent 5,665,373, "Pharmaceutical Compositions and Methods of
Treatment of the Corneal Following Laser Irradiation," issued 9 September
1997, to Robertson et al. ("Robertson")
3 U.S. Patent 6,410,045 B1, "Drug Delivery System for Antiglaucomatous
Medication," issued 25 June 2002 (based on application 09/507,437, filed 19
February 2000), to Schultz et al. ("Schultz")
4 U.S. Patent 5,607,688, "Contact Lens of Hydrophilic Gels with Inhibitor
and Swelling Agent," issued 4 March 1997 to Cejkova et al. ("Cejkova")
5 U.S. Patent 4,931,279, "Sustained Release Formulation Containing an Ion-
Exchange Resin," issued 5 June 1990 to Bawa et al. ("Bawa")
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the Examiner's Answer, the Examiner newly rejected claims 1-3, 5, 6, 8, 11-
16, and 34-37 under 35 U.S.C. § 103(a) as unpatentable over the combined
teachings of Ting,9 Robertson, Schultz, Cejkova, Bawa, and El Hage (Ans.
3).
On appeal, the initial procedural burden is on the Appellant to
demonstrate reversible error in the Examiner's rejections. Arguments not
made in the principal brief on appeal are deemed to have been waived,
absent a showing of good cause.
Appellant relies on four declarations, copies of which were provided
in the Evidence Appendix of the principal brief (App. Br. 31-101), i.e.,
Declaration of Dr. Clyde Schultz under 37 C.F.R. § 1.132, executed
March 13, 2006 ("Schultz I"),
Declaration of Dr. Clyde Schultz under 37 C.F.R. § 1.132, executed
November 13, 2006 ("Schultz II"),
Declaration of Dr. Peter A. Rapoza under 37 C.F.R. § 1.132, executed
April 21, 2006 ("Rapoza"), and
Declaration of Dr. Jonathan H. Talamo under 37 C.F.R. § 1.132,
executed April 27, 2006 ("Talamo").
Appellant did not present separate patentability arguments for any of
claims 2, 5, 6, 8, 11-16, 34, 36, and 37. Therefore, the patentability of these
claims stand or fall with the patentability of claim 1 from which they

6 U.S. Patent 5,695,509, "Aspherical Optical Molds for Continuous
Reshaping the Cornea Based on Topographical Analysis," issued 9
December 1997, to El Hage. ("El Hage")
7 Office action mailed 22 August 2006. ("FR")
8 Examiner's Answer mailed 8 August 2007. ("Ans.")
9 U.S.Patent 5,192,316, "Ocular Device," issued 9 March 1993, to Ting.
("Ting")
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depend. Thus, we decide this appeal on the basis of claims 1, 3, and 35.
37 C.F.R. § 41.37(c)(1)(vii).
II. Appellant's Invention
According to the 843 specification, there is a need for devices that
promote healing of corneal wounds resulting from injury, disease or
surgery. (Spec. 1-2) The 843 specification describes a hydrogel drug
delivery system in which a growth factor, e.g., EGF, is transferred from a
dilute aqueous solution into a hydrogel in the shape of a contact lens.
Subsequently, when the hydrogel is placed in contact with a wounded
tissue, the growth factor passively transfers out of the hydrogel into the
tissue environment. (Spec. 3:3-8, 20-25; 5:14-20) "The concentration of
growth factor into which the hydrogel is placed is typically 10 ng/µl or
less . . . ." (Spec. 6:19-20) "Typically, the concentration of growth factor
transferred to the hydrogel is substantially lower than the solution in which
the hydrogel is soaked", for example, "at least 2×, 5×, or 10× less than that
of the soaking solution." (Spec. 6:25-28) According to the 843
specification,
The amount of growth factor absorbed into the
hydrogel is low, e.g., ≤ 350 ppb, but this amount
surprisingly is effective in producing a therapeutic
effect likely because the delivery system is
localized and provides a sustained release of the
factor. (Spec. 3:8-12)
III. The Prior Art
Bawa states, "It is basically known in the art that medicinally active
substances may be dissolved in the aqueous constituent of hydrogels to
gradually release such substances over an extended period." (Bawa 1:16-19)
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Similarly, Schultz states, "It is known to use polymeric hydrogel
compositions to [sic] as medication delivery systems. The use of polymeric
hydrogels as contact lenses to dispense medications in the eye is known. . . ."
(Schultz 3:66-4:2).
Schultz, Cejkova, and Bawa each disclose polymeric hydrogel
compositions in the form of contact lenses which contain medications for the
eye. Schultz Examples 1-3 disclose etafilcon A polymer hydrogel contact
lenses containing a passively transferred antiglaucoma drug, timolol
maleate. (Schultz 3:5-7; 4:11-15, 26-27, 58-60; 5:16-19) Cejkova discloses
contact lenses of hydrophilic gels (hydrogels) containing antibiotics and
anti-inflammatory agents useful to treat eye wounds. (Cejkova abstract;
1:49-55). The contact lenses in Cejkova Examples 1-3 are poly (2-
hydroxyethyl methacrylate), Polymaconâ„¢, and Vifilcon Aâ„¢ hydrogel
polymers, respectively. (Cejkova 3:28-31, 40-45, 53-61) Bawa discloses
making contact lenses from a hydrogel containing a medicinal agent for
sustained release of the agent. (Bawa 2:39-68; 7:5-52). The hydrogel
contact lenses in Bawa Examples 1-3 are made from 2-hydroxyethyl
methacrylate (HEMA) and ethylene glycol dimethacrylate (EGDMA)
polymers. (Bawa 10:44-68) Exemplary medicinal agents useful in Bawa's
hydrogel contact lenses include antibiotics, anti-inflammatory agents, and
ophthalmic medicaments. (Bawa 9:50-56)
Ting discloses ocular devices, including contact lenses, containing a
component capable of being released from the lens to promote healing of a
damaged cornea. (Ting 2:5-8; 2:63-3:6) The contact lens is preferably made
of a hydrogel forming polymer "because of their outstanding permeability
characteristics." (Ting 4:27-31) According to Ting, "release of the added
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component from the lens structure can be . . . controlled so that a useful
amount of the added component is substantially continuously present to
promote the healing of the cornea." (Ting 3:12-15) Suitable components
include "various growth factors and adhesion factors, which promote the
growth and adhesion, respectively, of the corneal cells. . . ." (Ting 3:50-53)
"Fibronectin, derivatives of fibronectin, EGF, derivatives of EGF and
mixtures thereof are especially useful." (Ting 3:60-62) "This approach . . .
is far superior to repeatedly adding drops of material to the eye." (Ting 3:9-
11) In addition, the contact lens may be structured to correct vision
deficiencies of the eye of the user. (Ting 3:34-37)
Robertson discloses compositions containing "wound healing
modulators," including growth factors for use in preventing and treating
corneal hazing resulting from laser eye surgery. (Robertson 3:36-45; 4:2-5;
5:44-6:2) "The compositions can . . . be delivered via use of a collagen
shield, contact lenses or other solid matrixes capable of delivering drugs to
the cornea placed on the ocular surface." (Robertson 3:49-52) "Such
shields, lenses or matrices can provide for slow release of the modulators as
well as serving as a protective environmental barrier." (Robertson 10:37-39)
According to Robertson, ophthalmic preparations containing human EGF for
treatment of keratitis, corneal erosion, corneal infiltration, and corneal ulcers
are known. (Robertson 5:66-6:2, citing European Patent 140 998)
Robertson typically uses growth factors at concentrations between about
0.01 nanograms per milliliter (0.01 ppb) and 100 micrograms per milliliter
(100,000 ppb). (Robertson 6:11-14) "EGF can be used at concentrations
between about 500 ng/ml [500 ppb] and 100 µg/ml [100,000 ppb],
preferably between about 10 µg/ml [10,000 ppb] and 50 µg/ml
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[50,000 ppb] . . . ." (Robertson 6:15-17, bracketed text added) "TGF [tissue
growth factor] can be used at concentrations of at least about 100 ng/ml [100
ppb] . . . ." (Robertson 6:19-20, bracketed text added) Robertson is silent in
regard to the material from which the contact lens is made.
El Hage discloses a "continuous, aspherical optical mold . . . [which],
when applied to the cornea . . . exerts a selective pressure on the cornea
causing displacement of corneal tissue away from a zone of applied pressure
to a zone of relief, thereby reshaping the . . . cornea and improving . . .
vision without surgical intervention." (El Hage 1:54-60)
IV. The Declarations
Dr. Schultz testified that he is "an inventor" of the claimed invention
and has 15 years experience "in the fields of contact lens and treatment for
eye related diseases and conditions." (Schultz I ¶¶ 1-2; Schultz II ¶¶ 1-2)
Dr. Schultz further testified that as of October 3, 1998, Robertson's earliest
priority date, many contact lenses marketed were rigid gas permeable lenses,
not hydrogel contact lenses. (Schultz I ¶ 3; Schultz II ¶ 3) In Dr. Schultz's
opinion Robertson describes a contact lens as a solid matrix and specifically
distinguishes them from gels (Schultz I ¶ 3, citing Robertson 3:45-52;
Schultz II, ¶ 3, citing Robertson 3:45-52). Thus, Dr. Schultz concludes the
contact lenses discussed in Robertson are rigid gas permeable contact lenses.
(Schultz I ¶ 3; Schultz II ¶ 3) In Dr. Schultz's opinion, rigid gas permeable
contact lenses would not be able to take up or release a sufficient amount of
growth factor to produce a therapeutic effect. (Schultz I ¶ 3; Schultz II ¶ 3)
According to Dr. Schultz, methods existed at the time of Robertson's
filing to apply modulators via rigid gas permeable lenses at rate slower than
application via aqueous eye drops. (Schultz II ¶ 4) Thus, Dr. Schultz
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opined that Robertson's reference to lenses which can provide a slow release
of the modulator (col. 10, lines 37-38) does not exclude the lenses from
being rigid gas permeable lenses. (Schultz II ¶ 4) Dr. Schultz further opined
that "one skilled in the art reading this sentence in Robertson would not
believe it to be related to growth factors because growth factors are sensitive
molecules that are susceptible to denaturation and degradation." (Schultz II
¶ 4)
Dr. Rapoza stated he is an ophthalomogist and has a financial interest
in the assignee of the 843 application. (Rapoza ¶ 1) Dr. Rapoza testified
that, based on his experience as an ophthalmologist, he would not have
believed "a hydrogel contact lens containing a growth factor would have
been useful to treat ocular wounds. . . ." (Rapoza ¶ 3) Dr. Rapoza did not
further explain the basis of his belief. Dr. Rapoza stated, "After reviewing
the data in Appendix I and discussing the invention with Dr. Schultz, I now
believe it is possible to absorb a growth factor into or onto a contact lens and
to use such a lens to treat ocular wounds." (Rapoza ¶ 4) Dr. Rapoza did not
testify regarding the contents or data of Appendix I, nor did he explain what
data or what in the discussions caused him to change his belief.
Dr. Talamo stated he is an ophthalomogist and has a financial interest
in the assignee of the 843 application. (Talamo ¶ 1) Dr. Talamo testified
that, based on his experience as an ophthalmologist, he would not have
believed "a hydrogel contact lens containing a growth factor would have
been useful to treat ocular wounds. . . ." (Talamo ¶ 3) Dr. Talamo did not
further explain the basis of his belief. Dr. Talamo stated, "After reviewing
the data in Appendix I and discussing the invention with Dr. Schultz, I now
believe it is possible to absorb a growth factor into or onto a contact lens and
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to use such a lens to treat ocular wounds." (Talamo ¶ 4) Dr. Talamo did not
testify regarding the contents or data of Appendix I, nor did he explain what
data or what in the discussions caused him to change his belief.
V. Discussion
A. Legal standard
A claimed invention is not patentable if it would have been obvious to
a person having ordinary skill in the art. 35 U.S.C. § 103(a); KSR Int'l Co. v.
Teleflex, Inc., 127 S.Ct. 1727 (2007); Graham v. John Deere Co. of Kansas
City, 383 U.S. 1 (1966). Facts relevant to a determination of obviousness
include (1) the scope and content of the prior art, (2) any differences
between the claimed invention and the prior art, (3) the level of skill in the
art, and (4) any relevant objective evidence of obviousness or non-
obviousness. KSR, 127 S.Ct. at 1734; Graham, 383 U.S. at 17-18. All that
is required for obviousness under 35 U.S.C. § 103 is a reasonable
expectation of success. In re O'Farrell, 853 F.2d 894, 904 (Fed. Cir. 1988).
B. Rejection of claims 1-3, 5, 6, 8, 11-16, and 34-37 under
§ 103(a) over the combined teachings of Robertson, Schultz,
Cejkova, Bawa, and El Hage.
1. Examiner's findings and conclusions
The Examiner found Robertson teaches a composition comprising a
growth factor in concentrations from 0.01 ppb to 100,000 ppb incorporated
into a contact lens for treating corneal wounds. (Ans. 5) The Examiner
found Schultz, Cejkova, and Bawa teach drug delivery systems comprising
hydrogel contact lenses containing therapeutic agents. (Ans. 6) The
Examiner found "El Hage teaches corrective contact lenses, wherein the
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diopter and base curve are adjusted relative to the correction required (col. 7-
9)." (Ans. 6)
The Examiner concluded Bawa shows that one of ordinary skill in the
art would have known that the contact lens of Robertson "may comprise a
hydrogel forming polymer" in view of the teachings of Schultz, Cejkova,
and Bawa that hydrogel contact lenses made of various polymers are well
known in the art for delivery of therapeutics to the eye. (FR 4; Ans. 5-6)
The Examiner concluded,
as evidenced by the cited references, at the time of
the claimed invention one of ordinary skill in the
art would have been motivated by routine practice
. . . to optimize the specific parameters of the
contact lens obtained by the combined teachings,
with a reasonable expectation for successfully
obtaining an effective hydrogel contact lens
comprising a growth factor. (Ans. 7)
The Examiner further concluded the growth factor would have been
passively absorbed into the hydrogel polymer because "this limitation is
considered to be a product by process claim." (Ans. 5)
2. Appellant's arguments
According to Appellant, Robertson teaches eleven general classes of
"wound healing modulators," encompassing over 500 disclosed species,
which may be administered by any and all means of topical administration,
including aqueous solutions, emulsions or gels, collagen shields, contact
lenses, and other solid matrices. (App. Br. 10) Appellant argues Robertson
fails to teach or suggest the specific combination of contact lens and growth
factor claimed, fails to provide any motivation to use a hydrogel contact
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lens, and fails to provide any guidance as to which administration modes are
appropriate for which modulators. (App. Br. 9-10; Reply Br.10 4-8, 14-15)
Citing the two Schultz Declarations for support, Appellant further
argues the contact lens discussed by Robertson is a rigid gas permeable
contact lens, not a hydrogel contact lens. (App. Br. 17; Reply Br. 8-13)
According to Appellant, Bawa's teaching that hydrogel contact lenses were
known and used in the art as drug delivery systems is irrelevant to
Robertson's disclosure and insufficient to rebut the Schultz Declarations.
(App. Br. 18-20; Surreply11 6)
Appellant argues the skepticism testified to by two experts, Drs.
Rapoza and Talamo, is evidence of unexpected results. (App. Br. 22-23)
According to Appellant, the change in opinion of Drs. Rapoza and Talamo,
from unbelief that a hydrogel contact lens containing a growth factor would
have been useful to treat ocular wounds to a belief that it is possible to
absorb a growth factor into or onto a contact lens and to use such a lens to
treat ocular wounds, "weighs heavily in favor of the patentability of the
instant claims." (App. Br. 23; Surreply 5, 20-21)
Specifically in regard to claim 3, Appellant argues, given Robertson's
teaching of using EGF concentrations between about 500 ppb and 100,000
ppb, a skilled artisan would question the efficacy of a concentration of EGF
between 5 ppb and 350 ppb as claimed. (App. Br. 25-26; Surreply 6-7)
Specifically in regard to claim 35, Appellant argues Robertson does
not teach or suggest absorption of a wound healing modulator in a contact

10 Appellant's Reply Brief pursuant to 37 C.F.R. § 41.41, filed 9 October
2007 ("Reply Br.").
11 Appellant's second reply brief pursuant to 37 C.F.R. § 41.41, filed 31
December 2007 ("Surreply").
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lens, particularly a rigid gas permeable contact lens as opined in the Schultz
Declarations. (App. Br. 26-27)
Appellant presented arguments based on twelve patents said to be part
of "the Robertson patent family." (App. Br. 12-17; Reply Br. 13-15;
Surreply 16-17) Appellant also presented arguments based on U.S. Patent
5,723,131 for the first time in its reply brief. (Reply Br. 10-11; Surreply 15-
16) None of the thirteen references is evidence relied upon by the Examiner
as to the grounds of rejection to be reviewed on appeal. Appellant has not
shown good cause why these thirteen references were not relied on as
evidence relied on in their principal brief. Therefore, Appellant waived the
right to make arguments based on the thirteen references and we shall not
consider those arguments.
3. Analysis
We find no merit in Appellant's argument that Robertson fails to teach
the specific combination of contact lens and growth factor claimed. Such a
specific teaching is not required for a finding of obviousness under § 103.
Rather, the proper inquiry is what the collective teachings of the prior art
would have reasonably suggested to one of ordinary skill in the art. In re
Keller, 642 F.2d 413, 425 (CCPA 1981).
In the present case, Bawa and Schultz teach use of polymeric hydrogel
compositions as medication delivery systems. (Bawa 1:16-20; Schultz 3:66-
4:2) Schultz, Cejkova, and Bawa each teach such medication delivery
systems in the form of hydrogel contact lenses, albeit containing different
medications for treating eye diseases (glaucoma) and wounds. (Schultz 3:5-
7; 4:11-15, 26-32, 56-59; 5:16-22) (Cejkova abstract; 1:49-55; 3:28-31, 40-
45, 53-61) (Bawa 2:39-68; 7:5-52; 9:50-56; 10:44-68) Robertson teaches
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wound healing medication/modulator delivery systems, including contact
lenses. (Robertson 3:36-52; 4:2-8; 5:44-6:2) Robertson not only teaches
growth factors as suitable wound healing modulators, but also specifically
states that ophthalmic preparations containing human EGF are known for
treatment of eye wounds. (Robertson 3:36-45, 6:11-18) Robertson typically
uses growth factors at concentrations between about 0.01 ppb and 100,000
ppb. (Robertson 6:11-14) For example, tissue growth factor can be used at
a concentration of at least about 100 ppb (Robertson 6:19-20), while EGF
can be used at concentrations between about 500 ppb and 100,000 ppb
(Robertson 6:15-17). Thus, we find ample support in the record for the
Examiner's conclusion (Ans. 16), "[s]ince the claimed polymeric hydrogels
were known and used in the art for delivering medicaments to the eye at the
time of the claimed invention, one of ordinary skill in the art would have
been motivated to use a hydrogel contact lens in the compositions of
Robertson with a reasonable expectation for successfully obtaining an
effective contact lens composition for delivering growth factors to the eye"
in view of the combined teachings of Robertson, Schultz, Cejkova, and
Bawa. We also find the record supports the Examiner's finding (Ans. 14-15)
that Robertson teaches administering a growth factor in the claimed amounts
at column 6, lines 3-21, e.g., use of growth factor TGF at a concentration of
at least about 100 ppb. (Robertson 6:19-20) None of the four declarations
convince us otherwise.
Dr. Schultz testified that many, not all, contact lenses marketed as of
October 3, 1988, allegedly Robertson's earliest effective filing date, were
rigid gas permeable lenses. Notably, Dr. Schultz did not testify as to what
other types of contact lenses were marketed as of October 3, 1988. Bawa
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establishes that hydrogel contact lenses containing medicinal agents were
already known in the art at least three years earlier than October 3, 1988
based on its effective filing date. Cejkova establishes use of hydrogel
contact lenses to treat eye wounds at least two years earlier than October 3,
1988 based on its effective filing date. Dr. Schultz did not testify regarding
the state of the art of hydrogel contact lenses in 1988. Indeed, many factors
might have contributed to what type of lenses garnered what percent of the
market share over time, e.g., cost associated with newer generations of
lenses as technology improved. Thus, Dr. Schultz's testimony is insufficient
to establish that Robertson's contact lenses were rigid gas permeable lenses.
Neither Dr. Rapoza nor Dr. Talamo explained the basis for his
original belief or the reasons for changing his mind in anything but a
conclusory statement. Therefore, their testimony is entitled to little, if any,
weight. Rohm and Haas Co. v. Biotech Corp., 127 F.3d 1089, 1092 (Fed.
Cir. 1997) (nothing in the rules or in jurisprudence requires the fact finder to
credit unsupported or conclusory assertions); In re Schulze, 346 F.2d 600,
602 (CCPA 1965) (argument in the brief does not take the place of evidence
of record).
Furthermore, none of Drs. Schultz, Rapoza, and Talamo discussed
Appendix I and explained how the results related to the subject matter of the
claimed invention, what results were unexpected and why.
Based on the foregoing, we sustain the rejection of claim 1, as well as
claims 2, 5, 6, 8, 11-16, 34, 36, and 37, under § 103(a) as unpatentable over
the combined teachings of Robertson, Schultz, Cejkova, Bawa, and El Hage.
As to claim 3, Robertson teaches that growth factors are typically used
in a range which encompasses the claimed range. (Robertson 6:11-14)
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Appellant argues that Robertson suggests a minimum concentration of EGF
that is almost 30 times the maximum claimed. (App. Br. 25-26) However,
the rejection is not based on Robertson alone. Bawa teaches that the active
agent, here EGF, is dissolved in the aqueous constituent of hydrogels.
(Bawa 1:16-20) Thus, one of ordinary skill in the art would have reasonably
expected the amount of EGF taken up by a hydrogel contact lens to vary
with the aqueous content of the hydrogel. This is consistent with Dr.
Schultz's testimony that rigid contact lenses would not be able to take up a
sufficient amount of growth factor to produce a therapeutic effect. (Schultz I
¶ 3; Schultz II ¶ 3) Therefore, we find the preponderance of the evidence
indicates that it would have been within ordinary skill in the art to produce
hydrogel contact lenses, made from hydrogel forming polymers, such as
disclosed by Bawa, Schultz, and/or Cejkova, containing EGF within the
claimed parameters as dictated by the aqueous content of the hydrogel. To
hold otherwise presumes that a person having ordinary skill in the art is
unknowledgeable and unskilled. KSR Int'l Co. v. Teleflex Inc., 550 127
S.Ct. 1727, 1742 (2007) (. "A person of ordinary skill is also a person of
ordinary creativity, not an automaton."); In re Sovish, 769 F.2d 738, 743
(Fed. Cir. 1985). Thus, we sustain the rejection of claim 3 under § 103(a) as
unpatentable over the combined teachings of Robertson, Schultz, Cejkova,
Bawa, and El Hage.
As to claim 35, the rejection is not based on Robertson alone. Bawa
suggests the active agent is dissolved in the aqueous constituent of the
hydrogel. (Bawa 1:16-20) In other words, Bawa suggests the hydrogel
polymer passively absorbs active agent via its aqueous constituent. In
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addition, we agree with the Examiner (Ans. 19; Supp. Ans.12 5) that claim
35 is a product-by-process claim. Determination of patentability of a
product-by-process claim is based on the product itself. In re Thorpe, 777
F.2d 695, 697 (Fed. Cir. 1985). It is well settled law that "[i]f the product in
a product-by-process claim is the same as or obvious from a product of the
prior art, the claim is unpatentable even though the prior product was made
by a different process." Id., 772 F.2d at 697. Finally, Appellant has not
provided evidence showing that the process recited in claim 35 materially
alters the characteristics of the product of claim 1. Therefore, we sustain the
rejection of claim 35 under § 103(a) as unpatentable over the combined
teachings of Robertson, Schultz, Cejkova, Bawa, and El Hage.
A discussion of El Hage is unnecessary to our decision.
C. Rejection of claims 1-3, 5, 6, 8, 11-16, and 34-37 under
§ 103(a) over the combined teachings of Ting, Robertson,
Schultz, Cejkova, Bawa, and El Hage.
1. Examiner's findings and conclusions
The Examiner found Ting teaches a contact lens comprising a
hydrogel forming polymer and a growth factor, preferably EGF, which is
capable of being released the lens when the lens is placed on the eye. (Ans.
8) The Examiner further found Ting teaches the lens can be structured to
correct vision deficiencies. (Ans. 8) The Examiner again found Schultz,
Cejkova, and Bawa teach drug delivery systems comprising hydrogel
contact lenses containing therapeutic agents. (Ans. 9-10) The Examiner
found El Hage disclosed optimizing specific parameters of contact lenses,
i.e., diopter and base curve, to correct vision deficiencies as routine in the

12 Supplemental Examiner's Answer mailed 29 October 2007 ("Supp. Ans.").
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art. (Ans. 10) The Examiner concluded "it would have been obvious . . . to
add growth factors to the contact lens [of Ting] in the claimed amounts as
they were recognized effective amounts for healing the eye, as evidenced by
Robertson." (Ans. 9) According to the Examiner, it would have been a
matter of routine experimentation to optimize growth factor concentration to
the claimed levels since the growth factor is a result effective variable.
(Ans. 9) The Examiner again determined that the limitation that the growth
factor is passively absorbed in the hydrogel polymer is a process limitation
in a product by process claim. (Ans. 8)
2. Appellant's arguments13
Appellant reiterated many of the same arguments made above in
response to the rejection based on Robertson, Schultz, Cejkova, Bawa, and
El Hage and we will not repeat them here.
Appellant additionally argues Ting, like Robertson, teaches growth
factors and contact lenses but does not teach or suggest putting the two
together in the claimed amounts. (Reply Br. 16) Appellant emphasizes that
Robertson generally teaches using a concentration of growth factors
spanning eight orders of magnitude, while Ting teaches use of 1 wt.%
(10,000,000 ppb) fibronectin, which Appellant alleges Ting refers to as a
growth factor. (Reply Br. 16-17; Surreply 17-18) Appellant further argues
the majority of the Ting disclosure focuses on a surgically implanted lens

13 Appellant stated he was addressing this rejection as based on Ting and
Robertson only. (Reply Br. 16 n.1) The Examiner expressly clarified that
the rejection was based on all six references, i.e., Ting, Robertson, Schultz,
Cejkova, Bawa, and El Hage. (Supp. Ans. 9) Appellant replied accordingly.
(Surreply 16)
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device, not a contact lens device. (Reply Br. 16-17) Appellant emphasizes
that Ting only claims a surgically implanted lens. (Surreply 18-20)
As to claim 3, Appellant additionally argues since the only therapeutic
agent concentration in Ting is almost 300,000 times the maximum
concentration recited in claim 3, one skilled in the art would not look to
Robertson for guidance on a concentration to employ. (Reply Br. 18)
Appellant essentially argues that when the prior art discloses concentrations,
i.e., 10,000,000 ppb fibronectin in Ting and 500 ppb EGF in Robertson, so
much higher than the claimed 5 to 350 ppb EGF concentration, a general
desire to optimize a result effective variable based on the prior art would not
lead to the invention of claim 3. (Reply Br. 18-19)
3. Analysis
We reiterate our reasoned responses to Appellant's reiterated
arguments made above in response to the rejection based on Robertson,
Schultz, Cejkova, Bawa, and El Hage.
We find no merit in Appellant's argument that Ting, like Robertson,
fails to teach the specific combination of contact lenses and growth factors
in the claimed amounts. As stated above, such a specific teaching is not
required for a finding of obviousness under § 103. Rather, the proper
inquiry is what the collective teachings of Ting, Robertson, Schultz,
Cejkova, Bawa, and El Hage would have reasonably suggested to one of
ordinary skill in the art. In re Keller, 642 F.2d at 425.
Furthermore, it appears that the Examiner and Appellant have both
misapprehended at least one teaching in Ting. Fibronectin is not a growth
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factor: it is an adhesion factor.14 According to Ting, "[a]mong the added
components . . . are various growth factors and adhesion factors, which
promote the growth and adhesion, respectively, of the corneal cells . . . ."
(Ting 3:50-53, emphasis added) Thus, Ting does not teach or suggest using
a growth factor at concentrations almost 300,000 times the maximum
concentration recited in claim 1 or 3. As noted above, Robertson teaches
that growth factors are typically used in a range which encompasses the
claimed range. (Robertson 6:11-14) Bawa teaches that the active agent,
here EGF, is dissolved in the aqueous constituent of hydrogels. (Bawa 1:16-
20) One of ordinary skill in the art would have reasonably expected the
amount of EGF taken up by a hydrogel contact lens to vary with the aqueous
content of the hydrogel. This is consistent with Dr. Schultz's testimony that
rigid contact lenses would not be able to take up a sufficient amount of
growth factor to produce a therapeutic effect. (Schultz I ¶ 3; Schultz II ¶ 3)
Therefore, we find that it would have been within ordinary skill in the art to
produce hydrogel contact lenses, made from hydrogel forming polymers
such as disclosed by Ting, Bawa, Schultz, and/or Cejkova, containing EGF
within the claimed parameters as dictated by the aqueous content of the
hydrogel. To hold otherwise presumes that a person having ordinary skill in
the art is unknowledgeable and unskilled. KSR, 127 S.Ct. at 1742; In re
Sovish, 769 F.2d at 743.

14 See e.g., MOLECULAR CELL BIOLOGY, fourth edition, H. Lodish et
al., eds.,W.H. Freeman and Company, New York, NY (2000), glossary page
G-7, which defines fibronectin as "[a]n extracellular multiadhesive protein
that binds to other matrix components, fibrin, and cell-surface receptors of
the integrin family."
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Finally, it is immaterial that Ting only claims surgically implanted
lenses. It is well settled that a reference must be considered in its entirety
and that its disclosure is not limited to preferred embodiments or specific
working examples contained therein. In re Fracalossi, 681 F.2d 792, 794
n.1 (CCPA 1982); In re Lamberti, 545 F.2d 747, 750 (CCPA 1976). As
stated by Appellant, "Ting teaches two different devices." (Surreply 12)
Ting expressly teaches its contact lens embodiment is preferably made of a
hydrogel forming polymer "because of their outstanding permeability
characteristics." (Ting 4:27-31)
Since none of Appellant's additional arguments are persuasive of
reversible Examiner error, we sustain the rejection of claims 1-3, 5, 6, 8, 11-
16, and 34-37 under § 103(a) over the combined teachings of Ting,
Robertson, Schultz, Cejkova, Bawa, and El Hage.
VI. Order
Upon consideration of the record, and for the reasons given, it is
ORDERED that the decision of the Examiner rejecting claims 1-3, 5,
6, 8, 11-16, and 34-37 under 35 U.S.C. § 103(a) as unpatentable over the
combined teachings of Ting, Robertson, Schultz, Cejkova, Bawa, and El
Hage is AFFIRMED;
FURTHER ORDERED that the decision of the Examiner rejecting
claims 1-3, 5, 6, 8, 11-16, and 34-37 under 35 U.S.C. § 103(a) as
unpatentable over the combined teachings of Ting, Robertson, Schultz,
Cejkova, Bawa, and El Hage is AFFIRMED; and
FURTHER ORDERED that no time period for taking any subsequent
action in connection with this appeal may be extended under 37 C.F.R.
§ 1.136(a).
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AFFIRMED

rvb

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