Ex Parte Raja et al

Patent Trial and Appeal Board

Apr 19, 2016

11686979 (P.T.A.B. Apr. 19, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/686,979 03/16/2007
27777 7590 04/21/2016
JOSEPH F. SHIRTZ
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
FIRST NAMED INVENTOR
Ranganath R. Raja
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
VTN5143USNP 7362
EXAMINER
RICCI, CRAIG D
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
04/21/2016 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
jnjuspatent@corus.jnj.com
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RAN GANA TH R. RAJA, SHIVKUMAR MAHADEV AN,
BRIAN PALL, FRANKF. MOLOCK, AND AZAAM ALLI 1
Appeal2014-001525
Application 11/686,979
Technology Center 1600
Before FRANCISCO C. PRATS, ULRIKE W. JENKS, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to contact
lenses containing anti-allergy medication, which have been rejected as
anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
STATEMENT OF THE CASE
The invention relates to an ophthalmic device that comprises a
minimum effective amount of an anti-allergy medication. Spec. 2. In the
claimed embodiment, the ophthalmic device is a contact lens, specifically an
1 The real party-in-interest is Johnson & Johnson Vision Care, Inc. Br. 2.
Appeal2014-001525
Application 11/686,979
etafilcon A lens. Spec. 4. The preferred anti-allergy medication is ketotifen
fumarate. Spec. 3.
Claims 1, 12, 13, and 52-54 are on appeal. Claim 1 is illustrative and
reads as follows:
1. An ophthalmic device comprising
about a minimum effective amount of an anti-
allergic agent, wherein, the ophthalmic device is
prepared from a formulation comprising etafilcon
A, the anti-allergic agent is selected from the
group consisting of ketotifen, its pharmaceutically
acceptable salts and mixtures thereof, the
minimum effective amount of said anti-allergic
agent is 8 µg to 90 µg, and said ophthalmic device
releases between about 10% and about 90% of its
contained anti-allergic agent between
administering the device to the eye and about 60
minutes.
The claims stand rejected as follows:
Claims 1and52 have been rejected under 35 U.S.C. § 102(b) as
anticipated by Karlgard et al., In vitro uptake and release studies of ocular
pharmaceutical agents by silicon-containing and p-HEMS hydrogel contact
lens material, 257 Int'l J. Pharmaceuticals 141-51 (2003) ("Karlgard")
Claims 1, 12, 13 and 52-54 have been rejected under 35 U.S.C.
§ 103(a) as unpatentable over Trimming et al. (U.S. 2001/0006968
Al)(Published Jul. 5, 200l)("Trimming").
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Application 11/686,979
Issue
I
The Examiner has rejected claims 1 and 52 as anticipated by Karlgard.
Ans. 2. The Examiner finds that Karlgard discloses taking an etafilcon A
contact lens having no ketotifen fumarate present in the lens, soaking the
lens in an uptake solution containing ketotifen fumarate to produce a final
lens having 213 µg of ketotifen fumarate present. Ans. 3-4. "[P]roducing
an etafilcon A contact lens comprising 213 µg ketotifen fumarate (from a
starting concentration of 0 µg ketotifen fumarate) according to Karlgard et
al inevitably results in the production of an etafilcon A contact lens
comprising 8 µg to 90 µg ketotifen fumarate, regardless of the data provided
in Figure 2A." Ans. 4.
Appellants do not dispute that the etafilcon A lens in Karlgard
identified by the Examiner has the release properties required by claim 1.
Rather, Appellants contend that Karlgard only discloses a contact lens that
contains 213 µg of ketotifen fumarate, well above the upper limit of 90 µg
recited in the claims. Br. 4. Appellants argue that figure 2 of Karlgard does
not disclose an etafilcon A lens but rather an alphafilcon lens which has very
different uptake rates. Br. 4. Appellants go on to argue that Karlgard does
not teach or suggest making an etafilcon A lens with less than 213 µg of
Ketotifen fumarate. Br. 6
In light of the above, the issue with respect to this rejection is whether
the Examiner has established that Karlgard describes an etafilcon A contact
lens having 8 µg to 90 µg ketotifen fumarate as required by claims 1 and 52 ..
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Application 11/686,979
Findings of Fact
FF 1. Karlgard discloses making an etafilcon A contact lens
containing 213 µg ofketotifen fumarate. Karlgard, Table 3.
FF2. The lens ofKarlgard is produced by soaking a lens having no
ketotifen fumarate present in a solution containing ketotifen fumarate for at
least 24 hours. Karlgard, 144.
FF3. The amount of ketotifen fumarate present in the lens increases
over time. Karlgard, Fig. 2.
Principles of Law
"A reference may anticipate inherently if a claim limitation that is not
expressly disclosed 'is necessarily present, or inherent, in the single
anticipating reference.' The inherent result must inevitably result from the
disclosed steps; '[i]nherency ... may not be established by probabilities or
possibilities."' In re Montgomery, 677 F.3d 1375, 1379-80 (Fed. Cir. 2012)
(citations omitted, alterations in original).
An intermediate structure or product disclosed in a reference can
anticipate claim. In re Mullin, 481 F.2d 1333, 1335-6. (CCPA 1973) ("It
matters not one whit that it was intended to be and appreciated that it was an
intermediate structure rather than an end use item.")
Analysis
The Examiner has found that the process of producing an etafilcon A
lens containing 213 µg of ketotifen fumarate disclosed in Karlgard
inherently results in a lens containing between 8 µg and 90 µg of ketotifen
fumarate at some point during the process. Ans. 2. Thus, the Examiner
contends, Karlgard's lens meets the ketotifen content requirement of claims
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Application 11/686,979
1 and 52. Id. We agree. In the uptake process taught by Karlgard, the
starting lens contains no ketotifen fmnarate. FF2. Soaking the lens in an
uptake solution of ketotifen fmnarate produces a lens containing 213 µg of
ketotifen fmnarate. FF 1. Figure 2 of Karlgard shows that the amount of
ketotifen fumarate present in the lens increases over time. FF3. One skilled
in the art would understand that at some point in the uptake process, an
intermediate products exists that comprises an etafilcon A lens containing
from about 8 µg to about 90 µg. That the lens containing an amount of
ketotifen within the range recited in the instant claims is an intermediate
product and not the final product is irrelevant. In re Mullin, 482 F.2d at
1336.
Applicants' arguments have been considered and are not persuasive.
As discussed above, while an etafilcon A lens containing 213 µg of ketotifen
fumarate is the final product disclosed in Karlgard, the uptake process used
to make the lens invariably produces a lens contain ketotifen fumarate in the
amounts specified in the claims. With respect to Figure 2 of Karlgard, while
it is a chart of the uptake of ketotifen fumarate for an alphafilcon lens,
Karlgard also notes that the charts show a typical uptake/release profile and
that for all the lenses tested a gradual uptake release profile was observed.
Karlgard 144. A person of ordinary skill in the art reading Karlgard would
understand that at some point in the uptake process, the lenses would contain
between 8 µg and 90 µg of ketotifen fumarate. Therefore, Karlgard's
etafilcon lens meets the ketotifen content requirement of claims 1 and 52.
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Application 11/686,979
Conclusion of Law
Appellants' arguments do not persuade us that the Examiner has failed
to established by a preponderance of the evidence that Karlgard anticipates
claims 1and52 as defined by 35 U.S.C. § 102(b).
II
Issue
The Examiner has rejected claims 1, 12, 13, and 52-54 under 35
U.S.C. § 103(a) as unpatentable over Trimming. Final Act. 6-8. The
Examiner finds that Trimming teaches the introduction of solution of at least
50 µg of ketotifen fumarate into a patient's eye while the patient is wearing a
contact lens. Ans. 5. According to the Examiner, this results in a contact
lens comprising at least 50 µg ketotifen fumarate since the solution is in
contact with the surface of the lens, meeting the comprising requirement.
Ans. 5-6. With respect to the uptake requirement, the Examiner has found
that the claims only require that any amount be taken up by the lens and only
between 10 and 90% of the amount actually taken up by the lens needs to be
released by the lens. Ans. 6. The Examiner also finds that Trimming
teaches a ketotifen fumarate solution that contains 250 µg of ketotifen
fumarate which can be applied as a single dose. Ans. 6. The Examiner finds
that application of such a dose would result in a lens that contains 7.5 µg of
ketotifen fumarate after 3 minutes and 57.5 µg after thirty minutes. Ans. 6-
7. The Examiner finds that since blinking is not referenced by Trimming,
Appellants' argument about the eye holding only 10 microliters after
blinking is without merit. Ans. 7.
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Application 11/686,979
Appellants contend that Trimming teaches that "ketotifen is not
significantly absorbed in said contact lens." Br. 7. Appellants contend that
this would lead one skilled in the art to the conclusion that an ineffective
amount of ketotifen fumarate is absorbed by the lens. Id. Appellants also
note that Trimming does not teach solutions of 50 to 500 µg but instead
teaches ketotifen concentrations of from 0.005 to 0.05 wt%. Id. Appellants
also argue that a typical eye drop contains from 25 to 56 µl which would
result in a maximum amount of 25 µg being applied in Trimming. Br. 8.
Assuming that the entire amount stays in contact with the lens for 30
minutes, Appellants argue, only 5.75 µg of ketotifen fumarate would be
absorbed. Id. This is well below the 8 µg lower limit of the claims,
Appellants contend.
Finally, Appellants argue that the entire eye drop does not remain in
contact with the lens as a significant amount is lost when the patient blinks.
Br. 9. In addition, Appellants argue, the fluid in the eye is constantly
replenished resulting in a turnover of the entire tear volume in the eye every
2 to 3 minutes. Id. Appellants argue the solution of ketotifen fumarate
would therefore only remain in contact with the lens for about 3 minutes.
This is not long enough to reach the 8 µg lower limit of the claims. Id.
The issue with respect to this rejection is whether the Examiner has
established that the claims are unpatentable as obvious over Trimming as
defined by 35 U.S.C § 103(a).
Findings of Fact
FF4. Trimming discloses ophthalmic solutions containing 0.005 to
0.05 wt.% ketotifen fumarate. Trimming iJ 5.
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Application 11/686,979
FF5. Etafilcon is among the soft contact materials preferred by
Trimming. Trimming ii 11.
FF6. Trimming teaches that "ketotifen is not significantly absorbed in
said soft contact lens." Trimming ii 12.
FF7. Typical eye drops contain between 25 µland 56 µ1. Soluri
1141.2
FF8. When blinking occurs, the eye only hold about 10 µl resulting in
a loss of more than half the amount administered by an eye drop. The
Pharmaceutical and Compounding Laboratory, Ophthalmics. 3
FF9. The fluid in the eye is completely replaced every two to three
minutes. Id.
Principles of Law
"An examiner bears the initial burden of presenting a prima facie case
of obviousness. Once the examiner establishes a prima facie case of
obviousness, the burden shifts to the applicant to rebut that case. However,
once the applicant has come forward with rebuttal evidence, the examiner
must consider the totality of the evidence to determine whether the
obviousness rejection should stand." In re Huai-Hung Kao, 639 F.3d 1057,
1066 (Fed. Cir. 2011) (citations omitted).
2 Soluri et al., Delivery of ketotifen fumarate by commercial contact lens
materials, 89 Optometry and Vision Science 1140-1149 (2012), submitted
with the Request for Reconsideration filed on Aug. 14, 2012.
3 The Pharmaceutical and Compounding Laboratory,
http://pharmlabs.unc.edu/labs/parenterals/ophthalmics.htm, last visited on
Aug. 14, 2012, submitted with Request for Reconsideration filed on Aug.
14,2012
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Application 11/686,979
"[W]hile an analysis of obviousness always depends on evidence that
supports the required Graham factual findings, it also may include recourse
to logic, judgment, and common sense available to the person of ordinary
skill that do not necessarily require explication in any reference or expert
opinion." Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1329
(Fed. Cir. 2009).
Analysis
Appellants have argued that Trimming would not lead one skilled in
the art to the claimed invention. We agree with Appellants' reasoning.
Trimming clearly teaches that the lenses used in the practice of his
invention, including etafilcon lenses, do not take up significant amounts of
ketotifen fumarate. FF5 & 6. In addition, Appellants have shown that the
amount of ketotifen present in the solutions of Trimming along with the
short time the lenses are exposed to the solution would not create a lens
containing the claimed amounts of ketotifen.
The Examiner argues that the lens only need to come in contact with
the requisite amount of ketotifen to meet the claim limitation. Ans. 6. The
Examiner's position ignores the common meaning of the term comprising.
Comprising is synonymous with the word containing. MPEP § 2111.03 (91h
ed. Rev. 7, Nov. 2015), citing, Mars, Inc. v. H.J. Heinz Company, L.P., 377
F.3d 1369, 1375 (Fed. Cir. 2004). Thus, the lenses must contain ketotifen
fumarate. Ketotifen fumarate on the surface is not contained in the lens.
The Examiner next argues that the solutions disclosed in Trimming
would contain sufficient ketotifen fumarate and that the ketotifen would
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Application 11/686,979
remain in the eye long enough for the lens to absorb the amounts of ketotifen
recited in the claims. Ans. 6-7. However, as Appellants have demonstrated,
the maximum amount of ketotifen fumarate present in the solution taught by
Trimming would only be about 25 µg. Br. 7-8. Even if the solution were
left in the eye for thirty minutes, the total amount absorbed by the lens
would be below the lower than 9 µg the lower limit of claim 1.
The Examiner's hypothesis that the solution would remain in the eye
for up to thirty minutes has also been rebutted by the Appellants. Appellants
have shown that the fluid in the eye is replenished every two to three
minutes. FF9. This teaches that the solution would be present in the eye for
three minutes or less. As Appellants have demonstrated, this is insufficient
time for the lens to take up 9 µg of ketotifen fumarate. Ans. 9.
Next, the Examiner has found that since blinking is not addressed in
Trimming, blinking has no effect on the teachings of Trimming. Ans. 7.
This ignores the evidence of record. As Appellants have demonstrated, the
average person blinks about fifteen times a minute, limiting the amount of
fluid in the eye to about 10 µ1. Br. 9. As discussed above, this would limit
the amount of ketotifen present in the eye to less than 25 µg, far less than the
amount required to achieve a lens containing between 8 µg and 90 µg as
required by claim 1, the sole independent claim.
Conclusion of Law
We conclude the Examiner has failed to establish by a preponderance
of the evidence that the claims are obvious in view of Trimming as defined
by 35 U.S.C. § 103(a).
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Application 11/686,979
SUMMARY
We affirm the rejection of claims 1and52 under 35 U.S.C. §102(b) as
anticipated by Karlgard. We reverse the rejection of claims 1, 12-13, and
52-54 under 35 U.S.C. § 103(a) as obvious in view of Trimming.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l.136(a).
AFFIRMED-IN-PART
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