Ex Parte Bowman et al

Patent Trial and Appeal Board

May 9, 2018

13345087 (P.T.A.B. May. 9, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/345,087 01/06/2012
20277 7590 05/11/2018
MCDERMOTT WILL & EMERY LLP
The McDermott Building
500 North Capitol Street, N.W.
WASHINGTON, DC 20001
FIRST NAMED INVENTOR
Lyle M. BOWMAN
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.
075538-0435 2901
EXAMINER
BASQUILL, SEAN M
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
05/11/2018 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):
ipdocketmwe@mwe.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LYLE M. BOWMAN and KAMRAN HOSSEINI
Appeal 2016-007081
Application 13/345,087
Technology Center 1600
Before TONI R. SCHEINER, ULRIKE W. JENKS, and
ELIZABETH A. LA VIER, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellants 1 appeal from the
Examiner's decision to reject claims as obvious and on the ground of
nonstatutory obviousness-type double patenting. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
Claims 1, 2, 5-10, 15, 16, and 19-23 are on appeal, and can be found
in the Claims Appendix of the Appeal Brief. Claim 1 is representative of the
1 Appellants identify the real party in interest as InSite Vision Incorporated.
Appeal Br. 3.
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Application 13/345,087
claims on appeal, and reads as follows:
1. A method for extending the comfortable wear-time of a
contact lens comprising:
applying an ophthalmically acceptable solution to a
surface of the contact lens or the eye;
placing the contact lens in the eye,
wherein the ophthalmically acceptable solution is
acceptable for administration directly to the eye and comprises,
an aqueous polymeric suspension having a first viscosity, the
suspension comprising from about 0.1 % to about 6.5% by
weight, based on the total weight of the suspension, of a
carboxyl-containing polymer prepared by polymerizing one or
more carboxyl-containing monoethylenically unsaturated
monomers and less than about 5% by weight of a cross-linking
agent, the weight percentages of monomers being based on the
total weight of monomers polymerized, the carboxyl-containing
polymer having average particle size of not more than about 25
µm in equivalent hydrated spherical diameter, and wherein
upon contact with tear fluid, said solution gels to a second
viscosity which is greater than the first viscosity.
Appeal Br. 19 (Claims Appendix).
Appellants request review of the following grounds of rejection made
by the Examiner:
I. Claims 1, 2, 5-10, 15, 16, and 19-25 under 35 U.S.C. § I03(a) as
unpatentable over Bowman 2 and Vehige. 3
II. Claims 1, 2, 5-10, 15, 16, and 19-25 on the ground of nonstatutory
obviousness-type double patenting over Bowman and Vehige.
2 Bowman et al., US 6,265,444 Bl, issued July 24, 2001 ("Bowman").
3 Vehige, US 5,451,237, issued Sept. 19, 1995.
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I. Obviousness over Bowman and Vehige
The issue is: Does the preponderance of evidence of record support
the Examiner's conclusion that the combination of Bowman's ophthalmic
solution with Vehige solution and reason for applying the solution to a
contact lens would render the claims obvious?
Findings of Fact
FF 1. Bowman teaches that ophthalmic "compositions are formed by
combining the NSAI [(non-steroidal anti-inflammatory)] agent, a
divalent cation source, optionally a polymer, and water." Bowman
9:20-23.
[An] ophthalmic composition as either gel or liquid drops
that contain water insoluble, water-swellable polymers
which release the drug over time; i.e., over one or more
hours. Preferably, the polymer is contained in an amount
of about 0.1 to about 6.5%, more preferably about 0.5 to
about 1.3 % by weight based on the total weight of the
composition. These polymer carriers include lightly
crosslinked carboxycontaining polymers (such as
polycarbophil (NoveonAA-1) or Carbopol®) which
typically have an average dry particle size of not more
than about 50 µm in equivalent spherical diameter, more
preferably not more than 20µm in equivalent spherical
diameter. . . . These non-carboxy containing
comonomers are preferably present in an amount of not
more than 40 wt.%, more preferably Oto 20 wt.%,
based on the total weight of monomers present. The
amount of crosslinker employed is preferably from about
0.01 to 5%, more preferably from 0.1 to 1.0%, based on
the total weight of monomers present. ... A suitable
carboxy-containing polymer system for use in the present
composition is known by the tradename DuraSite®,
containing polycarbophil, which is a sustained release
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Application 13/345,087
topical ophthalmic delivery system that releases the drug
at a controlled rate.
Id. at6:21---60.
FF2. Bowman teaches that ophthalmic compositions
may be formulated so that there is increased gelation
upon contact with tear fluid. For instance, when a
formulation containing DuraSite® is administered to the
eye at a lower pH, the DuraSite® system swells upon
contact with tears. This gelation or increase in gelation
leads to entrapment of the suspended drug particles,
thereby extending the residence time of the composition
in the eye.
Id. at 7:18-24.
FF3. Bowman teaches a preservative system.
The preservative system can used in a variety of aqueous
ophthalmic compositions such as saline solutions for
cleaning contact lenses, as an eye wash, as an eye
lubricating or wetting composition, and as a medicated
composition. The preservative is . . . combined with the
above-described divalent cation containing ophthalmic
composition.
Id. at 9: 14--17.
FF4. Vehige teaches that the lifespan of a contact lens as well as fit and
comfort of the lens depends on proper cleaning. "If contact lenses are
not properly cleaned, lysozyme, mucoproteins and other soils can
accumulate on and/ or in the lens to a point where the lens wearer
begins to feel discomfort. . . . Such soiling decreases the overall
estimated useful lifetime of the lens." Vehige 1:27-35, see id. at
4:29-31 ("the lens is more comfortable to the lens wearer and the
amount of proteins adhering to the lens is noticeably decreased").
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Application 13/345,087
FF5. Vehige teaches ophthahnically safe compositions and methods for
cleaning contact lenses. Id. at 2:43--44. "The lens is soaked in the
solution having the chemical agent for a period of time sufficient to
substantially reduce and/ or inhibit the formation of protein deposits on
and/or in the lens." Id. at 3:13-16. Instead of soaking the lens, the
solution can be rubbed directly onto the lens before placing the lens in
the eye without the need to first rinse the lens. See Id. at 7:29-37
("tear itself will help wash away lysozyme which has been desorbed
from the lens").
FF6. Vehige teaches an ophthalmic solution ranging from pH 6-8.5, with
the preferred pH of 7.4. Id. at 5:28-31. The solution will contain
from 0.01-5% by weight of the chemical agent, with the rage of 0.05-
1 % preferred. Id. at 6:52-57. Vehige teaches that the solution can be
applied directly to the eye as long as the amount chemical agent does
not exceed 1 %. See Id. at 7:38--42 ("If the solution is to be contacted
with the lens while the lens is in the eye it is preferable that the
solution does not contain more than about 1.0% by weight of the
chemical agent").
FF7. Vehige teaches that chitosan is an example of positively charged
chemical agent for use in the ophthalmic solution. See Id. at 3 :43--44
("positively charged chemical agent selected from the group
consisting of basic polymeric carbohydrates, such as chitosan, and
mixtures thereof'); see also id. at 8:42--48.
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Principle of Law
"If the claim extends to what is obvious, it is invalid under§ 103."
KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007). "Obviousness does
not require absolute predictability of success .... For obviousness under
§ 103, all that is required is a reasonable expectation of success." In re
O'Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988).
Analysis
The Examiner finds that "Bowman describes ophthalmic
compositions and methods of treating the eyes by the topical application of
an aqueous gel or liquid containing between 0.1-6.5% water insoluble, water
swellable polymers such as the DuraSite polycarbophil polymers." Ans. 3;
FF 1-FF3. The Examiner finds that Bowman teaches various uses for the
aqueous compositions including "but not limited to the contact lens solution,
eye washes, and lubricating eye drops." Ans. 4; FF3. The Examiner
acknowledges that "Bowman does not specifically advocate the use of such
compositions as suitable for 'extending the comfortable wear-time of a
contact lens,' nor is the inclusion of positively charged chitosan specifically
recited." The Examiner relies on Vehige for these teachings. Ans. 4--5;
FF4-FF7.
The Examiner concludes that it would have been
obvious to one having ordinary skill in the art at the time of the
instant invention to have incorporated each of propylene glycol
and positively charged chitosan in amounts of about 0.01 %
into the 0.1-6.5% polycarbophil ophthalmic solutions of
Bowman and used these [ combined] ophthalmically acceptable
contact lens treating solutions in the manner claimed.
Ans. 5---6.
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We agree with the Examiner that it would have been obvious to
combine two solutions, each of which is taught in the art to be useful for
administering directly to the eye (FF1-FF3, FF6), to arrive at a solution that
is useful for the purpose treating contact lenses as taught by Vehige (FF5-
FF7). See In re Kerkhoven, 626 F.2d 846,850 (CCPA 1980). The
combination flows logically because each solution has been taught in the art
to be applied either directly to the eye or indirectly by applying the solution
to a contact lens before placing the contact lens into the eye. FF1-FF3, FF6.
We also agree with the Examiner that "[t]he skilled artisan
knowledgeable of each of the teachings of Bowman and Vehige, would
therefore expect that the inclusion of the chitosan and propylene glycol ...
into the solutions of Bowman, would improve the comfort of contact lens
wearers in the manner which has been claimed." Ans. 6. 4 Here, Vehige
teaches that improperly cleaned contact lenses eventually cause discomfort
to the lens wearer due to the protein adhering to the lens. FF4. Vehige
teaches that the application of solutions containing a chemical agent, such as
4 We note that the Answer as well as the Final Office Action mailed May 10,
2016 ("Final Act.") mentions a "Hong" reference. See Ans. 6; see Final
Act. 7. Generally, "[ w ]here a reference is relied on to support a rejection,
... there would appear to be no excuse for not positively including the
reference in the statement of rejection." In re Hoch, 428 F.2d 1341, 1342
n.3 (CCPA 1970). In this case, however, other than mentioning Hong once
in the Answer, we do not agree with Appellants' position that Hong is being
relied upon in formulating the rejection. Appeal Br. 3; Reply Br. 4.
Appellants have not directed us to teachings found only in Hong that were
necessary in formulating the rejection. On this record, it appears that the
inclusion of Hong in the Answer and Final Action is a typographical error,
as a remnant of an earlier rejection. Accordingly we are not persuaded by
Appellants' contention that the inclusion of Hong is a reversible error.
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Application 13/345,087
positively charged chitosan, can help displace protein deposits on the lens,
resulting in increased comfort to the wearer. See FF4--FF7. Based on these
teachings in Vehige we agree with the Examiner's conclusion that the
combination of Bowman's and Vehige's solutions would similarly improve
the comfort of a contact lens to the wearer. See Ans. 6. The prior art cited
by the Examiner provides a sufficient basis to conclude that there is a
reasonable expectation of success that the solution taught in Bowman and
Vehige could be combined to provide the third solution that would increase
the comfort of a contact lens in addition to extending the lifetime of the lens.
FF4; see O 'Farrell, 853 F.3d at 903---04.
Appellants contend: ( 1) that the Examiner has failed to provide an
articulated rationale to support a conclusion of obviousness (Reply Br. 3);
(2) Bowman does not suggest using solutions as contact cleaning solution,
citing the Bowman Declaration5 in support (see Appeal Br. 5-8); and
(3) Vehige teaches away from the claimed method (Appeal Br. 12) because
"Vehige suggests that chitosan does not act as an agent to remove deposits."
Reply Br. 6.
We are not persuaded. The Examiner reasoned that based on the
teachings of Vehige one of ordinary skill would "expect that the inclusion of
the chitosan and propylene glycol, ... into the solutions of Bowman, would
improve the comfort of contact lens wearers in the manner which has been
claimed." Ans. 6. We agree with the Examiner that it would have been
obvious to combine two solutions which were each taught in the art to be
compatible for application to the eye to formulate a third solution that would
5 Declaration under 3 7 CPR § 1.13 2 by Dr. Lyle M. Bowman signed
Sept. 15, 2015 ("Bowman Dec.").
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Application 13/345,087
similarly be compatible for application to the eye. Ans. 6; see FF1-FF7.
The benefit of cleaning the lenses with the positively charged chemical
agents to improve the comfort to the wearer as taught in V ehige and would
reasonably be expected to similarly function once the solutions are
combined as proposed by the Examiner. Accordingly, we are not persuaded
by Appellants' contention that the Examiner has not articulated a rationale to
combine the references.
Appellants contend that Bowman teaches three "separate and distinct
solutions." Bowman Dec. ,r 9; see Appeal Br. 8-9. "The fact that Bowman
'444 discloses its preservative systems can be used in combination with
other solutions does not mean the preservative system itself has the functions
of the other solutions it can be combined with." Bowman Dec. ,r 14.
We are not persuaded. The Examiner's position is, and we agree, that
the discussion of intent with respect to the three separate and distinct
solutions as presented in the Bowman Declaration is not persuasive because
this does not take into account all the teachings of the reference, including
teaching that the preservative may be combined with the divalent cation
containing compositions. See Ans. 8-9 (citing In re Pio, 217 F.2d 956
(CCPA 1954)); FF3. "Appellants['] argume[n]ts concerning the utility of
such preservative systems when used alone as lacking the ability to provide
the functions of compositions it could preserve is beside the point." Ans. 9.
Appellants do not provide support for the position that the inclusion of a
preservative with the anti-inflammatory active would render that solution
inoperative. We are not persuaded by Appellants' contention that the
Examiner did not consider the Bowman Declaration. Here, the record
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sufficiently supports that the Examiner considered the Bowman Declaration
but found it unpersuasive.
Finally, we are also not persuaded by Appellants' contention that
Vehige teaches away from the claimed method. See Appeal Br. 12 ("There
is no realistic reason why one of ordinary skill in the art would have
replaced the carboxyl-containing polymer of the claimed methods for the
'positively charged chemical agent' of Vehige."). This argument does not
take into account the Examiner's position that Bowman's solution and
Vehige's solution can be combined. In other words, the Examiner's
rationale for arriving at the claimed ophthalmic solution is not by
substituting one element for another. Additionally, as noted by the
Examiner, Vehige teaches that by "preloading contact lens polymers with
non-irritant positively charged polymers such a[s] chitosan, the uptake of
alternative and irritant positively charged compounds present in the ocular
environment is prevented or inhibited, and it is this displacement effect
which provides increased contact lens comfort." Ans. 10. Therefore,
notwithstanding Appellants' contention to the contrary, the evidence of
record fails to support a conclusion that Vehige teaches away from its
combination with Bowman.
We conclude that the evidence cited by the Examiner supports a prima
facie case of obviousness with respect to claim 1, and Appellants have not
provided sufficient rebuttal that outweighs the evidence supporting the
Examiner's conclusion of obviousness. As Appellants do not argue the
claims separately, claims 2, 5-10, 15, 16, and 19-23 fall with claim 1.
37 C.F.R. § 41.37 (c)(l)(iv).
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Application 13/345,087
Claim 24 and 25
Appellants contend that "V ehige does not teach or suggest that
chitosan or its derivative is an agent for cleaning a contact lens and thereby
improving comfort." Appeal Br. 13. "V ehige discloses that chitosan and
chitosan derivatives can be used 'in combination with' 'positive chemical
agents' taught for cleaning contact lenses, not that chitosan or its derivatives
are themselves such agents." Id.
We are not persuaded. The law does not require that the teachings of
the reference be combined for the reason or advantage contemplated by the
inventor, as long as some suggestion to combine the elements is provided by
the prior art as a whole. In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992);
In re Kronig, 539 F.2d 1300, 1304 (CCPA 1976).
The claims are not limited to a single chemically active agent and
include multiple active agents for the purpose of cleaning a contact lens.
Vehige teaches reducing surface deposition of proteins from the contact lens.
[To] reduce, inhibit and/or reverse the formation of protein
deposits on the surface and/ or in the inner bulk matrix of a
contact lens by contacting the contact lens with certain specific
chemical agents. In one preferred embodiment of the Powell et
al. method [incorporated by reference6], the contact lens is
contacted with a positively charged chemical agent selected
form the group consisting of basic polymeric carbohydrates,
such as chitosan, and mixtures thereof. This treatment step can
be preceded by a step involving contacting the lens with a
hypotonic solution for a time sufficient to cause the lens to
swell and the pores of the lens to expand. Powell et al. thus
provide highly effective methods for reducing, inhibiting and/or
reversing protein deposition on and in contact lenses.
6 Vehige 2:66-68 ("U.S. patent application Ser. No. 07/986,959, to Powell et
al., which is incorporated herein by reference").
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Application 13/345,087
Vehige 3:36-50; see FF7. These teachings in Vehige provide an adequate
basis to conclude that chitosan, or derivatives thereof, can act to reduce protein
deposition and adhesion to a contact lens.
Insofar as Appellants' arguments are directed to the amount of
chitosan necessary for keeping the carboxyl containing polymer suspended,
we are also not persuaded. Vehige teaches that the chemical agent, which
can contain chitosan, is present in the solution in a range form 0.01-5% by
weight. FF6. There is no requirement that the art recognize the benefit of
keeping the polymer suspended. Here, there is a reason to add chitosan in
the requisite amounts to Vehige's solution, which can then reasonably be
combined with Bowman's solution. Thus, the result of keeping the polymer
suspended in the combined solutions flows naturally from the mixing of the
individual solutions.
Accordingly, we find no error with the Examiner's conclusion that the
combination of references renders claim 24 and 25 obvious.
II. Nonstatutory obviousness-type double patenting
The issue is: Does the preponderance of evidence of record support
the Examiner's conclusion that the combination of Bowman's ophthalmic
solution with Vehige's solution and reason for applying the solution to a
contact lens would render the claims obvious?
Findings of Fact
FF8. Bowman's claim 1 is reproduced below:
1. An ophthalmic composition comprising an aqueous
medium containing an effective amount of a non-
steroidal anti-inflammatory agent, wherein from about
80 mol. % to less than 100 mol. % of said agent is in the
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Application 13/345,087
form of a precipitate, and at least about 0.5 mole
equivalents of a pharmacologically acceptable divalent
cation per mole of said non-steroidal anti-inflammatory
agent precipitate, said aqueous medium having a pH in
the range offrom 4.0 to 6.7.
FF9. Bowman's claim 14 is reproduced below.
14. The composition according to claim 13 [and
ultimately from claim 1 ], wherein said polymer is a
polycarbophil.
FFlO.Bowman's claim 21 reproduced below.
Analysis
21. A method for treating an eye, which comprises
administering to an eye in need thereof an effective
amount of the composition according to claim 1.
Appellants contend that "[ n Jo where do the claims of the Bowman
'444 patent suggest 'placing a contact lens in the eye' as required by claims
1 and 15." Appeal Br. 16.
We are not persuaded. Appellants err in attacking the references
individually, as the rejection is based on a combination of references. See In
re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986). The references
cannot be read in isolation, but for what they teach in combination with the
prior art as a whole. See id.
The Examiner explains that Bowman's claims teach treating the eye
with a composition that includes an anti-inflammatory agent that can
additionally encompass polycarbophil. Ans. 6-7; FF8-FF10. The Examiner
acknowledges that Bowman's claims do not recite treating a contact lens or
improving comfort of the contact lens to the wearer. Ans. 7. The Examiner
relies on Vehige for teaching these limitations.
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We agree with the Examiner that the combined solution of Bowman
and Vehige can reasonably be applied to the eye. See FF4-FF10. Vehige
explains that the improvement of the comfort of a contact lens by the wearer
is based the positively charged chemical agent binding the lens matrix. See
Vehige 7: 1-8 ("the positively charged chemical agent to be sorbed by the
lens, including in the lens matrix. . . As a result, when the contact lens is
first placed in the eye, the lysozyme in the eye will ... have fewer sites to
which to bind"). It is the combination of Bowman's claimed composition
(FF8-FF10) that is cable of being applied to the eye combined with
Vehige's composition (FF4-FF7) that can also be applied directly to the eye
that renders obvious a composition containing both solutions that would also
be capable ofbeing applied to the eye. See Kerkhoven, 626 F.2d at 850.
The improvement in the comfort of the contact lens to the wearer is a result
of including Vehige' s solution that contains the positively charged chemical
agent in a range of 0.01-5% by weight. FF4-FF7.
Accordingly, we affirm the rejection of claim 1 over the combination
of Bowman and Vehige. Claims 2, 5-10, 15, 16, and 19-23 were not
separately argued and fall with claim 1.
Claims 24 and 25
Appellants contend that "[ n Jo where do the claims of the Bowman
'444 patent suggest applying an ophthalmically acceptable solution
including a carboxyl-containing polymer and 'further compris[ing] a
sufficient amount of a positively charged chitosan allowing said carboxyl-
containing polymer to remain suspended' as required by claims 24--25."
Appeal Br. 1 7.
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We are not persuaded. V ehige teaches that the chemical agent, which
can contain chitosan, is present in the solution in a range form 0.01-5% by
weight. FF6. There is no requirement that the art recognize the reason or
benefit of keeping the polymer suspended. See Beattie, 974 F.2d at 1312.
Here, there is a reason to add chitosan in the requisite amounts to Vehige 's
solution, in this case to inhibit or reverse protein deposition on the contact
lens. FF5. Vehige's solution can be combined with Bowman's solution to
form a third solution and the result of keeping the polymer suspended in this
combined solution flows naturally from the formation of the third solution.
Accordingly, we find no error with the Examiner's conclusion that the
combination of references renders claims 24 and 25 obvious.
SUMMARY
We affirm the rejection of claims 1, 2, 5-10, 15, 16, and 19-25 under
35 U.S.C. § 103(a) over Bowman and Vehige.
We affirm the nonstatutory obviousness-type double patenting
rejection of claims 1, 2, 5-10, 15, 16, and 19-25.
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. § 1.136(a).
AFFIRMED
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