Ex Parte Gallois-Bernos et al

Patent Trial and Appeal Board

Mar 10, 2017

13495049 (P.T.A.B. Mar. 10, 2017)

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.
13/495,049 06/13/2012 Annabelle Gallois-Bernos VTN5319USNP 9451
27777 7590 03/14/2017
JOSEPH F. SHIRTZ
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
EXAMINER
RICCI, CRAIG D
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
03/14/2017 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):
j nju spatent @ corn s .j nj. com
lhowd@its.jnj.com
pair_jnj @ firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANNABELLE GALLOIS-BERNOS, FRANK F. MOLOCK, Jr.,
CARRIE L. DAVIS, KATHRINE OSBORN LORENZ,
JAMES K. YOUNG, and KRISTY L. CANAVAN
Appeal 2015-0066731
Application 13/495,049
Technology Center 1600
Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
RICHARD J. SMITH, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to an ophthalmic device for
treatment of ocular conditions. The ophthalmic device comprises a
composition comprising: an ester or amide of an anti-inflammatory lipid
mediator. The Examiner rejected the claims as obvious under 35 U.S.C.
§103 and under obviousness-type double-patenting. We have jurisdiction
under 35 U.S.C. § 134. The rejections are affirmed.
1 The Appeal Brief (“Appeal Br.”) 3 lists Johnson & Johnson Vision Care,
Inc., as the real-party-in-interest.
Appeal 2015-006673
Application 13/495,049
STATEMENT OF CASE
Claim 1, the only independent claim on appeal, reads as follows:
1. An ophthalmic device for treatment of ocular conditions, the
ophthalmic device comprising a composition comprising:
an ester or amide of an anti-inflammatory lipid mediator
that is a reaction product of the anti-inflammatory lipid
mediator and a monohydric alcohol or an amine;
wherein the composition is substantially free of the acid
form of the anti-inflammatory lipid mediator.
Claims 1, 2, 4—9, 16—27, and 41—43 stand finally rejected by the
Examiner as follows:
1. Claims 1, 2, A-9, 16-19, 23-27 and 41^13 under 35 U.S.C.
§ 103(a) as obvious in view of Aleo (WO 2010/106571 A2, published
9/23/2010) and Systane (www.systane.com (disclosing SYSTANE®
CONTACTS Lubricant Eyes Drops; available online as of 10/13/2009 as
evidenced by the attached Internet Archive Report). Final Rej. 3.
2. Claims 20-22 under 35 U.S.C. § 103(a) as obvious in view of
Aleo, Systane and Dana (WO 2006/007510 Al, published 1/19/2006). Final
Rej. 6.
3. Claims 1, 2, 4—9, 16—27 and 41—43 are provisionally rejected on
the ground of nonstatutory double patenting as being unpatentable over
claims 1-9, 16-23, 26-27, 29 and 42 of Application No. 13/495,052 (“the
’052 application”), now U.S. Pat. No, 8,865,685 B2, pat. Oct. 21, 2014 (“the
’685 patent”).
2
Appeal 2015-006673
Application 13/495,049
CLAIM INTERPRETATION
Claim 1 is directed to an ophthalmic device for treatment of ocular
conditions. The device “compris[es] a composition.” The composition
comprises: “an ester or amide of an anti-inflammatory lipid mediator that is
a reaction product of the anti-inflammatory lipid mediator and a monohydric
alcohol or an amine.”
The issue in the obviousness rejections is the relationship between the
ophthalmic device and the composition. The only term in the claim which
expressly states the relationship between the two is the term “comprising,”
namely, “the ophthalmic device comprising a composition.” The term
“comprising is a transitional phrase utilized in claims, “which is
synonymous with ‘including,’ ‘containing,’ or ‘characterized by.’” MPEP
§ 2111.03 (Ninth Edition, rev. Nov. 2015). “Comprising” is also “open-
ended” and does not exclude the presence of additional elements in the
composition. Id.; In re Baxter, 656 F.2d 679, 686-87 (CCPA 1981).
Thus, the term “comprising” indicates that the device can contain or
include the composition, but doesn’t define how the relationship is
physically achieved, e.g., whether the composition is: incorporated into the
body of the device or associated with its surface. For further guidance, we
turn to Appellants’ Specification.
Appellants’ Specification discloses:
FF1
Lenses may be packaged with esterified anti-inflammatory lipid
mediators in formulations and/or emulsions or may be hydrated
in such materials as dissolved in appropriate solvent(s), followed
by equilibration of the lens in packing solution.
Spec. 1 82.
3
Appeal 2015-006673
Application 13/495,049
FF2
Aqueous delivery systems are water based systems, which . . .
may be used to condition, store, or clean ophthalmic devices
which are placed in the ocular environment.
Id., 1 84.
FF3
In another embodiment the composition of the present
invention is incorporated into an ophthalmic device such as a
contact lens or, more particularly, a silicone hydrogel contact
lens. In this embodiment the esterified anti-inflammatory lipid
mediators, wherein the majority of the anti-inflammatory lipid
mediator is present in the ester form, may be incorporated into
the lens in a number of ways, including but not limited to
incorporating into the reaction mixture from which the lens is
polymerized, contacting the lens with a solution comprising the
esterified anti-inflammatory lipid mediators either before during
or after packaging.
Id., 194.
Appellants’ Specification, therefore, discloses that the lens can be
packaged (FF1) and stored (FF2) with the composition. When packaged or
stored with the composition, the lens is in contact with the solution and,
thus, can be said to include or comprise it. When the composition is
incorporated into the lens (FF3), the lens comprises the composition because
it is contained within it.
OBVIOUSNESS BASED ON ALEO AND SYSTANE
The Examiner found that Aleo describes an ophthalmic composition
comprising “eicosapentaenoic acid ethyl ester (0.4% by weight) ‘in an
aqueous vehicle containing one or more gelling polymers’ (Abstract)
wherein the composition is free of the acid form of the anti-inflammatory
4
Appeal 2015-006673
Application 13/495,049
lipid mediator (Page 17, Example 1).” Final Rej. 4. While the Examiner
determined that such disclosure in Aleo meets the “composition” limitation
of the claim, the Examiner found that Aleo does not describe an ophthalmic
device comprising the composition. Id. For this feature, the Examiner cited
Systane for its teaching of an ophthalmic aqueous composition, comprising a
gelling polymer hydroxypropyl methylcellulose (one of the same polymers
described in Aleo), that is used for “’moistening of daily and extended
wear’” contact lens “‘while on the eyes’.” Id. The Examiner determined it
would have been obvious to one of ordinary skill in the art “to administer the
ophthalmic aqueous composition containing a gelling polymer taught by
[Aleo] to a patient in need of treatment for dry eye while wearing a contact
lens on the eye with a reasonable expectation of success, resulting in the
instantly claimed device in the process” in view of Systane’s teaching. Id.,
5.
Appellants contend that the skilled worker would not have combined
the cited publication because “the gelling polymer could hinder the active
from getting into the lipid layer; the gelling polymer would provide a barrier
and entrap the active, thus, preventing the lipids on the surface of the eyelid
from extracting the active.” Appeal Br. 6
Appellants also argue that “the composition of Aleo is unsuitable for
use in an ophthalmic device such as contact lenses and punctal plugs
because Aleo’s composition comprises a gelling polymer and a
preservative.” Id., 8 (emphasis omitted).
As evidence, Appellants cited the June 25, 2014 declaration by
Annabelle Gallois-Bemos, Ph.D., Staff Scientist for Johnson & Johnson
5
Appeal 2015-006673
Application 13/495,049
Vision Care, Inc., the assignee of the application in this appeal (“Second
Gallois-Bemos Decl.”).
Gelling polymer
Appellants state there are two mechanisms that are being targeted with
the claimed anti-inflammatory lipid mediator in an ocular device (e.g., a
contact lens):
1) Mitigation of the inflammatory status of the ocular surface
by virtue of the material’s anti-inflammatory property; and
2) Biophysical effect: mitigation of evaporation through the
delivery of the anti-inflammatory lipid mediator material, which
Appellants note is a hydrophobic/lipoidal material, to the lipid
layer of the tear film.
Appeal Br. 9; Second Gallois-Bemos Decl. 17.
Dr. Gallois-Bemos testified that the “biophysical effect of mitigating
tear film evaporation will also reduce desiccative stress-mediated
inflammation because of a more robust/protective tear film.” Second
Gallois-Bemos Decl. | 8. Dr. Gallois-Bemos stated that “a gelling polymer
will impede this process because the anti-inflammatory lipid mediator will
be bound within the gel phase (or entangled within the gel network), and,
thus, will be less likely to freely migrate and interact with the lipid phase of
the tear film where it can strengthen the lipid layer.” Id. As evidence of
this, Dr. Gallois-Bemos cited the Khanal and Millar publication (6
Nanomedicine: Nanotechnology, Biology, and Medicine 707—713 (2010))
for teaching that a “gel-like hydrophilic polymer is more likely to end up in
tear menisci, followed by progressive elimination through the puncta, as can
be predicted from the use of quantum dots to monitor tear film layers
dynamics.” Id., 19.
6
Appeal 2015-006673
Application 13/495,049
Dr. Gallois-Bemos’s testimony is not supported by a preponderance
of the evidence. Dr. Gallois-Bemos states that the gelling polymer will
impede the anti-inflammatory process because the lipid mediator will be
bound by the gel phase and thus “less likely to freely migrate and interact
with the lipid phase of the tear film.” Id., 1 8. However, Dr. Gallois-Bemos
did not provide evidence that the specifically cited gelling polymer,
hydroxypropyl methylcellulose, would impede migration of the claimed
ester. Dr. Gallois-Bemos also states that the anti-inflammatory lipid
mediator would be “less likely” to reach the tear film but doesn’t expressly
say the lipid mediator would not “freely migrate and interact” with the tear
film.
We note that the gelling polymer, hydroxypropyl methylcellulose,
cited by the Examiner in both Aleo and Systane (Final Rej. 4), is also
described in the Specification as a suitable “wetting agent” for its
compositions (Spec. 192). The open-ended claims permit the addition of a
wetting agent, and certain dependent claim recite the presence of one (claims
20, 21). Thus, Dr. Gallois-Bemos’s testimony appears to be inconsistent
with the express disclosure in the Application that wetting agents, including
the specific gelling polymer in Aleo and Systane, are permitted in the
claimed composition.
Dr. Gallois-Bemos also cited the Khanal and Millar publication,
stating “A gel-like hydrophilic polymer is more likely to end up in tear
menisci, followed by progressive elimination through the puncta, as can be
predicted from the use of quantum dots to monitor tear film layers
dynamics.” Second Gallois-Bemos Decl. 19. However, Dr. Gallois-Bemos
did not identify where such teaching can be found in Khanal and Millar.
7
Appeal 2015-006673
Application 13/495,049
The quantum dots utilized in the publication were characterized as
“bioconjugated lipid-coated qdots” and as “Hydrophobic qdots.” Khanal
and Millar 708 (“Application and observation of the qdots”). Dr. Gallois-
Bemos did not explain how a teaching about lipid-coated hydrophobic qdots
is pertinent to a gel-like hydrophilic polymer. Furthermore, Khanal and
Miller suggests using polymers, indicating that a polymer per se is not
prohibited. Id., 712 (“Based on our study, mucoadhesive polymers would be
the most effective drug delivery system, because they would attach to the
mucin layer and remain on the ocular surface for a longer period than other
molecules.”).
Dr. Gallois-Bemos also cited the Matsukawa publication (136 Progr
Colloid Polym Sci 171—176 (2009)) as teaching:
a gellan gum-type or agar-type gel system, the mesh size of the
network, which relates to a hydrodynamic shielding parameter,
acts to restrict the diffusion of molecules. Thus, the diffusion
of an organic molecule such as the alpha linolenic acid ethyl
ester, will be hindered and won't happen fast enough to
overcome gel drop elimination from the ocular surface.
Second Gallois-Bemos Decl. 111.
Matsukawa describes diffusion in gels. Matsukawa, Abstract &
Introduction. Dr. Gallois-Bemos did not identity disclosure in Matsukawa
that teaches that the hydroxypropyl methylcellulose would prevent the
claimed anti-inflammatory lipid mediator from treating an ocular condition.
For example, Dr. Gallois-Bemos did not establish that the mesh size of the
network of hydroxypropyl methylcellulose polymer would limit diffusion of
the lipid mediator. Consequently, Dr. Gallois-Bemos’s testimony does
provide factual evidence for her statement that the polymer in Aleo and
Systane would “impede” the anti-inflammatory lipid mediator and “be less
8
Appeal 2015-006673
Application 13/495,049
likely to freely migrate and interact with the lipid phase of the tear film
where it can strengthen the lipid layer.” Second Gallois-Bemos Decl. 1 8.
Dr. Gallois-Bemos also stated:
polyquaterium-1 is taken up into ionic contact lenses,
e.g.Acuvue2®, PureVision®, and DailiesTotall®, and causes
staining of the contact lenses. Due to the staining, one skilled
in the art would not use Systane® drops with contact lenses.
Id., 12.
First, the claims are not limited to ionic contact lens, but read broadly
on ophthalmic devices, including contact lens made of other materials.
Thus, this argument is not commensurate with the full scope off the claim.
Secondly, the Examiner did not find that Systane’s drops would be
used with the contact lens. Rather, the Examiner determined it would have
been obvious to have utilized Aleo’s composition with a contact lens for dry
eye treatment as suggested by Systane. Final Rej. 5.
Furthermore, as stated by the Examiner,
even if the claims were directed to ionic contact lenses,
Appellant's arguments would actually bolster the basis of the
rejection since one of skill in the art would be further motivated
to use the ophthalmic composition of Aleo et al (as opposed to
Systane) to treat dry eye syndrome and as artificial tears in a
subject wearing contact lenses in an effort to avoid the known
problem of staining caused by the composition of Systane.
Ans. 8.
Dr. Gallois-Bemos also made additional arguments about the
inadequacy of Systane’s disclosure (Second Gallois-Bemos Decl. 113), but
failed to address the fact that the rejection was based on utilizing Aleo’s
composition, citing Systane only for its teaching of using a contact lens. As
stated by the Examiner, it was not disputed by Appellants that Aleo’s
9
Appeal 2015-006673
Application 13/495,049
composition is useful for the treatment of dry eye syndrome and as artificial
tears. Ans. 7.
Appellants generally deny that Systane “does not teach or suggest an
ophthalmic device comprising a composition.” Appeal Br. 11. This
statement is not supported by the evidence in this record. Systane expressly
states that its lubricant eye drops may be used with daily and extended
contact lens. Systane 1. Thus, Systane expressly teaches a lens, which is an
ophthalmic device, and a composition in contact with it (“comprises”).
Claim 2
Claim 2 requires that the ester is present in a therapeutically effective
amount. The Examiner found this limitation met by Aleo. Final Rej. 5
(116). Appellants traverse the rejection of claim 2, but do not identify a
defect in the Examiner’s fact-based reasoning. Appeal Br. 13.
Claims 4—6
Claims 4—6 require that the composition comprise 10%, 5%, and 1%,
respectively, by weight of less of the acid form of the lipid mediator.
Appellants contend that “Aleo also discloses fatty acids themselves and does
not teach or suggest that there should be little to no acid form of the anti­
inflammatory lipid mediator present.” Appeal Br. 14. The Examiner
specifically addressed these limitations in the Final Rejection, finding that
Example 1 of Aleo (at 17) meet such a limitation. Appellants did not
identify a defect in the Examiner’s finding. Consequently, we shall sustain
the rejection.
10
Appeal 2015-006673
Application 13/495,049
Claims 7—8
Claims 7 and 8 require that the ester is present in “the range of about
0.01 % to 5.0 % by weight” and “in the range of about 0.025 % to 0.5 % by
weight” based on the total composition. Appellants contend that Aleo
teaches amounts of ester greater than 5%, with examples greater that 25 wt%
and 50 wt%. Appeal Br. 14. However, the Examiner cited Example 1 of
Aleo as teaching a composition with eicosapentaenoic acid ethyl ester (0.4%
by weight) (“EPA EE”). Ans. 9; Final Rej. 4. Appellants did not address
this example. As found by the Examiner, Example 1 of Aleo discloses a
composition with 0.4 % w/w. Thus, the rejection is supported by a
preponderance of the evidence.
Uptake of composition into the contact lens
Appellants argue that “the Examiner’s Answer has provided no
technical basis for the assertion that adding eye drops to the eye of an
individual wearing contact lenses necessarily results in the uptake of the
composition into the contact lens already present in the eye, and, thus, that
such assertion [is] conclusory at best.” Reply Br. 3.
As discussed in the claim interpretation section, the claims do not
require the composition to be taken up and incorporated into the lens. While
there is an embodiment in which the composition is incorporated into the
lens (FF3), we discerned no language in the claim which would limit the
device to this embodiment. “[W]hile it is true that claims are to be
interpreted in light of the specification and with a view to ascertaining the
invention, it does not follow that limitations from the specification may be
read into the claims.” Sjolund v. Musland, 847 F.2d 1573, 1581 (Fed. Cir.
11
Appeal 2015-006673
Application 13/495,049
1988). “[L]imitations are not to be read into the claims from the
specification.” In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993).
REJECTION BASED ON ALEO, SYSTANE, AND DANA
Dependent claim 20 further requires specific amounts of alpha-
linolenic acid ethyl ester and the wetting agents methyl gluceth-20. Claims
21 and 22 further require additional ingredients, such as vitamin E. The
Examiner rejected the claims as obvious further in view of Dana’s teaching
of methyl gluceth-20 and vitamin E. Final Rej. 6.
Appellants contend that the Examiner did not provide a rational basis
to support the conclusion of obviousness because “compositions of Dana all
comprise acids, not esters. As such, Dana does not teach or suggest the
limitation ‘substantially free of the acid form of the anti-inflammatory lipid
mediator.’” Appeal Br. 16. This argument is not persuasive. The Examiner
relied upon Dana for its teaching of methyl gluceth-20 and vitamin E and
provided a reason to have utilized them in Aleo’s composition. Ans. 10—11.
Appellants did not identify a defect in the Examiner’s reasoning or fact­
finding.
OBVIOUSNESS-TYPE DOUBLE PATENTING REJECTION
The Examiner found that “[t]he ’052 claims embrace the elected
ophthalmic composition comprising alpha linolenic acid ethyl ester and an
aqueous delivery system which is substantially free from acid for
administration to a contact lens and which would necessarily result in the
instantly claimed device.” Final Rej. 8.
12
Appeal 2015-006673
Application 13/495,049
Appellants state the applications were filed on the same day and that a
terminal disclaimer was filed in the ’052 application, which is now the ’685
patent. Reply Br. 6. Appellants argue:
The MPEP [Section 804] states that if both applications are
filed on the same date, the Examiner should determine which
application claims the base invention and which application
claims the improvement (added limitations). The obviousness-
type double patenting rejection in the base application
should be withdrawn without a terminal disclaimer, while
the obviousness-type double patenting rejection in the
improvement application should not be withdrawn without a
terminal disclaimer. (Id., emphasis added).
Reply Br. 5.
We have not been directed to where in M.P.E.P. § 804 the statement is
made that obviousness-type double-patenting rejection on a “base
application” should be withdrawn if a terminal disclaimer in filed in an
“improvement” application.
“The doctrine of double patenting is intended to prevent a patentee
from obtaining a time-wise extension of patent for the same invention or an
obvious modification thereof.” In re Lonardo, 119 F.3d 960, 965 (Fed. Cir.
1997). ). “Obviousness-type double patenting . . . is judicially created and
prohibits an inventor from obtaining a second patent for claims that are not
patentably distinct from the claims of the first patent.” Lonardo, at 965.
With respect to improvement and basic patents, the issue is whether a
one-way test or two-way test is appropriate to determine whether the
application claims under examination are obvious in view of the patent
claims. In re Berg, 140 F.3d 1428, 1431 (Fed. Cir. 1998); In reFallaux, 564
F.3d 1313, 1316 (Fed. Cir. 2009). Neither Berg nor Fallaux require the PTO
to withdraw a rejection if a terminal disclaimer is filed in an improvement
13
Appeal 2015-006673
Application 13/495,049
patent. If the “basic” application claims are broader than the “improvement”
patent claims, it would be inconsistent to withdraw the requirement of a
terminal disclaimer in a later issued “basic” application because that would
mean its broader claims, when granted, would allow the patent owner to
obtain a “time-wise extension” of patent term for an obvious modification of
the earlier granted improvement claims. Rather, the question is whether a
one-way or two-test for would be applied to determine whether the claims of
the application are patentably distinct from the patent claims.
Summary
Rejections 1—3 are affirmed. To the extent claims were not separately
argued, they fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv)
TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
14