Ex Parte Scales et al

Patent Trial and Appeal Board

May 8, 2017

13682677 (P.T.A.B. May. 8, 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.
13/682,677 11/20/2012 Charles W. Scales VTN5317USNP 3433
27777 7590 05/10/2017
JOSEPH F. SHIRTZ
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
EXAMINER
BUCKLEY, AUDREA
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
05/10/2017 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):
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CHARLES W. SCALES, ERIC R. GEORGE, CHRISTOPHER D.
ANDERSON, ROBERT D. GLEIM, and BRENT MATTHEW HEALY1
Appeal 2016-005848
Application 13/682,677
Technology Center 1600
Before ULRIKE W. JENKS, JOHN G. NEW, and RICHARD J. SMITH,
Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a contact
lens. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 According to Appellants, the real party in interest is Johnson & Johnson
Vision Care, Inc. (Appeal Br. 3.)
Appeal 2016-005848
Application 13/682,677
STATEMENT OF THE CASE
Claims on Appeal
Claims 1—9, 11—21, and 32 are on appeal.2,3 (Claims Appendix,
Appeal Br. 18—20.) Claim 1 is illustrative and reads as follows:
1. A contact lens formed from a composition comprising a
plurality of engineered particles having an average particle size
of less than about 500 nm dispersed in a monomer system, each
of the engineered particles comprising a hydrophobic core and a
hydrophilic shell,
wherein the hydrophobic core comprises a silicone-based
polymer comprising multiple cross-links and the
hydrophilic shell is formed from a reactive
stabilizer, wherein a residue of the reactive
stabilizer covalently bonds to the silicone-based
polymer to form the particles; and
wherein the contact lens has a center thickness in the range
of about 50 to about 180 micron and a haze that is
less than 100% as compared to a CSI lens.
Examiner’s Rejections
1. Claims 1—9, 11—16, 19—21, and 32 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Scales.2 3 4 (Ans. 2—5.)
2. Claims 17 and 18 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Scales and Mahadevan.5 (Id. at 6—7.)
2 Claims 10, 22—31, and 33 are withdrawn. (Final Act. 2, dated May 22,
2015.)
3 The species polyethylene glycol is elected as the residue of the reactive
stabilizer. (Response to Restriction Requirement dated Jan. 27, 2015, at 8.)
4 Scales et al., US 2010/0249273 Al, pub. Sept. 30, 2010 (“Scales”).
5 Mahadevan et al., US 2008/0102122 Al, pub. May 1, 2008
(“Mahadevan”).
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Application 13/682,677
FINDINGS OF FACT
We adopt the Examiner’s findings as our own, including with regard
to the scope and content of the prior art. The following findings are included
for emphasis and reference purposes.
FF 1. The Specification states that “[i]t has been found that the use of
reactive stabilizers, such as water-soluble free radical initiators, having
functional end groups and emulsifying capabilities, can result in the
formation of engineered particles of desired properties.” (Spec, f 22.)
FF 2. The Specification states that
[reference to “reactive stabilizer” means a compound that is
capable of reducing the interfacial surface tension between the
continuous phase and discrete phase of two immiscible liquids
and is capable of reaction with the discrete phase components
under the selected polymerization conditions. It has been
surprisingly found that for the engineered particle systems of the
present invention, the reactive stabilizers contain functional
groups provided by a polymeric or oligomeric polymerization
initiator, such as a PEG-functional diazo-macroinitiator
{Id. at f27.)
FF 3. The Specification states that “[reference to ‘core’ means a polymer
that is encapsulated and partitioned from the continuous phase by the shell.”
{Id. at ^28.)
FF 4. The Specification states that “[reference to ‘shell’ means a
hydrophilic layer on the core that provides at least partial and at most
complete surrounding and/or encapsulation of the core. . . . The shell is
covalently bonded to the polymer of the core of the particle.” {Id.)
FF 5. The Specification states that “[reference to ‘dispersed’ means
particles are substantially uniformly distributed in a monomer system such
that there is minimal aggregation of the particles.” {Id. at f 26.)
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Application 13/682,677
FF 6. The Examiner finds that Scales teaches a contact lens formed from a
composition comprising a plurality of engineered particles having a particle
size less than about 500 nm dispersed in a monomer system. (Ans. 2, citing
Scales examples 1—11 and KK 29—31 and 80.)
FF 7. The Examiner finds that Scales teaches that the engineered particles
each comprise a hydrophobic core, comprising a silicone-based polymer
comprising multiple crosslinks, and a hydrophilic shell formed from a
reactive stabilizer, including polyethylene glycol-containing components,
and wherein a residue of the reactive stabilizer covalently bonds to the
silicone-based polymer. (Ans. 2—3, citing Scales ff 34, 37—38, 58, 60, and
74.)
FF 8. Scales teaches the use of water-soluble free radical initiators,
including “VPE-0201 (poly(ethylene glycol) macro initiator MW=2000
g/mole), VPE-0401 (poly(ethylene glycol) macro initiator MW=4000
g/mole), [and] VPE-0602 (polyethylene glycol) macro initiator MW=6000
g/mole).” (Scales ^58.)
FF 9. Scales teaches that
the choice of water-soluble free radical initiator may dictate the
final properties of the particles generated by
emulsion/microemulsion polymerization. For example, if a
hydroxyl- or PEG-fimctional initiator is employed in the
polymerization, the surface properties of the final siloxy-latex
may be modified, leading to controlled surface features, such as
but not limited to, increased surface polarity, hydrophilicity, and
consequently, biocompatibility.
(Scales f 59.)
FF 10. The Specification identifies the use of the following PEG functional
diazo-initiators:
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Application 13/682,677
VPE-0201: 2000 g/mole PEGylated diazo-initiator (PEG
functional diazoinitiator where the PEG has a molecular weight
of 2000 g/mole);
VPE-0401: 4000 g/mole PEGylated diazo-initiator (PEG
functional diazoinitiator where the PEG has a molecular weight
of 4000 g/mole);
VPE-0601: 6000 g/mole PEGylated diazo-initiator (PEG
functional diazoinitiator where the PEG has a molecular weight
of 6000 g/mole).
(Spec. fl9.)
DISCUSSION
We adopt the Examiner’s findings and conclusions as our own, as set
forth in the Final Action (Final Act. 6—10) and Answer (Ans. 2—6). We
discern no error in the Examiner’s rejections. Moreover, we find that the
Examiner has established a prima facie case of obviousness and that
Appellants have not provided persuasive evidence or arguments to overcome
that prima facie case. See In re Oetiker, 977 F.2d 1443, 1445—46 (Fed. Cir.
1992).
Rejection No. 1
Issue
Whether a preponderance of the evidence of record supports the
Examiner’s rejection for obviousness under 35 U.S.C. § 103(a).
Analysis
Claim 1
We begin with claim construction. Claims under examination are
given their broadest reasonable interpretation consistent with the
specification, as interpreted by one of ordinary skill in the art. In re Am.
Academy ofSci. Tech Center, 367 F.3d 1359, 1364 (Fed. Cir. 2004).
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Application 13/682,677
Claim 1 is directed to a contact lens which comprises a plurality of
engineered particles dispersed in a monomer system. Each of the engineered
particles comprises a hydrophobic core and a hydrophilic shell. The core
comprises a silicone-based polymer comprising multiple cross-links. The
shell is composed of a compound (“reactive stabilizer”)6 that includes a
residue (elected species polyethylene glycol (PEG)) covalently bound to the
core. The definitions of core and shell provided by Appellants do not
exclude a hollow particle having an inner layer (core) and outer layer (shell).
(FF 3 and 4.)
The term “reactive stabilizer” is interpreted to mean a compound that
may be a water-soluble free radical initiator (FF 1), and that includes
compounds such as polyethylene glycol diazo-microinitiators VPE-0201,
VPE-0401, and VPE-0601. (FF 2 and 10.) While Appellants refer to the
term “reactive stabilizer” as defined in the Specification by certain
capabilities or properties (Appeal Br. 10; FF 2), a compound that is a
reactive stabilizer (as that term is used in the Specification) will necessarily
have those capabilities or properties. In re Papesch, 315 F.2d 381, 391
(CCPA 1963) (“From the standpoint of patent law, a compound and all of its
properties are inseparable; they are one and the same thing.)
Hydrophobic core
Appellants argue that Scales does not teach or suggest a hydrophobic
core comprising a silicone-based polymer. (Appeal Br. 9-10.) Appellants
refer to the use of the terms “shell” and “core” in Scales and argue that “it
6 Because the claim is to a product (contact lens) rather than a process for
making the product, we construe the phrase “shell is formed from a reactive
stabilizer” as describing the composition of the shell.
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Application 13/682,677
cannot be a reasonable interpretation to conclude an inner hydrophobic layer
of the shell is a core as claimed.” {Id. at 10.) Appellants further argue that
the Examiner has provided “no reasoning as to why the hollow particles
embodiment [of Scales] . . . would have a cross-linked polymer core.” {Id.)
We are not persuaded. Appellants’ definitions of the terms “core” and
“shell” include the inner (hydrophobic) and outer (hydrophilic) structures or
layers as taught by Scales, regardless of whether Scales uses the terms shell
or core in reference thereto. (Ans. 2—3; see discussion, supra.) Moreover,
as explained by the Examiner, Scales’ teachings are not limited to hollow
nanoparticles, and include the use of a silicone-based, cross-linked polymer.
(Ans. 7—8; see, e.g., Scales f26\ “[sjpecific examples include ... [a] cross-
linked poly(dimethylsiloxane) core.”)7 See In re Lamberti, 545 F.2d 747,
750 (CCPA 1976) (a prior art reference is available for all that it discloses
and suggests to one of ordinary skill in the art).
Hydrophilic shell
Appellants argue that Scales does not teach or suggest a hydrophilic
shell formed from a “reactive stabilizer,” referring to the Specification’s
defmition/discussion of reactive stabilizers and the “residue” of the reactive
stabilizer. (Appeal Br. 10-12; Reply Br. 2—3.) In particular, Appellants
argue that the Examiner “has improperly taken disparate parts of the Scales’
publication for its obviousness position.” {Id. at 11.) For example,
Appellants argue that certain polyethylene glycol-containing components
referred to in paragraph 37 of Scales are not reactive stabilizers (nor
identified as being residues of a reactive stabilizer), and that the water-
7 The same compound is identified in paragraph 38 of Scales as an example
of a material from which an inner layer may be formed.
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soluble free radical initiators referred to in Scales are taught in the context of
“a different embodiment from the formation [of] hollow nanoparticles.”
(Id.)
We are not persuaded. As an initial matter, the selection of various
components from the prior art is permissible in an obviousness rejection. See
In reArkley, 455 F.2d 586, 587 (CCPA 1972) (“picking and choosing may
be entirely proper in the making of a 103, obviousness rejection”).
Furthermore, an obviousness analysis “need not seek out precise teachings
directed to the specific subject matter of the challenged claim, for a court
can take account of the inferences and creative steps that a person of
ordinary skill in the art would employ.” KSR Int 7 v. Teleflex Inc., 550 U.S.
398,418 (2007).
Here, Appellants do not explain why the referenced PEG compounds
in paragraph 37 of Scales are not reactive stabilizers, or why they do not
include PEG residues. Moreover, the Examiner establishes Scales’ teaching
or suggestion of the claimed reactive stabilizer and PEG residue by referring
to PEG-containing compounds taught by Scales, and specifically including
VPE-0201, VPE-0401, and VPE-0602 as examples of water-soluble free
radical initiators. (Ans. 3; FF 8.) Furthermore, the selection of the shell
composition from an embodiment in Scales other than the hollow
nanoparticle embodiment is clearly suggested by Scales’ teaching of the
advantages of using water-soluble free radical initiators. (See FF 9; Scales
H58-59.)
Appellants also argue that the Examiner has not shown that Scales
teaches a reactive stabilizer covalently bound to the silicone-based polymer
core. (Appeal Br. 11—12.) We are not persuaded. In considering the
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disclosure of a reference, it is proper to take into account not only specific
teachings of the reference but also the inferences that one skilled in the art
would reasonably be expected to draw therefrom. In re Preda, 401 F.2d
825, 826 (CCPA 1968).
Here, in addition to pointing to the particles of Scales as being capable
of covalently bonding to stabilizing surfactants, the Examiner also
reasonably interprets Scales as teaching or suggesting that the residue of the
reactive stabilizer covalently bonds to the silicone-based polymer (Ans. 3),
and Appellants have not provided persuasive arguments or evidence to the
contrary. Moreover, Appellants state that reactive stabilizers comprising
PEG-fimctional diazo-macro-initiators, at elevated temperatures, produce
hydrophilic free radicals that are referred to as the “residue” of the reactive
stabilizer and “initiate polymerization at the interface of the particle and/or
covalently bond to the particle core.” (Appeal Br. 10-11; Spec, f 27
(emphasis added).) Because Scales also teaches the use of PEG-fimctional
diazo-macro-initiators (FF 8), similar usage of those compounds would have
the same properties and provide a residue that covalently bonds with the
core. See Papesch, 315 F.2d at 391.
Dispersed particles
Appellants argue that Scales does not teach or suggest particles
dispersed in a monomer system. (Appeal Br. 12; Reply Br. 3—4.) In
particular, Appellants argue that Comparative Example 9 in the present
application shows that, in accordance with Examples 12—15 of Scales, the
subject particles “were not miscible with 2-hydroxy ethyl methacrylate
(HEMA)” and that “the particles of Examples 12—15 of Scales are not
dispersible in a monomer system.” (Appeal Br. 12.)
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We are not persuaded. Claim 1 is not limited to a particular monomer
system and, particularly, not limited to the use of HEMA as the monomer
system. Appellants’ Comparative Example 9 is thus not commensurate in
scope with claim 1. See In re Dill, 604 F.2d 1356, 1361 (CCPA 1979) (“The
evidence presented to rebut a prima facie case of obviousness must be
commensurate in scope with the claims to which it pertains.”). Moreover,
Scales teaches dispersed or distributed particles within the monomer system,
which is reasonably interpreted as particles “substantially uniformly
distributed in a monomer system.”8 (Scales fl', FF 5.) See In re Mills, 470
F.2d 649, 651 (CCPA 1972) (holding that “[a]ll the disclosures in a
reference must be evaluated . . . and a reference is not limited to the
disclosure of specific working examples.”) (internal citation omitted).
Claims 2 and 3
Appellants argue that dependent claims 2 and 3 recite that at least
50% by weight (claim 2) or 100% by weight (claim 3) of the hydrophilic
shell is the residue of the reactive stabilizer, which is not taught or suggested
by Scales. (Appeal Br. 12.) We interpret this language as claiming that the
shell is 100% or at least 50% by weight PEG (elected species).
We are not persuaded. The term “residue of the reactive stabilizer”
includes free-radicals that initiate polymerization, and Scales teaches water
soluble free radical initiators such as PEG-functional initiators. (Spec. H 27;
Scales f 59.) The Examiner points to Scales teaching that the outer layer
may be a polymer which can polymerize with itself, thereby comprising up
to 100% of the shell. (Ans. 4, citing Scales f 37.) That is, Scales teaches a
8 See also Scales ^46.
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range greater than 0% and up to 100% by weight may be PEG where PEG is
the residue of the reactive stabilizer. This range overlaps the claimed ranges
of 100% and at least 50%. See In re Peterson, 315 F.3d 1325, 1329 (Fed.
Cir. 2003) (“In cases involving overlapping ranges, we and our predecessor
court have consistently held that even a slight overlap in range establishes a
prima facie case of obviousness.”)
Claim 6
Dependent claim 6 recites, in pertinent part, “wherein the residue of
the reactive stabilizer comprises polyethylene glycol.” (Appeal Br. 18.)
Appellants argue that “residue of the reactive stabilizer” is different from the
claim term “reactive stabilizer,” and focus on the Examiner’s reference to
paragraphs 37 and 38 of Scales, arguing that none of those compounds
delivers a polymerization initiator. {Id. at 13.) We are not persuaded. In
addressing claim 6, the Examiner also points to paragraph 58 of Scales that
expressly teaches the use of polymerization initiators that include PEG
(elected species). (Ans. 3; FF 8.)
Claims 7—9
Dependent claims 7—9 recite that the reactive stabilizer comprises
polyethylene glycol diazo polymers, having a molecular weight that
encompasses one or more of compounds VPE-0201, VPE-0401, and VPE-
0602 taught by Scales as water-soluble free radical initiators (i.e. reactive
stabilizers). (Appeal Br. 18—19; FF 8.) Appellants argue that the Examiner
has failed to establish “why VPE-0201, VPE-0401, and VPE-0602 would be
specifically selected from the numerous choices of possible water-soluble
free radical initiators” set forth in Scales. (Appeal Br. 14.) We are not
persuaded, and find that the Examiner has explained the basis for the
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selection as including the advantages of water-soluble free radical initiators.
(Ans. 3; FF 9.) See also Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d
804, 807 (Fed. Cir. 1989) (“That the [prior art] patent discloses a multitude
of effective combinations does not render any particular formulation less
obvious”).
Unexpected Results
Appellants also argue that the claimed reactive stabilizers provide
unexpected results, referring again to Comparative Example 9 of the
Specification. (Appeal Br. 15—16.) However, unexpected results must also
be shown to be unexpected compared with the closest prior art. In re Baxter
Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991) (citing In re De Blauwe,
736 F.2d 699, 705 (Fed. Cir. 1984)).
Here, while Scales discloses embodiments that include a reactive
stabilizer, Appellants acknowledge that Examples 12—15 of Scales used VA-
044 “which is not a reactive stabilizer as defined by the present invention.”
(Appeal Br. 15.) Moreover, a comparison to Scales Examples 12—15 is not
persuasive because the claims are not limited to HEMA as the monomer
system. (See discussion, supra.)
Appellants also “reiterate that the choice of PEG-functional diazo-
macroinitiators as suitable reactive stabilizers to provide silicone-containing
monomers or reactive macromers that are compatible with hydrophilic
systems is unexpected in light of’ Scales. (Appeal Br. 16.) However, as
discussed above, Appellants have not persuasively established that the
results are unexpected, particularly in light of the teachings and suggestions
of Scales regarding PEG-functional diazo-macroinitiators as suitable
reactive stabilizers. (FF 8 and 9.)
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We find that the Examiner has established a prima facie case of
obviousness and that Appellants’ arguments and evidence of unexpected
results are not sufficient to rebut or overcome that prima facie case.
Accordingly, for the reasons of record and as set forth above, we affirm the
rejections of independent claim 1 and dependent claims 2, 3, 6, and 7—9.
Conclusion of Law
A preponderance of the evidence of record supports the Examiner’s
rejection of claims 1—3, 6, and 7—9. Claims 4, 5, 11—16, 19-21, and 32 were
not argued separately and fall with claim 1.
Rejection No. 2
Appellants argue that claims 17 and 18 “depend directly and indirectly
from claim 1 and are patentable for all the reasons discussed above with
respect to claim 1.” (Appeal Br. 17.) Accordingly, we affirm the rejection
of claims 17 and 18 for the reasons of record and as set forth above in
connection with claim 1.
SUMMARY
We affirm the rejections of all claims on appeal.
We limit this decision to the elected species, and take no position
respecting the patentability of the broader generic claims, including the
remaining, non-elected species.
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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