Ex Parte No Data

Board of Patent Appeals and Interferences

Jul 31, 2007

90005090 (B.P.A.I. Jul. 31, 2007)

The opinion in support of the decision being entered today is not binding
precedent of the Board.

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte RUSSELL A. NEEFE

Appeal 2007-1366
Application 90/005,090
Technology Center 1700
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Decided: July 31, 2007
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Before RICHARD E. SCHAFER, TEDDY S. GRON and
ADRIENE LEPIANE HANLON, Administrative Patent Judges.

SCHAFER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Patentee appeals from the final rejection of Claim 1 in the
reexamination of Patent 4,306,042. 35 U.S.C. §§ 134 and 306. We have
jurisdiction. 35 U.S.C. § 6(b).
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An examiner rejected Claim 1 under 35 U.S.C. § 103(a) as
unpatentable over the combined teachings of Quaal,1 Gaylord2 and Tanaka.3

1 US Patent 3,377,371.
2 US Patent 4,120,570.
3 US Patent 4,235,985.
Appeal 2007-1366
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We affirm.
FINDINGS OF FACT
Claimed Subject Matter
F. 1. Patentee claims a method of making an oxygen permeable contact
lens material.
F. 2. The method includes the step of copolymerizing certain comonomers
in the presence of a free radical or photo initiator.
F. 3. These comonomers are
(1) 5-90 weight percent of a specific siloxanyl alkyl ester;
(2) 3-90% of an ester of acrylic or methacrylic acid;
(3) 0.05%-90% of a surface wetting agent and
(4) an oxygen permeable multifunctional siloxanyl alkyl ester
cross-linking agent.

F. 4. The specific siloxanyl alkyl ester monomer is 1,1,1
tris(methylsiloxy)methacryloxypropylsilane (hereinafter TRIS), a
known siloxanyl alkyl ester having a known use in contact lens
materials.
F. 5. In addition to the copolymerization step, Claim 1 also specifies the
process for making TRIS.
F. 6. The specified steps for making TRIS include:
(1) mixing specified amounts of
methacryloxypropyltrimethoxysilane (MAS) and
trimethylchlorosilane (TMCS),
(2) adding this mixture to a specified amount of water,
(3) agitating this second mixture for a specified time,
(4) allowing the mixture to separate,
(5) removing and filtering the upper most layer and
(6) subjecting the removed material to vacuum distillation.

F. 7. Patentee’s Claim 1 is reproduced below:
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1. A method of making an oxygen permeable material for
the manufacture of contact lens by the synthesization of the
monomer 1,1,1 tris(methylsiloxy)methacryloxypropylsilane (a
siloxanyl alkyl ester) by the following procedures:
(a) a mixture is prepared having the relationship of
one mole of methacryloxypropyltrimethoxysilane with
three to forty moles of trimethylchlorosilane;
(b) the mixture is then added to water whose volume
is from 3 to 10 times that of the mixture;
(c) agitation is maintained for 30 minutes to 48 hours;
(d) then allow the mixture to separate into layers,
remove and filter the upper organic layer;
(e) the unwanted by-product (hexamethyldisilane) is
then removed by vacuum distillation;
(f) forming an oxygen permeable contact lens material
by copolymerizing from
5% to 90% by weight of the 1,1,1 -
tris(trimethylsiloxy)methacryloxy-
propylsilane prepared above;
3% to 90% by weight of an ester of acrylic or
methacrylic acid;
from 0.05% to 90% by weight of a surface wetting
agent,
from 0.01% to 90% by weight of an oxygen
permeable crosslinking agent selected from
the class of multifunctional siloxanyl alkyl
esters
in the presence of a free radical or a photo initiator.
Gaylord
F. 8. Gaylord relates to methods of making oxygen permeable contact lens
materials.
F. 9. Gaylord teaches forming a contact lens material by copolymerizing
specified comonomers in the presence of a free radical initiator.
Gaylord, 1:52-56, 4:32-38
F. 10. The comonomers may include
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(1) 10-70% by weight of siloxanyl alkyl ester (Gaylord,
4:14-16);
(2) 30-90% by weight acrylic or methacrylic acid ester
(Gaylord, 4:14-16);
(3) 0.01-10% of a surface wetting agent (Gaylord, 5:39-46); and
(4) 0.01%-2% a cross-linking agent (Gaylord, 6:3-12.)

F. 11. Gaylord teaches TRIS as a preferred siloxanyl alkyl ester. Gaylord,
Examples 1-7 and 22-23.
F. 12. Gaylord characterizes the described contact lens materials as having
“vastly increased oxygen permeability” as compared to
“conventional” contact lens materials. Gaylord, 4:57-59.
F. 13. Gaylord describes cross-linking agents including “polyol acrylic
ester[s] of higher functionality.” Gaylord, 6:3-12.
Diffferences Between Gaylord and the Claimed Invention
F. 14. Patentee characterizes his invention as “an improvement over the
Gaylord method of making contact lens materials.” Neefe
Declaration, filed January 19, 2001, p. 1, ¶ 2.
F. 15. Patentee states: “My invention was to substitute an oxygen-
permeable crosslinker for the impermeable EGDMA used in the prior
art.” Neefe Declaration, filed January 19, 2001, p. 2, ¶ 5.
F. 16. Gaylord does not teach the use of an oxygen permeable crosslinking
agent selected from the class of multifunctional siloxanyl alkyl esters.
F. 17. Gaylord does not teach the specific method of making TRIS required
by Patentee’s Claim 1.
Tanaka
F. 18. Tanaka relates to oxygen permeable copolymers for use in contact
lens materials and methods for forming those materials.
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F. 19. Tanaka notes the importance of oxygen permeability of contact lens
materials. Tanaka, 1:6-10.
F. 20. Tanaka notes that the utilization of comonomers having an alkylsiloxy
group is an available means of increasing oxygen permeability.
Tanaka, 2: 60-63.
F. 21. Tanaka describes methods of making crosslinked oxygen permeable
contact lens materials by copolymerization of certain specific
comonomers.
F. 22. Tanaka teaches that the copolymers may be crosslinked in a
conventional manner using a cross-linking agent added to the mixture
prior to polymerization. Tanaka, 2:30-31, 7: 59-8:2.
F. 23. Tanaka says cross-linking agents of the type conventionally used in
cross-linking vinyl monomers may be employed. Tanaka, 8: 2-10.
F. 24. Tanaka also teaches that multifunctional siloxyanyl alkyl ester cross-
linking agents may be substituted for the conventional cross-linking
agents conventionally used in polymerization of vinyl monomers.
Tanaka 8:2-10.
F. 25. Tanaka also teaches that the preferred cross-linking agents are
multifunctional monomers having siloxane bonds. Tanaka, 8:10-12.
F. 26. The preferred multifunctional monomers disclosed are multifunctional
siloxyanyl alkyl esters having a siloxane bond corresponding to
specified formulas referred to as Formulas [V] and [VI].
Tanaka, 8: 11-34.
F. 27. Tanaka says these are preferred because the siloxane bonds provide
high oxygen permeability to the cross-linked copolymer:
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Since these cross-linking agents of the general formulas
[V] and [VI] have siloxane bonds in their molecules, the
oxygen permeability of the obtained cross-linked
copolymers is high and, therefore, they are preferably
employed in the present invention.
Tanaka, 8:35-39.
F. 28. One having ordinary skill in the art would have understood Tanaka to
teach that the preferred multifunctional siloxyanyl alkyl ester cross-
linking agents contribute to the oxygen permeability of the contact
lens material. Tanaka, 8:35-39.
Quaal
F. 29. Quaal relates to the formation of “tris-siloxy acrylic silanes,” having
the general formula (R3SiO)3Si-R’-OOCC(R”)=CH2.
F. 30. Quaal teaches a general method of forming these silanes by the
cohydrolysis of (1) compounds having the formula
CH2=C(R”)COO-R’-SiX3 with (2) an excess amount of compounds
represented by R3SiX. Quaal, 1:25-28.
F. 31. R, R’, R” and X are each defined as a variety of moieties.
Quaal, 1:16-36.
F. 32. TRIS, MAS and TMCS are compounds meeting Quaal’s general
formula and the formulas for the two reactants, respectively.
F. 33. TRIS has the formula ((CH3)3SiO)3Si-(CH2)3-OOCC(CH3)=CH2 and
meets Quaal’s definitions of R, R’ and R” where R is methyl (-CH3),
R’ is the alkylene -(CH2)3-, R” is methyl (-CH3).
F. 34. MAS has the formula CH2=C(CH3)COO-(CH2)3-Si(OCH3)3 and meets
Quaal’s definitions of R’, R” and X where R’is the alkylene -(CH2)3-,
R” is methyl (-CH3), and X is methoxy (-(OCH3)).
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F. 35. TMCS has the formula (CH3)3SiCl and meets Quaal’s definitions of R
and X where R is methyl (-CH3) and X is Cl.
F. 36. Quaal teaches that the cohydrolysis is preferably carried out in a
water-solvent mixture but the solvent is characterized as “not essential
to the process.” Quaal, 1:55.
F. 37. Quaal also teaches that the amount of water is not critical but should
be sufficient to allow the reaction to proceed at a satisfactory rate.
Quaal, 1:51-53.
F. 38. Quaal’s Example 1 describes a method of making TRIS. Quaal 2: 3-
33.
F. 39. Quaal’s Example 1 describes the cohydrolysis of MAS, TMCS and a
third compound (CH3)3SiOCH3 to form TRIS. Quaal, Example 1,
2:4-30.
F. 40. (CH3)3SiOCH3 is also a compound having the formula R3SiX meeting
Quaal’s definitions of R and X.
F. 41. A mixture of MAS, TMCS, and (CH3)3SiOCH3 is added to a mixture
of water and ether and stirred overnight. Quaal, Example 1, 2:12-17.
F. 42. The mole weight of MAS is 248 grams.
F. 43. The mole weight of TMCS is 108 grams.
F. 44. The mole ratio of MAS (248 grams) to TMCS (325.5 grams) in the
mixture is 1:3.0.
F. 45. The water was removed using a separatory funnel. Quaal, 2: 17-19.
F. 46. The remaining layer was washed and subject to vacuum drying and
vacuum distillation to obtain TRIS. Quaal, 2: 25-28.
F. 47. The TRIS was apparently reasonably pure as indicated by the
comparison of the theoretical percentages of C, H and Si with the
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percentages that resulted from actually carrying out the process
described in Example 1. Quaal, 2:31-33.
F. 48. Quaal’s Example 4 identifies a number of different silane
cohydrolysis combinations and their resulting products. Quaal, Table,
columns 3-4.
F. 49. One having ordinary skill in the art would have understood that Quaal
describes a general technique for forming a variety of tris-type silanes,
including TRIS.
The Level of ordinary skill in the art
F. 50. The person having ordinary skill in the art was aware of the reasons
for and desirability of high oxygen permeability in contact lens
materials.
F. 51. The person of ordinary skill in the art would have fully understood the
copolymerization chemistry used to make contact lens materials
including the mechanism involved in cross-linking.
F. 52. One having ordinary skill in the art would have understood that cross-
linking takes place through unstaturated ethylenic bonds (=CH2).
F. 53. The person having ordinary skill in the art would also have
understood and been familiar with the processes and chemistry for
making the comonomers that are copolymerized in making contact
lens materials.
F. 54. One having ordinary skill in the art would have been familiar with the
properties of TRIS and the chemistry necessary to make it.
ISSUES
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A preliminary issue is whether Claim 1 should be given a broad
construction leaving the claim open to components in addition to those
specifically recited.
The overall patentability issue is whether Patentee has demonstrated
that the Examiner’s decision that the subject matter of Claim 1 would have
been obvious is erroneous. There are three sub issues: (1) whether Gaylord,
Tanaka and Quaal are analogous art; (2) whether Gaylord, Tanaka and Quaal
are properly combinable; and (3) whether patentee has provided evidence of
secondary considerations sufficient to prove non-obvioiusness.
PRINCIPLES OF LAW
Claim Construction
Patent claims involved in a reexamination are ordinarily given the
broadest reasonable construction. In re Yamamoto, 740 F.2d 1569, 1571,
222 USPQ 934, 936 (Fed.Cir. 1984) (in banc). However, a narrowed
construction is appropriate where the patent has expired. Ex parte Papst-
Motoren, 1 USPQ2d 1655, 1656 (BPAI 1986).
Obviousness
In evaluating obviousness under 35 U.S.C. § 103(a), the scope and
content of the prior art is determined, the differences between the prior art
and the claims are to be ascertained and the level of ordinary skill resolved.
Graham v. John Deere Co., 383 U.S 1, 15 (1966). The combination of
familiar elements according to known methods is likely obvious when the
combination does no more than the predictable results. KSR Int’l Co. v.
Teleflex Inc., 127 S. Ct. 1727, 1739 (2007). The obviousness inquiry asks
whether the improvement is more than the use of prior art elements
according to their established functions. KSR, 127 S.Ct. at 1740. Secondary
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considerations may also be considered to illuminate the circumstances
surrounding the origin of the invention. Graham, 383, U.S. at 17-18.
Analogous Art
Analogous art includes references which are in the field of the
applicant's endeavor or are reasonably pertinent to the problem with which
the inventor was concerned. In re Kahn, 441 F.3d 977, 986-87. 78 USPQ2d
1329, 1336 (Fed. Cir. 2006). The hypothetical person having ordinary skill
in the art is presumed to be aware of all prior art in the field of the invention.
In re Rouffet, 149 F.3d 1350, 1357, 47 USPQ2d 1453, 1457 (Fed. Cir.
1998).
Combining Teachings
Obviousness may be shown from the interrelated teachings of
multiple patents. However, there must be a reason to combine the prior art
elements in the way claimed. KSR 127 S.Ct. at 1741. In other words, there
must be “some articulated reasoning with some rational underpinning to
support the legal conclusion of obviousness.” KSR, 127 S.Ct. at 1741,
quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed.Cir.
2006). However, the obviousness analysis does not require that the prior art
include precise teachings as to the subject matter of the claimed invention.
Inferences and creative steps that a person of ordinary skill in the art would
take may be considered. KSR, 127 S.Ct. at 1741. Under the analysis any
need or problem known in the field of endeavor at the time of the invention
and addressed by the prior art can be a basis to combine the teachings of the
references. KSR, 127 S.Ct. at 1741. However when the prior art teaches
away from combining certain known elements, discovery of a successful
means of combining them is more likely to be nonobvious. KSR, 127 S.Ct.
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at 1740. A prior art reference may be considered to teach away when “a
person of ordinary skill, upon reading the reference, would be discouraged
from following the path set out in the reference, or would be led in a
direction divergent from the path that was taken by the applicant.” In re
Gurley, 27 F.3d 551, 553, 31 USPQ2d 1130, 1131 (Fed.Cir. 1994). But, a
statement that a particular feature is not preferred does not teach away
absent clear discouragement of that combination. Syntex (USA) LLC v.
Apotex Inc., 407 F.3d 1371, 1380, 74 USPQ2d 1823, 1830 (Fed. Cir. 2005).
Secondary Considerations
“Such secondary considerations as commercial success, long felt but
unsolved needs, failure of others, etc., might be utilized to give light to the
circumstances surrounding the origin of the subject matter sought to be
patented. As indicia of obviousness or nonobviousness, these inquiries may
have relevancy.” Graham, 383 U.S. at 18. Secondary considerations such
as commercial success, long felt need, and copying by others must be proved
with clear and convincing evidence. In re Snow, 471 F.2d 1400, 1404,
176 USPQ 328, 331 (CCPA 1973); In re Miegel, 404 F2d 378, 381159
USPQ 716, 717 (CCPA 1968); In re Heyna, 360 F2d 222, 228, 149 USPQ
692, 697 (CCPA. 1966); In re Lohr, 317 F.2d 388, 137 USPQ 548, 550-551
(CCPA 1963). To show unexpected results, a comparison of the invention
with the prior art must be under identical conditions except for the novel
features of the invention. In re Brown, 459 F.2d 531, 535, 173 USPQ 685,
689 (CCPA 1972).
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Analysis
Claim construction
In distinguishing certain portions of the prior art, Patentee argues that
the process of Claim 1 prepares TRIS from only two reactants, MAS and
TMS. Reply Brief filed June 16, 2003, pp 4-5: Reply Brief in Response to
Supplemental Examiner’s Answer filed September 9, 2005, pp. 6-7, footnote
1, pp. 14-15. Patentee also distinguishes the claimed subject matter from the
prior art by arguing that the claimed process does not include the use of a
water-solvent mixture. Reply Brief in Response to Supplemental
Examiner’s Answer filed September 9, 2005, pp. 18-19, n. 9. We
understand Patentee’s position to be that the literal scope of the mixture
employed to form TRIS in Claim 1 is limited to the mixture of MAS and
TMCS and the inclusion of different or additional silanes is excluded. We
also understand Patentee’s position to be that the literal scope of Claim 1 is
limited to the use of water as a solvent in making TRIS and that the use of
other solvents such as ether is excluded.
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Claims involved in a reexamination are ordinarily given the broadest
reasonable construction. Yamamoto, 740 F.2d at 1571, 222 USPQ at 936.
However, a narrowed construction is appropriate where the patent has
expired, as is the case here. Papst-Motoren, 1 USPQ2d at 1656. The
language of Claim 1 is susceptible to the narrow construction urged by
Patentee and we adopt that construction.4 Pabst-Motron, 1 USPQ2d at
1656.

4 We express no view on what mixtures might infringe or are “encompassed
by” the claims under the doctrine of equivalents. See Reply Brief in
Response to Supplemental Examiner’s Answer filed September 9, 2005, p.
7, n. 1 and accompanying text.
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Obviousness
Analogous Art
Patentee argues, in effect, that Quaal is non-analogous art. Quaal is
said to be non-analogous because Quaal does not relate to oxygen permeable
contact lens materials. Analogous art includes references which are in the
field of the inventor’s endeavor or are reasonably pertinent to the problem
with which the inventor was concerned. Kahn, 441 F.3d at 986-87, 78
USPQ2d at 1336.
The field of Patentee’s endeavor is making contact lens materials. As
part of Patentee’s claimed method of making contact lens materials, Patentee
expressly includes the method of making the comonomer TRIS. Thus,
methods of making TRIS are clearly part of the relevant field of endeavor.
Further, Gaylord describes methods of making TRIS as well as other
comonomers useful for making contact lens materials. Tanaka, while not
describing TRIS as a comonomer, describes methods of making the
comonomers used in the manufacture of contact lens materials there
described. These teachings show that methods of making comonomers are
part of the field of making contact lens materials. Quaal’s teaching of a
method of making the comonomer TRIS, a comonomer known to be used in
contact lens materials, is part of the field of Patentee’s endeavor. Quaal is
analogous art. Kahn, 441 F.3d at 986-87, 78 USPQ2d at 1336.
Gaylord and Tanaka both relate to forming contact lens materials by
copolymerization. They are part of the same art as the claimed invention.
Thus, Gaylord, Tanaka and Quaal are analogous art and part of the
presumed knowledge of the person having ordinary skill. The hypothetical
person of ordinary skill in the art is presumed to have knowledge of all prior
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art in the field of the invention. Rouffet, 149 F.3d at 1357, 47 USPQ2d at
1457).
Combining Teachings
Tanaka expressly teaches that multifunctional siloxyanyl ester cross-
linking agents may be used in place of conventional cross-linking agents,
such as ethylene glycol dimethacrylate, generally employed in the
polymerization of vinyl monomers. Tanaka, 8:2-14. Tanaka also teaches
that polyfunctional siloxyanyl ester cross-linking agents are preferred
because the siloxane bonds in those molecules provide high oxygen
permeability to the copolymer. Tanaka, 8:35-39. Thus, one having ordinary
skill in the art would have recognized that the oxygen permeability of
Tanaka’s contact lens materials was due, in part, to the use of Tanaka’s
preferred cross-linking agents. The person having ordinary skill in the art
would have been aware of the need for contact lens materials to have high
oxygen permeability. This known need in the art gives a reason for a person
of ordinary skill in the art to use Tanaka’s preferred cross-linking agents.
Any need or problem known in the field of endeavor at the time of the
invention and addressed by the prior art can be a basis to combine teachings
of the references. KSR, 127 S.Ct. at 1741. The person having ordinary skill
in the contact lens art would have expected Tanaka’s multifunctional
siloxyanyl ester cross-linking agents to act as cross-linking agents for the
comonomers used by Gaylord due to the presence of the terminal
unsaturated carbons (=CH
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2). The conventional cross-linking agents taught
by Gaylord and Tanaka, as well as Tanaka’s multifunctional siloxyanyl ester
cross-linking
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agents, have terminal unsaturated carbons. 5 It would have been expected,
and therefore obvious, to replace the conventional cross-linking agents
described by Gaylord with the multifunctional siloxyanyl ester cross-linking
agents preferred by Tanaka.
Patentee argues that Tanaka teaches away from using Tanaka’s
polyfunctional siloxanyl ester cross-linking agents with comonomers of the
type used by Gaylord. Patentee argues that Gaylord’s ester monomers do
not have an internal glycerol group for increased hydrophilicity which
monomers are taught by Tanaka as having undesirable water-repelling
properties when used in contact lens material. Patentee also relies on two of
Tanka’s 53 examples, Examples 29 and 42, as indicating that Tanaka’s
polyfunctional siloxanyl ester cross-linking agents actually decrease oxygen
permeability.
Tanaka does not teach away.
Tanaka provides ample reasons for using polyfunctional siloxanyl
ester cross-linking agents with comonomers other than those specifically

5 Ethylene glycol dimethacralate, described as crosslinkers by both Gaylord
and Tanaka, may be represented by the following formula:
CH3 CH3
│ │
CH2=C-C-O-(CH2)2-O-C-C=CH2
║ ║
O O
Tanaka’s preferred cross-linkers similarly have terminal unsaturated carbons
(=CH2). For example. Tanaka’s preferred siloxanyl alkyl esters include
those represented by general formula:
R1 CH3 CH3 R2
│ │ │ │
CH2=C─C─O─(CH2)n─Si─(O─Si)m-(CH2)n─O─C─C=CH2
║ │ │ ║
O CH3 CH3 O
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described by Tanaka. Tanaka teaches that the cross-linkers are a substitute
for “known cross-linking agents generally employed in the polymerization
of a vinyl monomer . . . .” Tanaka, 7:62-8:14. The cross-linking agents are
taught to be preferred because they provide contact lens materials having
good oxygen permability because of their siloxane bonds. Tanaka, 8:35-39.
Lastly, the polyfunctional siloxanyl ester cross-linking agents are said to
provide hydrophilic groups which are beneficial for the hydrophilic property
of contact lens materials. Tanaka, 8:39-46.
We fail to see why the fact that Gaylord’s comonomers do not include
an internal glycerol group would teach away from the use of the cross-
linking agents taught by Tanaka. The person having ordinary skill in the art
understands that the mechanism of cross-linking relies on the presence of the
terminal unsaturated carbon bonds. The person having ordinary skill in the
art would have expected that Tanaka’s preferred polyfunctional siloxanyl
ester cross-linking agents, which also include terminal unsaturated carbons
(=CH2), would also be effective cross-linking agents with Gaylord’s
comonomers. We have not been directed to evidence in the record which
shows the contrary.
With respect to the comparison of the oxygen permeability of
Examples 29 and 42, we can not draw any conclusion from these examples.
The two examples are not comparable because of the different amounts of
organosiloxane comonomer. The contact lens material of Example 29 is a
copolymer said to have been made from 40 grams of an organosiloxane
comomoner designated S3, 50 grams of methylmethacrylate (MMA) and 10
grams of a polyfunctional siloxanyl ester cross-linking agent, TMSBPGMA
(tetramethyldisiloxanylbis (propylglycerol methacrylate)). The oxygen
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permeability of this composition was said to be 6.3 x 10-10. The contact lens
material of Example 42 is a copolymer made from 50 grams of S3, 43 grams
of MMA and 7 grams of conventional cross-linking agent ethylene glycol
dimethacrylate (EDMA).6 The oxygen permeablility of the Example 42
copolymers is said to be 9.6 x 10-10. Based upon the difference in oxygen
permeability, Patentee asserts that the substitution of a polyfunctional
siloxanyl ester cross-linking agent, the conventional EDMA would be
expected to decrease oxygen permeability. However, it appears that the
increased oxygen permability of the Example 42 copolymer may result from
the 10 gram increase in the amount of S3 organosiloxane comonomer. As
noted by Tanaka, “[t]he oxygen permeability of the copolymers of the
present invention is in proportion to the content of the before-mentioned
particular organosiloxane . . . .” Tanaka, 11:23-25. See also Tables 3, 4 and
8 which demonstrate the significant increase in oxygen permeability in
proportion to an increase in organosiloxane comonomer. While we can not
draw any conclusion from a comparison of Examples 29 and 42, we note
that Tanaka credits at least a portion of the oxygen permeability of the
copolymer to the siloxane bonds in the multifunctional siloxanyl ester
crosslinking agent. Tanaka, 8:35-39 (“Since these cross-linking agents . . .
have siloxane bonds in their molecules, the oxygen permeability of the
obtained cross-linked copolymers is high . . . .”). A person of ordinary skill,
upon reading Tanaka, would neither be discouraged from following the path
set out in the reference, nor be led in a direction divergent from the path that
was taken by Patentee. Gurley , 27 F.3d at 553, 31 USPQ2d at 1131, Syntex,

6 The compound ethylene glycol dimethacrylate may also be called
ethylenedimethacrylate.
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407 F.3d at 1380, 74 USPQ2d at 1830. Tanaka does not teach away from
using multifunctional siloxanyl ester crosslinking agents.
Gaylord also does not describe the specifically claimed method of
making TRIS. At the time of Patentee’s invention, TRIS was a known
comonomer useful in making contact lens materials. The hypothetical
person having ordinary skill in the contact lens material art would have been
aware of the known techniques for forming the contact lens comonomers
such as TRIS. Gaylord, for example, describes ways of making
comonomers, including two techniques for making TRIS. Gaylord,
Examples 1 and 22, 6:40-7:18 and 11:25-51. Quaal describes another.
Based on the record before us, one having ordinary skill in the art would
have expected that the source of the TRIS comonomer, i.e., the method of
making TRIS, would have little or no effect on the copolymerization process
and resulting contact lens copolymer. It would have been obvious,
therefore, to use TRIS made by any known process, including the process
taught by Quaal as the source for TRIS in the copolymerization process
taught by Gaylord. The substitution of a known method of making TRIS for
the known method expressly taught by Gaylord gives nothing more than the
predictable result and would have been obvious. KSR, 127 S.Ct. at 1739.
“The results of ordinary innovation are not the subject of exclusive rights
under the patent laws.” KSR, 127 S.Ct. at 1745.
Patentee argues that there are differences between the claimed process
for making TRIS and the process specifically described by Quaal. For
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example, Patentee notes that Quaal does not expressly describe making
TRIS from MAS and TMCS alone.7
One having ordinary skill in the art would have understood the
chemistry involved in Quaal’s process and would have expected that TRIS
could be made by hydrolysis of MAS and TMCS alone. Quaal teaches a
general reaction for making tris-siloxy acrylic silanes, such as TRIS, having
the general formula (R3SiO)3Si-R’-OOCC(R”)=CH2. This process involves
the cohydrolysis of two compounds, a compound having the formula
X3Si-R’-OOCC(R”)=CH2 and an excess of a compound of the type R3SiX.
Thus, Quaal’s basic process only requires cohydrolysis of two compounds.
Patentee also makes much of the fact that Quaal’s Example 1, which
is directed to making TRIS, does not teach making TRIS by cohydrolysis of
MAS and TMCS alone.
Quaal’s Example 1 describes the cohydrolysis of MAS and TMCS
and a third compound, (CH3)3SiOCH3. Example 1 in no way diminishes
Quaal’s general teaching of reacting two compounds and is totally consistent
with that teaching. A reference must be evaluated for all that it teaches, and
is not limited to its examples or preferred embodiments. Merck & Co. v.
Biocraft Labs., Inc., 874 F.2d 804, 807, 10 USPQ2d 1843, 1846 (Fed. Cir.
1989); In re Fracalossi, 681 F.2d 792, 794 n.1, 215 USPQ 569, 570 n.1
(CCPA 1982); In re Lamberti, 545 F.2d 747, 750, 192 USPQ 278, 280
(CCPA 1976). Additionally, Quaal’s general reaction may be represented
by the following equation:
X3Si-R’-OOCC(R”)=CH2 + R3SiX (in H20) ═> (R3SiO)3Si-R’-OOCC(R”)=CH2

7 As we stated above at p. 9 we have adopted Patentee’s construction of the
literal scope of Claim 1 as permitting only the cohydrolysis of MAS and
TMCS.
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One having ordinary skill in the art would have fully understood the
chemistry of this reaction. In particular, that person would have understood
that the tris siloxy component ((R3SiO)3) in the product comes from the silyl
moiety (R3Si) provided by the R3SiX reactant. In Quaal’s Example 1, there
are two R3SiX reactants: (1) (CH3)3SiCl (TMCS) and (2) (CH3)3SiOCH3.
Both provide the same silyl moiety ((CH3)3Si) and both meet the Quaal’s
definitions for R3SiX. One having ordinary skill in the art would have
predicted and expected from Quaal’s general teaching and an understanding
of the chemistry of the Quaal’s cohydrolysis reaction that TMCS alone
would provide the necessary silyl moiety. Making TRIS by the cohydrolysis
of MAS and TMCS alone would have been obvious.
Patentee also notes that Quaal does not expressly describe forming
TRIS by adding the reactants to 3-10 volumes of water. Quaal, however,
provides an operative guideline for the amount of water to be used: “The
amount of water employed is not particularly critical except that enough
should be employed for the hydrolysis reaction to proceed at a satisfactory
rate.” Quaal, 1:50-53. Thus, it is within the skill of those working in the art
to determine the appropriate amounts of water for use in making TRIS. The
statement as to the amount of water does not distinguish Patentee’s method
of making TRIS from Quaal’s method in an unexpected or unobvious way.
Patentee also notes that Quaal uses a water-solvent mixture in the
hydrolysis reaction rather than water alone as required by Claim 1. Quaal,
while preferring to use a solvent, characterizes the solvent as “not essential
to the process.” Quaal, 1:55. Thus, the making of TRIS without the use of
a solvent is suggested, is within the ordinary skill in the art, and would have
been obvious.
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Patentee’s specific method of making TRIS follows Quaal’s teachings
and recites process specifics which are within the level of skill in the art and
provide only the expected results. The substitution of Quaal’s known
method for making TRIS for the method expressly described by Gaylord
would have been obvious.
Secondary considerations
Neefe Declaration
Patentee relies on the Neefe declaration asserting secondary
considerations of unexpected results, commercial success, long felt need and
copying of the invention by others. Reply Brief in Response to Supplemental
Examiner’s Answer, p. 3.
The Neefe declaration has been carefully considered. However, it is
insufficient to prove secondary considerations of non-obviousness.
Patentee argues that the contact lens materials which result from the
claimed process have unexpectedly high oxygen permeability as compared
to the materials described by Gaylord. Reply Brief in Response to
Supplemental Examiner’s Answer filed September 9, 2005, p. 3, p. 20.
Patentee asserts that the declaration establishes unexpected results in that the
“Claim 1 method provided contact lens polymer materials that were as much
as 30 times more oxygen permeable than were commercial products
manufactured according to the teachings of Gaylord.” Reply Brief in
response to Supplemental Examiner’s Answer filed September 9, 2005,
p. 20. Specifically, Patentee relies on ¶ 9 of the Neefe declaration.
Paragraph 9 relies on an Exhibit 3, said to be attached to the declaration, to
show a comparison between the Gaylord materials and those made with the
process of the invention. However, no document identifiable as Exhibit 3 is
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attached to the Declaration in the official PTO record and an Exhibit 3 was
not located in a review of that record.8 Based upon the record before us,
Patentee failed to prove unexpected results.
In any event, taking the declaration statements in ¶ 9 at face value, the
declaration does not establish that the materials were comparable and
differed only in the cross-linking agent. To show unexpected results, a
comparison of the invention with the prior art must be under identical
conditions except for the novel features of the invention. In re Brown,
459 F.2d 531, 173 USPQ 685 (CCPA 1972).
Patentee also relies on ¶¶ 8-10 of the Neefe declaration to show
commercial success, long felt need and copying by others. Reply Brief in
Response to Supplemental Examiner’s Answer filed September 9, 2005,
p. 3, p. 20.
Secondary considerations such as commercial success, long felt need,
and copying by others, while relevant to the obviousness inquiry, must be
proved with clear and convincing evidence. Snow, 471 F.2d at 1404,
176 USPQ at 331; Miegel, 404 F.2d at 381, 159 USPQ at 717; Heyna,
360 F.2d at 228, 149 USPQ at 697; Lohr, 317 F.2d at 388, 137 USPQ at
550-551. Patentee has provided only conclusory statements. With respect to
commercial success, Patentee has not provided evidence of actual sales,
market share, growth in market share, replacing earlier units sold by others
or of dollar amounts, and no evidence of a nexus between sales and the

8 There appears to be three documents attached to the declaration. The
documents marked Exhibit 1 and Exhibit 2 are single page documents
showing reproductions of chemical structure models. The third document is
titled “Declaration of Sutton under 37 CFR § 1.132.” The relevance of this
document to the appeal is not readily apparent.
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merits of the invention. Kansas Jack, Inc. v. Kuhn et al., 219 USPQ 857,
861 (Fed. Cir. 1983). Similarly, with respect to long-felt need, Patentee has
not proved that there was recognition in the art of a problem that existed for
a long period of time without solution. Iron Grip Barbell Co. v. USA Sports,
Inc., 392 F.3d 1317, 1325, 73 USPQ2d 1225, 1230 (Fed. Cir. 2004); In re
Mixon, 470 F.2d 1374, 1377, 176 USPQ 296, 299 (CCPA 1973). Lastly,
while copying of a claimed invention can be evidence of nonobviousness
(Panduit Corp. v. Dennison Manufacturing, 227 USPQ at 349 (Fed.Cir.
1985)), Patentee has provided only the bare statement “virtually the entire
RGP industry uses my invention.” Neefe Declaration, filed January 19,
2001, p. 3, ¶ 10. Assuming the truth of this statement, a mere use of the
invention alone is not sufficient to prove that the invention was copied. Iron
Grip Barbell, 392 F.3d 1317 at 1325, 73 USPQ2d at 1230 (“Not every
competing product that arguably falls within the scope of a patent is
evidence of copying.”).
Patentee’s declaration does not establish clear and convincing
evidence of any secondary considerations of non-obviousness.9 Indeed,
Patentee’s declaration does not establish secondary considerations by even a
preponderance of the evidence.
ORDER
The decision of the examiner is affirmed.

9 We have not separately listed each of the plethora of arguments raised by
Patentee. However, each has been carefully considered but not persuasive of
patentability and finds response in the analysis above.
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KENYON & KENYON LLP
1500 K STREET N.W.
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