Ex parte Thomas

Board of Patent Appeals and Interferences

Jan 25, 2001

08203837 (B.P.A.I. Jan. 25, 2001)

1
The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board
Paper No. 31
UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte LARRY K. THOMAS
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Appeal No. 1997-2087
Application No. 08/203,837
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ON BRIEF
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Before WILLIAM F. SMITH, SCHEINER, and MILLS, Administrative Patent Judges.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on the appeal under 35 U.S.C. § 134 from the examiner’s final
rejection of claims 4, 6, 8 through 11, 15, 18, 19, 21 through 23, 25, 26, and 28, all the
claims pending in the application. Claims 2, 3, 5, 7, 13, 16, and 17 were cancelled in the
amendment filed September 24, 1993 (Paper No. 4). Claims 1, 12, 14, 20, 24, and 27
were cancelled in the amendment filed February 7, 1994 (Paper No. 6), entered in
accordance with appellant's instructions filed February 28, 1994 (Paper No. 10).
Appeal No. 1997-2087
Application No. 08/203,837
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Claims 15 and 25 are representative of the claims on appeal:
15. A method for disinfecting a contact lens comprising:
contacting a contact lens with a liquid medium initially containing an effective
contact lens disinfecting amount of hydrogen peroxide in the presence of a composition
comprising a cellulose decomposing enzyme component, a cleaning enzyme component
and a hydrogen peroxide destroying component, said composition being structured so that
said cellulose decomposing enzyme component is released in said liquid medium before
said hydrogen peroxide destroying component is released in said liquid medium and said
cleaning enzyme component is released in said liquid medium after said contact lens is
disinfected, said cellulose decomposing enzyme component being present in an amount
effective to render acanthamoeba cysts present in said liquid medium more susceptible to
be killed by hydrogen peroxide in said liquid medium than by hydrogen peroxide in a
substantially identical liquid medium in the absence of said cellulose decomposing
enzyme component, said liquid enzyme component is present in an amount effective to
remove the protein deposits on said contact lens prior to said contacting and the protein
deposits formed on said contact lens during said contacting from said cellulose
decomposing enzyme component from said contact lens, and said hydrogen peroxide
destroying component is present in an amount effective to destroy all the hydrogen
peroxide contained in said liquid medium, said contacting being effective to disinfect said
contact lens, to form protein deposits from said cellulose decomposing enzyme on said
contact lens and to remove protein deposits present on said contact lens prior to said
contacting and protein deposits formed on said contact lens during said contacting from
said cellulose decomposing enzyme component from said contact lens.
25. A composition comprising a cellulose decomposing enzyme component, a
hydrogen peroxide destroying component, an amount of a cleaning enzyme component
effective to remove the protein deposits from a contact lens present in a liquid medium in
which said cleaning enzyme component is released, the protein deposits including the
protein deposits present on said contact lens prior to said contact lens being present in the
liquid medium and the protein deposits formed on said contact lens from said cellulose
decomposing enzyme component, and a delayed release component, said composition
being a solid and structured so that said cellulose decomposing enzyme component is
released in said liquid medium before said hydrogen peroxide destroying component is
released in said liquid medium and said cleaning enzyme component is released in said
liquid medium at substantially the same time said hydrogen peroxide destroying
component is released in said liquid medium, said cellulose decomposing enzyme
component being present in an amount effective to render acanthamoeba cysts present in
Appeal No. 1997-2087
Application No. 08/203,837
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said liquid medium more susceptible to being killed by hydrogen peroxide in said liquid
medium than by hydrogen peroxide in a substantially identical liquid medium in the
absence of said cellulose decomposing enzyme component and to form protein deposits
from said cellulose decomposing enzyme component in the presence of hydrogen
peroxide on said contact lens, said hydrogen peroxide destroying component being
present in an amount effective to destroy all the hydrogen peroxide contained in said liquid
medium, and said delayed release component being present in an amount effective to
delay the release in said liquid medium of said hydrogen peroxide destroying component
for a sufficient time to allow a contact lens introduced into said liquid medium at
substantially the same time as said composition to be disinfected.
The references relied upon by the examiner are:
Kaspar et al. (Kaspar) 4,568,517 Feb. 4, 1986
Huth et al. (Huth) 4,670,178 June 2, 1987
Kruse et al. (Kruse) 4,767,559 Aug. 30, 1988
Izumi et al. (Izumi), “The efficacy of disinfection system using hydrogen peroxide against
acanthamoeba,” Journal of the Japanese Contact Lens Soc., Vol. 33, No. 4,
pp. 282-86 (1991)
Grounds of Rejections
Claims 4, 6, 8 through 11, 15, 18, 19, 21 through 23, 25, 26, and 28 stand rejected
under 35 U.S.C. § 103. As evidence of obviousness, the examiner relies upon Kruse,
Kaspar, Huth and Izumi.
We reverse.
Background
The present invention is directed to compositions and methods for disinfecting
a contact lens (specification, page 1). Specifically, the present invention relates to
compositions and methods "useful to facilitate the action of hydrogen peroxide in
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disinfecting contact lenses and in destroying residual hydrogen peroxide present in a liquid
aqueous medium containing a contact lens which has been disinfected by the action of
hydrogen peroxide" (Id.)
The composition comprises a cellulose decomposing enzyme component (CDEC)
and a hydrogen peroxide destroying component (HPDC) (specification, page 4)
separated by a delayed release component, which can be in the form of a coating
(specification, page 15). The function of the CDEC is to "enhance the killing action of
hydrogen peroxide against hydrogen peroxide-resistant microorganisms, preferably
acanthamoeba cysts" (specification, page 7).
In addition, the claimed composition comprises a cleaning enzyme component
useful to remove proteinaceous deposit material from the contact lens resulting from the
CDEC (specification, page 9). The claimed composition also requires the composition to
be "a solid and structured" in a way to allow for dissolution of each component in a
particular sequence (Appendix A, claim 25, line 10). This structure includes a core that
contains the HPDC and the cleaning enzyme component; a delayed release layer covering
the core and the CDEC formed over the delayed
release layer (specification, page 9). Note that, alternatively, the cleaning enzyme
component may be provided as a coating directly adjacent to the core (Id.).
The method of the present invention comprises contacting a contact lens with a
liquid medium initially containing an effective contact lens disinfecting amount of hydrogen
peroxide in the presence of the claimed structured composition (specification, page 17).
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Thus, the CDEC is first released in the liquid medium (specification, page 7). After the
contact lens is disinfected, the HPDC and the cleaning enzyme component are released to
destroy all the hydrogen peroxide contained in said liquid medium and to remove the
protein deposits on said contact lens, respectively (specification, page 17).
THE REJECTION UNDER 35 U.S.C. § 103
The examiner has rejected all the claims on appeal as being obvious over Kruse,
Kaspar, Huth and Izumi.
Kruse discloses a solid composition for disinfecting contact lenses comprising the
structure of a core layer containing a neutralizing agent which neutralizes a disinfecting
agent, a time release coating and an outer layer containing the disinfecting agent (col. 2,
lines 15-26). The disinfecting agent is preferably one that supplies hydrogen peroxide (col.
2, lines 36-40). The neutralizing agent can include ascorbic acid and catalase (col. 3, lines
30-36). The time release layer can be made of polyvinyl alcohol, polyvinylpyrrolidone and
other materials (col. 4, lines 20-29). Kruse also discloses that the active ingredients are
released in a desired sequence (reverse sequence of manufacturing) (col. 2, lines 28-30).
Kaspar discloses a solid composition for disinfecting contact lenses comprising the
structure of a core layer containing a hydrogen peroxide neutralizing agent and a time
release coating (col. 2, lines 25-44). The neutralizing agent can include ascorbic acid and
catalase (col. 4, lines 29, 44). The time release layer can be made of cellulose based
materials, polyvinyl alcohols, and other materials (col. 5, line 62 to col. 6, line 4). Kaspar
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also discloses that the active ingredients are released in a desired sequence when placed
in a liquid medium containing hydrogen peroxide (col. 2, lines 16-44).
Both Kruse and Kaspar provide the basic structure of a core layer with a neutralizing
agent encapsulated by a time release layer and the basic concept of dissolving the
components of the solid composition in a particular sequence. However, neither of these
references suggest providing an outer layer containing a cellulose decomposing enzyme
component (CDEC) over the time release layer or providing a cleaning enzyme component
in connection with the core layer of neutralizing agent. The examiner seeks to rectify these
deficiencies with the teachings of Huth and Izumi.
Huth is directed to a process for cleaning and disinfecting contact lenses with a
"solution containing a mixture of peroxide and peroxide-active enzymes" (col. 1, lines
7-11). Huth acknowledges the problem of proteinaceous buildup on contact lenses (col. 1,
line 66 to col. 2, line 19). Huth addresses this problem by providing a solution of peroxide
for disinfecting combined with a cleaning enzyme (col. 3, lines 16-20). The examiner relies
on Huth to disclose "that it is conventional to use enzymes to remove proteinaceous build-
up on contact lenses which act to irritate the eyes' of the wearer" (Examiner's Answer, page
5).
Izumi is directed to a contact lens disinfecting system that employs a lysozyme
(chitin or cellulose decomposing enzyme component) combined with hydrogen peroxide to
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remove cysts (Abstract). This combination is reported to kill cysts of Acanthamoeba
castellani more effectively.
The examiner states that it would have been obvious to combine these references
and arrive at appellant's invention because
the practitioner would be aware that the lysozyme 1) would
potentiate the activity of the hydrogen peroxide in destroying
Acanthamoeba cysts per the disclosure of Izumi et al. and 2)
when lysozyme was included in the composition, [sic, it] would
need to be separated from the cleaning enzyme component
until after it has had its disinfecting effect because the cleaning
enzyme component would inactivate the lysozyme (Examiner's
Answer, paragraph bridging pages 6 and 7).
Upon consideration of the entire record before us, we cannot sustain the examiner's
rejection.
DISCUSSION
Patentability of a claim under 35 U.S.C. § 103 must be premised upon considering
the subject matter of a claim "as a whole." As recently stated in Pro-Mold
& Tool Co. v. Great Lakes Plastics, Inc., 75 F.3d 1568, 1573, 37 USPQ2d 1626, 1629
(Fed. Cir. 1996) (citation omitted): "It is well-established that before a conclusion of
obviousness may be made based on a combination of references, there must have been a
reason, suggestion, or motivation to lead an inventor to combine those references."
The nature of the problem which persisted in the art, and the inventor's solution, are
factors to be considered in determining whether the invention would have been obvious to
a person of ordinary skill in that art. Fromson v. Advance Offset Plate, Inc., 755 F.2d 1549,
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1556, 225 USPQ 26, 31 (Fed. Cir. 1985). It is part of the "subject matter as a whole" which
should always be considered in determining the obviousness of an invention under 35
U.S.C. § 103. In re Nomiya, 509 F.2d 566, 184 USPQ 607 (CCPA 1975). It is rare that
one factor will control the obviousness conclusion, and all evidence should be taken into
consideration when making such a determination.
Appellant argues that he discovered the problem that the CDEC "disadvanta-
geously forms protein deposits” on the contact lens in the presence of hydrogen peroxide
(Appeal Brief, page 11). Appellant further argues that the discovery of the problem led to
the solution of including a cleaning enzyme component "in an amount effective to remove
both the protein deposits previously on the contact lens and the protein deposits formed
from the CDEC" in the claimed invention (Appeal Brief, page 5). In this context, appellant
also argues extensively that there is no motivation to combine the references in a manner
that will lead to the claimed invention because the prior art was not aware of the problem
discovered by appellant (Appeal Brief, page 13).
On the other hand, the examiner is of the opinion that the "Appellant's discovery of
the problem is immaterial because Appellant's method of addressing the problem is not
patentable" (Examiner's Answer, page 14). Further, the examiner states that the
components of the claimed invention "are well known in the prior art to be used either
separately or in various combinations for the purpose of disinfecting and cleaning a
contact lens" (Examiner's Answer, page 9). From this, the examiner concludes that "[t]he
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idea of combining these components flows logically from their having been individually
taught in the prior art" (Id.). The examiner additionally argues that "[t]he motivation to
structure the components is also clear from a reading of the prior art taken as a whole"
(Examiner's Answer, page 10). The examiner supports this contention by relying on the
individual teachings of the cited references and the "awareness" of the practitioner in the
art (Examiner's Answer, page 15).
We disagree. A review of appellant's claims indicates that the claimed
composition and method require a distinctive and particular structure that will allow the
active ingredients to be released in a specific sequence. The examiner has pointed to no
evidence that would lead a person of ordinary skill to combine the teachings of the cited
references in a manner that yields the claimed structure (claim 25) and method (claim 15).
It is true that Kruse and Kaspar provide the basic structure of a core layer with a
neutralizing agent encapsulated by a time release layer and the basic method of dissolving
the components of the solid composition in a particular sequence. But, neither of the
references suggests the addition of CDEC as the outermost layer and a cleaning enzyme
component to the core layer for the purpose of removing protein deposits formed from the
CDEC. We note that Huth and Izumi may suggest the desirability of adding these
components in a contact lens cleaning/disinfecting solution. However, the examiner points
to no basis in any of the references that would lead a person of ordinary skill in the art to
assemble the components in a structure as claimed or use them in the order claimed.
The initial burden of establishing unpatentability rests on the examiner, In re Oetiker,
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977 F.2d 1443, 1446, 24 USPQ2d 1443, 1445 (Fed. Cir. 1992). To establish obviousness
based on a combination of the elements disclosed in the prior art, there must be some
motivation, suggestion or teaching of the desirability of making the specific combination
that was made by the applicant. See In re Dance, 160 F.3d 1339, 1343, 48 USPQ2d
1635, 1637 (Fed. Cir. 1998); In re Gordon, 733 F.2d 900, 902,
221 USPQ 1125, 1127 (Fed. Cir. 1984). The motivation, suggestion or teaching to modify
a reference may come explicitly from statements in the prior art, the knowledge of one of
ordinary skill in the art, or, in some cases the nature of the problem to be solved. See
Dembiczak, 175 F.3d 994, 999, 50 USPQ2d 1614, 1617 (Fed. Cir. 1999). In re Rouffet,
149 F.3d 1350, 1355-56, 47 USPQ2d 1453, 1456 (Fed. Cir.1998). Broad conclusory
statements standing alone are not “evidence.” Dembiczak, Id. However, when the high
level of skill in the art provides the necessary motivation, our appellate reviewing court has
instructed that such reliance must be accompanied by an explanation of "what specific
understanding or technological principle within the knowledge of one of ordinary skill in the
art would have suggested the combination."
In re Rouffet, 149 F.3d 1350, 1357, 47 USPQ2d 1453, 1458 (Fed. Cir.1998).
The examiner attempts to provide an explanation or motivation based on the
individual teachings of the cited references, relying on the "awareness" of the practitioner
(Examiner's Answer, paragraph bridging pages 6 and 7 and paragraph bridging pages 14
and 15). However, we do not find that the examiner has provided evidence of a "specific
understanding or technological principle within [that] knowledge" that "would have
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suggested the combination," such as a recognition in the prior art of the problem solved by
appellants or a suggestion of a structural solution to this problem. Id. Absent evidence of
such understanding or principle in the prior art, the examiner's arguments remain
unsupported and, thus, the examiner has not established a prima facie case of
obviousness. Consequently, we reverse.
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CONCLUSION
The examiner's decision, rejecting claims 4, 6, 8 through 11, 15, 18, 19,
21 through 23, 25, 26, and 28 under 35 U.S.C. § 103 is reversed.
REVERSED
)
William F. Smith )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Toni R. Scheiner )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Demetra J. Mills )
Administrative Patent Judge )
Appeal No. 1997-2087
Application No. 08/203,837
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DJM/cam
Frank J. Uxa
STOUT, UXA, BUYAN & MULLINS, LLP
4 Venture, Suite 300
Irvine, CA 92618