Ex Parte Smith

Patent Trial and Appeal Board

Mar 22, 2016

11613029 (P.T.A.B. Mar. 22, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111613,029 12/19/2006
127289 7590 03/24/2016
Schmeiser, Olsen & Watts, LLP/RO
Schmeiser, Olsen & Watts, LLP
11 Schoen Place, 7th Floor
Pittsford, NY 14534
FIRST NAMED INVENTOR
Francis X. Smith
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
BIOC. l 7348CIP-RO 7077
EXAMINER
FAY,ZOHREHA
ART UNIT PAPER NUMBER
1621
NOTIFICATION DATE DELIVERY MODE
03/24/2016 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):
RO 127289@iplawusa.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte FRANCIS X. SMITH1
Appeal2014-001428
Application 11/613,029
Technology Center 1600
Before ERIC B. GRIMES, JEFFREY N. FREDMAN and
JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to
ophthalmic and contact lens solutions and methods for using the same,
which have been rejected as obvious and for nonstatutory double patenting.
We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
The invention relates to a single-part ophthalmic solution, such as a
contact lens solution and a method for providing the solution. The solution
1 Appellant identifies the real party in interest as FXS Ventures, LLC (App.
Br. 3).
Appeal2014-001428
Application 11/613,029
comprises 0.00001 to 10 weight percent of a simple saccharide and at least
0.00001 to 10 weight percent of a preservative. The solution is
physiologically compatible with direct contact with corneal tissue and
exhibits improved preservative efficacy.
Claims 1 and 4-17 are on appeal.2 Claim 1 is illustrative and reads as
follows:
1. An ophthalmic solution comprising 0.00001 to
10.0 weight percent of a simple saccharide
chosen from the group consisting of: inositol;
ribose; triose; tetrose; erythrose; threose;
pentose; arabinose; ribulose; xylose; xylulose;
lyxose; hexose; allose; altrose; fructose;
galactose; glucose; gulose; idose; mannose;
sorbose; talose; tagatose; adlose; ketose;
heptose; sedoheptulose; and xylitol; at least
0.00001 weight percent of a preservative, and
not more than about 0.2 percent by weight
chloride; wherein said solution is an aqueous
solution effective as a single-part solution;
wherein said solution is physiologically
compatible with direct contact with corneal
tissue.
Claims 1and4-16 stand rejected under 35 U.S.C. §103(a) as obvious in
view of Asgharian. 3
2 While Appellant discussed claims 11 and 13 separately in his brief, the
rejection and arguments presented are the same as those presented for the
remaining product claims. We therefore address claims 1 and 4-16 together.
3 Asgharian et al., US 6,139,646, issued Oct. 31, 2000.
2
Appeal2014-001428
Application 11/613,029
Claim 17 stands rejected under 35 U.S.C § 103(a) as obvious in view
of Asgharian.
Claims 1 and 4-17 stand rejected under the judicially created non-
statutory doctrine of obviousness double patenting.
I
Issue
The Examiner has rejected claims 1 and 4-16 as obvious in view of
Asgharian. The Examiner finds that Asgharian teaches a contact lens
solution of a cationic polymeric preservative and a preservative enhancer
comprising glycerin, sorbitol and a propylene glycol (see Ans. 5).. The
Examiner finds that Asgharian further teaches that the compositions
described therein are "physiologically compatible with the eye" and that its
invention includes a stand-alone solution which does not contain an enzyme
(see Ans. 7). The Examiner finds that "[i]t would have been obvious to a
person skilled in the art, to use the claimed components in a single part
composition, considering the prior art, also has all the components of the
claimed invention in a single part before being mixed with the enzymic
solution." (Ans. 5)
Appellant contends that the teachings of Asgharian are directed to an
enzyme solution for cleaning and disinfecting contact lenses (see Appeal Br.
6). Appellant contends that the inclusion of an enzyme in the solution
renders the solutions incompatible for direct contact with the cornea and
therefore Asgharian teaches away from the claimed invention. (Appeal Br.
7-8.)
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Application 11/613,029
The issue with respect to this rejection is whether claims 1 and 4-16
are obvious in view of the teachings of Asgharian within the meaning of 3 5
U.S.C. § 103(a).
Findings of Fact
FF 1. Asgharian teaches that the "disinfecting solution will contain at
least one anti-microbial agent ... Preferred polymeric antimicrobial agents
include ... polyhexamethylene biguanide" (Asgharian et al., col. 10, 11. 16-
28). Instant claim 12 notes that polyhexamethylene biguanide is a
preserving agent.
FF2. Asgharian teaches disinfecting contact lens solutions containing
tonicity agents including sugars, a cationic polymeric preservative, chelating
agents, buffers, and wetting agents (Asgharian, col. 11, 11. 35-60)
FF3. Asgharian teaches the preparation of a stand-alone disinfecting
solution that is free of enzymes (Asgharian, col. 12, 11. 38-43).
FF4. Asgharian teaches that "the multipurpose compositions will be
physiologically compatible with the eye" (Asgharian, col. 9, 11. 63-65).
Principles of Law
A proper § 103 analysis requires "a searching comparison of the
claimed invention-including all its limitations-with the teaching of the
prior art." In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995). "In
determining whether the subject matter of a patent claim is obvious, neither
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Application 11/613,029
the particular motivation nor the avowed purpose of the patentee controls.
What matters is the objective reach of the claim. If the claim extends to
what is obvious, it is invalid under§ 103." KSR Int'! Co. v. Teleflex Inc.,
550 U.S. 398, 419 (2007). The "discovery that a claimed composition
possesses a property not disclosed for the prior art subject matter, does not
by itself defeat a prima facie case." In re Dillon, 919 F.2d 688, 693 (Fed.
Cir. 1990).
Analysis
The Examiner finds that Asgharian suggests all of the elements of the
instant claims. (Ans. 6) The Examiner finds that Asgharian refers to a
stand-alone disinfection composition that is physiologically compatible with
the eye. (Ans. 7)
We find that the Examiner has the better position for claims 1, 11, and
13. Here the claims extend to what is taught by Asgharian and are therefore
obvious. KSR Int'! Co., 550 U.S. at 419. We agree that all of the elements
required by claims 1, 11, and 13 are suggested in Asgharian for use in
disinfecting solutions and that one skilled in the art would have been
motivated to use the resulting solution as a single component. See Wm.
Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364 (Fed.
Cir. 2012)(The Federal Circuit found a "strong case of obviousness based on
the prior art references of record. [The claim] recites a combination of
elements that were all known in the prior art, and all that was required to
obtain that combination was to substitute one well-known ... agent for
another.")
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Application 11/613,029
Appellant contends that the "instant claims recite a specific list of
simple saccharides, none of which are taught by Asgharian" (Appeal Br. 6).
We find this argument unpersuasive because Asgharian specifically
teaches that the disinfecting solution may comprise tonicity agents that
comprise sugars (FF 2). Although Asgarian does not expressly suggest the
specific sugars listed in claim 1, it suggests including sugars as tonicity
agents (FF), and therefore would have made obvious the common sugars
(glucose, fructose, etc.) recited in claim 1. In the instant case, we find that
the ordinary artisan taught "sugars" would have reasonably found it obvious
to envisage and select the simple saccharides of claim 1.
Appellant contends that Asgharian's "enzyme composition would not
be suitable for direct eye contact as enzyme solutions are known to those
skilled in the art to be harmful to the eye" (Appeal Br. 7). Appellant cites
the Jahngen Declaration4 that due "to the extreme dangers of enzyme
solutions, such as those disclosed by Asgharian et al., it is not suitable to use
an enzyme solution for in-eye applications" (Jahngen Dec. ,-i9).We have
considered Appellant's arguments and find them unpersuasive. Asgharian
teaches that the recited compositions will be physiologically compatible with
the eye, which necessarily includes the cornea (FF 4). In addition, while
Asgharian is primarily directed to enzyme containing solutions, Asgharian
also teaches the preparation of a stand-alone disinfectant solution which is
enzyme free (FF 3). An enzyme free solution would not have the
incompatibility problem suggested by Appellant. The "discovery that a
4 Declaration of Dr. Ed Jahngen, dated Mar. 29, 2010.
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Application 11/613,029
claimed composition possesses a property not disclosed for the prior art
subject matter, does not by itself defeat a prima facie case." In re Dillon,
919 F.2d 688, 693 (Fed. Cir. 1990).
Conclusion of Law
We conclude that the Examiner has established that claims 1 and 4-
16 are obvious in view of Asgharian within the meaning of 35 U.S.C. §
103(a).
II
Issue
The Examiner has rejected claim 17 under 35 U.S.C. § 103(a) as
obvious in view of Asgharian The Examiner makes no specific finding with
respect to the method of claim 1 7.
Appellant contends that Asgharian does not disclose a solution that is
compatible with direct contact with the eye. In addition, Appellant contends
that Asgharian "is silent regarding a method for providing an ophthalmic
solution involving the step of contacting the eye with a single-part solution"
(Appeal Br. 10.)
The issue with respect to this rejection is whether claim 17 is obvious
in view of the teachings of Asgharian within the meaning of 35 U.S.C. §
103(a).
FF5. Asgharian is silent about applying the disinfecting, enzyme, or
combined solutions directly to the eye.
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Application 11/613,029
Principles of Law
"In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant." "The Patent Office has the initial duty of
supplying the factual basis for its rejection." In re Warner, 379 F.2d 1011,
1017 (CCPA 1967); In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993).
When a prima facie case of obviousness has not been established, the
rejection must be reversed. In re Fine, 837 F.2d 1071, 1075 (Fed. Cir.
1988).
Analysis
In the present case we find that the Examiner has failed to meet his
initial duty to supply a factual basis for rejecting claim 17. The Examiner
has articulated no factual basis or persuasive reasoning to explain why the
disinfecting solution alone, or in combination with the enzyme solution,
would have been used for contacting an eye. The Examiner also fails to
establish that these solutions would inherently contact the eye during routine
use because cleaned contact lenses are routinely washed to remove cleaning
solutions prior to insertion into the eye (see App. Br. 9). Since the Examiner
has failed to establish a prima facie case of obviousness with respect to
claim 17, the rejection must be reversed. In re Fine, 837 F.2d at 1075.
Conclusion of Law
We conclude that the Examiner has not established that claim 1 7 is
obvious in view of Asgharian within the meaning of 35 U.S.C. § 103(a).
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Application 11/613,029
III
Claims 1 and 4-17 stand provisionally rejected under the judicially created
doctrine of nonstatutory double patenting. Applicant has not specifically
addressed this rejection on appeal other than to say that "Applicant shall
consider filing a terminal disclaimer should corresponding claims be found
allowable in either this or the co-pending application." (App. Br. 10). We
therefore summarily affirm the obviousness-type double patenting rejection.
See Manual of Patent Examining Procedure§ 1205.02 ("If a ground of
rejection stated by the examiner is not addressed in the appellant's brief, that
ground of rejection will be summarily sustained by the Board.").
SUMMARY
We affirm the rejection of claims 1 and 4-16 and reverse the rejection
of claim 17 under Section 103(a) and affirm the rejection of claims 1 and
4-17 under nonstatutory double patenting.
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. § l.136(a).
AFFIRMED
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