Ex Parte Smith

Patent Trial and Appeal Board

Mar 21, 2016

10544151 (P.T.A.B. Mar. 21, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
10/544,151 08/01/2005
127289 7590 03/23/2016
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 7348US-RO 6429
EXAMINER
FAY,ZOHREHA
ART UNIT PAPER NUMBER
1621
NOTIFICATION DATE DELIVERY MODE
03/23/2016 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
Appeal2014-001421
Application 10/544, 151
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 contact
lens solutions and methods for using the same, which have been rejected as
obvious. We have jurisdiction under 35 U.S.C. § 6(b ).
We affirm-in-part.
STATEMENT OF THE CASE
The invention relates to a single-part ophthalmic solution, specifically
a contact lens solution and a method for providing the solution. The solution
comprises 0.001 to 10 weight percent of a simple saccharide and at least
1 Appellant identifies the real party in interest as FXS Ventures, LLC.
Appeal2014-001421
Application 10/544, 151
0.0001 to 10 weight percent polyhexamethylene biguanide. The solution is
physiologically compatible with direct contact with corneal tissue and
exhibits improved preservative efficacy.
Claims 1-4 and 6-11 are on appeal. 2 Claim 1 is illustrative and reads
as follows:
A contact lens solution comprising 0.001 to
10 weight percent of a preservative enhancer
chosen from the group consisting of: inositol;
mannitol; sorbitol; sucrose; dextrose; and glycerin;
at least 0.0001 weight percent of
polyhexamethylene biguanide; and where the
concentration of chloride in said solution is less
than 0.2 percent by weight; 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.
2 While the Appellant discussed claim 8 separately in his initial brief, the
rejection and arguments for claim 8 are identical to those presented for the
remaining product claims. We therefore address claim 8 in conjunction with
Claims 1--4, 6, 7, 9 and 10.
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Appeal2014-001421
Application 10/544, 151
Claims 1--4 and 6-10 stand rejected under 35 U.S.C §103(a) as
obvious in view of Asgharian. 3
Claim 11 stands rejected under 35 U.S.C § 103(a) as obvious in view
of Asgharian.
I
Issue
The Examiner has rejected claims 1-4 and 6-10 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. 6). 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
composition, considering that 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 and that
inclusion of an enzyme in the solution renders the solutions incompatible for
direct contact with the cornea. Thus Asgharian teaches away from the
claimed invention. (Appeal Br. 6-7.)
3 Asgharian et al., US 6,139,646, issued October 31, 2000
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Appeal2014-001421
Application 10/544, 151
The issue with respect to this rejection is whether claims 1-4 and
6-10 are obvious in view of the teachings of Asgharian within the meaning
of 35 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, col. 10, 11. 16-28).
FF2. Asgharian teaches disinfecting contact lens solutions containing
tonicity agents including sugars, a cationic polymeric preservative, chelating
agents, buffers, and wetting agents. Asgharian teaches that the "most
preferred disinfecting compositions comprise ... sorbitol" (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
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
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Application 10/544, 151
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
We find that the Examiner has the better position for claims 1 and 8.
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, 8, and 11 are suggested by Asgharian for use in
disinfecting solutions and that one skilled in the art would have been
motivated to pick and choose desired components for the resulting stand-
alone disinfecting solution. 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.")
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. 6). Appellant cites
the Jahngen Declaration4 that due "to the extreme dangers of enzyme
4 Declaration of Dr. Ed Jahngen, dated Mar. 29, 2010.
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Appeal2014-001421
Application 10/544, 151
solutions, such as those disclosed by Asgharian et al., it is not suitable to use
an enzyme solution for in-eye applications" (Jahngen Dec. iJ9).
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) and may contain
polyhexamethylene biguanide as an antimicrobial agent (FF 1) as well as
tonicity agents including sugars (FF 2) and specifically teaches the inclusion
of sorbitol (FF 2). An enzyme free solution would not have the
incompatibility problem suggested by Appellant. 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)
Conclusion of Law
We conclude that the Examiner has established that claims 1--4 and
6-10 are obvious in view of Asgharian within the meaning of 35 U.S.C. §
103(a).
II
Issue
The Examiner has rejected claim 11 under 35 U.S.C. § 103(a) as
obvious in view of Asgharian. The Examiner makes no specific factual
finding with respect to the method of claim 11.
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Application 10/544, 151
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. 9.)
The issue with respect to this rejection is whether claim 11 is obvious
in view of the teachings of Asgharian within the meaning of 35 U.S.C. §
103(a).
Findings of Fact
FF5. Asgharian is silent about applying the disinfecting, enzyme, or
combined solutions directly to the eye.
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 (CCP A 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 11. The Examiner
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Application 10/544, 151
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 11, 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 11 is
obvious in view of Asgharian within the meaning of 35 U.S.C. § 103(a).
SUMMARY
We affirm the rejection of claims 1--4 and 6-10 and reverse the
rejection of claim 11.
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-IN-PART
8