Ex Parte Millard et al

Patent Trial and Appeal Board

Nov 16, 2017

13835237 (P.T.A.B. Nov. 16, 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.
13/835,237 03/15/2013 Kimberly Anne Millard P05194C1 3338
23702 7590 11/20/2017
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EXAMINER
1400 North Goodman Street
Rochester, NY 14609
KASSA, JESSICA M
ART UNIT PAPER NUMBER
1616
NOTIFICATION DATE DELIVERY MODE
11/20/2017 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):
patents @ bausch. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KIMBERLY ANNE MILLARD, ERNING XIA,
SUZANNE F. GROEMMINGER, and JENILEE KILBURY1
Appeal 2016-007511
Application 13/835,237
Technology Center 1600
Before ERIC B. GRIMES, RYAN H. FLAX, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to a method of cleaning and disinfecting a contact lens.
Claims 1—6, 8—11, and 14—25 are on appeal as rejected under 35 U.S.C.
§ 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
1 Appellants identify the Real Party in Interest as “Bausch & Lomb
Incorporated.” App. Br. 1.
Appeal 2016-007511
Application 13/835,237
STATEMENT OF THE CASE
Claims 1,3, and 4 are independent claims. We find claim 1 to be
representative and it is reproduced below:
1. A method of cleaning and disinfecting a contact lens,
the method comprising instructing a consumer to disinfect their
contact lens comprising the following steps:
remove a contact lens from an eye and position the lens in
a lens assembly that includes a cap member;
attach a catalytic element comprising a P-metal to the lens
assembly; and
add a disinfection solution to a lens case, and insert the
lens assembly with the attached catalytic element into the lens
case such that the lens and catalytic element are submerged in
the solution upon closure of the lens case with the cap member,
said disinfection solution comprising 0.5 wt.% to 6 wt.%
hydrogen peroxide or a chemical precursor of hydrogen
peroxide, and a P-metal modulating compound, wherein the
molar ratio of the hydrogen peroxide to the P-metal modulating
compound is from 3:1 to 100:1, and wherein the solution exhibits
a pseudo first-order, half-life of hydrogen peroxide from 12
minutes to 30 minutes over an initial sixty minutes of
neutralization following exposure of the disinfection solution to
a catalyst comprising a P-metal.
App. Br. 12 (Claims App’x 1).
The following rejection is on appeal:
Claims 1—6, 8—11 and 14—25 stand rejected under 35 U.S.C. § 103(a)
over Gaglia,2 Cerola,3 and Xia.4 Final Action 3.
2 US 3,912,451 (issued Oct. 14, 1975) (“Gaglia”).
3 US 5,196,174 (issued Mar. 23, 1993) (“Cerola”).
4 US 2005/0266095 A1 (pub. Dec. 1, 2005) (“Xia”)
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Appeal 2016-007511
Application 13/835,237
DISCUSSION
In analyzing patentability and determining obviousness “[t]he
combination of familiar elements according to known methods is likely to be
obvious when it does no more than yield predictable results.” KSR Int’l Co.
v. Teleflex Inc., 550 U.S. 398, 416 (2007). However, “[i]n 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.” In re
Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993) (citation omitted). “[Tjhere
must be a showing of a suggestion or motivation to modify the teachings of
[a] reference.” In re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000).
“[Rejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness.” KSR, 550 U.S. at 418 (quoting In re Kahn, 441 F.3d 977, 988
(Fed. Cir. 2006)). 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).
In view of the above-cited precedent, we conclude the Examiner has
not established a prima facie case that claim 1 would have been obvious.
The Examiner’s determination of obviousness relies on the propriety of
combining the sterilizing agent of Xia with the sterilizing agent of Gaglia to
produce a contact lens solution with the claimed molar ratio of components.
We conclude the balance of evidence supports the Appellants’ contention
that such a combination would not reasonably have been made by the skilled
artisan.
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Appeal 2016-007511
Application 13/835,237
Appellants argue Xia, cited by the Examiner for teaching the inclusion
of UHPC (urea-hydrogen peroxide complex, urea being a P-metal
modulating compound (Spec. 9)) in a contact lens cleaning solution, requires
that the molar ratio of hydrogen peroxide to urea be 1:1 and, so, cannot teach
or suggest a molar ratio of 3:1 to 100:1, as claimed. App. Br. 6. Appellants
also argue there would be no motivation to supplement the H2O2 solution of
Gaglia with the UHPC composition of Xia to achieve the claimed molar
ratio of H202-to-P-metal modulator (urea) because Gaglia already contains
H2O2, which would provide the same preservative function as Xia’s UHPC,
making adding UHPC to Gaglia superfluous. Id. at 6—7. Appellants also
argue that Xia teaches that its UHPC solutions are gentle on the eyes as
compared to hydrogen peroxide-based solutions requiring neutralization and,
thus, Xia teaches away from its combination with Gaglia for this reason. Id.
at 8.
The Examiner responds, stating (in agreement with Appellants) that
the UHPC of Xia provides a 1:1 H202-to-urea molar ratio, but noting that
Gaglia’s system already includes H2O2, and, therefore, adding Xia’s UHPC
to Gaglia’s system would result in a greater than 1:1 ratio of H202-to-urea
(i.e., the 3:1 to 100:1 ratio range claimed). Ans. 3. To support this
determination, the Examiner identifies that Appellants’ Specification
includes examples where urea hydrogen peroxide complex was added to a
hydrogen peroxide containing formulation. Id. (citing Example 4B of
Spec.). The Examiner reasons that, because Xia states that its UHPC can be
used in cleaning and soaking contact lens solutions and discloses existing
commercially-available contact lens solutions, and because Xia states that an
objective of its invention is to enhance the biocidal activity of self-
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Appeal 2016-007511
Application 13/835,237
preserving ophthalmic systems, this means that Xia teaches adding its UHPC
to a contact lens solution already containing H2O2. Ans. 5. The Examiner
does not specifically respond to Appellants’ arguments about Xia’s gentle
versus Gaglia’s not-gentle formulations being incompatible.
We conclude the balance of the evidence supports Appellants’
arguments. “We must... be careful not to allow hindsight reconstruction of
references to reach the claimed invention without any explanation as to how
or why the references would be combined to produce the claimed
invention.” Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1374 n.3
(Fed. Cir. 2008). Thus, the Examiner’s reliance on Appellants’
Specification for the rational underpinning to combine Xia and Gaglia is
improper. Xia discloses that H2O2 contact lens solutions are known, but
teaches that they can be improved by using an UHPC system instead of pure
H2O2 to provide a gentle system that does not need a neutralizer to prevent
eye irritation, potentially caused by H2O2. Id. ]Hf 5—7, 12. Both the
Examiner and Appellants agree that Xia’s system would have a 1:1 molar
ratio of H202-to-urea. Furthermore, there is no dispute that the H2O2 of
Gaglia’s solution would have the preservative function provided by Xia’s
UHPC. Thus, we conclude Gaglia and Xia, in this respect, each teach
complete systems that, based on the references’ disclosures, would achieve
no advantage in their combination.
SUMMARY
The obviousness rejection is reversed.
REVERSED
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