Ex Parte Korb

Patent Trial and Appeal Board

Oct 30, 2013

12077807 (P.T.A.B. Oct. 30, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte DONALD R. KORB
__________

Appeal 2012-003745
Application 12/077,807
Technology Center 1600
__________

Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and
ERICA A. FRANKLIN, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal1 under 35 U.S.C. § 134. The Examiner has rejected
the claims for anticipation and obviousness. We have jurisdiction under
35 U.S.C. § 6(b).

1 Appellant identifies the real party in interest as Ocular Research of Boston,
Inc. (App. Br. 2.)
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STATEMENT OF CASE
1. A method for diagnosing and treating dry eye conditions associated
with compromised squamous epithelial cells of the lid wiper portion of the
eyelid, the lid wiper being that portion of the marginal conjunctiva that is in
contact with the tear film, said method comprising diagnosing the lid wiper
portion of the upper lid of the eye for compromised cells by staining the tear
film with a staining dye, everting the upper eyelid, and observing the lid
wiper portion of the everted eyelid for infiltration of the staining dye into the
cells thereof, and prescribing a treatment modality for an eye found to have
lid wiper compromised cells as determined by infiltration of the staining dye
into the cells of the lid wiper where the treatment modality is treatment for
dry eye.

10. The method of claim 1 where a combination of dyes is applied to
the eye.

17. The method of claim 1 where the dye is used in an amount of at
least 1 µl per application of dye.

36. The method of claim 1 where the treatment modality is upper
eyelid immobilization.

Cited References

Stamler US 6,034,293 Mar. 7, 2000
Chynn US 6,218,428 B1 Apr. 17, 2001

Donnenfeld et al., Lid Imbrication Syndrome Diagnosis with Rose Bengal
Staining, 101 OPHTHALMOLOGY 763-766 (1994).

Grounds of Rejection
1. Claims 1, 4-7, and 9 are rejected under 35 U.S.C. § 102(b) as being
anticipated by Donnenfeld.
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2. Claims 17-19 are rejected under 35 U.S.C. § 103(a) as being
obvious over Donnenfeld.
3. Claims 10-16 are rejected under 35 U.S.C. § 103(a) as being
obvious over Donnenfeld in view of Chynn.
4. Claim 36 is rejected under 35 U.S.C. § 103(a) as being obvious
over Donnenfeld in view of Stamler.

FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages 5-
11.

Discussion
Anticipation and Obviousness
ISSUE
The Examiner concludes that Donnenfeld teaches each element
claimed.
Appellant argues
Donnenfeld discloses diagnosing the condition of lid
imbrication (Donnenfeld at p. 763 (“Rose bengal staining of the
superior lid margin tarsal conjunctiva offers an extremely
reliable aid for diagnosing lid imbrication syndrome”)). There
is no teaching, or even a remote suggestion, in Donnenfeld that
lid imbrication syndrome will result in compromised squamous
epithelial cells of the lid wiper region of the eyelid.

(App. Br. 14.) Appellant further argues that, “Donnenfeld does not disclose
‘observing the lid wiper portion of the everted eyelid.’” (Id. at 15.) In
addition, Appellant argues that “Donnenfeld does not knowingly observe the
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Application 12/077,807

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lid wiper as required by claim 1 because Donnenfeld is not aware of the
existence of the lid wiper.” (Id. at 16.)
The issue is: Does the cited prior art teach each element of the
invention, as claimed?

PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
In order for a prior art reference to serve as an anticipatory reference,
it must disclose every limitation of the claimed invention, either explicitly or
inherently. See In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). To
anticipate, every element and limitation of the claimed invention must be
found in a single prior art reference, arranged as in the claim. Karsten Mfg.
Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir. 2001).
“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.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
of the prior art; (2) the differences between the prior art and the claims at
issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.
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“The 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).
“It is a general rule that merely discovering and claiming a new
benefit of an old process cannot render the process again patentable.” In re
Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990).
Discovery of a property inherent to a prior art process does not render
that process patentable, even if the prior art did not appreciate the property.
Verdegaal Bros., Inc. v. Union Oil Co., 814 F.2d 628, 633 (Fed. Cir. 1987).

ANALYSIS
We select claims 1, 10, 17, and 36 as representative of the rejections
before us. We agree with the Examiner’s fact finding, statement of the
rejection and responses to Appellant’s arguments as set forth in the Answer.
We find that the Examiner has provided evidence to support a prima facie
case of obviousness. We provide the following additional comment to
argument set forth in the Answer.
Appellant argues that
Donnenfeld discloses diagnosing the condition of lid
imbrication (Donnenfeld at p. 763 (“Rose bengal staining of the
superior lid margin tarsal conjunctiva offers an extremely
reliable aid for diagnosing lid imbrication syndrome”)). There
is no teaching, or even a remote suggestion, in Donnenfeld that
lid imbrication syndrome will result in compromised squamous
epithelial cells of the lid wiper region of the eyelid.

(App. Br. 14.)
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We are not persuaded by Appellant’s argument. In the Response to
Arguments section of the Answer, the Examiner argues that,
[A]pplicant’s response filed in the parent application
10/453,123 (see page 20, lines 19-25), on December 18, 2006,
which states: “The area described by Donnenfeld et al. is the
entire inner surface of the eyelid, the tarsal conju[n]ctiva, which
is the entire height of the upper eyelid.” Therefore, in reference
to Applicant’s Figure 4 found on page 3 of the Appeal Brief,
the section described by Donnenfeld et al. encompasses
[elements] 402 to 405.

(Ans. 12.) The Specification, Fig. 4, elements 402 to 405 (including lid
wiper 401) border the entire inner surface of the eyelid disclosed in
Donnenfeld. Appellant fails to provide rebuttal evidence showing that lid
wiper 401 is not part of the entire inner surface of the eyelid disclosed in
Donnenfeld or that this entire area is not diagnosed in Donnenfeld. (See
also, Ans. 12.)
Appellant further argues that, “Donnenfeld does not disclose
‘observing the lid wiper portion of the everted eyelid.’” (App. Br. 15.) We
agree with the Examiner that, “Donnenfeld et al. teaches that an everted lid
examination was then performed (see materials and methods section, in
particular), and thus teaches observing the everted eyelid for the staining
dye, as recited in claim 1.” (Ans. 14.)
In addition, Appellant argues that “Donnenfeld does not knowingly
observe the lid wiper as required by claim 1 because Donnenfeld is not
aware of the existence of the lid wiper.” (App. Br. 16.) We are not
persuaded. Donnenfeld stains and observes the entire portion of the upper
eyelid including the lid wiper (Ans. 14) and subsequently treats the entire
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portion with methyl-cellulose tear substitute, a dry eye treatment regimen
(id. at 13). Indeed, Donnenfeld expressly teaches “[r]ose bengal staining of
the superior lid margin tarsal conjunctiva offers an extremely reliable aid for
diagnosing this condition. The rose bengal staining is linear and contiguous
with the upper lid margin” (Donnenfeld 766, col. 2).
Even if Donnenfeld did not knowingly observe the lid wiper, the
discovery of a property inherent to a prior art process, such as observing the
entire inner upper eyelid with stain to determine which areas are stained,
including the lid wiper, does not render that process patentable, even if the
prior art did not appreciate the property. Verdegaal Bros. Inc. v. Union Oil
Co., 814 F.2d at 633.
We have also considered the Declaration of Dr. Korb, as well as
Appellant’s Brief exhibits A-C. We find that the Declaration and
accompanying e-mail evidence are not relevant to the anticipation rejection.
Such evidence can only be considered with respect to an obviousness
rejection. This evidence also fails to tip the balance in favor of patentability
with respect to the obviousness rejection over Donnenfeld. The e-mail
evidence fails to support either a long felt need in the art or provide a
preponderance of the evidence to support an unexpected result.
Remaining rejections 3 and 4 and other separately argued claims are
affirmed for the reasons set forth in the Answer.

CONCLUSION OF LAW
The cited references support the Examiner’s anticipation and
obviousness rejections, which are affirmed for the reasons of record.
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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

cdc