Ex Parte Smith et al

Patent Trial and Appeal Board

Nov 19, 2014

12380892 (P.T.A.B. Nov. 19, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte THOMAS SMITH, WAYNE H. KNOX, LI DING,
DHARMENDRA JANI, and JEFFREY G. LINHARDT
____________

Appeal 2012-011388
Application 12/380,892
Technology Center 1700
___________

Before TERRY J. OWENS, MARK NAGUMO, and
KAREN M. HASTINGS, Administrative Patent Judges.

HASTINGS, Administrative Patent Judge.

DECISION ON APPEAL
Appellants seek our review under 35 U.S.C. § 134 of the Examiner’s
decision rejecting claims 11–15 and 22–34 (Final Action mailed December
9, 2011). We have jurisdiction over the appeal under 35 U.S.C. § 6(b).
We AFFIRM.

Claims 11 and 22, the two independent claims on appeal, are
illustrative of the subject matter on appeal:
11. An optical device comprising an optical, hydrogel
polymeric material with irradiated regions that define refractive
structures, wherein the irradiated regions are characterized by a
positive change in refractive index and exhibit little or no
scattering loss, and the optical, polymeric material comprises a
photosensitizer to enhance the photoefficiency of two photon
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absorption by the polymeric material to form the refractive
structures, wherein the photosensitizer permits one to irradiate
the regions at a given average laser power using a scan rate that
is at least fifty times greater than a scan rate without the
photosensitizer in the material, or at a given scan rate that
permits one to set an average power of the laser to a value that
is at least two times less than an average laser power without
the photosensitizer in the material, yet provide a similar
positive change in refractive index within the irradiated regions.

22. An optical device comprising an optical, hydrogel
polymeric material that includes a photosensitizer to facilitate
the formation of refractive structures with a laser by irradiating
regions of the polymeric material, the laser light having a
wavelength from 650 nm to 950 nm and a pulse energy from
0.05 nJ to 100 nJ, wherein the refractive structures are
characterized by a positive change in refractive index of from
0.01 to 0.06 and exhibit little or no scattering loss, relative to
the optical hydrogel material outside the irradiated regions, said
optical, hydrogel polymeric material having a water content of
at least 15%.

The following rejections are on appeal:
Claims 11–13, 15, 29, and 30 under 35 U.S.C. § 102(b) as being
anticipated by Hampp1;
Claims 14, 22–28, 33, and 34 under 35 U.S.C. § 103(a) as
unpatentable over Hampp.
ANALYSIS
The main issue raised by Appellants in the appeal is whether the prior
art reference to Hampp is an enabling reference (App. Br. 4, 5; Reply Br. 1).

1 DE 10 2005 045 540 A1, published Sept. 23, 2005, as translated in US
Pub. 2009/0157178 A1, published June 18, 2009 (now US 8,109,999 B2,
issued Feb. 7, 2012).
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“In order to anticipate, a prior art disclosure must also be enabling,
such that one of ordinary skill in the art could practice the invention without
undue experimentation. The standard for enablement of a prior art reference
for purposes of anticipation under section 102 differs from the enablement
standard under 35 U.S.C. § 112.” Novo Nordisk Pharms., Inc. v. Bio-Tech.
Gen. Corp., 424 F.3d 1347, 1355 (Fed. Cir. 2005) (internal citations
omitted). While section 112 states that the specification must enable one
skilled in the art to ‘use’ the invention, “section 102 makes no such
requirement as to an anticipatory disclosure . . . . Rather, anticipation only
requires that those suggestions be enabled to one of skill in the art.”
“Whether a prior art reference is enabling is a question of law based upon
[the] underlying factual findings.” Id (internal citations omitted.)
It has also been held that “proof of efficacy is not required for a prior
art reference to be enabling for purposes of anticipation.” Impax Labs. Inc.
v. Aventis Pharms. Inc., 468 F.3d 1366, 1383 (Fed. Cir. 2006). “Rather, the
proper issue is whether the . . . patent is enabling in the sense that it
describes the claimed invention sufficiently to enable a person of ordinary
skill in the art to carry out the invention.” Id. at 1383.
We have thoroughly reviewed each of Appellants’ arguments as to
why Hampp does not enable the invention described therein. However, we
determine that a preponderance of the evidence supports the Examiner’s
finding that the claimed subject matter of representative claim 1 is
anticipated within the meaning of § 102 in view of the applied prior art of
Hampp. A preponderance of the evidence also supports the Examiner’s
§ 103 rejection based on Hampp. Accordingly, we will sustain the
Examiner’s rejections for essentially those reasons expressed in the Answer,
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including the Response to Argument section, and we add the following
primarily for emphasis.
Appellants’ main arguments focus on their position that “Hampp is all
make believe – all prophesy” (App. Br. 17), mainly because Hampp does not
contain any working examples of an intraocular lens (or a hydrogel of
sufficient thickness to be useful as an intraocular lens) undergoing a positive
change in refractive index. This argument is unpersuasive. On this record,
Appellants do not provide any factual evidence to support their arguments
that Hampp is non-enabling (Briefs generally).2 While Appellants state in
their Factual Findings that there is no evidence or information “as to how a
person of skill could actually conduct” the process to increase the index of
refraction (App. Br. 6; FF 7), Appellants do not support this with anything
more than attorney argument (Briefs generally). An attorney’s arguments in
a brief cannot take the place of evidence. In re Pearson, 494 F.2d 1399,
1405 (CCPA 1974). Furthermore, an artisan must be presumed to know
something about the art apart from what the references disclose. See In re
Jacoby, 309 F.2d 513, 516 (CCPA 1962). After all, “[a] person of ordinary
skill is also a person of ordinary creativity, not an automaton.” KSR Int’l.
Co. v. Teleflex lnc., 550 U.S. 398, 421 (2007).

2 We recognize that the Federal Circuit recently explained that “[t]he
presumption in [In re Antor Media Corp., 689 F.3d 1282 (Fed. Cir. 2012)
that publications used as prior art by the PTO are presumed enabling] is a
procedural one—designed to put the burden on the applicant in the first
instance to challenge cited prior art.” In re Morsa, 713 F.3d 104, 110 (Fed.
Cir. 2013). But “[o]nce an applicant makes a non-frivolous argument that
cited prior art is not enabling . . . the examiner must address that challenge.”
Id. In the case on appeal, the Examiner adequately addressed Appellants’
challenge (Ans. generally).
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As pointed out by the Examiner, Hampp discusses that “the refractive
index can be increased by cleavage of a cyclobutane ring” (Hampp ¶ [0017];
see also ¶¶ [0030], [0031]). Appellants have not presented any persuasive
technical reasoning or evidence that this process is non-enabled and would
not produce the desired results of the stated increase in the index of
refraction (App. Br., Reply Br. generally). Hampp describes an intraocular
lens that may be made of the same/similar materials, treated with the same
photosensitizer (e.g., coumarin), as taught by Appellants, and teaches
irradiating portions of these materials with a laser (with conditions of
wavelengths and energies that encompass or overlap the disclosed
conditions) to increase the index of refraction (e.g., Ans. 15–16). Hampp
describes an intraocular lens where “only certain areas are provided with
photochemically active groups, or only certain areas are exposed to light
thus allowing a photoreaction to occur in these areas only” (Hampp ¶
[0025]). Additionally, Hampp further comments that “an effect is obtained
that resembles that of a Fresnel lens” (id.), and thus is a refractive structure
(Ans. 15).
The Examiner also points out that Hampp discusses selecting the laser
energy
[I]n a way as to induce the photochemical reaction while
avoiding ablation of the lens material [0031]. Based on this
disclosure a skilled artisan could readily determine the proper
wavelength and dose needed to bring about an increase in
refractive index while avoiding ablation of the lens material.

(Ans. 16.)
A preponderance of the evidence supports the Examiner’s reasonable
determination that Hampp is enabling with respect to the invention described
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therein (Ans. generally). For example, Appellants have not set forth facts
sufficient to support a conclusion of undue experimentation under the Wands
factors, which the Federal Circuit has held “are a useful methodology for
determining enablement . . . .” Enzo Biochem, Inc. v. Calgene, Inc., 188
F.3d 1362, 1372 (Fed. Cir. 1999).3 Appellants de facto argue that the state
of the art at the time of the invention was such that one of ordinary skill in
the art would not have been enabled, based on the Hampp disclosure, to
make the claimed invention without undue experimentation. Yet that
argument appears to be contradicted by Hampp’s disclosure and Appellants’
own Specification, which discloses soaking known intraocular lens materials
with the photosensitizer (e.g. coumarin) and then irradiating the lens (e.g.,
Spec. ¶¶ [00113]–[00115]; Hampp ¶¶ [0019],4 [0028]).
In this regard, a preponderance of the evidence supports the
Examiner’s finding that claim 1 is anticipated by Hampp.
With respect to independent claim 22, which recites product-by-
process limitations as to the laser wavelengths and pulse energy used to
make the optical device, a preponderance of the evidence supports the
Examiner’s obviousness determination (e.g., Ans. 11, 12). It has been well

3 Factors to be considered in determining whether a disclosure would require
undue experimentation include: (1) the quantity of experimentation
necessary; (2) the amount of direction or guidance presented; (3) the
presence or absence of working examples; (4) the nature of the invention;
(5) the state of the prior art; (6) the relative skill of those in the art; (7) the
predictability or unpredictability of the art; and (8) the breadth of the claims.
In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
4 Appellants do not specifically dispute the Examiner’s finding that Hampp’s
disclosure also encompasses blending photochemically active groups (i.e.,
the same photosensitizers as Appellants’) with an intraocular lens polymer,
same as Appellants’ process (Ans. 18; Reply Br. generally).
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established that, when a product recited in product-by-process format
reasonably appears to be the same as or obvious from a product of the prior
art, the burden is on applicant to show that the prior art product is in fact
different from the claimed product, even though the products may be made
by different processes. In re Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985).
Appellants have also not sufficiently refuted the Examiner’s determination
that since Hampp discloses that a high water content is desired for an
intraocular lens, the claimed “water content of at least 15%” would have
been obvious (Hampp ¶ [0015]; Ans. 12). Indeed, Appellants have not
provided any persuasive reasoning or evidence that known intraocular lens
materials, including when already implanted in a patient since both Hampp
and Appellants’ encompass laser surgery performed thereon, would not have
possessed the claimed water content (Briefs generally).
To the extent additional arguments are presented for other claims,
including separately rejected claims, we find them unpersuasive for
essentially the reasons set out by the Examiner.
Accordingly, the preponderance of the evidence supports the
Examiner’s § 102 and § 103 rejections, and we sustain each of the rejections
on appeal.

DECISION
The decision of the Examiner is affirmed.

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1).

AFFIRMED
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