Ex Parte Homer

Patent Trial and Appeal Board

Jul 31, 2017

13456111 (P.T.A.B. Jul. 31, 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.
13/456,111 04/25/2012 Gregg S. Homer HLABP051 8307
75180 7590
Gregg Homer, JSD
668 North Coast Highway
Suite 1371
Laguna Beach, CA 92651
EXAMINER
NGUYEN, HIEN NGOC
ART UNIT PAPER NUMBER
3777
NOTIFICATION DATE DELIVERY MODE
08/02/2017 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):
gregg @ homerlabs. com
ghomer @ entlawgroup .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GREGG S. HOMER
Appeal 2016-002505
Application 13/456,1111
Technology Center 3700
Before JEFFREY N. FREDMAN, RICHARD J. SMITH, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a method
and system for reducing intraocular pressure in an eye, which have been
rejected as not meeting the written description requirement or the
enablement requirement, as being indefinite, and as being obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
Reducing intraocular pressure using laser radiation to create shrinkage
in the iris tissue is well-known in the art and involves applying the laser
energy to the peripheral iris in spots. (Spec. 129.) “The mechanisms of
1 Appellant identifies the Real Party in Interest as himself. (Appeal Br. 3.)
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action of iris tissue shrinkage is thought to be (a) an immediate thermal
response, whereby the laser energy is converted to heat that causes
contraction of stromal collagen, and (b) a later proliferation of fibroblasts
and the formation of a contraction membrane.” (Id.) There is still a need for
a treatment protocol with “good long-term efficacy and fewer side effects
and complications.” (Id. 1 8.) Appellant’s invention is directed at using
electromagnetic radiation to shrink iris tissue where the radiation is applied
to a larger area of the iris than the peripheral iris. (Id. 130)
Claims 1, 2, 6—12, 17, 18, 22—28, and 33 are on appeal. Claims 1 and
17 are representative and read as follows:
1. A method for reducing intraocular pressure in an eye,
comprising:
applying electromagnetic radiation to at least
approximately the entire anterior surface of the iris of the eye
outside of the collarette,
wherein the applying and the radiation are configured to
induce retraction of at least approximately the entire anterior
surface of the iris of the eye outside of the collarette.
17. A method for reducing intraocular pressure in an eye,
comprising: providing an electromagnetic device, configured to
apply electromagnetic radiation to at least approximately the
entire anterior surface of the iris of the eye outside of the
collarette, and further configured to induce retraction of at least
approximately the entire anterior surface of the iris of the eye
outside of the collarette.
(Appeal Br. 43^44.)
The following grounds of rejection by the Examiner are before us on
review:
1) Claims 1, 17, and 33 under 35 U.S.C. § 112, first paragraph as
failing to comply with the written description requirement.
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2) Claims 1, 17, and 33 under 35 U.S.C. § 112, first paragraph as
failing to comply with the enablement requirement.
3) Claims 1, 12, 17, 28, and 33 under 35 U.S.C. § 112, second
paragraph as being indefinite.
4) Claims 1, 2, 6, 17, 18, 22 and 33 under 35 U.S.C. § 103(a) as being
unpatentable over Kahook2 and Homer.3
5) Claims 7, 8, 23, and 24 under 35 U.S.C. § 103(a) as being
unpatentable over Kahook, Homer, and Williams.4
6) Claims 9—12 and 25—28 under 35 U.S.C. § 103(a) as being
unpatentable over Kahook, Homer, and Lin.5
DISCUSSION
I. Lack of Written Description
The Examiner finds that the limitation of the claims requiring that
“the applying and the radiation are configured to induce retraction of at least
approximately the entire anterior surface of the iris of the eye outside of the
collarette” is not disclosed in the Specification either literally or by way of
other evidentiary showing. (Ans. 3, 9, Final Action 3.) The Examiner
explains that application of the radiation could induce retraction in 50% or
25% of the anterior surface of the iris, and that “[tjhere is no technical,
scientific and factual support in the specification that radiation [that] is
applied to at least approximately the entire anterior surface of the iris of the
2 Malik Y. Kahook and Robert J. Noecker, Iridoplasty, 34 Glaucoma Today
34—36, Jul./Aug. 2006.
3 Homer et al., US 2005/0049584 Al, published Mar. 3, 2005.
4 Williams et al., US 2003/0069566 Al, published Apr. 10, 2003.
5 J. T. Lin, US 2005/0043722 Al, published Feb. 24, 2005.
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eye outside of the collarette will induce retraction [of] approximately the
entire anterior surface of the iris of the eye.” (Ans. 9.)
We agree with the Examiner’s factual findings and conclusion that the
claims reciting that “the applying and the radiation are configured to induce
retraction of at least approximately the entire anterior surface of the iris of
the eye outside of the collarette” are not adequately described.
The test for sufficiency of the Specification to satisfy the written
description requirement of 35 U.S.C. § 112, first paragraph “is whether the
disclosure of the application relied upon reasonably conveys to those skilled
in the art that the inventor had possession of the claimed subject matter as of
the filing date.” AriadPharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351
(Fed. Cir. 2010) (en banc). Although neither examples, nor an actual
reduction to practice are required to meet this requirement, the description in
the Specification “must ‘clearly allow persons of ordinary skill in the art to
recognize that [the inventor] invented what is claimed.’” Id. at 1351—52.
“[T]he purpose of the written description requirement is to ‘ensure that the
scope of the right to exclude, as set forth in the claims, does not overreach
the scope of the inventor’s contribution to the field of art as described in the
patent specification.’” Id. at 1353—54 (quoting University of Rochester v.
G.D. Searle & Co., Inc., 358 F.3d 916, 920 (Fed. Cir. 2004).)
Appellant argues that the Examiner has applied an incorrect legal
standard. (Reply Br. 5; Appeal Br. 9.) We disagree. The Examiner
articulated and applied the correct legal standard that is set forth above.
(Final Action 3; Ans. 9.)
Appellant argues that the Specification and the prior art, i.e., Kahook,
support the configured to retract “at least approximately the entire anterior
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surface of the iris of the eye outside of the collarette” limitation (a) because
they both indicate that (1) application of radiation to the iris can be
configured “to induce retraction of the iris tissue” (Appeal Br. 10, 11
(Kahook “describes the ability of applied EMR to induce iris tissue
retraction”)) and (2) because the Specification recites that the
electromagnetic radiation is applied to “at least approximately the entire
anterior surface of the iris of the eye outside of the collarette'1'’ (Appeal Br.
11—12). (See also Reply Br. 6.) We do not find this argument persuasive
because we find insufficient evidence in the Specification and the prior art
that indicates that applying radiation to a spot on the iris results in inducing
retraction of all or approximately all of the surface of the iris to which the
radiation was applied. The paragraph of Kahook that Appellant cites to
indicates only that the radiation is converted to heat, and causes contraction
of stromal collagen, and that subsequent thereto, fibroblasts proliferate
forming a contraction membrane. (Appeal Br. 11; Kahook 34.) That
teaching is not the same as saying that when the iris tissue is irradiated all or
approximately all of the surface of the iris that was irradiated contracts or
retracts. Moreover, Appellant does not point to any evidence in the
Specification demonstrating or indicating that when a surface of the iris is
irradiated all or approximately all of that iris surface that was irradiated is
induced to retract. Thus, Appellant’s Specification in view of the prior art
does not “‘clearly allow persons of ordinary skill in the art to recognize that
[the inventor] invented what is claimed.’” Ariad, 598 F.3d at 1351.
In light of the foregoing, we affirm the Examiner’s rejection of claims
1,17, and 33 for failing to comply with the written description requirement.
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II. Lack of Enablement
The Examiner finds that “[t]here is no explanation [in the
Specification] of how the applying and the radiation are configured to induce
retraction of at least approximately the entire anterior surface of the iris of
the eye outside of the collarette.” (Final Action 4.) The Examiner further
explains that the Specification does not provide evidence that radiation
applied to at least approximately the entire anterior surface of
the iris of the eye outside of the collarette will result in
retraction [of] approximately the entire anterior surface of the
iris of the eye outside of the collarette and not result in
retraction of 25% or 50% of the entire anterior surface of the
iris of the eye outside of the collarette.
(Ans. 10.) In light of the absence of explanation in the Specification, the
Examiner contends that “it would require undue experimentation for an
ordinary artisan to achieve the claimed result,” and thus, the Specification
does not enable one of ordinary skill in the art to make and/or use the
claimed invention. (Final Action 4; Ans. 10.)
We agree with the Examiner’s factual findings and conclusion that the
claims reciting “the applying and the radiation are configured to induce
retraction of at least approximately the entire anterior surface of the iris of
the eye outside of the collarette” are not sufficiently enabled.
The enablement requirement is satisfied when one skilled in the art,
after reading the Specification, and given what they already know “could
practice the claimed invention without undue experimentation.” AK Steel
Corp. v. Sollac, 344 F.3d 1234, 1244 (Fed. Cir. 2003); Amgen Inc. v.
Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1334 (Fed. Cir. 2003).
Appellant argues that the Examiner has not established a reasonable
basis for questioning enablement. (Appeal Br. 13; Reply Br. 6.) We
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disagree. As noted above, the prior art does not teach that when an area of
the surface of the iris is irradiated all or approximately all of that iris surface
irradiated is induced to retract, nor does Appellant’s Specification describe
the foregoing or even how such might occur. The fact that application of
laser energy to iris tissue is known to induce iris tissue retraction such that
tension is placed on the trabecular meshwork (“TM”) (Spec. 129), and that
the proposed mechanism by which that is believed to occur has been
reported (Kahook 34), does not address the Examiner’s noted concern, i.e.,
how does one apply and configure the radiation to induce retraction of at
least approximately the entire surface of the iris of the eye outside of the
collarette.
Furthermore, none of the “working examples” (Spec. 38-44)
Appellant refers to (Appeal Br. 13—14, Reply Br. 7), demonstrate or teach
one that the radiation applied to the at least approximately entire anterior
surface of the iris of the eye outside of the collarette is configured and
applied in such a way that approximately all of the anterior surface of the
iris in this same treated area is induced to retract.
Appellant further argues evaluation of all the Wands factors favors a
finding of enablement. (Appeal Br. 14—15; Reply Br. 6—7.) We disagree.
Appellant’s analysis presumes enabling disclosures that relate to achieving
induced retraction of at least approximately the entire anterior surface of the
iris of the eye outside of the collarette. (See, e.g., Appeal Br. 14 (“Breadth
of the Claims ” (“Application discloses broad enabling treatment
parameters”); Id. at 14—15 (“Direction Provided by the Inventor’’ (noting the
Application discloses 9 working examples of the claimed invention),
“Quantity of Experimentation” (noting that “the Enabling Disclosures,
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Working Examples, and Prior Art described above would provide
considerable guidance to a PHOSITA in making and using the invention,
particularly a PHOSITA with the Skill Level described above”).) However,
as already discussed, neither the prior art nor the Specification’s “working
examples” provide information that establishes achieving the claimed result
as to the retraction of the at least approximately the entire anterior surface of
the iris of the eye outside of the collarette.
Appellant also contends that, even without the guidance of the
Specification and skill level, the “required experimentation would not be
undue because it would involve the incremental testing of a limited number
of core EMR parameters, such as wavelength and fluence.” (Id. at 15.) We
do not find the foregoing persuasive as there is no direction provided in the
Specification or the prior art regarding how the experimentation should
proceed to assess whether the configuration and application of the
wavelength and fluence were sufficient to induce the claimed retraction “of
at least approximately the entire anterior surface of the iris of the eye outside
of the collarette.” Appellant has not provided sufficient evidence that one of
ordinary skill in the art would even know what testing to use to determine if
applying EMR laser energy induces the claimed retraction “of at least
approximately the entire anterior surface of the iris of the eye outside of the
collarette” or how one measures for the amount of retraction so as to be able
to determine the result is achieved. Thus, Appellant has not provided
sufficient evidence that whatever the requisite experimentation might be
would be routine to one of ordinary skill in the art.
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Consequently, for the foregoing reasons, we affirm the Examiner’s
rejection of claims 1,17, and 33 as failing to comply with the enablement
requirement of 35 U.S.C. § 112, first paragraph.
III. Indefiniteness
The Examiner finds that the use of the terms “about” and
“approximately” recited in claims 1, 12, 17, 28, and 33 render these claims
indefinite under 35 U.S.C. § 112, second paragraph because the boundary
for these terms is not defined clearly and definitely in the Specification.
(Final Action 4—5.) The Examiner’s rejection is premised on the fact that
“[Ajppellant’s specification does not disclose support for the express
outcome or how one can achieve it.” (Ans. 11.) The Examiner contends
that in light of this, one of ordinary skill in the art cannot “ascertain [the]
range” for the treatment boundary and the energy density boundaries such
that one can achieve the express outcome of the claims. (Ans. 10—11.)
We agree with the Examiner’s findings and conclusion.
“Claim language employing terms of degree has long been found
definite where it provided enough certainty to one of skill in the art when
read in the context of the invention.” Interval Licensing LLC v. AOL,
Inc., 766 F.3d 1364, 1370 (Fed. Cir. 2014) (citing Eibel Process Co. v.
Minnesota & Ontario Paper Co., 261 U.S. 45, 65—66 (1923) (finding
‘substantial pitch’ sufficiently definite because one skilled in the art ‘had no
difficulty ... in determining what was the substantial pitch needed’ to
practice the invention)). However, when a term of degree is used in the
claim, it is required that “[t]he claims, when read in light of the specification
and the prosecution history, . . . provide objective boundaries for those of
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skill in the art.” Id. at 1371. As the Examiner found (Final Action 4—5),
such objective boundaries are not present here. Contrary to Appellant’s
contention (Reply Br. 7), the Specification does not provide any standard for
measuring the degree of either the treatment boundary or the energy density
boundaries such that the express outcome of the claim is met. As discussed
in the enablement section above, it is not clear how one of ordinary skill in
the art would determine (i.e., what experimentation would demonstrate) the
claimed retraction boundary is met. Contrary to Appellant’s assertion
(Reply Br. 8), neither the Specification nor the prior art provides guidance in
that regard as explained above.
Moreover, regarding the “energy density,” we note that the
Specification states “the energy density of the beam is set to a level that
minimizes the damage to any ocular tissue while still providing satisfactory
tissue retraction.” (Spec. 134.) However, this description does not provide
one of ordinary skill in the art with information as to objective boundaries
for acceptable minimized damage and satisfactory results. As our reviewing
Court has noted, “a term of degree fails to provide sufficient notice of its
scope if it depends ‘on the unpredictable vagaries of any one person’s
opinion.’” Interval Licensing, 766 F.3d at 1371 (quoting Datamize, LLC v.
Plumtree Software, Inc., 417 F.3d 1342, 1350 (Fed. Cir. 2005).)
Although the Specification provides an example in which an energy
density of 1.0 J/cm2 is produced and applied in a spiral scan pattern across
the entire iris with a spot separation of 125 p and line separation of 250p,
(Spec. 138), such does not provide information that would allow one of
ordinary skill in the art to meaningfully extrapolate objectively what falls
within the boundaries of the density range claimed that meets the effect
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claimed. That is because, even with the specific example of a certain energy
density applied, that description does not indicate that the process results in
induced retraction of at least approximately the entire anterior surface of the
iris of the eye outside of the collarette.
Thus, for the foregoing reasons, we affirm the Examiner’s rejection of
claims 1, 12, 17, 28, and 33 as being indefinite under 35 U.S.C. § 112,
second paragraph.
IV. The Obviousness Rejections
a. Non-Obviousness Claim 1
Claim 1 is a one-step method for reducing intraocular pressure
requiring applying electromagnetic radiation to at least approximately the
entire anterior surface of the iris of the eye such that retraction of at least
approximately the entire anterior surface of the eye is induced to retract.
The Examiner finds that Kahook discloses a method for reducing intraocular
pressure by applying laser radiation to the anterior surface of the eye to
induce retraction of the iris tissue. (Ans. 11—12; Final Action 5.) The
Examiner notes that the difference between the claimed method and the
Kahook disclosure is that Kahook does not apply radiation that covers
approximately the entire anterior surface of the iris outside of the collarette.
(Id. ) The Examiner notes that Kahook teaches though that when the
peripheral iris shrinks after application of laser radiation, it pulls away from
the trabecular meshwork and opens the drainage angle. (Ans. 12; Final
Action 6.)
The Examiner finds that Homer, which is in the field of eye treatment
like Kahook (Ans. 13), teaches applying radiation to approximately the
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entire anterior surface of the iris of the eye outside of the collarette (Ans. 12;
Final Action 6.) The Examiner contends that in light of this teaching, it
would have been obvious to one of ordinary skill in the art to modify
Kahook
to apply radiation that cover[s] approximately the entire anterior
surface of the iris of the eye outside of the collarette and
wherein the applying and the radiation are configured to induce
retraction of at least approximately the entire anterior surface of
the iris of the eye outside of the collarette as taught by Homer
because a large laser spot that cover[s] approximately the entire
anterior surface of the iris of the eye would produce more iris
shrinkage and pull away more of the trabecular meshwork and
open a bigger drainage angle. This would relieve more
intraocular pressure.
(Final Action 6.)
We disagree with the Examiner’s conclusion of obviousness, which is
premised on the Examiner’s finding that Kahook and Homer are analogous
art. As Appellant notes (Appeal Br. 23), to be analogous art either (1) the
applied art must be from the same field as the inventor’s endeavor,
regardless of the problem addressed, or (2) if “not within the field of the
inventor’s endeavor,” the references are, nevertheless, “reasonably pertinent
to the particular problem with which the inventor is involved.” In re Clay,
966 F.2d 656, 658—59 (Fed. Cir. 1992). We agree with Appellant that
Homer does not meet either criteria. (Appeal Br. 23—24.)
As Appellant notes, the mere fact that Homer is in the field of eye
surgery does not mean that it is analogous to the claimed invention, which is
directed at eye surgery that is directed to relieving intraocular pressure. (Id
at 23.) Homer is directed at eye surgery to change eye color. (Id; Homer
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Abs.) Appellant explains that the appropriate EMR wavelengths differ for
these surgeries. (Appeal Br. 23.)
In addition, Homer is not pertinent to a problem with which the
invention is involved. Although Homer teaches that the laser can be directed
across the entire iris surface (Homer 121), it does so in order to effect a
change in the anterior stroma pigment, such as by using a specific laser to
remove a particular iris pigment without affecting non-pigmented cells of
the anterior stroma (Homer H 23—26, 29—30). The Examiner has not
established that Homer’s teaching would have suggested the use of laser
radiation to effect a change in intraocular pressure or that application of laser
radiation across approximately the entire anterior iris of the eye outside of
the collarette would achieve some beneficial result in the area of releasing
ocular pressure or effecting a change in the trabecular meshwork as
compared to applying it in just the peripheral region of the iris. Thus, we
agree with Appellant (Appeal Br. 22) that one of ordinary skill in the art
would not have been prompted to combine Homer’s teaching of applying
laser radiation to the entire anterior iris outside of the collarette in the
iridoplasty method described by Kahook because there is insufficient
evidence supporting that there would have been a reasonable expectation of
success.
Consequently, for the reasons discussed, we conclude the Examiner
has failed to establish a prima facie case that the subject matter of
independent claim 1 is obvious. We reverse the Examiner’s rejection of
claims 1, 2, and 6 as being obvious over Kahook and Homer.
The Examiner’s additional reliance on Williams to reject claims 7 and
8, and Lin to reject claims 9—12 does not cure the defect with regard to the
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combination of Kahook and Homer concerning the method of claim 1.
Thus, we also reverse the Examiner’s rejection of claims 7 and 8 as being
obvious over Kahook, Homer, and Williams and the Examiner’s rejection of
claims 9—12 as being obvious over Kahook, Homer, and Lin.
b. Obviousness: Claims 17 and 33
The Examiner does not differentiate among the independent claims in
rejecting them for obviousness. However, such differentiation is warranted
as will be discussed below.
“A process is a mode of treatment of certain materials to produce a
given result. It is an act, or a series of acts, performed upon the subject-
matter to be transformed and reduced to a different state or thing.”
Gottschalkv. Benson, 409 U.S. 63, 70 (1972) (quoting Cochrane v. Deener,
94 U.S. 780, 788 (1876)). Unlike claim 1, claim 17 is a one-step method for
reducing intraocular pressure that requires providing an electromagnetic
device that is “configured to” apply electromagnetic radiation to at least
approximately the entire anterior surface of the iris of the eye outside of the
collarette and “configured to” induce retraction of at least approximately the
entire anterior surface of the eye outside of the collarette. It does not recite
an actual step of effecting the result recited in the preamble.
Moreover, the preamble of claim 17 is not necessary to give life and
meaning to the claim. It does not serve to further define the structure of the
device. Kropa v. Robie, 187 F.2d 150, 152 (CCPA 1951). Nor does the
preamble’s statement of purpose give meaning to other positive limitations
recited in the method. Cf. Jansen v. Rexall Sundown, Inc., 342 F.3d 1329,
1333 (Fed. Cir. 2003) (In considering the effect of the preamble in a claim
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directed to a method of treating or preventing pernicious anemia in humans
by administering a certain vitamin preparation to “a human in need thereof,”
the court held that the claims’ recitation of a patient or a human “in need”
gives life and meaning to the preamble’s statement of purpose.). We find
that the body of the claim fully and intrinsically sets forth all of the
limitations of the claimed invention, and the preamble merely states the
intended use of the invention, rather than provide any distinct definition of
any of the claimed invention’s limitations. Thus, we do not consider the
preamble a limitation of claim 17 and it is of no significance to the
construction of the claim. See Pitney Bowes, Inc. v. Hewlett-Packard Co.,
182 F.3d 1298, 1305 (Fed. Cir. 1999). We find that claim 17 is more akin to
an apparatus having certain capabilities than a method.
Claim 33 is a “system” for reducing intraocular pressure that
comprises the same device recited in claim 17.
We now turn to whether there is a structural difference between the
recited devices set forth in claims 17 and 33 and the prior art relied on by the
Examiner. We do this because “the patentability of apparatus or
composition claims depends on the claimed structure, not on the use or
purpose of that structure.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com,
Inc., 289 F.3d 801, 809 (Fed. Cir. 2002); see also Hewlett-Packard Co. v.
Bausch &Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990) (“[Apparatus
claims cover what a device is, not what a device does.”).
It is not apparent to us from Appellant’s Specification that the laser
used in the process disclosed in the Specification is any different than the
prior art laser used in iridopathy. In fact, Appellant’s Specification explains
that the difference between the prior art and the claimed invention does not
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reside in the structure of the laser used to treat, but in the fact that “[t]he
present invention, by contrast [to the prior art laser trabeculoplasty and laser
iridoplasty], treats other areas of the anterior iris (which may or may not
include the peripheral iris, the TM, and/or the UM).” (Spec. 130.) Such
methodology is not a positive limitation of claims 17 and 33 as discussed
above.
Moreover, Appellant’s Specification explains that “[t]he use of laser
energy to shrink iris tissue is well-known in the art, and other glaucoma
therapies rely on iris tissue retraction to relieve IOP.” (Spec. 129.)
Consequently, we find that Kahook discloses a laser device that is
configured so as to apply radiation as claimed, and to the extent disclosed in
Appellant’s Specification, would also be configured to induce the claimed
retraction of the surface of the iris, and thus teaches the invention recited in
claims 17 and 33.
Appellant argues that “[t]he Kahook surgical contact lens occludes
most of the anterior iris (see Kahook, at 35-35) and would therefore prevent
an EMR pathway from being applied to at least a substantial portion of the
iris surface.” (Appeal Br. 25; see also id. (“The Kahook-Homer
combination would include the Kahook surgical contact lens.”).) Appellant
also argues that although Kahook discloses applying EMR, it does not teach
doing so to “at least a substantial portion of the iris.'” (Appeal Br. 26.) We
do not find these arguments persuasive as to claims 17 and 33.
We note that Kahook teaches maneuvering the laser in a way that it
overlaps with the limbus to treat the peripheral iris. (Kahook 35.) In other
words, the laser is movable, regardless of the presence of a surgical lens that
narrows the field of application of the laser radiation. This also appears to
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be true with the indirect application where Kahook indicates that the surgeon
should treat “as peripheral[ly] as possible.” (Id. ) Thus, we find that the
laser device of Kahook is capable of applying electromagnetic radiation to at
least approximately the entire anterior surface of the iris outside of the
collarette.
Appellant does not point to any structure of the claimed laser device
that is different from Kahook such that the laser of Kahook in the direct or
indirect process is not configured to apply radiation as directed. Appellant’s
argument is simply that the laser in Kahook is not applied across the claimed
anterior surface of the iris outside of the collarette. (Appeal Br. 25.) That
argument is directed to a method limitation that is not part of claims 17 and
33.
Moreover, Appellant does not point to any structure of the claimed
laser device that is different from Kahook such that after the laser radiation
was so applied, the laser would result in the claimed retraction. Appellant
merely indicates that Kahook does not induce retraction with respect to “at
least a substantial portion of the iris.” (Appeal Br. 26.) Here again, that
argument is directed to a method limitation that is not part of claims 17 and
33.
Appellant further argues that the claimed invention achieves
unexpected results in the “the extent and rapidity of retraction of the iris
tissue, as well as the extent and rapidity of the accompanying drop in IOP”
as described in the Declarations of Perry Binder and the inventor, Gregg
Homer (Appeal Br. 28), and that these same “experts expressed disbelief
with respect to the ability of the claimed invention to reduce IOP” (Id. at
29). Appellant also argues that the claimed invention provides synergy
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because “[t]he functionality of the claimed invention clearly exceeds the
functionality of the proposed Kahook-Homer combination.” (Id.) In
addition, Appellant argues that the art has tried and failed to solve the
problem of elevated IOP. (Id.)
We do not find Appellant’s evidence of secondary considerations
persuasive. First, “an affidavit by an applicant... as to the advantages of
his invention is less persuasive than one made by a disinterested person.” In
re Bulina, 362 F.2d 555, 559 (CCPA 1966). Second, the unexpected results
are not directed at the structure claimed, but at the fact that “applying
electromagnetic radiation (‘EMR’) to at least approximately the entire
anterior surface of the iris of the eye outside of the collarette” achieved
“reductions in IOP.” (Binder Decl.613.) Furthermore, Dr. Binder’s
conclusion that reductions in IOP were unexpected based on application of
EMR to the “approximately the entire anterior surface of the iris of the eye
outside of the collarette” (id.) is curious in light of the Specification’s
teaching that “[t]he use of laser energy to shrink iris tissue is well-known in
the art, and other glaucoma therapies rely on iris tissue retraction to relieve
IOP” (Spec. 129).
Regarding the alleged evidence of long-felt need and failure of others,
these too are directed to the method of treatment, not the device. (Homer
Decl.712; Binder Decl. 12.) Moreover, Appellant has not adequately
6 Declaration of Perry S. Binder, M.D. submitted with Appellant’s response
filed Dec. 22, 2014.
7 Declaration of Gregg Homer, JSD (PHD) submitted with Appellant’s
response filed Dec. 22, 2014.
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established that others skilled in the art tried and failed to find a way to make
a device configured as claimed.
Appellant’s argument concerning synergism is not supported by
objective evidence, and is thus not persuasive. See, e.g., In re Huang, 100
F.3d 135, 139-40 (Fed. Cir. 1996) (“[T]he Patent and Trademark Office
(PTO). . . must consider objective evidence of nonobviousness) (emphasis
added).
Thus, for the foregoing, reasons we do not find Appellant’s evidence
of secondary considerations persuasive with regard to independent claims 17
and 33.
A disclosure that anticipates under 35 U.S.C. § 102 also renders the
claim unpatentable under 35 U.S.C. § 103, for “anticipation is the epitome of
obviousness.” Jones v. Hardy, 727 F.2d 1524, 1529 (1984); see also In re
Fracalossi, 681 F.2d 792, 794 (CCPA 1982). Thus, although we rely only
on Kahook, we affirm the decision of the examiner to reject claims 17 and
33 under 35 U.S.C. § 103. /« re 296 F.2d 491, 496 (CCPA 1961) (the
Board may affirm a multiple reference rejection under 35 U.S.C. § 103
relying on fewer than all of the references relied on by the Examiner and
without designating it as a new ground of rejection.)
c. Obviousness: Claims 23 and 24
The Examiner relies on Williams for its disclosure of a scanning
system in eye surgery. (Final Action 7.) The Examiner contends that it
would have been obvious at the time the invention was made to include a
scanning system in Kahook
to effectively, accurately and conveniently scan treatment area
and apply treatment. Basically, this replaces a manual process
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in which the doctor determines treatment area and applies
treatment.
(Id.)
Appellant argues that Williams dismisses ‘“all scanning spot systems’
as ‘problematic’” and instead “advocates the ‘digital micromirror device.’”
(Appeal Br. 30.) We do not find this argument persuasive as Williams does
not “dismiss[]” the use of all scanning spot systems. (Williams 102—108
(discussing incorporating the use of scanning spot with a digital micromirror
device).) Appellant’s claims 23—24 are “comprising” claims. “‘Comprising’
is a term of art used in claim language which means that the named elements
are essential, but other elements may be added and still form a construct
within the scope of the claim.” Genentech, Inc. v. Chiron Corp., 112 F.3d
495, 501 (Fed. Cir. 1997). Thus, Appellant’s do not exclude the inclusion of
additional assistive means used as part of, or in conjunction with, the
scanning system described in Williams.
Appellant further argues that the Examiner’s rationale is not supported
by any “authority” regarding the improvement one of ordinary skill in the art
would expect to achieve by the addition of Williams’ scanning device.
(Appeal Br. 32.) We do not find this argument persuasive. Combining
references need not be premised on a reference’s specific teaching but can
be based on “an apparent reason to combine the known elements in the
fashion claimed.” KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
Replacing manual processes with “modem electronic components in order to
gain the commonly understood benefits of such adaptation, such as
decreased size, increased reliability, simplified operation, and reduced cost”
is such an apparent reason to combine known elements. Leapfrog
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Enterprises Inc. v. Fisher-Price Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007).
We find that the Examiner has properly relied on commonly understood
benefits of replacing manual treatment analysis with the automated treatment
scanning process of Williams, e.g., for improved accuracy and convenience
in the obviousness analysis.
That Williams is not directed to treating the iris (Appeal Br. 32) is not
dispositive. The Examiner relies on Kahook for a laser that is capable of
being used for irradiation of the iris. Williams is relied upon for teaching a
guidance system that relies on scanning to control the spot and scan the
treatment area. (Final Action 7.) As Williams explains, such control allows
for customization of laser eye surgery and generates the appropriate surgical
profile. (See, e.g., Williams 107—108.)
It is well known that “familiar items may have obvious uses beyond
their primary purposes, and in many cases a person of ordinary skill will be
able to fit the teachings of multiple patents together like pieces of a puzzle.”
KSR, 550 U.S. at 420. Moreover, “if a technique has been used to improve
one device, and a person of ordinary skill in the art would recognize that it
would improve similar devices in the same way, using the technique is
obvious unless its actual application is beyond his or her skill.” Id. at 417.
Appellant does not argue that adding a guidance system such as that
disclosed by Williams would be beyond the skill of one of ordinary skill in
the art. And, we agree with the Examiner that inclusion of such an assistive
device would have been obvious to one of ordinary skill in the art for the
reasons the Examiner set forth. We do not find the Examiner’s reason to be
based on hindsight, contrary to Appellant’s assertion (Appeal Br. 32), but
rather premised on Williams’ disclosure.
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Appellant also argues that Williams is non-analogous art. (Appeal Br.
33.) We do not agree. Although Williams is directed to corneal surgery and
reshaping the cornea, as discussed above, the scanning guidance described
by Williams allows for laser control during surgery and assists in generating
the appropriate surgical profiles. Thus, even though Williams as a whole
may not be considered to be within the field of the inventor’s endeavor, it’s
teaching regarding the scanning system is, nevertheless, reasonably pertinent
to the particular problem with which the inventor is involved, e.g., control
by a computerized scanning system. (See Spec. 136 (“Movement of the
beam may be guided by a computerized scanning system. Such systems are
well-known in the art.”).)
Appellant argues that combining Williams with Kahook would render
Kahook unsatisfactory for its intended purpose. (Appeal Br. 35.) However,
we agree with the Examiner (Ans. 16) that it is unclear how that would be so
simply by adding a computer controlled scanning guidance system.
For the foregoing reasons, we affirm the Examiner’s rejection of
claims 23—24 as being obvious over Kahook and Williams.
d. Obviousness: Claims 25—2 7
The Examiner relies on Lin for teaching the claimed laser medium
and laser output. (Final Action 7—8.) The Examiner contends that it would
have been obvious to one of ordinary skill in the art to use these materials
and the laser wavelength output claimed in light of the fact that Lin teaches
these are common and effective laser materials and wavelengths for eye
surgery in the same field as Kahook, i.e., glaucoma treatment. (Id.)
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Appellant argues that Lin is non-analogous art because it is directed to
applying laser energy to the sclera, which is the white part of the eye beyond
the iris and that
Appropriate EMR wavelengths for scleral ablation are selected
for water and/or collagen absorption and their limited depth of
penetration and therefore tend to lie in the ultraviolet range,
typically 126-351 nm (which is consistent with the teachings of
Lin at Lin: Abstract), whereas appropriate EMR wavelengths
for iris tissue retraction (without pigment removal) are chosen
for their damage to deeper tissue structures and therefore tend
to be longer, in the NIR range.
(Appeal Br. 38—39.) We do not find this argument persuasive. Lin teaches
an apparatus for correction of glaucoma that relies on a laser to emit
radiation, just as Kahook does. Kahook teaches that in iridopathy it is
believed that radiation is converted to heat and causes contraction of stromal
collagen. (Kahook 34.) It is true that Lin directs radiation at scleral tissue,
but we note that Appellant argues scleral ablation involves affecting
collagen tissue. Thus, similar tissue appears to be involved in scleral tissue
ablation and iris tissue contraction, i.e., collagen. Consequently, with
respect to the choice of laser medium and laser output capability of the
claimed device, we do not agree with Appellant’s conclusion that Lin and
Kahook are so disparate as to be non-analogous.
In light of the foregoing, we also disagree with the Appellant (Appeal
Br. 37) that the Examiner’s obviousness rationale lacks the requisite rational
underpinning required by KSR or that it relies on impermissible hindsight
(id. at 38).
Appellant argues that the modification with Lin would render Kahook
unsatisfactory for its intended purpose because Lin is directed to ablative
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scleral tissue removal. (Id. at 40.) We do not find this argument persuasive
as it ignores the relevant combined teachings of the two references, which is
that the Lin laser medium and wavelength teaching would be substituted into
the Kahook device, and as discussed above, collagen tissue is addressed in
both treatments.
For the foregoing reasons, we affirm the Examiner’s rejection of
claims 25—27 as being obvious over Kahook and Williams.
e. Obviousness: Claim 28
Regarding claim 28, which requires “the approximate energy density”
to be “between about 0.45 J/cmA2 and about 2.0 J/cmA2,” the Examiner
contends that it would have been obvious for the device of Kahook to be
configured to apply the claimed laser energy density as a matter of routine
optimization. (Final Action 8.) The Examiner notes that Professor Bor8
indicated that typical laser peripheral iridopathy uses energy density of 1.2
J/cm2. (Ans. 17.)
Appellant contends the Examiner’s rejection is in error because the
energy density claimed was not recognized as a result effective variable at
the time of the invention. (Appeal Br. 41.) We do not find Appellant’s
argument persuasive. While the Examiner relies on an obviousness rationale
and “routine optimization” to reject claim 28 over Kahook, Homer, and Lin,
we conclude that Kahook teaches all of the recited limitations of claim 28,
which is dependent from claims 17 and 18 (requiring the electromagnetic
radiation to comprise “laser energy”).
8 Declaration of Zsolt Bor, PH.D. submitted with Appellant’s response filed
Dec. 22, 2014
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As discussed above, we find Kahook teaches laser iridopathy and teaches the
same claimed structure recited in claim 17 for doing so. Regarding the
energy density of laser iridopathy Professor Bor indicates that it is typical in
such procedures to use an energy density of 1.2 J/cm2 (Bor Dec. 1 6), which
is within the claimed range of “between about 0.45 J/cmA2 and about 2.0
J/cmA2.” . Consequently, we find the method of providing a device recited
in claim 28 is in fact anticipated by Kahook.
Because a disclosure that anticipates under 35 U.S.C. § 102 also
renders the claim unpatentable under 35 U.S.C. § 103, Jones v. Hardy, 727
F.2d at 1529, we affirm the Examiner’s rejection of claim 28 under 35
U.S.C. § 103, Bush, 296 F.2d at 496.
SUMMARY
We affirm the rejection of claims 1, 17, and 33 under 35 U.S.C. § 112,
first paragraph as failing to comply with the written description requirement.
We affirm the rejection of claims 1, 17, and 33 under 35 U.S.C. § 112,
first paragraph as failing to comply with the enablement requirement.
We affirm the rejection of claims 1, 12, 17, 28, and 33 under 35
U.S.C. § 112, second paragraph as being indefinite.
We reverse the rejection of claims 1, 2, and 6 under 35 U.S.C.
§ 103(a) as being unpatentable over Kahook and Homer.
We affirm the rejection of claims 17, 18, 22 and 33 under 35 U.S.C.
§ 103(a) as being unpatentable over Kahook and Homer.
We reverse the rejection of claims 7 and 8 under 35 U.S.C. § 103(a)
as being unpatentable over Kahook, Homer, and Williams.
We affirm the rejection of claims 23 and 24 under 35 U.S.C. § 103(a)
as being unpatentable over Kahook, Homer, and Williams.
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We reverse the rejection of claims 9-12 under 35 U.S.C. § 103(a) as
being unpatentable over Kahook, Homer, and Lin.
We affirm the rejection of claims 25—28 under 35 U.S.C. § 103(a) as
being unpatentable over Kahook, Homer, and Lin.
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. § 1.136(a).
AFFIRMED
26