Ex Parte Renzi et al

Patent Trials and Appeals Board

Mar 15, 2019

14232171 - (D) (P.T.A.B. Mar. 15, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/232,171 04/14/2014 Lisa M. Renzi
70001 7590 03/19/2019
NIXON PEABODY LLP
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.
25287 l-000023USPX 1596
EXAMINER
70 West Madison Street, Suite 3500 FAY,ZOHREHA
CHICAGO, IL 60602
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
03/19/2019 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):
docketingchicago@nixonpeabody.com
ipairlink@nixonpeabody.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LISA M. RENZI and BILLY R. HAMMOND 1
Appeal2017-006545
Application 14/232, 171
Technology Center 1600
Before DEBORAH KATZ, JOHN G. NEW, and TIMOTHY G. MAJORS,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants identify the University of Georgia Research Foundation, Inc. as
the real party-in-interest. App. Br. 3.
Appeal2017-006545
Application 14/232, 171
SUMMARY
Appellants file this appeal under 35 U.S.C. § I34(a) from the
Examiner's Final Rejection of claims 49---66 and 68-76 as unpatentable
under 35 U.S.C. § I03(a) as being obvious over the combination of Sharoni
et al. (WO 2007 /046083 A2, April 26, 2007) ("Sharoni") and Eidenberger
(US 2011/0144200 Al, June 16, 2011) ("Eidenberger").
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellants' invention relates to a method of enhancing a subject's
macular pigment optical density, the method comprising administering to the
subject a pharmaceutically effective amount of one or more xanthophyll
carotenoids. Spec. Abstr.
REPRESENTATIVE CLAIM
Claim 49 is representative of the claims on appeal and recites:
49. A method of improving a visual-motor performance of a
healthy human subject comprising:
administering, on a daily basis, to the healthy human
subject a supplement containing at least about 20 milligrams of
a combination of zeaxanthin and lutein, wherein the healthy
human subject has no known or diagnosed ocular disorders, the
administering enhancing the visual-motor performance of the
healthy human subject.
App. Br. 19.
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ISSUES AND ANALYSIS
We adopt the Examiner's findings, reasoning, and conclusion that
Appellants' claims 49---66 and 68-7 6 are prima facie obvious over the
combined prior art. We address the arguments raised by Appellants below.
A. Independent claim 49
Issue
Appellants argue that the Examiner erred because the cited prior art
neither teaches nor suggests the limitation of claim 49 reciting: "the
administering enhancing the visual-motor performance of the healthy human
subject." App. Br. 8.
Analysis
The Examiner finds that Sharoni teaches a composition of lutein,
zeaxanthin, and lycopene for reducing the risk of certain eye disorders,
improving visual function, and for treating certain ophthalmic disorders.
Final Act. 3 ( citing Sharoni 7, 9). The Examiner finds that Eidenberger
teaches that the combination of epi-lutein with lutein, zeaxanthin, and
lycopene increases the plasma uptake of carotenoids, consequently, an
increase in the amount of carotenoids can effectively be delivered to the
macula to help support the health of tissue, as well as to prevent age-related
macular degeneration ("AMD"). Id. ( citing Eidenberger ,r 40). The
Examiner finds that both references also teach improvement in visual
performance. Id.
Appellants argue that the Examiner is incorrectly linking the teachings
of Sharoni and Eidenberger for preventing and reducing the risk of a visual
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disorder to Appellants' claimed method for improving the visual-motor
performance of a healthy human subject. App. Br. 8. However, Appellants
assert, the Examiner failed to provide any basis for such an association, or to
produce any evidence of record that discloses such a relationship. Id.
According to Appellants, prior art that is focused on compositions for
preventing or treating visual orders would not necessarily have led a person
of ordinary skill in the art to consider the use of such compositions for
improving visual-motor performance of a healthy human. Id.
Specifically, Appellants argue, Sharoni teaches compositions for
treating glaucoma, cataracts, diabetic retinopathy and age-related macular
degeneration. App. Br. 9 ( citing Sharoni 7). Appellants assert that
Eidenberger teaches compositions for treating age-related macular
degeneration, cataracts, pinguecula, etc. Id. ( citing Eidenberger ,r 12).
Appellants contend that the Examiner finds that these references teach
"improving visual function" through use of a combination of lutein,
zeaxanthin, lycopene, and fatty acids, however, Appellants contend, the
cited references fall short of teaching the use of such compounds for
improving visual-motor performance. Id.
Appellants adduce the Declaration of Dr. Dennis Gierhart ( the
"Gierhart Declaration"). Dr. Gierhart is the Chairman, Chief Scientific
Officer, and a part owner of Zea Vision, LLC, the licensee of the instant
application. Gierhart Deel. ,r,r 1, 4. Appellants point to Dr. Gierhart's
statement that:
The processes that lead to improved visual-motor skills in
otherwise healthy volunteers was thought to be immutable
except for applications of psychoactive drugs like
methamphetamines or caffeine or slowed by barbiturates. Such
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compounds, however, act very quickly by very different modes
of action and have been the subject of much abuse.
App. Br. 9 (quoting Gierhart, Deel. ,r 10). Appellants assert that the Gierhart
Declaration thus provides evidence that improving visual-motor skills in
healthy adults was thought to be unfeasible in the art of the time, except for
the possible use of drugs or caffeine, but not by the compositions recited in
Appellants' claimed method. Id. Appellants contend that, because there is
no teaching or suggestion in the cited references ( or elsewhere) that the
compositions of the present invention could lead to enhanced visual-motor
performance in a healthy human subject, the Examiner has failed to establish
a primafacie basis for rejecting claim 49 on grounds of obviousness. Id.
Appellants argue further that Dr. Gierhart's Declaration provides
evidence that improving the visual-motor performance by administering
compositions of the claimed invention was unexpected and could not have
been predicted from the prior art. App. Br. 9-10. Appellants note that Dr.
Gierhart attests to the results of studies showing a 20% improvement in
visual-motor performance in healthy, young adults that "stunned the
scientific community." Id. at 10 (quoting Gierhart Deel. 11).
We are not persuaded by Appellants' arguments. Appellants contend
that Sharoni and Eidenberger are primarily directed to the treatment and
prevention of various ocular diseases, and not for the purpose of improving
visuomotor performance. App. Br. 9, 10. We do not find this persuasive of
nonobviousness.
Eidenberger expressly teaches:
Therefore, providing lutein to an individual for use in their diet
or as nutritional supplements supports better human health and
healthy vision.
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Therefore, there is a high demand for xanthophyll crystals
containing high amounts of trans (E)-lutein and/ or zeaxanthin for
its use as antioxidants, prevention of cataract and macular
degeneration, [etc.].
Eidenberger ,r,r 36-37 (paragraph numbers omitted).
Eidenberger thus teaches administration of of zeaxanthin and lutein as
a nutritional supplement for the purpose, inter alia, of maintaining healthy
vision. Contrary to Appellants' argument, the teachings of the cited art are
not limited solely to administering these supplements to subjects to treat
existing medical conditions (i.e., macular degeneration, cataracts, etc.).
Rather, Eidenberger at least suggests administration as part of a dietary
supplement to healthy human individuals to provide for better health and
vision more generally-and this would encompass, at least partly, the same
population of subjects as recited in claim 49 (i.e., healthy humans without
known or diagnosed ocular disorders).
We agree with Appellants that Eidenberger does not expressly teach
the administration of high amounts of zeaxanthin and lutein for the
improvement of visuomotor performance. However, we agree with the
Examiner that administration of high amounts of zeaxanthin and lutein as a
nutritional supplement would necessarily, and thus inherently, improve the
visuomotor performance of a healthy individual.
[W]here the Patent Office has reason to believe that a functional
limitation asserted to be critical for establishing novelty in the
claimed subject matter may, in fact, be an inherent characteristic
of the prior art, it possesses the authority to require the applicant
to prove that the subject matter shown to be in the prior art does
not possess the characteristic relied on.
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In re Best, 562 F.2d 1252, 1254--55 (C.C.P.A. 1977) (quoting In re
Swinehart, 439 F.2d 210, 212-13 (C.C.P.A. 1971)). Appellants do not meet
this prescribed burden of showing that administration of zeaxanthin and
lutein, as taught by the cited prior art, do not inherently improve visuomotor
performance in healthy individuals.
Furthermore, "[i]n some cases, [an] inherent property corresponds to a
claimed new benefit or characteristic of an invention otherwise in the prior
art." Perricone v. Medicis Pharma Corp., 432 F.3d 1368, 1377 (Fed. Cir.
2005). As we have explained above, we are persuaded that the cited art
teaches or suggests administering the same supplements on a daily basis to
healthy subjects to improve visual health. Claim 49 therefore reads on the
methods taught or suggested in Eidenberger and Sharoni. Even assuming
Appellants were the first to appreciate an inherent improvement in
visuomotor performance, a "new realization alone does not render the old
invention patentable." Id.; see also In re Woodruff, 919 F.2d 1575, 1578
(Fed. Cir. 1990) (holding that "[i]t is a general rule that merely discovering
and claiming a new benefit of an old process cannot render the process again
patentable.").
To the extent Dr. Gierhart's declaration addresses such a new
realization, which the declaration describes as surprising and unexpected, we
are not persuaded that the declaration evidence is sufficient to overcome the
strong evidence of obviousness on this record. We consequently affirm the
Examiner's rejection of claim 49.
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B. Independent claim 66
Issue
Appellants argue that the Examiner erred by failing to cite any prior
art reference for teaching the limitation of claim 66 reciting: "the
administering enhancing the visual-motor performance such that a reaction
time of the subject decreases relative to a reaction time of the healthy human
subject prior to administering the pharmaceutically effective amount." App.
Br. 11.
Analysis
Appellants argue that, in addition to the alleged failure by the
Examiner to reach this limitation, neither Sharoni nor Eidenberger teach or
suggest the step of administering a pharmaceutically effective amount of one
or more xanthophyll carotenoids to result in a reduction in reaction time of a
subject relative to a reaction time prior to administering the
pharmaceutically effective amount. App. Br. 11. Appellants repeat their
arguments with respect to claim 49 supra, viz., that to the extent that either
reference teaches the act of "improving visual function," they relate only to
treating eye disorders and do not teach enhancing visual-motor performance.
Id.
Appellants argue further that claim 66 also requires that: "the
xanthophyll carotenoids includ[e] at least 20 mg of zeaxanthin." App. Br.
12. Appellants assert that, although both Sharoni and Eidenberger disclose
compositions including zeaxanthin, neither reference teaches compounds
including "at least 20 mg of zeaxanthin." Id. Appellants contend that
Sharoni discloses that zeaxanthin is about 2% w/w and the oral compositions
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of Sharoni contain 400 mg total weight, such that 2% of this total weight is
zeaxanthin, or about 8 mg. Id. (citing Sharoni 23). According to
Appellants, this is consistent with the oral composition in Example 1 of
Sharoni, which teaches: "about 8 mg lutein and zeaxanthin ( combined
- about 2% w/w)." Id. ( citing Sharoni 22). Therefore, Appellants argue,
because both lutein and zeaxanthin are present at about 8 mg, the amount of
zeaxanthin alone is considerably less than the 20 mg of zeaxanthin recited in
claim 66 (and in claim 60, which depends from claim 49). Id.
Appellants next point to Eidenberger, which provides a single
example that discloses a study of rats, and a feeding dosage of 4 mg
zeaxanthin/kg body weight (Group C). App. Br. 12 (citing Eidenberger
Example 1 ). However, Appellants argue, because this dosage is intended for
rats, and not for young, healthy human adults, this teaching gives little
guidance for administering amounts of zeaxanthin to humans. Id. As such,
Appellants contend, the cited references fail to disclose administering at
least 20 mg zeaxanthin to healthy human subjects. Id.
We do not find Appellants' arguments persuasive. We have
addressed, with respect to claim 49, why we are persuaded by the
Examiner's findings and conclusion with respect to the teachings of Sharoni
and Eidenberger concerning "the administering enhancing the visual-motor
performance of the healthy human subject." We incorporate by reference
our adoption of the Examiner's findings and conclusion with respect to the
corresponding limitations of claim 66.
With respect to Appellants' argument that neither reference teaches
the limitation of claim 66 reciting: "a pharmaceutically effective amount of
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one or more xanthophyll carotenoids, the xanthophyll carotenoids including
at least 20 mg of zeaxanthin," paragraph [0086] of Eidenberger teaches that:
Total dosage amounts of a xanthophyll(s) and epilutein
composition will typically be in the range of from about 0.0001
or 0.001 or 0.01 mg/kg/day to about 100 mg/kg/day, but may be
higher or lower, depending upon, among other factors, the
activity of the components, its bioavailability, the mode of
administration and various factors discussed above.
More specifically, paragraphs [0090]-[0092] of Eidenberger teach:
3. A composition comprising: from about 5 to about 95 weight
percent epi-lutein and from about 95 to about 5 weight percent
of a carotenoid, wherein the weight percentages equal 100 weight
percent.
4. The composition of paragraph 3, wherein the carotenoid is
lutein, zeaxanthin, B,B-carotene, violaxanthin, neoxanthin,
astaxanthin, lycopene, canthaxanthin, capsanthin, capsorubin,
derivatives thereof including esters, or mixtures thereof.
(Paragraph numbers omitted). Combining the teachings of these passages,
we find that a person of ordinary skill in the art would understand that a
composition comprising 5 weight percent of epi-lutein and 95% zeaxanthin,
administered in dosages of 0.01 mg/kg/day to about 100 mg/kg/day of the
zeaxanthin/epi-lutein composition, would include the dosage of: "at least 20
mg of zeaxanthin, recited in claim 66. We consequently affirm the
Examiner's rejection of claim 66.
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C. Dependent claims 54, 55, 56, 60, 64, 69, 70, 72, 73, 74, 75, and 76
Issue
Appellants argue that the Examiner erred by failing to address the
rejection of these dependent claims in the Final Office Action. App. Br. 11.
Analysis
Appellants assert that, in the Final Office Action, no comments are
directed to any of the above limitations, several of which are directed to
athletes or professionals who engage in activities or duties with a need for
improved visual-motor performance. App. Br. 11-12. According to
Appellants, there is no mention in either of the cited prior art references of
administering compounds to athletes or professionals as a way of improving
visual-motor performance. Id. at 12. Nor, contend Appellants, is there any
teaching of improving a visual-motor performance, such as reaction-time
ability, in a healthy, human subject. Id.
We are not persuaded. Appellants argue that the Examiner failed to
address the dependent limitations cited. On page 3 of the Final Office
Action, the Examiner expressly states that: "Claims 49---66 and 68-7 6 are
rejected under pre-AIA 35 U.S.C. [§] 103(a) as being unpatentable over
[Sharoni] in view ofEidenberger. ... " Although the Examiner does not
address all of the claims separately, the Examiner concludes that:
It would have been obvious to a person skilled in the art to
incorporate fatty acids into the composition of [Sharoni] and use
the combination of carotenoids and fatty acids in a food product
and dietary supplement[,] motivated by the teachings of
Eidenberger, which teaches the use of fatty acids in combination
with lutein, zeaxanthin and lycopene in a food product as old and
well known. The improvement in visual performance is also
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taught by the above references. The combination of relied upon
references make clear that the combination of lutein, zeaxanthin,
lycopene and fatty acids have been previously used in improving
visual function. Applicant has presented no evidence to establish
the unexpected or unobvious nature of the claimed invention, and
as such, claims 49---66 and 68-76 are properly rejected under 35
U.S.C. [§] 103(a).
Final Act. 3--4. The Examiner has thus established a prima facie case that
the dependent claims at issue are obvious over the combined cited prior art.
Appellants do not argue the merits of the dependent claims specifically, with
the exception of asserting that several of the claims (i.e., claims 71 and 75)
relate to sports, or to other visually demanding activities. See App. Br. 11-
12. Nevertheless, we do not see how the application of the claimed method
to a specific activity benefiting from increased visuomotor performance
makes the claims any less obvious than they would be over a more general
claim of increased visuomotor performance particularly where, as discussed
above, we find that the combined art suggests administering the recited
supplements to healthy individuals more generally to improve visual health.
Appellants also argue that, with respect to dependent claim 60, neither
Sharoni nor Eidenberger teach or suggest the use of zeaxanthin in a
supplement of at least 20 milligrams. App. Br. 60. We have explained
supra, with respect to claim 66, why we do not find this argument
persuasive. We consequently affirm the Examiner's rejection of the claims.
DECISION
The Examiner's rejection of claims 49---66 and 68-76 as unpatentable
under 35 U.S.C. § 103(a) is affirmed.
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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)(l )(iv).
AFFIRMED
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