Ex Parte Lewis

Patent Trials and Appeals Board

Mar 13, 2019

14201353 - (D) (P.T.A.B. Mar. 13, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/201,353 03/07/2014
118311 7590
Toering Patents PLLC
P.O. Box 1419
Leesburg, VA 20177
03/15/2019
FIRST NAMED INVENTOR
Michael D. Lewis
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.
LlOl 1010.1 7303
EXAMINER
PIHONAK, SARAH
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
03/15/2019 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):
rick@toeringpatents.com
admin@toeringpatents.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL D. LEWIS
Appeal 2018-006663
Application 14/201,353
Technology Center 1600
Before ULRIKE W. JENKS, TIMOTHY G. MAJORS, and
MICHAEL A. VALEK, Administrative Patent Judges.
VALEK, Administrative Patent Judge.
DECISION ON APPEAL
Appellant submits this appeal 1 under 35 U.S.C. § 134 involving
claims to methods for treating traumatic brain injury by administering an
omega-3 fatty acid mixture, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
Claims 1-11, 13-1 7 and 19 are on appeal, and can be found in the
Claims Appendix of the Appeal Brief. Claim 1 is the only independent
1 Herein we refer to the Final Office Action mailed January 6, 2017 ("Final
Act."), Appeal Brief filed January 5, 2018 ("App. Br."), Examiner's Answer
mailed April 12, 2018 ("Ans."), and Reply Brief filed June 12, 2018
("Reply").
Appeal 2018-006663
Application 14/201,353
claim and is representative of the claims on appeal. Claim 1 reads as
follows:
1. A method of treating a traumatic brain injury in a patient, the
method comprising oral administration of a composition
comprising an omega-3 fatty acid mixture to a patient having
a brain injury, wherein the omega-3 fatty acid mixture
comprises at least about 70% by weight of a combination of
(a) EPA glyceride, and (b) DHA glyceride, in a weight ratio
of a:b of from about 1.5:1 to about 1.3:1, wherein about
15,000 mg to about 25,000 mg of the combination of (a) and
(b) is administered daily.
App. Br. 10. Appellant does not argue dependent claims 2-11, 13-17 and
19 separately so those claims stand or fall with claim 1. 37 C.F.R. § 41.37
( C )(1 )(iv).
Appellant seeks review of Examiner's rejection of these claims as
obvious over Lewis2 and Hageman. 3
The issue is: Does the preponderance of evidence of record support
Examiner's conclusion that the cited prior art renders obvious the claimed
method of treatment?
Findings of Fact
FF 1. Lewis teaches the "prophylactic administration" of a daily dose of
omega-3 fatty acids (n-3 FA) comprising EPA and DHA "at [the] already
FDA-approved cardiovascular doses up to 4 g/d[ay]" to improve outcomes
following traumatic brain injury (TBI). Lewis 1124, left column. According
2 Michael D. Lewis et al., Neuroprotectionfor the Warrior: Dietary
Supplementation With Omega-3 Fatty Acids, MILITARY MEDICINE, Vol. 176,
10:1120 (2011) ("Lewis").
3 Robert Johan Joseph Hageman et al., US 2011/0009357 Al, published Jan.
13, 2011 ("Hageman").
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Application 14/201,353
to Lewis, "the beneficial effects extend to when n-3 FA are given before the
injury." Id. Lewis teaches that "[g]iven the safety profile, availability, and
affordability of n-3 FA, it should be considered a beneficial supplement for
the athlete and soldier, not only for its general health benefits, but particularly
for those at risk of high exposure to brain impacts." Id.
FF2. In addition to teaching n-3 FA as a nutritional supplement in advance
of injury to provide a prophylactic effect in the event of possible TBI, Lewis
teaches that n-3 FA has been used at higher doses to treat patients with TBI.
Lewis 1123, right column. In particular, Lewis teaches that a patient with
"severe carbon monoxide and methane poisoning ... was treated with 21.2
g/d[ay] ofn-3 FA that contributed to his neurological recovery following an
initial presentation in deep coma." Id. Lewis further reports an instance in
which a teenager with "severe TBI ... was started on a similar dosage of n-3
FA" and "progressed from vegetative state to attending his high school
graduation 3 months later." Id.
FF3. Hageman teaches a "lipid fraction" as a nutritional or pharmaceutical
product for "the support of brain function, the treatment of neurological
disorders or diseases." Hageman ,r,r 7-8. Hageman teaches that the lipid
fraction comprises DHA "in an amount of at least 0.5 ... more preferably 5-
30 wt% of the sum of fatty acids in that fraction and wherein the weight ratio
ofDHA to EPA is preferably in the range 0.2-7, more preferably 0.8-4." Id.
i1 15.
Analysis
Examiner finds that both Lewis and Hageman teach omega-3 fatty
acids comprising EPA and DHA for treating TBI and relies on Hageman's
teaching of a weight ratio of DHA to EPA that includes the ratio in claim 1.
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Application 14/201,353
Final Act. 6-8. Examiner determines that it would "have been prima facie
obvious ... to have adjusted this weight ratio range to ... arrive[] at the
range recited in the instant claims" because Hageman's range is inclusive of
the claimed range. Id. at 8. Regarding the dosage limitation, Examiner finds
that it would have been obvious to increase the daily dosage to the claimed
range of 15,000-25,000 mg, particularly in light of Lewis' teaching of
specific instances in which a dose of "21.2 g/ d[ ay ]" had been used to
successfully treat TBI. Ans. 9.
Appellant's arguments on appeal relate only to the dosage limitation
in claim 1. Appellant contends that Lewis teaches away from the dosage
range in claim 1 because it "poses constraints on the usage of omega-3 fatty
acids (i.e., EPA, DHA, etc.), namely that dosing be 'Generally Recognized
as Safe' and within FDA-approved levels." App. Br. 5. According to
Appellant, the claimed dosage range "exceeds the FDA-approved dosages
by factors of approximately 4 to 6 times ( e.g., 4000 mg versus 15,000 to
25,000 mg)." Id. at 6. In addition, Appellant argues that it would not be a
matter of routine experimentation, nor would the skilled artisan find it
obvious, to optimize Lewis' 4,000 mg dose up to the claimed range. Id. at
7-8.
We conclude that the preponderance of the evidence supports
Examiner's conclusion of obviousness. We agree that the skilled artisan
would be motivated to combine Lewis and Hageman as in the rejection and
that Hageman supports a prima facie case of obviousness for the claimed
weight ratio of EPA to DHA-findings that Appellant does not challenge on
appeal. We further agree that Lewis renders the dosage limitation obvious,
particularly given its express teaching of instances where dosages were
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Application 14/201,353
administered in the claimed range. FF2; See In re Peterson, 315 F.3d 1325,
1329 (Fed. Cir. 2003) ("[W]e and our predecessor court have consistently
held that even a slight overlap in range establishes a prima facie case of
obviousness.").
We are not persuaded by Appellant's teaching away argument. "A
reference does not teach away ... if it ... does not 'criticize, discredit, or
otherwise discourage' investigation into the invention claimed." Galderma
Labs., L.P. v. Tolmar, Inc., 737 F.3d 731, 739 (Fed Cir. 2013) (quoting
DePuy Spine Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327
(Fed. Cir. 2009)). Here, Lewis recommends a dose up to 4,000 mg/day as a
nutritional supplement and prophylaxis for those at risk of possible TBI.
FF 1. It does not "criticize, discredit, or otherwise discourage" the use of
higher doses to treat patients with TBI. To the contrary, Lewis describes the
"authors' personal experiences treating TBI" with much higher doses,
including 21,200 mg/day, that "has led [them] to believe that n-3 F As are
beneficial for support in neurological and systemic injury recovery." Lewis
1123, right column. Thus, far from teaching away, Lewis actually
encourages the use of daily dosages within the claimed range to treat severe
brain injuries. See FF2.
We are likewise not persuaded by Appellant's argument that the
skilled artisan would not arrive at the claimed dosage range by routine
experimentation. We agree with Examiner that it would be obvious for the
skilled artisan to experiment with doses in the claimed range, particularly
given the Lewis authors' report of their own success treating patients with
such dosages. See Ans. 11. In reply, Appellant contends that the skilled
artisan would not exceed the FDA-approved 4 g/day dose because higher
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Application 14/201,353
doses "are not recognized as safe by the FDA." Reply 4. But the fact that
the FDA has approved "cardiovascular doses up to 4 g/d[ay]" does not
evidence that higher dosages are unsafe. Lewis 1124, left column. Nor is
the 21.2 g/day dose in Lewis the only instance of higher doses in the prior
art of record. Examiner also points to Sorgi, 4 which describes the successful
use of a 16,200 mg/day oral dose ofEPA/DHA concentrates to treat children
with ADHD. See Final Act. 4 (citing Sorgi). Appellant does not respond to
this evidence.
For all these reasons, Appellant's arguments fail to persuade us that
Examiner erred in rejecting the claims. Accordingly, we affirm.
SUMMARY
We affirm the rejection of claims 1-11, 13-17 and 19 under 35 U.S.C.
§ 103 over Lewis and Hageman.
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
4 Sorgi et al., Effects Of An Open-label Pilot Study With High-Dose
EPA/DHA Concentrates On Plasma Phospholipids And Behavior In
Children With Attention Deficit Hyperactivity Disorder, NUTRITION
JOURNAL, Vol. 6, No. 16 (2007) ("Sorgi").
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