Ex Parte Klamer

Patent Trial and Appeal Board

Sep 20, 2018

12998843 (P.T.A.B. Sep. 20, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/998,843 06/07/2011
36844 7590 09/24/2018
Cermak Nakajima & McGowan LLP
127 S. Peyton Street, Suite 200
ALEXANDRIA, VA 22314
FIRST NAMED INVENTOR
Daniel Klamer
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.
125-001 3412
EXAMINER
KANTAMNENI, SHOBHA
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
09/24/2018 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):
CGOODE@cnmiplaw.COM
IP@cnmiplaw.com
ACERMAK@cnmiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DANIEL KLAMER 1
Appeal2017-001993
Application 12/998,843
Technology Center 1600
Before ULRIKE W. JENKS, RICHARD J. SMITH, RYAN H. FLAX,
Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims directed
to a method of administering L-lysine to a subject for the purpose of
improving the subject's cognitive function and performance. Examiner
rejects the claims as anticipated. We have jurisdiction under 35 U.S.C.
§ 6(b).
We AFFIRM.
1 According to Appellant, the real party in interest is Cognite, AB of
Goteborg, Sweden. Br. 2.
Appeal2017-001993
Application 12/998,843
STATEMENT OF THE CASE
Claims 28-33, 43, and 45--48 are on appeal, and can be found in the
Claims Appendix of the Appeal Brief. Claim 28 is representative of the
claims on appeal, and reads as follows:
28. A method comprising
providing a normal healthy human subject;
orally administering to the subject 3000-20,000 mg per
day of L-lysine in the form of a dietary supplement and thereby
improving the subject's cognitive function and performance.
Br. 9 (Claims Appendix). Claim 45, the only other independent claim,
recites the administration of L-lysine at a dose of about 500--40,000 mg/day.
The claims stand rejected as follows:
I. Claims 28-33, 43, and 45--48 under 35 U.S.C. § 102(b) as
being anticipated by Tome. 2
II. Claims 28-33, 43, and 45--48 under 35 U.S.C. § 102(b) as
being anticipated by Maxwell. 3
I. Anticipation by Tome
The issue is: Does the evidence of record support Examiner's
findings that Tome teaches a method of supplementing a human subject with
the daily dose of L-lysine as claimed?
Principle of Law
To anticipate a reference must expressly or inherently disclose "within
the four comers of the document not only all of the limitations claimed but
2 David Tome and Cecile Bos, Lysine Requirement through the Human Life
Cycle, 137 J. NUTRITION 1642S-1645S (2007) ("Tome").
3 Maxwell et al., US 6,117,872, issued Sept. 12, 2000 ("Maxwell").
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Application 12/998,843
also all of the limitations arranged or combined in the same way as recited in
the claim." Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed.
Cir. 2008).
Analysis
Examiner finds that Tome teaches "L-Lysine hydrochloride is used in
cereal fortification for human consumption." Final Act. 4 2. Examiner finds
that Tome teaches lysine requirements for infants and adults. Id. (citing
Tome Table 2). Examiner, based on Tome's disclosed daily lysine
requirements, calculates that the average human male weighing 88.5 kg
consumes lysine in an amount ranging between 3,540 mg- 15,930 mg/day.
Id. at 3. Tome "teaches administration of L-lysine to normal human (i.e
instant normal healthy human), the composition/diet comprising lysine in the
same effective amounts or doses upon administration, necessarily result in
improving" cognitive function, thereby anticipating the claims. Id.
Appellant contends that "[t]here is no information in Tome regarding
the ratio of L- to D-lysine that would enable the person of skill in the art to
determine how much L-lysine is present in any racemic mixture." Br. 5.
Additionally, Appellant contends that Tome establishes "the recommended
daily intake of lysine in adults is 30 mg/(kg·day)," but does not otherwise
teach that "L-lysine is administered as a dietary supplement, i.e., the amount
of lysine administered is in addition to the amount consumed by the subject
in their diet." Id. at. 6.
We are not persuaded by Appellant's contention that the L-lysine
concentration in a racemic mixture is not known. Examiner explains that a
4 Final Office Action mailed September 4, 2015 ("Final Act.").
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Application 12/998,843
"racemic mixture is defined as, 'mixtures of equal amounts of enantiomers
[that] are optically inactive, since the rotations cancel. Such mixtures are
called racemic mixtures."' Ans. 5 ( citing March 5). The evidence of record,
therefore, supports Examiner's position that a racemic mixture of lysine
contains 50% L-lysine.
We are, however, persuaded by Appellant's contention that Tome
does not disclose administering L-lysine in the form of a supplement as
claimed.
Tome's Table 2 is reproduced below:
TABLE 2 Protain and lysine requuements of infants.
children, adolescents, and adults
Pmtein, g-kri" 1-d" .. 1 Lysirie,i
Age, y Maintenance Grov.;tn mg-kg .. i. d .. i
tl5 0.600. 0.46 64
1-4 OJ386 0~9 45
4-'.0 0.600 0.06 35
10---A 0.696 0 .. 07 36
'14-'18 0.686 M4 34
::~1H tum 30
~ Suro of the 1vs1,1e requireme1n for rn«intemmce {mainteriance protein >< the adult
s..cnring p~nem/ arid gro-.0.1:h /!is~m~ oopc ... rsit:c,,, ~d1ustE'Sct fnr ll. 5fViG. d~taiy i;,ffir.iA11C'f' of
utiliwtion x the /.\A tiMllHl p,,ttem) !361
The data provided in table 2 shows the daily lysine requirements of
human subjects from infancy through adulthood. Tome explains that
"[l]ysine cannot be synthesized by mammal[]s," therefore, this amino acid is
indispensable and must be provided by the diet. Tome 1642S. Although we
recognize that Tome teaches supplementing food products with L-lysine,
there is no teaching in Tome that all L-lysine consumed by a human ( or
5 Jerry March, Advanced Organic Chemistry, McGraw-Hill publishers,
( 1977) page 87, paragraph 3.
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Application 12/998,843
animal) subject is in the form of fortified cereals. See id. As pointed out by
Appellant, because L-lysine in the diet can be derived from natural food
sources there is insufficient evidence in the record that the daily lysine
requirement as disclosed in Tome is supplied to the subject in the form of a
supplement.
We agree with Appellant's position that a dietary supplement is
reasonably understood to be a product that is consumed in addition to the
diet. See Br. 6. A "supplement"6 is something that completes or is added to
the diet or food stuff. Even though Tome discloses the use of supplemented
food stuff in the form of fortified cereal (see Tome 1642S), the evidence of
record is not sufficient to establish that the administration of the requisite
amounts of dietary lysine as suggested by Tome is solely provided from
fortified cereal as opposed to meats and other food substances that contain
lysine. Here, within its four comers the document does not provide a
sufficient evidentiary basis to establish that the amounts of lysine consumed
by the subject are in addition to the lysine provided in the diet.
The evidence of record does not support Examiner's finding that
Tome provides the requisite amounts of L-lysine as a dietary supplement.
Accordingly, we reverse the Examiner's anticipation rejection of claims 28-
33, 43, and 45--48 based on Tome.
6 Merriam-Webster.com. Merriam-Webster, https://www.merriam-
webster.com/dictionary/supplement, last accessed August 2018.
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Application 12/998,843
II. Anticipation by Maxwell
The issue is: Does the evidence of record support Examiner's
findings that Maxwell teaches a method of supplementing a human subject
with the daily dose of L-lysine as claimed?
Findings of Fact
FF 1. Maxwell teaches "administering high levels of the basic amino acids,
L-arginine and L-lysine, individually or combined, to individuals,
including humans and race animals, prior to physical exertion" in
order to improve performance. Maxwell 2:38--41 (emphasis added).
FF2. Maxwell teaches that "[t]he normal individual in the normal diet
ingests about 1-6 grams of arginine per day and about 1.5-7 grams of
lysine per day." Id. 2:54--56.
FF3. Maxwell teaches administering basic amino acids to a normal
individual 6--48 hours before physical exertion. See id. 2:56-59; see
also id. 3: 17-22 ("basic amino acid will be taken ... within 3 h[ ours]
of activity"), see id. 11:55-12:6 (claim 1). "[A] total of 4-9 g ofbasic
amino acid, usually not more than about 12 g, will be administered
orally as a bolus or in multiple doses .... " Id. 2:61-63; see also id.
12:3-5 ("at least one amino acid selected the group consisting of
arginine and lysine of at least about 60 mg/kg/day").
FF4. Maxwell teaches that "[t]he formulation may be in solid or liquid
form and may include tablets, capsules, powders, and the like."
Id. 3 :44--46. The basic amino acid composition can be in the form of
a food substance such as a drink, food bar. See id. 3:49-55.
FF5. Examiner finds that the average male weighs 88.5 kg. Final Act. 6.
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Principle of Law
"[ A ]nticipation does not require actual performance of suggestions in
a disclosure. Rather, anticipation only requires that those suggestions be
enabling to one of skill in the art." Bristol-Myers Squibb Co. v. Ben Venue
Labs., Inc., 246 F.3d 1368, 1379 (Fed. Cir. 2001) (citing In re Donohue, 766
F.2d 531, 533 (Fed. Cir. 1985) ("It is not, however, necessary that an
invention disclosed in a publication shall have actually been made in order
to satisfy the enablement requirement.")).
[P]roof of efficacy is not required for a prior art reference to be
enabling for purposes of anticipation .... [T]he proper issue is
whether the [prior art] 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.
Impax Labs., Inc. v. Aventis Pharms. Inc., 468 F.3d 1366, 1383 (Fed. Cir.
2006).
Analysis
Examiner finds that Maxwell teaches a method "of enhancing athletic
performance by administering basic amino acids, L-arginine and L-lysine,
individually or combined." Final Act. 5; FF1-FF5. Examiner finds that
Maxwell's disclosure of administering a concentration of 60
mg/kilogram/day for the average male weighing 88.5 kg is 5310 mg per day.
Final Act. 6; FF3, FF6. Because Maxwell teaches administration of L-lysine
to normal healthy human subjects in an amount that meets the instant claims,
the result of "improving pre-attentive and attentive information, attentional
capacity" is an inherent result. Final Act. 6; FF3.
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Appellant contends that there is no data in Maxwell that "arginine and
lysine are interchangeable with respect to their effect on nitric oxide
production." Br. 7. Appellant contends that lysine has an opposing effect
on nitric oxide production. Id. (citing the 2008 doctoral thesis by N.J.
Finnerty). Appellant reiterates their position that the Examiner's assumption
that "the ratio[] of enantiomers in the racemic mixture is 1: 1 is baseless." Id.
at 8.
On this record, we find that Examiner has the better position. As
explained by Examiner, Maxwell expressly discloses administering L-lysine
to a human subject for the purpose of improving endurance. FFl, FF3, FF4.
Therefore, Appellant's arguments that L-arginine and L-lysine are not
interchangeable are not persuasive.
Maxwell discloses administering high levels of L-lysine to
individuals, including humans, prior to physical exertion. FF 1. Maxwell
recognizes that individuals in the normal diet consume just about 1.5-7
grams of lysine a day. FF2. Maxwell expressly suggests administering
either L-arginine or L-lysine individually or as a combination prior to
physical exertion. FF3. Maxwell discloses that the formulation can be in
the form of pills or tablets and alternatively could also be included in food
substances. FF4.
Contrary to Appellant's contention, there is no requirement that
Maxwell have actually performed the disclosed methods in order for the
teachings of Maxwell to anticipate the claim. See Impax Labs, 468 F.3d at
1383. Here, Maxwell expressly suggests that either L-arginine or L-lysine
can be administered to a healthy subject. FF3. Examiner is not relying on
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the substitution L-lysine for L-arginine to arrive at the conclusion that
Maxwell anticipates. See Ans. 7.
Maxwell discloses the administration of L-Lysine within the claimed
range to the same patient population. FF3. Therefore, the result of
"improving the subject's cognitive function and performance" as claimed
naturally flows from such administration and is an inherent result of the
method taught by Maxwell. See Ans. 6 ("claimed improvement in cognitive
function would be inherent"). When considering a prior art method, the
anticipation doctrine examines the natural and inherent results in that
method without regard to the full recognition of those benefits or
characteristics within the art field at the time of the prior art disclosure.
Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1378 (Fed. Cir. 2005).
Here, Maxwell teaches supplementing the same patient population (normal
healthy adults) with the same supplement, therefore, the result of improving
cognitive function is inherent. See FF 1-FF3.
It is well-established that merely recognizing a result of an old process
that has not been recognized before is insufficient to confer patentability on
that old process. MEHL/Biophile Int'! Corp. v. Milgraum, 192 F.3d 1362,
1365 (Fed. Cir. 1999); see also In re Omeprazole Patent Litig., 483 F.3d
1364, 1373 (Fed. Cir. 2007); Perricone, 432 F.3d at 1378-79; In re
Cruciferous Sprout Litig., 301 F.3d 1343, 1351 (Fed. Cir. 2002); In re
Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). Therefore, it is not
dispositive that Maxwell did not appreciate that the L-lysine administration
in the amounts suggested results in "improving the subject's cognitive
function and performance" as claimed. Rather, as long as Maxwell
disclosed the same step as claimed and administration of the L-lysine to the
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same patient population, then Examiner had a sound basis to believe that
improved cognitive functions would be realized. Because Maxwell
expressly teaches the same method step applied to the same patient
population as recited in claim 28, the Examiner's burden was properly
discharged.
We are not persuaded by Appellant's contention that the Examiner has
not established that a racemic mixture is a 1: 1 mixture of enantiomers. See
Br. 8. As discussed above (see supra I.) we find that the Examiner has
provided sufficient evidence to support the position that a "racemic mixture
is defined as, 'mixtures of equal amounts of enantiomers are optically
inactive, since the rotations cancel."' Ans. 8 ( citing March). To reiterate,
Maxwell expressly discloses supplying L-lysine to a subject. See FFI.
Therefore, we are not persuaded by Appellant's argument that there is
uncertainty in the teachings of Maxwell with respect to the amounts of L-
lysine supplied to a subject.
We affirm the rejection of claim 28 under 35 U.S.C. § 102(b) over
Maxwell. Claims 29--33, 43, and 45--48 were not separately argued and fall
with claim 28. 37 C.F.R. § 4I.37(c)(l)(iv).
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Application 12/998,843
SUMMARY
We reverse the rejection of claims 28-33, 43, and 45--48 under
35 U.S.C. § 102(b) by Tome.
We affirm the rejection of claims 28-33, 43, and 45--48 under
35 U.S.C. § 102(b) by Maxwell.
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
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