Ex Parte Kobayashi et al

Patent Trial and Appeal Board

Apr 25, 2018

11909740 (P.T.A.B. Apr. 25, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/909,740 06/23/2010
38108 7590 04/27/2018
CERMAK NAKAJIMA MCGOWAN LLP
127 S. Peyton Street
Suite 210
ALEXANDRIA, VA 22314
FIRST NAMED INVENTOR
Hisamine Kobayashi
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.
US-222 8458
EXAMINER
KIM, JENNIFER M
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
04/27/2018 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
scermak@cnmiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HISAMINE KOBAYASHI, HIROMI SUZUKI,
ROBERT R. WOLFE, and CHRISTOS S. KATSANOS
Appeal2017-003713
Application 11/909,740
Technology Center 1600
Before RICHARD M. LEBOVITZ, TA WEN CHANG, and
TIMOTHY G. MAJORS Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
Appellants 1 submit this appeal under 35 U.S.C. § 134(a) involving
claims to an amino-acid-containing composition. The Examiner rejected the
claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the Real Party in Interest as Ajinomoto Co., Inc. Br. 3.
Appeal2017-003713
Application 11/909,740
STATEMENT OF THE CASE
Appellants' "invention relates to an amino-acid containing
composition which is orally ingested for preventing or remedying a decrease
in the skeletal muscle of aged people." Spec. 1:5-7. "An age-related
decrease of muscle mass occurs in skeletal muscle, which is called
sarcopenia." Id. at 1:10-11. According to the Specification, a
"countermeasure" to the decrease in skeletal muscle mass "is to promote the
protein anabolism of skeletal muscle by increasing the muscle protein
synthesis or reducing muscle protein degradation." Id. at 1: 17-20.
Claims 5 and 9 are on appeal and are reproduced below:
5. An amino acid-containing composition comprising
essential amino acids at the following molar composition
ratio (%) with respect to total of essential amino acids:
0.0 to 3.5 of L-histidine, 5.0 to 15 of L-isoleucine, 35 to
45 ofL-leucine, 8.0 to 16 ofL-lysine, 2.0 to 10 ofL-methionine,
2.5 to 8.0 ofL-phenylalanine, 7.0 to 14 of L-threonine, 5.0 to 15
of L-valine, and 0.0 to 2.0 of L-tryptophan;
wherein said composition is able to prevent or remedy a
decrease in skeletal muscle mass of an aged person when orally
administered to an aged person.
9. An amino acid-containing composition comprising amino
acids at the following molar composition ratio (%) with respect
to total of essential amino acids:
0.0 to 3.5 of L-histidine, 5.0 to 15 of L-isoleucine, 35 to
45 ofL-leucine, 12 to 16 ofL-lysine, 3.0 to 10 of L-methionine,
3.5 to 8.0 ofL-phenylalanine, 11 to 14 ofL-threonine, 8.5 to 15
of L-valine, 0.0 to 1.0 of L-tryptophan, and 0.0 to 10 of L-
argmme;
wherein said composition is able to prevent or remedy a
decrease in skeletal muscle mass of an aged person when
administered to said aged person.
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Application 11/909,740
Br. 11 (App'x A.).
The claims stand rejected by the Examiner under 35 U.S.C. § 103(a)
over Dioguardi. 2
DISCUSSION
The Examiner rejected the compositions of claims 5 and 9 as obvious
over the compositions taught or suggested by Dioguardi. Final Act. 2--4.
The Examiner finds that Dioguardi teaches compositions suitable for
treatment of conditions distinguished by reduced mitochondrial function
having, as the principal active ingredients, the essential amino acids leucine,
isoleucine, and valine. Id. at 2. The Examiner further finds that Dioguardi
teaches, in a working example, a composition comprising the nine essential
amino acids recited in claims 5 and 9. Id. at 2 ( citing Dioguardi Table 1 ).
According to the Examiner, the amounts of the 9 amino acids in this
working example are either within the amounts recited in the claims, or "so
close [in] proximity to what is claimed" that "one would find these amounts
obvious within amounts taught by the Dioguardi's mixture without side by
side comparison." Id. at 4; see also id. at 5 ("the comparative testing
composition ... employed by Applicant differ greatly with the composition
disclosed by the prior art (e.g. the composition of Table 2 ofDioguardi[)].")
In further support of this conclusion, the Examiner finds that Dioguardi
teaches "the mixtures can be formulated in various ranges when the amino
acids are integrated in a formulation." Id. at 3--4 (citing, e.g., Dioguardi's
teaching that L-isoleucine and L-valine may be included in a range of 0.2-
0. 7 grams for each gram of L-leucine). And, thus, the Examiner reasons "it
2 Dioguardi, WO 2005/034932 A2, published Apr. 21, 2005.
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Application 11/909,740
is well within the knowledge of the skilled artisan to optimize the dosage
ranges" to produce the claimed compositions. Id. at 4.
Appellants make several arguments. First, Appellants contend the
Examiner, in citing Dioguardi's Table 1, has not established obviousness
because "the amounts of amino acids listed in Dioguardi 's Table 1 ... are
not comparable because they relate to different ways of quantifying the
amounts of amino acids." Br. 7 (asserting that Table 1 expresses the amino
acid ratios as "g/1 OOg" and not "molar percentages" as in the present
claims). Appellants provide a "marked-up copy" of Dioguardi's Table 2,
which calculates the relevant molar ratios for comparison to the claims. Id.;
see also id. App'x B (Appellants' "marked-up copy of page 8 from
Dioguardi 's publication"). According to Appellants, "[ w ]hen the amounts
of each essential amino acid are calculated with respect to the sum of
essential amino acids, the amounts of leucine, isoleucine, valine, and
phenylalanine are outside the ranges of the pending claims." Br. 7. 3
3 It appears the amount of L-methionine in Dioguardi' s example ( 1.16%) is
also slightly outside the ranges of claims 5 and 9. Br. (App'x B); Dioguardi
8 (Table 2). Note that Table 1 and Table 2 of Dioguardi describe the same
composition, but "the amount in grams of the composition referred to in
Table 1 are expressed on the basis of molecular weight" and molar ratios in
Table 2. Dioguardi 7-8. The composition of Table I/Table 2 includes, in
addition to the nine essential amino acids, amounts of the non-essential
amino acids L-tyrosine and L-cysteine. Id. Appellants' marked-up version
of Table 2 calculates the amounts of each essential amino acid with respect
to the sum of all nine essential amino acids (like the claimed ratios), and thus
excludes the amounts for L-tyrosine and L-cysteine. To illustrate, the sum
of the molar amounts of the essential amino acids is 0.72548. The
composition includes 0.23824 moles of L-leucine, and thus the "molar
composition ratio (%) with respect to total of essential amino acids" ( as
recited in the claims) for L-leucine is 32.84%. Br. (App'x B).
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Application 11/909,740
Second, Appellants contend "Dioguardi does not suggest that the amount of
amino acids is expressed with respect to the sum of the amounts of essential
amino acids," and that no adequate reason is given for optimizing the
amounts to produce the claimed composition. Br. 7-8. Finally, regarding a
side-by-side comparison, Appellants cite Figure 12 of the Specification,
which shows the fractional synthesis rate of skeletal muscle protein in
subject rats administered compositions comprising, inter alia, 30% and 40%
L-leucine. Id. at 8; Spec. 9:2-3, 16:17-21, Fig. 12. Appellants contend
Dioguardi's composition comprising 32.84% L-leucine "approximately
corresponds" to the 30%-leucine composition, yet only the 40%-leucine
composition "produced a high effect." Id.
The preponderance of the evidence on this record supports the
Examiner's conclusion that claims 5 and 9 would have been obvious in light
of Dioguardi.
For clarity, we include below a table listing the amino acids recited in
claims 5 and 9, the molar composition ratios of those amino acids in the
claims, and the corresponding molar ratios of those amino acids in the
working example that is described in Tables 1 and 2 of Dioguardi.
L-Leucine 35--45 35--45 32.84
L-Isoleucine 5.0-15 5.0-15 16.42
L-Valine 5.0-15 8.5-15 18.39
L-Lysine 8.0-16 12-16 15.32
L-Threonine 7.0-14 8.5-15 10.13
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Application 11/909,740
L-Histidine 0.0-3.5
L-Phenylalanine 2.5-8.0
L-Methionine 2.0-10
L-Tryptophan 0.0-2.0
L-Arginine n/a
0.0-3.5 3.33
3.5-8.0 2.09
3.0-10 1.16
0.0-1.0 0.34
0.0-10 n/a
As this table illustrates, all nine of the essential amino acids recited in
the claims are present in Dioguardi's example composition in similar
proportions. 4 Several of the claimed ranges encompass the specific ratios in
Dioguardi's example composition (e.g., for claim 5, L-lysine, L-threonine,
L-phenylalanine, and L-tryptophan). The specific ratios for some of the
amino acids in Dioguardi's composition fall outside the claimed ranges (e.g.,
L-leucine is 32.84%, below 35% as claimed). But even those are reasonably
close - some are within less than 1 % from the claimed amount and none
are more than 3 .5% outside the range. The "outside" ratios are so close to
the claimed amounts that, as the Examiner determined, they would have
been obvious to the skilled person absent evidence to the contrary. 5 Final
4 L-arginine, which is only optionally required in claim 9, "is considered a
nonessential amino acid." Spec. 13.
5 "The law is replete with cases in which the difference between the claimed
invention and the prior art is some range or other variable within the claims.
. . . [I]n such a situation, the applicant must show that the particular range is
critical, generally by showing that the claimed range achieves unexpected
results relative to the prior art range." In re Woodruff, 919 F.2d 1575, 1578
(Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F.2d
775, 783, (Fed. Cir. 1985) ("The proportions [of the metals comprising the
claimed and prior art alloys] are so close that prima facie one skilled in the
art would have expected them to have the same properties."). Gentiluomo v.
Brunswick Bowling and Billiards Corp., 36 Fed.Appx. 433, 438-39 (Fed.
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Application 11/909,740
Act. 4; Ans. 4---6. That is particularly true because Dioguardi suggests the
amounts of the amino acids may be varied and routinely optimized when
used in mixtures for oral administration and because the compositions of
Dioguardi are indicated as useful for treating the same condition as the
claims-the loss of skeletal muscle in the aged. See, e.g., Dioguardi 4:26-
5:25, 9:30-31, 14:8-14 (describing treatment of "sarcopenia of the aged");
Spec. 1: 10-11 ( describing sarcopenia as "[ a ]n age-related decrease of
muscle mass occurs in skeletal muscle."). Id. at 1:10-11. Accordingly,
where, as here, "the general conditions of a claim are disclosed in the prior
art, it is not inventive to discover the optimum or workable ranges by routine
experimentation." In re Aller, 220 F.2d 454,456 (CCPA 1955) (holding a
claimed process reciting a temperature between 40°C and 80°C and an acid
concentration between 25% and 70% was prima facie obvious over process
performed at a temperature of 100°C and an acid concentration of 10%).
Appellants' arguments are unpersuasive in overcoming the rejection
on appeal. The record may have been clearer if, like Appellants, the
Examiner had focused on Dioguardi's Table 2, which expressly includes
molar concentration ratios for the various amino acids. Dioguardi 8. But
whether the Examiner focused on Table 1 or Table 2, what is clear is that
both tables describe the same composition. Dioguardi 7-8. They simply use
different units to do so (e.g., g/lOOg versus moles). It is also reasonably
Cir. 2002) (unpublished) (rejecting argument that overlap in ranges is
necessary to show obviousness, and explaining that evidence of criticality
from applicant may be required); MPEP § 2144.05 ("Generally, differences
in concentration or temperature will not support the patentability of subject
matter encompassed by the prior art unless there is evidence indicating such
concentration or temperature is critical.").
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Application 11/909,740
clear the Examiner is relying on both tables to support the rejection. See
Final Act. 2, 5. As explained above, the exemplary composition of Tables 1
and 2 includes all the amino acids required in claims 5 and 9, and several
amino acids are included in molar concentration ratios that fall squarely
within the claimed ranges. Appellants acknowledge that fact in their brief
and their marked-up version of Dioguardi's Table 2. Br. 7; see also id.
(App'x B).
Appellants contend Dioguardi expresses the amounts of amino acids
with respect to different bases (e.g., total amount of essential and non-
essential amino acid), not "with respect to the sum of the amounts of
essential amino acids" as claimed. Br. 8. This contention is unpersuasive.
Appellants' own calculations demonstrate Dioguardi's teachings can simply
be mathematically converted into the units of the claims. Br. (App'x B). So
converted, as already explained, the ratios of the amino acids in Dioguardi' s
example composition are within or in close proximity to the claimed ranges.
Appellants, on the other hand, did not provide persuasive argument or
evidence to rebut the Examiner's determination that the amino acid
concentrations in Dioguardi's example composition were either within or
close to the claimed concentrations. Final Act. 4; Ans. 2.
Appellants contend no motivation or logical reason is provided for
optimizing Dioguardi's compositions. Br. 7-8. We disagree. Given the
substantial overlap and closeness of the amino acid amounts in the claims
and the prior art, along with the fact that the claimed composition and
Dioguardi's composition are both described as useful for treating age-related
reduction in skeletal muscle, "[ t ]he normal desire of scientists or artisans to
improve upon what is already generally known provides the motivation" to
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Application 11/909,740
optimize the essential amino acid amounts in the composition. In re
Peterson, 315 F.3d 1325, 1329--30 (Fed. Cir. 2003); In re Aller, 220 F.2d at
456. Under such circumstances, and absent evidence otherwise, the skilled
artisan predictably would have arrived at a composition including the nine
essential amino acids in ratios encompassed by claims 5 and 9. 6
Finally, we are not persuaded that Figure 12 of the Specification
evidences nonobviousness or demonstrates error in the Examiner's rejection.
To the contrary, as the Examiner explained, "when relying on comparative
testing, the Appellant is under a duty to compare [the] claimed invention
with the closest prior art (i.e. the composition of Table 1 or 2 of Dioguardi)."
Ans. 5. In re Fenn, 639 F.2d 762, 765 (CCP A 1981) ("Although it is well
settled that comparative test data showing an unexpected result will rebut a
prima facie case of obviousness, the comparative testing must be between
the claimed invention and the closest prior art." (citation omitted)). The
allegedly poorer performing 30% L-leucine composition of Figure 12 to
which Appellants direct our attention is not Dioguardi' s exemplary
composition. Ans. 6. The Figure 12 composition includes, inter alia, about
3% less L-leucine, 5% less L-isoleucine, 7% less L-valine, and 4% more L-
threonine compared to Dioguardi's example. Spec. 16:17-21. Moreover, if
6 Appellants assert that "[ n Jo comparison is made to the composition of
claim 9, and hence it is not clear how or why this claim is even rejected."
Br. 7. The Examiner explains, however, that the findings and reasoning for
claim 5 also apply to claim 9. Ans. 2 ("Appellants' composition of claim 9
as well as ... claim 5 are so close [in] proximity to what is taught in the
Dioguardi' s formulation, one would find these amounts obvious variation of
amounts taught by the Dioguardi's mixture without side by side
comparison."). Appellants submitted no Reply Brief to further challenge the
Examiner on these (or other) points explained in the Answer.
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Application 11/909,740
Dioguardi's almost 33% L-leucine composition "approximately
corresponds" to Figure 12's 30% L-leucine composition, as Appellants
argue, Dioguardi' s composition would also seem to "approximately
correspond" to a composition having a 35% L-leucine ratio -the lower
bound of the ratio recited in both claims 5 and 9. Yet Appellants identify no
comparative testing on the performance of a 35% L-leucine composition.
And, insofar as Appellants rely on an allegedly "high effect" produced by
Figure 12's 40% L-leucine composition, that data is not commensurate in
scope with the claims. In re Peterson, 315 F.3d at 1330 ("[T]he applicant's
showing of unexpected results must be commensurate in scope with the
claimed range.").
SUMMARY
We affirm the rejection of claims 5 and 9 as obvious over Dioguardi.
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
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