Ex Parte Saito et al

Patent Trial and Appeal Board

Aug 8, 2016

12740934 (P.T.A.B. Aug. 8, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
121740,934
21874 7590
Locke Lord LLP
P.O. BOX 55874
BOSTON, MA 02205
04/30/2010
08/10/2016
FIRST NAMED INVENTOR
Masato Saito
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.
86212(49811) 2075
EXAMINER
KANTAMNENI, SHOBHA
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
08/10/2016 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):
patent@lockelord.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MASATO SAITO, HIROYUKI ARITA,
and MASANORI TAKAMURA1
Appeal2014-005465
Application 12/740,934
Technology Center 1600
Before ULRIKE W. JENKS, JOHN G. NEW, and TIMOTHY G. MAJORS,
Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to anti-
fatigue compositions which have been rejected as obvious and provisionally
rejected based on the nonstatutory doctrine of obviousness-type double
patenting. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse. The double patenting rejection is moot. We further enter
a new ground of rejection.
1 Appellants identify the Real Party in Interest as Meiji Co., Ltd. (App. Br.
2.)
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Application 12/740,934
STATEMENT OF THE CASE
According to the Specification, "both muscle fatigue and nervous
fatigue can be sufficiently prevented by constructing an amino acid
composition with novel composition and quantitative ratio." (Spec. i-f 15.)
Claims 29--49 are on appeal. Claim 29 is illustrative:
29. An anti-fatigue composition which comprises an amino
acid composition consisting of:
30-200 parts by weight of pro line,
60-140 parts by weight of glycine,
50-260 parts by weight of alanine,
50-130 parts by weight of lysine,
30-75 parts by weight of tryptophan, and
20-40 parts by weight of histidine.
(App. Br. 12 (Claims App'x).)
The claims stand rejected as follows:
I. Claims 29--49 under 35 U.S.C. § 103(a) over Abe et al. (US
2006/0128778 Al, publ. June 15, 2006) ("Abe").
II. Claims 30, 31, 33, 34, 36, 37, 39, 40, 42, 43, 45, 46, 48, and 49
under 35 U.S.C. § 103(a) over Abe et al. (US 2006/0079565 Al, publ. Apr.
13, 2006) ("Takashi '565").2
III. Claims 30, 31, 33, 34, 36, 37, 39, 40, 42, 43, 45, 46, 48, and 49
under 35 U.S.C. § 103(a) over Takeshi et al. (JP 3128318, published May
31, 1991) ("Takeshi '318").
2 Although the lead inventor's name on this reference is listed as "Takashi
Abe," we will describe as "Takashi '565" to maintain consistency with the
existing record. We note, however, that the record refers to this reference as
"Takeshi '565" not "Takashi '565," and we use the latter in this opinion.
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IV. Claims 29--49 are provisionally rejected under the judicially
created doctrine of obviousness-type double patenting over claims 1 and 10-
17 of Tsuchita et al. (US Application No. 12/449,663) ("Tsuchita"). Patent
Office records indicate Tsuchita was abandoned on December 2, 2015.
Therefore, the provisional obviousness-type double patenting rejection is
moot.
DISCUSSION: REJECTIONS I-III
Appellants and the Examiner construed the pending claims narrowly
- limiting the claims to only the amino acids recited in claims 29, 30, and
31. For the reasons discussed below related to the New Grounds of
Rejection, we conclude such a construction does not comport with the
broadest reasonable interpretation of the claims. The narrow construction is
thus inconsistent with the proper interpretation of claims in the course of
prosecution. In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).
Nevertheless, in order to address Rejections I-III as presented, we apply the
narrow interpretation for this portion of the discussion.
Based upon this narrow interpretation, Rejections I-III all suffer from
a similar deficiency. That is, the Examiner has not adequately explained
why the skilled artisan would have predictably, and with a reasonable
expectation of success, modified the prior art amino acid compositions to
arrive at the subject matter claimed. The Examiner's rejections presume the
skilled artisan would pick and choose the subset of amino acids expressly
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Application 12/740,934
recited in claims 29, 30, and 31. But based on the existing record, we are
not persuaded that would have happened.
Rejection I: Obviousness of Claims 29--49 over Abe
According to the Examiner, Abe teaches "compositions comprising
amino acids, proline, glycine, alanine, lysine, tryptophan, histidine, tyrosine,
arginine, valine, leucine, and isoleucine act[] on the muscle and nervous
system [and] are useful in improving central nervous functions following
fatigue when administered before exercise." (Ans. 4.) The Examiner
concludes "[i]t would have been obvious ... to employ/combine amino
acids proline, glycine, alanine, lysine, tryptophan, histidine, tyrosine,
arginine, valine, leucine, and isoleucine as in instant claims 29, 30, 31 in a
composition with a reasonable expectation of success of obtaining a
composition that is useful in improving central functions following fatigue."
(Id. at 5.) The Examiner also finds that Appellants' comparative evidence
(Spec. i-f 68, Table 1) is unpersuasive because the claimed compositions are
tested against a comparative example without amino acids. (Ans. 4.)
Appellants argue "[n]owhere does Abe teach or suggest an anti-
fatigue composition which consists of the specific amino acids as claimed .
. . [nor] suggest the specific amino acids in the particular amounts as
claimed." (App. Br. 7.) According to Appellants, "Abe teaches that the
removal of amino acids other than tryptophan from the composition
consisting of 17 types of amino acids (V AAM) deteriorates its anti-fatigue
effects on the central nervous functions." (Id.) Thus, Appellants' argument
goes, "one of ordinary skill in the art would not look at Abe and be
motivated to remove any other amino acid but tryptophan, much less pick
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Application 12/740,934
out the particular 6, 8, or 11 amino acid compositions in the specifically
claimed amounts of the present invention." (Id. at 8.)
Appellants and the Examiner disagree on the interpretation of
paragraph 9 of Abe. (Reply Br. 2-3.) The salient portion reads:
"improvement of the central nervous functions is hardly realized by removal
of one or more amino acids from the above amino acid composition [having
17 amino acids] ... removal of only tryptophan are exceptions and have
more excellent improvement of the central nervous functions than the above
amino acid composition." (Abe i-f 9.) According to the Examiner, this
paragraph shows the skilled artisan "can use 17 types of amino acids or even
lower types of amino acids (10 or 12 etc.) to improve nervous system
functions." (Ans. 6 (emphasis added).) Appellants, on the other hand,
contend paragraph 9 indicates that anti-fatigue effects "deteriorate[]" when
amino acids (except tryptophan) are removed. (App. Br. 7; Reply Br. 3.)
We are not persuaded Abe teaches anti-fatigue effects would
"deteriorate" when amino acids are removed as Appellants argue, but we are
also unpersuaded the Examiner's interpretation is accurate. Abe does not
clearly teach or suggest the skilled artisan could "improve" nervous system
functions by removing 5 to 7 amino acids to arrive at a 10 to 12 amino acid
composition as the Examiner finds. The Examiner points to no other
persuasive support or reasoning for such a finding.
Overall, Appellants have the better position with respect to the
rejection over Abe. Abe does not clearly teach or suggest a meaningful
benefit in removing the amino acids that would be necessary to design a
composition with only the amino acids listed in claims 29, 30, and 31. (Abe
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i-f 9.) And the Examiner has not provided other persuasive evidence or
reasoning why the skilled artisan would have done so. Moreover, the one
amino acid that Abe teaches and suggests may be removed to design an
improved composition is tryptophan. (Id; see also, id. at claims 3--4.) But
all the claims require tryptophan. On balance, therefore, we find the skilled
artisan would be unlikely to modify the compositions of Abe in the manner
suggested by the Examiner - removing 6 to 11 of the amino acids (but not
tryptophan) from Abe's 17-amino acid composition.
Because the Examiner has not met the burden of presenting a prima
facie case, we decline to consider whether Appellants' argument or evidence
of secondary considerations is sufficiently persuasive to show that the claims
are nonobvious.
The preponderance of the evidence of record does not show that
claims 29, 30, or 31 (narrowly interpreted) would have been obvious over
Abe. The preponderance of the evidence of record also does not show that
claims 32--49 would have been obvious over Abe, as claims 32--49 recite
methods of administering the compositions of claims 29, 30, or 31.
Rejection II: Obviousness of Claims 30, 31, 33, 34, 36, 37, 39, 40, 42,
43, 45, 46, 48, and 49 over Takashi '565
The Examiner finds Takashi '565 discloses a composition for
reducing fatigue that includes the amino acids identified in claims 30 and 31.
(Final Act. 6-7.) The Examiner finds Takashi '565 "does not teach the
particular composition consisting of pro line, glycine, alanine, lysine,
tryptophan, histidine, tyrosine, arginine, valine, leucine, [and] isoleucine as
in instant claims 30, 31 i.e. does not provide an example consisting of the
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specific amino acids." (Id. at 6.) The Examiner concludes, however, it
would have been obvious to select those particular amino acids in the
claimed amounts "with a reasonable expectation of success of obtaining a
composition that is useful in treating human[ s] for improving central
functions, and reducing muscle and nervous fatigue." (Id. at 6-7.)
Appellants argue Takashi '565 "discloses an amino acid composition
consisting of 17 types of amino acids (V AAM)3 and the addition of glutamic
acid, i.e., a composition consisting of 18 types of amino acids (GVAAM)."
(App. Br. 8.) Appellants contend the Examiner "omitted the fact that the
Takeshi '565 compositions also include at least aspartic acid, threonine,
serine, glutamic acid, methionine, and phenylalanine" - amino acids not
expressly listed in the claims. (Reply Br. 4.) Appellants also contend
Takashi '565 teaches that the addition of glutamic acid improves the effects
of the amino acid composition (V AAM) by, for example, increasing "the
ability of performing continuous motions under the aerobic respiratory
conditions." (Id.) Because Takashi '565 is related to the addition of amino
acids, Appellants argue, "there is no suggestion or motivation to remove
amino acids from the composition ... and employ only the particular 8 or
3 "V AAM" is an acronym for Vespa Amino Acid Mixture, which the
Specification describes as a composition that "comprises 1 7 kinds of amino-
acids that are contained in the saliva secreted by hornet larva." (Spec. i-f 7;
see also, Takashi '565 i-f 2.)
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11 amino acid compositions in the specifically claimed amounts to arrive at
the present invention." (Id.)
Appellants again have the better position. We are not persuaded,
based on Takashi '565 and the Examiner's reasoning of record, that the
skilled person would have predictably modified the amino acid compositions
disclosed in Takashi '565 to produce a composition having the 8 or 11
amino acids specifically listed in claims 30 and 31 respectively. The skilled
artisan would have more likely modified the amino acid composition
(V AAM) to add glutamic acid or glutamate - amino acids not listed in the
claims -because Takashi '565 teaches glutamic acid or glutamate should
be added to create compositions that improve human motor functions.
(Takashi '565 i-f 44 ("the inventors have found that an amino acid
composition effective even for the anoxic motions, during which a stronger
load is applied, can be obtained if glutamine is incorporated into
conventional V AAM."); see also, id. at i-f 68.)
In the Answer dated January 17, 2014, the Examiner points out that
Takashi '565 "teaches that amino acid concentrations in blood are reduced
during exercise, and supplementation of these amino acids improves motor
functions and recovery from fatigue[]." (Ans. 8.) This, however, does not
persuade us the skilled artisan would have predictably chosen only those
particular amino acids listed in the claims. In fact, the teachings of Takashi
'565 that the Examiner is relying upon are related to the 17-amino acid
V AAM composition. (Takashi '565 i-f 4 ("[T]he amino acid composition of
V AAM has an extremely high correlation with the blood amino acids whose
concentrations are reduced in proportion to the fatigues due to the practice of
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Application 12/740,934
exercise.") There is inadequate evidence or reasoning of record to
persuasively show that the skilled artisan would have formulated a
composition with the smaller set of amino acids listed in claims 30 or 31.
The preponderance of the evidence of record does not show that
claims 30 or 31 (narrowly interpreted) would have been obvious over
Takashi '565. The preponderance of the evidence of record also does not
show that claims 33, 34, 36, 37, 39, 40, 42, 43, 45, 46, 48, and 49 would
have been obvious over Takashi '565, as these claims recite methods of
administering the compositions of claims 30 or 31.
Rejection III: Obviousness of Claims 30, 31, 33, 34, 36, 37, 39, 40, 42,
43, 45, 46, 48, and 49 over Takeshi '318
The Examiner finds Takeshi '318 discloses an amino acid
composition that includes threonine, pro line, glycine, alanine, 4 valine,
isoleucine, leucine, tyrosine, phenylalanine, lysine, methionine, tryptophan,
histidine, and argmme. (Final Act. 7 (citing Takeshi '318 Abstract).) The
Examiner further finds "[t]he composition [of Takeshi '318] is a muscle
force sustaining agent and is administered to human[s] before exercise."
(Final Act. 7.) Although the Examiner agrees Takeshi '318 "teaches that the
use of a larger number of amino acids is desirable or superior," the Examiner
nevertheless concludes the claims would have been obvious, and that the
4 Alanine is not listed in the translated Abstract of Takeshi '318, but it does
appear to be listed elsewhere in the reference.
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Application 12/740,934
skilled artisan would have predictably selected the particular and smaller
number of amino acids listed in claims 30 and 31. (Ans. 10-11.)
Appellants argue Takeshi '318 discloses 13 types of amino acids, and
that its working examples are compositions having 18 and 25 amino acids.
(App. Br. 9.) According to Appellants, Takeshi '318 provides results
showing the 25-amino acid composition was superior to the 18-amino acid
composition in preventing fatigue. (Id.) Based on these teachings,
Appellants argue there is no suggestion to remove amino acids, or to design
a composition having only those amino acids listed in claim 30 or 31. (Id. at
10.)
We are unpersuaded the claims would have been obvious over
Takeshi '318. As an initial matter, a complete translation of Takeshi '318
appears to be absent in the record. The Examiner has cited only the
Abstract, and we find no other translated portions of Takeshi '318. As to
Appellants' arguments about the working examples in Takeshi '318, the
Examiner did not dispute Appellants' argument that Takeshi '318's
examples show compositions of 18 and 25 amino acids, and that the
composition having 25 amino acids provided superior results. (Ans. 10.)
The Examiner has not provided persuasive evidence or reasoning to
explain the modifications required to design a composition having only the
amino acids listed in claims 30 or 31. The skilled artisan would need to add
alanine (which is not identified in the Abstract ofTakeshi '318), and remove
at least threonine, methionine, and phenylalanine from the "objective
composition" disclosed in the Abstract of Takeshi '318. The record lacks a
sufficiently articulated rationale for why the skilled artisan would have made
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Application 12/740,934
such modifications. KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007)
("[R ]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness.") (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006).
The preponderance of the evidence of record does not support a
conclusion that claims 30 or 31 (narrowly interpreted) would have been
obvious over Takeshi '318. The preponderance of the evidence of record
also does not show that claims 33, 34, 36, 37, 39, 40, 42, 43, 45, 46, 48, and
49 would have been obvious over Takeshi '318, as these claims recite
methods of administering the compositions of claims 30 or 31.
NEW GROUND OF REJECTION
We enter a new ground of rejection pursuant to 37 C.F.R. § 41.50(b)
of claims 29--49 as anticipated under 35 U.S.C. § 102(b) by Abe.
During prosecution, we give claim terms the broadest reasonable
interpretation as understood by a person of ordinary skill in the art in light of
the specification. In re Morris, 127 F.3d at 1054 (Fed. Cir. 1997); In re Am.
Acad. Of Sci. Tech. Ctr., 367 F.1359, 1364 (Fed. Cir. 2004) ("Construing
claims broadly during prosecution is not unfair to the applicant ... because
the applicant has the opportunity to amend the claims to obtain more precise
claim coverage.") "An essential purpose of patent examination is to fashion
claims that are precise, clear, correct, and unambiguous. Only in this way
can uncertainties of claim scope be removed, as much as possible, during the
administrative process." In re Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989).
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Each of claims 29, 30, and 31 include the preamble: "An anti-fatigue
composition which comprises an amino acid composition consisting of:"
(App. Br. 12-13.) Thus the claim preamble uses both the transition
"comprises" and "consisting of."
Under these circumstances, the Federal Circuit's holding in In re
Crish is instructive. 393 F.3d 1253, 1257 (Fed. Cir. 2004). In Crish, the
Court held that the claimed oligonucleotide was not limited to a particular
portion of numbered nucleotides notwithstanding that such "portion" was
preceded with the transitional phrase "consists of." (Id.) The Court
affirmed the PTO' s construction that the claims were broader and could
include other nucleotides, including other portions of a broader sequence,
because the claims also used the open-ended transition "comprising." (Id. at
1256 (affirming the Board's determination "that the transition language
'comprising' allowed the claims to cover the entire involucrin gene plus
other portions of the plasmid, as long as the gene contained the specific
portions of SEQ ID NO: 1 recited by the claim.")
Likewise, we conclude the appealed claims do not exclude other
amino acids beyond the particular ones listed in claims 29, 30, or 31. The
claims must include a composition of the recited amino acids at the
particular concentrations, but the open-ended transition "comprises" means
that other ingredients, including other amino acids, may be present. The
Specification confirms other ingredients - including other amino acids
beyond the handful listed in the claims - may be present. For example, the
Specification states that "[i]n the anti-fatigue agent of the present invention,
in addition to the above amino acids [those recited in the claims], the
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following substances m[a]y be comprised if necessary: methionine ... ,
taurine, [etc.]" (Spec. i-f 4 7; see Abe Abstract (identifying the amino acid
methionine ).)5 Thus, applying the broadest reasonable interpretation, we
conclude that claims 29, 30, and 39 may include more than just the six,
eight, or eleven amino acids expressly listed in those respective claims.
We adopt the Examiner's findings regarding the scope and content of
Abe. (See Final Act. 2-3.) We further provide the following findings for
emphasis.
Abe teaches formulations comprising amino acids that "have effects
of improving central nervous functions such as healing fatigue." (Abe
Abstract.) Abe teaches the composition V AAM and, as a comparative
example, CAAM, which each include the amino acids proline, glycine,
alanine, lysine, tryptophan, histidine, tyrosine, arginine, valine, leucine, and
isoleucine, among other amino acids. (Id. at i-f 16, Table 1 (reciting molar
percentages of each amino acid).) Abe further teaches an embodiment of
VAAM including 17 amino acids in the following concentrations:
2 to 15 moles of threonine, 4 to 30 moles of pro line, 7 to 20
moles of glycine, 4 to 8 moles of valine, 3 to 9 moles of
isoleucine, 2 to 12 moles of leucine, 1to9 moles of tyrosine,
5 The Specification also discloses that "when the inventive agent is used as a
food composition, other components may be contained in the above food
composition ... [including] animal and plant proteins such as dry whole
milk ... and various milk-derived components such as butter [etc.]" (Spec. i-f
61.) Inclusion of such other protein sources indicates an even greater
number of amino acids may be included.
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0.5 to 5 moles of phenylalanine, 5 to 11 moles of lysine, 0.1 to
5 moles of aspartic acid, 0.1 to 5 moles of serine, 0.1 to 4
moles of glutamic acid, 0.1 to 12 moles of alanine, 0.1 to 5
moles of methionine, 0.1 to 5 moles of tryptophan, 0.1 to 5
moles of histidine and 0.1 to 5 moles of arginine
(Id. at i-f 16; see also, id. claims 1-2.) The formulation of Abe thus
encompasses the amino acids and concentrations listed in pending claims 29,
30, and 31.6 Abe teaches administration of VAAM to an athlete suffering
from central nervous fatigue to remove tiredness, thus teaching and
suggesting administration to a human suffering from or susceptible to
nervous or muscle fatigue. (Id. at i-f 15.) Abe further teaches that its
composition can be administered in daily doses of from 1 to 20 g. (Id. at i-f
21.)
Abe teaches each element, and thus anticipates, claims 29--49. The
fact that Abe's formulations include additional amino acids beyond those
recited in claims 29, 30, and 31 is not decisive because we conclude that
Appellants' claims are not limited to compositions including only the amino
acids expressly listed.
No inference should be drawn from the failure to make a new ground
of rejection based on Takashi '565 or Takeshi '318 because entry of a new
grounds by the Board is discretionary under 37 C.F.R. § 41.50(b). Should
there be further prosecution before the Examiner, we leave to the Examiner
6 Appellants have not identified differences between the claimed
concentrations for the amino acids in Abe's formulation and the
concentrations in claims 29, 30, or 31. Instead, Appellants focused their
argument on the fact that Abe taught formulations with additional amino
acids compared to those expressly recited in the pending claims.
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to determine whether additional rejections based on the art of record are
appropriate.
SUMMARY
The provisional obviousness-type double patenting rejection is moot
due to the abandonment of the Tsuchita application.
We reverse the Examiner's obviousness rejections (Rejections I-III)
for the reasons stated above.
We enter a new ground of rejection of claims 29--49 under 35 U.S.C.
§ 102(b) as anticipated by Abe.
This decision contains new ground of rejection pursuant to 37 C.F.R.
§ 41.50(b) (Sept. 13, 2004; revised, 76 FR 72270, Nov. 22, 2011, effective
Jan. 23, 2012). 37 C.F.R. § 41.50(b) provides "[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review."
37 C.F.R. § 41.50(b) also provides that Appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new grounds of rejection to
avoid termination of the appeal as to the rejected claims:
( 1) Reopen prosecution. Submit an appropriate amendment of the
claims so rejected or new evidence relating to the claims so rejected,
or both, and have the matter reconsidered by the Examiner, in which
event the proceeding will be remanded to the Examiner. ...
(2) Request rehearing. Request that the proceeding be reheard under§
41.52 by the Board upon the same record ....
REVERSED, 37 C.F.R. § 41.50(b)
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