Ex Parte Fowler et al

Patent Trial and Appeal Board

Jul 18, 2016

12847543 (P.T.A.B. Jul. 18, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/847,543 07/30/2010
23117 7590 07/20/2016
NIXON & V ANDERHYE, PC
901 NORTH GLEBE ROAD, 11 TH FLOOR
ARLINGTON, VA 22203
FIRST NAMED INVENTOR
Ann Fowler
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.
ES-4662-1641 4128
EXAMINER
HOFFMAN, SUSAN COE
ART UNIT PAPER NUMBER
1655
NOTIFICATION DATE DELIVERY MODE
07/20/2016 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):
PTOMAIL@nixonvan.com
pair_nixon@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANN FOWLER, REGINA GORALCZYK, CLAUS KILPERT,
HASAN HOHAJERI, GOEDE SCHUELER, and JONAS WITTWER1
Appeal2014-008769
Application 12/847,543
Technology Center 1600
Before ULRIKE W. JENKS, TIMOTHY G. MAJORS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims concerning
administering an effective amount of oregano extract or its active ingredients
to a patient to increase the patient's brain activity, which have been rejected
as being anticipated by and obvious from the prior art. We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm-in-part, but designate our affirmance as a New Ground of
Rejection.
1 Appellants identify the Real Party in Interest as DSM IP ASSETS B.V.,
which is a subsidiary ofKoninklijke DSM N.V. (Appeal Br. 1.)
Appeal2014-008769
Application 12/847,543
STATEMENT OF THE CASE
The Specification notes that people often tum to coffee "to naturally
fight tiredness and to increase attention and vigilance." (Spec. 1 :25-28).
However, "depending on the consumer and the amount of coffee intake,"
coffee can result in the following side effects: "insomnia, irritability, hand
tremors, restlessness, nervousness, headaches, extra heartbeats and ...
difficult[y in] ... concentrating." (Spec. 1:29-33.) Appellants' invention
seeks to provide individuals with a natural ingredient "having the positive
stimulating effects of coffee, but without the adverse side-effects." (Spec.
2:22-23.)
According to Appellants' Specification, "administration of an oregano
extract and/or its active ingredients results in a state of relaxation which is
combined with vigilance, i.e., wakefulness, alertness, the ability to focus,
and/or stimulates attention." (Spec. 2:26-30.) The Specification notes that
there are several cognitive tests that "have been developed and validated
which measure different aspects of cognition such as spatial learning
(cognitive development) or memory." (Spec. 7: 15-18.) "[T]hese tests
describe the outcomes of improved cognition, but do not focus on the
neurobiological activities." (Spec. 7: 20-22.) There are other tests used for
directly investigating "neuronal activity" related to cognitive function: they
are Electro Encephalograms (EEGs) (which measure brain waves) and Event
Related Potentials (ERPs) (which measures a P300 voltage peak in response
to a stimulus). (Spec. 7:28-8:26.) The Specification explains that "[a]n
increase in alpha [brain wave] activity has been associated with relaxation,
increased creativity, increased performance under stress and improved
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learning and concentration, as well as decreased anxiety," and that "[a]n
increase in beta [brain wave] activity is related to higher cortical activation,
an increased state of alertness and cognitive processing" (Spec. 9: I-7
(citations omitted).) Regarding P300 measurements, it is noted that patients
with neurodegenerative disorders such as Alzheimer's disease, Parkinson's
disease, and dementia, "tend to have prolonged P300 latencies," and that
"healthy people who are bored," likewise, "tend to show a lengthening of
P300 latency," as well as, "a shortening of P300 amplitude." (Spec. 8:20-
26.)
Claims I-2, 4-I2, I4-I5, I 7-2I, and 22-29 are on appeal. 2 Claims I,
I I, and 20 are representative and read as follows:
I. A method of increasing alpha-I and/or beta-I brain wave
activity comprising:
a) orally administering to an individual in need of same
an effective amount of oregano extract or its active ingredients;
and
b) observing an increase in the individual's alpha-I
and/or beta-I brain wave activity.
I I. A method of improving attention or vigilance while not
interfering with sleep patterns in an individual in need of same
compnsmg:
a) ingesting an effective amount of oregano extract or its
active ingredients; and
b) observing an improvement in the individual's attention
or vigilance.
20. A method of increasing evoked potential P300 peak
amplitude comprising:
2 Claims 3, I3, 22, 30, and 3 I are also pending, but stand withdrawn from
consideration. (See Br. 32, 34, and 36-38.)
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Application 12/847,543
a) orally administering to a subject in need of same of an
effective amount of oregano extract or its active ingredients;
and
b) observing the increased evoked potential P300 peak
amplitude.
(Br. 32 and 34--36.)
The following four rejections by the Examiner are before us on
review:
a. Claims 1, 2, 4--6, 8, 10-12, 14--16, 18, 20, 21, 23-25, 27, and 29
under 35 U.S.C. § 102(b) as anticipated by Newmark. 3
b. Claims 1, 2, 4--6, 9-12, 14--16, 19-21, 23-25, 28, and 29
under 35 U.S.C. § 102(b) as anticipated by Ando. 4
c. Claims 1, 7, 8, 11, 17, 18, 20, 26, and 27 under 35 U.S.C.
§ 103(a) as obvious over Newmark.
d. Claims 1, 7, 8, 11, 17, 18, 20, 26, and 27 under 35 U.S.C.
§ 103(a) as obvious over Ando.
DISCUSSION
Claim Construction
According to the Examiner, the "observation" step in the claims "is a
mental process that is not considered to place any positive limitations on the
claimed method." (Final Action 5, 7; Ans. 10 ("'observation' is a mental
process that is not considered to place any positive limitations on the
3 Newmark et al., US 7,067,159 B2, issued Jun. 27, 2006.
4 Yagi et al., JP2004-002237 A, published Jan. 8, 2004. The Examiner
referred to this reference as "Ando," which label we adopt for congruity with
the prosecution record to date.
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Application 12/847,543
claimed method because it does not require any active transformation of the
process."). We disagree with the Examiner's interpretation of the claims.
The analysis of whether elements of a claim transform the nature of the
claim into a patent-eligible application of a law of nature, natural
phenomena, or abstract idea does not lead to the Examiner's conclusion that
to be a positive limitation of a method claim, a recited step must involve an
"active transformation of the process" (Final Action 3; Ans. 10).
In a process claim, a positive limitation includes steps that involve an
activity. A characterization of a result of a method step without informing
the mechanics of a method would not be such a step. See Minton v. Nat 'l
Assoc. of Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir.
2003) ("The term 'efficiently' [in the whereby clause] on its face does not
inform the mechanics of how the trade is executed .... Rather, the term
'efficiently' is a laudatory one characterizing the result of the executing
step."). 5 The "observing" step here, however, is a claim limitation that
requires some kind of action. Appellants have not provided a special
definition of the term "observing" in their specification. However, with
respect to "observing enhanced vigilance," the Specification notes that
"observation" includes the activity of "a self-assessment, or may be based on
objective measureable criteria." (Spec 6: 4---6.) This comports with the
5 The claim interpreted in Minton read, in pertinent part: "1. A method for
trading securities between individuals, comprising: ... executing a trade of
the security based on information contained in the offer for consideration
specified in the reply to the offer, whereby the security is traded efficiently
between the first [offering] individual and the second [replying]
individual; ... . "Minton, 336 F.3d at 1380 (emphasis in original).
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ordinary and customary meaning of the verb "observing" requiring activity,
whether it be noticing, perceiving or watching. During patent examination,
the pending claims must be "given their broadest reasonable interpretation
consistent with the specification." See In re Suitco Surface, Inc., 603 F.3d
I255, I259 (Fed. Cir. 20IO). We interpret the "observing" step recited in the
representative claims as a positive limitation of the claims requiring an
action be taken.
Rejections based on Newmark
The Examiner's rejections based on Newmark are predicated on the
position that the "observation" step in the claims is not a positive limitation.
(Final Action 5, 7-8; Ans. IO.) The Examiner finds that "the same
composition as claimed" is administered in Newmark "to the same subjects
as defined by [Appellants'] specification as subjects in need of increased
alpha- I or beta- I brain waves, improvement in attention or vigilance while
not interfering with sleep patterns, and increased evoked potential P300 peak
amplitude [i.e., patients who are stressed, or patients who are old]," and "on
administering the oregano extract, the reference method" would "inherently
lead to an increase in alpha- I and beta- I brain waves and an increase in
potential 300 peak amplitude," as well as the improved attention or vigilance
claimed. (Final Action 5; Ans. IO.) The Examiner concludes, therefore, that
Newmark anticipates the claims. (Id.) The Examiner's obviousness
rejection is directed to addressing whether it would have been obvious to
administer the extract between the times recited or at the dosage ranges
recited in dependent claims. (Final Action 7-8.) For the reasons discussed
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above, we disagree with the Examiner's claim interpretation discounting the
"observing" limitation.
Moreover, based on the record before us, we agree with Appellants'
contention that Newmark fails to teach the observing step of the claims. (Br.
I9.) Newmark describes dosage escalation "if needed," which would
presumably be based on an observation that the lower dosage was not
working. (Newmark I 9: I 9-3 I.) However, it is not apparent that the
observation involves an observed amelioration of the side effect of the stress
of illness, or the claimed observation of "an increase in the individual's
alpha-I and/or beta-I brain wave activity," "an improvement in the
individual's attention or vigilance," or "the increased evoked potential P300
peak amplitude." (Claims I, I I and 20.) Moreover, the Examiner has not
relied on any passage in Newmark or any other teaching of the prior art to
assess whether Newmark teaches those observations or renders them
obvious.
In light of the foregoing, we reverse the Examiner's rejection of
claims I, 2, 4---6, 8, IO-I2, I4-I6, I8, 20, 2I, 23-25, 27, and 29 under 35
U.S.C. § I02(b) as anticipated by Newmark; and, the rejection of claims I,
7, 8, 11, I 7, I8, 20, 26, and 27 under 35 U.S.C. § I03(a) as obvious over
Newmark.
Rejections based on Ando
As with Newark, the Examiner's rejections based on Ando are
erroneously predicated on the position that the "observation" step in the
claims is not a positive limitation. (Final Action 7, 8-9; Ans. I 3.)
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As with Newmark, Appellants contend that Ando does not teach the
observing step required by the claims. (Br. 22.) Unlike with Newark,
however, we are not in complete agreement with Appellants.
a. Claims 11-12, 14-15, and 17-19
Claim 11 concerning "[a] method of improving attention or vigilance
while not interfering with sleep patterns," requires a step of "observing an
improvement in the individual's attention or vigilance." (Br. 34--35.)
Appellants' Specification defines the term "observing enhanced vigilance"
as follows:
The term "observing enhanced vigilance" means that the observer
may either be the person who ingests the active ingredients, or another
observer. The observation may be a self-assessment, or may be based
on objective measureable criteria.
(Spec 6: 4--6.) The Specification further indicates that an "assessment of
vigilance" can include tests which "measure different aspects of cognition
such as spatial learning (cognitive development) or memory." (Spec. 7: 15-
17.)
We find that Ando teaches evaluating the effect the administered
extract has on the patient's attention or vigilance. In particular, Ando
observes whether there is a decline in learning and memory capacity after
administration of the extract. (Ando i-fi-159---60, 65-74.) The patients are
mice, and the observation concerning state of learning and memory is the
passive avoidance measurement test, where improvement as to learning and
memory compared to an untreated group is observed. (Id.) In light of
Appellants' Specification teaching that tests that focus on memory
measurement are an assessment of vigilance, we find the observation in
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Ando concerning improvement in memory using the claimed extract meets
the observing limitation of claim 11.
The preamble of claim 11 recites "[a] method of improving attention
or vigilance while not interfering with sleep patterns in an individual in need
of same comprising:" (Br. 34.) "Preamble language that merely states the
purpose or intended use of an invention is generally not treated as limiting
the scope of the claim." Bicon, Inc. v. Strautmann Co., 441 F.3d 945, 952
(Fed. Cir. 2006). That is particularly true where "the body of the claim 'sets
out the complete invention'." Id. (quoting Schumer v. Lab. Computer Sys.,
Inc., 308 F.3d 1304, 1310 (Fed. Cir. 2002)). Here, the body of claim 11
does not relate back to an observation of interference with sleep patterns.
Consequently, we do not find the preamble limiting.
Though we disagree with the Examiner's claim interpretation, we
affirm the Examiners conclusion that claim 11 is anticipated, as well as
rendered obvious by Ando. Appellants' argument that the SAMP 8 mice
treated in Ando "have learning and cognition problems [due to oxidative
stress and abnormal expression of amyloid-B protein leading to an untimely
deterioration of brain structures] which are not associated with the same
pathway as the [claimed] invention," is not persuasive against a finding of
anticipation or obviousness. That is because the method of claim 11 simply
requires ingesting oregano extract or its active ingredients in an effective
amount to achieve an improvement in attention or vigilance. The pathway
affected so as to achieve the observed improvement (which, as discussed
above, can be via an assessment of memory) is not claimed. Furthermore,
Appellants have not provided sufficient evidence that the oregano extract
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administered in Ando, which achieved improved memory, did not do so as a
result of improved alertness or vigilance.
We also do not find Appellants' arguments that Ando "teaches a
complex mixture of herbal ingredients which is said to be an anti-aging
composition" (Br. 20, 27) persuasive of no anticipation or non-obviousness.
As the Examiner noted (Ans. 17), Appellants' claims use the transitional
phrase "comprising," which does not exclude administration of additional
components. In short, "[t]here is no requirement in the [Appellants'] claims
that oregano or an active oregano ingredient is administered alone." (Ans.
17).
With respect to claim 1 7, Appellants argue that "there is neither
guidance nor suggestion of why one should choose particular times of
administration to increase vigilance in the afternoon." (Br. 29.) The
Examiner was not required to establish the foregoing. Claim 17 simply
requires administration between 11 am and 2 pm. It is not necessary that
references be combined or modified for the same reasons as Appellants. In
re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992) ("As long as some [reason,]
motivation or suggestion to combine the references is provided by the prior
art taken as a whole, the law does not require that the references be
combined for the reasons contemplated by the inventor."); see also In re
Kemps, 97 F.3d 1427, 1430 (Fed. Cir. 1996). The Examiner provided
sufficient reason explaining why the skilled artisan would have predictably
administered the oregano extract between 11 am and 2 pm. In particular, the
Examiner noted that one of ordinary skill in the art would
reasonably expect that the time of day for administration of a
pharmaceutical can be varied to suit the needs of the user. In
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addition, it is well known to administer pharmaceuticals around
meal times. This would reasonabl[y] lead to the administration
of the oregano extract around the mid-day meal at a time
between I I AM and 2 PM.
(Ans. I 7.) Appellants have not argued claims I2, I4-I5, and I8-I9
separately. Those claims therefore fall with claim I 1. 37 C.F.R.
§ 41.37(c)(l)(iv).
Because our reasoning differs from that of the Examiner as it relates
to the "observing" step, we designate our affirmance of the rejection of
claims I I-I2, I4-I5, and I9 under 35 U.S.C. § I02(b) as anticipated by
Ando and claims I I, I 7, and I8 under 35 U.S.C. § I03(a) as obvious over
Ando as a New Ground of Rejection in order to provide Appellants with an
opportunity for further prosecution, if so desired. See In re Kronig, 539 F.2d
I300, I302 (CCPA I976) ("[T]he ultimate criterion of whether a rejection is
considered 'new' in a decision by the board is whether appellants have had
fair opportunity to react to the thrust of the rejection.").
b. Claims 1, 2, 4-10, 20--21, and 23-29
Like Newmark, it is not apparent that the observation in Ando
involves an observation of "an increase in the individual's alpha-I and/or
beta-I brain wave activity," or "the increased evoked potential P300 peak
amplitude." (Claims I and 20.) The Examiner has not relied on any passage
in Ando or any other teaching of the prior art to assess whether Ando
teaches those observations or renders them obvious. Consequently, in light
of our claim construction, we reverse the Examiner's rejection of claims I,
2, 4--6, 9-IO, 20-2I, 23-25, 28, and 29 under 35 U.S.C. § I02(b) as
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anticipated by Ando; and, the rejection of claims 1, 7, 8, 20, 26, and 27
under 35 U.S.C. § 103(a) as obvious over Ando.
SUMMARY
We reverse the rejection of claims 1, 2, 4--6, 8, 10-12, 14--16, 18, 20,
21, 23-25, 27, and 29 under 35 U.S.C. § 102(b) as anticipated by Newmark.
We reverse the rejection of claims 1, 2, 4--6, 9-10, 20-21, 23-25, and
28-29 under 35 U.S.C. § 102(b) as anticipated by Ando.
We affirm the rejection of claims 11, 12, 14, 15, and 19 under 35
U.S.C. § 102(b) as anticipated by Ando, but designate the rejection as a new
ground.
We reverse the rejection of claims 1, 7, 8, 11, 20, 26, and 27
under 35 U.S.C. § 103(a) as obvious over Newmark.
We reverse the rejection of claims 1, 7, 8, 20, 26, and 27 under
35 U.S.C. § 103(a) as obvious over Ando.
We affirm the rejection of claims 11, 17 and 18 under 35
U.S.C. § 103(a) as obvious over Ando, but designate the rejection as a
new ground as it relates to the "observing" step.
No inference should be drawn from the failure to make a new ground
of rejection of the other claims. Should there be further prosecution before
the Examiner, we leave it to the Examiner to determine whether to make a
new ground of rejection of any other claims. See 37 C.F.R. § 41.50(b).
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TIME PERIOD FOR RESPONSE
This decision contains new grounds of rejection pursuant to 37 C.F.R.
§ 41.50(b). 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 the Appellants, 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 prosecution 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 ....
}Jo time period for taking any subsequent action in connection \'l1ith
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED-IN-PART, 37 C.F.R. § 41.50(b)
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