Ex Parte Audino

Patent Trial and Appeal Board

May 25, 2016

12976524 (P.T.A.B. May. 25, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/976,524 12/22/2010 David Lawrence AUDINO
23599 7590 05/27/2016
MILLEN, WHITE, ZELANO & BRANIGAN, P,C
2200 CLARENDON BL VD.
SUITE 1400
ARLINGTON, VA 22201
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.
AMCN-0002 7619
EXAMINER
CLARK, AMYL YNN
ART UNIT PAPER NUMBER
1655
NOTIFICATION DATE DELIVERY MODE
05/27/2016 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):
docketing@mwzb.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAVID LA WREN CE AUDIN0 1
Appeal2014-005933
Application 12/976,524
Technology Center 1600
Before JEFFREY N. FREDMAN, JACQUELINE W. BONILLA, 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 to an herbal
composition and the containment of that composition, which have been
rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm and enter new grounds of rejection as to the claims
concerning containment of the composition.
STATEMENT OF THE CASE
Amaranthus blitoides is an herb that is known to relieve a variety of
discomforts and symptoms, such as those caused by or associated with
1 Appellant identifies the Real Party in Interest as the inventor, David
Lawrence Audino. (Appeal Br. 1.)
Appeal2014-005933
Application 12/976,524
inflammation and inflammatory processes; it is used widely in Europe to
relieve symptoms of Benign Prostatic Hyperplasia and is often administered
as a tea. (Spec. 1.) At times, the relief from discomfort or underlying
disease provided by this herb is not as complete as users and care providers
desire. (Spec. 2.) The claimed invention seeks to provide an improved
Amaranthus blitoides composition.
Claims 1-12 are on appeal. Claims 1, 5, and 9 are representative and
read as follows:
1. A composition comprising Vitamin D or a Vitamin D
derivative and Amaranthus blitoides, wherein the ratio of the
Vitamin D or Vitamin D derivative to the Amaranthus blitoides
is 2-2,000.
5. A beverage suitable for human consumption comprising or
made from a composition according to claim 1.
9. A water permeable container having disposed therein a
composition according to claim 1.
(Appeal Br. 9.)
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Application 12/976,524
There is a single rejection before us on review:
Claims 1-12 under 35 U.S.C. § 103(a) as obvious over Nedwig2 and
Deluca. 3
DISCUSSION
Claim 1: The composition
The Examiner finds that both of the ingredients in the claimed
composition, Amaranthus blitoides and vitamin D, were known to be used
individually in oral applications for treating herpes. (Final Action 2-3; Ans.
5.) In particular, Nedwig is said to disclose a) a composition that includes
an extract of Amaranthus blitoides, b) that the extract could be provided in a
tea to be administered orally for treating herpes (Ans. 5 (referencing Nedwig
claim 7), and c) that the extract can be administered in an amount of 33 to
100 mg/kg. (Final Action 2; Ans 2.) Deluca is said to disclose an orally
2 The Examiner's stated ground of rejection indicates Nedwig et al., WO
2004/112812 A 1, reference A2 on Applicant's information disclosure
statement dated June 24, 2011, is the Nedwig reference applied. However,
the paragraph numbers the Examiner refers to in the rejection with respect to
Nedwig do not appear in WO 2004/112812 Al-a German language
document. It is apparent from the file that DE 103 32 281 Al-identified as
reference Al on Applicant's information disclosure statement dated June 24,
2011,-identifying Maria Milovanovic, Jovan Radoijcic, and Eva-Maria
Nedwig as applicants and inventors, was the English language "Nedwig"
document relied upon in the rejection reference. DE 103 32 281 Al, which
is the laid open version of German application 103 32 281. 7-an application
listed as a priority application of WO 2004/112812 Al-, is prior art to the
claimed invention, having been published January 27, 2005. When we refer
to Nedwig, as the Examiner did, it is with reference to DE 103 32 281 Al.
3 Deluca et al., US 5,880,114, issued Mar. 9, 1999.
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Application 12/976,524
administered composition containing Vitamin D to treat herpes, where the
Vitamin D can be provided in an amount of 0.1 µg to about 2 mg per day.
(Final Action 2-3; Ans. 2.) The Examiner concludes that it would have been
obvious to combine these two ingredients into a single composition to treat
herpes and would have been motivated to do so to obtain the benefits of both
components in a single composition to obtain a more effective composition
to treat herpes. (Final Action 3 and 5; Ans. 3 and 6.)
We agree with the Examiner's fact-findings and conclusion of
obviousness.
According to Appellant, Nedwig and Deluca are "entirely different
areas of endeavor and [use different] means for treating human conditions"
in that Deluca discloses the use of "high oral doses" of a solid composition
to remedy immune system deficiencies in treating herpes, "whereas Nedwig
relates to mild herbal ointment compositions of Amaranthus blitoides to
topically treat herpes." (Appeal Br. 6.) We disagree.
As the Examiner notes, Deluca provides an administration range for
Vitamin D compounds that includes 0.1 µg per day up to 2 mg. (Deluca
(claims 1 and 4); Final Action 2-3).) We are not persuaded that
administering tenths of a microgram per day corresponds to a "high dose" in
the manner that is dispositive regarding non-obviousness, as Appellant
suggests. Moreover, there are many points in the dosage range of Deluca
that are within the International Unit ("IU") requirement for Vitamin D in
claim 1, including the lower dosage limit, which is equivalent to 4 IUs based
on the disclosed conversion provided in Appellant's specification. (Spec. 5-
6 (indicating that one IU is 0.025 µg of Vitamin D); Spec. 12:9-12
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Application 12/976,524
(indicating that ratio of Vitamin D to Amaranthus blitoides of 2-2,000,
which is claimed, refers to IU s of Vitamin D per gram equivalent of
Amaranthus blitoides).)
Additionally, while Example 8 ofNedwig may disclose an ointment
that contained an extract of Amaranthus blitoides was successfully used,
Nedwig discloses elsewhere that Amaranthus blitoides can be used orally.
(Nedwig i-f 13 and Exs. 6 and 7.) Indeed, as the Examiner explains, claim 7,
which depends from claim 6 and claim 1, provides for using an extract of
Amaranthus blitoides for the treatment of herpes "in the form of a tea"
(Ans. 5). Thus, we disagree with Appellant that Nedwig and Deluca are in
different areas of endeavor and use different means for treating herpes.
We also disagree that the Examiner has failed to provide sufficient
reasoning to establish a prima facie case of obviousness (Appeal Br. 5).
According to Appellant, there are "thousands [of agents] disclosed in the
art" for treating herpes and no reason has been given to select the two
claimed compounds for combination, particularly because there is no
evidence that the composition ofNedwig or Deluca can be fortified with
other agents. (Appeal Br. 5---6.) A fortification teaching is not necessary
here. "It is prima facie obvious to combine two compositions each of which
is taught by the prior art to be useful for the same purpose, in order to form a
third composition to be used for the very same purpose." In re Kerkhoven,
626 F .2d 846, 850 (CCP A 1980).
Regardless of whether there may be thousands of agents known for
treating herpes, the references relied upon particularly point to the use
individually of the two that are claimed. Moreover, each reference teaches
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Application 12/976,524
the particular agent at issue provides a different ameliorative benefit.
Deluca teaches the Vitamin D improves or restores immunity in a subject
having herpes (Deluca 14:30-32 and claim 1; Final Action 5), and Nedwig
teaches Amaranthus blitoides provides strong analgesic, antiphlogistic, and
spasmolytic properties (Nedwig i-f 14). "[I]t would be natural to suppose
that, in combination, they would produce the same effect [to treat herpes]
and would supplement each other." In re Crockett, 279 F.2d 274, 276
(CCP A 1960).
Appellant has not advanced an argument nor provided sufficient
evidence as to why one of ordinary skill in the art would not have expected
Vitamin D andAmaranthus blitoides, when combined together, to provide
those same benefits. "[W]hen a patent 'simply arranges old elements with
each performing the same function it had been known to perform' and yields
no more than one would expect from such an arrangement, the combination
is obvious." KSR Int'! Co. v. Teleflex, 550 U.S. 398, 417 (2007).
Furthermore, although not pointed out by the Examiner, Nedwig itself
suggests that the presence of a vitamin would not inhibit the herpes
treatment provided by the Amaranthus blitoides extract in light ofNedwig's
teaching that the extract includes Vitamin C in addition to the flavonoids. 4
(N edwig i-f 11.)
4 Reference AlO of the IDS filed June 24, 2011 discloses that flavonoids of
Amaranthus blitoides act as anti-inflammatory agents. Prof. Dr. sc med
Bogdan Boskovic, AMER PREPARATIONS, Amaranthus blitoides S.
Watson: Pharmacological-Toxicological-Clinical Expert Report, certified
translation, 1-31, 3 (Sept. 1, 2007).
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Appellant relies on Ex Parte Schaefer in arguing that a prima facie
case is not made out unless there is a suggestion directing one of ordinary
skill in the art to "which of many possible choices is likely to be successful."
(Appeal Br. 6). That reliance is inapt for at least two reasons. First,
Schaefer did not concern combining all elements from two different
compositions together to form a third composition. Ex parte Schaefer,
Appeal 2008-4620, Application 10/401,100, 2-3, (April 29, 2009). Rather,
it concerned substitution of components from one composition into a second
composition. Id. In particular, the issue there was whether a substitution of
a component in one prior art composition was suggested by a second prior
art composition, where the second composition described suitable
substitutions as to that second composition. Id.
Second, in Schaefer, as to whether components of the first
composition could be substituted, the prior art relied upon by the Examiner
taught certain advantages were obtained with the specific combination
disclosed for that first composition, and thus suggested a change would not
provide the same result. Id. As already discussed, there is insufficient
evidence that Vitamin D and Amaranthus blitoides would not achieve their
expected functions if put together in the same composition.
Appellant also contends that there is no reason to provide the
individual components together in the "amounts specified in the claims."
(Appeal Br. 6.) We do not find this argument compelling. The claims
simply provide for a broad ratio of Vitamin D to Amaranthus blitoides of 2-
2,000. The broad ranges of the individual components taught in Nedwig
(33-100 mg/kg) and Deluca (0.1 µg per day up to 2 mg) overlap with the
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Application 12/976,524
broad ratio claimed. For example, administration of 1 µg of Vitamin D,
which is 40 IUs of Vitamin D, according to the conversion provided in
Appellant's specification, with 33 mg of Amaranthus blitoides results in a
ratio of 1212. See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) ("In
cases involving overlapping ranges, we and our predecessor court have
consistently held that even a slight overlap in range establishes a prima facie
case of obviousness.")
Moreover, the Examiner persuades us that even if the claimed ratio
were not explicitly obtained by the combination, it would have been obvious
to modify amounts based on body weight and need. (Final Action 4.) Both
Deluca and Nedwig teach a dosage range of their respective active
ingredient for treatment of herpes, thus providing the teaching that dosage
amount is a result effective variable. Optimization of a variable that is
recognized in the prior art to be a result effective variable would ordinarily
be within the skill in the art. In re Aller, 220 F .2d 454, 456 (CCP A 1955)
("where 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."). Appellant neither argues nor provides sufficient
evidence that the dosage range is not a result effective variable; nor is there
adequate evidence that the claimed ratio provides any unexpected result.
In view of the foregoing, we disagree with Appellant's contention that
the Examiner's conclusion of obviousness to combine Vitamin D and
Amaranthus blitoides in a single orally administered composition to treat
herpes is based on improper hindsight (Appeal Br. 6). For the reasons
discussed, we affirm the Examiner's rejection of claim 1.
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Claims 2--4 and 11-12 have not been argued separately and therefore
fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
Claims 5--8: The beverage claims
Appellant contends the combined teachings ofNedwig and Deluca
provide no basis to form a beverage that includes both Amaranthus blitoides
and Vitamin D because the references do not disclose common forms of
administration, and neither discloses treating herpes with a beverage.
(Appeal Br. 8.) We do not find Appellant's argument persuasive. As
discussed above, Nedwig discloses treating herpes with Amaranthus
blitoides in the form of a tea (Nedwig (claim 7)), and Deluca discloses
Vitamin D can be "administered orally in a liquid vehicle ingestible by and
non-toxic to" the subject (Deluca (claim 6)). Moreover, Appellant's
specification admits that Vitamin D was known to be commercially
available in forms suitable for beverage use. (Spec. 10:26-31.) Thus, we
conclude that it would have been obvious to add Vitamin D to the
Amaranthus blitoides tea taught by Nedwig, and we affirm the Examiner's
rejection of claim 5.
Appellant does not argue claims 6-8 separately; those claims,
therefore, fall with claim 5. 37 C.F.R. § 41.37(c)(l)(iv). And in any event,
we agree with the Examiner's finding, which Appellant does not contest,
that "tea can be considered to be a sports drink and an energy drink, since
tea is used for rehydration and to provide energy." (Ans. 7.)
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Claims 9-10: The water permeable container claims
According to the Examiner, a "water permeable container reads on a
capsule" (Ans. 6), and it would have been obvious to provide an Amaranthus
blitoides and Vitamin D composition in a capsule, which is taught by both
Nedwig and Deluca to be a suitable form of administration for the
components individually (Final Action 4; Ans. 6-7). Appellant contests the
Examiner's unsubstantiated assertion that a capsule is a water permeable
container as claimed. (Reply Br. 3.) Appellant defines a water-permeable
container to be a container that acts much the same as a tea bag, "holding the
compositions herein disclosed while at the same time allowing them to come
in contact with liquid, infuse there into, and then be conveniently removed
there from." (Spec. 6.) Although we agree with Appellant that a capsule
does not meet the claimed water-permeable container limitation, we
nevertheless conclude that providing the composition of claim 1 in a water
permeable container would have been obvious in light ofNedwig. In
particular, N edwig teaches preparing Amaranth us blitoides for
administration as a tea where boiling water is poured over fresh or dried
plant parts, the infusion is allowed to steep, and the infusion "is then
strained" before it is administered to the subject. (Nedwig i-f 18.) The use of
tea ball strainers or loose leaf tea infusers to contain herbs in making teas,
instead of providing the herb loose in a container, has been done for
centuries to enable one to easily steep tea. See, e.g., Kendall Co. v. Tetley
Tea Co., Inc., 189 F.2d 558, 562 (1st Cir. 1951) ("No doubt, the idea ofa tea
ball or tea bag is quite old"); In re Barnett, 155 F.2d 540, 541 (CCPA 1946)
(case concerning a patent application directed to tea balls or bags). Putting
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Amaranthus blitoides plant parts in such a well-known water-permeable
container along with a known commercially available dried form of Vitamin
D, instead of providing the composition loose in a container, would have
merely represented the combination of familiar elements according to known
methods to produce predictable results. See KSR, 550 U.S. at 416.
Accordingly, we agree with the Examiner's conclusion claims 9-10 are
unpatentable under 35 U.S.C. § 103(a) as obvious over Nedwig and Deluca.
However, because our rationale differs from that used by the Examiner, we
denominate this as a new ground of rejection under 37 C.F.R. § 41.50(b).
SUMMARY
For the reasons discussed, we affirm the Examiner's rejection of
claims 1-12 under 35 U.S.C. § 103(a) as being unpatentable over Nedwig
and Deluca. However, we designate our affirmance as to claims 9-10 as a
new ground of rejection.
TIME PERIOD FOR RESPONSE
This decision contains a new ground 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,
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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 ....
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, 37 C.F.R. § 41.50(b)
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