ABOCA S.P.A. SOCIETA' AGRICOLA

Patent Trials and Appeals Board

Apr 19, 2021

2020006450 (P.T.A.B. Apr. 19, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
14/377,723 08/08/2014 Valentino Mercati 4286.0030001 4031
26111 7590 04/19/2021
STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
1100 NEW YORK AVENUE, N.W.
WASHINGTON, DC 20005
EXAMINER
YU, HONG
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
04/19/2021 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):
e-office@sternekessler.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte VALENTINO MERCATI,
ANNA MAIDECCHI, and LAURA CAPONE1
____________

Appeal 2020-006450
Application 14/377,723
Technology Center 1600
____________

Before RICHARD M. LEBOVITZ, JOHN G. NEW, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

NEW, Administrative Patent Judge.

DECISION ON APPEAL

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies ABOCA S.p.A. Societa Agricola
the real party-in-interest. App. Br. 3.

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Application 14/377,723

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SUMMARY
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Non-Final Rejection of claims 1, 11–14, 18–22, 26, and 28.
Specifically, claims 1, 12–14, and 18–21 stand rejected as unpatentable
under 35 U.S.C. § 103 as being obvious over the combination of K. Abascal
et al., Combining Herbs in a Formula for Irritable Bowel Syndrome, ALT. &
COMPLEMENTARY THERAPIES 17–23 (Feb. 2005) (“Abascal”), Wang (CN
1175460 A, March 11, 1998) (“Wang”), and Liu et al.(CN 1990030 A, July
4, 2007) (“Liu”).2
Claims 11, 22, 26, and 28 stand rejected as unpatentable under
35 U.S.C. § 103 as being obvious over the combination of Abascal, Wang,
Liu, and Augusta (ZA 201002664 A, January 26, 2011) (“Augusta”).
A hearing was heard in this appeal on April 8, 2021.
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

NATURE OF THE CLAIMED INVENTION
Appellant’s claimed invention is directed to an effective formulation
for the treatment or the prevention of irritable bowel syndrome, a method for
treating irritable bowel syndrome, and processes for preparing such
formulations. Abstr.

2 The Examiner relies upon Google Translate translations of the Wang and
Liu references. See, e.g., Ans. 5. We rely on those versions of the
references as well despite the limited coherence of those translations.
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REPRESENTATIVE CLAIM
Independent claim 1 is representative of the claims on appeal and
recites:
1. A composition for treatment of a patient suffering from
irritable bowel syndrome (IBS), which protects the patient's
intestinal mucosa by producing a barrier effect thereon and
increasing adhesivity of said barrier to the patient's intestinal
mucosa, comprising: (a) resin incense extract in a weight
percentage from 20% to 60%, (b) one or more polysaccharides
and/or plant extracts comprising polysaccharides in a weight
percentage from 12% to 22%, and (c) one or more antioxidants
and/or plant extracts comprising antioxidants in a weight
percentage from 35% to 65%; wherein said polysaccharides are
selected from the group consisting of polysaccharides extracted
from Aloe vera, polysaccharides extracted from chamomile, and
polysaccharides extracted from althea; wherein said plant
extracts comprising polysaccharides are selected from the group
consisting of extracts of Aloe vera, extracts of chamomile, and
extracts of althea; wherein said antioxidants are selected from the
group consisting of antioxidants extracted from chamomile and
antioxidants extracted from lemon-balm; and wherein said plant
extracts comprising antioxidants are selected from the group
consisting of extracts of chamomile an extracts of lemon-balm.

App. Br. 14.

ISSUES AND ANALYSIS
We decline to agree with, or adopt, the Examiner’s findings,
reasoning, and conclusion that the claims are obvious over the combined
cited prior art. We address below the arguments raised by Appellant.

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Issue
Appellant argues that the Examiner erred because the combined cited
prior art neither teaches nor suggests combining the elements of the claimed
compositions at the claimed concentrations. App. Br. 8.

Analysis
The Examiner finds that, with respect to claim 1, Abascal teaches
chamomile flower (limitation b) with antispasmodic effect and lemon balm
(limitation c) being used in the treatment of irritable bowel syndrome
(“IBS”), together with formulations adapted to include herbs with action
specific to the individual patient. Non-Final Act. 4 (citing, e.g., Abascal
Abstr., Table 4, 22). The Examiner finds that Abascal does not teach: (1)
incense resins extract and Aloe vera; and (2) the various weight percentages
and specific weight amounts of chamomile, lemon balm, incense resins
extract, and Aloe vera in the formulations; and (3) the specific form of each
component such as lyophilized resin incense extract and resin incense
powder, dehydrated Aloe vera leaf gel, lyophilized chamomile flower
extract, and lemon-balm leaf. Id.
The Examiner finds that Liu teaches an incense extract used to treat
constipation, which, the Examiner finds, Appellant’s Specification discloses
as symptomatic of IBS. Non-Final Act. 4 (citing Liu, Abstr. Spec. 1). The
Examiner finds that Wang teaches that Aloe vera can be used to treat
inflammation and habitual constipation. Id. (citing Wang Abstr.).
The Examiner also finds that a person of ordinary skill in the art
would have known how much drug to give the patient, i.e., the specific
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percentages and amounts of each of the components in a dosage used to treat
IBS. Non-Final Act. 5.
The Examiner concludes that it would have been prima facie obvious
to a person of ordinary skill in the art to combine the teachings of the cited
references, adding incense extract and Aloe vera, as taught by Liu and Wang
respectively, to the composition taught by Abascal for treating IBS. Non-
Final Act. 5. The Examiner also concludes that a skilled artisan would have
been motivated to combine the references because the constituent elements
are taught by the prior art as being useful in the treatment of
IBS/constipation. Id.
The Examiner further concludes that it would have been prima facie
obvious to a person of ordinary skill in the art to arrive at the specific
percentages of each of the components used in the treatment of IBS. Non-
Final Act. 5. The Examiner finds that a skilled artisan would have been
aware that the appropriate dosage scheme, including the amount of drug in
each dose, the frequency of dosage, the total amount of drug per day, and the
length of treatment, would vary depending on the subject and the condition
to be treated. Id. at 5–6. The Examiner finds that a skilled artisan would
have known how much drug to give the patient, and that the manufacturer of
dosage forms would have known how to make them with the appropriate
amount of drug. Id. at 6.
The Examiner further reasons, in the alternative, that obviousness is
based upon the principle that “where the general conditions of a claim are
disclosed by the prior art, it is not inventive to discover the optimum or
workable ranges by routine experimentation.” Non-Final Act. 6 (quoting In
re Aller, 20 F.2d 454, 456 (C.C.P.A. 1955). The Examiner finds that the
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claimed herbs were already known in the art at the time of filing for treating
the condition recited in the claims. Id. The Examiner concludes that the
claimed dosage represents no more than a determination of the workable
range or amount of drug for achieving the known effect. Id.
Appellant argues that neither Wang nor Liu teaches or suggests the
addition of incense resin extract and Aloe vera to IBS formulations taught in
Abascal, removing the many other components taught by Abascal, or
employing the components in the claimed percentages. App. Br. 9.
Appellant contends that Wang teaches preparing an Aloe vera emulsion as a
health-care beverage prepared from Aloe vera, citric acid, and mineral water
via removing the thorns and peel from fresh leaves of Aloe vera, mincing the
leaves into a collagen body, and proportionally mixing it with citric acid and
mineral water. Id. Appellant notes that Wang teaches that its beverage
promotes health care, beautifying, and curing diseases. Id.
Appellant also argues that Liu teaches:
a fragrant bag having anti-inflammation activity, which is
prepared from nine kinds of Chinese medicinal herbs including
Bletilla striata, borax, boneol, cow-bezoar, Apocynum venetum
linn, ginkgo leaves, mentha, centipede and licorice root through
steps of supercritical extracting, dissolving into water or alcohol.
The bag is not ingested, but rather the medicine is administered
by igniting and smelling the smoke or the smell of the
medicament.
App. Br. 10.
According to Appellant, the combined cited prior art provides no
guidance to a skilled artisan as to which compounds from among the
hundreds disclosed should be selected or discounted, or the specific amount
of each ingredient to use. App. Br. 10. Appellant also contends that a
person of ordinary skill in the art would not have had a reasonable
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expectation of success in combining the teachings of the references, because
they lead the skilled artisan to merely pursue a “general approach that
seemed to be a promising field of experimentation, where the prior art gave
only general guidance as to the particular form of the claimed invention or
how to achieve it.” Id. (citing Medichem S.A. v. Rolabo S.L., 437 F.3d 1157,
1165 (Fed. Cir. 2006).
We are not persuaded that the Examiner established a prima facie case
of obviousness. As an initial matter, however, we do not agree with
Appellant’s contention that the Examiner needs to provide a reason as to
why a person of ordinary skill in the art would “remov[e] the many other
components [taught by] Abascal” or “discount[ ]” the other ingredients
taught by Abascal. See App. Br. 9, 10. Claim 1 recites, in relevant part: “A
composition for treatment of a patient suffering from irritable bowel
syndrome (IBS), … comprising.” Claims 22 and 28, the other independent
claims on appeal, similarly recite “comprising” in its preamble. “In the
parlance of patent law, the transition ‘comprising’ creates a presumption that
the recited elements are only a part of the device, that the claim does not
exclude additional, unrecited elements.” Crystal Semiconductor Corp. v.
TriTech Microelectronics Int’l, Inc., 246 F.3d 1336, 1348 (Fed. Cir. 2001).
Consequently, we find that Appellant’s claimed composition does not
preclude inclusion of all of the other constituents recited in Abascal and still
remain within the scope of the claims, if it were also the case that all the
limitations recited in the claims were taught or suggested by the prior art.
Nevertheless, we are not persuaded that the combined cited prior art
teaches or suggests all of the limitations of the claims. Claim 1 recites a
“resin incense extract in a weight percentage from 20% to 60%.”
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Appellant’s Specification provides no express definition of the claim term
“resin incense extract,” but discloses, by way of example that:
According to the present invention, in accordance with the
scientific literature, resins of plant origin in particular are
understood to mean oleo-gum resins … formed by a complex
group of solid, translucent, occasionally liquid, water-insoluble,
alcohol-soluble, acetone, ether and chloroform substances.

Such resins contain complex mixtures of alcohols or aliphatic
acid, lignans, resin acids, resinotannols, esters and resins (that
originate from processes of polymerisation or oxidation of
terpenes of essential oils), etc.

From a chemical point of view, many different components are
found in the resins: alcohols or aliphatic acids of various carbon
chain length, free aromatic acids, resin acids, monoterpene
alcohols, diterpene alcohols, triterpene alcohols, resinols,
phenolic compounds belonging to the family of sterols, etc.

According to the present invention, the resins for example can be
represented by incense, myrrh, or mixtures thereof.

A person skilled in the art will, however, be able to identify
further resins other than those indicated herein easily be analogy.

Spec. 11.
Liu teaches:
[T]he preparation method of incense according to claim 1 and 2;
it is characterized in that: the first-class Pseudobulbus Bletillae
(Rhizoma Bletillae), Borax, Borneolum Syntheticum, Calculus
Bovis, Herba Apocyni veneti, Folium Ginkgo, Herba Menthae,
Scolopendra, nine kinds of Chinese herbal medicine of Radix
Glycyrrhizae are mixed water-soluble and alcohol blend through
supercritical extraction; wherein the volume ratio of water and
ethanol is 2:3; mixeding [sic] liquid volume and above-
mentioned medicine volume ratio are that soaked after 2–3 hour
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2:8 or 1:9, are used for the human respiratory
anti[-]inflammation.

Liu claim 3.
Liu thus expressly teaches the preparation of a plant extract, but it is
not plainly evident from these teachings that the “mixed water-soluble and
alcohol blend through supercritical extraction” produces an incense resin
extract, particularly given the known water insolubility of plant resins. Id.
However, assuming, arguendo, that this teaching of Liu does in fact
teach a “resin incense extract,” our analysis of Liu does not end there. Liu is
directed to “a fragrant bag having anti-inflammation actions, which is
prepared from nine kinds of Chinese medicinal herbs” and which “can be
used for treating enteritis, constipation, hemorrhoid and stomach diseases.”
Liu Abstr. Liu teaches that its incense bag is administered via “smelt breath
method, physical chemistry method, is sucked [inhaled] method.” Liu 2.
This is in contrast to the teachings of Abascal, which teaches oral
administration of herbs as a treatment for IBS. See Abascal, Tables 2, 4
(summarizing studies). The Examiner provides no reason as to why a person
of ordinary skill in the art would have been motivated to combine a
compound containing a resin extract, that is meant to be ignited and inhaled,
as taught by Liu, with the orally administered compositions taught by
Abascal.
Furthermore, Liu also provides no guidance with respect to the
concentration of resin to be combined with the compositions of Liu. The
Examiner’s position that the appropriate concentrations would have been
known by a person of ordinary skill in the art is unsatisfactory because the
Examiner has failed to adduce any evidence of record to demonstrate that
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such knowledge would be within the ordinary skill of the art. See, e.g.,
Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17 (1966) (requiring
that, in an obviousness analysis, a factual determination of the level of
ordinary skill in the pertinent art be made). In particular, as discussed, the
Examiner has not established that the general conditions of providing a resin
incense extract for ingestion to treat any condition, much less enteritis,
constipation, hemorrhoid and stomach diseases set forth in Liu was disclosed
in the prior art. See In re Aller, 220 F.2d 454, 456 (CCPA 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.”).
Finally, independent claims 22 and 28 further require that the resin
incense extract be in a lyophilized form. The Examiner points to no
teaching or suggestion of the cited prior art that demonstrates incorporation
of lyophilized resin incense extract into a composition, as recited in these
claims.
Summarizing, even if the Examiner has demonstrated that Liu teaches
a “resin incense extract” (and we find that showing to be dubious), the
Examiner has not demonstrated sufficient motivation for a skilled artisan to
combine the teachings of Liu and Abascal. Nor has the Examiner provided
any evidence of record to show that a knowledge of the correct
concentrations of resin incense extract, combined with a knowledge of the
concentrations of constituents of the compositions of Abascal, would be
within the ordinary skill in the art. The Examiner has also failed to
demonstrate any teaching or suggestion of Liu with respect to lyophilizing a
resin incense extract, as recited in independent claims 22 and 28. We
consequently reverse the Examiner’s rejection of the claims. Because we
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find this issue to be dispositive of the appeal, we do not reach Appellant’s
additional arguments.

CONCLUSION
The rejection of claims 1, 11–14, 18–22, 26, and 28 as unpatentable
under 35 U.S.C. § 103 is reversed.
REVERSED

Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 12–14, 18–21 103 Abascal, Liu, Wang 1, 12–14,
18–21
11, 22, 26, 28 103 Abascal, Liu, Wang,
Augusta
11, 22, 26,
28
Overall
Outcome
1, 11–14,
18–22, 26,
28