Ex Parte Bombardelli et al

Patent Trial and Appeal Board

Mar 21, 2017

12988897 (P.T.A.B. Mar. 21, 2017)

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.
12/988,897 12/16/2010 Ezio Bombardelli SS122.1024 5474
122515 7590
Silvia Salvadori, P.C.
Silvia Salvadori
270 Madison Avenue, 8th Floor
New York, NY 10016
EXAMINER
CLARK, AMY LYNN
ART UNIT PAPER NUMBER
1655
NOTIFICATION DATE DELIVERY MODE
03/23/2017 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):
silvia@salvadorilaw.com
silvia30121 @ me. com
eofficeaction @ appcoll.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte EZIO BOMBARDELLI, GABRIELE FONTANA,
ANDREA GIORI, PAOLO MORAZZONI, ANTONELLA RIVA, and
MASSIMO RONCHI1
Appeal 2016-004083
Application 12/988,897
Technology Center 1600
Before DEMETRA J. MILLS, ERIC B. GRIMES, and
RICHARD J. SMITH, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of treating bacterial or fungal vaginal infections, which have been rejected as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
Claims 21—23 are on appeal. Claim 21 is representative and reads as
follows:
1 Appellants identify the Real Party in Interest as INDENA S.P.A. (Appeal
Br. 3.)
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Application 12/988,897
21. A method of treatment of bacterial or fungal vaginal infections
and resulting inflammatory states thereof, said method comprising:
preparing topical formulations consisting essentially of
a) benzophenanthridine alkaloids;
b) benzofuran compounds and
c) extract of Zanthoxylum bungeanum or Echinacea angustifolia;
administering said topical formulations and treating said bacterial or
fungal vaginal infections and resulting inflammatory states.
DISCUSSION
The Examiner has rejected claims 21—23 under 35 U.S.C. § 103(a) as
obvious based on Squires,2 Vipont,3 Steinman,4 and Bombardelli.5 (Nonfmal
Action6 6.) The Examiner finds that Squires teaches treating bacterial and
fungal infections, including vaginal infections, using an antimicrobial isolate
from Echinacea, preferably Echinacea augustifolium. {Id.)
The Examiner finds that Vipont “teaches an antimicrobial composition
comprising benzophenanthridine alkaloid . . . that can be incorporated into
vehicles for topical applications . . . and treats bacterial and fungal
infections.” {Id.) The Examiner finds that “Steinman teaches antimicrobial
2 Squires, US 6,355,684 Bl, pat. Mar. 12, 2002.
3 Ladanyi, GB 2,078,109 A, pub. Jan. 6, 1982. The Examiner and Appellants
cite this reference as “Vipont” or “Vipoint.”
4 Steinman, US 3,944,672, pat. Mar. 16, 1976.
5 Bombardelli et al., US 2001/0046525 Al, pub. Nov. 29, 2001.
6 Office Action mailed Sept. 26, 2014.
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Application 12/988,897
benzofuran compounds for treating bacterial, fungal and protozoan
infections” and can be administered as vaginal suppositories. {Id. at 7.)7
The Examiner concludes that it would have been obvious to combine
the Echinacea augustifolium extract taught by Squires with the benzo-
phenanthridine alkaloid taught by Vipont and the benzofuran compounds
taught by Steinman because “it is prima facie obvious to combine two or
more ingredients each of which is taught by the prior art to be useful for the
same purpose in order to form a third composition which is useful for the
same purpose.” {Id. at 7—8, citing In re Kerkhoven, 626 F.2d 846, 850
(CCPA 1980).)
We agree with the Examiner that the method of claim 21 would have
been obvious based on the cited references. Squires discloses a “medicine
. . . which, when applied in the topical manner, rapidly relieves pain and
heals lesions of herpes virus.” (Squires 2:18—20.) Squires states that,
“[w]hile the novel medicine and antimicrobial compound is particularly
useful in dramatically inhibiting herpes virus . . . , it may be useful in treating
other microbial diseases,” including those caused by staphylococci and
streptococci. {Id. at 2:45—51.)
Squires states that its composition desirably “includes microbe
inhibitors which inhibit, suppress and stop microbial infections from
microbe-causing diseases. The microbe inhibitors comprise antimicrobial
isolates, botanical extracts or phytochemicals.” {Id. at 3:4—8.) Squires states
that its composition preferably includes a surfactant, or more specifically, “an
7 The Examiner cites Bombardelli only with respect to claim 23, which is not
argued separately.
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antimicrobial detergent surfactant, with botanical extracts.” (Id. at 3:50-57.)
Suitable botanical extracts include those from Echinacea augustifolium. (Id.
at 4:51—60.) Squires states that “[t]he phytochemicals in the botanical
Echinacea have demonstrated impressive activity against bacteria, viruses,
and some fungi.” (Id. at 5:45—47.) Squires discloses that its composition can
be applied to vaginal tissue. (Id. at 3:34—38.)
Vipont discloses “[a]ntimicrobial compositions compris[ing] a mineral
acid salt of a benzophenanthridine alkaloid and a non-toxic metal salt of an
acid in a suitable solvent vehicle.” (Vipont, abstract.) Vipont states that its
composition is “useful in dental preparations, mouthwashes, rinses, surgical
soaps, shampoos, creams, lotions, powders, injectables, etc., and other forms
of drug preparation and disinfectants.” (Id. at 1:61—65.) Vipont discloses
that its composition is effective against a variety of bacteria, as well as the
fungi Candida albicans and Saccharomyces cerevisiae. (Id. at 8:5—19.)
Steinman discloses antimicrobial compounds; specifically, 2-
aminoalkyl-3-aryl-herero-indenes. (Steinman 1:14—15.) Steinman states that
‘“[a]ntimicrobial’ as used herein refers to antibacterial, antifungal or
antiprotozoal activity.” (Id. at 1:11—13.) Steinman also states that
‘“[hjeteroindene’, as used herein, is an . . . indole, benzothiophene [or]
benzofuran.” (Id. at 1:38-41.) Steinman discloses that its compounds are
effective against a variety of bacteria and fungi (id. at 9:17—22) and can be
used in vaginal suppositories (id. at 13:61 to 14:2).
Based on these disclosures, it would have been obvious to combine:
1) the Echinacea augustifolium extract disclosed by Squires (and
optionally also an antimicrobial detergent surfactant), with
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Application 12/988,897
2) the mineral acid salt of a benzophenanthridine alkaloid and
non-toxic metal salt of an acid disclosed by Vipont, and
3) the benzofuran disclosed by Steinman,
and to use the resulting composition to treat bacterial or fungal vaginal
infections. The references provide reasons to combine their teachings
because they all teach that their compositions are effective against bacteria
and fungi. In addition, both Squires and Steinman disclose that their
compositions are suitable for vaginal use, and Vipont discloses that its
composition can be used in various topical preparations (creams, lotions, and
powders) and other forms of drug preparation.
“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 which is to be used for the very same purpose. . . . [T]he
idea of combining them flows logically from their having been individually
taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980).
The same is true for combining three (or more) antimicrobial agents into a
single antimicrobial composition. The use of the combination of an
Echinacea augustifolium extract, a benzophenanthridine alkaloid, and a
benzofuran to treat bacterial or fungal infections is nothing “more than the
predictable use of prior art elements according to their established functions.”
KSRIntI Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007).
Appellants argue that the claimed method requires “preparing topical
formulations consisting essentially of benzophenanthridine alkaloids,
benzofuran compounds and extracts of Zanthoxylum bungeanum or
Echinacea Angustifolia.” (Appeal Br. 9.) Appellants argue that “Squires
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describes that the antimicrobial activity is provided also by the surfactant”
{id. at 10) and “teaches that a medical composition is a phytochemical
compound combined and simultaneously or concurrently applied with an
antimicrobial surfactant” {id. at 12). Appellants argue that “Vipont also does
not disclose Appellants’ invention because it provides for a composition of a
mineral acid salt of a benzophenanthridine alkaloid and a non-toxic metal salt
of an acid.” {Id. at 10.)
To the extent that Appellants are implying that claim 21 excludes
components other than those specifically recited, the argument is
unpersuasive. Claim 21 uses the transition phrase “consisting essentially of,”
which “opens the claims to the inclusion of ingredients which would not
materially affect the basic and novel characteristics of appellant’s
compositions as defined in the balance of the claim.” In re Janakirama-Rao,
317 F.2d 951, 954 (CCPA 1963).
Appellants do not provide any definition of the “basic and novel”
characteristics of the claimed composition, or point to one in their
Specification. “It is the applicants’ burden to precisely define the invention,
not the PTO’s. See 35 U.S.C. § 112,12. . . . [T]his section puts the burden
of precise claim drafting squarely on the applicant.” In re Morris, 127 F.3d
1048, 1056 (Fed. Cir. 1997). See also PPG Indus, v. Guardian Indus. Corp,
156 F.3d 1351, 1355 (Fed. Cir. 1998) (“PPG could have defined the scope of
the phrase ‘consisting essentially of for purposes of its patent by making
clear in its specification what it regarded as constituting a material change in
the basic and novel characteristics of the invention.”).
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The Specification states that the disclosed compositions “possess anti­
inflammatory, antibacterial and antifungal activity useful in the treatment of
vaginal infections and the resulting inflammatory states.” (Spec. 1:3—5.)
Thus, as we understand it, the basic and novel characteristics of the
composition recited in claim 21 are its anti-inflammatory, antibacterial and
antifungal activity. The addition of other antibacterial or antifungal agents
would therefore not affect the basic and novel characteristics of the claimed
composition. We agree with the Examiner (Nonfmal Action 7) that the
broadest reasonable interpretation of claim 21, consistent with the
Specification, encompasses the additional ingredients disclosed by the cited
references.
Appellants also argue that Vipont discloses that its composition is to be
used as a dentifrice. (Appeal Br. 10.) Appellants argue that “Vipont clearly
describes that the composition is suitable for the prevention and treatment of
infections and diseases in mammals, and is particularly in the form of a
dentifrice.” (Id. at 13.)
This argument is not persuasive. Vipont discloses that its composition
is useful “particularly in the form of a dentifrice” (Vipont, abstract) but it also
discloses that it is useful in a variety of other applications (id. at 1:61—65).
Vipont provides a working example that describes use of its composition to
treat ringworm, athlete’s foot fungus, cold sores, and scours in addition to
dental use. (Id. at 8:85—130.) Thus, a skilled artisan would not have read
Vipont’s disclosure to mean that its composition was limited to use in a
dentifrice.
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Appellants argue that “Steinman describes a compound which is not
the compound presently claimed” because the formula of Steinman’s
heteroindene compounds does not correspond to the benzofuran compound
recited in the Specification. (Appeal Br. 11.)
This argument is also unpersuasive, because claim 21 does not limit
the structure of the benzofuran in the recited composition, and “the claims
define the invention. . . . [L] imitations from the specification are not to be
read into the claims.” Sjolund v. Musland, 847 F.2d 1573, 1582 (Fed. Cir.
1988). Steinman discloses that its heteroindene compounds include
benzofurans (Steinman 1:3 8—41) and therefore its disclosure meets the
limitation of “benzofuran compounds” as recited in claim 21.
Claims 22 and 23 have not been argued separately and therefore fall
with claim 21. 37 C.F.R. § 41.37(c)(l)(iv).
SUMMARY
We affirm the rejection of claims 21—23 under 35 U.S.C. § 103(a) as
obvious based on Squires, Vipont, Steinman, and Bombardelli.
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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