Ex Parte Palatnik De Souza et al

Patent Trial and Appeal Board

Nov 16, 2017

11920521 (P.T.A.B. Nov. 16, 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.
11/920,521 12/16/2008 Clarisa B. Palatnik De Souza P-703 84-US 7967
49443 7590 11/20/2017
Pearl Cohen Zedek Latzer Baratz LLP
1500 Broadway
12th Floor
New York, NY 10036
EXAMINER
DUFFY, PATRICIA ANN
ART UNIT PAPER NUMBER
1645
NOTIFICATION DATE DELIVERY MODE
11/20/2017 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):
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CLARIS A B. PALATNIK DE SOUZA and
ELVIRA MARIA SARAIVA CHEQUER BOU-HABIB
Appeal 2016-004446
Application 11/920,5211
Technology Center 1600
Before FRANCISCO C. PRATS, JEFFREY N. FREDMAN, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to a method of
impeding the transmission of leishmaniasis disease from an infected canine
to humans or animals. The Examiner rejected the claims as failing to
comply with the written description requirement.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
1 Appellants state that the “real party in interest in this Appeal is
Universidade Federal Do Rio de Janeiro, Av. Brigadeiro Trompowski, S/N,
Cidade Universitaria, 20.530-310 Ilha do Govemador, Rio de Janeiro,
Brazil, by virtue of an assignment recorded against the above-identified
application at Reel/Frame 20990/328.” Appeal Br. 1.
Appeal 2016-004446
Application 11/920,521
STATEMENT OF THE CASE
The Specification explains that “visceral human Leishmaniasis [is] a
serious disease that can be fatal if not adequately treated.” Spec. 1. The
Specification explains that the disease’s etiological agents, Leishmania
chagasi and Leishmania infantum, are transmitted from infected dogs by
Phlebotominae insect vectors, such as the sandfly Lutzomyia longipalpis.
See id. at 6—7.
Specifically, when the insect vector consumes a blood meal from an
infected dog, and thereby ingests the disease-causing organisms, the
organisms initially bind to the intestinal epithelium of the insect. See id.
The disease-causing organisms subsequently develop into a virulent phase of
their life cycle, “metacyclic promastigotes non-divided[,] that are separated
from the medium intestine epithelium migrating to the buccal cavity and
infecting new vertebrates during the next blood meal.” Id. at 7.
Appellants’ invention is directed to a vaccine that contains “a
product called FML antigen,... or ‘Fucose Mannose Ligand’ for
Leishmania donovani comprising a glycoprotein complex whose
carbohydrate portion presents 10% of Fucose and 47% of Man[n]ose,
justifying the utilized name.” Id. at 2.
The Specification explains that the FML antigen is a “surface antigen
of L. donovani promastigotes and amastigotes, highly immunogenic and
protective in the canine vaccination, so it could also be recognized by
specific receivers [sic, receptors] in the medium intestine of vectors as
Lutzomyia longipalpis, acting as a parasite ligand for the medium intestine
membrane of the same.” Id. at 7.
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Application 11/920,521
The Specification discloses a working example in which “[f]our
healthy adult dogs without defined race were vaccinated with Leishmune
(licentiated industrialized vaccine),” after which IgG was purified from their
sera. Id. at 8. The Specification discloses that binding inhibition assays
using “the purified IgG Fab fraction from dogs vaccinated with Leishmune®
(4, 40 and 400 jig/ml)” were performed. Id. at 9.
The Specification discloses that the IgG Fab fraction from the
vaccinated dogs was observed to inhibit binding of both L. donovani and L.
chagasi to dissected intestinal membranes of the insect vector, Lutzomyia
longipalpis. See id. at 9-10; see also Figs. C and D. The Specification
discloses that these results indicate that “antibodies induced by vaccinated
dogs impede the binding of the procyclical promastigotes phases of both
parasites to the medium intestine of the vectors, blocking and impeding the
disease transmission.” Spec. 10.
Claim 4, the sole independent claim on appeal, is representative and
reads as follows:
4. A method of impeding the transmission of leishmaniasis
disease from a canine subject infected with Leishmania to
humans or animals, the method comprising administering a
composition comprising 1.5 mg of Fucose Mannose Ligand
(FML) and 0.5 mg of Riedel De Haen saponin to said canine
subject, said administration being effective to produce an
antibody to said FML that inhibits the binding of promastigotes
of said Leishmania to the intestine of a leishmaniasis disease
sandfly vector having ingested a blood meal from said canine
subject, thereby impeding the transmission of said
leishmaniasis disease from said canine subject to said humans
or animals.
Appeal Br. 11.
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Application 11/920,521
The following rejections are before us for review:
(1) Claims 4, 6, and 7, under 35 U.S.C. § 112, first paragraph, as
lacking descriptive support for a composition comprising 1.5 mg of Fucose
Mannose Ligand (FML) and 0.5 mg of Riedel De Haen saponin (Ans. 2-4);
and
(2) Claims 4, 6, and 7, under 35 U.S.C. § 112, first paragraph, as
lacking descriptive support for administering the composition to a canine
subject infected with Leishmania (Ans. 4—5).
STANDARD OF REVIEW
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
WRITTEN DESCRIPTION—REJECTION 1
To meet the initial burden of establishing a prima facie case of
unpatentability based on a lack of written description, the Examiner must
“present[] evidence or reasons why persons skilled in the art would not
recognize in the disclosure a description of the invention defined by the
claims.” In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996).
In the first rejection, the Examiner notes that the “claims have been
amended to recite 1.5 mg of Fucose Mannose Ligand (FML) and 0.5 mg of
Riedel De Haen saponin (claim 4).” Ans. 2. The Examiner reproduces the
paragraphs from the Specification asserted by Appellants during prosecution
as providing support for that composition {id. at 3), but finds that “[njone of
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these paragraphs provide for the specific claimed amount of 1.5 mg of FML
or 0.5 mg of Riedel De Haen saponin. The specification does not support
the specific amounts of antigen and adjuvant of the claims nor does it
support the Riedel De Haen saponin per se” {id. at 4).
Moreover, the Examiner contends, the “reference to a trademarked
vaccine does not provide for any particulars of the components or amount of
thereof in vaccine per se. As such, the amendment to the claims represent
new matter.” Id.
Appellants contend that the rejection should be withdrawn because,
“at least by the priority date of the application, a person having ordinary skill
in the art would have understood that the LEISHMUNE® vaccine recited in
the specification comprises 1.5 mg of FML and 0.5 mg of Riedel De Haen
saponin.” Appeal Br. 3.
In particular, Appellants contend, the Borja-Cabrera2 (Exhibit A),
Santos3 (Exhibit B), and de Sousa4 (Exhibit C) articles demonstrate that “a
person having ordinary skill in the art would have understood that the term
LEISHMUNE® recited in the specification is comprised of 1.5 mg of FML
2 G.P. Borja-Cabrera et al., Phase I safety and immunogenicity trial of
LeishmuneR in dogs of an endemic area, XX Annual Meeting of the
Brazilian society of Protozoology; XXXI Annual Meeting of Basic
RESEARCH IN CHAGAS’ DISEASE, p. IM13 (2004).
3 Wania Renata Santos et al., Saponins, IL12 and BCG adjuvant in the FML-
vaccine formulation against murine visceral leishmaniasis, 21 Vaccine 30—
43 (2002).
4 C.B. Palatnik de Sousa et al., Protective vaccination against murine
visceral leishmaniasis using aldehyde-containing Quillaja saponaria
sapogenins, 22 Vaccine 2470—2479 (2004).
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and 0.5 mg of Riedel De Haen saponin.” Id. at 4; see also id. at 5—8; Reply
Br. 1-5.
Having carefully reviewed the contentions and evidence advanced by
both the Examiner and Appellants, we find that the preponderance of the
evidence supports the Examiner’s position.
As stated in Turbo Care Div. of Demag Delaval Turbomachinery
Corp. v. General Elec. Co., 264 F.3d 1111, 1118 (Fed. Cir. 2001):
The written description requirement and its corollary, the new
matter prohibition of35U.S.C. § 132, both serve to ensure that
the patent applicant was in full possession of the claimed
subject matter on the application filing date. When the
applicant adds a claim or otherwise amends his specification
after the original filing date . . ., the new claims or other added
material must find support in the original specification.
The test for determining whether a specification is sufficient to
support a particular claim “is whether the disclosure of the application relied
upon ‘reasonably conveys to the artisan that the inventor had possession at
that time of the later claimed subject matter.’” Ralston Purina Co. v. Far-
Mar-Co, Inc., 772 F.2d 1570, 1575 (Fed. Cir. 1985) (quoting In re Kaslow,
707 F.2d 1366, 1375 (Fed. Cir. 1983)).
Thus, “[i]t is not necessary that the application describe the claim
limitations exactly, but only so clearly that persons of ordinary skill in the
art will recognize from the disclosure that appellants invented processes
including those limitations.” In re Wertheim, 541 F.2d 257, 262 (CCPA
1976) (citation omitted); see also Purdue Pharma L.P. v. Faulding, Inc., 230
F.3d 1320, 1323 (Fed. Cir. 2000) (“In order to satisfy the written description
requirement, the disclosure as originally filed does not have to provide in
haec verba support for the claimed subject matter at issue.”).
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Claim 4 recites administering a “composition comprising 1.5 mg of
Fucose Mannose Ligand (FML) and 0.5 mg of Riedel De Haen saponin.”
Appeal Br. 11. Appellants do not dispute that the Specification does not
provide word-for-word support for that composition.
Instead, as noted above, Appellants contend that the Specification’s
recitation of the term “Leishmune” inherently provides support for the
claimed composition, because an ordinary artisan would have recognized,
based on the Borja-Cabrera, Santos, and de Sousa articles that “Leishmune”
inherently contains 1.5 mg of Fucose Mannose Ligand (FML) and 0.5 mg of
Riedel De Haen saponin.
We are not persuaded.
We acknowledge the Specification’s disclosure of a vaccine
composition using the term Leishmune. See Spec. 7 (“Leishmune® (FML
vaccine under industrialized license)”); id. at 8 (“Leishmune (licentiated
industrialized vaccine)”); id. at 9 (“Leishmune®”). The Specification does
not, however, identity the ingredients in the Leishmune product. Neither
can we conclude that these compositions are identical to the claimed
composition merely based on the trademarked name. Cf. Manual of Patent
Examining Procedure § 608.0 l(v) (“The relationship between mark or trade
name and the product... is sometimes indefinite, uncertain, and arbitrary.
[T]he formula or characteristic of a product may change . . . and yet it may
continue to be sold under the same mark or trade name.”).
Appellants, moreover, do not identity any specific evidence, either in
the disclosures of the cited articles, or elsewhere in the record, suggesting
that the Leishmune product was so well known that ordinary artisans would
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immediately recognize that Leishmune contains 1.5 mg of Fucose Mannose
Ligand (FML) and 0.5 mg of Riedel De Haen saponin.
In addition, the articles cited by Appellants do not use terminology
that is consistent with the language in claim 4. Nor do the articles cited by
Appellants use consistent terminology between them.
The Borja-Cabrera article is the only article purporting to describe the
ingredients of the Leishmune product. Borja-Cabrera discloses only the use
of “Leishmune^ (1.5mg of FML and 0.5mg of Saponin R).” Borja-Cabrera
1M13. Claim 4, however, does not require the presence of Saponin R, but
instead recites “Riedel De Haen saponin.” Appeal Br. 11.
We acknowledge Santos’s disclosure of a vaccine containing “Riedel
de Haen (R).” Santos 30 (Abstract); see also id. at 31 (disclosing “Riedel
De Haen saponin”); id. (“Saponins were purchased from: Riedel De Haen,
Saponin pure (R) (8047-15-2) EINECE (West Germany). . . .”).
We acknowledge also de Sousa’s disclosure of “Riedel de Haen
saponin (R).” de Sousa 2470 (Abstract).
Neither Santos nor de Sousa, however, disclose or explain that
“Riedel de Haen (R)” is the same product as the “Saponin R” disclosed by
Borja-Cabrera as being present in the Leishmune product. Nor do Santos or
de Sousa describe “Riedel de Haen (R)” or Riedel De Haen saponin as being
present in the Leishmune product.
Thus, the articles cited by Appellants either do not use terminology
that is consistent with the language in claim 4, or do not use terminology that
is sufficiently consistent with each other to demonstrate that the Leishmune
product was so well known that ordinary artisans would immediately
recognize that Leishmune contains 1.5 mg of Fucose Mannose Ligand
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(FML) and 0.5 mg of Riedel De Haen saponin, as required by claim 4.
Appellants, therefore, do not persuade us that a preponderance of the
evidence fails to support the Examiner’s finding that the composition recited
in claim 4 lacks sufficient descriptive support. Accordingly, we affirm the
Examiner’s first rejection for lack of written description.
WRITTEN DESCRIPTION—REJECTION 2
In the second rejection, the Examiner contends that, although “the
specification supports administration to uninfected canines, the specification
does not support administration to an infected canine to reduce the incidence
of transmission of Leishmania.” Ans. 4. In particular, the Examiner
contends, the Specification “only supports administration to healthy dogs at
page 8, lines 15-30[].” Id. at 5.
Having carefully reviewed the contentions and evidence advanced by
both the Examiner and Appellants, we again find that the preponderance of
the evidence supports the Examiner’s position.
Appellants contend:
The term “blocking vaccine” and the phrase “impede the
Leishmaniasis transmission” are sufficient to demonstrate that
the inventors contemplated administering a vaccine to an
infected animal, since the plain meanings of the terms
“blocking vaccine” and “impede the Leishmaniasis
transmission” connote a vaccine used for inhibiting
transmission of an infection from an infected animal to an
uninfected animal. A person of ordinary skill in the art would
readily understand that such a transmission-blocking vaccine
would be administered to an infected animal.
Appeal Br. 9 (citing Spec. 8:9-11); see also Reply Br. 5—6.
We acknowledge the following passage in the Specification:
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The term Transmission Blocking Vaccine (TBV) is used
for anti-malaria vaccines that stimulate the antibodies
production in humans against the sexual forms (gametes) of
parasites present in the medium intestine of the Anopheles
vector. Mosquitos acquire those antibodies during blood
feeding, blocking the fertilization process and subsequent
development of the parasites in the medium intestine of the
vector, impeding the disease transmission by the insect.
Spec. 6.
Even acknowledging the above-quoted passage in the Specification,
Appellants do not identify any persuasive objective evidence of record as to
the plain meaning of a “blocking vaccine.” Nor do Appellants advance
evidence suggesting that use of a blocking vaccine would have been readily,
or even necessarily, recognized by an ordinary artisan as describing
administration of the vaccine to an infected animal.
To the contrary, as noted above, Appellants’ Specification describes
the FML antigen as a “surface antigen of L. donovani promastigotes and
amastigotes, highly immunogenic and protective in the canine
vaccination.” Id. at 7 (emphasis added); see also id. at 5 (“The present
invention describes the development of a prophylaxis vaccine against canine
visceral leishmaniasis . . . .”).
As noted above also, the Specification discloses administering the
vaccine to healthy dogs (Spec. 8), and then demonstrates that the IgG from
vaccinated dogs inhibits binding of the disease-causing organism to the
intestinal epithelium of the insect vector, “indicating that antibodies induced
by vaccinated dogs impede the binding of the procyclical promastigotes
phases of both parasites to the medium intestine of the vectors, blocking and
impeding the disease transmission” {id. at 10).
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Given the Specification’s description of the FML antigen as a
protective vaccine, and given the working example of administering the
vaccine to uninfected dogs, Appellants do not persuade us that the only
“rational reading” of the Specification (Reply Br. 6) is the disclosure of
administration to infected dogs.
We acknowledge the passage at page 6 of the Specification
summarized above, explaining the life cycle of the disease-causing
organisms, as well as the use of Leishmune “for blocking the adhesion of
Leishmania donovani and Leishmania chagasi procyclical promastigotes to
the membrane of the medium intestine of the vector, the ‘sandfly’ Lutzomyia
longipalpis, making possible to characterize the potential blocking effect for
the FML vaccine.” Spec. 7; see also Appeal Br. 9-10 (citing Spec. 6—7 and
arguing that “[s]uch a mechanism implicitly provides for vaccination of
infected animals”); Reply Br. 5—6 (citing pages 6 and 7 of the Specification).
That such disclosures might imply, or make it obvious, that the
vaccine could be administered to infected animals does not demonstrate that
the Specification actually describes administration to an infected animal.
See Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1352
(Fed. Cir. 2010) (“[A] description that merely renders the invention obvious
does not satisfy the requirement.”).
In sum, for the reasons discussed, Appellants do not persuade us that a
preponderance of the evidence fails to support the Examiner’s finding that
the administration of the claimed composition to infected dogs, recited in
claim 4, lacks sufficient descriptive support. Accordingly, we affirm the
Examiner’s second rejection for lack of written description.
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SUMMARY
For the reasons discussed, we affirm the Examiner’s rejections for
failure to comply with the written description requirement.
TIME PERIOD
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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