Ex Parte Sirard et al

Patent Trial and Appeal Board

Jan 25, 2019

14185077 (P.T.A.B. Jan. 25, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/185,077 02/20/2014
30743 7590 01/25/2019
W&CIP
11491 SUNSET HILLS ROAD
SUITE 340
RESTON, VA 20190
FIRST NAMED INVENTOR
Jean-Claude Sirard
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.
l 1450139US2 1203
EXAMINER
MARTINEZ, TARA L
ART UNIT PAPER NUMBER
1654
MAIL DATE DELIVERY MODE
01/25/2019 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JEAN-CLAUDE SIRARD and JOSE A. CHABALGOITY
Appeal2017-007361
Application 14/185,077 1
Technology Center 1600
Before DEBORAH KATZ, RACHEL H. TOWNSEND, and DAVID
COTTA Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of treating an acute respiratory tract infection, which have been rejected as
obvious and on the ground of obviousness-type double patenting. Oral
argument was heard on January 17, 2019. We have jurisdiction under 35
U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
"Current therapies for respiratory tract infections involve the
administration of antiviral agents, anti-bacterial, and antifungal agents for
1 Appellants identify the real party in interest as Institut National de la Sante
et de la Recherche Medicale. (Appeal Br. 3.)
Appeal2017-007361
Application 14/185,077
the treatment, prevention, or amelioration of viral, bacterial, and fungal
respiratory tract infections, respectively." (Spec. 1.) An example of a
bacterium that causes upper and lower respiratory tract infections is
Streptococcus pneumoniae." (Id.)
"Unfortunately, in regard to certain infections, there are no therapies
available, infections have been proven to be refractory to therapies, or the
occurrence of side effects outweighs the benefits of the administration of a
therapy to a subject." (Id.) "Therefore, new therapies for the treatment,
prevention, management, and/ or amelioration of respiratory tract infections
and symptoms thereof are needed." (Id. at 2.)
"Activation of innate defen[ s Jes is essential to control pneumococcal
infection." (Id.) "Modulating immunity by the activity of innate receptors is
an emerging concept to elicit protective responses against infections." (Id.)
"The effectiveness of TLR [(toll-like receptor)] agonists for therapeutic
treatment of infectious diseases has been demonstrated in several animal
models, including models of respiratory tract infections." (Id.) "Various
cells of the pulmonary tract including the epithelial cells express TLR5 but
the modulation of the TLR5 signalling pathway has not yet been investigated
for the treatment of respiratory tract infections." (Id.) "[T]he present
invention relates to a TLR5 agonist for use in a method for treating a
respiratory tract infection." (Id. at 3.)
Claims 24, 27, 28-35, and 41--46 are on appeal. Claim 24 is
representative and reads as follows:
24. A method of treating an acute respiratory tract infection
comprising administering to a subject that has an acute
respiratory tract infection caused by Streptococcus pneumonia a
therapeutically effective amount of a TLR5 agonist, wherein the
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Application 14/185,077
TLR5 agonist consists of a flagellin polypeptide, and wherein
said TLR5 agonist is administered topically by intranasal
administration or pulmonary administration.
(Appeal Br. 27.)
The following grounds of rejection by the Examiner are before us on
review:
Claims 24 and 27 under 35 U.S.C. § I03(a) as unpatentable over
Aderem2 and CDC. 3
Claims 28-32 under 35 U.S.C. § I03(a) as unpatentable over Aderem
and Sirard '415.
Claims 33, 35, 41--44, and 46 under 35 U.S.C. § I03(a) as
unpatentable over Aderem, Sirard '415, 4 and Nempont. 5
Claims 28-34 and 41--45 under 35 U.S.C. § I03(a) as unpatentable
over Aderem and Sirard '962. 6
Claims 24 and 26--46, provisionally, for nonstatutory double patenting
as being unpatentable over claims 1, 8-11, 13, and 20 of copending
Application No. 13/000167 in view of Aderem.
2 Aderem et al., US 2009/0297552 Al, published Dec. 3, 2009.
3 Centers for Disease Control and Prevention, Pneumococcal Disease, In
Hamborsky J, Kroger A, Wolfe S, (Eds.), Epidemiology and Prevention of
Vaccine-Preventable Diseases, 13th Ed. (2015), retrieved from
https ://www.cdc.gov/vaccines/pubs/pinkbook/pneumo .html.
4 Sirard et al., US 2006/0257415 Al, published Nov. 16, 2006.
5 Nempont et al., Deletion of Flagellin 's Hypervariable Region Abrogates
Antibody-Mediated Neutralization and Systemic Activation of TLR5-
Dependent Immunity, 181 J. Immunol., 2036-2043 (2008).
6 Sirard, US 2011/0110962 Al, published May 12, 2011.
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Application 14/185,077
DISCUSSION
Obviousness
The Examiner finds that Aderem teaches that flagellin polypeptides
stimulate an innate immune response and that endogenously expressed
flagellin polypeptides stimulate TLR5. (Final Action 3.) The Examiner
further finds that Aderem teaches a method of treating or reducing the risk of
pathogenic infection such as viral, bacterial, and parasitic infections, that
includes administration of flagellin. (Id.) The Examiner finds that Aderem
"clearly states [in paragraph 4] that the flagellin can be used alone or in
conjunction with antigens." (Ans. 14; Final Action 4.)
The Examiner notes that while Appellants' claim requires that the
"TLR5 agonist consists of a flagellin polypeptide" and therefore cannot
include any other elements other than being a flagellin polypeptide, the
composition that is "administered for treatment ... is open and does not
exclude additional, unrecited elements" because the claim recites "[a]
method of treating acute respiratory tract infection comprising
administering .... " (Ans. 14.)
The Examiner further finds that Aderem discloses intranasal
administration of flagellin polypeptide and provides an example of such
intranasal administration. (Final Action 4.)
Regarding the requirement that the treatment be for an acute
respiratory tract infection, the Examiner points out that Aderem teaches
"treatment of Streptococcus pneumonia" and that "[t]he CDC-Pneumococcal
diseases reference teaches that Streptococcus pneumonia causes an acute
bacterial infection." (Id.)
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We disagree with the Examiner's factual finding that Aderem teaches
administration of flagellin polypeptide alone and the Examiner's conclusion
of obviousness based thereon. Paragraph 4 of Aderem, which the Examiner
relies on as the disclosure in Aderem supporting the use of flagellin
polypeptides alone states in its entirety:
The invention relates to vaccines that provide flagellin
polypeptides for stimulation of an innate immune response.
The flagellin polypeptides may be used alone or in conjunction
with antigens for eliciting adaptive immune responses.
As Appellants point out, the vaccine to which this paragraph of Aderem
refers is discussed more fully under the section entitled "Disclosure of the
Invention," which beings at paragraph 15. There it is noted that the vaccine
employs flagellin polypeptides that are able to elicit both extracellular and
intracellular based innate immune responses. (Aderem ,r 15.) It is further
explained that toll like receptor 5 (TLR5) and Ipaf mediate aspects of the
innate immune response and that Ipaf is an intracellular pathway, while
TLR5 molecules are on the cell surface. (Id. ,r,r 25, 34.) It is noted that (1)
the innate immune responses due both to the response to TLR5 and Ipaf are
"independent of specific antigens, but can act as an adjuvant to an adaptive
immune response that is antigen specific," and (2) the antigen for the
adaptive immune response "may be supplied externally in the form of a
vaccine or infection, or may be indigenous, for example, as is the case for
tumor-associated antigens." (Id. ,r 10.)
The specification of Aderem goes on to explain that direct
administration of isolated flagellin polypeptides does not stimulate an Ipaf-
mediated response because it does not enter the cytoplasm of a targeted
immune cell in intact form that is capable of stimulating Ipaf. (Id. ,r 34.)
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The invention is thus to "vaccine compositions [that] include nucleic acids
that encode an immunomodulatory flagellin polypeptide and direct[ s] its
expression, thereby stimulating certain aspects of the innate immune
response." (Aderem ,r 33.) The Aderem specification explains that such
expression can result in flagellin being released into the extracellular
environment by cell lysis or secretion where the flagellin can interact with
and/or stimulate TLR5. (Id.) Aderem further explains that where the
flagellin remains in the cytosol of a mammalian cell that has been infected
with a flagellin-expressing transgenic virus or bacterium ( or by use of a
fusion protein consisting essentially of an immunomodulatory flagellin
polypeptide fused to an antigen and/or an amino acid sequence that
facilitates cell penetration in the cells), the cytosolic flagellin may "interact
with and/or stimulate an Ipaf-mediated signaling pathway within the cell."
(Id.; see also Aderem claim 1.)
Example 1 of Aderem describes creation of recombinant viruses
expressing flagellin, and Example 2 indicates that the flagellin expressed
thereby once in the extracellular space is capable of activating TLR5.
Example 3 indicates that when the flagellin is expressed as a free protein in
the cytosol of a macrophage infected with the recombinant virus expressing
flagellin, Ipaf signaling is activated. ( Aderem ,r,r 102-105.)
In light of the foregoing, we understand the second sentence of
paragraph 4 of Aderem to indicate that, in the context of the vaccine that
provides flagellin for stimulation of the innate immune response, the
flagellin polypeptide produced from the flagellin-expressing transgenic virus
or bacterium flagellin polypeptide is used by the cell alone to produce the
adaptive immune response or in conjunction with antigens to produce the
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adaptive immune response. We do not understand Aderem to teach or
suggest administering flagellin polypeptide to treat an infection, as the
Examiner asserted.
While it is true, as the Examiner asserted in the Answer (Ans. 14), that
Appellants' claim allows for additional, unrecited elements in the treatment,
it does require administration of a flagellin polypeptide. Aderem teaches
administration of a recombinant vaccine where the vaccine produces
flagellin. We do not find that such an administration of the vaccine is
administration of flagellin.
"A rejection based on section 103 clearly must rest on a factual basis,
and these facts must be interpreted without hindsight reconstruction of the
invention from the prior art". In re Warner, 379 F.2d 1011, 1017 (CCPA
1967). For the reasons discussed above, we determine that the Examiner has
not set forth a factual basis that is sufficient to support a conclusion of
obviousness of the Appellants' claimed invention. Accordingly, we reverse
the Examiner's rejection of claims 24 and 27 under 35 U.S.C. § 103(a) as
unpatentable over Aderem and CDC.
The Examiner's rejections of the remaining claims as obvious rest on
the position that Aderem teaches administration of flagellin to treat infection
(Final Action 5, 8, and 11 ), which we rejected above. Accordingly, we
reverse the remaining obviousness rejections for the reasons provided above.
Nonstatutory Double Patenting
The Examiner's nonstatutory double patenting rejection also rests on
the position that Aderem teaches administration of flagellin to treat infection
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(Final Action 19), which we rejected above. Accordingly, we reverse this
rejection of the claims as well.
SUMMARY
We reverse the rejection of claims 24 and 27 under 35 U.S.C. § 103(a)
as unpatentable over Aderem and CDC.
We reverse the rejection of claims 28-32 under 35 U.S.C. § 103(a) as
unpatentable over Aderem and Sirard '415.
We reverse the rejection of claims 33, 35, 41--44, and 46 under 35
U.S.C. § 103(a) as unpatentable over Aderem, Sirard '415, and Nempont.
We reverse the rejection of claims 28-34 and 41--45 under 35 U.S.C.
§ 103(a) as unpatentable over Aderem and Sirard '962.
We reverse the rejection of claims 24 and 26--46, provisionally, for
nonstatutory double patenting as being unpatentable over claims 1, 8-11, 13,
and 20 of copending Application No. 13/000167 in view of Aderem.
REVERSED
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