Ex Parte Gomer et al

Patent Trials and Appeals Board

Feb 25, 2019

13571841 - (D) (P.T.A.B. Feb. 25, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/571,841 08/10/2012
122973 7590 02/27/2019
Baker Botts L.L.P. /f AMUS
The Texas A&M University System
2001 Ross Avenue, 6th Floor
SUITE 900
Dallas, TX 75201
FIRST NAMED INVENTOR
Richard Gomer
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.
017575.1455 (TAMUS
3431)
CONFIRMATION NO.
5033
EXAMINER
YAMASAKI, ROBERT J
ART UNIT PAPER NUMBER
1657
NOTIFICATION DATE DELIVERY MODE
02/27/2019 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):
otc-paralegal@sagomail.tamus.edu
PTOmaill@bakerbotts.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RICHARD GOMER, JONATHAN PHILLIPS, SARAH
HERLIHY, ANU S. MAHARJAN, and DARRELL PILLING
Appeal2017-004449
Application 13/571,841
Technology Center 1600
Before FRANCISO C. PRATS, DEBORAH KATZ, and RYAN H. FLAX,
Administrative Patent Judges.
KATZ, Administrative Patent Judge.
DECISION ON APPEAL
Appeal2017-004449
Application 13/571,841
Appellants 1 seek our review, under 35 U.S.C. § 134(a), of the
Examiner's decision to reject claims 1---6, 11-13, 45--49, and 51---62.
(Appeal Brief filed January 19, 2016 ("App. Br.") 2.) We have jurisdiction
under 35 U.S.C. § 6(b). We AFFIRM.
Appellants' specification is directed to regulating neutrophils, which
are cells involved in the early stages of immune responses and inflammation.
(See Spec. 1:15-16, 3:7-8.) According to Appellants, regulation of the
amounts and activity of a protein dipeptidyl peptidase-IV ("DPPIV") can
affect neutrophil movement in a patient and numbers of neutrophils in a
particular region of the body. Specifically, Appellants have found that
neutrophil movement into a body region can be suppressed by establishing a
DPPIV gradient at that location and neutrophil movement out of a body
region can be enhanced by increasing the concentration of DPPIV at the
region. (Spec. 1: 15-23.)
The Examiner rejected all of Appellants' pending claims as being
anticipated under 35 U.S.C. § 102(b) by Chang2 or, in the alternative, as
being obvious under 35 U.S.C. § 103(a) over Chang. (See Examiner's
1 Appellants report that the real party in interest is the Texas A&M
University System. (App. Br. 3.)
2 Chang, U.S. Patent Application Publication 2006/0051366, published
March 9, 2006.
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Appeal2017-004449
Application 13/571,841
Answer issued August 4, 2016 ("Ans.") 2-9.) The Examiner cites
Abraham3, Nakamura4, and Herlihy5 as evidence.
Appellants' claim 1 recites:
A method of reducing the number of neutrophils in a body
region comprising administering a dipeptidyl peptidase-IV (DPPIV)
composition to the body region in an amount and for a time sufficient
to establish a concentration gradient of DPPIV of at least 0.10
ng/ml/µm in the body region, the gradient sufficient to suppress
neutrophil movement into the body region or enhance neutrophil
movement out of the body region.
(App. Br. 13, Claims App'x.) Appellants do not argue for the separate
patentability of any of the rejected claims. We focus on claim 1 in our
analysis. See 37 C.F.R. § 4I.37(c)(l)(iv).
Findings of Fact
1. Chang is directed to uses of DPPIV, which is referred to as
"CD26," to inhibit angiogenesis and inflammation in a mammal. (Chang
abstract, ,r,r 30, 58; see also id. ,r 11 ("Human CD26, also known as a
dipeptidyl peptidase IV (DPPIV) .... ").)
3 Abraham et al., Neutrophils as early immunologic effectors in hemorrhage-
or endotoxemia-induced acute lung injury, 279 AM. J. PHYSIOL. LUNG CELL
MOL.. PHYSIOL. Ll 137-Ll 145 (2000).
4 Nakamura et al., Neutrophil Elastase in Respiratory Epithelial Lining
Fluid of Individuals with Cystic Fibrosis Induces lnterleukin-8 Gene
Expression in a Human Bronchial Epithelial Cell Line, 89 J. CLIN. INV.
1478-84 (1992).
5 Herlihy, et al., Dipeptidyl Peptidase IV Is a Human and Murine Neutrophil
Chemorepellent, 190 J. IMMUNOL. 6468-77 (2013).
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Appeal2017-004449
Application 13/571,841
2. Chang teaches administering DPPIV /CD26 to an affected body
region, including "locally to the area in need of treatment." (Chang ,r 107;
see also id. ,r,r 30-36, 105, 106, 108-121.)
3. Chang teaches treating acute or chronic inflammatory lung
conditions, such as bronchitis or cystic fibrosis, by inhalation of
DPPIV/CD26 using a nebulizer. (See Chang ,r,r 76-78, 107.)
4. Appellants' Specification describes treating lung irritation via
inhalation, for instance using a nebulizer. (Spec. 18: 14--15.)
5. The Examiner finds that locally administering DPPIV will
necessarily create a higher concentration at or near the site of administration
relative to other areas of the body- a DPPIV concentration gradient. (Ans.
3--4.)
6. Appellants' Specification discloses that "DPPIV will likely
move out from its administration site to form a concentration gradient in a
body region." (Spec. 19:3-5.)
7. Chang teaches administering DPPIV at from 1 mg/kg/day to
100 mg/kg/day to the subject. (See Chang ,r 117 .)
8. Appellants' Specification discloses administering DPPIV/CD26
at between 30 µg and 50 µg per kg body weight showed efficacy. (Spec.
21:4--7.)
9. Appellants' Specification discloses the "[ n ]eutrophils showed
biased movement away from higher concentrations of rDPPIV in a variety of
rDPPIV concentration gradients (Table 1 )." (Spec. 26.)
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Appeal2017-004449
Application 13/571,841
10. Chang teaches that an effective amount ofDPPIV is an amount
of drug effective to treat or prevent disease, which can be determined by an
ordinary physician. (See Chang ,r,r 100, 116, 117.)
11. Abraham teaches that inflammation and lung injury associated
with acute-lung injury and cystic fibrosis are mediated by neutrophil
infiltration. (See Abraham abstract.)
Analysis
The Examiner finds that treating acute or chronic inflammatory lung
conditions by administering DPPIV/CD26 by inhalation to the lungs at a
concentration of from 1 mg/kg/day to 100 mg/kg/day, as taught in Chang,
would be at least twenty times the amount disclosed in Appellants'
Specification (30 - 50 µg/kg) for the treatment as claimed, and, therefore,
would achieve the gradient of "at least 0.10 ng/ml/µm in the body region"
recited in Appellants' claims. (See Ans. 4.) The Examiner also finds that
this administration of DPPIV to the lungs to treat inflammatory lung
conditions as taught in Chang would necessarily result in the same effect on
neutrophil movement as recited in the claimed method. (See Ans. 6.)
Appellants argue that Chang is directed to methods of inhibiting
angiogenesis by administering effective amounts of DPPIV /CD26, not a
method of establishing a gradient of DPPIV /CD26 to suppress neutrophil
movement as Appellants claim. (See App. Br. 6.) Appellants argue that
Chang fails to expressly teach a concentration gradient of at least O .10
ng/ml/µm of DPPIV /CD26 and does not teach a gradient that is sufficient to
suppress or enhance neutrophil movement into or out of a body region. (See
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Application 13/571,841
App. Br. 7.) We agree that these claim elements are not expressly taught in
Chang, but note that the Examiner's rejection is based on the inherency of
these elements, which is supported by the evidence cited by the Examiner.
(See Ans. 3---6; see also Findings of Pact 1-11.)
Appellants argue that Chang does not inherently disclose "reducing
the number of neutrophils in a body region" as claimed because the
teachings in Chang regarding inflammation are not necessarily related to
neutrophils. (See App. Br. 7-8.) According to Appellants, the inflammatory
conditions discussed in Chang are complex conditions, involving a large
number of cells, not necessarily neutrophils. (See id.)
We are not persuaded by Appellants' argument because we agree with
the Examiner that "Chang teaches administering the same active ingredient
with the same mode of administration to achieve the same effects as in the
claimed method." (Ans. 10.) Appellants do not dispute that Chang teaches
administering DPPIV /CD26 by routes encompassed by the claimed method
(for example, inhalation with a nebulizer) at concentrations encompassed by
the claimed method (from 1 mg/kg/day to 100 mg/kg/day) and that after one
has done so, the number of neutrophils will be reduced in the body region
(for example the lung). Appellants do not argue, and we do not find, that the
Specification teaches forming a DPPIV/CD26 gradient requires any special
techniques or conditions. Accordingly, even if Chang does not teach the
result of the steps recognized by Appellants, we have no reason to consider
that the result would not necessarily occur. See In re Best, 562 F.2d 1252,
1255 (CCPA 1977) ("Where, as here, the claimed and prior art products are
identical or substantially identical, or are produced by identical or
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Application 13/571,841
substantially identical processes, the PTO can require an applicant to prove
that the prior art products do not necessarily or inherently possess the
characteristics of his claimed product.").
Appellants argue that Chang fails to enable claim 1 because it
describes administering DPPIC only to inhibit angiogenesis. (See App. Br.
8-9.) Appellants argue that Chang provides no information about how
DPPIV affects inflammatory diseases and no information about neutrophils.
(See id.) According to Appellants, the laundry list of diseases recited in
Chang does not enable claim 1 because it is directed to a completely
different component of inflammation. (See id.)
We are not persuaded by Appellants' argument because Chang need
not provide information about neutrophils to anticipate the elements of
Appellants' claimed method. "Where, as here, the result is a necessary
consequence of what was deliberately intended, it is of no import that the
articles' authors did not appreciate the results." Mehl/Biophile Int'! Corp. v.
Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999) (holding claims to be
inherently anticipated where "MEHL/Biohile does not dispute on appeal that
the laser operating parameters disclosed in the article substantially coincide
with those disclosed in the patent [and] to the extent that the embodiment in
the patent achieves hair depilation, so does the [prior art] method.").
Appellants do not direct us to evidence that one of ordinary skill in the art
would not have known how to administer a dipeptidyl peptidase-IV (DPPIV)
composition to a body region in an amount and for a time sufficient to
establish a concentration gradient of DPPIV of at least 0.10 ng/ml/µm in the
body region, as taught in Chang and recited in claim 1. (See Ans. 13.)
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Accordingly, Appellants fail to persuade us that Chang inherently
anticipates Appellants' claimed method. Therefore, we affirm the
Examiner's rejection under 35 U.S.C. § 102(b).
Appellants also address the rejection of their claims as being obvious
over Chang under 35 U.S.C. § 103(a). Anticipation is the epitome of
obviousness. In re McDaniel, 293 F.3d 1379, 1385 (Fed. Cir. 2002).
Accordingly, we summarily affirm the Examiner's rejection under 35 U.S.C.
§ 103(a). To be complete, we briefly address Appellants' arguments
regarding obviousness.
Appellants argue that the Examiner based the obviousness rejection
on an obvious to try rationale. (See App. Br. 10-11.) According to
Appellants, the list of diseases recited in Chang are provided in respect to
angiogenesis and its roles in inflammation and would have failed to guide an
inventor to use DPPIV/CD26 to suppress neutrophil movement into the body
region or enhance neutrophil movement out of the body region. (See App.
Br. 10.)
Appellants argue that the Examiner's alleged "attempts to dismiss the
elements of Claim 1 relating to gradients as merely result-effective variables
determinable through routine experimentation" are misguided. (See App.
Br. 10-11.) Appellants argue that none of the cited references teach a
gradient of DPPIV or that such a gradient would have any effect on
neutrophil movement or any other biological process. (See id.)
We are not persuaded by this argument because the Examiner's
finding that the concentration of the gradient formed by local administration
of DPPIV is a result effective variable is supported by the teachings in
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Application 13/571,841
Chang that an effective amount of DPPIV is an amount of drug effective to
treat or prevent disease, which can be determined by an ordinary physician.
(See Chang ,r,r 100, 116, 117.) Regardless of the mechanism by which
disease is prevented by administering DPPIV, this teaching demonstrates
that the dose of DPPIV is a result effective variable.
"'The discovery of a new property or use of a previously known
composition [or an unappreciated natural result of a known method], even
when that property and use are unobvious from the prior art, can not impart
patentability to claims to the known composition.' In re Spada, 911 F .2d
705, 708 (Fed. Cir. 1990) (noting that 'a new use of a known composition ..
. may be patentable as a process')." Tyco Healthcare Group LP v. Mutual
Pharma Co., Inc., 642 F.3d 1370, 1373 (Fed. Cir. 2011). Here, Appellants'
do not claim a new use for DPPIV, but a use as disclosed by Chang, that is,
an anti-inflammation treatment.
Because we are not persuaded by Appellants' arguments that the
Examiner determined the claimed method would have been obvious, we
affirm the Examiner's rejection under 35 U.S.C. § 103(a).
Conclusion
Upon consideration of the record and for the reasons given, the
rejection of Appellants' claims 1---6, 11-13, 45--49, and 51-62 under 35
U.S.C. §§ 102(b) and 103(a) is sustained.
Therefore, we affirm the decision of the Examiner.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136.
AFFIRMED
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