Ex Parte Weaver et al

Patent Trial and Appeal Board

Oct 26, 2016

12992913 (P.T.A.B. Oct. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/992,913 12/09/2010
21839 7590 10/28/2016
BUCHANAN, INGERSOLL & ROONEY PC
POST OFFICE BOX 1404
ALEXANDRIA, VA 22313-1404
FIRST NAMED INVENTOR
Eric Weaver
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.
0086030-000010 1947
EXAMINER
SZPERKA, MICHAEL EDWARD
ART UNIT PAPER NUMBER
1644
NOTIFICATION DATE DELIVERY MODE
10/28/2016 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):
ADIPDOC 1@BIPC.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ERIC WEA VER, JOY CAMPBELL, LOUIS RUSSELL, MIQUEL
MORETO PEDRAGOSA, ANNA PEREZ-BOSQUE,
FRANCISCO JAVIER POLO POZO, and JOSEPH CRENSHAW 1
Appeal2014-001116
Application 12/992,913
Technology Center 1600
Before ERIC B. GRIMES, JACQUELINE T. HARLOW, and KRISTI L. R.
SA WERT, 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 reducing pulmonary inflammation, which have been rejected for
obviousness and obviousness-type double patenting. We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm-in-part.
1 Appellants identify the Real Party in Interest as The Lauridsen Group, Inc.
(Appeal Br. 2.)
Appeal2014-001116
Application 12/992,913
STATEMENT OF THE CASE
The Specification states that "a plasma composition comprising
immunoglobulin including concentrated levels of IgG, when administered
orally, reduces pulmonary inflammation, and induces a lowering of pro-
inflammatory cytokines." (Spec. 3: 10-12.)
Claims 1-19 are on appeal. Claims 1 and 12 are illustrative and read
as follows:
1. A method of reducing pulmonary inflammation in an animal
comprising: administering to an animal having pulmonary inflammation an
effective amount of a plasma fraction comprising at least 30% by weight
IgG and 10% or less by weight IgA, wherein the plasma fraction is
administered to provide a dose range from about 10 mg to 500 mg per kg
body weight per day.
12. The method of claim 1 whereby the plasma fraction is administered
intrapulmonarily.
The claims stand rejected as follov;s:
Claims 1-11, 15, and 16 under 35 U.S.C. § 103(a) as obvious based
on Campbell2 (Final Rej. 33);
Claims 12-14 and 17-19 under 35 U.S.C. § 103(a) as obvious based
on Campbell and Blumberg4 (Final Rej. 5-6);
Claims 1-11, 15, and 16, provisionally, for obviousness-type double
patenting based on the claims of application 13/402,291 (Final Rej. 7); and
2 Campbell et al., US 2005/0271674 Al, published Dec. 8, 2005.
3 Office Action mailed Jan. 25, 2013.
4 Blumberg et al., US 2004/0063912 Al, published Apr. 1, 2004.
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Application 12/992,913
Claims 12-14 and 17-19, provisionally, based on the claims of the
'291 application and Blumberg (Final Rej. 8).
I
The Examiner has rejected claims 1-11, 15, and 16 as obvious based
on Campbell. The Examiner finds that Campbell discloses oral
administration of a plasma fraction meeting the requirements of claim 1 to
treat respiratory diseases such as pneumonia. (Final Rej. 3.) The Examiner
finds that Campbell does not disclose the dosages recited in claim 1 but
suggests optimizing dosages for different patients. (Id. at 4.) The Examiner
concludes that it would have been obvious to optimize the dosages
administered by Campbell, because dosage is a result-effective variable. (Id.)
Appellants argue that Campbell is not enabling for the method of
claim 1. (Appeal Br. 8-10.) Appellants also argue that the recited dosage
range would not have been obvious based on Campbell. (Id. at 10-13.)
Finally, with respect to claim 1, Appellants argue that the Specification's
working example provides evidence of the criticality of the recited dosage
range. (Id. at 13-14.)
We agree with the Examiner that Campbell supports a prima facie
case of obviousness. Campbell discloses that "a plasma composition
comprising immunoglobulin, when administered orally, regulates and lowers
nonspecific immunity responses and induces a lowering and regulation of
serum IgG levels and TNF -a levels relative to animals not orally fed
immunoglobulin or plasma fractions." (Campbell ,-i 9.) Campbell states that
the "immunoglobulin concentrate powder has been found to contain
approximately 35-50% IgG." (Id. ,-i 28.)
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Application 12/992,913
Campbell does not disclose the amount of IgA in its composition but
Appellants' Specification states that "[a] preferred method of manufacturing
the plasma fraction of the application is set forth in U.S. Pat. App. Serial No.
10/470,982, the disclosure of which is incorporated herein by reference."
(Spec. 7:13-15.) The '982 application was published as the Campbell
reference. (Campbell, front page.) Thus, the evidence shows that the
plasma fraction disclosed by Campbell meets the IgG and IgA requirements
of claim 1.
Campbell discloses that its plasma fraction can be used for prevention
and treatment of various diseases (id. ii 38), including avian influenza,
sinusitis, and pneumonia (id. ii 39). Appellants' Specification states that
diseases associated with pulmonary inflammation include "influenza or
other infection caused by the influenza virus; pneumonia caused by virus or
bacteria; sinusitis or other inflammation of the sinus cavities;" etc. (Spec.
10:26-28, 11-5.) Thus, Campbell suggests treating animals having
pulmonary inflammation.
Campbell does not disclose the dosage range recited in claim 1.
However, Campbell states that
[ t ]hose skilled in the medical arts will readily appreciate that the
doses and schedules of the immunoglobulin will vary depending
on the age, health, sex, size and weight of the patient rather than
administration, etc. These parameters can be determined for
each system by well-established procedures and analysis e.g., in
phase I, II and III clinical trials.
(Campbell ii 30.) We agree with the Examiner that this guidance would
have made it obvious to a person of ordinary skill in the medical arts to
optimize the dosages of Campbell's plasma fraction based on known
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Application 12/992,913
parameters and using well-established procedures and analysis, such as those
used in clinical trials.
In short, Campbell supports a prima facie case of obviousness with
respect to claim 1. Appellants argue, however, that Campbell is not
enabling, for the same reasons that the patent at issue was found to be
nonenabling for the use of riluzole to treat ALS in Impax Laboratories, Inc.
v. Aventis Pharmaceuticals Inc., 545 F.3d 1312 (Fed. Cir. 2008). (Appeal
Br. 8-9.)
We disagree. Campbell discloses the same plasma fraction
composition recited in claim 1, suggests using that composition to treat
animals having diseases associated with pulmonary inflammation, and
expressly suggests optimizing the dosages based on specific parameters and
well-known procedures. Thus, the facts of this appeal are very different
from the facts (see Appeal Br. 8) of Impax.
Appellants also argue that Campbell is nonenabling because it lists a
variety of diseases (Appeal Br. 8) but "provides no specific dosages for its
immunoglobulins to treat any of the numerous types of diseases it lists" (id.
at 10).
However, "a prior art printed publication cited by an examiner is
presumptively enabling barring any showing to the contrary by a patent
applicant." In re Antor Media Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012).
Appellants' argument that effective dosages would need to be established for
any particular disease does not show that such experimentation would be
undue, especially in view of Campbell's disclosure that such optimization
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Application 12/992,913
depends on known parameters and can be done using well-established
procedures.
Appellants argue that their "claimed invention is not the result of
'routine optimization' since the cited prior art provides no information that
can be optimized." (Appeal Br. 12.) Appellants argue that, because
Campbell's working experiments involved ad libitum access to the plasma
fraction, "persons skilled in the art would have no ability to determine how
much plasma fraction each animal received let alone an appropriate dosage
range and frequency." (Id.)
However, Campbell expressly states that "doses and schedules of the
immunoglobulin will vary" depending on several parameters. (Campbell
iJ 30.) Campbell therefore recognized dosage and schedule as result-
effective variables. The fact that Campbell did not expressly identify a
range of potential dosages does not mean that dosage would not have been
obvious to optimize, or that the dosages recited in claim 1 would have been
nonobvious.
Finally, with respect to claim 1, Appellants argue that the
Specification's example demonstrates the criticality of the claimed range.
(Appeal Br. 12-13.) However, the example states that "C57BL/6 Hsd mice
were fed diets supplemented with 8% SDPP [spray-dried plasma protein]
(SDPP group), 1.5% PF [plasma fraction] (immunoglobulin concentrate; PF
group) or with milk proteins (Control group)." (Spec. 13:2-3.) Thus, as the
Examiner has pointed out (Ans. 5-6), the example appears to involve the
same ad libitum access to plasma fraction that is described in Campbell's
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examples. The example, in any event, does not describe administering any
specific dosage of plasma fraction.
Claims 2-11, 15, and 16 have not been argued separately and
therefore fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
II
The Examiner has rejected claims 12-14 and 17-19 as obvious based
on Campbell and Blumberg. The Examiner finds that Campbell would have
made obvious the method of claim 1 but does not teach intrapulmonary
administration, as required by claims 12-14 and 17-19. (Final Rej. 6.) The
Examiner finds that Blumberg discloses intrapulmonary administration of
antibodies and concludes that pulmonary administration of Campbell's
antibody composition would have been obvious because Blumberg teaches
that pulmonary administration has advantages over other forms of
administration. (Id.)
Appellants argue that Campbell teaches the disadvantages of
intravenous administration and teaches that oral administration has
numerous advantages. (Appeal Br. 16.) Appellants conclude that
"Campbell provides no basis or incentive for persons skilled in the art to
administer immunoglobulins to animals by a non-oral route, and in fact
discourages persons skilled in the art from employing a non-oral route of
administration." (Id. at 17.)
We agree with Appellants that the Examiner has not shown that a
person of ordinary skill in the art would have considered it obvious to
modify Campbell's method to include intrapulmonary administration.
Campbell focuses exclusively on oral administration of its composition, and
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does not suggest other modes of administration as alternatives. For example,
Campbell states that "oral administration of plasma protein can induce a
change in serum immunoglobulin and TNF-a as well as other nonspecific
immunity responses." (Campbell iJ 10.)
Campbell teaches that oral administration "greatly simplifies the
administration of immunomodulating compositions ... as these
compositions ... can now be simply added to feedstuff or even water to
modulate vaccination, to modulate disease challenge, or to treat animals with
immune dysfunction disease states." (Id., see also iii! 41-45 (discussing
further advantages of oral administration).)
Blumberg discloses "includ[ing] a neonatal Fe receptor (FcRn)
binding partner by their administration to central airways of the lung. Such
therapeutics include therapeutic and diagnostic IgG antibodies." (Blumberg
iJ 2.) Blumberg discloses that the FcRn binding partner can be a non-
specific IgG (id. iJ 35), or it can be any of a variety of therapeutic or
diagnostic antibodies (id. iJ 4 7). Blumberg states that the "methods and
compositions are useful for any indication for which the therapeutic is itself
useful in the detection, treatment or prevention of a disease, disorder, or
other condition of a subject." (Id. iJ 2)
We do not agree, however, with the Examiner's conclusion that
Blumberg' s disclosure would have made obvious intrapulmonary
administration of Campbell's composition. Neither of the cited references
discloses pulmonary administration of a plasma fraction, as in Campbell, as
compared to purified antibodies, as in Blumberg. Blumberg discloses that
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pulmonary administration is non-invasive (id. ii 12) but that does not
represent an advantage over Campbell's oral administration.
The Examiner also points to Blumberg' s statement that its method is
especially useful for infants and neonates. (Ans. 6, citing Blumberg ii 17.)
The context of this statement in Blumberg, however, is that its methods "do
not require breath holding, deeper-than-normal inhalation, or special
timing." (Blumberg ii 17.) The Examiner has not persuasively explained
why pulmonary administration would have advantages over oral
administration with infants or neonates.
In summary, the Examiner has not shown that the cited references
would have provided a reason to modify Campbell's method to include
Blumberg' s pulmonary administration. We therefore reverse the rejection of
claims 12-14 and 17-19 based on Campbell and Blumberg.
III
The Examiner has provisionally rejected claims 1-11, 15, and 16 for
obviousness-type double patenting based on the claims of application
13/402,291 (Final Rej. 7).
The Examiner finds that the claims of the '291 application "recite
treating respiratory diseases in animals by orally administering
immunoglobulin concentrate derived from blood plasma, with specific
conditions including pneumonia and Pasturella infection being recited." (Id.
at 7-8.) The Examiner finds that the '291 application identifies the
application that became the Campbell publication as a preferred source for
practicing its methods, which states that it is routine to determine effective
dosages for disease treatment. (Id.) We agree with the Examiner's findings
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and conclusion that the copending claims are directed to inventions that are
not patentably distinct.
Appellants argue that the '291 application is a continuation of the
application that was published as the Campbell reference and therefore "has
the same disclosure as the cited Campbell et al. reference. As such, and for
the same reasons described in detail above, the '291 application is also not
enabling for the invention of claims 1-11, 15 and 16 of the instant
application." (Appeal Br. 18.)
This argument is unpersuasive for the reasons discussed above in
regard to the rejection under§ 103(a) based on Campbell. The provisional
rejection of claims 1-11, 15, and 16 based on the '291 application is
affirmed.
The Examiner has provisionally rejected claims 12-14 and 1 7-19
based on the claims of the '291 application and Blumberg (Final Rej. 8).
The Examiner relies on Blumberg for its teaching of pulmonary
administration and concludes that claims 12-14 and 17-19 are not
patentably distinct from claims of the '291 application, which do not recite
pulmonary administration. (Id.)
However, for the reasons discussed above with regard to the§ 103(a)
rejection based on Campbell and Blumberg, we conclude that the references
do not provide sufficient reason to modify Campbell to include the
pulmonary administration taught by Blumberg. We therefore reverse the
provisional rejection of claims 12-14 and 1 7-19.
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SUMMARY
We affirm the rejection of claims 1-11, 15, and 16 under 35 U.S.C.
§ 103(a) based on Campbell. We also affirm the provisional rejection of
claims 1-11, 15, and 16 for obviousness-type double patenting based on the
claims of the '291 application.
We reverse the rejection of claims 12-14 and 17-19 under 35 U.S.C.
§ 103(a) based on Campbell and Blumberg. We also reverse the provisional
rejection of claims 12-14 and 17-19 based on the claims of the '291
application and Blumberg.
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. § l.136(a).
AFFIRMED-IN-PART
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