Ex Parte Campbell et al

Patent Trial and Appeal Board

Mar 3, 2017

13402291 (P.T.A.B. Mar. 3, 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.
13/402,291 02/22/2012 Joy M. Campbell 0087303-000010 7651
21839 7590 03/07/2017
BUCHANAN, INGERSOLL & ROONEY PC
POST OFFICE BOX 1404
ALEXANDRIA, VA 22313-1404
EXAMINER
EWOLDT, GERALD R
ART UNIT PAPER NUMBER
1644
NOTIFICATION DATE DELIVERY MODE
03/07/2017 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):
ADIPDOCl@BIPC.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOY M. CAMPBELL, RONALD E. STROHBEHN,
ERIC M. WEAVER, BARTON S. BORG,
LOUIS E. RUSSELL, FRANCISCO JAVIER POLO POZO,
JOHN D. ARTHINGTON, and JAMES D. QUIGLEY III
Appeal 2014-005160
Application 13/402,291
Technology Center 1600
Before CHRISTOPHER G. PAULRAJ, JACQUELINE T. HARLOW, and
DAVID COTTA, Administrative Patent Judges.
PAULRAJ, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to methods
of treatment of respiratory disease in an animal with an immunoglobulin
concentrate derived from blood plasma. The Examiner rejected the claims
for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
1 Appellants identify the Real Party in Interest as Lauridsen Group
Incorporated. See Appeal Br. 3.
Appeal 2014-005160
Application 13/402,291
STATEMENT OF THE CASE
Background
The Specification states that “applicants have identified purified and
isolated plasma, components, and derivatives thereof, which are useful as a
pharmaceutical composition for immune modulation of animals.” Spec. 4,
11. 24—26. The Specification further states that “Applicants have
unexpectedly shown that oral administration of plasma protein can induce a
change in serum immunoglobulin and TNF-a as well as other non-specific
immunity responses,” and “[t]his is unexpected as traditionally it was
thought that plasma proteins such as immunoglobulins, must be introduced
intravenously to affect circulating IgG, TNF-a, or other components of
nonspecific immunity.” Id. at 5,11. 4—9.
Additionally, the Specification teaches that “[o]ral doses of globulin
or plasma protein according to the invention were found to modulate the
primary and secondary immune response to rotavirus and PRRS
vaccinations by helping to modulate IgG and/or TNF-a and the immune
system.” Id. at 11,11. 21—24. “Furthermore, oral administration of plasma
proteins were found to modulate (enhance) the immune system in both
starting animals and after a respiratory disease challenge.” Id. at 11,11. 24—
26.
The Claims
Claims 126, 127, 129-134, 136—141, and 143—146 are under appeal,
and are reproduced in the Claims Appendix of the Appeal Brief. Appellants
have not argued the claims separately, so we choose independent claim 126
as representative for our analysis. The remaining claims stand or fall with
claim 126. 37 C.F.R. § 41.37(c)(l)(iv); see also In re McDaniel, 293 F.3d
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1379, 1383 (Fed. Cir. 2002) (“[T]he Board is free to select a single claim
from each group of claims subject to a common ground of rejection as
representative of all claims in that group and to decide the appeal of that
rejection based solely on the selected representative claim” in the absence of
a clear statement asserting separate patentability of the claims). Claim 126
reads as follows:
126. A method of treating a respiratory disease-afflicted
animal, comprising:
orally administering to an animal afflicted with a
respiratory disease state a treatment effective amount of a non­
specific immunoglobulin concentrate derived from animal
blood plasma;
wherein the respiratory disease state is selected from the
group consisting of avian influenza, chronic respiratory disease,
infectious sinusitis, pneumonia, fowl cholera, infectious
synovitis, PRRS and pasteurella infection.
Appeal Br. 24 (Claims App’x).
The Rejection
The Examiner has rejected the claims under 35 U.S.C. § 103(a) as
being unpatentable over the combination of Weaver,2 Mengeling,3 Burch,4
Paul,5 and Borg.6
2 Weaver et al., US 6,004,576, issued Dec. 21, 1999 (“Weaver”).
3 Mengeling et al., US 5,976,537, issued Nov. 2, 1999 (“Mengeling”).
4 Burch et al., US 6,001,370, issued Dec. 14, 1999 (“Burch”).
5 Paul et al., US 6,251,404 Bl, issued June 26, 2001 (“Paul”).
6 Borg et al., Effects of a Water Soluble Plasma Protein Product on
Weanling Pig Performance and Health With and Without Escherichia coli
Challenge, Material presented at the Allen D. Lehman Conferences
Proceedings, (Abstract only) (1999).
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FINDINGS OF FACT
We adopt the Examiner’s findings of fact. We add the following for
emphasis:
FF1. Weaver teaches a feed supplement comprising animal plasma
purified from animal which is granulated. Weaver, Abstract. Weaver
teaches that “[ajnimals fed this supplement experienced a significantly
higher average daily gain and increased average daily feed intake when
compared with a control of feed supplemented with plasma protein powder.”
Id.
FF2. Weaver teaches that “pigs and calves are commonly weaned at
a younger age (1 to 35 days of age) to reduce the cost of production and in
some cases to improve health status.” Id. at 1:14—17. Weaver teaches that
young animals are susceptible to disease, noting that the “[t]he dam is a
recognized vector and source of disease exposure for enteric and respiratory
disease agents.” Id. at 1:18—26.
FF3. Weaver also teaches that “very young pigs and calves in the
postweaning period experience a syndrome identified as postweaning lag.”
Id. at 1:38—40. According to Weaver, “[p]ost-weaning lag (poor appetite,
slow growth and diarrhea) is dramatically-reduced when newly-weaned pigs
are fed a starter diet supplemented with dried animal plasma.” Id. at 2:11—
13.
FF4. Mengeling teaches that porcine reproductive and respiratory
syndrome (PRRS) “was recognized for the first time in the United States in
North Carolina in 1987,” and “today PRRS has almost worldwide
distribution” and is “currently one of the most serious economic threats
faced by the swine industries.” Mengeling, 1:5—19.
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FF5. Burch teaches that PRRS is a disease “characterized by lack of
appetite, anorexia, reproductive disorders (abortion, premature parturition,
birth of dead or weak piglets, and fetal death, with or without
mummification).” Burch, 2:16—19. Burch further teaches that “disease
onset occurs when the level of colostral-acquired maternal antibodies has
decreased.” Id. at 2:59-60.
FF6. Paul teaches that “[rjecently, a more virulent form of PRRS has
been occurring with increased incidence in 3-8 week old pigs in the
Midwestern United States. Typically, healthy 3-5 week old pigs are weaned
and become sick 5-7 days later.” Paul, 2:41^44.
FF7. Borg teaches that “[t]wo trials were conducted to evaluate the
effect of a water soluble source of plasma proteins (WSPP) offered to newly
weaned pigs on pig performance and health.” Borg, Abstract. “These
experiments suggest that WSPP improves pig performance when
administered with and without plasma proteins in the feed and that WSPP
may reduce the morbidity of pigs challenged with pathogenic Escherichia
coli.” Id.
FF8. Weaver teaches feed compositions comprising 5% spray-dried
powder plasma or spray-dried granular plasma. Weaver, 9:15—16 (Table 1).
Appellants’ Specification teaches dietary treatments comprising 6% spray-
dried plasma and 10% spray-dried plasma. Spec. 19,11. 24—25, 25 11. 1—2.
DISCUSSION
The Examiner finds that Weaver teaches the administration of a
plasma-derived immunoglobulin (Ig) supplement (obtained from various
animals, including cow, sheep, horse, etc.) to an animal, particularly a pig, at
any time in which it would be desirable to increase growth, particularly “at
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the early stages of life.” Ans. 2 (citing Weaver, 4:7—9); see also FF1. The
Examiner further finds that Weaver teaches that very young animals are
particularly susceptible to “respiratory disease agents.” Id. (citing Weaver,
1:12—50); see also FF2—3. The Examiner acknowledges that Weaver does
not teach administering the supplement to animals infected with a
respiratory disease, including specifically PRRS, or administration through
the animal’s water supply. Id.
The Examiner finds that Mengeling teaches that PRRS is one of the
most serious economic threats facing the swine industry, particularly in
young pigs. Id.', see also FF 4. The Examiner finds that Burch teaches that
PRRS-infected pigs eat less and show more respiratory problems, and in
piglets, disease onset occurs when the level of colostral-acquired antibodies
has decreased. Id. at 3; see also FF5. The Examiner further finds that Paul
teaches that a more virulent strain of PRRS has been occurring in 3—8 week
old pigs, and that the disease typically occurs between 5—7 days after
weaning. Id.; see also FF6. Additionally, the Examiner finds that Borg
teaches the administration of an immunoglobulin concentrate through an
animal’s water supply. Id.; see also FF7.
The Examiner asserts that “[i]t would have been prima facie obvious
to one of ordinary skill in the art at the time the invention was made to
administer a plasma derived immunoglobulin supplement to
starting/young/weanling pigs susceptible to respiratory diseases, as taught by
[Weaver].” Id. The Examiner further asserts that “[a]s taught by
[Mengeling], [Burch], and [Paul], starting/young/weanling pigs have
particular problems, including a problem gaining weight, when infected by
PRRS.” Id. Accordingly, the Examiner asserts it would have been obvious
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at the time of the invention to administer an immunoglobulin supplement to
said pigs to improve weight gain. Id', see also id. at 7 (“PRRS-afflicted pigs
eat less food, gain less weight, and are of less economic value. Thus, the
addition of a well-known food supplement to the afflicted pig’s water supply
would have been obvious at the time of the invention as a method of
improving weight gain”). Moreover, the Examiner asserts that a skilled
artisan would have been motivated to administer the immunoglobulin
supplement through the water supply, as taught by Borg, “as a preferred
route given the fact that all animals require and will take water unless they
are seriously ill or unable to.” Id. at 4. The Examiner notes that “the water
administration route is further preferred over the food route given the fact
that under some circumstances animals that will not eat will still take water.”
Id.
Prima Facie Case
Appellants argue that the Examiner’s prima facie case of obviousness
rests on an improper application of the principles of inherency. Appeal Br.
12—18. The current rejection, however, is based on obviousness, not
inherent anticipation. See Ans. 6 (“no rejection has been made for
anticipation based on the principles of inherency”). Although “inherency
may supply a missing claim limitation in an obviousness analysis,” the
Federal Circuit has also explained that “the use of inherency, a doctrine
originally rooted in anticipation, must be carefully circumscribed in the
context of obviousness.” PAR Pharm., Inc. v. TWIPharms., Inc., 773 F.3d
1186, 1194—95 (Fed. Cir. 2014). Here, the Examiner does not rely upon the
doctrine of inherency to supply any particular claim limitation that is
missing, but rather asserts it would have been obvious to perform the
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claimed methods (e.g., “orally administering to an animal afflicted with
[PRRS] a treatment effective amount of a non-specific immunoglobulin
concentrate derived from animal blood plasma”) based on express teachings
in the combination of the prior art, albeit for a different purpose than the
purpose recited in the claims. As such, we find Appellants’ arguments
regarding the Examiner’s failure to meet the requirements for inherency to
be largely inapplicable to the rejection on appeal.
Appellants contend that “[i]n Weaver, young animals are fed
immunoglobulin concentrate to combat ‘post-weaning lag, ’ not to treat
present or impending respiratory diseases.” Appeal Br. 13. Thus,
Appellants assert
it would not have been obvious to one of ordinary skill in the
art, in possession of Weaver, that an animal afflicted by a
respiratory disease or exposed to a respiratory disease challenge
(at any stage of life) could be treated with the immunoglobulin
concentrate with the expectation that its chance of survival
would be improved or the severity of the disease would be
lessened.
Id. Appellants further argue that
while Weaver provides a solution to post-weaning lag, and also
discloses the problem of the susceptibility of young pigs to
respiratory diseases, neither Weaver nor the secondary
references disclose or suggest a treatment for respiratory
disease-afflicted animal or animals threatened by impending
disease — such as when a few animals in a herd are found to be
infected — comprising administering an effective amount of
immunoglobulin to these animals.
Appeal Br. 16. We are unpersuaded by these arguments.
Appellants do not dispute that Weaver teaches the exact same
composition as claimed, with an immunoglobulin concentrate (spray-dried
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plasma) in the same “effective” amount taught in the Specification (FF8), as
a dietary supplement for young, post-weaning pigs. Appellants also do not
dispute that survival in the animal would improve when the composition
taught by Weaner is administered to post-weaning pigs, i.e., through the
resulting weight gain. Although Weaver itself does not disclose specifically
the treatment of PRRS-afflicted pigs with the dietary supplement, the
Examiner relies upon the other references to show that young, post-weaning
pigs are susceptible to PRRS and that PRRS-afflicted pigs would also suffer
from poor growth/lack of appetite such that they would benefit from the
dietary supplement taught by Weaver. FF4—6.
Accordingly, we agree with the Examiner that it would have been
obvious to treat the known symptoms of PRRS-afflicted pigs — that the pigs
suffer from poor growth/lack of appetite — with a food supplement known to
improve growth in pigs. See FF1 and FF3. It is of no consequence that the
inventors may have had different or additional motivations for treating
PRRS afflicted pigs than the motivation identified by Examiner — i.e.
improving growth. In re Dillon, 919 F.2d 688, 692—93 (Fed. Cir. 1990); In
reLinter, 458 F.2d 1013, 1016 (CCPA 1972). Similarly, it does not matter
that Appellants may have discovered that supplying the claimed supplement
to PRRS afflicted pigs provides previously unrecognized benefits in addition
to the benefit of improving growth. In re Woodruff, 919 F.2d 1575, 1577
(Fed. Cit. 1990) (“It is a general rule that merely discovering and claiming a
ne w benefit of an old process cannot render the process again patentable.”)
With respect to the teachings of Mengeling, Burch, and Paul,
Appellants argue that “since these patents do not disclose or suggest that this
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respiratory syndrome can be treated by oral administration of plasma
immunoglobulin concentrate, it is further necessary for the Examiner to
refute Appellants characterization of the claims as directed to a new use for
an old compound.” Appeal Br. 13. We are also unpersuaded by these
arguments.
As discussed above, the prior art suggests supplying the claimed
supplement to PRRS afflicted pigs. Accordingly, regardless of whether
Appellants alleged use was “new,” it was would have been obvious to
perform the steps of the claimed method. Moreover, we do not agree with
Appellants’ characterization of Federal Circuit and Supreme Court precedent
as suggesting that simply reciting a new use or purpose confers patentability
over a prior art process otherwise disclosing the same steps. Appellants cite
to the Supreme Court’s decision in Mayo Collaborative Servs. v.
Prometheus Labs., Inc., 566 U.S. 66, 87 (2012), as reaffirming the patent-
eligibility of a “new way of using an existing drug.” Appeal Br. 14.
However, Mayo addressed patent-eligibility under 35 U.S.C. § 101 and did
not address whether a new way of using an existing drug is patentable under
§ 102 or § 103. Appellants also rely upon the Federal Circuit’s decisions in
Bristol-Myers Squibb Co. v. Ben Venue Labs., 246 F.3d 1368 (Fed. Cir.
2001) and Perricone v. Medicis Pharm. Corp., 432 F.3d 1368 (Fed. Cir.
2005), both of which involved questions of anticipation. Appeal Br. 14—16.
In Bristol-Myers Squibb, the court found that claims reciting a method
“‘for reducing hematological toxicity’” or “associated with reduced
hematologic toxicity” in a cancer patient comprising administering an
antineoplastically effective dosage of taxol, a known anti-cancer drug, were
anticipated. 246 F.3d at 1375—76. The court noted that “the claimed process
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here is not directed to a new use; it is the same use, and it consists of the
same steps as described by [the prior art],” and the “[n]ewly discovered
results of known processes directed to the same purpose are not patentable.”
Id. at 1376. In Perricone, the court found that prior art teaching a cosmetic
composition for topical application on the skin did not anticipate claims
directed toward using the same ingredients for “[a] method for treating skin
sunburn,” but did anticipate claims for “[a] method of preventing sunburn
damage to exposed skin surfaces.” 432 F.3d at 1376—79. The court
recognized that “[i]f [the prior art] discloses the very same methods, then the
particular benefits must naturally flow from those methods even if not
recognized as benefits at the time of [the prior art’s] disclosure. Thus, [the
prior art] anticipates if its disclosure of ‘topical application’ satisfies the
application step in Dr. Perricone’s various asserted claims.” Id. at 1378.
Moreover, the Perricone court noted that “[i]f [the prior art] did teach
sunburn prevention, as well as the mechanism behind that prevention, those
teachings might suggest that Dr. Perricone’s sunburn treatment claims would
have been obvious.” Id. at 1379.
As such, contrary to Appellants’ characterization of these cases,
simply reciting a new purpose does not necessarily render a process
patentable over a prior art process otherwise involving the same steps.7
7 See also MEHL/Biophile Int'l Corp. v. Milgraum, 192 F.3d 1362, 1366
(Fed. Cir. 1999) (“Where, as here, the result is a necessary consequence of
what was deliberately intended, it is of no import that the [prior art] article’s
authors did not appreciate the results.”); In re May, 574 F.2d 1082, 1090
(CCPA 1978) (“Both appellants and May describe methods for effecting
analgesia. While appellants have discovered a hitherto unknown property,
to wit, nonaddictiveness, of the species disclosed by May, such discovery
does not constitute a new use.”).
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Accordingly, we determine that the Examiner made a prima facie
showing of obviousness.
Unexpected Results
Appellants further argue that unexpected results demonstrated in the
Specification and in supporting Declarations submitted during examination
are sufficient to rebut any prima facie case of obviousness. Appeal Br. 18—
22.
A showing of “unexpected results” can be used to demonstrate the
nonobviousness of the claimed invention. In re Soni, 54 F.3d 746, 750 (Fed.
Cir. 1995) (“One way for a patent applicant to rebut a prima facie case of
obviousness is to make a showing of ‘unexpected results,’ i.e., to show that
the claimed invention exhibits some superior property or advantage that a
person of ordinary skill in the relevant art would have found surprising or
unexpected.”). Those results must be “surprising or unexpected” to one of
ordinary skill in the art when considered in the context of the closest prior
art. Soni, 54 F.3d at 750; Iron Grip Barbell Co. v. USA Sports, Inc., 392
F.3d 1317, 1322 (Fed. Cir. 2004) (A showing of “new and unexpected
results” must be “relative to the prior art.”); In re Baxter TravenolLabs., 952
F.2d 388, 392 (Fed. Cir. 1991) (“[W]hen unexpected results are used as
evidence of nonobviousness, the results must be shown to be unexpected
compared with the closest prior art”).
With respect to the Specification, Appellants contend that Example 4
“describes significant decreases in specific antibody titers in pigs dosed with
plasma protein following primary and secondary PRRS vaccinations
compared to vaccinated pigs not receiving plasma protein,” and that
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Example 5 shows that “survival was improved in pasteurella-challenged
turkeys administered the recited immunoglobulin (Ig) concentrate compared
to challenged turkeys not receiving the Ig concentrate.” Appeal Br. 19.
Appellants rely upon Declarations filed under 37 C.F.R. § 1.132 on
December 8, 2010, June 13, 2011, and February 20, 2012 by co-inventor Joy
M. Campbell to further allege unexpected results. Specifically, Appellants
allege that the December 8, 2010 Declaration provides data indicating that in
the mouse model of acute lung injury, leukocyte recruitment to the lung was
reduced 37% by administration of the Ig concentrate, and that spray dried
plasma and Ig concentrate were each effective in reducing concentrations of
certain inflammatory cytokines. Id. at 19. Appellants contend that the
December 8, 2010 Declaration also shows that the “oral administration of
spray dried plasma to pigs intra-nasally challenged with PRRS virus caused
a reduction in the incidence of viremia at day 29 compared to challenged
control animals not receiving the plasma.” Id. at 20. Additionally,
Appellants contend that the June 13, 2011 Declaration shows that lung
lesions were reduced in pigs consuming spray-dried plasma (SDP) in their
feed and/or spray-dried serum in their water, compared to challenged
controls that did not receive supplementation. Id. Finally, the third
Campbell Declaration refers to an article by Messier8 demonstrating that 10-
week old pigs with PRRS that were fed SDP supplement experienced
reduced mortality compared to the control group. Id.
8 Messier et al., Dietary spray-dried porcine plasma reduces mortality
attributed to porcine circovirus associated disease syndrome, Proceedings of
the 38th Annual Meeting of the American Association of Swine
Veterinarians, March 3—6 2007, 147—150 (2007) (“Messier”).
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We have reviewed the data in the Specification and the Campbell
Rule 132 Declarations, and agree with Appellants that they tend to show that
respiratory disease, such as PRRS, or certain underlying symptoms (cytokine
production or leukocyte recruitment) can be alleviated in animals with the
administration of a plasma/Ig concentrate compared to animals who did not
receive any such treatment. However, Appellants have not shown that such
results are unexpected over Weaver or any other prior art teaching. As such,
Appellants have not shown unexpected results over the closest prior art. See
In re Longi, 759 F.2d 887, 897 (Fed. Cir. 1985) (“There is nothing to show
that the results attested in the declaration were unexpected. The fact that
some titanium compounds function more effectively, and that the exact
magnitude of the increased catalytic activity might not be predictable, does
not preclude a conclusion of obviousness.”); see also MPEP § 716.02(E)
(“An affidavit or declaration under 37 CFR 1.132 must compare the claimed
subject matter with the closest prior art to be effective to rebut aprima facie
case of obviousness.”).
Accordingly, we are not persuaded that Appellants made the requisite
showing for unexpected results sufficient to rebut the Examiner’s prima
facie case.
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SUMMARY
We affirm the rejection of claims 126, 127, 129-134, 136—141, and
143—146 under 35 U.S.C. § 103(a) as being unpatentable over the
combination of Weaver, Mengeling, Burch, Paul, and Borg.
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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