Ex Parte Weaver et al

Patent Trial and Appeal Board

Nov 5, 2014

11926470 (P.T.A.B. Nov. 5, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte ERIC M. WEAVER and DANIEL U. THOMSON1
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Appeal 2012-006333
Application 11/926,470
Technology Center 1600
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Before DEMETRA J. MILLS, MELANIE L. McCOLLUM, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a weight
gain and growth improvement method. The Examiner has rejected the
claims as obvious, indefinite, and lacking written description. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.
STATEMENT OF THE CASE
Claims 22–31 and 43 are on appeal (App. Br. 4).2 Claims 22, 24, and
29 are representative and read as follows:

1 Appellants identify the real party in interest as APC, Inc. (App. Br. 2.)
2 Claims 1–8 are also pending but have been withdrawn from consideration
(App. Br. 4).
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22. A method of improving weight gain and growth, while decreasing
morbidity and mortality in a pig, cow or horse comprising:
providing water supplemented with an effective amount of a water
miscible and stable immunoglobulin concentrate to the pig, cow or horse,
wherein the source of the concentrate is blood plasma from which the fibrin
has been separated, wherein the concentrate comprises at least 15% by
weight IgG, wherein the concentrate is not a component of a milk replacer,
and wherein the pig, cow or horse is at any stage of life from weaning
up to about six weeks of age;
so as to improve weight gain and growth, while decreasing morbidity
and mortality in the pig, cow or horse.
24. The method according to claim 22 wherein the water is provided
to a cow.
29. The method according to claim [22 wherein the immunoglobulin
concentrate is dispersed in the water in a concentration of from about 0.375
to about 3.0% by weight and] wherein the dispersion yields a concentration
of IgG in the water from about 0.1-0.75% by weight.
Claims 22–31 and 43 stand rejected under 35 U.S.C. § 112, second
paragraph, as being indefinite (Ans. 4).
Claims 22–31 and 43 stand rejected under 35 U.S.C. § 112, first
paragraph, for reciting new matter (Ans. 5).
Claims 22, 23, 26–31, and 43 stand rejected under 35 U.S.C. § 103(a)
as obvious over Paul (US 5,531,988, July 2, 1996), as evidenced by the
Specification and in view of Elliot et al. (US 4,623,541, Nov. 18, 1986)
(Ans. 6).
Claims 24 and 25 stand rejected under 35 U.S.C. § 103(a) as obvious
over Paul, as evidenced by the Specification and in view of Elliot and
Hastings (US 5,017,372, May 21, 1991) (Ans. 8).
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I
The Examiner finds:
Claim 22 currently recites “wherein the concentration is not a
component of a milk replacer”. As evidenced by the
specification in p. 5 and the declaration of Weaver filed on
11/17/10, the spray dried animal plasma [SDAP] is
acknowledged as milk replacer and the 5% spray dried animal
plasma have been used in the study. The specification of the
instant application defines milk replacer broadly (p. 6-7)
including various immunoglobulins and plasma products but
has not defined components that are not classified by milk
replacer components. Moreover, the spray-dried porcine
immunoglobulin concentrate has been used in the examples in
the specification (p. 19-28). It is not clear how spray dried
animal plasma can be and cannot be a component of the milk
replacer at the same.
(Ans. 4–5.)
Appellants argue:
[B]oth Appellants’ specification and the general understanding
of those of skill in the art clearly and definitely provide that
Appellants’ immunoglobulin concentrate, whether in powder
form or dissolved/dispersed in water, is neither itself a milk
replacer, nor is it necessarily used as a component of a milk
replacer. While SDAP and/or immunoglobulin concentrate
may, in some instances, be added to milk replacer, this does not
render these compositions indistinguishable. Those of skill in
the art, upon reading the claim in light of the specification,
would readily understand the scope of the claim as limited to
immunoglobulin concentrate that is not a component of a milk
replacer.
(Reply Br. 6.)
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Findings of Fact
1. The Specification states that “[m]ilk replacers are typically dry
powders containing milk by-products (whey, dried skim milk, whey protein
concentrate), soluble, further processed grain products (soy protein
concentrate or wheat gluten), fats and oils and appropriate vitamin and
mineral fortification” (Spec. 5).
2. The Specification also states that SDAP is “utilized
commercially in milk replacement products (milk replacers) for pigs, calves
and sheep” (id.).
3. However, the Specification states that the “administration of
SDAP in milk-replacers has several drawbacks” (id.).
4. The Specification discloses that the “present inventors have
now synthesized a purified, water-stable immunoglobulin product that can
be administered inexpensively through the water supply of animals” (id. at
8).
5. In particular, the Specification discloses that “one could simply
inject the water-stable plasma into the water as the immunoglobulin source”
(id. at 14).
6. The Specification also discloses that the “globulin concentrate
is administered to the animal by placing it in the animal’s water system via a
stock solution and a liquid dispenser” (id. at 16).
7. In addition, the Specification discloses:
Porcine immunoglobulin was substantially purified from
porcine plasma using the previously described procedures. The
porcine immunoglobulin concentrate was spray-dried and
analyzed for porcine IgG content. In powder form, the product
contained by analysis 45% IgG. This powder was then
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reconstitu[t]ed with tap water and the pH reduced to
approximately 4.5 with citric acid to produce a 30% w/w stock
solution. This stock solution was then injected into the water
line in a ratio of 1 part per 100 parts water which was used as
the sole water source for 6 pens of 24 pigs/pen in the trial.
(Id. at 19.)
Principles of Law
“[A] claim is not indefinite merely because its scope is not
ascertainable from the face of the claims.” Amgen, Inc. v. Hoechst Marion
Roussel, Inc., 314 F.3d 1313, 1342 (Fed. Cir. 2003). Rather, “[a] claim is
indefinite if, when read in light of the specification, it does not reasonably
apprise those skilled in the art of the scope of the invention.” Id.
Analysis
Claim 22 recites that “the concentrate is not a component of a milk
replacer.” When viewed in context with the Specification, we do not agree
with the Examiner that this phrase is indefinite.
The Specification discloses that it was known in the art to add SDAP
to a milk replacer, but that this has several drawbacks (Findings of Fact (FF)
2–3). Thus, the Specification discloses adding its immunoglobulin
concentrate directly to water, that is, not as part of a milk replacer (FF 4–7).
In view of these teachings in the Specification, we interpret the disputed
phrase to mean that the specific concentrate that is added to the water is not
part of a milk replacer.
Conclusion
The evidence does not support the Examiner’s conclusion that
claim 22 is indefinite. We therefore reverse the rejection under 35 U.S.C.
§ 112, second paragraph.
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II
The Examiner finds:
The specification or the original claim as filed does not provide
a written description for “wherein the concentrate is not a
component of a milk replacer”. The specification or the
original claim does not provide any specific spray dried animal
plasma that is not a component of a milk replacer. As disclosed
in the specification of the instant application, the spray dried
plasma has been defined as a milk replacer (note p. 19-28 of the
specification of the instant application).
(Ans. 5.)
Appellants argue that the “specification provides ample description of
blood-derived spray dried plasma that is not a component of a milk replacer”
(App. Br. 10).
Analysis
As discussed above, the Specification discloses adding its
immunoglobulin concentrate directly to water, that is, not as part of a milk-
replacer (FF 2–7). Based on how we are interpreting the disputed phrase, we
agree with Appellants that the Specification discloses a concentrate that is
not a component of a milk replacer.
Conclusion
The evidence does not support the Examiner’s conclusion that
claim 22 lacks written description. We therefore reverse the rejection under
35 U.S.C. § 112, first paragraph.
III
The Examiner relies on Paul for teaching “a method of administering
an immunoglobulin composition to an animal in drinking water source . . .
for promoting gastrointestinal health” (Ans. 6). In particular, the Examiner
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finds that Paul teaches that “the immunoglobulin is from blood,” “the
composition comprises at least 7% of immunoglobulins,” and “the
immunoglobulins encompass IgG” (id.). However, the Examiner finds that
the “disclosure of [Paul] differs from the instant claimed invention in that it
does not teach administering an immunoglobulin concentrate to post
weaning piglets to improve weight gain and decrease morbidity in animals
. . . and [that] the immunoglobulin concentrate comprises at least 15% IgG
by weight” (id. at 7).
The Examiner relies on Elliot for teaching “a method of improving
weight gain and decrease morbidity and mortality by administering
immunoglobulin concentrate to post weaning piglets” (id.).3 In particular,
the Examiner finds that Elliot “teaches that the immunoglobulin concentrate
is prepared from blood plasma and fibrin has been removed” and “that the
immunoglobulin concentrate comprises IgG at 25% by weight (Table 2) and
about 33% (claim 4)” (id.) The Examiner concludes:
It would have been obvious to one of ordinary skill in the art at
the time the invention was made to substitute the
immunoglobulin composition in the method of improving
gastrointestinal health taught by [Paul] in the method of
improving weight gain and decreasing morbidity by
administering the immunoglobulin concentrate to the post-
weaning piglets taught by [Elliot] . . . because of [the] well
known characteristics and effects of the immunoglobulin
compositions derived from plasma which promote weight gain
and decrease morbidity and mortality as taught by [Elliot].
(Id. at 7–8.)

3 The Examiner relies on the Specification as providing evidence that Elliot
discloses post-weaning pigs (Ans. 7).
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Appellants argue that Paul and Elliot fail to disclose or suggest
“providing water supplemented with an immunoglobulin concentrate
containing at least 15% by weight IgG to a pig, cow or horse, and wherein
the concentrate is not a component of a milk replacer” (App. Br. 14).
Appellants also argue that their “Declarations under 37 C.F.R. § 1.132
clearly describe unexpected results due to the claimed method that are
sufficient to overcome any prima facie case of obviousness” (id.).
Findings of Fact
8. Elliot “relates to a method for the continuous production of a
purified immunoglobulin preparation” (Elliot, col. 1, ll. 5–7).
9. Elliot discloses that the “immunoglobulin can be prepared from
either porcine or bovine blood” and that the “preparation from porcine blood
has application in the rearing of neonatal pigs” (id. at col. 1, ll. 10–14).
10. Elliot also discloses:
The purified immunoglobulin product is then subjected to
appropriate concentration and treatment for storage (eg. freeze-
drying), or is blended with suitable protein sources to provide
an appropriate daily intake of immunoglobulins for the intended
animal. For example, the immunoglobulin product intended
for piglets derived from porcine blood may be blended with
condensed skim milk to give a solids ratio of about 1:3
(immunoglobulins/skim milk solids), and the resulting mixture
spray dried to yield a pig-milk replacer component which can
be reconstituted and fed as required.
(Id. at col. 2, l. 62, to col. 3, l. 5.)
11. Thus, Elliot specifically discloses providing the
immunoglobulins as part of a milk replacer (id. at col. 6, ll. 9–18).
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12. Paul also relates to compositions comprising an
immunoglobulin concentrate (Paul, col. 4, ll. 58–62).
13. Paul discloses that “[s]uch immunoglobulin concentrates can be
prepared from any starting material containing sufficient concentrations of
immunologically active immunoglobulins, such as milk, whey, blood, and
the like” (id. at col. 5, ll. 46–51).
14. To administer the immunoglobulins, Paul discloses “stirring
[the composition] into water . . . and drinking the resulting suspension” (id.
at col. 9, ll. 37–46).
Principles of Law
“The patentability of a product does not depend on its method of
production. If the product in a product-by-process claim is the same as or
obvious from a product of the prior art, the claim is unpatentable even
though the prior product was made by a different process.” In re Thorpe,
777 F.2d 695, 697 (Fed. Cir. 1985).
“[W]hen unexpected results are used as evidence of nonobviousness,
the results must be shown to be unexpected compared with the closest prior
art.” In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991).
Analysis
Claim 22 recites a single active step: providing a composition to a
pig, cow, or horse at any stage of life from weaning up to about six weeks of
age. The claim recites that the composition is water supplemented with an
effective amount of an immunoglobulin concentrate comprising at least 15%
by weight IgG, wherein the concentrate is not a component of a milk
replacer. However, claim 22 does not recite an active step of adding the
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concentrate to the water. Therefore, we interpret this recitation as a product-
by-process limitation.
We agree with Appellants that the Examiner has not specifically
pointed to a teaching of an immunoglobulin concentrate comprising at least
15% by weight IgG (App. Br. 15–16; Reply Br. 7–8). In particular, we do
not agree with the Examiner that Elliot’s Figures 1–3 demonstrate that the
gamma-globulin referred to therein is immunoglobulin G (Ans. 14).
However, given that claim 22 does not recite the amount of
concentrate or the amount of water to which the concentrate is added, we
conclude that Appellants have not adequately explained why the claimed
supplemented water is not the same as or obvious over the supplemented
water suggested by Paul and Elliot. In particular, concentrates with different
concentrations of IgG can be used to make compositions having the same
concentration of IgG by varying the amount of concentrate and/or water to
which the concentrate is added. For example, although one of ordinary skill
in the art might begin with a concentrate that comprises at least 15% by
weight IgG as claimed, one could add copious amounts of water (amounts of
water not specified in the claim) and end up with potentially a very small
amount of IgG in the final product used in the claimed method. For this
reason, Appellants have not adequately explained why the claimed
supplemented water (which could contain only very small amounts of IgG in
the final product) is not the same as or obvious over the immunoglobulin
(inherently including IgG) supplemented water suggested by Paul and Elliot.
With regard to the Declaration evidence, Appellants have not
compared the claimed invention to the closest prior art, namely Elliot, which
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discloses an immunoglobulin-supplemented milk replacer, which is
“reconstituted and fed as required” (FF 10). Thus, we do not agree that
Appellants’ evidence is sufficient to overcome the prima facie case of
obviousness.
With regard to claim 29, Appellants additionally argue that Elliot
“cannot be read to yield a concentration of IgG from about 0.1-0.75% by
weight” (App. Br. 16). The Examiner finds that Elliot “teaches a method of
improving weight gain and decrease morbidity and mortality by
administering immunoglobulin concentrate to post weaning piglets . . . in
concentration encompassing . . . ‘about 0.1-0.75% concentration of IgG’ . . .
(example1)” (Ans. 7). We have reviewed Example 1 of Elliot. However,
we agree with Appellants that the Examiner has not adequately explained
how Elliot suggests a dispersion having a concentration of IgG in the water
from about 0.1–0.75% by weight.
Conclusion
The evidence supports the Examiner’s conclusion that Paul and Elliot
suggest the method of claim 22. We therefore affirm the obviousness
rejection of claim 22. Claims 23, 26–28, 30, 31, and 43 have not been
separately argued and therefore fall with claim 22. 37 C.F.R.
§ 41.37(c)(1)(vii).
The Examiner has not, however, set forth a prima facie case that Paul
and Elliot suggest the method claim 29. We therefore reverse the
obviousness rejection of claim 29.
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IV
With regard to claim 24, the Examiner additionally relies on Hastings
for teaching “a method of administering an immunoglobulin composition to
. . . cows” (Ans. 8). Appellants argue that Hastings does not cure the above-
mentioned deficiencies of Paul and Elliot (App. Br. 19). However, we are
not persuaded by Appellants’ argument for the reasons discussed above.
We therefore affirm the obviousness rejection of claim 24. Claim 25
has not been separately argued and therefore falls with claim 24. 37 C.F.R.
§ 41.37(c)(1)(vii).
SUMMARY
We affirm the obviousness rejections of claims 22–28, 30, 31, and 43.
However, because our reasoning differs from that of the Examiner, we
designate the affirmance as a new ground of rejection.
We reverse the obviousness rejection of claim 29. We also reverse
the rejections under 35 U.S.C. § 112, first and second paragraphs. Thus,
claim 29 is not currently subject to a rejection.
TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960
(August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)).
37 C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this
paragraph shall not be considered final for judicial review.”
37 C.F.R. § 41.50(b) also provides that Appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
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the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the Examiner, in which event the proceeding
will be remanded to the Examiner. . . .
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record. . . .

AFFIRMED-IN-PART; 37 C.F.R. § 41.50(b)

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