Ex Parte Merchant et al

Patent Trial and Appeal Board

Sep 14, 2018

11640421 (P.T.A.B. Sep. 14, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/640,421 12/14/2006
29166 7590 09/18/2018
Jones Walker LLP
5th Floor, Four United Plaza
8555 United Plaza Boulevard
Baton Rouge, LA 70809
FIRST NAMED INVENTOR
Mark E. Merchant
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.
43345/120124-00 6274
EXAMINER
LANDAU, SHARMILA GOLLAMUDI
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
09/18/2018 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):
j wpatents@j ones walker .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARKE. MERCHANT and FREDERICK LEMIEUX, JR.
Appeal2017-009634 1
Application 11/640,421
Technology Center 1600
Before RICHARD M. LEBOVITZ, FRANCISCO C. PRATS, and
RYAN H. FLAX, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to a feed
composition for a weanling pig or poultry hatchling, the feed composition
containing a blood product from a crocodylian species. The Examiner
rejected the claims for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b )(1 ).
We reverse.
STATEMENT OF THE CASE
The following rejections are before us for review:
(1) Claims 8, 9, 11, and 13-15, under 35 U.S.C. § 103(a) as being
1 Appellants state that the real party in interest is McNeese State University.
Appeal Br. 1.
Appeal2017-009634
Application 11/640,421
unpatentable over CN '147, 2 Odmn, 3 and Kats4 (Final Act. 2-5); 5
(2) Claims 8, 9, 11, and 13-15, under 35 U.S.C. § 103(a) as being
unpatentable over Siruntawineti,6 CN '147, Odum, and Kats (id. at 5-7);
(3) Claims 8, 9, 11, and 13-16, under 35 U.S.C. § 103(a) as being
unpatentable over CN '147, Odum, Kats, and Merchant7 (id. at 7-8); and
(4) Claims 8, 9, 11, and 13-16, under 35 U.S.C. § 103(a) as being
unpatentable over Siruntawineti, CN '147, Odum, Kats, and Merchant (id. at
8-10).
Claim 8 is the only independent claim on appeal, and reads as follows:
8. A feed composition for a weanling pig or poultry
hatchling comprising:
a commercial feed product digestible by said weanling
pig or said poultry hatchling; and
a feed supplement, said feed supplement is a blood
product from at least one Crocodylian species in an amount
2 CN 1634147 A (published June 7, 2005). In citing to CN '147, we cite to
the machine translation to which the Examiner and Appellants cite.
3 J. Odum, et al., Effect of Rodent Diets on the Sexual Development of the
Rat, 61 TOXICOLOGICAL SCIENCES, 115-127 (2001).
4
, L.J. Kats et al., The Effects of Spray-Dried Blood Meal on Growth
Performance of the Early-Weaned Pig, 72 J. ANIM. SCI. 2860-2869 (1994).
5 Final Action entered August 12, 2015.
6 Jindawan Siruntawineti et al., Crocodile Blood as Food Supplement: Its
Effects on Hematological Values in Wistar Rats, 30th Congress on Science
& Technology of Thailand (2004) (citation provided by Examiner). The
copy of the Siruntawineti provided by the Examiner does not include page
numbers. We cite to the first page as page 1, and the remaining pages as if
numbered consecutively.
7 Mark E. Merchant et al., Comparisons of innate immune activity of all
known living crocodylian species, 143 COMPARATIVE BIOCHEMISTRY AND
PHYSIOLOGY, PART B 133-137 (2006).
2
Appeal2017-009634
Application 11/640,421
effective to increase weight gain of said pig or poultry hatchling
being fed said feed composition;
wherein the effective amount of the blood product to
increase weight gain of the weanling pig or poultry hatchling is
0.5% to 1.0% by weight of the feed composition; and
wherein said feed composition is palatable to said
weanling pig or poultry hatchling.
Appeal Br. 16.
OBVIOUSNESS-
CN '147, ODUM, AND KATS
The Examiner's Prima Facie Case
In rejecting claim 8 over CN '147, Odum, and Kats, the Examiner
cited CN '14 7 as disclosing "a feed composition comprising a commercial
feed product and a feed supplement, wherein the feed supplement is a blood
product from at least one Crocodylian species (see translation, abstract,
claim 1 ). " Final Act. 3.
The Examiner found that CN '14 7 teaches that its feed composition
"may be administered to rodents and that compositions comprising the blood
product may be prepared to contain, for instance, 40 µg/ml or 1000 mg/L of
the blood product, which is 4% or 0.1 % (see translation, p. 4, par. 3, p. 6,
par. 3 and tables 3, 8)." Id.
Therefore, the Examiner found, although CN ' 14 7 does not
"specifically teach feed products comprising the use of 0.5 to 1 %
[Crocodylian blood product as recited in Appellants' claim 8], the reference
teaches that the blood products may be administered in compositions
wherein the blood products are present at values near this range ( e.g., 0.1 %
and 4%)." Id.
3
Appeal2017-009634
Application 11/640,421
The Examiner further found:
Since the [ CN '14 7] reference also teaches that the
compositions may be administered as food products, one of
ordinary skill in the art would have been motivated to
administer to the subjects a commercial feed product
comprising the blood product within the claimed range in the
course of routine experimentation and given the guidance of the
prior art. This amount would inherently be effective to possess
the characteristics recited in the claims (e.g., the increase in
weight gain in a weanling pig or poultry hatchling).
Final Act. 3--4.
The Examiner found that CN ' 14 7 also differs from the feed
composition of Appellants' claim 8 in that, "[a]lthough the reference does
not specifically teach that the feed composition is digest[i]ble by and
palatable to weanling pigs or poultry hatchlings, the reference teaches that
the composition may be administered to rodents (see translation p. 3, par.
2)." Id. at 4.
Despite that difference, the Examiner concluded that a feed
composition palatable to a weanling pig or poultry hatchling as recited in
Appellants' claim 8 would have been obvious:
A commercial feed composition for rodents would be expected
to be digest[i]ble by and palatable to weanling pigs, as
evidenced by Odum, which teaches standard rodent feed
containing, for instance, com, soybean meal and fish meal ( see
abstract, p. 118, table 1 ), and Kats, which teaches that standard
weanling pig feed may also contain com, soybean meal and fish
meal (seep. 2864, table 5). Also, note the instant specification,
page 2, first paragraph that teaches the use of the same the
components to make a weanling pig food product. Thus, a feed
composition prepared based on the teachings of [CN '147]
would contain a commercial feed product that would be
expected to be digest[i] ble by and palatable to weanling pigs.
Final Act. 4.
4
Appeal2017-009634
Application 11/640,421
Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
prima facie case of unpatentability ....
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), although the
Supreme Court emphasized "an expansive and flexible approach" when
analyzing the issue of obviousness, id. at 415, the Court also reaffirmed the
importance of determining "whether there was an apparent reason to
combine the known elements in the fashion claimed by the patent at issue."
Id. at 418.
Ultimately, therefore, as our reviewing court has stated, "[i]n
determining whether obviousness is established by combining the teachings
of the prior art, the test is what the combined teachings of the references
would have suggested to those of ordinary skill in the art." In re GPAC Inc.,
57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal quotations omitted).
Having carefully considered all of the arguments and evidence
advanced by Appellants and the Examiner, Appellants persuade us that the
preponderance of the evidence does not support the Examiner's
determination of obviousness as to Appellants' claim 8. In particular,
Appellants persuade us (see Appeal Br. 8-9; Reply Br. 2-3) that the
Examiner has not shown by a preponderance of the evidence that the
combination of CN '14 7, Odum, and Kats would have suggested preparing
claim 8 's feed composition palatable to weanling piglets or poultry
hatchlings, the feed composition containing 0.5% to 1.0% by weight of a
5
Appeal2017-009634
Application 11/640,421
crocodylian blood product.
We acknowledge, as the Examiner found, that CN '14 7 discloses
using "crocodile blood in preparation for the treatment of anti-tumor anti-
viral drug to enhance immunity and health food applications." CN '14 7 at 1
( claim 1 ).
CN '147 explains that its objective in preparing foods containing
crocodile blood is to address the increasing rate of cancer and viral diseases
in humans. See id. at 2 ("China's current cancer patients [number] about
400 million people. Newly diagnosed each year 1.6 million cancer
patients."); see also id. ("Meanwhile, the viral disease is harmful to human
health a major killer, the number of infected is increasing every year, in
order to cause great harm to society and human health.').
CN '14 7 discloses a broad oral dosage range of crocodile blood
products to address these human disorders:
Typically for oral use, of course, also possible to use other
modes of administration, the manner of administration of
different doses vary; the use of a solid oral dose per day is
generally from about 0.001 to 100,000 mg, for adults the
amount used is from 0.05 to 60,000 mg per day[.] The most
commonly used dose of 5 to 5000 mg; once a day or several
times to use.
CN '147 at 2.
As noted above, the Examiner relies on pages 4 and 6 of CN ' 14 7 as
disclosing compositions administered orally to rodents, and reasons that, as
required by Appellants' claim 8, the rodent-administered compositions
would be palatable to weanling pigs and poultry hatchlings, as evidenced by
Odum and Kats. Final Act 3--4. The Examiner finds, moreover, that the
rodent-administered compositions described by CN '14 7 contain crocodile
6
Appeal2017-009634
Application 11/640,421
blood products at concentrations "near" the 0.5 to 1.0% by weight
concentration range required by Appellants' claim 8. J d. at 3.
The machine translation of CN '14 7 provided by the Examiner,
including pages 4 and 6 cited by the Examiner, includes extensive passages
which are grammatically confusing. In any event, the disclosures relied
upon by the Examiner on page 4 of CN '14 7 appear to describe experiments
in mice to show that oral administration of crocodile blood elicits anticancer
effects, and the disclosures relied upon by the Examiner on page 6 of CN
'14 7 appear to describe experiments in mice to show that oral administration
of crocodile blood elicits antiviral effects. See CN '14 7 at 4, 6.
Specifically, page 4 of CN '14 7 discloses that nasopharyngeal tumor
tissue was "inoculated subcutaneously in nude mice ... to become human
nasopharyngeal cancer nude mouse model." CN ' 14 7 at 4.
Page 4 of CN ' 14 7 appears to disclose that different crocodile blood-
containing products were administered orally, by "gavage," rather than as a
supplement to the feed provided to the mice. Id.
Page 4 of CN ' 14 7 also appears to disclose a number of different
dosages of crocodile blood products, and the respective level of cancer
inhibition elicited by those dosages. See id. ("the experimental results in ...
Table 3 crocodile plasma lyophilized powder on HepG2 cells, inhibit cancer
cell B16 dose rate (µg/mL) 900 400 150 60 40 inhibition rate ofHepG2 84.5
75.9 62.3 51.2 44.3 (%) B16 78.2 60.151.248.9 33.2.").
Page 6 of CN '14 7, including paragraph 3 cited by the Examiner,
appears to disclose the pneumonia-protecting effects in mice of a variety of
different orally administered dosages of crocodile blood-containing
compositions:
7
Appeal2017-009634
Application 11/640,421
Table 8 dose oral gavage for 10 consecutive days in each group
Table 8 crocodile lyophilized plasma of mice infected with viral
pneumonia caused by the protective effect of death (x ± SD, n =
10) group N / only administered concentration (mg/ L) of death
(n) Mortality(%) Average survival (d) the virus control group
10 5% PVP-K30 8 80 9.7 ± 3.1 normal control group 10 5%
PVP-K30 0 0 15.0 ± 0.0 *** ribavirin group 10 1000 5 50 13.6
± 0.6 *** Crocodile plasma lyophilization 10 60 6 60 12.0 ± 2.8
**powder administered group 10 120 3 30 13.7 ± 2.4 *** 10
240 3 30 14.3 ± 1.3 *** logic Lo crocodile plasma frozen 10 60
6 60 12.2 ± 2.7 Li dry powder administered group 10 120 3 30
13.9 ± 1.9 *** 10 240 2 20 14.7 ± 0.7 *** Compared with the
control group, L'iP> 0.05, * P <0.05, ** P <0.01, *** P <0.001.
CN '147 at 6.
The Examiner identifies no specific evidence in the record suggesting
that the amounts of the crocodile blood products used in CN '14 7 to elicit its
anticancer and antiviral effects in mice would overlap, or even be close to,
the range recited in Appellants' claim 8, which recites an entirely different
effect, and in different animals-increasing weight gain in weanling pigs or
poultry hatchlings. Nor has the Examiner explained specifically why an
ordinary artisan would have expected that optimizing the amount of
crocodile blood to achieve the anticancer and antiviral effects CN '14 7 in
mice would yield a concentration within the range of Appellants' claim 8,
which recites an effect entirely different than the effects described in CN
'14 7, in entirely different animals.
In addition, as seen above, the crocodile blood products in CN '14 7 's
mouse experiments were administered by gavage, as opposed to in the form
of a feed product. Thus, even when viewed in light of the teachings in
Odum and Kats regarding suitable rodent and weanling piglet feed
8
Appeal2017-009634
Application 11/640,421
compositions, we are not persuaded that the Examiner has explained
sufficiently why the amounts of crocodile blood products allegedly
described as being administered orally to mice on pages 4 and 6 of CN '14 7
for anticancer and antiviral effects, would have suggested a feed
composition, palatable to weanling piglets or poultry hatchlings, having an
amount of crocodile blood effective to increase the weight gain in weanling
pigs or poultry hatchlings.
The Examiner, moreover, provides no specific explanation as to the
calculation (see Final Act. 3) used to determine that a composition
containing 40 µg/ml of a crocodile blood product (i.e., 40 micrograms of
crocodile blood product per gram of total weight), contains 4% by weight of
the crocodile blood product (i.e., 40 milligrams crocodile blood product per
gram of total weight). We are not persuaded, therefore, that the Examiner
has explained sufficiently how or why the antiviral/anticancer amounts of
crocodile blood product used in CN '14 7 would overlap, or even be close to,
the concentration range of blood product recited in Appellants' claim 8.
In response to Appellants' arguments regarding the cited references'
failure to suggest the pig weanling/poultry hatchling feed having the claimed
percentage of crocodylian species blood product, the Examiner contends that
CN '14 7 includes a broad disclosure of suitable dosages of the crocodylian
blood product, and based on that disclosure, urges that an ordinary artisan
"could have arrived at the amount of crocodilian blood product recited in the
claims in the course of routine experimentation, and could have done so with
a reasonable expectation of success." Ans. 3 (citing CN '147); see also id. at
5---6 (reiterating routine experimentation argument).
9
Appeal2017-009634
Application 11/640,421
We are not persuaded that the preponderance of the evidence supports
the Examiner's alternative rationale for holding the composition of
Appellants' claim 8 obvious. We acknowledge CN 14 7 's disclosure, noted
above, that crocodile blood products may be orally administered at a wide
range of dosages to human subjects to elicit anticancer and antiviral effects.
See CN '14 7 at 2 ("[T]he use of a solid oral dose per day is generally from
about 0.001 to 100,000 mg, for adults the amount used is from 0.05 to
60,000 mg per day[.] The most commonly used dose of 5 to 5000 mg; once
a day or several times to use.").
That CN '14 7 discloses a broad range of dosages of crocodile blood
suitable for oral administration to humans to provide an anticancer and/or
antiviral effect does not persuade us that CN '14 7 would have suggested a
feed composition, palatable to weanling piglets or poultry hatchlings, having
an amount of crocodile blood effective to increase the weight gain in
weanling pigs or poultry hatchlings, as recited in Appellants' claim 8. In
particular, the Examiner identifies no specific evidence in the record
suggesting that even the broadly disclosed amounts of the crocodile blood
products described in CN '14 7 as eliciting its anticancer and antiviral effects
in humans would overlap, or even be close to, the range recited in
Appellants' claim 8, which elicits an entirely different effect in different
animals-increasing weight gain in weanling pigs or poultry hatchlings.
Nor has the Examiner explained specifically why an ordinary artisan
would have expected that optimizing the amount of crocodile blood to
achieve the anticancer and antiviral effects CN '14 7 in humans would yield
a concentration within the range of Appellants' claim 8, which, again, recites
an effect entirely different than the effects described in CN '14 7, in entirely
10
Appeal2017-009634
Application 11/640,421
different animals. The Examiner, moreover, fails to identify any specific
evidence supporting the assertion (see Ans. 5) that a food composition for
use in humans would necessarily be palatable to a weanling pig or poultry
hatchling, as Appellants' claim 8 requires.
In sum, for the reasons discussed, Appellants persuade us that the
Examiner has not shown by a preponderance of the evidence that the feed
composition of Appellants' claim 8 would have been obvious over CN '14 7,
Odum, and Kats. We, therefore, reverse the Examiner's rejection of claim 8,
and its dependent claims 9, 11, and 13-15, over CN '147, Odum, and Kats.
OBVIOUSNESS-
SIRUNTA WINETI, CN '147, ODUM, AND KATS
The Examiner's Prima Facie Case
In rejecting claim 8 over Siruntawineti, CN '14 7, Odum, and Kats, the
Examiner cited Siruntawineti as disclosing "supplements for addition to feed
for rats, wherein the feed supplement is a freeze-dried blood product (whole
blood) from a Crocodylian, specifically Crocodylus siamensis (abstract)."
Final Act. 5.
The Examiner found that Siruntawineti differs from claim 8 in that the
"reference does not teach the specific amounts in which the blood product is
provided in the food or the formulation of the product for a weanling pig or
poultry hatchling." Id.
As evidence that the feed composition of Appellants' claim 8 would
have been obvious despite that difference between claim 8 and
Siruntawineti, the Examiner cited the disclosures in CN '14 7, discussed
above, as evidence that it was known in the art to administer crocodile blood
products to rodents at concentrations "near" the concentration range recited
in claim 8. Id. at 6.
11
Appeal2017-009634
Application 11/640,421
In particular, the Examiner reasoned, "one of ordinary skill in the art
would be motivated to use the amounts that are known to be useful for feed
products based on the prior art, and would therefore have been motivated to
use amounts of blood product similar to those of [ CN '14 7]." Id.
The Examiner again cited Odum and Kats as evidence that rodent and
weanling pig feeds contain ingredients in common, and that the rodent feed
composition suggested by Siruntawineti and CN '14 7, therefore, would be
palatable to weanling pigs, as required by Appellants' claim 8. J d. at 7.
Analysis
For reasons similar to those discussed above, we also reverse this
rejection.
We acknowledge Siruntawineti' s disclosure that, based on its reported
antimicrobial activity, 300 µl of fresh crocodile blood or 50 mg of freeze-
dried crocodile blood was administered to Wistar rats for 45 consecutive
days "to determine whether the crocodile blood is safe to use as human food
supplement by observing hematological changes in rat." Siruntawineti at 1.
As to the results of its study, Siruntawineti discloses that its "data suggest
the safety of crocodile blood as food supplement in animal." Id.
As noted above, however, the Examiner relies entirely on the
teachings in CN '14 7 to show that the concentration of blood product from
crocodylian species recited in Appellants' claim 8 would have been an
obvious component in a rodent feed. See Final Act. 6.
As discussed above in relation to the previous rejection, the Examiner
identifies no specific evidence in the record suggesting that the amounts of
the crocodile blood products used in CN '147 to elicit its anticancer and
antiviral effects in mice would overlap, or even be close to, the range recited
12
Appeal2017-009634
Application 11/640,421
in Appellants' claim 8, which recites an entirely different effect, in different
animals-increasing weight gain in weanling pigs or poultry hatchlings.
Nor has the Examiner explained specifically why an ordinary artisan would
have expected that optimizing the amount of crocodile blood to achieve the
anticancer and antiviral effects CN '14 7 in mice would yield a concentration
within the range of Appellants' claim 8, which recites an effect entirely
different than the effects described in CN '14 7, in entirely different animals.
As also discussed above, we are not persuaded that the Examiner has
adequately explained the calculations used to arrive at the finding that the
amounts of crocodile blood products used in the mice experiments in CN
'14 7 were close to the amounts recited in Appellants' claim 8. Moreover,
although we note Siruntawineti's disclosure that crocodile blood has
antimicrobial properties (Siruntawineti at 1 ), the Examiner does not identify
any specific evidence suggesting that the amounts used by Siruntawineti as a
food supplement for rats would be useful in a feed palatable to weanling pigs
or poultry hatchlings, in an amount that increases weight gain in the
weanling pigs or poultry hatchlings, as recited in Appellants' claim 8.
Because we are not persuaded, for the reasons discussed, that the
Examiner has shown by a preponderance of the evidence that the feed
composition of Appellants' claim 8 would have been obvious over
Siruntawineti, CN '147, Odum, and Kats, we reverse the Examiner's
rejection of claim 8, and its dependent claims 9, 11, and 13-15, over
Siruntawineti, CN '147, Odum, and Kats.
REMAINING REJECTIONS
In the remaining rejections, the Examiner rejected claims 8, 9, 11, and
13-16 over CN '147, Odum, Kats, and Merchant (Final Act. 7-8), and also
13
Appeal2017-009634
Application 11/640,421
rejected claims 8, 9, 11, and 13-16 over Siruntawineti, CN '147, Odum,
Kats, and Merchant (id. at 8-10).
In both of the remaining rejections, the Examiner relies on the
previously discussed combination of either CN '14 7, Odum, and Kats, or
Siruntawineti, CN '14 7, Odum, and Kats, and cites Merchant as evidence
that it would have been obvious to use the blood product recited in
Appellants' claim 16, which depends from claim 8, in the feed composition
suggested by the other references. See id. at 7-8, 8-10.
Because the Examiner does not explain, nor do we discern, how
Merchant remedies the shortcomings of the other references in relation to
claim 8, discussed above, we reverse these rejections as well.
SUMMARY
For the reason discussed, we reverse each of the Examiner's
obviousness rejections.
REVERSED
14