Ex Parte Dominowski et al

Patent Trial and Appeal Board

Apr 5, 2016

12820566 (P.T.A.B. Apr. 5, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/820,566 06/22/2010
110408 7590 04/07/2016
Zoe tis
100 Campus Drive
Florham Park, NJ 07932
FIRST NAMED INVENTOR
Paul J. Dominowski
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.
PC25246C 2388
EXAMINER
HILL, MYRON G
ART UNIT PAPER NUMBER
1648
NOTIFICATION DATE DELIVERY MODE
04/07/2016 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):
AnimalHealthDocketing@zoetis.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PAUL J. DOMINOWSKI,
MICHAEL JOHN HUETHER, and
MARK D. GOODYEAR
Appeal2013-010377
Application 12/820,566
Technology Center 1600
Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a method
of vaccinating cows to prevent abortion. The Examiner rejected the claims
as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.
1 Appellants identify the Real Party in Interest as AH USA 42 LLC
(see App. Br. 4).
Appeal2013-010377
Application I2/820,566
Statement of the Case
Background
"Five viral agents associated with the bovine respiratory disease
(BRD) complex- Bovine Herpes Virus Type- I (BHV- I), also known as
infectious bovine rhinotracheitis virus (IBR), Bovine viral diarrhea virus
(BVDV) Types I and 2, Bovine Respiratory Syncytial Virus (BRSV), and
Parainfluenza Virus (Pb), cause respiratory and reproductive system
infections of great economic importance to the cow-calf and dairy industries
worldwide" (Spec. I). "Abortions induced by IBR and BVDV virus can
occur in all three trimesters, but chiefly during the last half of gestation, and
often without evidence of other clinical signs" (Spec. I).
The Claims
Claims 32, 34--36, 39, 40, 65, 67----69, 72, 73, and 84-9I are on
appeal. 2 Independent claim 32 is representative and reads as follows:
32. A method of preventing abortion caused by Bovine
Herpes Virus (BHV- I) in a cow or heifer comprising
administering to said cow or heifer a therapeutically effective
amount of a vaccine composition comprising:
a modified live Bovine Herpes Virus (BHV-I);
a modified live parainfluenza virus Type 3 (PI3);
a modified live Bovine Respiratory Syncytial Virus
(BRSV);
a Bovine Viral Diarrhea Virus Type-I (BVDV-I);
a Bovine Viral Diarrhea Virus Type-2 (BVDV-2);
an adjuvant; and
a veterinarily-acceptable carrier.
2 Claims I2-I9 and 43----64 were withdrawn and claims I-I I, 20-
3 I, 33, 37, 38, 4I, 42, 66, 70, 7I, and 74--83 were cancelled (see
App. Br. 6).
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Application 12/820,566
The Issues
A. The Examiner rejected claims 32, 34--36, 39, 40, 65, 67----69, 72, 73,
84, and 88 under 35 U.S.C. § 103(a) as obvious over Bowland3 and Fulton4
(Ans. 3-5).
B. The Examiner rejected claims 85, 87, 89, and 91 under 35 U.S.C.
§ 103(a) as obvious over Bowland, Fulton, and Brake5 (Ans. 5----6).
C. The Examiner rejected claims 86 and 90 under 35 U.S.C. § 103(a) as
obvious over Bowland, Fulton, Brake, and Lidgate6 (Ans. 6-7).
A. 35 U.S.C. § 103(a) over Bowland and Fulton
The Examiner finds that Bowland teaches "commercial vaccines
available in Canada for bovine respiratory disease. Vaccines include
infectious bovine rhinotrachetitis virus (IBRV), bovine herpesvirus-1,
(BHV-1), bovine respiratory syncytial virus (BRSV), parainfluenza-3 virus
(PI-3) as included in a modified live virus vaccine (page 35) and also teach
bovine viral diarrhea virus (BVDV) and adjuvant containing vaccines" (Ans.
3). The Examiner acknowledges that Bowland does "not teach a vaccine
composition comprising BVDV types 1 and 2" (Ans. 4).
3 Bowland et al., Bovine respiratory disease: Commercial vaccines
currently available in Canada, 41 Can. Vet. J. 33--48 (2000).
4 Fulton et al., Bovine viral diarrhea virus types 1 and 2 antibody
response in calves receiving modified live virus or inactivated
vaccines, 19 Vaccine 264--274 (2001).
5 Brake et al., US 6,787,146 B2, issued Sept. 7, 2004.
6 Lidgate et al., Formulation of Vaccine Adjuvant
Muramyldipeptides. 3. Processing Optimization, Characterization,
and Bioactivity of an Emulsion Vehicle, 6 Phann. Res. 748-752
(1989).
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Application 12/820,566
The Examiner finds that Fulton teaches "a vaccine composition
comprising BVDV types 1 and 2" (Ans. 4).
The Examiner finds it obvious "to use both BVDV types 1 and 2
because Fulton et al. teach both types cause disease in cattle, and ...
combination vaccines were already known and used in the art, as disclosed
in Bowland" (Ans. 4).
The issue presented is: Does the evidence of record support the
Examiner's conclusion that Bowland and Fulton render the claims obvious?
Findings of Fact
1. Bowland teaches that "[b ]ovine respiratory disease (BRD)
remains a significant cost to both the beef and dairy industries .... The
objectives of this paper were (a) to summarize information available
concerning commercial vaccines currently used in Canada for protection
against BRD" (Bowland, abstract).
2. Table 1 of Bowland teaches that "[m]odified live BRSV does
not appear to be abortigenic when administered to pregnant cows" (Bowland
34).
3. Bowland teaches modified-live virus (ML V) vaccines with one,
two, three and four different agents, including the 3-way "BoviShieldâ„¢
IBR-PI3-BRSV" vaccine that includes IBRV (another name for Bovine
Herpesvirus 1 as discussed at Bowland 34), PI-3V (parainfluenza virus type
3), and BRSV (Bovine Respiratory syncytial virus) and the 4-way MLV
BoviShieldâ„¢4 that further includes BVDV (Bovine viral diarrhea virus)
(Bowland 35-36).
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4. Table 1 of Bowland teaches that none of the modified-live virus
vaccines other than the 2-way TSV-2 vaccine are expressly authorized for
use in pregnant cows, at best indicating that the use is "not stated" for some
of the vaccines, and generally stating "NO, incl. calves nursing pregnant
cows" (see Bowland 34--36).
5. Table 1 of Bowland specifically teaches that the killed virus
vaccines Cattlemasterâ„¢BVD-K, Triangleâ„¢!, Triangleâ„¢3, Virabosâ„¢-3,
Dairymuneâ„¢4, Sentryâ„¢4, Triangleâ„¢4, and Virabosâ„¢-4 all comprise killed
BVDV agents and may be used in pregnant cows (see Bowland 37-38).
6. Bowland teaches the use of adjuvants including aluminum
hydroxide, Immunostim®, and Prolong® (Bowland 37, 39).
7. Fulton teaches the ViraShield®5 vaccine that comprises
inactivated BHV-1, PI-3V, BRSV, and BVDV types 1 and 2 (Fulton 265,
Table 1).
8. Fulton teaches administration of the ViraShield®5 vaccine to
calves (Fulton 267) and finds that "[a]ll eight calves developed antibodies to
the types 1 and 2 strains [of BVDV] after two doses of vaccine (days 0 and
28)" (Fulton 269).
Principles of Law
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Where, as here, the claimed and prior art products are
identical or substantially identical, or are produced by
identical or 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. ... Whether the rejection is based on
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Application 12/820,566
"inherency" under 35 U.S.C. § 102, on "prima facie
obviousness" under 35 U.S.C. § 103, jointly or alternatively,
the burden of proof is the same, and its fairness is evidenced
by the PTO' s inability to manufacture products or to obtain
and compare prior art products.
In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
Analysis
Claims 32 and 65
Appellants contend that "neither Bowland nor Fulton discloses that
the vaccines published in those documents can prevent BHV-1 caused
abortions in cows" (App. Br. 11 ). Appellants contend that "inherency may
not be proven by probabilities and the law on inherency requires that the
missing characteristics should be necessarily and always present in the prior
art" (App. Br. 12). Appellants contend that "the only thing that the
Examiner has demonstrated is that certain vaccines are suitable for
administration to pregnant bovines. There is absolutely no scientific proof on
record that vaccines suitable for administration to pregnant bovines prevent
BHV-1 caused abortions" (App. Br. 12).
We are not persuaded. We begin by noting that the preambles of
claims 32 and 65 recite the purpose or intended use of the claimed method,
but do not otherwise impose any specific limitations on the claimed method.
Therefore, the preambles read in light of the entire claims simply require
vaccination with a product that results in prevention of abortion in pregnant
cows. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305
(Fed. Cir. 1999).
We further note that claims 32 and 65 do not require administration to
pregnant cows, but consistent with dependent claims 36 and 69, may be
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Application 12/820,566
administered to prebreeding cows or heifers that may or may not ever
become pregnant. Thus, claims 32 and 65 broadly encompass vaccine
administration to cows in general, whether pregnant or not, as rendered
obvious by the combined suggestions of Bowland and Fulton (FF 1-8).
These two claims therefore lack any requirement regarding administration to
cows while pregnant.
Bowland teaches that "[ m ]odified live BRSV does not appear to be
abortigenic when administered to pregnant cows" (Bowland 34). This
provides the necessary underpinning for finding the inherency of the
"preventing abortion" limitation along with Bowland's teaching that killed
BVDV vaccines may be administered to pregnant cows (FF 5). We note that
claims 32 and 65 encompass vaccines comprising killed BVDV.
Best teaches that inherency may be applied in obviousness rejections
where the obvious product would reasonably be expected to necessarily have
the inherent properties, and places the burden on Appellants to rebut this
presumption. Best, 562 F.2d at 1255. Here, Appellants have provided no
evidence suggesting that the obvious combination of Bowland's modified-
live virus vaccines with BHV-1, PI-3V, and BRSV with Fulton's killed virus
BVDV type-I and type-2 vaccine would not have inherently functioned in
"preventing abortion" as required by claim 32 or "preventing persistent fetal
infection" as required by claim 65.
Appellants contend that "the obviousness argument advanced by the
Examiner is essentially predicated on what is unknown, which, under
Spormann is impermissible" (App. Br. 13).
We are not persuaded. In Spormann, the prior art alkali metal sulfate
production processes differed from the claimed process, and the court found
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Application 12/820,566
"nothing to suggest" the product low in sulfate content. Jn re Spormann,
363 F.2d 444, 448 (CCPA 1966). By contrast, the instant case provides
Bowland's direct teaching of 4-way vaccines for cattle that include
modified-live BHV-1, PI-3V, BRSV, and BVDV (FF 3) and Fulton teaches
the ViraShield®5 vaccine that comprises inactivated BHV-1, PI-3V, BRSV,
and BVDV types 1 and 2 (FF 7). Thus, the prior art reasonably suggests
vaccines encompassing all of the components required by claims 3 2 and 65.
This is similar to Perricone v. Medicis Pharm. Corp., 432 F.3d 1368,
1378-79 (Fed. Cir. 2005), where a method claim preamble which required
"preventing sunburn damage to exposed skin surfaces," was found satisfied
by a prior art skin composition which had been applied to skin surfaces, but
for a different purpose. "[T]he new realization alone [that the old
composition would prevent sunburn damage] does not render the old
invention patentable." Id. at 1377. Similarly, the new realization that the
obvious composition of Bowland and Fulton would prevent abortion in
pregnant cows does not render the method unobvious when administered to
cows in general.
Appellants separately argue that "Cattlemaster® vaccines were known
to decrease frequency of BHV-1 caused abortions. However, the Examiner
has to present the evidence showing that Bowland's vaccines decrease
frequency of persistent fetal infection (for the claims of Group II)" (Reply
Br. 11).
We find this argument unpersuasive for the same reasons given above.
Claim 65 does not require administration to a cow that is pregnant, and
therefore a cow carrying a fetus at risk for fetal infection, as evidenced by
dependent claim 69, which recites administering to a prebreeding cow. The
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Application 12/820,566
new realization that the obvious composition of Bowland and Fulton would
treat or prevent fetal infection does not render the method obvious when
administered to cows in general.
Claims 34, 35, 67, and 68
Appellants contend that "Bowland discloses that this vaccine is not
suitable for administration to pregnant animals" (App. Br. 13). Appellants
contend that "none of 3-way multivalent vaccines listed in Bowland that
contain modified live BHV-1, BRSV, and PI-3 are suitable for
administration to pregnant cows .... Further, none of 4-way vaccines
containing only modified live antigens is suitable for administration to
pregnant cows" (Reply Br. 8).
The Examiner finds that the "teaching of Bowland et al. that not all
vaccines can be used on pregnant cows provides guidance for one of
ordinary skill in the art to proceed in vaccinating cattle" (Ans. 8).
We find that Appellants have the better position. While the prior art
renders a method of administering the combined vaccines to any cow
population obvious for the reasons given above, Bowland specifically
teaches away from administering modified-live virus vaccines to pregnant or
lactating cows (FF 4).
Conclusion of Law
The evidence of record supports the Examiner's conclusion that
Bowland and Fulton render claims 32 and 65 obvious.
The evidence of record does not support the Examiner's conclusion
that Bowland and Fulton render claims 34, 35, 67, and 68 obvious.
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B. 35 U.S.C. § 103(a) over Bowland, Fulton, and Brake
Appellants reiterate the arguments found unpersuasive above
regarding the obviousness of the combination of Bowland and Fulton based
on the preamble language of preventing "abortion" or "persistent fetal
infection" (see App. Br. 16-17).
Appellants contend that "Brake describes a parasite vaccine, while
Appellants' invention comprises viral and bacterial vaccines. Brake
describes a homogenate vaccine while Appellants' vaccine is a whole virus
or whole bacteria vaccine. Bacteria, viruses, and parasites do not stimulate
the immune system in the same way" (App. Br. 17).
We are not persuaded. The Examiner relies upon Bowland and Fulton
to suggest the 4-way viral vaccine for administration to cattle (FF 7).
Bowland teaches the use of adjuvants including aluminum hydroxide (FF 6).
The Examiner relies upon Brake to teach that "vaccine[ s] ... may further
comprise one or more additional immunomodulatory components such as,
e.g., an adjuvant" (Brake, col. 8, 11. 36-38). Brake further teaches a wide
variety of known equivalent adjuvants that are useful for immune
stimulation including "aluminum hydroxide gel, [or] oil-in-water emulsions"
and teaches that "[ s ]pecific non-limiting examples of oil-in-water emulsions
useful in the vaccine of the invention include SEAM62" (Brake, col. 8, 11.
41--49). Brake teaches that SEAM62 comprises Quil A, cholesterol,
lecithin, and oil (see Brake, col. 12, 11. 62----67).
The Examiner has therefore reasonably established that SEAM62 was
a known equivalent adjuvant to the aluminum hydroxide adjuvant employed
by Bowland, rendering the substitution obvious. This result is consistent
with Wrigley, which found a "strong case of obviousness based on the prior
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Application 12/820,566
art references of record. [The claim] recites a combination of elements that
were all known in the prior art, and all that was required to obtain that
combination was to substitute one well-known ... agent for another." Wm.
Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364 (Fed.
Cir. 2012). The same result obtains here.
Appellants contend that it "is well known that different adjuvants may
act upon different immune pathways and therefore exert different effects"
(Reply Br. 13), but provide no evidence demonstrating that the adjuvant of
Bowland and the adjuvants of Brake would not have been equivalent,
instead relying solely upon attorney argument. See In re Pearson, 494 F.2d
1399, 1405 (CCPA 1974) ("Attorney's argument in a brief cannot take the
place of evidence.").
Appellants contend that "if one administers a hypothetical vaccine to
bovines, the probability that the vaccine will do more harm than good if
administered to pregnant animals is about 60% (31/52), which is about 50%
higher than the probability that this hypothetical vaccine will be suitable for
administration to pregnant animals" (App. Br. 18). Appellants contend that
"none of the vaccines suitable for administration to pregnant or nursing cows
comprises the adjuvant of the instant invention or the individual components
thereof as saponin, Quil A or cholesterol" (App. Br. 19).
We do not find this argument persuasive because claims 85, 87, 89,
and 91 do not require administration to pregnant animals, but rather the
recited vaccine may be administered to any cow, including prebreeding
cows. That is, this argument is directed towards a limitation that is not
present in the rejected claims or claims 32 and 65 from which the rejected
claims depend. See In re Self, 671F.2d1344, 1348 (CCPA 1982)
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("[A]ppellant's arguments fail from the outset because ... they are not based
on limitations appearing in the claims.")
C. 35 U.S.C. § 103(a) over Bowland, Fulton, Brake, and Lidgate
Appellants contend that "Lidgate did not test vaccines for their ability
to trigger an immunoprotective response, but instead for only their ability to
induce an immunogenic response" (App. Br. 21 ). Appellants contend that
they "have demonstrated an immunoprotective response. In addition Lidgate
does not teach an adjuvant comprising Quil A, lecithin and oil blend, and
cholesterol" (App. Br. 21 ).
We do not find these arguments persuasive because they fail to
address the combination of references that renders the claims obvious.
Bowland and Fulton teach the specific vaccine components required by
independent claims 32 and 65 including adjuvants (FF 1-8), Brake teaches
SEAM62 as a known equivalent adjuvant, and Lidgate teaches "a
microfluidization process, which produced the most stable and elegant
emulsion vehicle. The microfluidized emulsion also elicited equivalent
biological response in the animal model tested" (Lidgate 748, abstract).
Lidgate further notes that the "microfluidized emulsion, with its small
particle size, appeared to be the most physically elegant emulsion,
demonstrating ease of manufacture with a high degree of reproducibility.
These attributes lend themselves to commercial viability for this parenteral
emulsion" (Lidgate 752, col. 1). We agree with the Examiner's finding that
it would have been obvious to "modify the adjuvant taught by Brake et al.
because of the benefits of the formulation taught by Lidgate et al. of
improving stability and viability of commercial vaccines" (Ans. 6). See In
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re Keller, 642 F.2d413, 425(CCPA1981) ("The test for obviousness is not
whether the features of a secondary reference may be bodily incorporated
into the structure of the primary reference; nor is it that the claimed
invention must be expressly suggested in any one or all of the references.
Rather, the test is what the combined teachings of the references would have
suggested to those of ordinary skill in the art.")
SUMMARY
In summary, we affirm the rejection of claims 32 and 65 under
35 U.S.C. § 103(a) as obvious over Bowland and Fulton. Claims 36, 39, 40,
69, 72, 73, 84, and 88 fall with claims 32 and 65. 37 C.F.R. § 41.37(c)(iv).
We reverse the rejection of claims 34, 35, 67, and 68 under 35 U.S.C.
§ 103(a) as obvious over Bowland and Fulton.
We affirm the rejection of claims 85, 87, 89, and 91 under 35 U.S.C.
§ 103(a) as obvious over Bowland, Fulton, and Brake.
We affirm the rejection of claims 86 and 90 under 35 U.S.C. § 103(a)
as obvious over Bowland, Fulton, Brake, and Lidgate.
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-IN-PART
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