Ex Parte Nicholas

Board of Patent Appeals and Interferences

Jun 28, 2010

10476508 (B.P.A.I. Jun. 28, 2010)

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.
10/476,508 04/16/2004 Robin Ashley John Nicholas N079 1010 .1 4215
26158 7590 06/28/2010
WOMBLE CARLYLE SANDRIDGE & RICE, PLLC
ATTN: PATENT DOCKETING
P.O. BOX 7037
ATLANTA, GA 30357-0037
EXAMINER
TONGUE, LAKIA J
ART UNIT PAPER NUMBER
1645
MAIL DATE DELIVERY MODE
06/28/2010 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ROBIN ASHLEY JOHN NICHOLAS
__________

Appeal 2010-000806
Application 10/476,508
Technology Center 1600
__________

Decided: June 28, 2010
__________

Before CAROL A. SPIEGEL, MELANIE L. MCCOLLUM, and STEPHEN
WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
protective immunogenic composition comprising an inactivated
Mycoplasma bovis and a method of preventing respiratory disease in cattle.
The Patent Examiner rejected the claims as anticipated and obvious. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.
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STATEMENT OF THE CASE
The invention concerns an immunogenic composition comprising
saponin inactivated Mycoplasma bovis. Mycoplasma bovis is a primary
cause of calf pneumonia, arthritis, mastitis, and eye disease. (Spec. 1, l. 19).
The Specification states that “[r]ecent strains of Mycoplasma bovis are
showing increased resistance to a range of antibiotics….” (Id. at 1, ll. 25-
26). According to the Specification, inactivating Mycoplasma bovis with
saponin is believed to partially disrupt its cell membrane resulting in a
particularly effective vaccine. (Id. at 3, l. 24 - 4, l. 1).
Claims 19, 21, 22, and 24-29, which are all the pending claims, are on
appeal. Claims 19 and 26 are representative and read as follows:
19. A protective immunogenic composition comprising an
inactivated Mycoplasma bovis, wherein said Mycoplasma bovis is
inactivated with saponin.

26. A method of preparing the immunogenic composition of
Claim 19 comprising contacting Mycoplasma bovis with saponin.

The Examiner rejected the claims as follows:
• claims 19, 21, 22, 24, and 25 under 35 U.S.C. § 102(e) as
anticipated by Hymas;1 and
• claims 19, 21, 22, 24, and 25 under 35 U.S.C. § 103(a) as
unpatentable over an abstract by Rosenbusch2 in view of Tola3.

1 US Patent No. 6,548,069 B2, issued to Hymas et al., Apr. 15, 2003.
2 R. Rosenbusch, “Test of an Inactivated Vaccine Against Mycoplasma
bovis Respiratory Disease by Transthoracic Challenge with an Abscessing
Strain,” Abstracts of the 12th Int’l Org. of Mycoplasmology Conf., Sydney,
Australia 185 (July 22-28 1998).
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• claims 26-29 under 35 U.S.C. § 103(a) as unpatentable over Hymas
in view of Rurangirwa.4
Claims 21, 22, and 24-29 have not been argued separately and,
therefore, stand or fall with claim 19. 37 C.F.R. § 41.37(c)(1)(vii).

ANTICIPATION
The Issue
The Examiner’s position is that Hymas disclosed a composition
comprising inactivated Mycoplasma bovis, an adjuvant and a
pharmaceutically acceptable carrier. (Ans. 3). The Examiner also found
that Hymas disclosed that the composition can further include carriers such
as wetting agents and adjuvants such as oil and water emulsions, dextran
sulfate, saponin, and aluminum hydroxide. (Id.). According to the
Examiner, the composition of the prior art is the same as the claimed
invention given the open language of the instant claim. (Id.).
Appellant contends that Hymas is not prior art under 35 U.S.C. §
102(e). (App. Br. 3). According to Appellant, the Rule 131 Declaration of
Dr. Robin Ashley John Nicholas dated June 6, 2006 demonstrated an actual
reduction to practice of the claimed invention prior to Hymas’ February 3,
2001 filing date. (Id.). Further, Appellant asserts that Hymas did not
expressly or inherently disclose inactivating Mycoplasma bovis with
saponin. (Id. at 5).

3 S. Tola et al., “Experimental vaccination against Mycoplasma agalactiae
using different inactivated vaccines,” 17 Vaccine 2764-2768 (1999).
4 F. R. Rurangirwa et al., “An inactivated vaccine for contagious caprine
pleuropneumonia,” 121 The Veterinary Record 397-402 (1987).
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The dispositive issue with respect to this rejection is whether the
Examiner erred in concluding that the Declaration of Dr. Nicholas failed to
establish that Hymas does not qualify as prior art under 35 U.S.C. § 102(e).

Findings of Fact
1. Hymas filed its application on February 3, 2001. (Hymas, (22)).
2. Robin Ashley John Nicholas filed a Rule 131 Declaration signed
June 6, 2006. (Decl.)
3. The Nicholas Declaration includes a copy of an agreement, Exhibit
A, between Veterinary Laboratories Agency (VLA) and Akadimpex
Foreign Trade Co., Ltd. (AKADIMPEX), said to represent Professor
Laszlo Stipkovits at the Veterinary Medicine Research Institute of the
Hungarian Academy of Sciences. (Decl. ¶ 4.)
4. The Nicholas Declaration includes a copy of a report, Exhibit B,
signed by Dr. Stipkovits. (Decl. ¶ 6.)
5. The Nicholas Declaration states that “on or before February 3, 2001,
the saponin-inactivated Mycoplasma bovis vaccine mentioned in the
protocol attached to the agreement and described in the above referenced
patent application was prepared by me, or someone under my direction and
control… and sent to Dr. Stipkovits” (Decl. ¶ 5), and “Dr. Stipkovits
injected calves with the saponin-inactivated Mycoplasma bovis vaccine …
according to the protocol … marked Exhibit A” (id. ¶ 6).
6. Exhibit A includes “Protocol For Mycoplasma Bovis Vaccine Trial,”
which bears the name Robin Nicholas VLA and date December 2000.
(Decl. Exh. A.)
7. The Protocol attached to Exhibit A references “calves vaccinated
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with 2ml of 108 of saponin vaccine subcut” and “calves each inoculated
with 2ml of 108 CFU of killed saponin vaccine,” among other things.
(Decl. Exh. A.)
8. Dr. Nicholas declared that “the invention claimed in the present
application was conceived and reduced to practice in the United Kingdom
prior to February 3, 2001.” (Id. ¶ 7).
9. Declaration Exhibit A, entitled “Agreement,” states: “[s]ubject of
the Agreement is to carry out certain exploratory studies (Studies) with
Mycoplasma bovis strain in order to develop vaccine against this disease in
calves as fully set out in the Protocol no. 1 (the protocol).” (Decl. Ex. A).
10. Declaration Exhibit A appears to bear the signatures of Dr. Nicholas
and Dr. Stipkovits, both dated Jan. 25, 2001. (Id.)
11. Declaration Exhibit B is entitled “Report On study of efficacy of
experimental Mycoplasma bovis vaccines for prevention of respiratory
disease induce by artificial challenge of eight week old calves. (Protocol
No.:Ni-MBo2).” (Decl. Ex. B).
12. Declaration Exhibit B appears to bear the signature of Dr.
Stipkovits, dated Mar. 15, 2001. (Id.)
13. Exhibit B references the use of an experimental Mycoplasma bovis
vaccine, but does not explain that the vaccine was saponin-inactivated.
(Id.) at 3.

Principles of Law
A declaration may supply a missing feature from an evidentiary
exhibit. See Ex Parte Ovshinsky, 10 U.S.P.Q.2d, 1075, 1076 (Bd. Pat. App.
Interf. Feb. 3, 1989).
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Analysis
The filing date of Hymas was February 3, 2001. (FF-1). Dr.
Nicholas, the inventor, declared that the saponin-inactivated Mycoplasma
bovis of the present invention was prepared by himself, or someone under
his direction and control on or before February 3, 2001. (FF-5). Dr.
Nicholas further declared that “the invention claimed in the present
application was conceived and reduced to practice in the United Kingdom
prior to February 3, 2001.” (FF-8). Dr. Nicholas referenced two exhibits in
his declaration which evidenced an agreement and a protocol for developing
a vaccine against the Mycoplasma bovis disease in calves. (FF-3 and 4).
The Examiner found this evidence to be insufficient because the exhibits did
not expressly state that the vaccine was saponin-inactivated. (Ans. 7, FF-
13). However, as Appellant has argued (App. Br. 4) a declaration may
supply such a missing feature from an accompanying exhibit. See
Ovshinsky, 10 U.S.P.Q.2d. at 1076. Thus, we find that Appellant has
established with declaratory evidence that the Mycoplasma bovis vaccine
referenced in the protocol exhibit B was saponin-inactivated Mycoplasma
bovis (FF-5 and 8) and that the composition of claim 19 was, therefore,
reduced to practice prior to the filing date of Hymas. Consequently, we
agree with Appellant that the Examiner has not provided adequate basis for
finding the declaratory evidence insufficient to antedate Hymas.
Accordingly, we reverse the anticipation rejection of claims 19, 21,
22, 24, and 25.

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OBVIOUSNESS
The Issues
A. Rejection over Hymas and Rurangirwa
The Examiner relied on the Hymas patent, as in the anticipation
rejection. (Ans. 4). Appellant contends that Hymas is not valid prior art.
(App. Br. 11). For the reasons explained above, we agree with Appellant
that the Examiner has not provided adequate basis for finding the declaratory
evidence insufficient to antedate Hymas. We will therefore reverse this
rejection.
B. Rejection over Rosenbusch and Tola
The Examiner’s position is that Rosenbusch taught a formalin-
inactivated Mycoplasma bovis vaccine. (Ans. 4). The Examiner found that
Tola disclosed a study in which goats were immunized using five sets of
vaccines inactivated with phenol, formalin, heat-treatment, sodium
hypochlorite or saponin. (Id.). The Examiner found that Tola concluded
that the saponin-inactivated vaccine was one of the preparations that
provided complete protection from infection. (Id.). According to the
Examiner, it would have been obvious to a person of ordinary skill in the art
at the time the invention was made to prepare the vaccine disclosed in
Rosenbusch by inactivating Mycoplasma bovis with saponin because Tola
taught that its saponin-inactivated vaccine protected against disease. (Id.).
The Examiner further reasoned that characteristics such as dosage of the
inactivated Mycoplasma bovis would have been an obvious matter of
optimization. (Id.).
Appellant contends that the Examiner has not provided a rational
underpinning or suggestion based upon the references or knowledge of those
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of ordinary skill in the art for combining Rosenbusch and Tola. (App. Br.
11). According to Appellant, Tola provides “evidence of a structural
difference between inactivation with saponin as compared with inactivation
with formalin.” (Id. at 9). Additionally, Appellant asserts that Mycoplasma
species vary in response to inactivation, so that Tola’s inactivation of a
Mycoplasma agalactiae with saponin does not suggest using saponin to
inactivate the Mycoplasma bovis of Rosenbusch. (Id.). Appellant further
asserts that “it is highly unpredictable whether using saponin to inactivate
mycoplasma species will generate a protective immunogenic composition
[because] saponin-inactivation yields unpredictable results within species of
mycoplasma.” (Id. at 10). Therefore, Appellant asserts that it would not
have been obvious to try using saponin as the inactivation agent for the
Mycoplasma bovis disclosed by Rosenbusch. (Id.).
The issue with respect to this rejection is whether it would have been
obvious to a person of ordinary skill in the art at the time of the invention to
inactivate the Mycoplasma bovis disclosed in Rosenbusch with saponin, a
mycoplasma inactivation agent disclosed in Tola, to provide an effective
Mycoplasma bovis vaccine.

Additional Findings of Fact
14. Rosenbusch is a journal article describing the preparation and test of
an inactivated vaccine against Mycoplasma bovis respiratory infection.
(Rosenbusch, Abstract).
15. Rosenbusch disclosed that the Mycoplasma bovis was inactivated
with formalin. (Id.).
16. Tola is a journal article describing experimental vaccination against
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Mycoplasma agalactiae using different inactivated vaccines. (Tola, title).
17. Tola described preparing five sets of vaccines using Mycoplasma
agalactiae inactivated with phenol (1), formalin (2), heat-treatment (3),
sodium hypochlorite (4) and saponin (5). (Id. at Abstract).
18. Tola disclosed inoculating five groups of ewes (sheep) with the
inactivated Mycoplasma agalactiae. (Id.).
19. Tola concluded that the ewes vaccinated with Mycoplasma
agalactiae inactivated with either phenol or saponin resisted experimental
challenge suggesting that these two vaccines “guarantee complete
protection from M. agalactiae infection.” (Id. at 2768).
20. Tola taught that the suitability of saponin as adjuvant was known in
the art and that “in mycoplasmas, its adjuvant effect combines with
inactivation. This eliminates the problems of mixing the inoculation dose
and the toxicity caused by separate adjuvants.” (Id.).

Principles of Law
When a claim is to a combination that “simply arranges old elements
with each performing the same function it had been know to perform’ and
yields not more than one would expect from such an arrangement, the
combination is obvious.” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 417
(2007), quoting Sakraida v. AG Pro, Inc., 425 U.S. 273, 282 (1976).
Obvious variants of prior art teachings are themselves part of the public
domain. In re Translogic Tech., Inc., 504 F.3d 1249, 1259 (Fed. Cir. 2007).
Discovery of an optimum formulation by selecting one of a number of
known compounds in a limited class of compounds is usually obvious. See
Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1368 (Fed. Cir. 2007).
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Analysis of the Rejection over Rosenbusch and Tola
We are not persuaded by Appellants’ arguments that it would not have
been obvious to a person of ordinary skill in the art at the time the invention
was made to use saponin to inactivate the Mycoplasma bovis disclosed in
Rosenbusch to provide an effective Mycoplasma bovis vaccine.
Tola disclosed that it was known in the art to inactivate mycoplasmas
with saponin. Tola further disclosed that the suitability of using saponin as
an adjuvant was also known in the art. To this end, Tola explained that in
mycoplasmas, the adjuvant effect of saponin combines with its inactivation
and therefore eliminates the problems of mixing the inoculation dose and the
toxicity caused by separate adjuvants. (FF-20). Thus, Tola described an
advantage of using saponin as an inactivation agent in “mycoplasmas,” and
did not limit this teaching to M. agalactiae. (Id.). For these reasons, we find
that Tola’s disclosure would have suggested to a person of ordinary skill in
the art at the time of the invention selecting saponin to inactivate a
mycoplasma, including Mycoplasma bovis, to provide an effective
Mycoplasma vaccine. See KSR, 550 U.S. at 417; Translogic Tech.,
504 F.3d at 1259.
The obviousness of this combination is not negated by the fact that
structural differences may exist between inactivation with saponin as
compared with inactivation with formalin. Nor is obviousness negated by
the fact that mycoplasma species vary in response to inactivation. “[T]he
question is whether there is something in the prior art as a whole to suggest
the desirability, and thus the obviousness, of making the combination,” not
whether there is something in the prior art as a whole to suggest that the
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combination is the most desirable combination available.” In re Fulton,
391 F.3d 1195, 1200 (Fed. Cir. 2004).
Moreover, Tola disclosed only four chemical inactivation agents (FF-
17), only one of which was used in Rosenbusch (FF-15). Selecting any of
the remaining three disclosed agents known to be used to inactivate
mycoplasmas would have been nothing more than routine optimization. See
Pfizer, 480 F.3d at 1368.
Consequently, we find that the evidence as a whole supports the
Examiner’s position that it would have been obvious to a person of ordinary
skill in the art at the time the invention was made to inactivate the
Mycoplasma bovis of Rosenbusch with saponin, as taught by Tola, to
provide an effective Mycoplasma bovis vaccine.
Accordingly, we affirm the obviousness rejections of claims 19, 21,
22, 24, and 25 over Rosenbusch in view of Tola.

CONCLUSIONS OF LAW
The Examiner erred in concluding that the Appellants’ declaratory
evidence failed to establish that Hymas is not prior art for the 102(e) and
103(a) rejections.
It would have been obvious to a person of ordinary skill in the art at
the time of the invention to inactivate the Mycoplasma bovis disclosed in
Rosenbusch with saponin, a mycoplasma inactivation agent disclosed in
Tola, to provide an effective Mycoplasma bovis vaccine.

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SUMMARY
We reverse the rejection of claims 19, 21, 22, 24 and 25 under
35 U.S.C. § 102(e) as anticipated by Hymas; and
we affirm the rejection of claims 19, 21, 22, 24, and 25 under
35 U.S.C. § 103(a) as unpatentable over Rosenbusch in view of Tola; and
we reverse the rejection of claims 26-29 under 35 U.S.C. § 103(a) as
unpatentable over Hymas in view of Rurangirwa.

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

lp

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