Ex Parte Babich

Board of Patent Appeals and Interferences

Oct 5, 2009

10084638 (B.P.A.I. Oct. 5, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte MICHAEL BABICH
__________

Appeal 2009-003335
Application 10/084,638
Technology Center 1600
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Decided: October 05, 2009
__________

Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN,
and STEPHEN WALSH, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
diagnostic test for allergies. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

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Statement of the Case
Background
“Profilins are cytoskeletal proteins expressed in all eukaryotic cells
that sequester G-actin and bind to membrane-associated
phosphatidylinositol-4,5-bisphosphate” (Spec. 1, ll. 13-15). According to
the Specification, “[m]ultimers of plant profilin are a preferred form for
diagnosis and treatment of allergies” (Spec. 1, ll. 8-9).
The Claims
Claims 17 and 22-28 are on appeal. Independent claim 17 is
representative and reads as follows:
17. A diagnostic test for allergies, said test comprising:
(a) obtaining a pharmaceutical composition of
multimeric profilin;
(b) administering the composition to a subject; and
(c) determining a reaction from which allergenicity is
inferred.

The prior art
The Examiner relies on the following prior art references to show
unpatentability:
Valenta US 5,583,046 Dec. 10, 1996

Vrtala et al., Induction of IgE antibodies in mice and rhesus monkeys
with recombinant birch pollen allergens: Different allergenicity of Bet v 1
and Bet v 2, 98 J. ALLERGY CLIN. IMMUNOL 913-921 (1996).

The issue
The Examiner rejected claims 17 and 22-28 under 35 U.S.C. § 102(b)
as being anticipated by Valenta as evidenced by Vrtala (Ans. 3-4).
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The Examiner finds that Valenta “teaches obtaining and administering
the recombinant or synthetic P14 allergen,” which is the same as the claimed
profilin, in pharmaceutically acceptable carriers, into patients to
diagnostically determine allergenicity to said protein (Ans. 3). The
Examiner finds that Valenta is “silent as to whether the Bet v2 [profilin] is
multimeric” (Ans. 3). The Examiner finds that Vrtala “teaches that Bet v2
naturally polymerizes in solution to form stable polymers” (Ans. 3).
Appellant contends that “[t]here is no teaching in the [Valenta] '046
patent that when Bet v2 is placed in solution, as required to administer to a
subject in non-lyophilized form, it polymerizes due to the physical properties
of the molecule” (App. Br. 5). Appellant contends that “[t]he form Vrtala
injected into the animal models is not clear, but likely is a monomeric form.
Conditions to make a soluble form were followed that would produce mostly
monomeric profilin” (App. Br. 6).
In view of these conflicting positions, we frame the anticipation issue
before us as follows:
Has Appellant demonstrated that the Examiner erred in finding that
the profilin of Valenta is inherently multimeric based upon the evidence of
Vrtala?
Findings of Fact (FF)
1. Valenta teaches “a method for detecting allergic reactions to a
P14 allergen by administering a recombinant P14 of the invention to a
subject, so as to provoke a bronchial, conjunctival, dermal, nasal or oral
immunological reaction” (Valenta, col. 4, ll. 32-36).
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2. The Examiner finds, and Appellant does not dispute, that the
Bet v2 P14 allergen of Valenta is identical to the profilin of claim 17 (see
Ans. 3).
3. Valenta teaches that the “polypeptides can be administered to a
human subject either alone or in combination with pharmaceutically
acceptable carriers or diluents, in accordance with standard pharmaceutical
practice” (Valenta, col. 11, ll. 36-40).
4. Vrtala teaches that “birch pollen profilin (Bet v 2) induces IgE
antibodies in about only 10% to 20% of patients allergic to pollen . . . ,
showing, however, extensive cross-reactivities with profilins from pollen
and food” (Vrtala 913, col. 2).
5. Vrtala teaches that “rBet v 2 migrated as a single band at 14 kd
only under reducing conditions. When β-mercaptoethanol was omitted from
the sample buffer, additional bands could be stained, of which one migrated
at 28 kd” (Vrtala 916, col. 2).
6. Vrtala teaches that “[t]o further investigate whether the higher
molecular bands that were observed in the Bet v 2 preparation under
nonreducing conditions might be due to formation of polymers through
disulfide bonds, immunoblots were done. Two different anti-profilin
antisera identified the higher molecular weight bands as Bet v 2 polymers”
(Vrtala 916, col. 2).
7. Vrtala teaches that “[i]t is hence suggested that the binding
[between labeled and unlabeled Bet v 2] occurs through the formation of
disulfide bonds” (Vrtala 916, col. 2).
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8. Vrtala teaches that “it is hence possible that the weaker capacity
of rBET v 2 to induce IgE antibodies might be linked to the ability of Bet v 2
to form natural polymers through disulfide bonds” (Vrtala 920, col. 1).
Principles of Law
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d
628, 631 (Fed. Cir. 1987). Analysis of whether a claim is patentable over
the prior art under 35 U.S.C. § 102 begins with a determination of the scope
of the claim. We determine the scope of the claims in patent applications not
solely on the basis of the claim language, but upon giving claims their
broadest reasonable construction in light of the specification as it would be
interpreted by one of ordinary skill in the art. In re Am. Acad. of Sci. Tech.
Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). The properly interpreted claim
must then be compared with the prior art.
“[A] prima facie case of anticipation [may be] based on inherency.”
In re King, 801 F.2d 1324, 1327 (Fed. Cir. 1986). Once a prima facie case of
anticipation has been established, the burden shifts to the Appellant to prove
that the prior art product does not necessarily or inherently possess the
characteristics of the claimed product. In re Best, 562 F.2d 1252, 1255
(CCPA 1977) (“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
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characteristics of his claimed product.”). See also In re Spada, 911 F.2d 705,
708-09 (Fed. Cir. 1990).
Analysis
Valenta teaches a diagnostic test for allergies comprising obtaining a
pharmaceutical composition of a P14 profilin (FF 3), administering the P14
profilin to a subject and determining an allergic reaction (FF 1). The P14
profilin of Valenta is identical to the Bet v2 antigen (FF 2).
While Valenta does not teach that P14 profilin (Bet v2) is multimeric,
the Examiner relies upon Vrtala to demonstrate that in solution, Bet v2 is
inherently multimeric (FF 4-8). Vrtala expressly demonstrates the presence
of both the 14 kd monomeric band and the 28 kd multimeric (dimeric) band
and shows that the 28 kd band is reactive to antibodies to Bet v2 (FF 5-6)
We agree with the Examiner that Vrtala demonstrates the Bet v2 in
solution forms a composition composed of both monomers and multimers
(FF 4-8).
We are not persuaded by Appellant’s argument that the “examiner has
not demonstrated recognition of multimeric profilin as a hyposensitizing
agent” (App. Br. 3). As we find above, Valenta expressly teaches the use of
profilin as a hyposensitizing agent and Vrtala demonstrates that when
profilin is in solution, profilin is multimeric (FF 1-8). In Schering, the
Federal Circuit noted that “this court rejects the contention that inherent
anticipation requires recognition in the prior art.” Schering Corp. v. Geneva
Pharm., Inc., 339 F.3d 1373, 1377 (Fed.Cir.2003). Schering also
commented that “[o]ther precedents of this court have held that inherent
anticipation does not require that a person of ordinary skill in the art at the
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time would have recognized the inherent disclosure. E.g., In re Cruciferous
Sprout Litig., 301 F.3d 1343, 1351 (Fed.Cir.2002).” Id. Also see
MEHL/Biophile Int'l Corp. v. Milgraum, 192 F.3d 1362, 1366
(Fed.Cir.1999) ( “Where ... the result is a necessary consequence of what
was deliberately intended, it is of no import that the article's authors did not
appreciate the results.”)
We are not persuaded by Appellant’s argument that “there is no
justification for adding Vrtala to what should be a rejection based on a single
case.” The use of additional references to evidence that a reference
inherently satisfies the claims is permitted. See In re Samour, 571 F.2d 559,
563 (CCPA 1978) (“Additional references cited in a rejection under
35 U.S.C. § 102(b) are not relied on for a suggestion or incentive to combine
teachings to meet claim limitations (as in a rejection under 35 U.S.C. s 103),
but, rather, to show that the claimed subject matter, every material element
of which is disclosed in the primary reference, was in possession of the
public.”).
We are not persuaded by Appellant’s argument that “[a]s the examiner
admits, the ‘046 patent does not disclose all the claim elements” (App. Br.
4). The element missing from Valenta (the ‘046 patent) is the inherent fact
that P14 (Bet v2) is multimeric in solution. The Examiner provides specific
and credible evidence, which is not rebutted by Appellant, that Bet v2 is
multimeric in solution (FF 4-8). “It is well settled that a prior art reference
may anticipate when the claim limitations not expressly found in that
reference are nonetheless inherent in it.” In re Cruciferous Sprout
Litigation, 301 F.3d 1343, 1349 (Fed. Cir. 2002). See, e.g., MEHL/Biophile
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Int'l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed.Cir.1999) (“Under the
principles of inherency, if the prior art necessarily functions in accordance
with, or includes, the claimed limitations, it anticipates.”)
We are not persuaded by Appellant’s argument that the “form Vrtala
injected into the animal models is not clear, but likely is a monomeric form”
(App. Br. 6). Appellant also argues that “[p]roduction of a monomeric form
. . . for injection is consistent with the production in animal models of
monomeric-recognizing IgG and IgE (lesser degree) shown in Figure 3.
Indeed, there were no noted antibodies that recognized the larger profilin
forms” (App. Br. 6).
Valenta expressly teaches the use of profilin as a hyposensitizing
agent in a solution (FF 1-3). Vrtala demonstrates that when profilin is in
solution, profilin is multimeric (FF 4-8). Appellant has provided no
evidence to rebut Vrtala’s showing of “the ability of Bet v 2 to form natural
polymers through disulfide bonds” (Vrtala 920, col. 1). This provides
evidentiary support that profilin will inherently form natural polymers in
solution, as used by Valenta. Further, Vrtala expressly teaches “[t]wo
different anti-profilin antisera identified the higher molecular weight bands
as Bet v 2 polymers” (Vrtala 916, col. 2; FF 6), which rebuts Appellant’s
argument that “there were no noted antibodies that recognized larger profilin
forms” (App Br. 6). Vrtala expressly suggests that “the decreased
allergencity of rBet v 2 might be related to its tendency to polymerize”
(Vrtala 914, col. 1), which teaches that Vrtala expects that the rBet v 2 forms
polymers in solution.
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We are not persuaded by Appellant’s argument that “Vrtala teaches
against the present invention” (App. Br. 5). Appellant argues that “[t]he
utility of profilin polymers was not recognized nor was it obvious that the
profilin polymers would be a key allergen” (App. Br. 7).
The rejection at issue is under 35 U.S.C. § 102(b), as anticipated by
Valenta, and is not an obviousness rejection. Vrtala is relied upon by the
Examiner solely to evidence the inherent fact that Bet v2 is multimeric in
solution, in order to demonstrate that Valenta inherently anticipates the
claims. Therefore, we find that Appellant’s “teaching away” argument
misplaced because the Examiner has rejected the claims under 35 U.S.C.
§ 102. Our reviewing court has determined that “[t]eaching away is
irrelevant to anticipation.” Seachange International, Inc., v. C-Cor, Inc., 413
F.3d 1361, 1380 (Fed. Cir. 2005).
Conclusion of Law
Appellant has not demonstrated that the Examiner erred in finding that
the profilin of Valenta is inherently multimeric based upon the evidence of
Vrtala.
SUMMARY
In summary, we affirm the rejection of claim 17 under 35 U.S.C.
§ 102(b) as anticipated by Valenta as evidenced by Vrtala. Pursuant to
37 C.F.R. § 41.37(c)(1)(vii)(2006), we also affirm the rejection of claims 22-
28 as these claims were not argued separately.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2006).
AFFIRMED
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