Ex Parte Gerber

Board of Patent Appeals and Interferences

Sep 7, 2007

10426654 (B.P.A.I. Sep. 7, 2007)

The opinion in support of the decision being entered today
is not binding precedent of the Board.

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JAY D. GERBER
__________

Appeal 2007-2371
Application 10/426,654
Technology Center 1600
__________

Decided: September 7, 2007
__________

Before DONALD E. ADAMS, ERIC GRIMES, and LORA M. GREEN,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for delivering a vaccine to a mucosal surface. The Examiner has rejected the
claims as anticipated and obvious. We have jurisdiction under 35 U.S.C.
§ 6(b). We affirm.
BACKGROUND
Because mucosal surfaces are the entry point for most infectious
agents, it is important that animals develop “a strong protective antibody and
Appeal 2007-2371
Application 10/426,654

cell-mediated immune response at the portal of entry. This is best done with
an adjuvant and delivery system that targets vaccine antigens to . . . the
mucous membranes” (Specification 1, citation omitted).
Thus, compared to an injected vaccine, orally administering a vaccine
against a gut pathogen “may engender a stronger immune response against
such pathogens by eliciting the production of secretory immunoglobulin A
antibodies at the mucosal site. . . Likewise, administration of vaccine
against an upper respiratory pathogen may be most effective if delivered to
the mucosal-associated lymphoid tissue in the oral cavity or nasal passages”
(id. at 1-2, citation omitted).
The Specification discloses “an adjuvant composition that includes
lecithin and a polymer that is preferably an acrylic polymer or copolymer.
The preferred acrylic polymer is a polyacrylic acid polymer. The lecithin
and polymer form a matrix or net-like structure which is effective in
trapping or encapsulating vaccine antigen” (id. at 6). The Specification
states that “the strong mucoadhesive and adsorptive properties of the
polymer and lecithin combination enhances the adsorption of vaccine
antigen onto mucosal surfaces” (id. at 6).
DISCUSSION
1. CLAIMS
Claims 1-9 and 20-22 are pending and on appeal. Claim 1 is
representative and reads as follows:
1. A method for delivering a vaccine to a human or an
animal mucosally comprising:
formulating a vaccine comprising an antigen and an adjuvant
comprising lecithin and an acrylic polymer combined together
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to form a matrix structure; and administering the vaccine to a
mucosal surface.

Thus, claim 1 is directed to a method of delivering a vaccine to a
mucosal surface of a human or animal. The vaccine is first formulated by
combining an antigen with lecithin and an acrylic polymer “to form a matrix
structure.” The vaccine is then administered to a mucosal surface.
The meaning of “combined together to form a matrix structure” is
central to the disposition of this appeal.
It is well settled that “claims in an application are to be given their
broadest reasonable interpretation consistent with the specification and that
claim language should be read in light of the specification as it would be
interpreted by one of ordinary skill in the art.” In re Sneed, 710 F.2d 1544,
1548, 218 USPQ 385, 388 (Fed. Cir. 1983) (citation omitted). However,
“[a]bsent claim language carrying a narrow meaning, the PTO should only
limit the claim based on the specification or prosecution history when those
sources expressly disclaim the broader definition.” In re Bigio, 381 F.3d
1320, 1325, 72 USPQ2d 1209, 1211 (Fed Cir. 2004). Thus, “during patent
prosecution when claims can be amended, ambiguities should be recognized,
scope and breadth of language explored, and clarification imposed.” In re
Zletz, 893 F.2d 319, 322, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989).
Appellant does not point to any dictionary meaning for the term
“matrix,” and the Specification does not define the term. However, the
Specification states that “[w]hen the acrylic polymer and lecithin are
combined, a matrix or net-like structure is formed” (Specification 12,
¶ [0055]). The Specification also states that “[e]lectron microscopic
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evaluation shows that there exists a physical and/or chemical affinity
between lecithin and polymer. This affinity or association appears as a
matrix, or net-like structure” (id. at 12, ¶ [0056]). Regarding methods for
combining the acrylic polymer and lecithin to produce an adjuvant
composition, the Specification states that “[t]he two components may be
mixed together using conventional methods, such as, for example, a Waring
Blender, emulsification equipment or a microfluidizer” (id. at 10, ¶ [0048]).
When given its broadest reasonable interpretation in light of the
Specification, we interpret the term “matrix” as encompassing a structure
that forms when lecithin and an acrylic polymer are combined, because of
the physical and/or chemical affinity between lecithin and the acrylic
polymer.
2. PRIOR ART
The Examiner relies on the following references:
Roth US 4,199,561 Apr. 22, 1980
Anselem US 5,716,637 Feb. 10, 1998

3. ANTICIPATION
Claims 1, 2, 6, 8, and 20-22 stand rejected under 35 U.S.C. § 102(b)
as anticipated by Anselem (Answer 3-4).
The Examiner cites Anselem as disclosing “nanoemulsion of particles
that have a lipid core surrounded by at least a phospholipids bi-layer; the
nanoemulsion composition is administered parenterally, orally, intranasally,
rectally, vaginally and topically” (id. at 3). The Examiner states that
“Anselem prepares [an] extrinsic mucoadhesive emulsome vaccine in
example 4 by mixing egg-lecithin and carbopol in the presence of trica[pr]in,
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cholesterol, oleic acid, tocopherol succinate and organic solvent” (id.). The
Examiner concludes that “[s]ince combining lecithin and acrylic polymer
form[s] a matrix according to the teaching of appellant’s specification and
claim 1, the combination of lecithin and carbopol, a specific acrylic
polymer[,] would inherently form a matrix. Thus, Anselem meets the
limitations of the claim 1” (id. at 4).
“To anticipate a claim, a prior art reference must disclose every
limitation of the claimed invention, either explicitly or inherently.” In re
Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). Thus, “a prior art
reference may anticipate when the claim limitation or limitations not
expressly found in that reference are nonetheless inherent in it.” Atlas
Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1946
(Fed. Cir. 1999).
Inherency cannot be established by merely showing that an asserted
limitation is probable or possible. In re Oelrich, 666 F.2d 578, 581 (CCPA
1981). “If, however, the disclosure is sufficient to show that the natural
result flowing from the operation as taught would result in the [the limitation
in question], it seems to be well settled that the disclosure should be
regarded as sufficient.” Id. (quoting Hansgirg v. Kemmer, 102 F.2d 212,
214 (CCPA 1939).
Anselem discloses preparing lipid-in-water emulsions containing very
small lipid particles, termed “emulsomes[,] . . . which are useful as delivery
vehicles for both hydrophilic and lipophilic immunogens . . .” (Anselem, col.
1, ll. 11-19). Example 4 of Anselem discloses preparing a lipid mixture
containing lecithin, drying the mixture, adding an aqueous EDTA solution,
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and then homogenizing the lipid/aqueous mixture with a Microlab 70 Gaulin
Homogenizer (id. at col. 17, ll. 45-61). “Then . . . a 1% Carbopol
[(polyacrylic acid)] solution was added and stirred for 20 min to confer
mucoadhesive properties to the emulsome preparation” (id. at col. 17, l. 66
through col. 18, l. 1).
As discussed above, because the Specification discloses that lecithin
and acrylic polymers have a physical and/or chemical affinity that results in
formation of a matrix when those ingredients are combined, claim 1
encompasses the structure that results from combining lecithin and an
acrylic polymer. We therefore agree with the Examiner that Anselem’s
disclosure of preparing a mixture of lecithin and Carbopol inherently meets
claim 1’s limitation that the ingredients be combined to form a matrix
structure.
In Example 18, Anselem discloses intranasally administering
antigen-containing preparations made according to Example 4 to mice
(Anselem, col. 25, ll. 20-43). Anselem therefore discloses both the
formulating step and the administering step recited in claim 1. We agree
that the Examiner has made a prima facie case of anticipation with respect to
claim 1. “[A]fter the PTO establishes a prima facie case of anticipation
based on inherency, the burden shifts to appellant to ‘prove that the subject
matter shown to be in the prior art does not possess the characteristic relied
on.’” In re King, 801 F.2d 1324, 1327 (Fed. Cir. 1986) (quoting In re
Swinehart, 439 F.2d 210, 212-13 (CCPA 1971)).
Appellant argues that “formulation of an adjuvant having a matrix or
net-like structure comprised of lecithin and acrylic polymer as recited in the
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claims is not inherent from the Anselem teachings, and . . . would not, in
fact, be produced if the actual teachings of the Anselem patent are followed”
(Br. 5).1 Specifically, Appellant argues that, while Anselem discloses a
combination of lecithin and acrylic polymer, the disclosed combination does
not produce a matrix structure because Anselem does not combine the
acrylic polymer with the lecithin until after the lecithin-containing lipid
particles, or “emulsomes,” are formed (id. at 6). Appellant argues that the
methods used by Anselem to incorporate biodegradable polymer into the
compositions are different than the methods involving acrylic polymers
“and, more importantly, these methods provide for mixing the acrylic
polymer with the lecithin-containing emulsomes after the latter are
preformed and without a prior step wherein the lecithin and acrylic polymer
are hydrated together” (id. at 7; see also Reply Br.2 2).
We are not persuaded by this argument. Claim 1 does not require the
lecithin and acrylic polymer to be hydrated together. Nor does claim 1
require the adjuvant to be prepared by any particular steps. Rather, claim 1
requires only that the lecithin and acrylic polymer be “combined together to
form a matrix structure.”
As discussed above, the Specification discloses that “[w]hen the
acrylic polymer and lecithin are combined, a matrix or net-like structure is
formed.” (Specification 12, ¶ [0055].) The Specification also states that
“there exists a physical and/or chemical affinity between lecithin and
polymer. This affinity or association appears as a matrix, or net-like

1 Appeal Brief filed August 25, 2006.
2 Reply Brief filed January 16, 2007.
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structure” (id. at 12, ¶ [0056]). When combining the lecithin and the
polymer, “[t]he two components may be mixed together using conventional
methods, such as, for example, a Waring Blender, emulsification equipment
or a microfluidizer” (id. at 10, ¶ [0048]).
Thus, the Specification does not disclose that forming a matrix
structure requires hydrating the lecithin and polymer together, or performing
a particular series of steps. Rather, when claim 1 is viewed in light of the
Specification, it is evident that a combination of lecithin and acrylic polymer
mixed by conventional methods will result in a matrix because of the affinity
between the two ingredients. Because Anselem mixed the two ingredients
together by stirring (Anselem, col. 17, l. 66 to col. 18, l. 1), it is reasonable
to conclude that Anselem “combined [them] together to form a matrix
structure” as required by claim 1.
Appellant argues that a theoretical comparison of Anselem’s adjuvant
to the claimed adjuvant demonstrates that the two products are different (Br.
7-9; see also Reply Br. 3). Specifically, Appellant relies on Figures 1
through 3 of Exhibit A (Br., Evidence Appendix) to illustrate the argument
that, because the claimed adjuvant is made by hydrating the lecithin and
acrylic polymer together, the lecithin’s hydrophobic tails are exposed and
bound to the hydrophobic portion of the acrylic polymer (id. at 8).
Appellant argues that, “[i]n contrast, the hydrophobic non-polar fatty acid
tails are not exposed in Anselem and, therefore, the phospholipids do not
bind to the acrylic polymer and thus do not form a matrix or net-like
structure comprised of lecithin and acrylic polymer” (id.).
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We are not persuaded by these arguments. Claim 1 does not require
the matrix structure to be made by hydrating the lecithin and polymer
together. Nor does claim 1 recite that the matrix consists of a structure in
which the hydrophobic tails are bound to the hydrophobic portion of the
acrylic polymer. Rather, claim 1 recites only that the two ingredients be
“combined together to form a matrix structure.”
As discussed above, the Specification does not disclose that forming a
matrix structure requires hydrating the lecithin and polymer at the same
time, or using any particular technique or series of steps. Instead, the
Specification discloses that a combination of lecithin and acrylic polymer
mixed by conventional methods will result in a matrix because of the affinity
between the two ingredients. Because Anselem combined the two
ingredients by stirring, Anselem combined the two ingredients “together to
form a matrix structure” as required by claim 1. Thus, because claim 1 does
not limit the adjuvant to any specific preparation method, Appellant’s
theoretical comparison between Anselem’s adjuvant and an adjuvant
produced by hydrating the lecithin and polymer together does not serve to
distinguish claim 1 from Anselem.
Appellant argues that the electron micrographs presented as Figures 1
through 5 of Exhibit B (Br., Evidence Appendix) demonstrate that the
claimed adjuvant is different from the adjuvant made by Anselem’s methods
(Br. 9-11; Reply Br. 4). Appellant states that Figures 3 and 4 are electron
micrographs showing lecithin and Carbopol 934 “after being hydrated
together and mixed together in the manner provided in this application”
(Br. 9), and that Figure 5 is an electron micrograph of a lecithin/acrylic
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polymer combination in which Carbopol was added to preformed lecithin
vesicles prepared by homogenization (id. at 10-11). Appellant argues that
comparing Figures 3 and 4 (adjuvant of claimed invention) to Figure 5
(Anselem’s adjuvant) shows that, in the claimed adjuvant, “[t]he
phospholipids appear to be fused to the polymer and, as clearly shown,
extend from one polymer fragment to another, producing a net- or matrix-
like appearance” (id. at 10), whereas in Anselem’s adjuvant “there appears
to be some kind of repulsion between the lecithin vesicles and the acrylic
polymer” (id. at 11).
We do not find this argument persuasive. First, Appellant states that
the figures attached to the Brief “were presented at an interview during
prosecution” (Br. 9) but the figures were not presented as part of a
declaration under 37 C.F.R. § 1.132. That rule requires that “any evidence
submitted to traverse [a] rejection or objection on a basis not otherwise
provided for must be by way of an oath or declaration under this section.”
Thus, the electron micrographs and accompanying discussion are not
entitled to any presumption of accuracy and truthfulness, like a signed oath
or declaration; in other words, Appellant’s assertions regarding the electron
micrographs are nothing more than attorney argument.
Moreover, Appellant’s argument is again based on the premise that
claim 1’s recitation “combined together to form a matrix structure” requires
the lecithin and polymer to be hydrated together and then homogenized. As
is evident from the discussion above, we do not agree with that premise
because the Specification simply does not state that forming the matrix
structure requires performing any particular series of steps.
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Rather, the Specification states that “[w]hen the acrylic polymer and
lecithin are combined, a matrix or net-like structure is formed”
(Specification 12, ¶ [0055]), and that “there exists a physical and/or
chemical affinity between lecithin and polymer. This affinity or association
appears as a matrix, or net-like structure” (id. at 12, ¶ [0056]). Thus, when
the Specification discusses the term “matrix,” it does so without any
qualifications regarding its method of preparation, other than the
combination of the two claimed ingredients.
Appellant argues that the “very general statement [in ¶ [0055] of the
Specification] about making the adjuvant clearly should not be taken to
mean that any combining of lecithin and acrylic polymer results in the
formation of a matrix or net-like structure” (Br. 12). Appellant argues that
“[t]he instant specification describes a preparation method which will
produce such a matrix structure which includes hydrating the lecithin and
polymer together and then mixing the two, and as discussed above, the
mixing of lecithin and acrylic polymer provided b[y] Anselem will not
produce the claimed adjuvant” (id.).
We are not persuaded by this argument. Appellant in effect seeks to
limit claim 1’s “matrix” to a structure resulting from a specific process, such
as that presented in the Examples. However, it is well settled that
“limitations are not to be read into the claims from the specification.” In re
Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993); see also Sjolund v.
Musland, 847 F.2d 1573, 1581 (Fed. Cir. 1988) (“[W]hile it is true that
claims are to be interpreted in light of the specification and with a view to
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ascertaining the invention, it does not follow that limitations from the
specification may be read into the claims.”).
We agree with the Examiner that claim 1 encompasses the adjuvant
formulated by Anselem, and that Anselem anticipates claim 1. Thus, we
affirm the Examiner’s anticipation rejection of claim 1. Claims 2, 6, 8, and
20-22 fall with claim 1 because they were not argued separately. 37 C.F.R.
§ 41.37(c)(1)(vii).
4. OBVIOUSNESS -- CLAIMS 3-5, 7, AND 9
Claims 3-5, 7, and 9 stand rejected under 35 U.S.C. § 103 as obvious
over Anselem and Roth (Answer 4-5).
Claim 3 is representative of the rejected claims, and recites “[t]he
method of claim 1 wherein the vaccine is administered to the human or
animal by placing the vaccine in a food or a beverage.” Conceding that
Anselem does not disclose administering its vaccine in a food or beverage,
the Examiner cites Roth as disclosing that “vaccines can be included in
food,” and concludes that it would therefore have been obvious to administer
Anselem’s vaccine in a food material (id. at 5).
Appellant argues that because Roth does not remedy Anselem’s
failure to meet all the limitations of claim 1, “assuming, arguendo, that the
proposed combination of Anselem and Roth is a valid one, the dependent
claims rejected based on the combination are patentable for at least the
reasons set forth herein in support of the patentability of parent claim 1”
(Br. 12).
As discussed above, we agree with the Examiner that Anselem
teaches all of the limitations in claim 1. Appellant’s argument fails to
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demonstrate that the Examiner erred in concluding that claim 3 is obvious
over Anselem and Roth. We therefore affirm the Examiner’s obviousness
rejection of claim 3. Claims 4, 5, 7, and 9 fall with claim 3 because they
were not argued separately. 37 C.F.R. § 41.37(c)(1)(vii).
SUMMARY
We affirm the Examiner’s rejection of claims 1, 2, 6, 8, and 20-22
under 35 U.S.C. § 102(b) as anticipated by Anselem. We also affirm the
Examiner’s rejection of claims 3-5, 7, and 9 under 35 U.S.C. § 103 as
obvious over Anselem and Roth.
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

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