Ex Parte Naidu

Board of Patent Appeals and Interferences

Aug 17, 2007

09980062 (B.P.A.I. Aug. 17, 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is not binding precedent of the Board.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
A. SATYANARAYAN NAIDU
__________

Appeal 2006-3089
Application 09/980,062
Technology Center 1600
__________

DECIDED: August 17, 2007
__________

Before TONI R. SCHEINER, ERIC GRIMES, and RICHARD M. LEBOVITZ,
Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims directed to
immobilized lactoferrin, an antimicrobial agent. The claims stand rejected
as anticipated by, and obvious over the prior art. We have jurisdiction under
35 U.S.C. § 6(b).

Appeal 2006-3089
Application 09/980,062

BACKGROUND
Lactoferrin (LF) is an iron-binding glycoprotein present in milk
and various mammalian secretions (e.g. saliva, tears, mucus,
and seminal fluids). Crystallographic studies of LF indicate a
bilobate structure (N-terminus and C-terminus lobes) with one
iron-binding site in each lobe. . . . Various laboratory studies
have reported that the structural integrity of LF is critical for its
antimicrobial effects against bacteria, fungi, protozoa, and
viruses.

However, the activity of LF, like the activity of most proteins,
is highly dependent on the three-dimensional or tertiary
structure of the protein. If the protein does not have the proper
conformation its activity is diminished or lost. LF’s instability
limits its usefulness. . . .

In fact, under certain conditions, when the LF molecule is
degraded or denatured, cationic peptide fragments are generated
. . . [which] exhibit a non-specific antimicrobial activity,
making them absolutely unsuitable as an ingredient in a food
product.

Spec. 7: 8-25.

The present invention includes compositions of matter
comprising a defined dispersion of lactoferrin (LF) immobilized
on a naturally occurring substrate via the amino-terminus (N-
terminus) region of the lactoferrin. Such substrates . . . attach
to the LF peptide at the amino-terminus (N-terminus), leaving
the carboxy-terminal (C-terminal) end of the LF peptide free to
interact with microbes. The inventive compositions containing
immobilized lactoferrin (herein also referred to as “Im-LF”) are
effective in treating a wide variety of microbes including
bacteria, fungi, protozoa and viruses.

Id. at 7: 34 to 8: 5.

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The Specification does not further define the term “immobilized,” but
does indicate that “[i]mmobilization neutralizes the cationic effect of LF
peptide fragments, and eliminates the undesirable, non-specific cidal activity
characteristic of lactoferrin” (id. at 11: 12-13).
According to the Specification, suitable substrates for immobilization
include “polysaccharides, such as mucin, heparan-sulfates, carrageenan, and
cellulose” (Spec. at 10: 35 to 11:1), especially galactose-rich
polysaccharides (id. at 10: 23); “proteins, such as collagen, denatured
collagen (gelatin), fibronectin, and casein” (id. at 10: 35-36); “nucleic acids
and their nucleotides, such as deoxyribonucleic acid and adenosine
triphosphate; and lipids such as triglycerides” (id. at 11: 1-2).
Further, according to the Specification, “LF is immobilized on the
substrate using any suitable technique. For example, LF can be immobilized
simply by mixing the LF with the . . . substrate in a suitable medium, such as
deionized water” (Spec. at 11: 3-5).
In Example 1 of the Specification, “[a] mixture of Im-LF and native
LF was prepared by mixing a solution of [galactose-rich polysaccharide]
(1% wt/vol) in deionized water with LF (1% wt/vol), . . . (also in deionized
water) in a 1:100 ratio. The mixture was kept at room temperature with
gentle stirring for 90 minutes. The formation of Im-LF was confirmed by
gel-filtration chromatography” (Spec. at 33: 4-8).
An antimicrobial assay was performed to determine the effects of the
Im-LF/LF mixture, as compared to native LF, on the growth of E. coli
serotype O157:H7. “Both the LF and [the] Im-LF/LF mixture reduced the
growth of the E. coli.” Incubation with 1% LF resulted in a 64% reduction
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in growth compared with the control, while incubation with 1% Im-LF/LF
mixture resulted in a 72% reduction compared with the control. No
statistical analysis was provided, so it cannot be determined whether the
difference in growth reduction between the two samples was statistically
significant. “[T]he Im-LF/LF mixture in buffer solution totally inhibited [ ]
growth” (Spec. 34: 1-14), but no data were provided for native LF in buffer
solution.
DISCUSSION
Claim 1-49, 51, and 56-202 are pending. Claims 1, 2, 5, 11, 18-20,
22, 28, 31, 32, 38, 39, 86, 101-104, 106, 115-117, 119-124, 126-129, 131-
138, 142-151, 153, 154, 157-159, 162-165, 171-173, 175, 176, 179-181,
184-187, 193-197, and 200-202 are rejected and on appeal. In addition,
the status of claim 3 is unclear because it is listed as merely objected to in
the Final Rejection mailed April 7, 2003, but it is rejected under 35 U.S.C.
§ 102(e) in the Final Rejection and the Answer. The remaining claims have
either been allowed, or are merely objected to.
Claims 1, 18, 38, 102, and 149 are representative, and read as follows:
1. A composition of matter comprising a dispersion of isolated
lactoferrin immobilized on a naturally occurring substrate not including
gelatin via the N-terminus region of the lactoferrin.

18. A method for reducing the microbial contamination of a
composition subject to microbial contamination by a microbe, comprising:
treating the composition with a sufficient amount of isolated lactoferrin
immobilized on a naturally occurring substrate not including gelatin via the
N-terminus region of the lactoferrin to reduce microbial contamination.

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38. The method in accordance with claim 18, wherein the
concentration of lactoferrin on the surface of the composition subject to
microbial contamination is from about 0.0001 to about 10 mg/sq. inch.

102. A composition of matter comprising a dispersion of isolated
lactoferrin immobilized on a naturally occurring substrate not including
gelatin via the N-terminus region of the lactoferrin; and at least one
pharmaceutically acceptable carrier.

149. The method of claim 18, wherein said composition subject to
microbial contamination is a human.

The claims stand rejected as follows:

I. Claims 1, 11, 18, 28, 31, 38, 39, 101, 102, 119-124, 126-129,
131, 132, 134, 142-148, 197, and 200 under 35 U.S.C. § 102(b)
as anticipated by Kruzel ‘982.1, 2

II. Claims 149-151, 153, 164, 171-173, 175, 186, and 193-195
under 35 U.S.C. § 103(a) as unpatentable over Kruzel ‘982.

III. Claims 1-3, 5, 18-20, 22, 31, 32, 102-104, 106, 115, 119, 124,
137, 138, 142-150, 154, 164, and 165 under 35 U.S.C. § 102(e)
as anticipated by Kruzel ‘469.3

IV. Claims 1, 2, 5, 18, 19, 22, 31, 101-103, 106, 115-117, 119-124,
126-129, 131-132, 134, 136, 142-151, 153, 164, 171-173, 175,
186, 193-197, and 200-202 under 35 U.S.C. § 102(b) as
anticipated by Valenti ‘309.4

1 International Patent Application WO 91/13982 of Kruzel et al., published
September 19, 1991.
2 Withdrawn with respect to claims 2, 19, and 103 (Answer 2).
3 U.S. Patent 6,066,469 to Kruzel et al., issued May 23, 2000.
4 European Patent Application EP 0 753 309 A2 of Valenti et al, published
January 15, 1997.
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V. Claims 38 and 39 under 35 U.S.C. § 103(a) as unpatentable
over Valenti ‘309.

VI. Claims 1, 2, 5, 18, 19, 22, 31, 32, 101-103, 106, 115, 119-124,
126-129, 131-136, 142-151, 153, 159, 162-165, 171-173, 175,
181, 184-187, 193-197, and 200-202 under 35 U.S.C. § 102(b)
as anticipated by Valenti ‘308.5

VII. Claims 38 and 39 under 35 U.S.C. § 103(a) as unpatentable
over Valenti ‘308.

VIII. Claims 102-104, 115-117, 119, 124, 127, 128, 137, 138, 142-
148, 154, 157, 158, 171, 172, 176, 179, 180, 186, and 193-196
under 35 U.S.C. § 102(e) as anticipated by Gohlke.6

IX. Claims 86 and 120-122 under 35 U.S.C. § 112, second
paragraph, as indefinite.

Appellant does not present separate arguments for any particular
claim with respect to any one rejection, therefore, the claims subject to each
rejection will stand or fall together. We select claims 1, 38, 102, and 149 as
representative of the subject matter on appeal. 37 C.F.R. § 41.37(c)(1)(vii).

REJECTIONS OVER PRIOR ART
“[I]n an ex parte proceeding to obtain a patent, . . . the Patent Office
has the initial burden of coming forward with some sort of evidence tending
to disprove novelty.” See In re Wilder, 429 F.2d 447, 450, 166 USPQ 545,
548 (CCPA 1970). “A claim is anticipated only if each and every element as

5 European Patent Application EP 0 753 308 A2 of Valenti et al., published
January 15, 1997.
6 U.S. Patent 6,475,511 to Gohlke et al., issued November 5, 2002.
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set forth in the claim is found, either expressly or inherently described, in a
single prior art reference.” Verdegaal Bros., Inc. v. Union Oil Co., 814 F.2d
628, 631, 2 USPQ2d 1051, 1053 (Fed. Cir. 1987) (emphasis added). “‘[I]t is
elementary that the mere recitation of a newly discovered function or
property, inherently possessed by things in the prior art, does not cause a
claim drawn to those things to distinguish over the prior art. Additionally,
where the Patent Office has reason to believe that a functional limitation
asserted to be critical for establishing novelty in the claimed subject matter
may, in fact, be an inherent characteristic of the prior art, it possesses the
authority to require the applicant to prove that the subject matter shown to be
in the prior art does not possess the characteristic relied on.’” In re Best, 562
F.2d 1252, 1254-55, 195 USPQ 430, 433 (CCPA 1977) (quoting In re
Swinehart, 439 F.2d 210, 212-13, 169 USPQ 226, 229 (CCPA 1971)). That
is, “when the PTO shows sound basis for believing that the products of the
applicant and the prior art are the same, the applicant has the burden of
showing that they are not.” In re Spada, 911 F.2d 705, 708, 15 USPQ2d
1655, 1658 (Fed. Cir. 1990).
In the present case, there is no dispute that none of the references cited
as evidence of anticipation explicitly describes lactoferrin immobilized via
its N-terminus region to a substrate. The issue raised by this appeal with
respect to each of the prior art rejections, then, is whether the Examiner has
provided a reasonable basis for shifting the burden to Appellant to establish
that the claimed lactoferrin compositions are distinguishable from the prior
art compositions; and if so, whether Appellant’s burden has been met.

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Kruzel ‘982
The Examiner rejected claims 1, 11, 18, 28, 31, 38, 39, 101, 102, 119-
124, 126-129, 131, 132, 134, 142-148, 197, and 200 under 35 U.S.C. § 102(b)
as anticipated by Kruzel ‘982 (Rejection “I”).
As discussed above, Appellant does not argue the claims separately
with respect to this ground of rejection. We select claim 1 as representative,
and the remaining claims will stand or fall accordingly.
Kruzel ‘982 describes lactoferrin compositions, including antiseptic
compositions comprising lactoferrin “in the form of a powder, solution,
ointment, aerosol spray, or cream” (Kruzel ‘982 at 7: 30-34), “either alone or
compounded with carriers such as, saline silica, talcum, stearic acid, its
magnesium or calcium salt, polyethylene[ ]glycol, and fatty emulsions and
suspensions” (id. at 8: 3-8). Kruzel ‘982 also teaches that the antiseptic
compositions can “contain . . . preserving, stabilizing, wetting or emulsifying
agents, solution promoters, salts . . . and/or buffers” (id. at 9: 17-21).
The Examiner, noting that “[b]uffers can be present in the antiseptic
compositions” (Answer 4), contends that “lactoferrin in combination with
stearic acid (which is a lipid . . .) . . . will be immobilized via its N-terminus
to the stearic acid to the same extent claimed” (id.), because “the same
components are present in the same defined dispersion” (id.).
As discussed above, the Specification teaches that suitable substrates
include lipids (Spec. 11: 2); that lactoferrin may be in solution, either alone
or in combination with carriers like stearic acid (a lipid); and that lactoferrin
may be immobilized via its N-terminus “simply by mixing the LF with the
. . . substrate in a suitable medium, such as deionized water” (id. at 11: 3-5).
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(See also Spec. 33 describing the immobilization of LF on galactose-rich
polysaccharide by mixing it with water). Thus, the Specification does not
state that anything more than combining LF with a substrate in water is
needed to achieve “lactoferrin immobilized on a naturally occurring
substrate . . . via the N-terminus region of the lactoferrin” as recited by claim
1. We also find nothing in the Specification to indicate that stearic acid, a
lipid, is not a suitable substrate.7 Accordingly, we find that the Examiner
has established a reasonable basis for believing that the prior art lactoferrin,
in solution with stearic acid, is attached to, or immobilized on, stearic acid
via the N-terminus of lactoferrin, and the burden is properly shifted to
Appellant to show otherwise.
Appellant relies on “factual evidence, in the form of the declaration of
Dr. Andrew [R.] Barron,”8 to establish that Kruzel ‘982 does not “inherently
disclose[ ] the formation of lactoferrin immobilized on a naturally occurring
substrate via the lactoferrin’s N-terminus region” (Br. 12). Dr. Barron
asserts that “the mere presence in a mixture of LF and stearic acid or any of
the other naturally occurring carriers or diluents taught in . . . [Kruzel] ‘982
would not inherently result in the LF becoming attached via its N-terminus
on a substrate” (Decl. ¶ 19), and “[m]erely compounding solid LF with other
solids, such as stearic acid, will not provide an environment suitable to cause

7 We note that the Examiner has previously asserted, and it has not been
disputed by Appellant, that stearic acid has a negatively charged carboxyl
group (Final Rejection, dated April 7, 2005, at 12).
8 Declaration of Dr. Andrew R. Barron, dated July 26, 2004, submitted
under the provisions of 37 C.F.R. § 1.132 (hereinafter “Decl.”).
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the LF to become attached to the other solid via LF’s N-terminus region”
(id. at ¶ 20).
Nevertheless, as discussed above, Kruzel ‘982 describes more than
just compounding solid lactoferrin with other solids. Kruzel ‘982 also
describes antiseptic compositions comprising lactoferrin in solution, “either
alone or compounded with carriers such as . . . stearic acid, its magnesium or
calcium salt” (Kruzel ‘982 at 8: 3-6).
Inasmuch as Kruzel describes lactoferrin and stearic acid in solution,
and the Specification teaches that “LF can be immobilized simply by mixing
the LF with the . . . substrate in a suitable medium, such as deionized water”
(Spec. at 11: 3-5), we are not persuaded by Dr. Barron’s assertions regarding
solid compounding.
Nor are we persuaded by Dr. Barron’s assertion that “[s]tearic acid
with a molecular weight of only 284.47 is not a substrate” and “LF could not
become immobilized on such a small molecule” (Decl. ¶ 17) “as the term is
to be understood in the context of the instant specification and claims” (Br.
21-22). The Specification makes no mention of size in describing suitable
substrates for immobilizing lactoferrin, and in fact mentions nucleotides
(e.g., adenosine triphosphate), which are considerably smaller than
lactoferrin, as suitable substrates.
Finally, while acknowledging that Dr. Barron’s declaration is
inconsistent with the Specification on the issue of substrate size, Appellant
argues that “[w]hat is wrong . . . is not applicant’s argument, as supported by
Dr. Barron’s declaration. Instead, what was wrong was the original
inclusion of lipids, such as stearic acid, among the examples of suitable
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substrates . . . LF could not become immobilized on such a small molecule”
(Br. 22).
Nevertheless, this is not a matter of right or wrong, it is a matter of
interpretation based on the Specification. The term “substrate” is defined in
the Specification in functional terms, and by inclusive examples. As
discussed above, the Specification teaches that suitable substrates for
immobilizing lactoferrin are compounds that “attach to the LF peptide at the
amino-terminus (N-terminus), leaving the carboxy-terminal (C-terminal) end
of the LF peptide free to interact with microbes” (Spec. 8: 1-3), and the list
of examples of suitable substrates explicitly includes compounds as small as
adenosine triphosphate. Dr. Barron has not explained why his more
restrictive interpretation of “substrate” should take precedence over the way
the term is interpreted based on substrates asserted to be suitable in the
Specification.
We find that the Examiner has established a reasonable basis for
believing that the prior art compositions meet all the limitations of claim 1,
properly shifting the burden to Appellant to show otherwise. We further
find that Appellant has not adequately discharged the burden of rebuttal, by
argument or evidence. The rejection of claim 1 as anticipated by Kruzel
‘982 is affirmed, and claims 11, 18, 28, 31, 38, 39, 101, 102, 119-124, 126-
129, 131, 132, 134, 142-148, 197, and 200 fall accordingly.
The Examiner rejected claims 149-151, 153, 164, 171-173, 175, 186,
and 193-195 under 35 U.S.C. § 103(a) as unpatentable over Kruzel ‘982
(Rejection “II”).
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Appellant argues only that the claimed invention would not have been
obvious over Kruzel ‘982, because the reference does not teach and “would
not have suggested immobilizing LF on a naturally occurring substrate via
its N-terminus region” (Br. 23).
This argument is not persuasive as we have already found that the
Examiner has established a reasonable basis for believing that Kruzel ‘982
describes lactoferrin immobilized on a substrate via its N-terminus region,
which Appellant has not adequately rebutted by argument or evidence.
The rejection of claims 149-151, 153, 164, 171-173, 175, 186, and
193-195 as unpatentable over Kruzel ‘982 is affirmed.

Kruzel ‘469
Claims 1-3, 5, 18-20, 22, 31, 32, 102-104, 106, 115, 119, 124, 137,
138, 142-150, 154, 164, and 165 stand rejected under 35 U.S.C. § 102(e) as
anticipated by Kruzel ‘469 (Rejection “III”).
Appellant does not argue the claims separately with respect to this
ground of rejection. We select claim 1 as representative, and the remaining
claims will stand or fall accordingly.
Kruzel ‘469 describes nutritional supplements comprising “liquids
containing [ ] lactoferrin together with adjuvants or diluents, such as . . .
cellulose, . . . starch, . . . geslatin [sic], tragacanth, methyl-cellulose, [and]
sodium carboxymethylcellulose” (Kruzel ‘469 col. 8, ll. 51-56). The
supplements can also contain buffers (id. at col. 9, l. 36).

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The Examiner contends that “inherently the lactoferrin in the
nutritional supplements . . . will be immobilized via its N-terminus to the
carriers or diluents to the same extent claimed” (Answer 8), “[b]ecause the
same components are present in the same defined dispersion” (id.).
Appellant again relies on the Declaration of Dr. Andrew R. Barron to
establish that Kruzel ‘469 does not describe immobilized lactoferrin (Br.
12). Dr. Barron asserts that “[m]erely compounding LF with other solids,
such as by cold-pressing two or more solids, will not provide an
environment suitable to cause the LF to become immobilized via its N-
terminus region” (Decl. ¶ 38), and “the mere presence in a mixture of LF
and any of the adjuvants or diluents, such [as] the solids cellulose, starch,
tragacanth, or sodium carboxymethylcellulose would not inherently result in
immobilization of the LF via its N-terminus” (id. at ¶ 37). Finally, Dr.
Barron asserts that “[c]ellulose and starch do not carry any charges. As a
result, neither cellulose nor starch contains a region that will attach LF’s
positively charged N-terminus region” (id. at ¶ 36).
Nevertheless, as discussed above, Kruzel ‘469 describes more than
just solid lactoferrin compounded with other solids. Kruzel ‘469 also
describes “liquids containing the lactoferrin together with adjuvants or
diluents, such as . . . cellulose, . . . starch, . . . geslatin [sic], tragacanth,
methyl-cellulose, [or] sodium carboxymethylcellulose” (Kruzel ‘469, col. 8,
ll. 51-56). Moreover, the present Specification explicitly lists cellulose as a
suitable substrate (Spec. 10: 20 and 11: 1).
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Inasmuch as Kruzel ‘469 describes a liquid containing lactoferrin and
cellulose, and the Specification teaches that “LF can be immobilized simply
by mixing the LF with the . . . substrate in a suitable medium, such as
deionized water” (Spec. at 11: 3-5), we are not persuaded by Dr. Barron’s
assertions that Kruzel ‘469 does not describe lactoferrin immobilized via its
N-terminus to cellulose.
We find that the Examiner has established a reasonable basis for
believing that the compositions described by Kruzel ‘469 meet all the
limitations of claim 1, properly shifting the burden to Appellant to show
otherwise. We further find that Appellant has not adequately discharged the
burden of rebuttal, by argument or evidence. The rejection of claim 1 as
anticipated by Kruzel ‘469 is affirmed, and claims 2, 3, 5, 18-20, 22, 31, 32,
102-104, 106, 115, 119, 124, 137, 138, 142-150, 154, 164, and 165 under 35
U.S.C. § 102(e) fall accordingly.

Valenti ‘309
Claims 1, 2, 5, 18, 19, 22, 31, 101-103, 106, 115-117, 119-124, 126-
129, 131-132, 134, 136, 142-151, 153, 164, 171-173, 175, 186, 193-197, and
200-202 stand rejected under 35 U.S.C. § 102(b) as anticipated by Valenti
‘309 (Rejection “IV”).
Appellant does not argue the claims separately with respect to this
ground of rejection. We select claim 1 as representative, and the remaining
claims will stand or fall accordingly.
Valenti ‘309 describes solutions of lactoferrin and desferrioxamine
methanesulfonate, “in solvents acceptable for pharmaceutical use, in
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particular water or hydroalcholic [sic] solvents such as water-ethanol
mixtures” (Valenti ‘309 4: 16-22). The Examiner notes that “[t]he
compositions are in the form of ointments, creams, [and] gels” (Answer 5),
and comprise “lactoferrin and carriers such as paraffin oil and Vaseline . . . ,
xantan gum and corn starch (which are polysaccharides), and lecithin (which
is an emulsifier” (id.). Example 7 of Valenti ‘309, e.g., describes a gel
containing lactoferrin, xantan gum, lecithin and distilled water.
The Examiner argues that “inherently the lactoferrin in the
composition of . . . [Valenti] ‘309 will be immobilized via its N-terminus . . .
to the same extent claimed” (Answer 6).
Appellant, again relying on the declaration of Dr. Barron, argues that
“[l]ecithin is a low molecular weight compound” and “LF could not become
immobilized on such a small molecule” (Decl. ¶ 27). Moreover, “[x]antan
gum and cornstarch do not carry any charges. As a result, neither xantan
gum nor cornstarch contains a region that will attach LF’s positively charged
N-terminus region” (Decl. ¶ 26).
These arguments are not persuasive. As discussed above, the
Specification makes no mention of size in describing suitable substrates for
immobilizing lactoferrin, and in fact mentions nucleotides (e.g., adenosine
triphosphate), which are considerably smaller than lactoferrin, as suitable
substrates. In addition, also as discussed above, the Specification explicitly
lists cellulose as a suitable substrate (Spec. 10: 20 and 11: 1), even though
cellulose carries no charge.
We find that the Examiner has established a reasonable basis for
believing that the compositions described by Valenti ‘309 meet all the
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limitations of claim 1, properly shifting the burden to Appellant to show
otherwise. We further find that Appellant has not adequately discharged the
burden of rebuttal, by argument or evidence. The rejection of claim 1 as
anticipated by Valenti ‘309 is affirmed, and claims 2, 5, 18, 19, 22, 31, 101-
103, 106, 115-117, 119-124, 126-129, 131-132, 134, 136, 142-151, 153,
164, 171-173, 175, 186, 193-197, and 200-202 fall accordingly.
Claims 38 and 39 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Valenti ‘309 (Rejection “V”).
Appellant argues only that the claimed invention would not have been
obvious over Valenti ‘309 because the reference does not teach and “would
not have suggested immobilizing LF on a naturally occurring substrate via
its N-terminus region” (Br. 25).
This argument is not persuasive as we have already found that the
Examiner has established a reasonable basis for believing that Valenti ‘309
describes lactoferrin immobilized on a substrate via its N-terminus region,
which Appellant has not adequately rebutted by argument or evidence.
The rejection of claims 38 and 39 over Valenti ‘309 is affirmed.

Valenti ‘308
Claims 1, 2, 5, 18, 19, 22, 31, 32, 101-103, 106, 115, 119-124, 126-
129, 131-136, 142-151, 153, 159, 162-165, 171-173, 175, 181, 184-187,
193-197, and 200-202 stand rejected under 35 U.S.C. § 102(b) as anticipated
by Valenti ‘308 (Rejection “VI”).
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Appellant does not argue the claims separately with respect to this
ground of rejection. We select claim 1 as representative, and the remaining
claims will stand or fall accordingly.
Valenti ‘308 describes preparations of lactoferrin “in solvents
acce[p]table for pharmaceutical use, in particular water or hydro-alcoholic
solvents such as water-ethanol mixtures” (Valenti ‘308 3: 34-36). The
Examiner notes that “[t]he compositions are in the form of gargles, aqueous
solutions, [and] chewing gum[s]” (Answer 7), and comprise “lactoferrin and
peppermint oil, gum base and corn starch (which are polysaccharides),
glucose, and additional antibiotic compounds” (id.). Example 5 of Valenti
‘308, e.g., describes a gargle containing lactoferrin, peppermint oil and
purified water, while Example 7 describes a chewing gum comprising
lactoferrin, gum base and peppermint oil.
The Examiner argues that “inherently the lactoferrin in the
composition of . . . [Valenti] ‘308 will be immobilized via its N-terminus . . .
to the same extent claimed” (Answer 7).
Appellant, again relying on the declaration of Dr. Barron, argues that
“[p]eppermint oil is a low molecular weight compound, not a substrate” and
“LF could not become immobilized on such a small molecule” (Decl. ¶ 30).
Moreover, “[p]eppermint oil, gum base and cornstarch do not carry any
charges. As a result, neither gum base nor cornstarch contains a region that
will attach LF’s positively charged N-terminus region” (Decl. ¶ 31).
These arguments are not persuasive. Again, the Specification makes
no mention of size in describing suitable substrates for immobilizing
lactoferrin, and in fact mentions nucleotides (e.g., adenosine triphosphate),
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which are considerably smaller than lactoferrin, as suitable substrates. In
addition, also as discussed above, the Specification explicitly lists cellulose
as a suitable substrate (Spec. 10: 20 and 11: 1), even though cellulose carries
no charge.
We find that the Examiner has established a reasonable basis for
believing that the compositions described by Valenti ‘308 meet all the
limitations of claim 1, properly shifting the burden to Appellant to show
otherwise. We further find that Appellant has not adequately discharged the
burden of rebuttal, by argument or evidence. The rejection of claim 1 as
anticipated by Valenti ‘309 is affirmed, and claims 2, 5, 18, 19, 22, 31, 32,
101-103, 106, 115, 119-124, 126-129, 131-136, 142-151, 153, 159, 162-165,
171-173, 175, 181, 184-187, 193-197, and 200-202 fall accordingly.

Claims 38 and 39 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Valenti ‘308 (Rejection “VII”).
Appellant argues only that the claimed invention would not have been
obvious over Valenti ‘308 because the reference does not teach and “would
not have suggested immobilizing LF on a naturally occurring substrate via
its N-terminus region” (Br. 27).
This argument is not persuasive as we have already found that the
Examiner has established a reasonable basis for believing that Valenti ‘308
describes lactoferrin immobilized on a substrate via its N-terminus region,
which Appellant has not adequately rebutted by argument or evidence.
The rejection of claims 38 and 39 over Valenti ‘308 is affirmed.

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Appeal 2006-3089
Application 09/980,062

Gohlke
Claims 102-104, 115-117, 119, 124, 127, 128, 137, 138, 142-148,
154, 157, 158, 171, 172, 176, 179, 180, 186, and 193-196 stand rejected
under 35 U.S.C. § 102(e) as anticipated by Gohlke (Rejection “VIII”).
We will reverse this rejection.
Gohlke describes combining powdered lactoferrin with powdered
colostrum, and cold pressing the mixture into a lozenge. The Examiner
contends that “inherently the lactoferrin in the lozenges of Gohlke [ ] will be
immobilized . . . to the proteins, polysaccharides, and lipids which are
present” in the colostrum “[b]ecause the same components are present in the
same compositions” (Answer 9).
Appellant, again relying on Dr. Barron’s declaration, argues that
“immobilized LF will not be formed, if LF is simply admixed with another
solid” (Br. 19). As explained by Dr. Barron, “mixing LF with colostrum
(and modified pectin) and cold pressing will not provide an environment
suitable to cause the LF to become attached to colostrums or modified pectin
via LF’s N-terminus region” (Decl. ¶ 14).
Appellant has the better argument. The Examiner has pointed to no
evidence of record to support his position that cold-pressing lactoferrin and a
substrate would result in immobilization, while Appellant has provided
declaratory evidence that it would not. Appellant’s evidence is sufficient to
rebut the rejection based on Gohlke. The rejection of claims 102-104, 115-
117, 119, 124, 127, 128, 137, 138, 142-148, 154, 157, 158, 171, 172, 176,
179, 180, 186, and 193-196 is reversed.

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Appeal 2006-3089
Application 09/980,062

INDEFINITENESS
The Examiner rejected claims 86 and 120-122 under 35 U.S.C. § 112,
second paragraph, as indefinite (Rejection “IX”).
Appellant does not address this rejection in the Brief, or the Reply
Brief.
Accordingly, the rejection of claims 86 and 120-122 as indefinite is
affirmed.
SUMMARY
Rejections I, IV, and VI under 35 U.S.C. § 102(b) are affirmed.
Rejections II, V, and VII under 35 U.S.C. § 103(a) are affirmed.
Rejection III under 35 U.S.C. § 102(e) is affirmed.
Rejection VIII under 35 U.S.C. § 102(e) is reversed.
Rejection IX under 35 U.S.C. § 112, second paragraph is affirmed.
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

lbg

KENNETH J. HOVET
NORDMAN, CORMANY, HAIR & COMPTON LLP
P.O. BOX 9100
1000 TOWN CENTER DRIVE
OXNARD CA 93031-9100
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