Ex Parte Maurer

Board of Patent Appeals and Interferences

Feb 3, 2011

10907531 (B.P.A.I. Feb. 3, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte GERALD L. MAURER
__________

Appeal 2010-010184
Application 10/907,531
Technology Center 1600
__________

Before ERIC GRIMES, MELANIE L. McCOLLUM, and STEPHEN
WALSH, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 involving claims to a
precipitating reagent for isolating protein. The Examiner has rejected the

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
Appeal 2010-010184
Application 10/907,531

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claims as anticipated. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm.
STATEMENT OF THE CASE
The Specification discloses “a high resolution method of isolating a
desired protein population from a proteinaceous material comprising
providing a critical concentration of a precipitating reagent comprised of an
alkali metal salt of a polyfunctional organic acid” (Spec. 4-5, ¶ 8). The
Specification discloses that the “alkali metal salts of polyfunctional organic
acids are preferably derived from monovalent alkali metals of citric acid and
tartaric acid, such as lithium citrate, potassium citrate, and sodium citrate”
(id. at 6, ¶ 10).
Claims 16, 17, 20-23, and 25 are on appeal. Claim 16 is
representative and reads as follows:
16. A high resolution precipitating reagent for selectively isolating a
desired protein population from a proteinaceous material comprising:
an alkali metal of a polyfunctional organic acid in a concentration
suitable for selectively isolating the desired protein population; and
a buffer for adjusting pH of said reagent whereby the desired protein
population is selectively isolated from the proteinaceous material in a
concentrated, substantially pure and biologically active form.

The claims stand rejected 35 U.S.C. § 102(b) as follows:
• Claim 16 in view of Dissing;2
• Claims 16, 17, 20-23, and 25 in view of Samoto;3 and
• Claims 16, 17, 20-23, and 25 in view of Ruzin.4

2 U. Dissing et al., Polyelectrolyte complexes as vehicles for affinity
precipitation of proteins, 52 J. OF BIOTECHNOLOGY, 1-10 (1996)
3 Samoto et al., US 5,597,607, Jan. 28, 1997
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I.
Issue
The Examiner has rejected claim 16 under 35 U.S.C. § 102(b) as
anticipated by Dissing, on the basis that Dissing’s “use of polyacrylic acid
sodium salt, and a buffer … in the affinity precipitation of LDH [lactate
dehydrogenase] from heart extract meets the limitation of claim 16”
(Answer 4).
Appellant contends that Dissing does not anticipate claim 16 because
Dissing’s polyacrylic acid is not a polyfunctional organic acid (Appeal Br.
13).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s finding that Dissing discloses a reagent that
comprises a polyfunctional organic acid?
Findings of Fact
1. Dissing discloses a protein precipitation method in which affinity
“ligands are coupled to polymers that can be precipitated by changing
environmental conditions” (Dissing 1).
2. Dissing discloses using polymer complexes of polyethylene imine
derivatized with the dye Cibacron blue and complexed with polyacrylic acid
sodium salt to selectively precipitate lactate dehydrogenase (id. at 2).
3. Appellant has provided a declaration under 37 C.F.R. § 1.132
(Declaration of Patrick A. Limbach, filed September 8, 2008).

4 Buffers (From Ruzin, 1999, Plant Microtechnique and Microscopy),
http://microscopy.berkeley.edu/Resources/instruction/buffer.html, 6 pages
(retrieved on Nov. 19, 2008)
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4. Dr. Limbach declares that “[p]olyfunctional is an adjective used in
chemistry meaning ‘Of a compound: having two or more different functional
groups in the molecule’ (Oxford English Dictionary). More specifically, a
polyfunctional organic acid is then an organic acid having two or more
different (emphasis added) functional groups in the molecule.” (Limbach
Declaration, ¶ 9.)
5. Dr. Limbach declares that polyacrylic acid “does not contain
different functional groups that would affect the chemical reactivity of
polyacrylic acid in ways that would be difficult to predict. Polyacrylic acid
cannot be a polyfunctional organic acid because it simply has only one
functional group available for typical chemical reactions.” (Limbach
Declaration, ¶ 12.)
Analysis
Claim 16 is directed to a reagent comprising an alkali metal of a
polyfunctional organic acid and a buffer.
Appellant contends that Dissing’s polyacrylic acid is not a
polyfunctional organic acid (Appeal Br. 13), and cites the Limbach
Declaration as evidence that one of skill in the art would understand a
“polyfunctional organic acid” to be an organic acid that has two different
functional groups, unlike polyacrylic acid, which has only one functional
group (id. at 13-14).
The Examiner responds that “[i]n the absence of a proper definition
for ‘polyfunctional organic acid’ in the instant specification and the
availability/applicability of multiple different definitions … in the prior art
one of ordinary skill in the art would practice the instant invention using
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organic acids” that comprise multiple different functional groups or that
comprise only one type of functional groups (Answer 8).
Appellant’s arguments are persuasive. The Limbach Declaration
provides evidence that those of skill in the art would interpret the term
“polyfunctional organic acid” to require an organic acid with more than one
type of functional group. The Examiner has not provided evidence to the
contrary, or any other reasonable basis to question the evidence provided in
the Limbach Declaration.
Conclusion of Law
The evidence of record does not support the Examiner’s finding that
Dissing discloses a reagent that comprises a polyfunctional organic acid.
II.
Issue
The Examiner has rejected claims 16, 17, 20-23, and 25 under 35
U.S.C. § 102(b) as anticipated by Samoto. Claim 23 was argued separately;
claims 17, 20-22, and 25 stand or fall with claim 16. 37 C.F.R.
§ 41.37(c)(1)(vii).
The Examiner finds that Samoto discloses “a method [for the]
precipitation of soy protein by addition of sodium citrate and the pH was
adjusted to 3 … with hydrochloric acid” (Answer 12).
Appellant contends that Samoto does not disclose that “the desired
protein population is selectively isolated from the proteinaceous material in
a concentrated, substantially pure and biologically active form,” as recited in
claim 16 (Appeal Br. 20-24).
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The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s finding that Samoto discloses the
precipitating reagent of claim 16?
Additional Findings of Fact
6. Samoto discloses a “process for preparing low-allergenic
fractionated soybean proteins by treating soybean proteins under acidic
conditions with an aqueous solution in which a salt is dissolved to
selectively concentrate Gly m Bd 30k in a precipitation fraction and
collecting a supernatant fraction” (Samoto, abstract).
7. Samoto discloses that a “pH of 3.5 to 5.0, normally 3.8 to 4.7 may
be selected” (id. at col. 3, l. 67 to col. 4, l. 1).
8. Samoto discloses that “[t]o raw soybean milk … tri-sodium citrate
was added in a concentration of 5 mM. The pH was adjusted to 3.0 with
hydrochloric acid and the precipitation fraction was removed by
centrifugation” (id. at col. 8, ll. 34-39).
9. Samoto discloses that
[t]o raw soybean milk … was added a salt selected from the
group consisting of tri-sodium citrate, sodium tartarate, sodium
sulfate, sodium acetate and sodium chloride … After adjusting
the pH of the mixture to 4.5 with a hydrochloric acid solution,
the supernatant fraction and the precipitation fraction were
obtained separately.
(Id. at col. 6, ll. 25-38.)
Principles of Law
“Where … a patentee defines a structurally complete invention in the
claim body and uses the preamble only to state a purpose or intended use for
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the invention, the preamble is not a claim limitation.” Rowe v. Dror, 112
F.3d 473, 478 (Fed. Cir. 1997).
“A ‘whereby’ clause that merely states the result of the limitations in
the claim adds nothing to the patentability or substance of the claim.” Texas
Instruments, Inc. v. International Trade Comm., 988 F.2d 1165, 1171 (Fed.
Cir. 1993).
Analysis
Samoto discloses selectively precipitating the allergenic soy protein
Gly m Bd 30k (FF 6) by adding a salt such as tri-sodium citrate (FF 8) and
adjusting the pH to “3.5 to 5.0, normally 3.8 to 4.7” (FF 7).
Appellant contends that Samoto discloses removing an allergenic
protein as a contaminant, not isolating it “in a concentrated, substantially
pure and biologically active form,” as required by claim 16 (Appeal Br. 22-
23).
This argument is not persuasive. Claim 16 is directed to a
composition, and Appellant has not pointed to any structural difference
between the claimed composition and the composition disclosed by Samoto.
Both the preamble and the “whereby” clause of claim 16 merely state
the intended use of the claimed composition, and therefore do not limit the
claim. The whereby clause does not change anything about the recited
composition components but simply states the anticipated results of using
the composition for its intended purpose. Thus, the whereby clause is not
entitled to weight in construing the claims.
Appellant also argues that the Examiner has pointed to an example in
Samoto in which the precipitation was carried out at a pH of 3, which is not
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within the pH range of about 4 to about 9, as required by claim 23 (Appeal
Br. 21). This argument is not persuasive because Samoto exemplifies
protein precipitation with tri-sodium citrate at a pH of 4.5 (FF 9) and
discloses that a pH in the range of 3.8 to 4.7 is “normally selected” (FF 7).
Conclusion of Law
The evidence of record supports the Examiner’s finding that Samoto
discloses the precipitating reagent of claim 16.
III.
Issue
The Examiner has rejected claims 16, 17, 20-23, and 25 under 35
U.S.C. § 102(b) as anticipated by Ruzin. The claims have not been argued
separately and therefore stand or fall with claim 16. 37 C.F.R.
§ 41.37(c)(1)(vii).
The Examiner finds that Ruzin “discloses the preparation of … citrate
buffer that comprises … mixing sodium citrate solution with citric acid.…
The sodium citrate is the alkali metal salt of an organic polyfunctional acid
and citric acid is buffer for adjusting the pH of the solution” (Answer 17).
Appellant contends that Ruzin does not anticipate claim 16 because it
does not disclose the use of citrate buffer to selectively isolate a protein in a
concentrated, substantially pure and biologically active form (Appeal Br. 25-
27).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s finding that Ruzin’s citrate buffer anticipates
claim 16?
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Additional Findings of Fact
10. Ruzin discloses a citrate buffer that comprises a mixture of citric
acid and sodium citrate (Ruzin 3).
Analysis
We agree with the Examiner that Ruzin’s citrate buffer, which
comprises sodium citrate and citric acid, anticipates the reagent of claim 16
(see Answer 17).
Appellant argues that the whereby clause of claim 16 is a material
limitation of the claimed composition (Appeal Br. 25). Appellant argues
that Ruzin does not disclose “that the citrate buffer can be used to selectively
isolate a desired protein population from a proteinaceous material in a
concentrated, substantially pure and biologically active form” (id. at 27).
These arguments are not persuasive because, as discussed above, the
whereby clause of claim 16 does not structurally limit the claimed
composition and therefore is not entitled to weight in construing the claim.
Appellant argues that the whereby clause is a “material limitation,” but does
not point to any specific way in which the claimed composition differs from
Ruzin’s as a result of the intended use and anticipated result that are recited
in the claim. Appellant therefore has not established that the whereby clause
in fact limits the claim in a manner that distinguishes the claimed
composition from that of Ruzin.
Conclusion of Law
The evidence of record supports the Examiner’s finding that Ruzin’s
citrate buffer anticipates claim 16.
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SUMMARY
We affirm the rejection of claims 16, 17, 20-23, and 25 under 35
U.S.C. § 102(b) based on either Samoto or Ruzin. However, we reverse the
rejection of claim 16 under 35 U.S.C. § 102(b) based on Dissing.
TIME PERIOD FOR RESPONSE
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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