Ex Parte Stone et al

Patent Trial and Appeal Board

Dec 15, 2012

11445091 (P.T.A.B. Dec. 15, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte HENRY D. STONE, CAM R. GREENE, PETER S. HOLT,
RICHARD K. GAST, and KUNHO SEO
__________

Appeal 2012-002394
Application 11/445,091
Technology Center 1600
__________

Before DONALD E. ADAMS, LORA M. GREEN, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) from the rejection of
claims directed to a method for extraction of a biological sample. The
Patent Examiner rejected the claims for anticipation and obviousness. We
have jurisdiction under 35 U.S.C. § 6(b). We reverse.
Appeal 2012-002394
Application 11/445,091

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STATEMENT OF THE CASE
“This invention relates to methods for extraction and concentration of
water and oil soluble compounds from a biological sample using liquid
carboxylic acids.” (Spec. 1, [0001].) The invention is said to provide a
“fast” method of extraction which “provides a concentrated sample.” (Id. at
5, [0007].)
Claims 5, 13, and 33-40 are on appeal. Claim 5 is representative and
reads as follows (emphasis added):
5. A method for extraction of a biological sample consisting essentially
of:
(a) adding at least one liquid carboxylic acid to a biological sample
to form a first composition,
(b) mixing said first composition to form a second composition that
contains an aqueous soluble product,
(c) centrifuging said second composition to form an aqueous layer
and an oily layer, and
(d) harvesting said aqueous layer to produce a concentrated sample
selected from the group consisting of proteins, bacteria, virus, and mixtures
thereof.

The Examiner rejected the claims as follows:
I. claims 5, 13, 33, and 34 under 35 U.S.C. § 102(b) as anticipated by
McLaren;
1
and
II. claims 35-40 under 35 U.S.C. § 103(a) as unpatentable over McLaren
and Lee.
2

1
R.D. McLaren et al., The use of caprylic acid for the extraction of the
immunoglobulin fraction from egg yolk of chickens immunised with ovine
α-lactalbumin, 177 J. IMMUNOL. METH. 175-184 (1994).
2
Young-Zoon Lee, US 5,367,054, issued Nov. 22, 1994.
Appeal 2012-002394
Application 11/445,091

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DISCUSSION
The Issue
The Examiner‟s position is that McLaren described Appellants‟
method in section 2.3 (entitled “Extraction and purification of egg yolk
immunoglobulin”). (Ans. 5.) The Examiner acknowledged that the appealed
claims use the transitional phrase “consisting essentially of” but explained:
Although the method steps of McLaren include additional steps
beyond those set forth in the claimed method (i.e., the steps of
treatment with ammonium sulfate and further centrifugation), the
additional steps are not expected to interfere with the characteristics of
the antibodies themselves.

(Id.)
Appellants “assert[ ] that the basic and novel characteristics of the
invention are materially changed or not taught by the prior art of
McLAREN.” (App. Br. 5.) The same issue applies to both rejections.
The issue is:
whether the additional steps in McLaren materially affect the basic
and novel characteristics of Appellants‟ method.

Findings of Fact
1. Appellants‟ Specification states:
The present invention provides a method for extracting such proteins
and/or infectious agents from biological samples which is fast,
provides a concentrated sample, provides increased sensitivity when
used in diagnostic testing, and is different from prior art methods ….

(Spec. 5, [0007].)
2. Appellants‟ Specification provides Example 3 of the claimed method,
which explains that “[n]o sensitivity is lost since there is no dilution of
Appeal 2012-002394
Application 11/445,091

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the sample as would occur if the albumin or yolk is diluted with saline
and added directly to the test strip.” (Spec. 30, [0051].)
3. McLaren described the following method for “Extraction and
purification of egg yolk immunoglobulin:”
Eggs collected from immunised hens were processed in batches
of 10. Each batch yielded a harvested egg yolk volume between 150
ml and 190 ml. The pooled egg yolk from each bird was diluted with
2 vols. of phosphate buffered saline (PBS) . . . . The pH of the diluted
egg yolk was adjusted to 4.6 with acetic acid and caprylic acid was
slowly added . . . . The mixture was stirred . . . and centrifuged . . . .
The resultant internatant, containing the immunoglobulin fraction,
was collected . . . .

(McLaren 177, section 2.3, emphasis added.)

Principles of Law
If an Applicant contends that additional steps or materials in the prior
art are excluded by the transitional phrase “consisting essentially of,”
Applicant has the burden of showing that the introduction of additional steps
or components would materially change the characteristics of Applicant‟s
invention. In re De Lajarte, 337 F.2d 870, 874 (CCPA 1964) (reversing
Board because Appellant met burden (composition claim)). See also, Ex
parte Hoffman, 1989 WL 274371 *3, 12 U.S.P.Q.2d 1061, 1063-64 (Bd. Pat.
App. & Inter. 1989) (“[I]t is an applicant‟s burden to establish that step
practiced in a prior art method is excluded from [the] claims by „consisting
essentially of‟ language.”).

Appeal 2012-002394
Application 11/445,091

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Analysis
A basic feature of Appellants‟ invention, alleged to be novel, is that it
provides “increased sensitivity.” (FF 1.) When the method is used for
example on eggs, “[n]o sensitivity is lost since there is no dilution of the
sample as would occur if the albumin or yolk is diluted with saline.” (FF 2.)
In contrast to Appellants‟ claims, which do not include a dilution step,
McLaren‟s method additionally dilutes the yolk with saline, among other
additional steps. (FF 3.) McLaren‟s method is prima facie different because
it includes dilution. Based on the portions of the Specification Appellants
cite, dilution affects sensitivity, and sensitivity is a basic and novel
characteristic of the method. We conclude that Appellants met the burden of
showing that McLaren‟s additional steps would materially change the
sensitivity characteristics of the claimed method.
To assess whether the basic and novel characteristics of the method
were affected, the Examiner looked to the antibody McLaren isolated. The
Examiner‟s analysis was flawed because the invention is a method, not an
antibody. The question is not whether McLaren isolated the same antibody
but whether McLaren‟s additional steps affect extraction sensitivity. We
reverse the rejections for the reason Appellants present:
Sensitivity is a characteristic of the invention that would be materially
changed. The examiner has not provided a response as to why the
teachings of McLAREN, specifically dilution of the product for assay,
would not materially change the sensitivity characteristic of
applicant's invention, especially when applicant explicitly teaches that
non-dilution is a key feature or characteristic of the invention.

(App. Br. 7-8.)

Appeal 2012-002394
Application 11/445,091

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SUMMARY
We reverse the rejection of claims 5, 13, 33, and 34 under 35 U.S.C.
§ 102(b) as anticipated over McLaren.
We reverse the rejection of claims 35-40 under 35 U.S.C. § 103(a) as
unpatentable over McLaren and Lee.

REVERSED

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