Ex Parte Beebe et al

Patent Trial and Appeal Board

Jan 5, 2018

13326832 (P.T.A.B. Jan. 5, 2018)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/326,832 12/15/2011 David Beebe 282.146 6325
72088 7590 01/09/2018
WISCONSIN ALUMNI RESEARCH FOUNDATION
C/O BOYLE FREDRICKSON S.C
840 North Plankinton Avenue
Milwaukee, WI53203
EXAMINER
LYONS, MARY M
ART UNIT PAPER NUMBER
1645
NOTIFICATION DATE DELIVERY MODE
01/09/2018 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
docketing @boylefred.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAVID BEEBE, LINDSAY STROLMAN, and
SCOTT M. BERRY1
Appeal 2016-007082
Application 13/326,832
Technology Center 1600
Before ERIC B. GRIMES, ULRIKE W. JENKS, and DAVID COTTA,
Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims directed
to a method of extracting a fraction of interest from a biological sample.
The Examiner rejects the claims as obvious. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.
1 According to Appellants, the real party in interest is the Wisconsin Alumni
Research Foundation, a Wisconsin Corporation. Appeal Br. 3.
Appeal 2016-007082
Application 13/326,832
STATEMENT OF THE CASE
Claims 1,9, 17, and 19 are on appeal, and can be found in the Claims
Appendix of the Appeal Brief. Claim 1 is representative of the claims on
appeal, and reads as follows:
1. A method for facilitating extraction of a fraction from a
biological sample, the biological sample including non-desired
material and a fraction-bound solid phase substrate, the method
comprising the steps of:
sequentially drawing an isolation buffer and the biological
sample into a barrel of a syringe, the isolation buffer and the
biological sample being immiscible;
capturing the fraction-bound solid phase substrate at a
fixed location within the barrel of the syringe;
urging the biological sample from the barrel of the syringe
while maintaining the captured fraction-bound solid phase
substrate at the fixed location so as to extract the captured
fraction-bound solid phase substrate from the biological sample;
and
urging the isolation buffer into contact with the captured
fraction-bound solid phase substrate at the fixed location to
purity the captured fraction-bound solid phase substrate.
Appeal Br. 11, Claims Appendix.
Appellants request review of the Examiner’s rejection of claims 1, 9,
17, and 19 under 35 U.S.C. § 103(a) as unpatentable over Vorpahl2 and
Miltenyi.3
The Examiner finds, in relevant part, that the Vorpahl teaches a
method of extraction using stationary fluids with moving particles while the
claimed invention is directed to extraction using stationary particles with
moving fluids. See Ans. 4. Miltenyi teaches a method “for separating a
2 John Vorpahl, US 5,279,936, issued Jan 18, 1994 (“Vorpahl”).
3 Miltenyi et al., US 5,691,208, issued Nov. 25, 1997 (“Miltenyi”).
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Application 13/326,832
target fraction from a biological sample, using magnetic beads, wherein it is
advantageous to maintain the magnet in a fixed position because the magnet
is a relatively heavy component of a magnetic separation system.” Ans. 5.
The Examiner concludes “one of ordinary skill in the art would have
recognized that applying the known technique (i.e. using a fixed location
with moving fluids) taught by Miltenyi. . . would have yielded predictable
results (i.e. better isolation of the target fraction bound to the magnetic
beads) and an improved system (e.g. easier and more efficient).” Ans. 8.
Appellants contend that the combination of references does not
disclose “drawing two immiscible fluids into a barrel of a syringe.” Reply
Br. 4, see also Reply Br. 5 (“nothing in the cited references . . . contemplates
. . . facilitating extraction of a fraction from a biological sample wherein two
immiscible fluids are sequentially drawn into a common container, namely,
a syringe, and thereafter, sequentially urged from the common container”);
see Appeal Br. 9.
The issue is: Does the preponderance of evidence of record support
the Examiner’s conclusion that the combined teachings of the references
render the steps of using a syringe to carry out the claimed extraction
method obvious?
Findings of Fact
FF1. Vorpahl teaches “separation of a component of interest from other
components in a mixture by causing the binding of the component of
interest to magnetic particles. ... [To separate the component of
interest] the media are subjected to a magnetic field gradient to cause
the magnetic particles to migrate from the first liquid medium into the
second liquid medium.” Vorpahl 4:10—25. “The higher the strength
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Application 13/326,832
of the magnetic field and the higher the gradient, the faster the
migration.” Id. at 19:24—26.
FF2. Vorpahl teaches that the first and second mediums do not mix when
placed into a tube. “A first liquid medium containing the component
of interest bound to magnetic particles and the other components of
the mixture is contacted with, without mixing with, a second liquid
medium that is of different density than and/or of different viscosity
than the first medium.” Id. at 4:17—23; see also id. at 15:57—60
(“[w]hen the second liquid medium is miscible with the first liquid
medium, the contacting of the media is carried out in such a way as to
minimize or avoid mixing of the two media”); see also id. at 16:41—43
(“[w]hen aqueous, the second liquid medium will usually differ in
viscosity and/or density from the first medium and may be miscible or
immiscible”). The mediums can be layered
by allowing one medium to flow onto the upper surface
of the other medium which is stationary and of higher
density or viscosity or both. . . . Alternatively, one
medium can be introduced at the lower most portion of
the other stationary medium by means of a delivery tube
such as a pipette.
Id. at 15:60-68.
FF3. Vorpahl teaches that separation using migrating particles “is
exceptionally efficient because the component of interest is washed by
the second medium during separation.” Id. at 5:36—38.
FF4. Vorpahl teaches performing a separation in a tube with a diameter
ranging “from about 2 to 50 mm.” Id. at 19:27—30. Vorpahl teaches
that the media in the tube “can be separated from one another by any
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Application 13/326,832
convenient means such as for example, decantation, pipetting and the
like.” Id. at 19:41^13.
FF5. Miltenyi teaches separation using magnetic particles. The system of
Miltenyi has two main components: a magnetic separator and a cell
separation reagent. Miltenyi 3:47—48. Miltenyi teaches that “[tjhere
are many well[-]known magnetically responsive materials used in
magnetic separation methods.” Id. at 4:2-4. “The target cells or
analyte which have been bound by a magnetic reagent are retained in
the separation column in the presence of the magnetic field.” Id. at
16:1-3.
In the collection phase, a magnet is positioned
relative to separation column 40 such that a magnetic
field is applied to the separation column. Relative
positioning may entail moving a magnet around or
adjacent to the separation column, or moving the
separation column into the magnetic field.
Id. at 15:43—51. “Unlabeled cells and/or other fluid components pass
through the system” leaving the magnetically responsive material in
the column. Id. at 16:4—5. To elute the magnetically responsive
material the magnet is turned off or removed. See id. at 17:39.
Principle of Law
“If the claim extends to what is obvious, it is invalid under § 103.”
KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007). “Express
suggestion to substitute one equivalent for another need not be present to
render such substitution obvious.” In re Fout, 675 F.2d 297, 301 (CCPA
1982).
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Application 13/326,832
Analysis
Upon consideration of the evidence on this record, and each of
Appellants’ contentions, we find that the preponderance of evidence
supports the Examiner’s conclusion that the subject matter of Appellants’
claims is unpatentable. Accordingly, we affirm the Examiner’s rejections
for the reasons set forth in the Answer and Final Action,4 which we adopt as
our own, including the Examiner’s responses to Appellants’ arguments.
Briefly, the Examiner finds that Vorpahl isolates components of
interest from biological samples using magnetic particles. See Ans. 2-4;
FF1—FF4. The Examiner finds that “the difference between the prior art
[Vorpahl] and the invention is (a) the use of a syringe as compared to a
pipette and/or glass or plastic tube; and (b) the movement of the magnet
compared to the fluid (i.e. prior art: stationary fluids with moving magnetic
particles vs. instant [claims]: stationary magnetic particles with moving
fluids).” Ans. 4.
The Examiner finds that Miltenyi teaches “separating a target fraction
from a biological sample, using magnetic beads, wherein it is advantageous
to maintain the magnet in a fixed position because the magnet is a relatively
heavy component of a magnetic separation system.” Ans. 5; see FF5.
The Examiner concludes
that applying a known technique to a known device, method or
product ready for improvement is obvious because a particular
known technique is recognized as part of the ordinary
capabilities of one skilled in the art. In the instant case,
Vorpahl contains a “base” method of isolating a target fraction
from a biological sample comprising immiscible/unmixed
fluids, layered and unmixed in a device, using a target bound to
4 Final Office Action mailed December 12, 2014 (“Final Act.”).
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Application 13/326,832
magnetic beads; and Miltenyi. . . contains a similar method for
isolating a target fraction, bound to magnetic beads, from a
biological sample wherein the technique of using a fixed
location of the magnet, and thus the corresponding magnetic
beads, is taught as advantageous. Thus, one of ordinary skill in
the art would have recognized that applying the known
technique (i.e. using a fixed location with moving fluids) taught
by Miltenyi. . . would have yielded predictable results (i.e.
better isolation of the target fraction bound to the magnetic
beads) and an improved system (e.g. easier and more efficient).
Therefore, the claimed invention is prima facie obvious in view
of the teachings of the prior art, absent any convincing evidence
to the contrary.
Ans. 7—8.
Appellants contend that “the device (including the pipette) in the
[Vorpahl] ’936 patent does not show, suggest or contemplate the
methodology of the present invention.” Appeal Br. 7. “[A] pipette may be
used to deposit the first and second mediums in a container to form layers of
media. However, nothing in the [Vorpahl] ’936 patent shows or suggests
sequentially drawing multiple fluids into the pipette (the alleged syringe), as
required by claim 1.” Id.
We are not persuaded by Appellants’ contentions. We agree with the
Examiner that a pipette, tube, and a syringe are functional equivalents,
particularly given the broad description of syringe embodiments in the
Specification. See Ans. 5 (“[T]he devices have been interpreted as
functionally equivalent standard laboratory supplies (e.g. pipettes, syringes,
test tubes, etc.))”; Spec. 14 (“other configurations of barrel 162 are possible,
. . . [f]or example, barrel 162 may take the form of a tube . . . [fjurther,
opening 166 in the first end of 164 of barrel 162 need not be substantially
smaller than opening 170 in second end 168”). “It is noted that substituting
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Application 13/326,832
equivalents known for the same purpose supports an obvious rejection (see
MPEP § 2144.06 and KSR International Co. v. Teleflex Inc., Ill S. Ct.
1727, 1741 (2007)”).” Ans. 5.
Vorpahl teaches the use of a tube to layer two mediums within the
tube’s confines that do not mix. FF2 and FF4. Vorpahl teaches that the
medium may be layered by adding the second medium either on top of or
below the first medium that is already in the tube. FF2; see Ans. 10.
Vorpahl teaches that the first medium contains the component of interest
bound to the magnetic particle. See FF1—FF4. Vorpahl recognizes that the
migrating particles are washed in the process of moving into the second
medium. FF3.
Miltenyi teaches binding a component of interest to a magnetic
particle and capturing the particle at a fixed location followed by flowing
liquids over the particle. FF5; see Ans. 5 (“using magnetic beads, wherein it
is advantageous to maintain the magnet in a fixed position because the
magnet is a relatively heavy component of a magnetic separation system.”).
The combined teachings provide a first medium containing a
component of interest attached to a magnetic particle placed into a tube and
a second medium layered on top of first medium. FF2. We agree with the
Examiner that it would have been obvious to apply the magnetic field to
VorpahFs tube in a fixed location as taught Miltenyi. Ans. 5—6. The
magnetic particles would move into the space with the strongest magnetic
field. FF1. The position of the magnet in relation to the first and second
medium in the tube would determine where the magnetic particles become
fixed in place. See FF1—FF3 and FF5. Additionally, Vorpahl teaches that
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Application 13/326,832
the media in the tube can be separated from one another by any convenient
means. FF4.
The Examiner concludes that
it would be obvious to urge the immiscible fluids back out of
the device [(i.e. the tube)] in the reverse order to obtain the
captured fraction. Further, it is noted that because there is only
one opening of a pipette or test tube (or syringe etc.) that is
used for both drawing in and urging out fluids, the
immiscible/unmixed fluids would obviously have to come back
out the same opening in the reverse order (i.e. nothing in the
prior art teaches leaving both fluids in the device permanently).
Ans. 4.
We agree with the Examiner that the combined references suggest
layering two liquids into a tube so that they do not mix. FF2. We also agree
with the Examiner’s finding that extracting the liquids in the reverse order
than they were placed into the tube is obvious because this facilitates the
separation of the component of interest from the other components in the
original sample. Separating the liquids in reverse order would result in the
removal of the other components from the original sample so that all that
remains in the tube is the component of interest attached to the magnetic
particle. See Ans. 4.
We conclude that the evidence cited by the Examiner supports a prima
facie case of obviousness with respect to claim 1, and Appellants have not
provided sufficient rebuttal evidence or evidence of secondary
considerations that outweighs the evidence supporting the Examiner’s
conclusion of obviousness. As Appellants do not argue the claims
separately, claims 9, 17, and 19 fall with claim 1. 37 C.F.R. § 41.37
(c)(l)(iv).
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SUMMARY
All claims 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
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