Ex Parte Neas et al

Patent Trial and Appeal Board

Sep 19, 2018

13331552 (P.T.A.B. Sep. 19, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/331,552 12/20/2011 Edwin Dean Neas
88484 7590 09/21/2018
CR MILES P.C.
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
CMXY-4 Cont 2 3470
EXAMINER
405 Mason Court, Suite 119 LUDLOW, JANM
Fort Collins, CO 80524
ART UNIT PAPER NUMBER
1798
NOTIFICATION DATE DELIVERY MODE
09/21/2018 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):
crmiles@crmiles.com
patents@stgen.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte EDWIN DEAN NEAS, JERALD EDWARD KUIKEN,
JOHN LOUIS SCHENK, and THOMAS BOYD GILLIGAN
Appeal2017-011713
Application 13/331,552
Technology Center 1700
Before BEYERL YA. FRANKLIN, JEFFREY R. SNAY, and
JANEE. INGLESE, Administrative Patent Judges.
SNAY, Administrative Patent Judge.
DECISION ON APPEAL 1
Appellants2 appeal under 35 U.S.C. § 134(a) from the Examiner's
decision rejecting claims 1-5 and 7-23. We have jurisdiction under
35 U.S.C. § 6(b).
We affirm-in-part.
1 We refer to the Specification ("Spec.") filed December 20, 2011; Final
Office Action ("Final Act.") dated May 19, 2016; Appellants' Appeal Brief
("Br.") filed September 19, 2016; Examiner's Answer ("Ans.") dated March
23, 2017; and Appellants' Reply Brief ("Reply Br.") filed May 22, 2017.
2 Appellants identify XY, LLC as the real party in interest. App. Br. 3.
Appeal 2017-011713
Application 13/331,552
BACKGROUND
The subject matter on appeal relates to flow cytometry. Spec. 1.
Claim I-the sole independent claim on appeal-reads:
1. A method of operating a flow cytometer, comprising:
providing a variable volume container having a flexible
wall;
establishing an amount of fluid in said variable volume
container;
exerting an amount of pressure with an amount of a gas
on an exterior surface of said flexible wall of said variable
volume container;
providing a conduit between said variable volume
container and a flow path of said flow cytometer;
generating a fluid stream of said amount of fluid in said
flow path of said flow cytometer by exerting said amount of
pressure with an amount of gas on said exterior surface of said
flexible wall of said variable volume container;
generating a fluid pressure of said fluid stream of said
amount of fluid inside of said flow cytometer within the range
of about 25 psi and about 50 psi;
regulating said fluid stream within said flow path of said
flow cytometer having said fluid pressure within the range of
about 25 psi and about 50 psi for analysis of a plurality of
particles entrained within said fluid stream;
intermittently entraining one of said plurality of particles
in said fluid stream in said flow path of said flow cytometer;
and
analyzing said plurality of particles entrained within said
fluid stream.
App. Br. 28 (Claims Appendix) (underlining omitted).
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Application 13/331,552
REJECTIONS
I. Claims 1-5, 7, 8, and 16-23 stand rejected under 35 U.S.C. § I03(a)
as unpatentable over Haug, 3 Sasaki, 4 and Whittier. 5
II. Claims 9-11 and 13-15 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over Haug, Sasaki, Whittier, Bannister, 6 and Knuth. 7
III. Claim 12 stands rejected under 35 U.S.C. § I03(a) as unpatentable
over Haug, Sasaki, Whittier, Bannister, Knuth, and Yanase. 8
OPINION
We review the appealed rejections for error based upon the issues
identified by Appellants and in light of the arguments and evidence
produced thereon. Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010)
(precedential), cited with approval in In re Jung, 637 F.3d 1356, 1365 (Fed.
Cir. 2011) ("[I]t has long been the Board's practice to require an applicant to
identify the alleged error in the examiner's rejections .... "). After
considering the evidence presented in this Appeal and each of Appellants'
arguments, we are not persuaded that Appellants identify reversible error.
Thus, we affirm the Examiner's rejections for the reasons expressed in the
Final Office Action and Answer. We add the following primarily for
emphasis.
3 US 2005/0011582 Al, published January 20, 2005 ("Haug").
4 US 5,466,572, issued November 14, 1995 ("Sasaki").
5 US 2002/0096123 Al, published July 25, 2002 ("Whittier").
6 US 3,756,459, issued September 4, 1973 ("Bannister").
7 US 6,959,826 B2, issued November 1, 2005 ("Knuth").
8 US 4,600,104, issued July 15, 1986 ("Yanase").
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Application 13/331,552
Rejection I
With regard to Rejection I, Appellants separately argue only claims 1
and 23. Each of claims 2-5, 7, 8, and 16-22 stands or falls with claim 1.
Separately argued claim 23 is separately addressed.
Claim 1
Relevant to Appellants' arguments on appeal, the Examiner finds that
Haug discloses a process for operating a flow cytometer that includes each
step recited in claim 1, except that Haug does not specify an operating
pressure within the range of about 25 psi and about 50 psi within the
cytometer, and does not specify intermittent entrainment of sample particles
to be analyzed. Final Act. 3--4. The Examiner points to Sasaki and Whittier,
respectively, as evidence of a reason why one of ordinary skill in the art
would have chosen the above-mentioned conditions when performing
Haug's cytometry method. Id.
Appellants point out that Haug teaches providing sheath fluid to a
cytometer by applying an external pressure of 60 psi or greater to a sheath-
fluid-containing bag, and argue that the evidence identified by the Examiner
does not demonstrate that such pressure would achieve the claimed pressure
of 25 to 50 psi within the cytometer. App. Br. 11 (referencing the Sharpe
Declaration). 9 Appellants acknowledge that Sasaki teaches a preferred
pressure of about 40 psi within a flow cytometer, but argue that Sasaki does
not disclose whether or how that preferred pressure could be achieved using
Haug's flexible bag sheath fluid source. Id. at 11-12. Appellants argue that
common sense may not be relied upon to support a finding that the
9 Declaration of Johnathan Charles Sharpe Under 37 C.F.R. § 1.132, of
record.
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Application 13/331,552
cytometer operating pressure taught by Sasaki could have been achieved and
regulated in the context of Haug's fluid delivery system. Id. at 14; Reply Br.
generally.
Appellants' arguments are not persuasive of reversible error. As the
Examiner explains, Haug is relied upon for teaching a method of providing
sheath fluid under pressure to a flow cytometer, and Sasaki is relied upon for
teaching that operating pressure within a flow cytometer is within the
claimed range of25 to 50 psi. Ans. 7. Neither Haug's exemplary pressure
applied to the compressible bag for delivering sheath fluid nor Sasaki's non-
disclosure of a flexible bag sheath fluid delivery system is persuasive of
error in the Examiner's reasoning based on the combined teachings of Haug
and Sasaki. Appellants do not point to persuasive evidence or credible
technical reasoning to suggest that one of ordinary skill in the art would have
encountered difficulty or lack of a reasonable expectation of success in
operating Haug' s sheath and sample delivery systems so as to achieve the
desired operating pressure within the flow cytometer.
Appellants also argue that the evidence relied upon does not support
the Examiner's determination that it would have been obvious to "regulate"
fluid pressure within the cytometer within the recited range of 25-50 psi.
App. Br. 13. We disagree. Haug teaches that flow within a cytometer
results from different pressures driving the respective sheath and sample
fluid flows into the cytometer. Haug ,r 12. "Precise delivery of the cells is
required." Id. ,r 4. Thus, as Appellants elsewhere acknowledge (see App.
Br. 24 ), Haug recognizes that a constant pressure within the cytometer is
desired. Haug ,r 12. In light of these teachings in Haug, we are not
persuaded of error in the Examiner's determination that it would have been
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Application 13/331,552
obvious to regulate pressure within Haug's cytometer, to maintain constant
pressure.
Appellants argue that Haug fails to teach intermittently entraining
particles or analyzing the entrained particles. App. Br. 15. Haug states that
the disclosed sheath and sample fluid delivery systems are intended for use
with any standard cytometer. Haug ,r 43. Haug further states that standard
cytometers operate to deliver sample particles, such as cells, single file in a
fluid stream to be analyzed and sorted. Id. ,r 3. Moreover, the Examiner
additionally refers to Whittier for its teaching, which Appellants do not
dispute, that presentation of cells for cytometric analysis and sorting
involves generating distinct cell-containing droplets. Final Act. 4 ( citing
Whittier, Fig. 2). On this record, we are not persuaded of error. The
Examiner's finding that the evidence relied upon teaches intermittent
entrainment of particles for analysis and sorting is supported by a
preponderance of the evidence.
Appellants contend that one of ordinary skill would not have been
motivated to combine the teachings of Haug, Sasaki, and Whittier (App. Br.
18-24 ), and that the art is unpredictable such that the proposed
modifications to Haug would not have involved a reasonable expectation of
success (id. at 24--26). Appellants' contentions, however, are based on the
same unpersuasive arguments discussed above-namely, that Haug provides
sheath fluid via a compressible bag whereas Sasaki and Whittier disclose
flow cytometry conditions where sheath fluid is provided by other means.
See id. at 18-26. Appellants do not present persuasive evidence or technical
reasoning sufficient to refute the Examiner's findings that one skilled in the
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Application 13/331,552
art would have had a reason to adopt Sasaki' s preferred cytometer operating
pressure in Haug's cytometry process. Nor do Appellants persuade us that
the art of flow cytometry was unpredictable with respect to achieving a
desired cytometer operating pressure, or that one of ordinary skill would not
have held a reasonable expectation of success in achieving the desired
operating pressure using Haug's sheath and sample fluid delivery systems.
Claim 23
With regard to claim 23, Appellants argue that the Examiner failed to
identify evidence to support the determination that it would have been
obvious to provide a plurality of flow cytometers. App. Br. 17-18. We
disagree. The Examiner reasons that one skilled in the art would have had a
reason to provide duplicate flow cytometers to permit simultaneous analysis
of multiple samples. Final Act. 3; see In re Harza, 274 F.2d 669, 671
(CCPA 1960) (The mere duplication of parts has no patentable significance
unless a new and unexpected result is produced.).
For the foregoing reasons, Appellants do not persuade us of reversible
error in the Examiner's rejection of claims 1-5, 7, 8, and 16-23. Rejection I
is sustained.
Re} ection II
With regard to Rejection II, Appellants argue claims 11 and 15, but do
not present separate arguments directed to claim 9, 10, 13, or 14, except to
rely on the same arguments directed to claim 1. See App. Br. 16-17.
With regard to claim 11, Appellants argue that the relied upon
references do not teach the recited step of "collecting said amount of gas
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Application 13/331,552
between said first flexible layer and said second flexible layer." In that
regard, the Examiner determines that it would have been obvious to form
Haug's flexible container from plural layers to provide increased barrier
protection. Final Act. 5. However, we do not find a finding or relied-upon
evidence of record that relates to collecting gas between two such layers.
For that reason, we are persuaded that the Examiner has not presented
sufficient findings to support a determination of obviousness with regard to
claim 11.
With regard to claim 15, Appellants argue that the Examiner's
determination that it would have been obvious to form Haug's flexible
container from three layers is conclusory. App. Br. 17. We disagree. The
Examiner points to evidence in Bannister and Knuth to support the finding
that multi-layer fluid containers provide improved barrier protection. Final
Act. 4--5 (citing Bannister 2:50-55; Knuth 5:46-62). Knuth states at the
relied upon passage, "a multi-layer material can be used to provide for
improved barrier protection." Knuth 5:57-58. In light of the Examiner's
particular identification of supporting evidence in the relied upon references,
Appellants' argument that the Examiner's finding is conclusory is not
persuasive.
For the foregoing reasons, we sustain Rejection II as applied to each
of claims 9, 10, and 13-15. We do not sustain Rejection II as applied to
claim 11.
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Rejection III
Appellants do not present separate arguments directed to claim 11,
except to rely on the same arguments directed to claim 1. See App. Br. 17.
Accordingly, we sustain Rejection III for the reasons set forth above.
DECISION
The Examiner's decision rejecting claims 1-5, 7-10, and 12-23 is
affirmed.
The Examiner's decision rejecting claim 11 is reversed.
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
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