Ex Parte Holm

Patent Trial and Appeal Board

Nov 9, 2017

13819616 (P.T.A.B. Nov. 9, 2017)

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.
13/819,616 02/27/2013 Claus Holm 8472D-000025-US-NP 2716
30593 7590 11/14/2017
HARNESS, DICKEY & PIERCE, P.L.C.
P.O. BOX 8910
RESTON, VA 20195
EXAMINER
CLARKE, TRENT R
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
11/14/2017 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):
dcmailroom@hdp.com
pshaddin@hdp.com
j Castellano @hdp. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CLAUS HOLM
Appeal 2017-004948
Application 13/819,6161
Technology Center 1600
Before ULRIKE W. JENKS, JOHN E. SCHNEIDER, and
KRISTI L. R. SAWERT, Administrative Patent Judges.
SAWERT, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) from the rejection of
claims 1—10. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellant identifies Foss Analytical A/S as the real party in interest.
Appeal Br. 2.
Appeal 2017-004948
Application 13/819,616
STATEMENT OF THE CASE
Claims 1—10 stand rejected as unpatentable under 35 U.S.C. § 103(a)
for obviousness over Hageltom,2 in view of Rivas,3 and Oda.4 Independent
claim 1 is representative. See 37 C.F.R. § 41.37(c)(l)(iv). Claim 1
provides:
1. A method for determining a degree of infection
comprising the steps of
i) preparing a mammalian milk sample containing
somatic cells, the somatic cells not being isolated from
interfering particles, by adding a reagent comprising a
differentiating marker in a concentration sufficient to provide
differentiation between somatic cells types and providing a
dilution ratio of less than 1:200;
ii) measuring, for each of one or more leukocyte types of
somatic cell selected from the group: lymphocyte, monocyte,
macrophage and polymorphonuclear types of leukocyte
differentiated by the differentiating marker, a cell count in the
sample by means of a flow cytometer having a detection system
sensitive to differences in the differentiating marker resulting
from the differentiating marker becoming differently associated
with each of the one or more leukocyte types of somatic cell
selected from the group in the un- isolated sample; and
iii) determining an indication of the degree of infection
dependent on the measured cell count by comparing the
measured cell count with one or more reference values each
2 M. Hageltom & M. Alaa Saad, Flow cytofluorometric
characterization of bovine blood and milk leukocytes, Am. J. Vet. Res.
47(9):2012—16 (1986) (“Hageltom”).
3 Ariel L. Rivas et al., U.S. Patent No. 6,979,550 B1 (Dec. 27, 2005)
(“Rivas”).
4 Yasumasa Oda & Keiichi Inami, JP Publication No. 2003-310299
(Nov. 5, 2003), machine translation of record (“Oda”).
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Application 13/819,616
being predetermined to be associated with the degree of
infection.
Appeal Br. 10 (Claims App.) (emphasis added).
DISCUSSION
On appeal, the Board “reviews the obviousness rejection for error
based upon the issues identified by appellant, and in light of the arguments
and evidence produced thereon.” Ex parte Frye, 94 USPQ2d 1072, 1075—76
(BPAI 2010) (Precedential). After considering the entirety of the evidence
and Appellant’s arguments, we conclude that the weight of the evidence
favors the Examiner’s conclusion of obviousness. Accordingly, we adopt as
our own the Examiner’s reasoning for the rejection, see Final Act. 10—19,
and agree that the Examiner properly found Appellant’s arguments
unpersuasive, see Ans. 11—21 (Response to Argument), which we also adopt
in full. We address the following arguments for emphasis only.
Appellant argues that “Hageltom teaches that the somatic cells must
be isolated in order to be analyzed, and thus fails to disclose or suggest at
least ‘preparing a mammalian milk sample containing somatic cells, the
somatic cells not being isolated from interfering particles,’ as recited in
independent claim 1.” Reply Br. 2—3. Appellant submits a Declaration
under 35 U.S.C. § 131 executed by Claus Holm, the inventor of the claimed
subject matter, with the Reply Brief. See Deck 11. Normally, in the
absence of good cause, the Board does not consider evidence not previously
submitted to the Examiner. See 37 C.F.R. § 41.41(b)(2). In the interest of
compact prosecution for this case, however, we have considered the
Declaration, but find it unpersuasive.
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Application 13/819,616
In the Declaration, Mr. Holm states that he “believe[s] that Hageltom
teaches that the somatic cells must first be isolated in order to be analyzed.”
Decl. 17 (emphasis added). Mr. Holm points to three passages in Hageltom
as supporting his belief:
(1) Hageltom’s teaching “that ‘[f]at droplets in milk, however,
make it difficult to evaluate directly the [somatic] cell
population in the milk,’” id. 1 5 (quoting Hageltom 2012
(col. 1));
(2) Hageltom’s teaching “that ‘[dilution of the milk 200 times
reduced the risk of coincidence of [somatic] cells and fat
droplets in the measuring point in the flow chamber of
the FCM,5”’ id. (quoting Hageltom 2014 (col. 2)); and
(3) Hageltom’s teaching “that it is beneficial ‘to differentiate
[somatic] cells from droplets of fat in samples of milk,”’
id. 16 (quoting Hageltom 2014 (col. 2)).
We find that these passages do not support Mr. Holm’s statement that
Hageltom teaches “that the somatic cells must first be isolated in order to be
analyzed.” Decl. 17; see also Reply Br. 4—6. Although Hageltom
acknowledges the difficulties in evaluating the somatic cell population in
milk (Hageltom 2012 (col. 1)), Hageltom employs flow cytometry, rather
than isolation, as the means for addressing that problem. See Hageltom
2012 (col. 1—2) (“The purpose of the present study was to evaluate bovine
cells and cell populations in samples of blood and milk, using FCM.”).
Specifically, Hageltom collected milk samples, mixed the samples 1:200
5 FCM is an abbreviation for flow cytometry. Hageltom 2012 (col. 1).
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Application 13/819,616
with a staining solution of acridine orange, filtered the samples through a
50 pm nylon mesh, and then subjected the samples to flow cytometry. Id. at
2012 (col. 2). Using flow cytometry, Hageltom identified four classes of
leukocytes in the milk: lymphocytes, neutrophils, monocytes, and
macrophages. Id. at 2013 (col. 2).
Hageltom teaches that the acridine orange stain “can be used to
differentiate cells from droplets of fat in samples of milk.” Id. at 2014 (col.
2). Specifically, Hageltom recognized that the membranes of the fat
droplets contain protein, which stain a faint green with acridine orange, and
therefore, can be differentiated from somatic cells by their lower
fluorescence intensity. Id. Put differently, Hageltom teaches
“differentiating” not by first isolating the somatic cells from the fat droplets,
as Appellant suggests (Reply Br. 5; Deck 16), but by relying on the
different fluorescent intensities of the somatic cells and fat droplets.
Finally, Hageltom’s teaching that “dilution of the milk 200 times
reduced the risk of coincidence of cells and fat droplets in the measuring
point in the flow chamber of the FCM” (Hageltom 2014 (col. 2)), does not
equate to an isolation step, as Appellant implies (Reply Br. 5; Decl. 1 5). As
an initial matter, the Specification distinguishes between “isolation” and
“dilution.” See Spec. 114 (referring to the milk sample as “un-isolated” and
“essentially undiluted”). And claim 1 only recites “somatic cells not being
isolated from interfering particles.” Appeal Br. 10 (Claims App.) (emphasis
added). Thus, we do not understand “dilution” to be equivalent to
“isolation.” In any event, Hageltom teaches that the 1:200 dilution of milk
with the staining solution reduces the chance that a somatic cell and fat
droplet will pass through the flow cytometer’s measuring point (i.e., laser) at
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Application 13/819,616
the same time. Hageltom 2012 (col. 2), 2014 (col. 2). Thus, in Hageltom’s
description, both the somatic cells and the fat droplets are present in the milk
sample (i.e., not isolated from one another) that undergoes flow cytometry;
that any one drop of liquid that passes through the flow cytometer’s laser
may happen to contain only a somatic cell or only a fat droplet does not
support the argument that the somatic cells in Hageltom’s milk sample are
isolated from the fat droplets. See Deck 1 5.
For these reasons, we are not persuaded that the Examiner erred.
DECISION
We affirm the rejection of claims 1—10 under 35 U.S.C. § 103(a) on
appeal.
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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