Ex Parte Lohse et al

Patent Trial and Appeal Board

Oct 16, 2017

13306470 (P.T.A.B. Oct. 16, 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.
13/306,470 11/29/2011 Jesper Lohse 09138.0138-00000 9391
22878 7590
Agilent Technologies, Inc.
Global IP Operations
5301 Stevens Creek Blvd
Santa Clara, CA 95051
EXAMINER
THIRUGNANAM, GANDHI
ART UNIT PAPER NUMBER
2666
NOTIFICATION DATE DELIVERY MODE
10/18/2017 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):
IPOPS .LEGAL @ agilent.com
Agilentdocketing@cpaglobal.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JESPER LOHSE, HANS CHRISTIAN PEDERSEN,
JOACHIM SCHMID, JEFF CARON, ROHIT JAIN, and
THOMAS BRISCOE
Appeal 2016-002997
Application 13/306,470
Technology Center 2600
Before CAROLYN D. THOMAS, LINZY T. McCARTNEY, and
ADAM J. PYONIN, Administrative Patent Judges.
McCARTNEY, Administrative Patent Judge.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from a rejection of claims
1—11, 14—35, and 38—60. Claims 12, 13, 36, and 37 have been canceled, and
claims 61—85 have been withdrawn. We have jurisdiction under 35 U.S.C.
§ 6(b). We heard oral argument on September 19, 2017.
We REVERSE.
Appeal 2016-002997
Application 13/306,470
STATEMENT OF THE CASE
The present patent application concerns “quantitative staining and
imaging of histochemically stained tissue specimens.” Specification 12,
filed November 29, 2011 (“Spec.”). Claims 1, 24, 46, and 53 are
independent. Claim 1 illustrates the claimed subject matter:
1. A method of optically quantifying expression of at least
one target molecule in at least one region of interest of a
specimen comprising:
producing optically recognizable dots at sites of the
specimen wherein one dot corresponds to a single
immunohistochemical binding agent bound to a single target
molecule,
wherein the dots are characterized by in-situ
programmable features of size and shape and at least one
additional programmable optical feature,
wherein the number of dots produced at the sites within a
given region are representative of a fractional sub-population of
a total population of target molecules within that region;
imaging the specimen;
selecting at least one region of interest within the image;
recognizing at least one dot within the at least one region
of interest and-;
quantifying the dots within the at least one region of
interest.
Appeal Brief 22, filed July 6, 2015 (“App. Br.”).
REJECTIONS
Claims 24, 26—31, 34, 35, 38, 39, 53, and 56—60 stand rejected under
35 U.S.C. § 112 as indefinite. Final Office Action 4—6, mailed January 7,
2015 (“Final Act.”)
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Application 13/306,470
Claims 1—7, 9—11, 16, 24—32, 34, 35, 38, 46—51, and 53—59 stand
rejected under 35 U.S.C. § 102 as anticipated by Mass (U.S. Patent
Application Publication No. 2002/0064785 Al; May 30, 2002). Final Act.
6-12.
Claims 8, 14, 15, 17—23, 33, 39-45, 52, and 60 stand rejected under
35 U.S.C. § 103 as obvious in view of one or more of Mass, Becker et al.
(U.S. Patent No. 5,187,066; Feb. 16, 1993), Notka et al. (U.S. Patent
Application Publication No. 2009/0324546 Al; Dec. 31, 2009), Elling (U.S.
Patent No. 2002/0159625 Al; Oct. 31, 2002), Weiss (U.S. Patent No.
6,243,486 Bl; June 5, 2001). Final Act. 13-20.
ANALYSIS
Indefiniteness Rejection
Claims 24, 26—31, 34, 35, 38, and 39 each recite “a first kit for
detecting a fractional sub-population of the at least one target molecule in
the specimen” and “a second kit for producing optically recognizable dots at
the sites of the specimen wherein one dot corresponds to a single
immunohistochemical binding agent bound to a single target molecule.”
Claims 53 and 56—60 each recite nearly identical limitations.
The Examiner concluded these limitations are means-plus-fimction
limitations under 35 U.S.C. § 112 | 6 because the claims use “the
nonstructural term ‘kit’ with no structural modifier and [are] not modified by
sufficient structure or material.” Answer 5, mailed December 2, 2015
(“Ans.”); see also Final Act. 5 (concluding the “first kit” and “second kit”
limitations invoke 35 U.S.C. § 112 | 6). The Examiner found Appellants’
“written description fails to disclose the corresponding structure, material, or
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Application 13/306,470
acts for the claimed fimction[s]” and rejected these claims as indefinite
under 35 U.S.C. § 112. Final Act. 4—5.
Appellants argue “the words of the claim [kits] are understood by
persons of ordinary skill in the art to have a sufficiently definite meaning as
the name for structure” and therefore 35 U.S.C. § 112 | 6 does not apply.
Reply Brief 2, filed January 27, 2016 (“Reply Br.”) (alteration in original).
In particular, Appellants contend that Figure 1 and paragraph 104 of
Appellants’ written description establish that one of ordinary skill in the art
would understand the term “kits” to have sufficiently definite structure.
Reply Br. 2.
To determine whether a claim limitation is a means-plus-fimction
limitation under 35 U.S.C. § 112 | 6, we must consider whether the
limitations, viewed in light of the specification, “are understood by persons
of ordinary skill in the art to have a sufficiently definite meaning as the
name for structure.” Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1349
(Fed. Cir. 2015) (en banc in relevant part) (quoting Watts v. XL Sys. Inc.,
232 F.3d 877, 800 (Fed. Cir. 2000)). See also Media Rights Techs., Inc. v.
Capital One Fin. Corp., 800 F.3d 1366, 1372 (Fed. Cir. 2015) (“In
undertaking this [means-plus-function] analysis, we ask if the claim
language, read in light of the specification, recites sufficiently definite
structure to avoid § 112, | 6” (quoting Robert Bosch, LLC v. Snap-On Inc.,
769 F.3d 1094, 1099 (Fed. Cir. 2014)). Because the limitations at issue do
not include the word “means,” a presumption exists that the limitations do
not invoke § 112 | 6. Williamson, 792 F.3d at 1349.
As argued by Appellants, their figures and written description indicate
that one of ordinary skill in the art would understand the recited “first kit”
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Application 13/306,470
and “second kit” to have a sufficiently definite meaning as the name for
structure. Appellants’ Figure 1 explicitly depicts a kit. See Spec. Fig. 1,
item 112. Although the Examiner characterizes the kit shown in Figure 1 as
“a plurality of unlabeled bottles,” Answer 5, Appellants written description
discloses that the illustrated kit includes materials used to perform the
functions recited in the disputed limitations. For example, the written
description states “[k]its 112 may include reagents for producing optically
recognizable dots at sites of single detected target molecules. The dots are
characterized by a plurality of programmable optical features, for example,
size, shape, color, hue . . . .” Spec. 1105. The written description explains
“a dot may in fact be formed centered around the binding point of the
detecting antibody at the site of a single target molecule.” Id. 1164. The
written description also notes the “programmable dots may be produced at
the sites of a fractional sub-population of a total population of target
molecules. Id. 1106. See also id. Tffl 140-142 (describing in-situ
programmable dots), 277-433 (describing binding agents).
In light of the disclosures discussed above and the presumption that
claims that lack the words “means” do not invoke 35 U.S.C. §112 | 6, we
agree with Appellants that the recited “first kit” and “second kit” are not
means-plus-function limitations under §112 | 6. We therefore do not sustain
the Examiner’s indefmiteness rejection of claims 24, 26—31, 34, 35, 38, 39,
53, and 56—60.
Prior Art Rejections
Independent claims 1, 24, 46, and 53 each recite “wherein the dots are
characterized by in-situ programmable features of size and shape and at least
one additional programmable optical feature.” With respect to this
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limitation, the Examiner found (1) Mass discloses fluorophores that “can be
combined with [a] probe” and (2) fluorophores each “inherently [have] a
different shape, size and florescence.” Ans. 10; see also Final Act. 7
(finding “[e]ach dot inherently has a shape, size and florescence”). The
Examiner also found Mass discloses “using conventional technology where
the choice of probe depends on the characteristic of the target gene . . . and
selecting] the fluorescence based on necessity.” Ans. 10. Based on these
findings, the Examiner found Mass discloses this limitation. Id.
Appellants argue that even assuming fluorophores inherently have a
shape, size, and florescence and can be selected as necessary, these facts do
not establish the fluorophores have “in-situ programmable features” as
required by the independent claims. See App. Br. 16—17; Reply Br. 3^4.
We agree with Appellants. Appellants’ written description defines
“in-situ” as “occurring at or near the environment of the specimen,” Spec.
1 88 and “programmable” as “changeable or variable to produce a
predetermined set or range of results in response to intentional variation of
chemical reaction conditions including chemical components, temperature,
time, concentrations, chemical reactions, immunochemical reactions, etc,”
id. 1 82. Thus, one of ordinary skill in the art would understand “in-situ
programmable features” as features that are “changeable or variable to
produce a predetermined set or range of results in response to intentional
variation of chemical reaction conditions,” the changes or variations
“occurring at or near the environment of the specimen.” Even if Mass’s
fluorophores inherently have certain characteristics and a user can choose
fluorophores as needed, these facts alone do not establish the fluorophores
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have features that are “in-situ programmable” in the manner required by the
claims.
For this reason, we do not sustain the Examiner’s anticipation
rejection of independent claims 1, 24, 46, and 53 and dependent claims 2—7,
9—11, 16, 25—32, 34, 35, 38, 47—51, and 54—59. We also do not sustain the
Examiner’s obviousness rejection of dependent claims 8, 14, 15, 17—23, 33,
39-45, 52, and 60, as the obviousness rejection relies on the erroneous
finding discussed above.
DECISION
For the above reasons, we reverse the Examiner’s rejections of (1)
claims 24, 26—31, 34, 35, 38, 39, 53, and 56—60 under 35 U.S.C. § 112 as
indefinite; (2) claims 1—7, 9—11, 16, 24—32, 34, 35, 38, 46—51, and 53—59
under 35 U.S.C. § 102 as anticipated; and (3) claims 8, 14, 15, 17—23, 33,
39-45, 52, and 60 under 35 U.S.C. § 103 as obvious.
REVERSED
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