Kromnigon AB

Patent Trials and Appeals Board

Dec 8, 2021

2021001206 (P.T.A.B. Dec. 8, 2021)

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.
15/538,691 06/22/2017 Per Fogelstrand 14003-000089/US/NPA 1044
112467 7590 12/08/2021
RMCK Law Group, PLC
PO Box 210280
Auburn Hills, MI 48321
EXAMINER
BELEI, CARMENCITA
ART UNIT PAPER NUMBER
1641
NOTIFICATION DATE DELIVERY MODE
12/08/2021 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):
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mailbox@rmcklaw.com
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte PER FOGELSTRAND and ULF YRLID
__________

Appeal 2021-001206
Application 15/538,691
Technology Center 1600
__________

Before ERIC E. GRIMES, JEFFREY N. FREDMAN, and
ULRIKE W. JENKS, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a method
for forming an immunolabeling complex. The Examiner rejected the claims
as anticipated and as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the Real Party in Interest as
KROMNIGON AB (see Appeal Br. 3). We have considered the
Specification of June 22, 2017 (“Spec.”); Final Office Action of Nov. 29,
2019 (“Final Action”); Appeal Brief of June 24, 2020 (“Appeal Br.”); and
Examiner’s Answer of Sept. 30, 2020 (“Ans.”).
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Statement of the Case
Background
“In immunolabeling, antibodies are used for detection of molecules in
biological and non-biological samples. Antibodies are immunoglobulin (Ig)
proteins that bind with high specificity through [their] antigen-binding site to
an antigen” (Spec. 1:7–9). Indirect labeling “is a two-step labeling method
that results in signal amplification. It involves a primary antibody (first step)
that binds to the target molecules in the sample and a labeled secondary
antibody (second step) that binds to the bound primary antibody” (id. at
1:24–27). Streptavidin or avidin “can also be used in immunolabeling with
the indirect method by using biotinylated antibodies” (id. at 2:5–6).
The Claims
Claims 1–14, 16, and 17 are on appeal.2 Claim 1 is an independent
claim, is representative and reads as follows:
1. A method for forming an immunolabeling complex,
wherein the method comprises:
- selecting a first biotinylated primary antibody;
- selecting a first monovalent biotin-binding composition
labeled with a first reporter element, and
- mixing, in a liquid phase in a reaction vessel, the first
biotinylated primary antibody with the first labeled monovalent
biotin-binding composition.

The Rejections
A. The Examiner rejected claims 1–13 under 35 U.S.C. § 102(a)(1) as

2 Claims 15 and 18–22 were withdrawn from consideration (cf. Final Act. 2).
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anticipated by Katayose3 (Final Act. 3–4).
B. The Examiner rejected claims 1–3, 6–8, 16, and 17 under 35 U.S.C.
§ 102(a)(1) as anticipated by Ting4 (Final Act. 5–6).
C. The Examiner rejected claim 14 under 35 U.S.C. § 103 as
unpatentable over Ting and Lazar5 (Final Act. 6–7).

A. 35 U.S.C. § 102(a)(1) over Katayose
The Examiner finds
Katayose et. al. teaches throughout the patent and especially in
Fig. 1, to a method for forming an immunolabeling complex,
wherein the method comprises: mixing in a liquid phase [0051]
a first biotinylated probe as for example an[] antibody specific
to a target [0003] which reads to a primary antibody with a
biotin-binding composition labeled with a first reporter element
as for example streptavidin labeled with a particle (Fig. 1
Example 2) wherein the streptavidin can be monovalent [0024].
(Final Act. 3 (emphasis omitted)). The Examiner further finds “[r]eagents
are necessarily selected prior to mixing” (id.).
Appellant contends “[t]here is no discussion, suggestion, or mention
in Katayose of ‘selecting a first monovalent biotin-binding composition
labeled with a first reporter element’ and mixing it with ‘a first biotinylated
primary antibody’ as claimed. In fact, Katayose does not use or suggest the
term ‘monovalent’ whatsoever’” (Appeal Br. 9).
The issue with respect to this rejection is: Does a preponderance of the

3 Katayose, S., US 2012/0171763 A1, published July 5, 2012.
4 Ting et al., US 2007/0099248 A1, published May 3, 2007.
5 Lazar, J., EP 1,488,000 B1, published Mar. 12, 2014.
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evidence of record support the Examiner’s conclusion that Katayose
anticipates claim 1?
Findings of Fact
1. Figure 1 of Katayose is reproduced below:

“FIG. 1 is a diagram illustrating that a capturing carrier used in an
embodiment of the invention is bound to a target cell” (Katayose ¶ 21).
2. Katayose teaches a “target substance may be captured by use of
this carrier, for example, a biotin-labeled probe molecule (such as an
antibody having binding affinity for the target substance)” (Katayose ¶ 3).
3. Katayose teaches: “Examples of the avidin or streptavidin
derivative include chemically modified (for example, succinylated) avidin or
streptavidin . . . , and an avidin or streptavidin monomer” (Katayose ¶ 24).
4. The Specification teaches: “Monovalent streptavidin can be
achieved by generating monomers of streptavidin” (Spec. 7:5).
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5. Katayose teaches, in Preparation Example 2:
1 mg of streptavidin magnetic particles (Dynabeads M-
280 Streptavidin, manufactured by Invitrogen (Co.)) and 2 μg
of the desthiobiotin-bound anti-Ep-CAM antibody yielded in
Preparation Example 1 were added into a test tube, and were
mixed in PBS for 30 minutes to bind streptavidin to
desthiobiotin. Next, a magnetic stand was used to isolate the
magnetic particles from the reaction liquid. The reaction liquid
was washed with 0.05%-Tween-20-containing PBS 3 times to
remove unreacted desthiobiotin-bound probe molecules, to
yield an avidin-biotin complex (capturing carrier) in which the
desthiobiotin-bound probe molecules were bound to the
streptavidin magnetic particles.
(Katayose ¶ 63).
Principles of Law
Anticipation under 35 U.S.C. § 102 requires that “‘each and every
element as set forth in the claim is found, either expressly or inherently
described, in a single prior art reference.”’ In re Robertson, 169 F.3d 743,
745 (Fed. Cir. 1999).
Analysis
We adopt the Examiner’s findings of fact and conclusion of law (see
Final Act. 3–4; FF 1–5) and agree that Katayose anticipates claim 1. We
address Appellant’s arguments below.
We are not persuaded by Appellant’s argument that “[t]here is no
discussion, suggestion, or mention in Katayose of ‘selecting a first
monovalent biotin-binding composition labeled with a first reporter element’
and mixing it with ‘a first biotinylated primary antibody’ as claimed”
(Appeal Br. 8). Instead, we agree with the Examiner that in performing the
method, the components “are necessarily selected prior to reacting to form a
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complex” (Ans. 11). This is supported by Preparation Example 2 of
Katayose, where the streptavidin and biotin components were necessarily
“selected” from among all possible streptavidin and biotin components and
were mixed together (FF 5).
We also are unpersuaded by Appellant’s argument that “Katayose
does not use or suggest the term ‘monovalent’ whatsoever” (Appeal Br. 9).
The Specification explains that monomers of streptavidin are equivalent to
monovalent streptavidin (FF 4) and Katayose expressly teaches the use of
“an avidin or streptavidin monomer” (FF 3). This broad interpretation is
consistent with the Specification, which states “[i]n accordance to the
invention, the expression ‘monovalent biotin-binding composition’ is to be
interpreted broadly” (Spec. 6:29–30). We note that Perricone rejected “the
notion that [a compound] cannot anticipate because it appears without
special emphasis in a longer list.” Perricone v. Medicis Pharm. Corp., 432
F.3d 1368, 1376 (Fed. Cir. 2005) and the types of streptavidin appear in a
list (FF 3).
Conclusion of Law
A preponderance of the evidence of record supports the Examiner’s
conclusion that Katayose anticipates claim 1.

B. 35 U.S.C. § 102(a)(1) over Ting
The Examiner finds:
Ting et. al. teach throughout the patent and especially in
Abstract methods for using monovalent streptavidin
compositions comprising: mixing a first labeled monovalent
biotin-binding composition as for example monovalent
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streptavidin compositions wherein the streptavidin can be
labeled [0007] [0066] with a biotinylated molecule as for
example a biotin-antibody conjugate [0068] wherein in some
embodiments, the binding can occur in solution [0068] or on
solid phase [0068] which reads on a liquid phase absent a
definition of a solution in the specification as the end result of a
solution always exists as a single phase. Mixing in solution
necessarily requires mixing in a reaction vessel.
(Ans. 5).
Appellant contends “Ting does not describe the creation of an
‘immunolabeling complex’ by ‘selecting a first monovalent biotin-binding
composition labeled with a first reporter element’ and mixing it with ‘a first
biotinylated primary antibody’ in the absence of a target sample as claimed”
(Appeal Br. 9).
The issue with respect to this rejection is: Does a preponderance of
the evidence of record support the Examiner’s conclusion that Ting
anticipates claim 1?
Findings of Fact
6. Ting teaches “a streptavidin monomer subunit or streptavidin
tetramer of the invention is linked to a detectable label” (Ting ¶ 66).
7. Ting teaches “the use of a streptavidin monomer or tetramer of
the invention to bind to a biotin molecule or fragment thereof that is
conjugated to an additional molecule or compound. Examples of such
molecules . . . include . . . antibodies” (Ting ¶ 68).
8. Ting teaches the “invention includes in some aspects, a
monovalent streptavidin tetramer. A monovalent streptavidin tetramer
includes one wild-type streptavidin monomer subunit” (Ting ¶ 55).
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Analysis
We adopt the Examiner’s findings of fact and conclusion of law (see
Final Act. 5–6; FF 6–8) and agree that Ting anticipates claim 1. We address
Appellant’s arguments below.
We are not persuaded by Appellant’s argument that “Ting does not
describe the creation of an ‘immunolabeling complex’ by ‘selecting a first
monovalent biotin-binding composition labeled with a first reporter element’
and mixing it with ‘a first biotinylated primary antibody’ in the absence of a
target sample as claimed” (Appeal Br. 9).
Ting expressly teaches binding a monovalent streptavidin (FF 8) to a
biotin molecule that is conjugated to additional molecules such as antibodies
(FF 7). As above, we agree with the Examiner that in performing the
method, the components “are necessarily selected prior to reacting to form a
complex” (Ans. 11).
Conclusion of Law
A preponderance of the evidence of record supports the Examiner’s
conclusion that Ting anticipates claim 1.

C. 35 U.S.C. § 103 over Ting and Lazar
Appellant does not substantively separately argue this obviousness
rejection, instead relying upon their arguments to overcome Ting. The
Examiner provides sound fact-based reasoning for combining Ting with
Lazar (see Final Act. 7). Having affirmed the anticipation rejection of
claim 1 over Ting for the reasons given above, we also find that the further
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combination with Lazar renders the rejected claim 14 obvious for the
reasons given by the Examiner.

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–13 102 Katayose 1–13
1–3, 6–8,
16, 17
102 Ting 1–3, 6–8,
16, 17

14 103 Ting, Lazar 14
Overall
Outcome
1–14, 16, 17

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