ELECTROPHORETICS LIMITED

Patent Trials and Appeals Board

Mar 22, 2021

2020002657 (P.T.A.B. Mar. 22, 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.
15/577,522 11/28/2017 Ian Hugo Pike 033945-00040 9669
38485 7590 03/22/2021
ARENT FOX LLP - New York
1717 K Street, NW
Washington, DC 20006-5344
EXAMINER
CHERNYSHEV, OLGA N
ART UNIT PAPER NUMBER
1649
NOTIFICATION DATE DELIVERY MODE
03/22/2021 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):
patentdocket@arentfox.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte IAN HUGO PIKE, MALCOLM ANDREW WARD,
CLAIRE LOUISE RUSSELL, and VIKRAM MITRA
Appeal 2020-002657
Application 15/577,522
Technology Center 1600

Before ERIC B. GRIMES, FRANCISCO C. PRATS, and
DEBRA L. DENNETT, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 55–74. 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(a). Appellant identifies the real party in interest as Electrophoretics
Limited, the assignee of record. Appeal Br. 3.
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Application 15/577,522

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CLAIMED SUBJECT MATTER
Appellant’s Specification discloses that it is widely accepted that a
specific protein, known as “tau,” is involved in the pathology of
neurodegenerative diseases like Alzheimer’s Disease (“AD”), and that tau
“actively participates in the formation of neurofibrillary tangles.” Spec. 17.
The inventors of the present application “have surprisingly found that
multiple cellular processes, the associated proteins and/or their levels are
modified in a tau dose-dependent manner and that these affected pathways
are correlated with several hallmarks of AD.” Spec. 17–18.
Based on this discovery, Appellant’s Specification identifies a panel
of peptide biomarkers which are not only expressed in the brain, but “are
surprisingly also identifiable in the cerebrospinal fluid (CSF) and most
importantly their abundance in CSF is regulated between non-AD and AD
patients with substantive memory effects.” Spec. 18.
The Specification explains that the AD biomarkers identified by the
inventors may be quantified in patient samples by a technique termed
“selected reaction monitoring” (“SRM”), which is a specific type of mass
spectrometry assay that involves fragmentation of a target parent ion and
counting of daughter ions of a predefined mass-to-charge ratio. Spec. 14.
SRM assays involve the use of a reference peptide as an internal
standard for quantifying the target peptide of interest. See Spec. 14
(“Typically, an equivalent precursor ion bearing a predefined number of
stable isotope substitutions but otherwise chemically identical to the target
ion is included in the method to act as a quantitative internal standard.”).
The claims on appeal are directed to kits that contain sets of reference
peptides. See Appeal Br. 7 (claim 55). The kits are useful in assays for
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Application 15/577,522

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measuring specific tau protein variants or peptide fragments, as well as other
proteins. See id. at 7–8.
Claims 55 and 61 illustrate the appealed subject matter and read as
follows:
55. A kit for assaying and/or measuring one or more
biomarkers of a panel in a sample, comprising:
a set of reference peptides in an assay-compatible format,
wherein each reference peptide is uniquely representative of a
single biomarker in the panel;
wherein the panel comprises a tau protein or a fragment
thereof, wherein the tau protein:
i) comprises the amino acid sequence of SEQ ID
NO:29, and
ii) comprises one or more phosphorylated amino
acids selected from T39, S46, T50, T52,
T56, S61, T63, S64, S68, T69, S113, T181,
S184, S185, S191, S195, S198, S199, S202,
S205, S208, S210, T212, S214, T217, T231,
S235, S237, S238, S258, S262, S285, S289,
S356, Y394, S396, S400, T403, S404, S409,
S412, S413, T414/S416 or S422 of SEQ ID
NO:29;
wherein when the phosphorylated amino acid is T181,
the panel further comprises a tau protein or a fragment thereof
having at least one more phosphorylated amino acid.

61. The kit of claim 55, wherein the panel further comprises
one or more biomarkers selected from: Actin alpha cardiac
muscle 1 (SEQ ID NO:11), Antithrombin-III (SEQ ID NO:12),
BH3-interacting domain death agonist (SEQ ID NO:3), cAMP-
dependent protein kinase type I-beta regulatory subunit (SEQ
ID NO:24), Catenin delta-1 (SEQ ID NO:4), Centrosomal
protein of 170 kDa (SEQ ID NO:23), Clathrin light chain B
(SEQ ID NO:5), Egl nine homolog 1 (SEQ ID NO:13),
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Fibrinogen gamma chain (SEQ ID NO:14), GMP reductase 1
(SEQ ID NO:27), Guanine nucleotide-binding protein G(q)
subunit alpha (SEQ ID NO:6), Insulin-like growth factor-
binding protein 6 (SEQ ID NO:15), KxDL motif-containing
protein 1 (SEQ ID NO:28), Lambda-crystallin homolog (SEQ
ID NO: 18), Myelin-associated oligodendrocyte basic protein
(SEQ ID NO:20), Neutral alpha-glucosidase AB (SEQ ID
NO:7), Nuclear pore complex protein Nup155 (SEQ ID
NO:19), OCIA domain-containing protein 1 (SEQ ID NO:16),
Protein KIAA1045 (SEQ ID NO:25), Secernin-2 (SEQ ID
NO:8), Serum albumin (SEQ ID NO:17), Short-chain specific
acyl-CoA dehydrogenase (SEQ ID NO:9), Synaptoporin (SEQ
ID NO:22), Syntaphilin (SEQ ID NO:10), Transmembrane
protein 119 (SEQ ID NO: 21) and/or Tubulin alpha chain-like 3
(SEQ ID NO:26).
Appeal Br. 7–8.
REJECTIONS
The following rejections are before us for review:2
(1) Claims 55–74, under 35 U.S.C. 112(a) or 35 U.S.C. § 112 (pre-
AIA), first paragraph, as failing to comply with the written description
requirement (Final Act. 4–5; Ans. 3–6); and
(2) Claim 61, on the basis that it contains an improper Markush
grouping of alternatives (Final Act. 2–4; Ans. 7–8).

2 The Examiner also entered an objection to the Specification for failure to
comply with the sequence requirements of 37 C.F.R. §§ 1.821–1.825, and
Appellant traverses that objection on appeal. See Final Act. 2 (entered
February 14, 2019); Appeal Br. 5. We will not review the Examiner’s
objection to the Specification. See MPEP § 706.01 (9th Ed., Rev. 10.2019,
June 2020) (“The practical difference between a rejection and an objection is
that a rejection, involving the merits of the claim, is subject to review by the
Patent Trial and Appeal Board, while an objection, if persisted, may be
reviewed only by way of petition to the Director of the USPTO.”) (emphasis
added).
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WRITTEN DESCRIPTION
The Examiner’s Rejection
In rejecting claim 55 and its dependent claims for failure to comply
with the written description requirement, the Examiner found that
Appellant’s Specification “describes [the] tau protein in full by reference to
the amino acid sequence of SEQ ID NO: 29. The specification further
describes the phosphorylated residues of tau, see pp. 27-33.” Ans. 4.
Rather than being directed to kits that contain the tau protein or its
fragments, however, the Examiner determined that
[t]he essential elements of the claimed kits are reference
peptides uniquely representative of tau protein, and their
description is limited to the text at lines 5-11 at p. 83 (or
paragraph [0460] of the published patent application) – “a set of
references peptides (e.g. SRM peptides) in an assay compatible
format wherein each peptide in the set is uniquely
representative of [tau].”
Ans. 4 (brackets in original).
The Examiner determined that the reference peptides recited in claim
55 “are not described by any physical, structural, and/or meaningful
boundaries” because claim 55 “only require[s] that the ingredients of the kit,
‘set of reference[] peptides’, are uniquely representative of tau protein or
fragments thereof and [are] suitable for assaying and/or measuring tau
protein and its fragments in biological samples.” Ans. 4. Therefore, the
Examiner reasoned, “the claims are drawn to a vast genus of chemical
embodiments that is defined only by reference to their ability to assay or
measure other chemical embodiments.” Id.
The Examiner determined that the Specification does not establish
that Appellant was in possession of the genus of reference peptides recited in
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claim 55 because the Specification “does not provide a complete structure of
those reference peptides uniquely representative of tau and its fragments
which are within the claimed genus and fails to provide a representative
number of species for the claimed genus.” Ans. 4–5.
In particular, the Examiner reasoned, “[m]erely teaching the structure
of the molecule to which the claimed reagent serves as an assaying molecule
does not tell anything at all about the structure of the reagent.” Ans. 6.
Therefore, the Examiner concluded, “in the absence of sufficient recitation
of distinguishing identifying characteristics, the specification does not
provide adequate written description of the claimed genus of reference
peptides uniquely representative of tau protein and its fragments.” Id.
Analysis
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant in
response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992); see also In re Jung, 637
F.3d 1356, 1365 (Fed. Cir. 2011) (holding that requiring an applicant to
identify “reversible error” in an examiner’s rejection is consistent with long
standing Board practice).
Having carefully considered all of the evidence and argument
presented by Appellant and the Examiner, we are not persuaded that
Appellant has shown reversible error in the Examiner’s determination that
Appellant’s Specification does not provide adequate written description
support for the kit recited in Appellant’s representative claim 55.
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“[T]he written description requirement with respect to particularly
claimed subject matter is met if the specification shows that the stated
inventor has in fact invented what is claimed, that he had possession of it
. . . . [P]ossession is shown by disclosure in the patent.” AbbVie
Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1299
(Fed. Cir. 2014) (citation omitted); see also Ariad Pharms., Inc. v. Eli Lilly
& Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (The test for sufficiency of the
disclosure “requires an objective inquiry into the four corners of the
specification from the perspective of a person of ordinary skill in the art.
Based on that inquiry, the specification must describe an invention
understandable to that skilled artisan and show that the inventor actually
invented the invention claimed.”).
“One particular question regarding the written description requirement
has been raised when a genus is claimed but the specification only describes
a part of that genus that is insufficient to constitute a description of the
genus.” AbbVie, 759 F.3d at 1299. “[A] sufficient description of a genus
. . . requires the disclosure of either a representative number of species
falling within the scope of the genus or structural features common to the
members of the genus so that one of skill in the art can visualize or
recognize the members of the genus.” Id. (citations and internal quotations
omitted); see also id. at 1300 (“[A]nalogizing the genus to a plot of land, if
the disclosed species only abide in a corner of the genus, one has not
described the genus sufficiently to show that the inventor invented, or had
possession of, the genus.”).
In the present case, the genus identified by the Examiner is the set of
reference peptides recited in claim 55, that are “uniquely representative of a
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single biomarker” in a panel of biomarkers that includes tau protein or any
fragment of tau protein, having one or more of the phosphorylated amino
acids recited in the claim. Appeal Br. 7. As seen in the preamble of claim
55, the claimed set of reference peptides is a component of a kit for assaying
and/or measuring, in a sample, one or more biomarkers of the claimed panel
of biomarkers. Id.
Thus, as the Examiner found, the genus of reference peptides recited
in claim 55 is not limited to the set of peptides that constitutes the claimed
biomarker panel. Rather, the claimed genus encompasses any peptides that
are “uniquely representative” of the peptides in the biomarker panel, and
which are useful as reference peptides in any type of assay that detects or
quantifies any of the biomarkers in the claimed biomarker panel.
The sole disclosure in Appellant’s Specification as to the claimed
genus of peptides that are uniquely representative as recited in claim 55
appears on page 83 of the Specification as originally filed, and reads as
follows:
In one embodiment, the kit may be for performance of a
mass spectrometry assay and may comprise a set of reference
peptides (e.g. SRM peptides) in an assay compatible format
wherein each peptide in the set is uniquely representative of i)
one or more of the biomarkers of Groups A, B, C or D;[] ii)
phosphorylated tau comprising or having the amino acid
sequence of SEQ ID NO: 29 or one or more fragments thereof;
or iii) one or more of the proteins listed in Tables 5 to 13.
Preferably two or more of such unique peptides are used for
each biomarker for which the kit is designed, and wherein each
set of unique peptides are provided in known amounts which
reflect the amount or concentration of such biomarker in a
sample of a healthy subject.
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Spec. 83. The above-quoted passage includes the disclosure at paragraph
460 of the published version of this application,3 cited by Appellant as
supporting claim 55. See Appeal Br. 5.
As is evident, the cited portion of Appellant’s Specification does not
include a description of the structural features common to the claimed genus
of reference peptides that are uniquely representative of the disclosed (and
claimed) biomarker panels, nor does the allegedly supporting disclosure
provide any examples of the peptide species falling within claimed genus of
uniquely representative reference peptides. Appellant does not persuade us,
therefore, that the Examiner erred in finding that the claimed genus of
peptides lacks adequate written description support in the Specification. See
AbbVie, 759 F.3d at 1299 (“[A] sufficient description of a genus . . . requires
the disclosure of either a representative number of species falling within the
scope of the genus or structural features common to the members of the
genus so that one of skill in the art can visualize or recognize the members
of the genus.” (emphasis added)).
Appellant also argues that claim 55 is supported in the published
application at paragraphs 17–20 and in SEQ ID NO: 29. Appeal Br. 5. We
are not persuaded.
Paragraphs 17–20 of the published application merely set forth the
panel of biomarkers recited in claim 55, and SEQ ID NO: 29 merely sets
forth the amino acid sequence of the tau protein. See the published
application ¶¶ 17–20; see also Spec. 3–4 (disclosure in original Specification
corresponding to ¶¶ 17–20 of the published application). As noted above,

3 US 2018/0140585 A1 (published May 24, 2018) (“the published
application”).
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however, the claimed genus of peptides at issue is not the set of peptides
constituting the claimed panel of biomarkers. Rather, the genus at issue is
the genus of “reference peptides” that are “uniquely representative” of the
claimed biomarker panel. Appeal Br. 7 (claim 55). Accordingly, the fact
that the Specification adequately describes the peptides in the assayed
biomarker panel recited in claim 55 does not persuade us that the
Specification adequately describes the claimed genus of reference peptides
that are “uniquely representative” of the peptides in the biomarker panel.
Appellant argues that, as evidenced by the disclosure on page 14 of
the Specification (noted above), SRM mass spectrometry was a known
method for quantifying the concentration of one or more proteins in a
sample comprising multiple proteins. Reply Br. 2–3. Therefore, Appellant
argues, a skilled artisan would have readily understood that reference
peptides useful in a kit for analyzing biomarkers in the panel recited in claim
55 using SRM mass spectrometry would necessarily be “uniquely
representative” peptides in the biomarker panel. Id. at 3. Otherwise,
Appellant argues, “these kits would be non-functional for their expressly
stated purpose.” Id.
We are not persuaded. We first note that claim 55 is not limited to
kits containing reference peptides useful in SRM assays. Accordingly, even
if we agreed (which, as discussed above, we do not) that the Specification
adequately described kits containing uniquely representative reference
peptides useful in SRM assays, that would not constitute an adequate written
description of the full scope of claim 55. See AbbVie, 759 F.3d at 1300
(“[A]nalogizing the genus to a plot of land, if the disclosed species only
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abide in a corner of the genus, one has not described the genus sufficiently to
show that the inventor invented, or had possession of, the genus.”).
Moreover, page 83 of the Specification, cited by Appellant as support
for the claimed genus of peptides, only states that the claimed genus of
reference peptides can be used in SRM assays. See Spec. 83. As discussed
above, however, page 83 does not include a description of the common
structural features of the genus of reference peptides that are uniquely
representative of the claimed biomarker panel, nor does page 83 provide any
examples of the peptide species falling within the claimed genus of uniquely
representative reference peptides. Thus, that a skilled artisan knew that
SRM assays required reference peptides that are uniquely representative of
the assayed biomarker panel does not establish that the Specification would
have advised a skilled artisan as to the specific structural features of the
claimed genus of peptides encompassed by claim 55, or that Appellant was
in possession of those peptides.
Appellant argues:
One of ordinary skill in the art would immediately understand
that Appellant’s disclosure cannot set forth the full genus of
uniquely representative peptides compatible with the present
kits, as this genus will vary depending on the biomarker panel
selected by the user (e.g., sequences that are unique in one
panel may not be unique in another panel which includes an
additional, sequentially similar, protein). Nonetheless, one of
ordinary skill in the art would appreciate that unique sequences
may be identified and selected using known techniques, which
are commonly applied by those practicing SRM mass
spectrometry.
Reply Br. 3.
We are not persuaded. Appellant points to no authority suggesting the
written description requirement need not be enforced when claimed subject
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matter is complex, or when the claimed subject matter is difficult to describe
because it is broad. At best, Appellant’s argument, which is unsupported by
evidence, might show that a skilled artisan would have considered it an
obvious matter to generate a set of uniquely representative reference
peptides encompassed by claim 55. That is insufficient to satisfy the written
description requirement, however. See Ariad, 598 F.3d at 1352 (“[A]
description that merely renders the invention obvious does not satisfy the
requirement.”).
In sum, for the reasons discussed, Appellant does not persuade us of
reversible error in the Examiner’s determination that Appellant’s
Specification does not provide adequate written description support for the
kit recited in Appellant’s representative claim 55. Claims 56–74 fall with
claim 55. See 37 C.F.R. § 41.37(c)(1)(iv) (2018).
IMPROPER MARKUSH
The Examiner’s Rejection
In rejecting Appellant’s claim 61 as reciting an improper Markush
group, the Examiner found that the biomarkers alternatively recited in the
claim “are independent and distinct, each from each other, because they are
products which possess characteristic differences in structure and function
and each has independent utility that is distinct for each invention which
cannot be exchanged.” Ans. 7.
Analysis
Appellant’s claim 61 recites “[t]he kit of claim 55, wherein the panel
further comprises one or more biomarkers selected from” a list of 26 distinct
biomarkers. Appeal Br. 8.
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In traversing this rejection, Appellant argues that “MPEP § 2117
states: ‘[c]laim language defined by a Markush grouping requires selection
from a closed group ‘consisting of’ the alternative members.’ Current Claim
61 does not recite ‘consisting of.’” Appeal Br. 5–6.
The Examiner responds that “any claim that recites alternatively
usable members, regardless of format, should be treated as a Markush
claim.” Ans. 10 (citing MPEP § 2117) (emphasis in original).
We find that the Examiner has the better position. As noted above,
the sole error identified by Appellant as to this ground of rejection is the fact
that the list of biomarkers in claim 61 is not recited in terms of the phrase
“the group consisting of.” See Appeal Br. 5–6.
As the Examiner notes, however, the MPEP expressly provides that,
regardless of the language used, a claim reciting a list of alternatives is to be
treated as a Markush claim, and examined under the case law governing
such claims. See MPEP § 2117 (“Treatment of claims reciting alternatives is
not governed by the particular format used (e.g., alternatives may be set
forth as ‘a material selected from the group consisting of A, B, and C’ or
‘wherein the material is A, B, or C’).” (emphasis added)).
Accordingly, the fact that Appellant’s claim 61 does not use the
phrase “the group consisting of” in relation to the list of alternative
biomarkers included in the kit recited in claim 61 does not persuade us that
the Examiner erred in determining that claim 61 recites an improper
Markush group. We therefore affirm the Examiner’s rejection of claim 61
based on that ground.
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DECISION SUMMARY
In summary:
Claim(s)
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
55–74 112(a) or
112, first
paragraph
Written
Description
55–74
61 Improper Markush
Grouping
61
Overall
Outcome
55–74
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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED