Siemens Healthcare Diagnostics Inc.

Patent Trials and Appeals Board

May 26, 2021

2020005446 (P.T.A.B. May. 26, 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.
15/440,628 02/23/2017 Tie Q. Wei 2013P02827US01 1345
28524 7590 05/26/2021
SIEMENS CORPORATION
IP Dept - Mail Code INT-244
3850 Quadrangle Blvd
Orlando, FL 32817
EXAMINER
GROSSMAN, ANDREA S
ART UNIT PAPER NUMBER
1641
NOTIFICATION DATE DELIVERY MODE
05/26/2021 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):
ipdadmin.us@siemens.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TIE Q. WEI and IZAK BAHAR
Appeal 2020-005446
Application 15/440,628
Technology Center 1600
Before ERIC B. GRIMES, ULRIKE W. JENKS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims for determining isomeric analytes of
vitamin D3 as not complying with the written description requirement. We
have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies the real party in interest as Siemens Healthcare
Diagnostics Inc. Appeal Br. 1.
Appeal 2020-005446
Application 15/440,628

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STATEMENT OF THE CASE
Appellant’s Specification explains that “measuring vitamin D levels in
biological samples is important since vitamin D deficiency is related to a
number of disorders in mammals.” (Spec. ¶ 2.) “[V]itamin D3 must
undergo metabolic activation to generate bioactive metabolites.” (Id. ¶ 4.)
In humans, the initial step of vitamin D3 activation involves formation of the
intermediate metabolite 25-hydroxyvitamin D3. (Id.) The Specification
notes that “[t]he vitamin D compound[] 25-hydroxyvitamin D3 [is] epimeric
at the 3-position with the epimers being designated 25-hydroxyvitamin D3
and 3-epi-25-hydroxyvitamin D3.” (Id. ¶ 5.) The Specification explains that
only 25-hydroxyvitamin D3 is the active metabolite form. (Id.) Appellant
explains that:
In order to obtain an accurate measurement of the active form
of an analyte, the presence of the non-active isomer of the
analyte must be addressed.
(Spec. ¶ 2.) The claims are directed to a method for determining the
epimeric forms of 25-hydroxyvitamin D3. Claim 21, reproduced below, is
illustrative of the claimed subject matter:
21. A method of determining in a sample an amount of non-epi-
25-hydroxy vitamin D3 and 3-epi 25-hydroxy vitamin D3, the
method comprising:
(a) conducting an assay on a first portion of the sample
using an assay protocol wherein assay reagents utilized in the
assay protocol of this step (a) comprise vitamin D3 conjugated to
a label and a first antibody having a binding affinity for each of
non-epi-25-hydroxy vitamin D3 and 3-epi 25-hydroxy vitamin
D3 of 108 to 1014 liters/mole and are combined to form a first
complex comprising the first antibody and non-epi-25-hydroxy
vitamin D3 and a second complex comprising the first antibody
and 3-epi 25-hydroxy vitamin D3 wherein the first complex and
the second complex include vitamin D3 conjugated to a label
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wherein an amount of signal from the first complex and the
second complex is related to a total amount non-epi-25-hydroxy
vitamin D3 and 3-epi 25-hydroxy vitamin D3 in the sample to
obtain a first measurement value; and
(b) conducting the assay on a second portion of the sample
using the same assay protocol as in step (a) wherein assay
reagents utilized in the assay protocol in this step (b) comprise
the vitamin D3 conjugated to a label and the first antibody, and a
second antibody having a binding affinity for the non-epi-25-
hydroxy vitamin D3 of 106 to 108 liters/mole and a binding
affinity for the 3-epi 25-hydroxy vitamin D3 of less than about
104 liters/mole and are combined, wherein the second antibody
is employed in an amount of about 5 to about 200 times the
amount of the first antibody, wherein the binding affinity of the
second antibody for non-epi-25-hydroxy vitamin D3 is less than
the binding affinity of the first antibody for non-epi-25-hydroxy
vitamin D3 by a factor of at least about 10, wherein the second
antibody binds the non-epi-25-hydroxy vitamin D3 such that the
non-epi-25-hydroxy vitamin D3 does not bind to the first
antibody, and wherein a complex is formed comprising the first
antibody and the epi-25-hydroxy vitamin D3, wherein the
complex includes the vitamin D3 conjugated to a label wherein
an amount of signal from the complex is related to an amount of
the 3-epi 25-hydroxy vitamin D3 in the sample to obtain a second
measurement value;
determining an amount of the non-epi-25-hydroxy vitamin
D3 in the sample by subtracting the second measurement value
from the first measurement value.
REJECTION
The following ground of rejection by the Examiner is before us on
review:
Claims 21–25 are rejected under 35 U.S.C. § 112 (pre-AIA), first
paragraph, as failing to comply with the written description requirement.

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In the Final Rejection, the Examiner also rejected claims 21–25 on the
ground of non-statutory obviousness-type double patenting as being
unpatentable over claims 1–4 of U.S. Patent No. 6,618,523. However,
Appellant expressly states that it is only appealing the written description
rejection. (Appeal Br. 6.) Because Appellant does not contest the
obviousness-type double patenting rejection and has not filed a terminal
disclaimer to obviate that outstanding rejection, the rejection is summarily
affirmed. Hyatt v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008) (“When the
appellant fails to contest a ground of rejection to the Board, . . . the Board
may treat any argument with respect to that ground of rejection as waived.”).
DISCUSSION
The Examiner finds that claim 21 contains subject matter which was
not described in the Specification in such a way as to reasonably convey to
one skilled in the relevant art that, at the time the application was filed, the
inventor had possession of the claimed invention. (Final Action 2.) In
particular, the Examiner finds that the claim is drawn to using “broad genii
[sic] of antibodies” but claims them by function not structure and the
Specification only identifies “two commercial antibodies, which may satisfy
these limitations: 510 and 10H9.” (Final Action 5–6.) The Examiner finds
that “the group of antibodies claimed cannot be identified (as there is no
clear structural correlation to the function),” including that there is no
identification of a complementarity determining region (“CDR”), and the
“[o]ne commer[]cially available antibody that meets this description does
not provide enough description for an entire group of antibodies.” (Id. at 8.)
Appellant argues that the Examiner’s rejection is in error because (1)
the claims are not directed to antibodies, but rather a method of using
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antibodies, (2) the antigen at issue is not new, but rather is well known and
well characterized, and (3) the method can be carried out with previously
known and commercially available antibodies. (Appeal Br. 9–10; Reply Br.
8.) Appellant argues that in view of the foregoing the Specification is
sufficient to meet the “conventional tests for written description spelled out
in Ariad v. Eli Lilly[, 598 F.3d 1336 (Fed. Cir. 2010) (en banc)].” (Reply
Br. 6; Appeal Br. 9–10.)
We agree with the Examiner’s conclusion that the claims are not
adequately described. First, the fact that Appellant’s claims are directed to a
method of using antibodies and not to antibodies themselves (Appeal Br. 9)
does not obviate the need to adequately describe the genus of antibodies
required to carry out the invention. It is well settled that:
Regardless whether a compound is claimed per se or a method
is claimed that entails the use of the compound, the inventor
cannot lay claim to that subject matter unless he can provide a
description of the compound sufficient to distinguish infringing
compounds from non-infringing compounds, or infringing
methods from non-infringing methods.
University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 926 (Fed.
Cir. 2004.
When a genus of compounds is required to be used in a method, it
follows that the genus of compounds must be adequately described. “[T]he
purpose of the written description requirement is to ‘ensure that the scope of
the right to exclude, as set forth in the claims, does not overreach the scope
of the inventor’s contribution to the field of art as described in the patent
specification.’” Ariad, 598 F.3d at 1353–54.
A sufficient description of a genus “requires a precise definition, such
as by structure, formula, chemical name, physical properties, or other
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properties, of species falling within the genus sufficient to distinguish the
genus from other materials.” Id. at 1350. The description sufficient to
support a genus may be made by disclosing “‘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.’” Amgen Inc. v. Sanofi, 872 F.3d
1367, 1373 (Fed. Cir. 2017) (quoting Ariad, 598 F.3d at 1350).
Although “functional claim language can meet the written description
requirement when the art has established a correlation between structure and
function,” “merely drawing a fence around the outer limits of a purported
genus is not an adequate substitute for describing a variety of materials
constituting the genus and showing that one has invented a genus and not
just a species.” Ariad, 598 F.3d at 1350. When relying on functional
language to define a desired result to describe a genus, “the specification
must demonstrate that the applicant has made a generic invention that
achieves the claimed result and do so by showing that the applicant has
invented species sufficient to support a claim to the functionally-defined
genus.” AbbVie Deutschland GmbH v. Janssen Biotech, Inc., 759 F.3d
1285, 1299 (Fed. Cir. 2014) (quoting Ariad, 598 F.3d at 1349).
It may be the case, as Appellant argues, that “[t]he inventors
discovered a novel and useful method to measure only the non-epi-25-
hydroxy Vitamin D3 and not its epimeric counterpart or vice versa.”
(Appeal Br. 10), but the claimed method to do this requires two different
antibodies each of which is within a differently described genus, defined by
its particular function, as the Examiner found. (See, e.g., Ans. 9–10.) The
first antibody has to have a binding affinity for non-epi-25-hydroxy vitamin
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D3 and 3-epi-25-hydroxy vitamin D3 of 108 to 1014 liters/mole. The second
antibody has to have (a) a binding affinity for non-epi-25-hydroxy vitamin
D3 of 106 to 108 liters/mole (b) a binding affinity for 3-epi-25-hydroxy
vitamin D3 of less than 104 liters/mole, and (c) a binding affinity for non-epi-
25-hydroxy vitamin D3 that is less than the binding affinity of the first
antibody for non-epi-25-hydroxy vitamin D3 by a factor of at least about 10.
In addition, the second antibody has to bind the non-epi-25-hydroxy vitamin
D3 in a manner that blocks binding of non-epi-25-hydroxy vitamin D3 to the
first antibody. As the Examiner noted, the Specification does not describe
the structure of any antibodies that perform these functions, but does identify
two commercial antibodies that can serve as the first and second antibody.
(See Spec. ¶¶ 93, 102; Appeal Br. 9.) The identification of two
commercially available antibodies, one of which has the capability to
function as the first antibody and the other of which can function as the
second antibody does not serve to identify the structure of the antibody that
provides for the requisite binding affinities or the ability of the second
antibody to block the first antibody from binding to non-epi-25-hydroxy
vitamin D3. Appellant presents no evidence, nor argument, that a skilled
artisan could identify the structure of these antibodies based on the names in
the Specification or that the disclosure of the methods by which these
antibodies could be generated and screened discloses anything about their
structure.
Furthermore, the Specification does not even identify peptide
sequences of the antigen or epitopes of the antigen to which the claimed
antibodies must bind to achieve the claimed functions. Nor does Appellant
explain or provide evidence that, in the prior art, there is a known structure-
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function correlation to achieve the requisite affinity binding and blocking
functions. That the antigen is well-characterized does not elucidate the
structure of antibodies that have the binding affinity characteristics required
by the claim. As the Examiner notes, merely describing the antigen to which
an antibody binds does not demonstrate possession of the antibody itself,
much less the full scope of the genus of antibodies recited here. (See Final
Action 3–4 (citing Amgen, 872 F.3d at 1378–79 and USPTO Memorandum
dated Feb. 22, 2018 clarifying written description examination guidance in
light of Amgen).
Although those of ordinary skill in the antibody art may understand
how to prepare antibodies, “it is the specification itself that must
demonstrate possession. And while the description requirement does not
demand any particular form of disclosure, . . . or that the specification recite
the claimed invention in haec verba, a description that merely renders the
invention obvious does not satisfy the requirement.” Ariad, 598 F.3d at
1352.
Moreover, Appellant does not identify any specific evidence of record
suggesting that a genus of antibodies meeting the affinity binding
characteristics of the first antibody was common or well-known in the art or
that a genus of antibodies meeting the affinity binding and blocking
characteristics of the second antibody was common or well-known in the art.
In light of the above regarding that lack of disclosure even as to the
structure of the antigen to which the antibody of each claimed genus must
bind in order to achieve their respective functions, we also conclude that a
single antibody named that meets the affinity criteria of the first antibody
and a single antibody named that meets the affinity and blocking criteria of
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the second antibody is not sufficient to identify a representative number of
species of antibodies that meet the respective functional criteria. As the
Examiner noted (see e.g., Ans. 11), Appellant admits that it was difficult to
detect the antigens in an immunoassay, because antibodies bound to both
epimers. We agree with the Examiner that:
Describing one antibody (without any structural properties) is
not a representative number of species of the whole genus of
first or second antibodies. Since, no direction is given in the
specification about what structure correlates to the claimed
functional properties, one is not able to envision the broad
genus of antibodies that meet the claim. One cannot even
fathom the size of the genus that meets this claim.
(Ans. 10.) In other words, one cannot “‘visualize or recognize’ the members
of the genus,” Amgen, 872 F.3d at 1373 (quoting Ariad, 598 F.3d at 1350),
from one commercially available antibody in each genus required by the
claim.
Appellant has failed to establish that antibodies with the claimed
binding affinities and blocking characteristic were so well-known in the art
that it was unnecessary for Appellant’s Specification to provide either a
representative number of species, or a specific structural description of the
genus, to satisfy the written description requirement as to the genera of
antibodies recited in Appellant’s representative claim 21. “An applicant
cannot under 35 U.S.C. § 112 claim a broader invention than that set forth in
the written description contained in his specification.” In re Sus, 306 F.2d
494, 505 (C.C.P.A. 1962).
Consequently, we affirm the Examiner’s rejection of claim 21 under
35 U.S.C. § 112 (pre-AIA), first paragraph, as failing to comply with the
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written description requirement. Claims 22–25 have not been argued
separately and, therefore, fall with claim 21. 37 C.F.R. § 41.37(c)(1)(iv).
DECISION SUMMARY
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
21–25 112, first
paragraph
Written
Description
21–25

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