Patricius Hendrikus Cornelis. Van Berkel et al.

Patent Trials and Appeals Board

Jul 23, 2019

14434812 - (D) (P.T.A.B. Jul. 23, 2019)

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.
14/434,812 04/10/2015 Patricius Hendrikus Cornelis Van Berkel MEWB-35691/US-6/PCT 6595
72960 7590 07/23/2019
Casimir Jones, S.C.
2275 Deming Way Ste 310
Middleton, WI 53562
EXAMINER
HUFF, SHEELA JITENDRA
ART UNIT PAPER NUMBER
1643
NOTIFICATION DATE DELIVERY MODE
07/23/2019 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):
docketing@casimirjones.com
pto.correspondence@casimirjones.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte PATRICIUS HENDRIKUS CORNELIS VAN BERKEL
and PHILIP WILSON HOWARD1
____________

Appeal 2018-008330
Application 14/434,812 2
Technology Center 1600
____________

Before RICHARD M. LEBOVITZ, GEORGIANNA W. BRADEN, and
RYAN H. FLAX, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This appeal involves claims directed to an antibody conjugate
comprising an antibody and a pyrrolobenzodiazepine. The Examiner
rejected the claims on the ground of obviousness-type double-patenting.
Pursuant to 35 U.S.C. § 134, Appellants appeal the Examiner’s
determination that the claims are unpatentable. We have jurisdiction for the
appeal under 35 U.S.C. § 6(b). The Examiner’s decision is affirmed.

1 The Appeal Brief (“Br.” entered May 4, 2018) lists ADC Therapeutics
S.A. and Medimmune Limited as the Real Parties in Interest. Br. 1.
2 “The ’812 Application.”
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STATEMENT OF THE CASE
Claims 117, 118, 120, 121, 123, 124, 126, 128, and 129 stand rejected
by the Examiner on the ground of obviousness-type double patenting under
35 U.S.C. § 101 as unpatentable over claims 2–13 and 17 of U.S. Pat.
No. 9,889,207 B2 (“the ’207 Patent”). Ans. 4.
Claim 117, the only independent claim on appeal, and dependent
claim 118, are representative of the appealed claims and are reproduced
below:
117. A conjugate of formula ConjE:

ConjE

where Ab is an antibody that binds to PSMA, the
antibody comprising a VH domain having the sequence
according to SEQ ID NO: 3; optionally further comprising a
VL domain having the sequence according to SEQ ID NO: 4;
and wherein the drug loading of drugs to antibody is an integer
from 1 to about 8.

118. The conjugate according to claim 117 wherein the
antibody comprises a VH domain paired with a VL domain, the
VH and VL domains having sequences of SEQ ID NO. 3 paired
with SEQ ID NO. 4.
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RELATED APPEALS
This appeal is related to Appeal 2018-009106 in Application
No. 14/434,818 and Appeal 2018-008180 in Application No. 14/434,821.

REJECTION
The Examiner rejected claims 117, 118, 120, 121, 123, 124, 126, 128,
and 129 on the ground of obviousness-type double patenting as obvious over
claims 2–13 and 17 of the ’207 Patent. Ans. 4.
Rejected claim 117 is directed to a chemical compound known as a
pyrrolobenzodiazepine (’812 Application 1) conjugated to an antibody
(“AB”) that binds to PSMA.
The Examiner found that ConjB recited in claim 2 of the ’207 Patent
corresponds to ConjE of rejected claim 117.3 Non-Final Act. 7 (dated
July 19, 2016). ConjB comprises a pyrrolobenzodiazepine conjugated to a
cell binding agent (“CBA”), but not a CBA which is an antibody that binds
to PSMA as required by all the claims of the ’812 Application.
Claim 5 of the ’207 Patent, which depends4 on claim 2 from its
dependency on claim 3, is directed to conjugate ConjB (ConjE of the
rejected claims) comprising the pyrrolobenzodiazepine and a CBA

3 ConjB of claim 2 of the ’207 Patent comprises substituents R10 and R11
which form a double-bond in ConjE. Claim 2, depends from claim 1; claim
1 recites that substituents R10 and R11 can form a double-bond. A
double-bond is present at these positions in ConjE.
4 “3. The conjugate according to claim 2, wherein the cell binding agent
[(“CBA”)] is an antibody or an active fragment thereof.” “5. The conjugate
of claim 3 wherein the antibody or antibody fragment is an antibody which
binds to one or more tumor-associated antigens or cell-surface receptors
selected from (1)-(88).”
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which is an antibody or antibody fragment that binds to one or more
“tumor-associated antigens or cell-surface receptors” selected from a list
of 88. The list of 88 includes “(37) PSMA-FOLH1” which is “(Folate
Hydrolase (Prostate-Specific Nucleotide Membrane Antigen) 1).” ’207
Patent, col. 28, ll. 36–37. It is also known as “PSMA” (id. at col. 28, l. 53),
which is the term used in the claims of the ’812 Application. Patented claim
5, therefore, covers the same PSMA antibody conjugate recited in claim 117
of the ’812 Application.
Claim 5 of the ’207 Patent does not recite that the anti-PSMA
antibody comprises SEQ ID NOS. 3 and 4 of rejected claims 117 and 118.
SEQ ID NOS: 3 and 4 are amino acid sequences. The amino acid sequences
correspond to the variable chains of an intact anti-PSMA antibody. The
Examiner found that SEQ ID NOS: 3 (variable heavy chain) and 4 (variable
light chain) recited in claims 117 and 118 correspond to SEQ ID NOS. 19
(variable heavy chain) and 20 (variable light chain) disclosed (but not
claimed) in the ’207 Patent. Non-Final Act. 7 (dated July 19, 2016); Br. 6;
’207 Patent, cols. 53–54.
Although the claims of the ’207 Patent do not recite the amino acid
sequences of SEQ ID NOS. 3 and 4, the Examiner found that the rejected
claims are not patentably distinct from the claims of the ’207 Patent because
the rejected claims are within the scope of the patented claims. Non-Final
Act. 7 (dated July 19, 2016). The Examiner based this determination on the
claims of the ’207 Patent, but after consulting the specification of the ’207
Patent and determining that the claimed sequences are examples of PSMA
antibody chains covered by the claims of the ’207 Patent. Final Act. 4 (Aug.
17, 2017); Ans. 6–7. The Examiner found that it is permissible to consult
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the specification of the ’207 Patent to determine the meaning of the generic
term “antibody” recited in its claims. Ans. 6–7. Based on these findings,
the Examiner determined that claims 117 and 118 are obvious in view of the
claims of the ’207 Patent.
Appellants do not dispute that ConjE of rejected claim 117 is recited
in the patented claims of the ’207 Patent. Appellants state that rejected
claim 117 recites a species of the claimed anti-PMSA antibody of patented
claim 5, namely an antibody comprising the VH domain having the amino
acid sequence according to SEQ ID NO: 3. Br. 6–7. Appellants state that
“none of the cited claims of the [’]207 patent recites a PSMA-binding
antibody comprising VH domain having the sequence according to SEQ ID
NO: 3 and optionally a VL domain having the sequence according to SEQ
ID NO: 4, as required by appealed claim 117.” Br. 9. Appellants argue that
the patented claims of the ’207 Patent “dominate[]” the rejected claims
because they encompass the narrower claims of the ’812 Application, but
“[d]omination by itself, i.e., in the absence of statutory or non-statutory
double patenting grounds, cannot support a double patenting rejection.”
Br. 9.
SEQUENCES
The ’207 Patent discloses the amino acid sequences (cols. 53–54)
which are now claimed in the ’812 Application. These sequences were not
presented in the claims for examination when the application on which the
patent is based was filed October 11, 2013 or during its prosecution. See
claims filed Oct. 11, 2013 in U.S. Appl. No. 14/051,743 which matured into
the ’207 Patent. The claims of the ’207 Patent are not limited to a specific
sequence and therefore can be considered a genus.
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Claims comprising a conjugate with an antibody having SEQ ID NO:
3 and other amino acid sequences were presented in the ’812 Application
when it was filed. See claims filed Apr. 10, 2015 in U.S. Appl.
No. 14/434,812. Thus, Appellants voluntarily presented claims to the genus
claimed in the ’207 Patent in one application and species claims in another
application.
A restriction to a specific pyrrolobenzodiazepine formula and an
election of a species of amino acid sequence was initially required by the
Examiner. Requirement for Restriction/Election (dated Mar. 28, 2016).

DISCUSSION
The issue in this appeal is whether the claimed anti-PSMA
antibody conjugate (“ConjE”) comprising SEQ ID NO: 3 as the amino acid
sequence of the antibody’s variable heavy chain is unpatentable under
obviousness-type double patenting over claim 5 of the ’207 Patent which
comprises an anti-PSMA antibody comprising the same structure as ConjE,
but which is unrestricted as to the amino acid sequence of the antibody.
Generally, an obviousness-type double patenting analysis
entails two steps. First, as a matter of law, a court construes the
claim in the earlier patent and the claim in the later patent and
determines the differences.[] . . . Second, the court determines
whether the differences in subject matter between the two
claims render the claims patentably distinct. . . . A later claim
that is not patentably distinct from an earlier claim in a
commonly owned patent is invalid for obvious-type double
patenting. . . . A later patent claim is not patentably distinct
from an earlier patent claim if the later claim is obvious over, or
anticipated by, the earlier claim.
Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 967–72 (Fed. Cir. 2001).
We begin with claim interpretation. In an obviousness-type
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double-patenting analysis, while the earlier patent’s specification cannot be
used as prior art to the later patent application claims, it can be consulted to
ascertain the meaning of the words in the claim to interpret the patented
claim’s proper scope. As held in Sun Pharmaceutical Industries Ltd. v. Eli
Lilly and Co., 611 F.3d 1381, 1387 (Fed. Cir. 2010):
In Geneva [Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349
F.3d 1373 (Fed. Cir. 2003)], we acknowledged the general rule
that an earlier patent’s specification is not available to show
obviousness-type double patenting. 349 F.3d at 1385. We have
held, however, that there are “certain instances” where the
specification of an earlier patent may be used in the
obviousness-type double patenting analysis. In re Basell
[Poliolefine Italia S.P.A., 547 F.3d 1371, 1378 (Fed. Cir.
2008).] Specifically, the specification’s disclosure may be used
to determine whether a claim “merely define[s] an obvious
variation of what is earlier disclosed and claimed,” “to learn the
meaning of [claim] terms,” and to “interpret [ ] the coverage of
[a] claim.” Id. As we recognized in Geneva, a court
considering a claim to a compound must examine the patent’s
specification to ascertain the coverage of the claim, because a
claim to a compound “[s]tanding alone . . . does not adequately
disclose the patentable bounds of the invention.” 349 F.3d at
1385. In examining the specification of the earlier patent, the
court must consider “the compound’s disclosed utility.” Id.
In this case, claim 5 is directed to an anti-PSMA-FOLH1 antibody
conjugated to a pyrrolobenzodiazepine. PSMA-FOLH1 is also known as
PSMA. Neither of these terms are expressly defined in the ’207 Patent.
However, the same sequences, which are claimed, namely SEQ ID NOS. 3
and 4, are listed in the ’207 Patent under the heading “Anti-PSMA.” ’207
Patent, cols. 53–54 (SEQ ID NOS. 19 and 20). Based on this disclosure, we
interpret the anti-PSMA antibody of patented claim 5 to cover antibodies
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with the claimed amino acid SEQ ID NOS: 3 (rejected claim 117) and 4
(rejected claim 118), but not to be necessarily limited to these sequences.
In the second step of the analysis, we must determine whether the
difference between patented claim 5 and rejected claim 117 renders the
claims patentably distinct. In making this determination, we are instructed
to generally apply the principles utilized in making an obviousness
determination under 35 U.S.C. § 103. However, the analysis of obviousness
in the double-patenting context is not strictly coincident with obviousness
under § 103 because of the underlying differences in the policy concerns.
Otsuka Pharmaceutical Co., Ltd. v. Sandoz, Inc., 678 F.3d 1280, 1297 (Fed.
Cir. 2012). As explained in Basell, 547 F.3d at 1375:
“The doctrine of double patenting is intended to prevent a
patentee from obtaining a time-wise extension of [a] patent for
the same invention or an obvious modification thereof.” In re
Lonardo, 119 F.3d 960, 965 (Fed. Cir. 1997). The judicially
created doctrine of obviousness-type double patenting
“prohibit[s] a party from obtaining an extension of the right to
exclude through claims in a later patent that are not patentably
distinct from claims in a commonly owned earlier patent.” Eli
Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 967 (Fed. Cir.
2001).
Based on this principle, the court in Sun Pharmaceuticals determined
that a later claimed method of using the drug gemcitabine to treat cancer was
obvious, and not patentably distinct from, an earlier patented claim to
gemcitabine, itself, because the earlier patent disclosed but did not claim the
same treatment utility. Sun Pharmaceuticals, 611 F.3d at 1389; see also
Geneva, 349 F.3d 1373, and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc.,
518 F.3d 1353 (Fed. Cir. 2008) for similar holdings.
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Despite arguments by the patent holder in Sun Pharmaceuticals that
the earlier patent disclosure had been improperly used to determine the
obviousness of the treatment claims, the court adhered to the principle
articulated in Basell that “a patent’s disclosure may be used to determine
whether an application claim is merely an obvious variation of an invention
claimed in a patent.” Basell, 547 F.3d at 1378. Similarly, we find that here
the Examiner properly consulted the disclosure of the ’207 Patent in
reaching the determination that the claims to an anti-PMSA antibody
comprising a SEQ ID NO: 3 is no more than an obvious variation of the
already patented anti-PMSA antibody conjugate.
Appellants characterize the differences between the patented claims
and the rejected claims in this appeal as genus and species. Br. 7.
Appellants contend that the “Examiner provides no reason as to why one of
ordinary skill in the art would be motivated to modify the cited genus claims
of the [’]207 [P]atent to arrive at the rejected species claims of the present
application.” Br. 7. Appellants also contend that domination of the species
claims by the ’207 Patent claims is insufficient to establish obviousness of
the claimed species. Id.
Patented claim 5, which is directed to an anti-PMSA antibody
conjugate, includes the amino acid sequence of SEQ ID NO:3 in its scope
because claim 5 is not restricted to a specific amino acid sequence as long as
the antibody binds to PMSA. Nonetheless, under obviousness-type double
patenting, a claimed species is not necessarily obvious based on a broader
claimed genus. (“To be sure, obviousness is not demonstrated merely by
showing that an earlier expiring patent dominates a later expiring patent. . . .
It is well-settled that a narrow species can be non-obvious and patent eligible
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despite a patent on its genus.” Abbvie Inc. v. The Mathilda and Terence
Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 1379 (Fed. Cir.
2014)).
For example, in Otsuka, a “traditional obviousness analysis” was
applied to determine “whether one of ordinary skill in the art would have
had reason or motivation to modify the earlier claimed compound to make
the compound of the asserted claim with a reasonable expectation of
success.” Otsuka, 678 F.3d at 1298. In Otsuka, the issue was whether the
specific structure of the chemical compound aripiprazole was obvious over
an unsubstituted butoxy of the earlier patent claims. Id.
However, the structural approach to obviousness invoked in Otsuka
does not necessarily apply to DNA and protein sequences. Specifically, in
In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009), a nucleotide sequence encoding
a polypeptide was found to be obvious to one of ordinary skill in the art
because one of ordinary skill in the art could have routinely cloned it using
available starting materials. Kubin, 561 F.3d at 1360–61. Although the
court acknowledged that the structure of the claimed nucleotide sequence
could not be predicted, the sequence was determined to be obvious because a
known and routine method had been used to clone it and it was predictable
that such cloning method would have successfully culminated in
ascertaining the claimed sequence. Id.
In our opinion, the same principles articulated in Kubin apply here.
As discussed above, claim 5 of the ’207 Patent is directed to a conjugate
comprising an anti-PMSA antibody. The description of the antibody in the
’207 Patent disclosure includes SEQ ID NOS. 19 and 20, which are the same
amino acid sequences recited in rejected claims 117 and 118. The
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obviousness of an amino acid sequence can be determined based on whether
there is reasonable expectation of success of obtaining it using known and
conventional techniques. Kubin, 561 F.3d at 1360–61. The ’207 patent
claims are presumptively fully enabled, and thus it would have been obvious
to one of ordinary skill in art at the time of the invention to have identified
the claimed variable chain amino acid sequences of the anti-PSMA antibody
of patented claim 5 using conventional technology. One of ordinary skill in
the art would have had reason to do so because the patented antibodies are
described in the ’207 Patent as useful therapeutic agents (at col. 2, ll. 25–63)
and, as found by the Examiner, are described in the ’207 Patent as the amino
sequences which define the variable regions of the patented antibody
conjugate.
The determination that claim 117 is obvious based on claim 5 of the
’207 Patent is also consistent with In re Schneller, 397 F.2d 350 (CCPA
1968), which found claims to a “wire clip” comprising a combination of
elements obvious under double-patenting in view of already patented claims
to a wire clip reciting a combination of elements which the court determined
“covered” the preferred and subsequently claimed embodiment. Schneller,
397 F.2d at 354–55. The court explained:
[The inventor’s] first application disclosed ABCXY and other
matters. He obtained a patent claiming BCX and ABCX, but so
claiming these combinations as to cover them no matter what
other feature is incorporated in them, thus covering effectively
ABCXY. He now, many years later, seeks more claims
directed to ABCY and ABCXY. Thus, protection he already
had would be extended, albeit is somewhat different form, for
several years beyond the expiration of his patent, were we to
reverse.
Id. at 355–56.
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In reaching the determination that the later filed claims were
unpatentable because of double-patenting over the earlier patented claims,
the court held that “even a minimal concern for the public interest requires
an applicant to establish that the inventions are in fact independent and
distinct and hence that the grant of a patent on the later application will not
result in a timewise extension of the protection afforded by his earlier
patent.” Id. at 354. Here, the patented claims cover the rejected ’812
Application claims as they did in Schneller. As recognized in In re
Metoprolol Succinate Patent Litigation, 494 F.3d 1011, 1018 (Fed. Cir.
2007), Schneller is still controlling.
Appellants chose to pursue the generic and species claims in different
applications (see above, section titled “SEQUENCES”). Appellants have
not established that claims to the specifically claimed antibody sequences,
which provide written description support for the claimed generic antibody
of claim 5,5 are independent from the patented claims.

SUMMARY
For the foregoing reasons, the obviousness-type double patenting
rejection of claims 117 and 118 is affirmed. Claims 120, 121, 123, 124, 126,
128, and 129 fall with claims 117 and 118 because separate reasons for their
patentability were not provided. 37 C.F.R. § 41.37(c)(1)(iv).

5 The written description requirement under 35 U.S.C. § 112 requires
disclosure of representative species of the antibody genus. AbbVie
Deutschland GMBH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285 (Fed.
Cir. 2014). It seems reasonable for the Examiner to presume that, absent
evidence to the contrary, the amino acid sequences necessary to support a
generic antibody claim are not independent and distinct from it.
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TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED