Ex Parte Goldmakher

Patent Trials and Appeals Board

Apr 9, 2019

10975434 - (D) (P.T.A.B. Apr. 9, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
10/975,434 10/29/2004
46002 7590 04/11/2019
JOYCE VON NATZMER
A GRIS & VON NA TZMER LLP
43 West 43rd Street, Suite 104
New York, NY 10036-7424
FIRST NAMED INVENTOR
Viktor S. Goldmakher
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
3028-101 6873
EXAMINER
YAO,LEI
ART UNIT PAPER NUMBER
1642
NOTIFICATION DATE DELIVERY MODE
04/11/2019 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):
uspto-mail@NATZMER-LAW.COM
eofficeaction@appcoll.com
46002 © avn-law .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte VIKTOR S. GOLDMAKHER
Appeal2018-006671
Application 10/975,434
Technology Center 1600
Before ULRIKE W. JENKS, TIMOTHY G. MAJORS, and
MICHAEL A. VALEK, Administrative Patent Judges.
VALEK, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant 1 appeals from Examiner's
rejection of claims 1, 3, 8, 10, 11, 13-18 and 39 for obviousness-type double
patenting ("ODP"). We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
STATEMENT OF THE CASE
Claims 1, 3, 8, 10, 11, 13-18 and 39 are on appeal, and can be found
in the Claims Appendix of the Appeal Brief. The only independent claim is
claim 1. Claim 1 reads as follows:
1 Appellant identifies the real parties in interest as Biotest AG, Germany and
ImmunoGen Inc. USA. App. Br. 3. Herein we refer to the Final Office
Action dated February 10, 2017 ("Final Act."), Appeal Brief filed January
10, 2018 ("App. Br."), Examiner's Answer, mailed April 16, 2018 ("Ans."),
and Reply Brief filed June 16, 2018 ("Reply").
Appeal2018-006671
Application 10/975,434
1. An imnmnoconjugate comprising: at least one
targeting antibody selectively targeting cell-surface expressed
CD138, wherein the targeting antibody binds to a linear epitope
between residues 90-95 of the core protein of human CD138
and wherein the targeting antibody is a chimerized or
humanized BB4 antibody or antibody binding fragment thereof,
and at least one effector molecule, wherein said effector
molecule is a maytansinoid and has a molecular weight of less
than 2kD, wherein said targeting antibody is functionally and
releasably attached to said effector molecule to form said
immunoconjugate, and the immunoconjugate is configured so
that the effector molecule is released from the
immunoconjugate by cleavage or dissociation in, at or close to
cells targeted by said targeting antibody.
App. Br. 19. Appellant does not argue claims 3, 8, 10, 11, 13-16 and 39
separately from claim 1 so those claims stand or fall with claim 1. 37 C.F.R.
§ 4I.37(c)(l)(iv).
Appellant separately argues claims 17 and 18. These claims are
directed to kits that include a pharmaceutical composition comprising the
immunoconjugate of claim 1. They read as follows:
1 7. A kit comprising, in separate containers,
pharmaceutical compositions for use in combination to inhibit,
delay and/or prevent the growth of tumors and/or spread of
tumor cells, wherein one container comprises an effective
amount of the pharmaceutical composition of claim 16, and
wherein, a separate container comprises a second
pharmaceutical composition comprising an effective amount of
an agent for the inhibition, delay and/or prevention of the
growth of tumors and/ or spread of tumor cells, and one or more
pharmaceutically acceptable excipients.
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18. The kit of claim 17, wherein said agent in said second
pharmaceutical composition is a chemotherapeutic agent or another
immunocon jugate.
App. Br. 20.
Appellant seeks review of Examiner's rejection of claims 1, 3, 8, 10,
11, 13-18, and 39 for ODP over the claims of the following patents: US
8,613,930, us 9,061,995, us 9,221,914, us 8,624,003, us 8,795,673, us
9,428,543 and US 9,376,500. 2
The issues for each of these rejections is: Does the preponderance of
evidence of record support Examiner's obviousness-type double patenting
rejection over the claims of the reference patent?
Analysis
In addition to disputing Examiner's ODP rejections on a patent-by-
patent basis, Appellant advances two general arguments. First, Appellant
contends that requiring a terminal disclaimer "is at odds with the patent
systems [sic] goal of an early and full disclosure" because there is no
improper timewise extension of the right to exclude under the facts here.
App. Br. 7. Second, Appellant argues that the two-way obviousness analysis
should apply for those reference patents that issued after the first office
action "that contained exclusively ODP rejections." Id. at 8. We address
each of those general arguments, before turning to Appellant's patent
specific arguments.
2 Examiner has withdrawn the prior obviousness-type double patenting
rejections over the claims of US 9,384,261, US 9,289,509, US 9,011,864
and US 9,446,146 in view of terminal disclaimers filed by Appellant after
the Final Action. Ans. 5-6.
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With respect to Appellant's first argument, we are unpersuaded that a
terminal disclaimer should not be required because Appellant's claims, if
allowed, would expire before those of the reference patents. An improper
timewise extension is only one of the justifications for ODP doctrine.
Another "rationale is to prevent multiple infringement suits by different
assignees asserting essentially the same patented invention." In re Hubbell,
709 F.3d 1140, 1145 (Fed. Cir. 2013). For this reason, the Office's
regulation requires that terminal disclaimers filed to obviate an ODP
rejection include "a provision that any patent granted on that application ...
shall be enforceable only for and during such period that said patent is
commonly owned with the application or patent which formed the basis for
the judicially created double patenting." 37 C.F.R § 1.32 l(c )(3) ( emphasis
added). By tying enforceability to continued common ownership, the
regulation mitigates against the risk of multiple, essentially redundant,
lawsuits thereby supporting this rationale for ODP doctrine.
Our reviewing court has likewise determined that it is "desirable to
tie both termination and the ownership of the two patents together." In re
Van Ornum, 686 F.2d 937, 948 (C.C.P.A. 1982) (emphasis added). In Van
Ornum, the patent applicants' terminal disclaimer was rejected because it did
not include the regulation's "commonly owned" provision. Id. at 939. On
appeal of the ODP rejection, applicants challenged the validity of the
regulation. Id. at 944. The court, after extensive discussion of precedent
and policy underlying ODP doctrine, held "it to be a valid regulation." Id. at
948. Nowhere does the Van Ornum court suggest that this holding is limited
to the particular facts of the patents and applications at issue there and, as
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Application 10/975,434
explained below, we conclude the holding is applicable to the facts
presented here.
The distinction Appellant attempts to draw over the facts of Van
Ornum, i.e., that the presently-rejected claims arise from "an earlier filed
more generic application," makes no difference to the rationale underlying
Examiner's ODP rejections. App. Br. 8. The same potential for multiple
lawsuits from different assignees exists here just as it did in Van Ornum.
Accordingly, even if we were not bound to follow precedent and require
compliance with the regulation to obviate an ODP rejection by terminal
disclaimer, Appellant has not provided any persuasive reason to depart from
such.
We are likewise unpersuaded by Appellant's argument that the two-
way obviousness test should apply for the reference patents that issued after
June 24, 2015. "A two-way test is to be applied only when ... the Office is
solely responsible for any delays." MPEP § 804 II(B)(2)( c) ( citing In re
Berg, 140 F.3d 1428, 1435 (Fed. Cir. 1998)) (emphasis added). Appellant
presents no argument that the Office is solely responsible for the reference
patents issuing before the claims on appeal, nor would the record support
such. From our review of the prosecution, Appellant has filed five requests
for continued examination and more than a dozen petitions for extensions of
time, totaling almost three years of time. Four of those extensions were
requested after June 24, 2015. Accordingly, Examiner was correct in
applying the one-way obviousness test for all of the ODP rejections here.
Having rejected both of the general arguments, we now address each
of Appellant's reference patent specific arguments.
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Reference Patent US 8,613,930
Appellant contends that the ODP rejection over the '930 patent claims
should be reversed because "none of the claims of the '930 patent constitutes
a species of the presently claimed invention." App. Br. 11. Moreover,
Appellant argues that the '930 patent claims do not "make a reference to
cleavability/releasability" and thus do not render obvious claim 1 's
requirement of that the targeting antibody be "releasably attached" to the
maytansinoid. Id. Appellant also argues that "[t]he '930 patent does not
contain any claims directed to a kit as set forth in claims 17 and 18." Id.
"As a general rule, obviousness-type double patenting determinations
tum on a comparison between a patentee's earlier and later claims, with the
earlier patent's written description considered only to the extent necessary to
construe its claims." Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., 689
F.3d 1368, 1378 (Fed. Cir. 2012). This is so because ODP doctrine is
intended to prevent the applicant "from claiming an obvious variant of what
it has previously claimed, not what it has previously disclosed." Id.
( emphasis in original).
With this in mind, we focus our analysis on a comparison of the '930
patent claims that are closest in subject matter to the claims on appeal here.
Claim 1 of the '930 patent is directed to a "cell-binding agent-drug
conjugate" with a "cytotoxic drug" linked to the "cell-binding agent" by a
"disulfide" bond. '930 patent col. 65, 11. 50-64. Appellant's Specification
states that "disulfide bonds" are "suitable linkers" for "an immunoconjugate
according to the present invention." Spec. 3, 1. 36 - 4, 1. 13. Thus, the
broadest reasonable interpretation of the "releasably attached" and
"configured so that the effector molecule is released from the
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imnmnoconjugate by cleavage or dissociation" limitations recited in
Appellant's claim 1 includes linkages established by the disulfide bonds to
which claim 1 of the '930 patent is directed.
The '930 patent claims also recite the other elements of Appellant's
claim 1. Claims 2, 3, and 22 of the '930 patent each depend from claim 13
and specify that the cytotoxic drug either is a "maytansinoid" or is selected
from a group of drugs that includes "maytansinoids." '930 patent col. 67, 11.
16-17, 11. 41--42; col. 70, 1. 57. Claim 4 depends from claim 1 and specifies
that the cell-binding agent targets cells expressing CD 13 8. Claim 10
specifies that the cell-binding agent recited in claim 1 is a humanized BB4
antibody.
Appellant's argument that "none of the claims ... constitutes a
species" of the rejected claims is apparently premised on the fact that claims
2, 3, and 22 (which are directed to the particular "effector molecule" in
Appellant's claim 1) do not depend from claims 4 and 10 ( which are directed
to the "targeting antibody" in Appellant's claim 1). But OD P is not limited
only to those instances where the reference patent expressly combines all of
the limitations into a single, anticipatory species claim. See MPEP II.B
( explaining that a nonstatutory double patenting rejection may be premised
on either an anticipation or an obviousness analysis). Here, claims 2--4, 10,
and 22 all depend from independent claim 1. This indicates that the species
of cytotoxic drug and cell-binding agent they recite are included within the
3 Claim 22 depends from claim 20, which in term depends from claim 1.
Claim 20 specifies formulae for three different linker groups. The first of
those formulas shows the drug conjugated to the cell-binding agent by a
disulfide bond.
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larger genus to which claim 1 is directed. The fact that the narrower
dependent claims of the '930 patent expressly recite these particular species
of drug and cell-binding agent provides sufficient rationale for a skilled
artisan to select them as the cell-binding agent and cytotoxic drug of the
conjugate in '930 patent claim 1. Indeed, Appellant has identified no reason
why a conjugate comprising the drug and antibody specified in the
dependent claims would not be an obvious species within the broader genus
of conjugates in claim 1. Accordingly, we agree with Examiner's
determination that Appellant's claim 1 is directed to an obvious variant of
the immunoconjugates in claims 1, 2--4, 10, and 22 of the '930 patent and
therefore affirm the ODP rejection. Since Appellant does not present any
separate argument as to rejected claims 3, 8, 10, 11, 13-16, and 39
separately, we affirm the ODP rejection for those claims as well.
With respect to claims 17 and 18, we determine that Examiner's ODP
rejection is not supported by a preponderance of the evidence. Claims 17
and 18 are directed to a "kit" that, inter alia, requires a "second
pharmaceutical composition" in a "separate container[]" to be used in
combination with a pharmaceutical composition comprising the claimed
immunoconjugate. The claims of the '930 patent do not refer to a "kit,"
"separate containers," or a "second pharmaceutical composition."
Moreover, Examiner has not articulated any explanation for why one of skill
would find such limitations obvious over the '930 patent claims.
Accordingly, we reverse as to claims 17 and 18.
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Reference Patent US 9,061,995
The '995 patent is related to the '930 patent4 and likewise claims
immunoconjugates comprising a cytotoxic drug and a cell-binding agent.
The arguments Appellant presents against the ODP rejection over the '995
patent are essentially the same as those asserted for the '930 patent. As
before, we are not persuaded by Appellant's arguments as they pertain to
rejected claims 1, 3, 8, 10, 11, 13-16 and 39.
Like claim 1 of the '930 patent, claim 1 of the '995 patent is directed
to a "cell-binding agent-drug conjugate" with a "cytotoxic drug" linked to
the "cell-binding agent." '930 patent col. 64, 11. 1-64. Claim 1 of the '995
patent provides a generalized formula linking the two with a bond ("Y") that
represents a "disulfide" group. Id. As explained above, this disulfide linker
is "releasably attached" as recited in Appellant's claim 1. Claims 2, 3, 19
and 20 of the '995 patent each depend from claim 1 and specify that the drug
either is a "maytansinoid" or is selected from a group of drugs that includes
"maytansinoids." Id. at col. 65, 1. 43, col. 66, 11. 1-2, col. 68, 1. 52-55.
Claim 4 depends from claim 1 and specifies that the cell-binding agent
targets cells expressing CD138. Claim 10 depends from claim 1 and
specifies that the cell-binding agent is a humanized BB4 antibody. For the
same reasons explained above with regarding the '930 patent, we agree with
Examiner's determination that Appellant's claim 1 is directed to an obvious
variant of the immunoconjugates in claims 1, 2--4, 10 and 22 of the '930
patent and therefore affirm the ODP rejection. Because Appellant does not
4 The '995 patent was issued from a continuation of the application that
issued as the '930 patent.
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present any separate argument as to rejected claims 3, 8, 10, 11, 13-16 and
39 separately, we affirm the ODP rejection for those claims as well.
With respect to claims 17 and 18, we determine that Examiner's ODP
rejection is not supported by a preponderance of the evidence. The claims of
the '995 patent do not refer to a "kit," "separate containers," or a "second
pharmaceutical composition." Moreover, Examiner has not articulated any
explanation for why one of skill would find those limitations obvious over
the '995 patent claims. Accordingly, we reverse as to claims 17 and 18.
Reference Patent US 9,221,914
We agree with Appellant that Examiner's ODP rejection over the '914
patent claims is improper because it was premised on the disclosure in the
specification as opposed to what is claimed in the '914 patent. See App. Br.
13-14. Unlike the claims of the '930 and '995 patents, the claims of the
'914 patent are directed to an antibody, not to an immunoconjugate of that
antibody with a maytansinoid drug. It may be, as Examiner found, that the
specification of the '914 patent discloses that the claimed antibodies can be
releasably attached to a maytansinoid to form an immunoconjugate as in
rejected claim 1, but that is not the proper analysis for ODP. "When
considering whether the invention defined in a claim of an application would
have been an obvious variation of the invention defined in the claim of a
[reference] patent, ... the disclosure of the patent may not be used as prior
art." MPEP § 804 II.B(2)(a); see also Eli Lilly, 689 F.3d at 1378. While the
specification may be consulted, e.g., to determine the meaning of a term in
the claim, the analysis must remain focused on a comparison of the claims.
Id. We determine that Examiner here erred by relying on the disclosure in
the specification of the '914 patent as prior art and combined that disclosure
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with the antibody in the '914 patent claims to formulate the ODP rejection.
Because that disclosure is not prior art, we reverse the ODP rejection over
the '914 patent as to all claims.
Reference Patents US 8,624,003 and 8,795,673
Appellant groups its arguments concerning the '003 and '673 patents,
both of which claim processes for making an immunoconjugate, together.
Appellant does not dispute that a claim to an immunoconjugate is an obvious
variant of a claim to a process for making that immunoconjugate. Instead,
Appellant urges that the ODP rejections over these patents should be
reversed because "the immunoconjugate as claimed [is not] necessarily a
product of the methods set forth in these patents." App. Br. 15. In
particular, Appellant argues that the claims of these patents only disclose a
"generic anti-CD138 antibody" as opposed to the "specific anti-CD138
antibody currently claimed." Id. at 16. Moreover, Appellant contends that
"[t]he '673 and '003 patents do not contain any claims directed to a kit as set
forth in claims 1 7 or 18." Id.
We are not persuaded by Appellant's arguments as they pertain to the
ODP rejection of claims 1, 3, 8, 10, 11, 13-16 and 39 over the '003 patent.
Claim 1 of the '003 patent is directed to a process for preparing a "purified
conjugate" that "comprises a maytansinoid molecule linked to an antibody."
'003 patent col. 33, 11. 2--4. Claim 7 depends from claim 1 further specifies
that the antibody binds to an antigen selected from a group that includes
CD138. Claim 8 specifies that the antibody in claim 1 is humanized BB4.
Accordingly, we disagree with Appellant's argument that the claims of the
'003 patent disclose only a "generic anti-CD138 antibody." App. Br. 16.
Claim 9 further specifies that the linker in claim 1 is "a cleavable or non
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cleavable linker." '003 patent col. 34, 11. 17-18. Accordingly, one of skill
in the art would understand that claim 1, and claim 8 by dependency, is
directed to a maytansinoid that is "releasably attached" to the antibody by a
cleavable linker. For these reasons, we agree with Examiner's determination
that Appellant's claim 1 is directed to an obvious variant of the
immunoconjugates produced by the process in claim 9 of the '003 patent and
therefore affirm the ODP rejection. Because Appellant does not present any
separate argument as to rejected claims 3, 8, 10, 11, 13-16 and 39
separately, we affirm the ODP rejection for those claims as well.
We are likewise not persuaded by Appellant's arguments as they
pertain to the ODP rejection of claims 1, 3, 8, 10, 11, 13-16 and 39 over the
'673 patent. Claim 1 of the '673 patent claims a process for preparing "an
antibody maytansinoid conjugate ... wherein the antibody is chemically
coupled through the linker to the maytansinoid." '673 patent col. 39, 11. 44--
53. Claim 20 depends from claim 1 and further specifies that the
maytansinoid is coupled "via chemical bonds selected from the group
consisting of disulfide bonds." Id. at col. 42, 11. 30-31. As explained above,
one of skill in the art would understand the broadest reasonable
interpretation of Appellant's claim 1 to include linkages formed by disulfide
bonds.
While none of the claims of the '673 patent expressly recite a BB4
antibody, claim 16 specifies that the antibody of claim 1 is "an antibody that
binds to CD138." Id. at col. 41, 6-7. Appellant recognizes that the '673
patent specification teaches that BB4 is an antibody that binds to CD138, but
urges that it would be improper to rely on that teaching for ODP. App. Br.
16. We disagree. "[T]hose portions of the specification which provide
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support for the reference claims may ... be examined and considered when
addressing the issue of whether a claim in the application defines an obvious
variation of an invention claimed in the reference patent." MPEP § 804
II.B(2)(a) (citing In re Vogel, 422 F.2d 438, 441--42 (CCPA 1970)). The
portion of the '673 patent specification that provides support for the
"antibody that binds to CD138" limitation of claim 16 teaches that these
antibodies are those "described in U.S. Patent Application Publication
2007/0183971 (such as huB-B4)." '673 patent col. 16, 11. 1-3 (emphasis
added). A skilled artisan would therefore understand the BB4 antibody in
Appellant's claim 1 to be an obvious variant of the genus of anti-CD138
antibodies in '673 patent claim 16. For these reasons, we agree with
Examiner's determination that Appellant's claim 1 is directed to an obvious
variant of the immunoconjugates produced by the process in claim 16 of the
'673 patent and therefore affirm the ODP rejection. Because Appellant does
not present any separate argument as to rejected claims 3, 8, 10, 11, 13-16
and 39 separately, we affirm the ODP rejection for those claims as well.
With respect to rejected claims 17 and 18, we determine that
Examiner's ODP rejections for both the '003 and '673 patents are not
supported by a preponderance of the evidence. None of the claims of these
patents refer to a "kit," "separate containers," or a "second pharmaceutical
composition." Moreover, Examiner has not articulated any explanation for
why one of skill would find those limitations obvious over the '003 and '673
patent claims. Accordingly, we reverse both rejections as to claims 17 and
18.
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Reference Patents US 9,428,543 and 9,376,500
These patents are related to the '003 and '673 patents 5 and likewise
claim processes for preparing an antibody maytansinoid conjugate.
Appellant advances essentially the same arguments for the ODP rejections
over the '543 and '500 patents as above. See App. Br. 16-17.
As before, we are not persuaded by Appellant's arguments as they
pertain to the ODP rejection of claims 1, 3, 8, 10, 11, 13-16, and 39 over the
claims of the '543 patent. Claim 1 of the '543 patent claims a "process for
preparing an antibody maytansinoid conjugate ... wherein the antibody is
chemically coupled through the linker to the maytansinoid." '543 patent col.
39, 11. 55-65. Claim 23 depends from claim 1 and further specifies that the
maytansinoid is coupled "via chemical bonds selected from the group
consisting of disulfide bonds .... " Id. at col. 42, 11. 30-32. As explained
above, one of skill in the art would understand the broadest reasonable
interpretation of Appellant's claim 1 to include linkages formed by disulfide
bonds. Claim 5 depends from claim 1 and specifies that the antibody is
selected from a group that includes "an antibody that binds to CD138." For
the same reasons we explained above regarding the identical language in the
'673 patent, a skilled artisan would understand that the BB4 antibody in
Appellant's claim 1 is an obvious variant of the anti-CD138 antibodies in
claim 5 of the '543 patent. For these reasons, we agree with Examiner's
determination that Appellant's claim 1 is directed to an obvious variant of
the immunoconjugates produced by the process in claim 5 of the '543 patent
5 The '543 patent issued from a continuation of the application that issued as
the '673 patent. The '500 patent issued from a continuation of the
application that issued as the '003 patent.
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and therefore affirm the ODP rejection. Because Appellant does not present
any separate argument as to rejected claims 3, 8, 10, 11, 13-16, and 39
separately, we affirm the ODP rejection for those claims as well.
We are likewise not persuaded by Appellant's arguments as they
pertain to the ODP rejection of claims 1, 3, 8, 10, 11, 13-16, and 39 over the
claims of the '500 patent. Claim 1 of the '500 patent claims a process for
preparing a conjugate comprising "an effector or a reporter molecule linked
to a cell binding agent through a disulfide bond." '500 patent col. 33, 11. 46-
4 7. As explained above, a disulfide bond is encompassed within the
broadest reasonable interpretation of the "releasably attached" limitation of
Appellant's claim 1. Claims 5-9 depend from claim 1 and specify that the
effector molecule in claim 1 is a maytansinoid. Claim 13 depends from
claim 1 and further specifies that the cell binding agent in claim 1 is an
antibody that binds to an antigen selected from a group that includes CD138.
Claim 14 is even more specific, specifying that the cell-binding agent is
humanized BB4. While the claims specifying maytansinoid as the drug do
not depend from claims 13 and 14, all of the claims depend from claim 1. In
this regard, the claims of the '500 patent are similar to those of the '930
patent. For the same reasons explained above for the '930 patent, we agree
with Examiner's determination that Appellant's claim 1 is directed to an
obvious variant of the immunoconjugates produced by the processes in
claims 1, 5-9, 13, and 14 of the '930 patent and therefore affirm the ODP
rejection. Because Appellant does not present any separate argument as to
rejected claims 3, 8, 10, 11, 13-16, and 39 separately, we affirm the ODP
rejection for those claims as well.
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Finally regarding 17 and 18, we determine that Examiner's ODP
rejections over both the '543 and '500 patent claims are not supported by a
preponderance of the evidence. Like the other reference patents, none of the
claims of these patents refer to a "kit," "separate containers," or a "second
pharmaceutical composition." Moreover, Examiner has not articulated any
explanation for why one of skill would find those limitations obvious over
the '543 and '500 patent claims. Accordingly, we reverse both rejections as
to claims 17 and 18.
SUMMARY
We affirm the rejection of claims 1, 3, 8, 10, 11, 13-16 and 39 for
obviousness-type double patenting over the claims of the '930, '995, '003,
'673, '543, and '500 patents.
We reverse the rejection of claims 17 and 18 for obviousness-type
double patenting over the claims of the '930, '995, '003, '673, '543, and
'500 patents.
We reverse the rejection of 1, 3, 8, 10, 11, 13-18, and 39 for
obviousness-type double patenting over the claims of the '914 patent.
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).
AFFIRMED-IN-PART
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