Ex Parte Goldenberg

Patent Trial and Appeal Board

Sep 26, 2016

13332614 (P.T.A.B. Sep. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/332,614 12/21/2011
37013 7590 09/28/2016
Rossi, Kimms & McDowell LLP
20609 Gordon Park Square
Suite 150
Ashburn, VA 20147
FIRST NAMED INVENTOR
David M. Goldenberg
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.
IMMU-0007US7 3464
EXAMINER
DENT, ALANA HARRIS
ART UNIT PAPER NUMBER
1643
NOTIFICATION DATE DELIVERY MODE
09/28/2016 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):
mail@rkmllp.com
EOfficeAction@rkmllp.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAVID M. GOLDENBERG 1
Appeal2014-002993
Application 13/332,614
Technology Center 1600
Before ULRIKE W. JENKS, JACQUELINE T. HARLOW, and
RICHARD J. SMITH, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
uECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims directed
to an immunoconjugate, that are rejected by the Examiner on the grounds of
nonstatutory obviousness-type double patenting. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.
1 According to Appellant, the real party in interest is Immunomedics, Inc.
(App. Br. 2.)
Appeal2014-002993
Application 13/332,614
STATEMENT OF THE CASE
Claims 1--43 are on appeal, and can be found in the Claims Appendix
of the Appeal Brief. Claim 1 is representative of the claims on appeal, and
reads as follows:
1. A therapeutic composition comprising a pharmaceutically
[acceptable] carrier and an immunoconjugate comprising an
anti-CD22 antibody or fragment thereof conjugated to one or
more therapeutic agents selected from the group consisting of a
drug and a radioisotope via a free sulfuydryl group in the hinge
region of the anti-CD22 antibody or fragment.
Appellant requests review of the Examiner's rejection of the claims on
the grounds of nonstatutory obviousness-type double patenting.
Specifically, the claims stand rejected as follows:
Claims 1--43 on the grounds of nonstatutory obviousness-type
double patenting over claims 1--43 of Goldenberg '073 2.
Claims 1--43 on the grounds of nonstatutory obviousness-type
double patenting over claims 1, 5-9, 12-17, and 21 of Goldenberg
'5963 in view of Goldenberg '073.
Nonstatutory Obviousness-Type Double Patenting over Goldenberg '073
The issue is: Does the preponderance of evidence of record support
the Examiner's conclusion that the present claims are not patentably distinct
from the claims in Goldenberg'073.
2 Goldenberg, US 7,939,073 B2, issued May 10, 2011 (hereinafter
"Goldenberg '073").
3 Goldenberg, US 8,105,596 B2, issued Jan. 31, 2012 (hereinafter
"Goldenberg '596").
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Application 13/332,614
Findings ofFact
FF 1. Claim 1 of Goldenberg' 073 reads as follows:
1. A method for treating a subject having a B-cell
malignancy, comprising administering to the subject a
therapeutic composition comprising a pharmaceutically
acceptable carrier, and an immunoconjugate, wherein the
immunoconjugate comprises:
(i) at least one anti-CD22 antibody or a fragment thereof, and
(ii) a therapeutic agent that is a drug or a radioisotope, wherein
the therapeutic agent is attached to the anti-CD22 antibody or
antibody fragment via a free sulfuydryl group in a hinge region
of the anti-CD22 antibody or fragment thereof.
Principle of Law
"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., 251F.3d955, 968 (Fed. Cir. 2001)
(citations omitted).
However, an exception applies in situations in which a divisional
patent application results from an Examiner-imposed restriction
requirement. In that situation, the divisional application cannot later be
rejected on the grounds of nonstatutory obviousness-type double-patenting
in light of the parent application pursuant to the safe harbor provisions of
35 U.S.C. § 121 (pre-AIA).
Analysis
We have reviewed Appellant's contentions that the Examiner erred in
rejecting claims 1--43 on the grounds of obviousness-type double patenting
(App. Br. 3-5). We disagree with Appellant's contentions and adopt the
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Application 13/332,614
findings, conclusions, and responses as set forth in the Examiner's Answer
and the Final Action dated March 5, 2013.
According to Appellant "the product claimed in this application, and
the method claimed in Goldenberg '073 meet both criteria for patentable
distinctness as set forth in the MPEP, and appellant is entitled to claim them
in separate application without filing a terminal disclaimer" (Reply Br. 2).
Appellant's argument is: claims which would be restricted if presented in a
single application should not fall under the rubric of obviousness-type
double patenting if presented in separate applications at a later time (App.
Br. 3-5).
While this argument has a certain logical appeal, the standards for
restriction practice are unrelated to the standards applied for patentability.
To restrict out claims, an Examiner need only show certain elements (e.g.,
differing classification) and issues of patentability are not considered (see,
e.g., MPEP § 808.02).
In the present Appeal, the obviousness-type double patenting rejection
of claim 1 turns on a two-part analysis. First, the analysis requires inquiry
into whether 35 U.S.C. § 121 precludes the double patenting rejection of
claim 1. If 35 U.S.C § 121 does not preclude the double patenting rejection
of claim 1, then we must determine whether the invention as defined in
appealed claim 1 is an obvious variant of the invention as defined in claims
1--43 of the Goldenberg '073 patent. The analysis employed in an
obviousness-type double patenting rejection parallels the analysis used to
determine obviousness under 35 U.S.C. § 103.
No evidence has been proffered that at any time during the
prosecution of the present application, or any of the benefit applications, that
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Application 13/332,614
the Examiner required a restriction between the product and methods of
using the product (Ans. 4 ("Appellant[] did not set forth a claim set at the
time of filing including two different inventions ... there was no restriction
between methods and products presented in the instant case, nor in patent
'073.")). Having determined that safe harbor provisions under 35 U.S.C.
§ 121 are inapplicable, we tum to the determination of whether the invention
defined in appealed claim 1 is an obvious variant of the invention defined in
claims 1--43 of Goldenberg '073.
If a claim sought in the application is not identical to, yet not
patentably distinct from, a claim in an inventor's earlier patent, then the
claim must be rejected under obviousness-type double patenting (see, e.g.,
MPEP §§ 804--804.03). As explained by the Examiner, "[t]he pending
application reads on a product, the said therapeutic composition and the
method of Goldenberg implements the same, exact therapeutic composition.
These taught antibodies can be formed as immunodulators [sic] further
comprising therapeutic agents, i.e. radioisotopes and attached to a
carbohydrate moiety and a free sulfuydryl group" (Ans. 2). We find no error
with the Examiner's determination that the differences between the present
claims and the prior patent claims are not sufficient to render the present
claims not obvious over the prior patent claims, and the present claims are
thereby not patentably distinct.
We do not agree with Appellant's contention that patentability
determinations under restriction practice should be applied to claims in two
different applications (see App. Br. 3-5 and Reply Br. 1--4). As explained
above, the standards for restriction practice are unrelated to the standards
applied for patentability. Rejoinder practice provides further insight into
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Application 13/332,614
these different standards. Rejoinder practice recognizes that even in the
context of restriction practice there is a special relationship between
products and methods of using the products (see MPEP § 821.04).
Rejoinder practice instructs that if "the product invention was elected and
subsequently found allowable, all claims to a nonelected process invention
... [are] eligible for rejoinder" (id.). Thus, with the proper use of rejoinder
practice, product and methods of using the product are linked together in one
application. The end result of rejoinder is same as linking the claims at a
later time using a terminal disclaimer between two different applications as
suggested by the Examiner in the present application based on an
obviousness analysis between the prior art method claims and the present
product claims. Indeed, MPEP § 821.04 warns that "[w]here applicant
voluntarily presents claims to the product and process, for example, in
separate applications (i.e., no restriction requirement was made by the
Office), and one of the applications issues as a patent, the remaining
application may be rejected under the doctrine of obviousness-type double
patenting." Here, the Examiner explained that there was no restriction
issued between the product and process claims in any of the benefit
applications, thus, a rejection under nonstatutory obviousness-type double
patenting is proper(Ans. 4 ("Appellant[] did not set forth a claim set at the
time of filing including two different inventions ... there was no restriction
between methods and products presented in the instant case, nor in patent
'073.")).
Because Appellant voluntarily presented claims to products and
processes in separate applications, we agree with the Examiner's conclusion
that the claims are obvious in light of the earlier issued claims. Accordingly,
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we find no error in the Examiner's rejection based on obviousness criteria
between the product claims and the prior issued method claims that require
the claimed product (FFl). We affirm the rejection of claim 1. Claims 2--43
were not separately argued and fall with claim 1. 37 C.F.R.
§ 41.37(c)(l)(iv).
Nonstatutory Obviousness-Type Double Patenting over Goldenberg '596 in
view of Goldenberg '073
The issue is: Does the preponderance of evidence of record support
the Examiner's conclusion that the present claims are not patentably distinct
from the claims in Goldenberg '596 in view of Goldenberg '073.
Findings of Fact
FF2. Claim 1 of Goldenberg'596 reads as follows:
1. A therapeutic composition comprising a combination of
antibodies, wherein one of the antibodies is an anti-CD22
antibody and the other antibody is an anti-CD20 antibody.
FF3. Claim 5 of Goldenberg' 596 reads as follows:
5. The therapeutic composition according to claim 1, wherein at
least one of the antibodies is conjugated to a drug.
FF4. Claim 6 of Goldenberg'596 reads as follows:
6. The therapeutic composition according to claim 5, wherein the
immunoconjugate comprises a chemotherapeutic drug.
Analysis
Appellant contends that the product of Goldenberg '596 "(a
combination of anti-CD22 and anti-CD22 antibodies) is patentably distinct
from the product presently claimed (an anti-CD22 immunoconjugate with
attachment to a free sulfuydryl in the hinge region)" (App. Br. 6). Appellant
explains that Goldenberg '596 "claims therapeutic conjugates, but does not
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Application 13/332,614
include any claim with a recitation that attachment is via a free sulthydryl
group in the hinge region" (App. Br. 7).
The Examiner explains that difference between Goldenberg '596 and
the present claims is that Goldenberg '596 is directed to a composition that
includes anti-CD22 and/or anti-CD20 immunoconjugates (Goldenberg '596,
see claims 1, 5, and 6; Final Act. 6). The Examiner recognizes that
Goldenberg '596 does not, however, claim a particular place of attachment
for the conjugate. The Examiner looks to Goldenberg '073 for teaching "a
therapeutic agent that is a drug or a radioisotope, wherein the therapeutic
agent is attached to the anti-CD22 antibody or antibody fragment via a free
sulfuydryl group in a hinge region of the anti-CD22 antibody or fragment
thereof' (FF 1; see also Final Act. 6 (the Examiner finds that
Goldenberg '073 claim 1 teaches "agents attached to an anti-CD22 antibody
or antibody fragment via a free sulfuydryl group in a hinge region")). The
Examiner concludes that it would have been obvious to attach the
immunoconjugate as disclosed in the claims of Goldenberg '596 to the
sulfuydryl groups of the hinge region as taught in Goldenberg '073 claims.
On the present facts, we find no evidence that there was a restriction
requirement issued by the Examiner at any point during the prosecution of
the present application or any of the benefit applications. As such,
Appellant voluntarily presented claims to the products and processes in
separate applications. Accordingly, we find no error in the Examiner's
rejection of the present product claims based on the combination of the prior
claimed composition (FF2-FF4) and method claim of Goldenberg '073 that
requires the claimed product (FF 1) but more broadly teaches attaching the
therapeutic agent to the antibody via a free sulfuydryl group in a hinge
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region (id.). We atlirm the rejection of claim 1 for the reason given by the
Examiner in the Final Action and Answer. Claims 2--43 were not separately
argued and fall with claim 1.
SUMMARY
We affirm the rejection of claim 1 on the grounds of nonstatutory
obviousness-type double patenting over claims 1--43 of Goldenberg '073.
Claims 2--43 were not separately argued and fall with claim 1.
We affirm the rejection of claim 1 on the grounds of nonstatutory
obviousness-type double patenting over claims 1, 5-9, 12-17, and 21
Goldenberg '596 in view of Goldenberg '073. Claims 2--43 were not
separately argued and fall with claim 1.
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
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