Ex Parte Goldenberg

Patent Trial and Appeal Board

Sep 29, 2016

12987814 (P.T.A.B. Sep. 29, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/987,814 01/10/2011
37013 7590 10/03/2016
Rossi, Kimms & McDowell LLP
20609 Gordon Park Square
Suite 150
Ashburn, VA 20147
FIRST NAMED INVENTOR
Milton David 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-0003US3 9261
EXAMINER
DAHLE, CHUN WU
ART UNIT PAPER NUMBER
1644
NOTIFICATION DATE DELIVERY MODE
10/03/2016 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 MIL TON DAVID GOLDENBERG
Appeal2012-009092
Application 12/987,814
Technology Center 1600
Before DONALD E. ADAMS, ERIC B. GRIMES, and
RYAN H. FLAX, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL 1
This appeal2 under 35 U.S.C. § 134(a) involves claims 1, 2, and 4--13
(App. Br. 2). Examiner entered rejections under the written description and
enablement provisions of 35 U.S.C. § 112, first paragraph, 35 U.S.C.
§ 102(b ), and obviousness-type double patenting. We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM.
1 "The real party in interest [] is Immunomedics, Inc." (App. Br. 2).
2 This Appeal is related to Appeal 2011-010821 (Application 10/002,211 ).
A Decision on Appeal was entered into the record of Appeal 2011-010821
on July 30, 2013.
Appeal2012-009092
Application 12/987,814
STATEMENT OF THE CASE
Appellant's "invention provides an immunological method of ablating
a cell [(i.e., a B cell)] in a mammalian subject" with an immune disease
(Spec. 6: 15-17; see also id. at 7: 5-7, 12: 12-16, and Title). Claim 1 is
representative and reproduced below:
1. A method of ablating a targeted non-malignant B cell,
compnsmg:
administering to a human subject having an immune disease an
unconjugated monoclonal antibody or antibody fragment which
binds to a marker that is specific for a B cell, wherein the
monoclonal antibody or antibody fragment binds specifically to the
marker on the B cell,
thereby ablating the targeted non-malignant B cell to treat an
immune disease associated with the targeted non-malignant B cell.
(App. Br. 28. 3)
The claims stand rejected as follows:
Claims 1, 2, and 4--13 stand rejected under the written description
provision of 35 U.S.C. § 112, first paragraph.
Claims 9-13 stand rejected under the written description provision of
35 U.S.C. § 112, first paragraph as containing new matter.
Claims 1, 2, and 4--13 stand rejected under the enablement provision
of 35 U.S.C. § 112, first paragraph.
3 We note that all of the pages in Appellant's Appeal Brief are not
numbered. Therefore, for clarity, all page numbers relating to Appellant's
Appeal Brief are referred to herein as if Appellant's Appeal Brief was
numbered consecutively starting with the first page.
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Application 12/987,814
Claims 1, 2, and 4--13 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Meyer.4
Claims 1, 2, and 4--13 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Hansen. 5
Claims 1, 2, and 4--13 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Goldenberg '403. 6
Claims 1, 2, and 4--13 stand rejected under the judicially created
doctrine of obviousness-type double patenting as being unpatentable over
claims 1-3 of Goldenberg '570.7
Claims 1, 2, and 4--13 stand rejected under the judicially created
doctrine of obviousness-type double patenting as being unpatentable over
claims 1-20 of Goldenberg '403.
Obviousness-type Double Patenting:
Appellant's sole response to the obviousness-type double patenting
rejections on this record is that "[A]ppellant is deferring incurring the
expense of filing terminal disclaimers until such time as the other rejections
in this case have been resolved favorably" (App. Br. 26 and 27). Appellant
has, therefore, waived any appeal of the obviousness-type double patenting
rejections of record. Accordingly, we decline to address the merits of the
obviousness-type double patenting rejections.
4 Meyer, Jr. et al., US 4,861,579, issued Aug. 29, 1989.
5 Hansen et al., US 7,151,164 B2, issued Dec. 19, 2006.
6 Goldenberg et al., US 7,074,403 Bl, issued July 11, 2006.
7 Goldenberg, US 7,811,570 B2, issued Oct. 12, 2010.
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Application 12/987,814
Written Description:
ISSUE
Does the preponderance of evidence on this record support
Examiner's finding that Appellant's Specification fails to provide written
descriptive support for Appellant's claimed invention?
FACTUAL FINDINGS (FF)
FF 1. Appellant discloses
an immunological method of ablating a cell in a mammalian
subject [] comprising administering to the subject requiring
ablation of [a] cell, a composition comprising an antibody or
fragment specific to a hormone receptor or growth factor
receptor on a cell targeted for ablation, wherein the antibody or
fragment is conjugated to a chemical or radiation ablation
agent.
(Spec. 6: 15-22; see generally Ans. 13 and 14.)
FF 2. Appellant discloses the "ablation of certain normal organs and
tissues for [] therapeutic purposes, such as the spleen in patients with
immune disease or lymphomas, the bone marrow in patients requiring bone
marrow transplantation, or normal cell types involved in pathological
processes, such as certain T-lymphocytes in particular immune diseases"
(Spec. 7: 5-10; see id. at 9: 2-10; see Ans. 13).
FF 3. Appellant discloses that "[s]everal methods are known to those
skilled in the art for producing organ or tissue associated or specific
antibodies, if existing antibodies are considered unsuitable or if different or
more discriminating specificities are desired" (Spec. 9: 17-21; see generally
id. at 9: 17 - 12: 3).
FF 4. Appellant discloses that "[a]ntibodies and fragments useful in the
methods of [Appellant's] invention include those against antigens associated
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Application 12/987,814
or produced by normal organs, tissues, and cells, and may or may not be
cross-reactive with certain neoplastic tissues," wherein "[s]pecific examples
include antibodies and fragments against ... B-cells" (Spec. 12: 4--7 and 12-
16).
FF 5. Appellant discloses "the LL2[SJ (also known as EPB-2) monoclonal
antibody, ... which is directed against normal and malignant B-cells, and
which can be used for treating normal spleen cells in patients with immune
diseases, lymphoma, and other diseases" (Spec. 12: 30-35).
FF 6. Examiner finds that Appellant's "[S]pecification has not disclosed
'fully characterized antigen or a marker associated with a B-cell, either by its
structure, formula, chemical name or physical properties, or by depositing
the protein in a public depository' for [sic] which the B-cell antibody would
bind" (Ans. 14, citing Noelle v. Lederman, 355 F.3d 1343, 1349 (Fed. Cir.
2004) (emphasis removed); see also id. at 4 and 30).
FF 7. Examiner finds that Appellant's claimed invention "is generic in the
sense that it includes antibodies that specifically bind[] to B cell surface
antigens as well as intracellular proteins inside a B-cell to ablate any or all
cell[ s] that [are] not malignant B cell[ s] for treating any or all
disease/immune disease" (Ans. 15).
FF 8. Examiner relies on Y ouinou9 to "teach that B-cells express a variety
of different cell surface markers depending on the B-cell subsets and
locations" (Ans. 15, citing Youinou 217: Table 1 ).
8 Appellant states that the LL2 antibody is an "anti-CD22 antibody" (App.
Br. 17).
9 Pierre Youinou et al., B lymphocytes on the front line of autoimmunity, 5
Autoimmunity Reviews 215-221 (2006).
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Application 12/987,814
FF 9. Examiner relies on Seed 10 to teach that "a mammalian cell (e.g. B
cell) may contain up to 30,000 different mRNA sequences that can be
translated to proteins" (Ans. 15; see also id. at 5 (Appellant's
"[S]pecification further discloses that[, in the context of organ-associated
and organ-specific antigen,] the antibodies can be produced by cell
membrane antigens but preferably intracellular antigens (e.g. see lines 10-12
on page 11 of the [S]pecification)"); see id. at 32).
FF 10. Poon declares that "a large number ofB-cell antibodies have been
described and were commercially and/or publicly available prior to 1992"
(Poon Decl. 11 i-f 9; see also id. i-fi-13-9, citing pre- and post-filing date
references).
FF 11. Epstein discloses that "[ m ]onoclonal antibodies to human B-cell
antigens have been developed by a number of laboratories in the last several
years" (Epstein12 830: col. 1, Introduction).
FF 12. Domer declares that he "ha[s] no difficulty in ascertaining the scope
of the term 'immune disease' in the context of the present disclosure as
referring to classical autoimmune diseases" (Domer Decl. 13 i-f 4; see also id.
,-r,-r 3-5).
FF 13. Domer declares that Appellant
was in possession of a method of using B-cell antibodies
generally to treat immune diseases, and not just the LL2 B-cell
10 Seed et al., EP 0 739 980 A2, published Oct. 30, 1996.
11 Declaration of Kenneth Poon, dated Nov. 28, 2007.
12 Alan L. Epstein et al., Two New Monoclonal Antibodies, Lym-I and Lym-
2, Reactive with Human B-Lymphocytes and Derived Tumors, with
Immunodiagnostic and Immunotherapeutic Potential, 4 7 Cancer Research
830-840 (1987).
13 Declaration of Thomas Domer, dated Nov. 28, 2007.
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Application 12/987,814
antibody specifically. The skilled artisan would understand that
[Appellant's] contribution to the art was the teaching that B
cells generally could be used to treat immune diseases. The
skilled artisan would not need to know the structure of
particular B-cell antibodies in order to be apprised of the full
scope of applicant's invention.
(Domer Deel. ,-r 5; see also Poon Deel. ,-r 10.)
FF 14. Domer '06 discloses that "anti-B cell immunotherapy with the
humanized anti-CD22 antibody epratuzumab was evaluated in [systemic
lupus erythematosus patients resulting in] ... evidence of clinical
improvement after the first infusion and durable clinical benefit across most
body systems" (Domer '06 14 Abstract; see also Steinfeld15 Abstract
("epratuzumab appears to be a promising therapy in active [primary
Sjogren's syndrome], suggesting that further studies be conducted")).
FF 15. Press discloses that the intravenous infusion of the unmodified, anti-
CD20, murine monoclonal antibody 1 F5 resulted in clinical responses in
"[f]our patients with refractory malignant B cell lymphomas" (Press16
Abstract; see generally Poon Deel. i-f 5).
14 Thomas Domer, et al., Initial clinical trial of epratuzumab (humanized
anti-CD22 antibody) for immunotherapy of systemic lupus erythematosus, 8
Arthritis Research & Therapy R 7 4 (2006).
15 Serge D. Steinfeld, Epratuzumab (humanized anti-CD22 antibody) in
primary Sjogren 's syndrome: an open-label phase 1111 study, 8 Arthritis
Research & Therapy R129 (2006).
16 Oliver W. Press et al., Monoclonal Antibody 1 F5 (Anti-CD20)
Serotherapy of Human B Cell Lymphomas, 69 Blood 584--591 (1987).
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FF 16. PRNewswire-FirstCall reports that "Trubion's TRU-Ols[l7J for
rheumatoid arthritis (RA) provided statistically significant efficacy after a
single infusion of 800 mg or 1,600 mg" (PRNewswire-FirstCall18).
FF 17. Winter discloses that "[r]ituximab, a chimeric mouse/human
monoclonal antibody targeting the pan-B-cell antigenic marker CD20, was
the first monoclonal antibody licensed for use in the treatment of cancer"
and reports that "[r]ituximab has demonstrated significant clinical efficacy in
the treatment of [B-cell non-Hodgkin lymphoma], particularly in
combination with chemotherapy" (Winter19 Abstract).
FF 18. Poon '86 discloses that
[ m ]onoclonal antibody therapy has several shortcomings that
must be addressed[, including,] modulation of the antigen from
the cell surface, which prevents antibody binding to the tumor
cells. The[, anti-CDS,] Tl 01 antigen-antibody complex is
pinocytosed into the cytoplasm,[] a phenomenon that might be
advantageous when drugs or toxins are linked to the antibody to
enhance its cytotoxicity.
(Poon '8620 18: col. 1, third indented paragraph (endnote omitted); see id. at
S: Table 6 (the TIOI antibody is an anti-CDS antibody); see generally Poon
Deel. i-f 6.)
17 Appellant states that "Trubion has a Fab-based product made from [the
anti-CD20 antibody] IFS [] B-cell antibody" (App. Br. 17).
18 PRNewswire-FirstCall via COMTEX News Network, Trubion
Pharmaceuticals Announces Presentation of Positive Data From Phase IIb
and Re-treatment Studies With TRU-015 in Patients With Rheumatoid
Arthritis (Nov. 8, 2007).
19 MC Winter et al., Ten years of rituximab in NHL, 8 Expert Opin. Drug
Saf. 223-23S (2009) (MEDLINE Abstract PMID: 19243307).
2° Kenneth A. Poon et al., Immunologic Classification of Leukemia and
Lymphoma, 68 Blood 1-31 (1986).
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Application I2/987,8 I4
FF I9. Epstein "describe[s] the development and characterization of two
new B-cell specific monoclonal antibodies, designated Lym-I and Lym-2"
(Epstein 830: col. 2, last indented paragraph).
FF 20. Wiirflein discloses that the
Lym-I and Lym-2 [antibodies] may have the additional
advantage that they bind preferentially to HLA class II in
malignant human B cells compared to normal B cells and
monocytes[]. A clinical Phase I trial with murine Lym-I
showed minimal toxicity in lymphoma patients[]. However,
clinical responses with the unconjugated antibody were
unsatisfactory, and the Lym-I antibody is currently evaluated as
a radioimmunoconjugate.
(Wiirflein21 3056-3057, bridging paragraph (endnotes omitted).)
ANALYSIS
Examiner finds that Appellant's Specification fails to establish that
Appellant was "in possession of the claimed method of ablating a targeted
non-malignant B cell[] in a human patient by administering an antibody that
specifically binds to a marker that is specific for a B cell[], thereby treating
an immune disease[] associated with said cell" (Ans. I6).
The evidence of record establishes that: (I) there are a multitude of
different markers on B cells; (2) antibodies to B cell markers and method of
making antibodies against B cell markers where known in the art at the time
of Appellant's claimed invention and (3) a person of ordinary skill in this art
would understand the scope of the phrase "immune disease," as the phrase is
used in Appellant's Specification and claims (FF 3 and 8-I3). While the
evidence of record establishes that the genus of antibodies encompassed by
21 Dieter Wiirflein, et al., Evaluating Antibodies for Their Capacity to Induce
Cell-mediated Lysis of Malignant B Cells, 58 Cancer Research 305 I-3058
(1998).
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Application 12/987,814
Appellant's claimed invention is extremely large, Appellant discloses a
single unconjugated anti-CD22 antibody, "LL2," which is directed against
normal and malignant B cells and is disclosed as useful "for treating normal
spleen cells in patients with immune diseases" (FF 5; see FF 7; see generally
FF 9 and 13; see also FF 14 (relating to the post-filing date results obtain
through the use of an anti-CD22 antibody in patients with systemic lupus
erythematosus and primary Sjogren's syndrome)).
Nevertheless, we recognize that the evidence of record supports a
finding that a second unmodified anti-B cell antibody was known in the art
at the time of Appellant's claimed invention, specifically, the unconjugated
anti-CD20 murine monoclonal antibody IFS, which was capable of eliciting
clinical responses in "four patients with refractory malignant B cell
lymphomas" (FF 15; see also FF 16-17 (relating, respectively, to the post-
filing date results obtain through the use of the anti-CD20 antibodies
"Trubion's TRU-015" and "rituximab")).
Notwithstanding the unconjugated anti-CD20 and anti-CD22
antibodies discussed above, the evidence of record also establishes that:
(1) there were recognized shortcomings in the practice of antibody therapy,
for example the modulation of antigen from the cell surface thereby
preventing the antibody from binding the cell and (2) unconjugated
antibodies directed against B cell markers produced unsatisfactory clinical
results, but may instead produce satisfactory results when conjugated to
another agent, e.g., a radioimmunoconjugate (FF 18-20). Appellant's
claimed invention requires the use of an unconjugated antibody (see App.
Br. 28).
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Application 12/987,814
Based on the foregoing, the issue before this panel distills down to
whether Appellant's Specification provides a description of the genus of B
cell markers encompassed by Appellant's claimed invention that, when
targeted with an unconjugated antibody, results in the ablation of a non-
malignant B cell in order to treat an immune disease associated with the
targeted non-malignant B cell. On this record, we find that Examiner has the
better argument (see FF 6, 7, and 9). "[A] patentee of a biotechnological
invention cannot necessarily claim a genus after only describing a limited
number of species because there may be unpredictability in the results
obtained from species other than those specifically enumerated." In re
Alonso, 545 F.3d 1015, 1020 (Fed. Cir. 2008) (citing Noelle v. Lederman,
355 F.3d 1343, 1350 (Fed. Cir. 2004).
We recognize that anti-B cell antibodies were known in the art at the
time of Appellant's claimed invention (see App. Br. 11-20; see also Reply
Br. 3--4). For the reasons discussed above, however, Appellant has not
provided an adequate written description of the large genus of antibodies
and/or B cell markers encompassed by Appellant's claimed invention that
would have reasonably been expected to ablate a targeted non-malignant B
cell to treat an immune disease associated with the targeted non-malignant B
cell as required by Appellant's claimed invention. Notwithstanding
Appellant's contentions to the contrary, the written description requirement
"requires a description of an invention, not an indication of a result that one
might achieve if one made that invention." Regents of the University of
California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997). Stated
differently, to comply with the written description requirement, Appellant
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Application 12/987,814
must "describe [] the invention, with all its claimed limitations, not that
which makes it obvious." Id. at 1566 (citation omitted).
CONCLUSION OF LAW
The preponderance of evidence on this record supports Examiner's
finding that Appellant's Specification fails to provide written descriptive
support for the claimed invention. The rejection of claim 1 under the written
description provision of 35 U.S.C. § 112, first paragraph is affirmed. Claims
2 and 4--13 are not separately argued and fall with claim 1.
New Matter:
ISSUE
Does the evidence of record support Examiner's finding that certain
phrases in Appellant's claims 9-13 represent new matter on this record?
ANALYSIS
Examiner finds that various phrases set forth in Appellant's claims 9-
13 introduce new matter into this record (see Ans. 16-17). For the reasons
set forth in Appellant's Brief, we find that a person of ordinary skill in this
art would recognize that the claim phrases identified by Examiner do not
represent new matter on this record (see App. Br. 7-9). "In order to satisfy
the written description requirement, the disclosure as originally filed does
not have to provide in haec verba support for the claimed subject matter at
issue." Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d 1320, 1323 (Fed.
Cir. 2000).
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Application 12/987,814
Enablement:
ISSUE
Does the evidence of record support Examiner's conclusion that
undue experimentation would be required to practice Appellant's claimed
invention?
FACTUAL FINDINGS (FF)
FF 21. Examiner finds that Appellant's "[S]pecification fails to disclose the
structure of [an] antibody or fully characterized antigen" that is
commensurate in scope with, and capable of performing, the method set
forth in Appellant's claimed invention (Ans. 20; see also id. at 19).
FF 22. Examiner finds that Appellant's Specification fails to provide
working examples of "a method of ablating normal cells in a subject by
administering a B-cell antibody that specifically binds to a B-cell" (id. at
19).
FF 23. Examiner finds that Appellant's "[S]pecification has not provide[d]
guidance as to how one of skill in the art would select a species of a
particular antibody that binds to a marker for a B cell or a marker specific
for a normal B cell from the large genus [encompassed by Appellant's
claimed invention] to administer to a human patient suffering from [an]
unspecified immune disease" (id. at 21 ).
FF 24. Examiner finds that
it is unpredictable whether all of the B-cell antibodies
(including antibodies that bind B-cell surface or intracellular
proteins as well as antibodies [that] cross-react [with] common
antigens expressed on a B-cell surface and other cell types, e.g.
T cells) can be administered [in an unconjugated form] to treat
immune disease as broadly claimed.
(Id. (emphasis removed).)
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Application 12/987,814
FF 25. Examiner relies on Vitetta22 to
teach that [the design of] therapeutic antibodies can be
unpredictable; [for example,] in the case of anti-CD28 antibody
[ (designed to bind to the CD28 molecule on the surface of
regulatory T cells)], although preclinical data show that the
antibody was safe when administered to two species of
monkeys, healthy humans injected with the anti-CD28 antibody
suffered immediate and profound side effects.
(Id., citing Vitetta 308-309.)
ANALYSIS
Examiner reasons that "even if a person skilled in the art could
produce an antibody that binds to a B-cell specifically, it would take undue
experimentation to determine which antibody can be administered to ablate
[a] non-malignant B cell ... to treat any or all immune disease" (Ans. 21).
Therefore, Examiner concludes that given "the lack of working examples,
the unpredictability of the art, the lack of sufficient guidance in the
specification, and the breadth of the claims, it would take undue
[experimentation] to practice the claimed invention" (id. at 22). See In re
Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
We agree with Appellant's contentions that a skilled artisan would
have no difficulty selecting: ( 1) "human patient[ s] who are suffering from
an immune disease" or (2) "a marker specific for a B cell" (App. Br. 19).
The question, however, is not whether it would require undue
experimentation to identify an individual suffering from an immune disease
or any of an extremely large number of markers on a B cell (cf App. Br. 19).
To the contrary, the question is whether, based on the limited disclosure in
22 Ellen S. Vitetta et al., Considering Therapeutic Antibodies, 313 Science
308-309 (2006).
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Application 12/987,814
Appellant's Specification, it would have required undue experimentation to
identify those B cell markers and unconjugated anti-B cell marker antibodies
that are capable of ablating targeted non-malignant B cells to treat an
immune disease associated with the targeted non-malignant B cell, as
required by Appellant's claimed invention (see, e.g., App. Br. 28, Claim 1).
On this record, we find that the preponderance of the evidence supports
Examiner's conclusion (FF 21-25).
Appellant's claimed invention is directed to a method of ablating a
targeted non-malignant B cell, therefore, we are not persuaded by
Appellant's reliance on the Poon Declaration and Poon '86 to suggest "B-
cell antibodies [that] are useful in monoclonal antibody therapy of B-cell
cancers, [wherein the Poon Declaration and Poon '86] cit[e] studies which
showed that the binding of B-cell antibodies to cancerous B cells affected
[cancer] progression" (App. Br. 21). We recognize, but are not persuaded
by, Appellant's contention that Poon '86 "shows that B-cell antibodies have
been demonstrated to possess a commonality of function both in terms of
their ability to specifically bind to B cells and also in the ability to affect
disease progression in cancer as a result of that binding" and "a skilled
artisan would [] extend that commonality of function to immune diseases"
(id.; cf FF 15 and 18-20). Poon '86 discloses that
[ m ]onoclonal antibody therapy has several shortcomings that
must be addressed[, including,] modulation of the antigen from
the cell surface, which prevents antibody binding to the tumor
cells. The[, anti-CDS,] Tl 01 antigen-antibody complex is
pinocytosed into the cytoplasm,[] a phenomenon that might be
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Application 12/987,814
advantageous when drugs or toxins are linked to the antibody to
enhance its cytotoxicity.
(FF 18.) On this record, Appellant's claimed method requires the use of
unconjugated antibodies and Appellant's Specification does not address how
a person of ordinary skill in this art would identify those B cell markers that,
inter alia, would not result in marker suppression and/or internalization of
the antibody through the process of pinocytosis (see id.). Appellant further
fails to establish an evidentiary basis on this record to support a conclusion
that a person of ordinary skill in this art would have recognized that an
unconjugated antibody that is internalized into a B cell would have
reasonably been expected to result in the ablation of a targeted non-
malignant B cell (FF 18). Therefore, we are not persuaded by Appellant's
contention that the evidence of record supports enablement of the claimed
method.
CONCLUSION OF LAW
The evidence of record supports Examiner's conclusion that undue
experimentation would be required to practice the claimed invention. The
rejection of claim 1 under the enablement provision of 35 U.S.C. § 112, first
paragraph, is affirmed. Claims 2 and 4--13 are not separately argued and fall
with claim 1.
Anticipation:
ISSUE
Does the preponderance of evidence on this record support
Examiner's finding that any one of Meyer, Hansen, or Goldenberg '403
teaches Appellant's claimed invention?
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FACTUAL FINDINGS (FF)
FF 26. Meyer teaches the "[s]elective suppression of[] B-lymphocytes can
be accomplished by treatment with an adequate amount of antibody to a
mature B-lymphocyte surface marker" (Meyer 2: 52-54; see Ans. 22).
FF 2 7. Meyer teaches the use of "therapeutic monoclonal antibodies in the
treatment of diseases such as ... autoimmune diseases" (Meyer 3: 45--49;
see Ans. 22).
FF 28. Examiner finds that while Meyer "is silent about the ablation of
[targeted non-malignant BJ cells, the claim language or limitation of ablating
[a targeted non-malignant BJ cell does not result in a manipulative difference
in [Appellant's] method steps when compared to" Meyer (Ans. 22).
FF 29. Examiner finds that Hansen anticipates Appellant's claims 1, 2, and
4--13 (Ans. 23-24).
FF 30. Examiner finds that Goldenberg '403 anticipates Appellant's claims
1, 2, and 4--13 (Ans. 25-26).
ANALYSIS
The rejection over Meyer:
Examiner finds that Meyer anticipates Appellant's claimed invention
(Ans. 22-23).
We recognize, but are not persuaded by, Appellant's contention that
Meyer does not teach: (1) "an anti-B cell antibody for therapy, but merely to
counteract the side effects of therapy" or (2) "a method of ablating normal
cells in a subject, in which a B-cell antibody or fragment thereof is
administered to treat an immune disease" (App. Br. 24 (emphasis removed);
cf FF 26-28).
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Application I2/987,8 I4
We recognize, but are not persuaded by, Appellant's contention that
"[t]he Lym-I and Lym-2 antibodies are not B-cell antibodies (App. Br. 24;
cf FF I9). Appellant's contention that the Lym-I and Lym-2 antibodies
cross-react with malignant B-cells is not persuasive (App. Br. 25; cf FF 4).
Appellant fails to establish an evidentiary basis on this record to support a
finding that the Lym-I and Lym-2 antibodies' "[l]ow levels of binding to
normal B cells leads to the conclusion that the antibodies are not 'B-cell
antibodies' and would not be effective for treating immune diseases" (App.
Br. 25). In re Pearson, 494 F.2d I399, I405 (CCPA I974) ("Attorney's
argument in a brief cannot take the place of evidence.").
The rejection over Hansen or Goldenberg '403:
Examiner finds that either of Hansen or Goldenber '403 anticipate
Appellant's claimed invention (FF 29-30). Appellant contends that neither
Hansen nor Goldenberg '403 are prior art against Appellant's claimed
invention, because Appellant is "entitled[, by way of continuing
applications,] to a filing date of April 7, I 992" (App. Br. 25-26). We are
not persuaded.
In order to gain the benefit of the filing date of an earlier application
under 35 U.S.C. § I20, each application in the chain leading back to the
earlier application must comply with the written description requirement of
35 U.S.C. § I I2. In re Hogan, 559 F.2d 595, 609 (CCPA I977). For the
reasons set forth above, Appellant failed to establish written descriptive
support for the subject matter of the claimed invention. Therefore, we
summarily affirm the anticipation rejection over each of Hansen and
Goldenberg '403.
I8
Appeal2012-009092
Application 12/987,814
CONCLUSION OF LAW
The preponderance of evidence on this record supports Examiner's
finding that Meyer, Hansen, or Goldenberg '403 teaches Appellant's
claimed invention. The rejection of claim 1under35 U.S.C. § 102(b) as
being anticipated by Meyer, Hansen, or Goldenberg '403 is affirmed.
Claims 2 and 4--13 are 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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