Ex Parte Hyde et al

Patent Trial and Appeal Board

Jun 12, 2018

12228892 (P.T.A.B. Jun. 12, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/228,892 08/13/2008 Roderick A. Hyde
39124 7590 06/14/2018
CAROL NOTTENBURG
264 SENECA PLACE NW
RENTON, WA 98057
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.
AJE203 6539
EXAMINER
SZPERKA, MICHAEL EDWARD
ART UNIT PAPER NUMBER
1644
NOTIFICATION DATE DELIVERY MODE
06/14/2018 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):
carol.nottenburg@cougarlaw.com
chris. pratt@cougarlaw.com
cnot@comcast.net
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RODERICK A. HYDE, MURIEL Y. ISHIKAWA,
EDWARD K.Y. JUNG, WILLIAM GATES, ALOIS A. LANGER,
ERIC C. LEUTHARDT, ROYCE A. LEVIEN, MARK A. MALAMUD,
CLARENCE T. TEGREENE, THOMAS A. WEA VER,
CHARLES WHITMER, LOWELL L. WOOD JR.,
and VICTORIA Y.H. WOOD 1
Appeal2017-005763
Application 12/228,892
Technology Center 1600
Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and
JOHN G. NEW, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants identify Deep Science LLC as the real party-in-interest. App.
Br. 4.
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Application 12/228,892
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner's Final Rejection of claims 1-5. Specifically, claims 1--4 stand
rejected as unpatentable under 35 U.S.C. § 103(a) as being obvious over the
combination of Coller (US 5,328,840, July 12, 1994) ("Coller") and
Pallenberg et al. (US 2007 /0059316 A 1, March 15, 2007) ("Pallenberg").
Claims 1--4 also stand rejected as unpatentable under 35 U.S.C.
§ 103(a) as being obvious over the combination of Pallenberg and N. Hamdy
et al., Sheep Red Blood Cells Armed with Anti-CD20 Single-Chain Variable
Fragments (ScFvs) Fused to a Glycosylphosphatidylinositol (GP!) Anchor:
A Strategy to Target CD20-Positive Tumor Cells, 297 J. IMMUNOL.
METHODS, 109-124 (2005) ("Hamdy").
2
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Application 12/228,892
Claims 1-5 stand rejected as unpatentable under 35 U.S.C. § 103(a)
as being obvious over the combination of Coller, Pallenberg, and Wilson et
al. (WO 2005/034997 A2, April 21, 2005) ("Wilson"). 2, 3
We have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellants' invention is directed to compositions and methods of
using modified red blood cells, including a target-binding agent bound to the
cells, for targeted delivery of imaging agents, drugs, and peptide and protein
pharmaceuticals. Abstract.
2 The Examiner also rejected claims 1-5 as unpatentable under the
judicially-created doctrine of nonstatutory obviousness-type double
patenting over: (1) claims 1-24 of Hyde et al. (US 8,211,656 B2, July 3,
2012) ("Hyde") and "Kaplan et al." (but see fn.3, infra); (2) claims 1-24 of
Hyde in view of Wilson et al. (WO 2005/034997 A2) and "Kaplan et al.";
and (3) further provisionally rejected claims 1-5 on the same ground over
claims 1-16 of Appellants' copending Application No. 12/228,893, as
evidenced by Pallenberg. Final Act. 14--16. The Examiner has withdrawn
the latter provisional rejection because Appellants' copending application
has been abandoned. Ans. 13. Appellants do not argue or otherwise
mention the other obviousness-type double patenting rejections in their
Appeal Brief. We consequently summarily affirm the Examiner's
rejections on this ground. See 37 C.F.R. § 4I.37(c)(iv) ("[A]ny arguments
or authorities not included in the appeal brief will be refused consideration
by the Board for purposes of the present appeal").
3 We are unable to locate any prior art reference by "Kaplan et al." in the
record on appeal. However, because Appellants do not argue the rejections
citing this prior art, the actual identity of the "Kaplan et al." reference is
immaterial.
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Application 12/228,892
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A pharmaceutical composition, comprising: a red blood
cell including at least one target-binding agent including a target
recognition moiety coupled to a photoactivatable molecule and a
quencher molecule, wherein the at least one target-binding agent
is configured to emit at least one singlet oxygen radical molecule
upon exposure to electromagnetic radiation of a suitable
wavelength when the at least one target-binding agent is bound
to a target molecule; and a pharmaceutically acceptable
excipient.
App. Br. 26.
ISSUES AND ANALYSES
We agree with, and adopt, the Examiner's findings and conclusion
that the appealed claims are obvious over the combined cited prior art. We
address the arguments raised by Appellants below.
A. Rejection of claims 1--4 over Coller and Pallenberg
Issue 1
Appellants argue that the Examiner erred because the Examiner failed
to set forth a rational underpinning explain why a person of ordinary skill in
the art would have been motivated to combine the teachings of Coller and
Pallenberg. App. Br. 14.
Analysis
The Examiner finds Coller teaches methods of administering
erythrocytes which are targeted to desired locations in vivo; and that such
targeting molecules comprise one or more peptides, proteins, antibodies,
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lectins, carbohydrates, and steroids. Final Act. 3 (citing Coller, e.g., cols. 9,
18). The Examiner finds Coller particularly teaches the use of antibodies
comprising single chain variable domains ("scFvs"). Id. ( citing Coller col.
19). The Examiner points out that that scFvs are disclosed as "target binding
agents" in Examples 1-3 of Appellants' Specification. Id. at 4. The
Examiner further finds that Coller teaches that the targeted erythrocytes can
be loaded with a variety of diagnostic imaging reagents, including contrast
agents and radionuclides, as well as therapeutic agents such as
chemotherapeutics and thrombolytic agents. Id. ( citing Coller col. 17). The
Examiner finds, however, that Coller does not teach that the targeting
molecules bound to red blood cells are conjugated to a photosensitizer and a
quencher molecule. Id.
The Examiner finds Pallenberg teaches therapeutic and diagnostic
methods involving photodynamic therapy, which is efficacious for the
treatment of tumors although it can often damage non-target cells. Ans. 3
(citing Pallenberg Abstr., ,r,r 6, 7, 11, claims 1-64). The Examiner finds that
Pallenberg teaches that an advantage of its methods and compositions is that
its compositions are inactive, and hence non-toxic, until bound to the desired
target and irradiated with light ( electromagnetic radiation) of the appropriate
wavelength to release singlet oxygen radicals. Id. ( citing Pallenberg ,r,r 5---6,
Fig. 1).
Specifically, the Examiner finds that Pallenberg expressly teaches that
its compositions comprise a donor, such as a fluorophore, photosensitizer or
other such agent, linked to a targeting moiety and to an acceptor moiety,
such as a quenching agent, in such a way that activation of the donor, such
as the fluorophore or the photosensitizer, is quenched unless and until the
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targeting moiety is bound to a target. Id. The Examiner further finds that
Pallenberg teaches that, upon binding to a target, the acceptor moiety, such
as the quenching agent, dissociates or moves away from the donor agent,
such as the photosensitizer, whereby the donor is activated or active. Id.
The Examiner finds that Pallenberg teaches, by way of example, that for
conjugates containing a photosensitizer, binding to the target results in
activation of the photosensitizer upon irradiation with light of a suitable
wavelength. Id. The Examiner also finds that Pallenberg teaches antibodies
as targeting moieties. Id. (citing Pallenberg ,r,r 49, 66, 143-145, 246, and
claims 7, 8).
The Examiner concludes that it would have been obvious to a person
of ordinary skill in the art to substitute the antibody used in the antibody-
targeted red blood cells of Coller for the antibody-based targeting molecules
taught by Pallenberg. Final Act. 4. The Examiner concludes that a person
of ordinary skill would have been motivated to combine the references to
gain the advantage taught by Pallenberg that their modified antibodies are
essentially non-toxic and inert until they bind the desired target antigen
whereupon they become activated. Id.
Appellants argue that there would have been no need for the
advantage found by the Examiner, because the targeting disclosed in Coller
was found to be: (1) "safe material" ( citing Coller col. 4); (2) advantageous
because it is not subject to non-specific endocytosis (id. at col. 27); (3)
precise in targeting specific tissues (id. at, e.g., cols. 4, 5); and (4) as
achieving "highly selective binding" and "specific targeting of a drug to the
site where it is needed" (id. at col. 17). App. Br. 14.
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According to Appellants, the stated advantage of Pallenberg, viz., that
its "modified antibodies are essentially non-toxic and inert until they bind
the desired target antigen," was used by the Examiner as supplying
motivation for combining the references. App. Br. 15. Appellants contend
that the Examiner finds that the antibodies of Coller result in systemic
toxicity and are not inert before binding, notwithstanding numerous
statements in Coller to the contrary. Id. Furthermore, Appellants assert, it is
not the antibodies of Pallenberg that are non-toxic and inert until binding the
desired antigen: Appellants point out that the Examiner agreed with
Appellants that the antibodies do not have "any toxic effect in and of
themselves." Id. (quoting Final Act. 7). Rather, Appellants argue,
Pallenberg teaches that it is the photosensitizer that is non-toxic until bound
to a target. Id. (citing, e.g., Pallenberg ,r 7).
Appellants assert that Coller neither teaches nor suggests a
photosensitizer, making it unclear to Appellants what the Examiner found to
be toxic and active in Coller's compositions. App. Br. 15. Appellants argue
that the Examiner finds that the problem addressed by Coller is the "side
effects of conventional chemotherapeutic agents, such as nausea, hair loss,
and fatigue." Id. (citing Final Act. 5). Appellants note, however, that the
compositions of Coller that include chemotherapeutic agents are taught as
being loaded in the erythrocytes to avoid indiscriminate delivery. Id. ( citing
Coller col. 17).
Appellants contend that the Examiner's finding of an "increased level
of safety" as motivation to combine the references is specious because the
substitution of the antibody of Coller for the complexed antibody of
Pallenberg results in the addition of a toxic therapy. App. Br. 16.
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Appellants assert that the Examiner has failed to explain, and failed to cite
any factual evidence, as to how the addition of a photodynamic therapeutic
system provides improved safety. Id.
Furthermore, Appellants question why a person of ordinary skill in the
art would make such a substitution, when Coller already discloses a means
of delivering a drug to a specific target. App. Br. 16. Appellants point to
the Examiner's finding that adding photodynamic therapy agents makes
Coller's erythrocytes with antibodies on them safer. Id. However,
Appellants argue that not all of the compositions of Coller recite
chemotherapeutic agents loaded into erythrocytes, rather, Appellants argue,
Coller teaches a variety of materials for targeted delivery, including imaging
agents, enzyme, neurotoxin, growth factor, hormone, nucleic acid sequences
for gene therapy, anti-sense RNA or DNA, sperm, plasmids, modified virus
or viral nucleic acids. Id. Appellants assert that the Examiner focused only
on one of a number of compositions of Coller, i.e., that of a red blood cell
loaded with a chemotherapeutic agent, and used it to allege a motivation. Id.
at 16-17.
We do not find Appellants arguments persuasive. Coller teaches a
method for the targeted delivery of different agents, including
chemotherapeutic agents, via peptides, including antibodies, bound to
erythrocyte cell membranes. Specifically, Coller teaches:
According to the instant invention, erythrocytes, or in
particular thrombo-erythrocytes, prepared in accordance with the
present invention can be modified for delivery, to various target
tissues, of labels or biologically active agents that have been
incorporated into the erythrocytes (i.e. taken up by erythrocyte
ghosts) to form carrier erythrocytes ....
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The carrier erythrocytes have advantages over liposomes
by virtue of their larger size, which avoids the problem of non-
specific endocytosis of liposomes by scavenging cells such as
macrophages, and because of the presence of an extensive
cytoskeleton, that, for example, protects the erythrocytes from
complete osmotic lysis under hypotonic conditions. Moreover,
the cell surface integral membrane proteins of erythrocytes
provide a convenient scaffold for cross-linking targeting
molecules. Most importantly, since erythrocytes are inherently
biocompatible, the carrier erythrocytes are more likely also to
be biocompatible.
Coller col. 17, 11. 14--35 (emphasis added). Coller thus teaches that red
blood cells are highly advantageous for the targeted delivery of biologically
active agents (including cytotoxic agents, see, e.g., col. 17, 11. 49--54) for
numerous reasons, including especially their biocompatibility.
Pallenberg teaches:
[C]onjugates ... includ[ing] a fluorophore or photosensitizer
linked to a targeting moiety and a quenching agent in such a way
that activation of the fluorophore or the photosensitizer is
quenched unless the targeting moiety is bound to a target,
whereupon the quenching agent dissociates or moves away from
the photosensitizer, enabling activation of the photo sensitizer
upon irradiation with light of a suitable wavelength.
Pallenberg Abstr. Pallenberg teaches that its targeting agents include:
"compound[ s] that home[ ] in on or preferentially associate[ ] or bind[ ] to a
particular tissue, receptor, infecting agent or other area of the body of the
subject to be treated, such as a target tissue or target composition," and can
include, inter alia, an antibody. Pallenberg ,r 66. Pallenberg also teaches
that the term: "photosensitizer" or "photo sensitizing agent" denotes a
chemical compound that upon exposure to photoactivating light is activated,
converting the photosensitizing agent itself, or some other species, into a
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cytotoxic form, whereby target cells are killed or their proliferative potential
diminished." Id. at 21. Pallenberg further teaches that:
Virtually any chemical compound that, upon exposure to
photoactivating light, is converted into or gives rise to a cytotoxic
form may be used in this invention. Generally, the chemical
compound is nontoxic to the animal to which it is administered
or is capable of being formulated in a nontoxic composition, and
the chemical compound in its photodegraded form is also
nontoxic.
Id. Pallenberg thus teaches all of the limitations of the claims, with the
exception of teaching that its composition is bound to the surface of a red
blood cell. Appellants do not dispute these findings.
We agree with the Examiner that a person of ordinary skill in the art
would have been motivated to combine the teachings of Coller and
Pallenberg to arrive at Appellants' claimed invention. Such a combination
would combine the directed targeting of both references with the several
advantages of Coller, quoted supra, of delivering a targeting agent bound to
the cell membrane of an erythrocyte, with the photoactivated cytotoxicity of
Pallenberg' s compositions.
Appellants argue, essentially, that because both mechanisms are
"safe" to administer, there would be no motivation to combine. We
disagree; in fact, we find that the Examiner's findings that both methods are
safe to use would be a factor contributing to a person of ordinary skill's
motivation to combine the references, because both methods can be
practiced together, without risk of generally toxic, or other dangerous
effects, from either. We conclude that a person of ordinary skill,
understanding the teachings of Coller and Pallenberg, would be motivated to
combine the advantages of using a targeted molecule bound to the cell
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membrane of an erythrocyte taught by Coller, with the photoactivatable
cytotoxic agent of Pallenberg, because, unlike other cytotoxic agents,
Pallenberg teaches that its compositions are not cytotoxic until illuminated
by electromagnetic radiation of the requisite wavelength. See, e.g.,
Pallenberg ,r 21. We consequently affirm the Examiner's rejection upon this
ground.
Issue 2
Appellants argue that the Examiner erred in finding that claims 3 and
4 are unpatentable because the combination of Coller and Pallenberg fail to
teach the limitations of the claims reciting: "wherein the target is selected
from the group consisting of at least one of ... diseased cells in which the
disease is one of an autoimmune and an inflammatory disease" and "wherein
the target includes at least one of a bacteria .... ," respectively. App. Br. 9.
Analysis
Appellants point to the language of the Final Office Action, in which
the Examiner finds: "[s]uch a combination [of Pallenberg's photodynamic
antibody complexes and Coller's antibody-targeted RBCs] would be
particularly useful in the cancer treatment methods of Collar [sic]." App. Br.
10 ( quoting Final Act. 4 ). By contrast, Appellants argue, the claims recite,
in relevant part, that the targets are "diseased cells in which the disease is
one of an autoimmune and an inflammatory disease" and "bacteria." Id.
Appellants note that the Examiner then made two unsubstantiated
allegations: (1) "that such a delivery system would also reduce systemic
toxicity for all other disclosed diseases and disorders, such as bacterial
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infections as also disclosed by Pallenberg et al."; and (2) "that cancer and
bacterial infections are inflammatory diseases." Id. ( quoting Final Act. 4).
Appellants assert that, in response to their request that these
statements, the Examiner provided four additional references4 to support the
allegation that "cancer and bacterial infections are inflammatory diseases."
App. Br. 10. However, Appellants argue, these references do not support the
Examiner's position that cancer is an inflammatory disease, but rather
merely state an "association" of inflammation with some malignancies. Id.
Similarly, Appellants contend, the Examiner has conceded that there is a link
between bacterial infections and inflammation, but Appellants assert that
association is not the same thing as identity. Id. Appellants argue at some
length that there is no identity between the nature of cancer and
inflammation. Id.
We are not persuaded by Appellants' argument. Coller is not
restricted solely to the use of chemotherapeutic agents against neoplasms.
Rather, Coller teaches that:
In another embodiment, the carrier erythrocyte can be loaded
with one or more therapeutic agents. For example, and not by
way of limitation, the therapeutic agent can be a
chemotherapeutic, an enzyme, a neurotoxin, a growth factor, a
neurotrophic factor, a hormone, a thrombolytic agent, or any
4 A. Federico et al., Chronic inflammation and oxidative stress in human
carcinogenesis, 121 INT'LJ. CANCER 2381-86 (2007) ("Federico"); S.A.
Weitzman et al., Inflammation and cancer: role of phagocyte-generated
oxidants in carcinogenesis, 76(4) BLOOD 655-63 (1990) ("Weitzman"); J.
Parsonnet, Bacterial Infection as a Cause of Cancer, 103 (Supp. 8) EXP.
HEALTH PERSPEC. 263---68 (1995) ("Personnet"); Merck Manual of
Diagnosis and Therapy, Chapters 155-157, 1135-1209 (Seventeenth Ed.
1999) ("Merck Manual"
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drug. Generally, specific targeting of a drug to the site where it
is needed results in more effective therapy because a larger
therapeutic dose can be delivered than could be tolerated
systemically.
Coller col. 17, 11. 48-57.
Pallenberg is directed to:
[C]onjugates, kits, articles of manufacture and methods for
detection, diagnosis and treatment by photodynamic therapy of
certain undesired biological substrate targets, including, but not
limited to bacteria, viruses, and other pathogenic
microorganisms, tumors and hyperproliferative tissue.
Pallenberg Abstr. Specifically, Pallenberg teaches:
"Target compositions" as used herein are those
compositions that are intended to be impaired or destroyed by
this treatment method, and may include one or more pathogenic
agents, including but not limited to bacteria, viruses, fungi,
protozoa, and toxins as well as cells and tissues infected or
infiltrated therewith.
Id. at ,r 53 (emphasis added). Pallenberg teaches further that:
"Hyperproliferative disorders" as used herein denotes
those conditions sharing as an underlying pathology excessive
cell proliferation caused by unregulated or abnormal cell growth,
and include uncontrolled angiogenesis. Examples of such
hyperproliferative disorders includes, but are not limited to ...
psoriasis, atherosclerosis, psoriatic arthritis, rheumatoid
arthritis ....
Id. at ,r 55 (emphases added). Psoriasis, psoriatic arthritis, and rheumatoid
arthritis are all well known in the art to be inflammatory autoimmune
diseases. Given these teachings of the cited prior art, we do not find
persuasive Appellants' argument that Coller and Pallenberg fail to teach or
suggest the disputed limitations of claims 3 and 4.
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B. Rejection of claims 1--4 over Hamdy and Pallenberg
Issue 1
Appellants argue the Examiner erred because neither prior art
reference teaches or suggests the limitation of claim 1 reciting "red blood
cell including at least one target-binding agent including a target recognition
moiety." App. Br. 18.
Analysis
Appellants argue that Hamdy only incidentally teaches applying an
anti-CD20 scFv to erythrocytes as a means to demonstrate the presence of a
functional GPI anchor. App. Br. 18 (citing Hamdy 122). Rather, Appellants
point to Hamdy's statement that: "Our ultimate goal is to use the anti-CD20
scFv to target liposome-encapsulated drugs to CD20-expressing
hematological malignancies." Id. at 19. Appellants argue that, even if the
teachings of Hamdy and Pallenberg can be properly combined, the
combination of the references results in liposomes carrying photodynamic
therapeutic antibodies, rather than erythrocytes. Id.
We do not find Appellants' argument persuasive. Hamdy is entitled:
"Sheep red blood cells armed with anti-CD20 single-chain variable
fragments (scFvs) fused to a glycosylphosphatidylinositol (GPI) anchor: a
strategy to target CD20-positive tumor cells." (Emphasis added). Further,
Hamdy expressly teaches as the object of its reported study: "We show that
this GPI-tagged scFv can be loaded onto the surface of sheep erythrocytes
(Esh), which then specifically form rosettes with CD20-bearing tumor cells"
and that:
In order to demonstrate the presence of a functional GPI anchor,
we "painted" sheep erythrocytes with the GPI-tagged anti-CD20
scFv and formed rosettes after incubation with WSU-FSCCL
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cells. These experiments demonstrate that the binding of the scFv
to erythrocyte membranes is attributable to the GPI moiety,
whereas the scFv specifically recognized the CD20 antigen on
WSU-FSCCL cells.
Hamdy 111, 122. Although we agree with Appellants that Hamdy also
teaches: "Our ultimate goal is to use the anti-CD20 scFv to target liposome-
encapsulated drugs to CD20-expressing hematological malignancies;
therefore the glycosylphosphatidylinositol signal (GPI) of alkaline
phosphatase was attached to the C-terminus of the scFv" (Hamdy 122), we
agree with the Examiner that the stating of this aspiration in no way detracts
from the fact that Hamdy expressly teaches "red blood cell including at least
one target-binding agent including a target recognition moiety."
Issue 2
Appellants argue that the Examiner erred because a person of ordinary
skill in the art would not have been motivated to combine the teachings of
Hamdy and Pallenberg. App. Br. 20. Appellants rely upon essentially the
same arguments advanced with respect to the Examiner's combination of
Coller and Pallenberg, viz., that neither reference teaches or suggests that at
the antibody is anything but non-toxic. Id. at 20-21.
We have explained supra why we are not persuaded by Appellants'
arguments. We consequently affirm the Examiner's rejection of claims 1--4
on this ground.
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C. Rejection of claims 1-5 over Coller, Pallenberg, and Wilson
Appellants rely upon the same arguments presented in Sections A and
B supra with respect to the rejection of claims 1--4 over Coller and
Pallenberg. App. Br. 21-24. Appellants assert that Wilson does not cure the
alleged deficiencies of Coller and Pallenberg. Id. at 11. Because, for the
reasons we have explained with respect to that rejection, we do not find
Appellants' arguments persuasive, we affirm the Examiner's rejection of
claims 1-5 on this ground. 5
DECISION
The Examiner's rejection of claims 1-5 as unpatentable under 35
U.S.C. § 103(a) is affirmed.
The Examiner's rejection of claims as unpatentable under the
judicially-created doctrine of obviousness-type double patenting is affirmed.
No time period for taking any subsequent action in connection with
this appeal maybe extended under 37 C.F.R. § 1.136(a)(l). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED
5 Appellants also argue the patentability of claims 6-8. App. Br. 24. The
claims have been withdrawn as being directed to a non-elected species.
Final Act. 2. Since these claims are not presented on appeal, we do not
reach Appellants' arguments.
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