Ex Parte Kundra

Patent Trial and Appeal Board

Jan 24, 2017

13821541 (P.T.A.B. Jan. 24, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/821,541 06/26/2013 Vikas Kundra UTSC.P1065US 5797
108197 7590 01/26/2017
Parker Highlander PLLC
1120 South Capital of Texas Highway
Bldg. 1, Suite 200
Austin, TX 78746
EXAMINER
KELLY, ROBERT M
ART UNIT PAPER NUMBER
1633
NOTIFICATION DATE DELIVERY MODE
01/26/2017 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):
docket @ phiplaw .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte VIKAS KUNDRA1
Appeal 2016-002000
Application 13/821,541
Technology Center 1600
Before FRANCISCO C. PRATS, RICHARD J. SMITH, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to methods of
treating tumors. The Examiner rejected the claims for indefiniteness, lack of
enablement, and lack of written description.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
The following rejections are before us for review:
(1) Claims 1—3,1,9, 11, 12, 14—26, and 59-66, under 35 U.S.C.
§112, second paragraph, for indefiniteness (Ans. 3—4);2
1 Appellant states that the “real party in interest for this appeal is the
assignee Board of Regents, The University of Texas System.” App. Br. 3.
2 Examiner’s Answer issued December 16, 2015.
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Application 13/821,541
(2) Claims 1—3, 7, 9, 11, 12, 14—26, and 59-66, under 35 U.S.C.
§112, first paragraph, as failing to comply with the enablement requirement
(Ans. 4—12);
(3) Claims 1—3,1,9, 11, 12, 14—26, and 59—66, under 35 U.S.C.
§112, first paragraph, as failing to provide adequate descriptive support for
generic stem cells (Ans. 13—18);
(4) Claims 1—3, 7, 9, 11, 12, 14—26, and 59—66, under 35 U.S.C.
§112, first paragraph, as failing to provide adequate descriptive support for
a generic cell engineered to localize to a tumor (Ans. 19-20); and
(5) Claims 1—3, 7, 9, 11, 12, 14—26, and 59—66, under 35 U.S.C.
§112, first paragraph, as failing to provide adequate descriptive support for
generic administration of ligands and cells that bind to each other (Ans. 20—
21).
Claim 1, the sole independent claim on appeal, illustrates the claimed
subject matter and reads as follows (App. Br. 26):
1. A method of treating a tumor, comprising the steps of:
a) providing stem cells, immune cells or fibroblast cells having
the ability to migrate to and localize to a tumor upon parenteral
administration to a subject having a tumor, wherein the cells are
engineered cells that comprise an exogenous expression construct
having a nucleic acid sequence encoding a somatostatin receptor,
wherein the somatostatin receptor is a native somatostatin receptor or
a mutant thereof, wherein the receptor comprises a ligand binding
domain that is competent to bind a somatostatin receptor ligand;
b) introducing the engineered cells parenterally to a subject
having a tumor; and
c) administering to the subject a somatostatin receptor ligand
and an anti-tumor therapeutic that specifically binds the ligand and
that is effective to kill the engineered cells and thereby effect a
damage on the tumor, whereby the tumor is treated.
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STANDARD OF REVIEW
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
INDEFINITENESS
The Examiner’s Rejection
The Examiner finds that two recitations in the appealed claims render
the claims indefinite under § 112, second paragraph. The Examiner initially
contends:
Claim 1 recites “binds the ligand”. There is insufficient
antecedent basis to know what ligand is being referred to. To
wit, is this the somatostatin ligand or the receptor or other?
There is no “a ligand” prior to recitation, leaving one to wonder
if it is one or the other, or yet another species, because even the
receptor may be considered the ligand for the substance that
binds it.
Ans. 3^4.
The Examiner subsequently contends:
Claim 59 recites “the tumor is further defined as a solid
tumor”. It is not clear what the scope is which is being claimed.
Is Applicant claiming that it is a solid tumor, or that someone
defined it as a solid tumor? Is Applicant claiming solid tumor
versus soft-tissue tumor (e.g., connective tissue tumor?) or
versus being disseminated (e.g., hematological)? The scope is
simply not clear as the Artisan would not what it is, and
whether it must me simply defined to be something by
someone, or it must actually be a “solid tumor”.
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Ans. 4
Analysis
As our reviewing court has explained, the “test for definiteness is
whether one skilled in the art would understand the bounds of the claim
when read in light of the specification.” Miles Laboratories, Inc. v. Shandon
Inc., 997 F.2d 870, 875 (Fed. Cir. 1993).
In the present case, as Appellant argues (App. Br. 4—5), the full
recitation at issue in claim 1 recites “administering to [a] subject a
somatostatin receptor ligand and an anti-tumor therapeutic that specifically
binds the ligand.” Id. at 26.
We agree with Appellant that, read in context, the recitation at issue at
the very least clearly requires the anti-tumor therapeutic to bind to the
somatostatin receptor ligand. Accordingly, because a skilled artisan would
have understood the bounds of the claim when read in context, we reverse
the Examiner’s indefmiteness rejection of claim 1, and its dependents.
That the anti-tumor therapeutic might bind to ligands other than that
required by claim 1, as the Examiner argues (see Ans. 22—23), does not
render claim 1 indefinite. See In re Miller, 441 F.2d 689, 693 (CCPA 1971)
(“[Bjreadth is not to be equated with indefmiteness.”).
To that end, we note that claim 59 encompasses treating any tumor
that a skilled artisan would define as a solid tumor. That the recitation at
issue in claim 59 might be broad, however, does not demonstrate its
indefmiteness. See In re Miller, 441 F.2d at 693. Accordingly, we also
reverse the Examiner’s indefmiteness rejection of claim 59, and its
dependents.
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ENABLEMENT
The Examiner’s Rejection
The Examiner concludes that the Specification fails to enable the full
scope of the subject matter claimed
because the specification, while being enabling for
administration of MSCs [mesenchymal stem cells] by
intravenous and direct injection routes, that target tumor cells
expressing VEGF, and radioactively labeled ligands for the
receptor, as well as receptors that are bound to the MSCs and
bind to the somatostatin ligand/analog which contains a
radiolabel, and also only for allogenic or autologous
transplantations, or autologous administration of tumor-derived
macrocytes/monocytes, as well as the specific cell-tumor-
administration combinations already established in the prior art,
does not reasonably provide enablement for other, as
necessitated by amendment.
Ans. 4—5.
The Examiner contends that, viewed in light of the
Specification, practicing the full scope of the claimed subject matter
would require undue experimentation. Id. at 5—7. The Examiner
advances a number of references in support of that contention. Id. at
7-12.
Analysis
As our reviewing court has explained, the Examiner “bears an initial
burden of setting forth a reasonable explanation as to why it believes that the
scope of protection provided by that claim is not adequately enabled by the
description of the invention provided in the specification of the application.”
In re Wright, 999 F.2d 1557, 1561-62 (Fed. Cir. 1993).
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“The scope of enablement... is that which is disclosed in the
specification plus the scope of what would be known to one of ordinary skill
in the art without undue experimentation.” National Recovery Technols. Inc.
v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1196 (Fed. Cir. 1999).
While the Specification must enable the skilled artisan to practice the
full scope of the claimed subject matter, “[i]t is well settled that patent
applicants are not required to disclose every species encompassed by their
claims, even in an unpredictable art.” In re Vaeck, 947 F.2d 488, 496 (Fed.
Cir. 1991). Moreover, a claim does not lack enablement merely because it
encompasses inoperative embodiments. Atlas Powder Co. v. E.I. du Pont
De Nemours & Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984).
Rather, as our reviewing court has noted:
[Tjhere must be sufficient disclosure, either through illustrative
examples or terminology, to teach those of ordinary skill [in the
art] how to make and how to use the invention as broadly as it
is claimed. This means that the disclosure must adequately
guide the art worker to determine, without undue
experimentation, which species among all those encompassed
by the claimed genus possess the disclosed utility.
Vaeck, 947 F.2d at 496 (footnote omitted).
In the present case, having carefully considered the positions of the
Examiner and the Appellant, and the evidence advanced in support of those
positions, we conclude that a preponderance of the evidence does not
support the Examiner’s conclusion of lack of enablement.
Claim 1 recites a method of treating a tumor. App. Br. 26. In the first
step, the practitioner provides stem cells, immune cells, or fibroblast cells
capable of migrating and localizing to a tumor upon parenteral
administration to a tumor-harboring subject. Id. Claim 1 requires the
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provided cells to be engineered to have an exogenous expression construct
composed of a nucleic acid sequence encoding a somatostatin receptor, the
somatostatin receptor being a native or mutant receptor with a ligand binding
domain competent to bind a somatostatin receptor ligand. App. Br. 26.
In its second step, claim 1 requires introducing the engineered cells
parenterally to the tumor-harboring subject. Id. In its third step, claim 1
requires administering to the subject a somatostatin receptor ligand and an
anti-tumor therapeutic that specifically binds to the ligand. Id. Claim 1
requires the somatostatin ligand-binding therapeutic to be effective to kill
the engineered cells that have localized to the tumor, thereby damaging, as
well as treating, the tumor. Id.
As Appellant contends (App. Br. 8—10), the Specification3 provides an
in vivo working example in a mouse model in which systemically
administered stem cells encompassed by claim 1, and a systemically
administered somatostatin ligand-binding therapeutic agent encompassed by
claim 1, act to inhibit tumor growth.
Specifically, as seen at 1262, nude mice were induced to exhibit
palpable tumors by injecting human ovarian cancer cells (Hey A8 cells), and
were subsequently given (1) intravenous administration of a radioactive
agent bound through chelation to a somatostatin receptor ligand (“[90]Y-
octreotate (primarily beta emitter)”)4 and (2) intracardiac (i.e. systemic)
3 In citing to the Specification, Appellant and Examiner, for the most part,
cite to the published application, US 2013/0287681 A1 (published Oct. 31,
2013). We do the same for consistency.
4 Octreotate is a somatostatin analogue and, thus, is a somatostatin receptor
ligand. See Spec. 134. Although not explained as straightforwardly as it
might be, Appellant’s Figure 9 shows that the 90Y-octreotate used was Y90-
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administration of stem cells engineered to express a mutant somatostatin
receptor capable of binding a somatostatin ligand (HS5 human stem cells
expressing the mutant somatostatin receptor SSTR2D314). The
Specification discloses that “[tjumors to which HS5 cells expressing the
HA-SSTR2D314 mutant homed and incorporated were growth inhibited
compared to control.” Spec. 1262; see also Appellant’s Fig. 9.
It may be true, as the Examiner contends (Ans. 32—38), that claim 1
encompasses stem cells beyond those exemplified in the Specification, and
that claim 1 encompasses immune cells and fibroblast cells for which no
working examples have been provided. Nonetheless, to the extent that
certain stem cells, immune cells, and fibroblast cells were known in the art
not to localize to tumor cells, those cells are expressly excluded from
Appellant’s claim 1. See App. Br. 26 (claim 1 reciting “stem cells, immune
cells or fibroblast cells having the ability to migrate to and localize to a
tumor upon parenteral administration to a subject having a tumor”).
It may be true, as the Examiner contends (Ans. 34—35), that not every
type of stem cell, immune cell, or fibroblast cell capable of localizing to
tumors would have worked in accordance with the invention as described. It
may also be true, as the Examiner contends (id. at 38—40), that not every
combination of somatostatin receptor, ligand, and ligand-binding anti-tumor
therapeutic would function in every conceivable circumstance encompassed
by the claims. As discussed above, however, the Specification provides a
DOTATATE. Appellant’s Specification explains that Y90-DOTATATE is
octreotate that contains a chelator, “DOTA,” which binds the 90Y moiety.
Spec. 134.
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working example specifically explaining how to practice the claimed
invention.
The Examiner does not explain sufficiently why an ordinary artisan,
armed with Specification’s exemplifying disclosure, explaining how to
practice the claimed invention, would have needed to experiment unduly to
determine whether a particular stem cell, immune cell, or fibroblast cell
encompassed by claim 1 would function in accordance with the claimed
invention. That claim 1 might encompass a variety of inoperative
embodiments is not evidence, by itself, that undue experimentation would
have been required to practice the full scope of the claimed subject matter.
See Atlas Powder v. DuPont, 750 F.2d at 1576 (a claim does not lack
enablement merely because it encompasses inoperative embodiments); see
also In re Anderson, 471 F.2d 1237, 1242 (CCPA 1973) (“It is always
possible to put something into a combination to render it inoperative. It is
not the function of the claims to exclude all such matters but to point out
what the combination is.”).
In sum, because the Specification includes an undisputedly enabling
disclosure of an in vivo embodiment of the process recited in claim 1, and
the Examiner’s evidence supports only the potential for a number of
inoperative embodiments, but does not demonstrate that, as described, undue
experimentation would have been required to practice the full scope of the
claimed process, the Examiner does not persuade us that the Specification
fails to adequately enable the full scope of the subject matter encompassed
by claim 1. See Johns Hopkins Univ. v. CellPro, Inc., 152 F.3d 1342, 1361
(Fed. Cir. 1998) (“The enablement requirement is met if the description
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enables any mode of making and using the invention.”) (quoting Engel
Indus., Inc. v. Loclformer Co., 946 F.2d 1528, 1533 (Fed. Cir. 1991)).
Because, for the reasons discussed, we conclude that a preponderance
of the evidence of record does not support the Examiner’s conclusion that
claim 1 lacks enabling support in the Specification, we reverse the
Examiner’s rejection of claim 1, and its dependents, on that ground.
WRITTEN DESCRIPTION-
STEM CELLS, IMMUNE CELLS, FIBROBLASTS
The Examiner’s Rejection
The Examiner’s first rejection under the written description
requirement of § 112, first paragraph, is based on a finding that the “claims
are generic for ‘stem cells’, ‘immune cells’, and ‘fibroblasts’ that have the
ability to migrate to and localize at a generic tumor upon parent[er]al
administration.” Ans. 13.
The Examiner contends that viewed in light of the Specification, as
well as the knowledge in the prior art, the full scope of the cells claimed
encompasses numerous embodiments, including inoperative ones, for which
Appellant has not shown possession. Id. at 13—18. The Examiner
summarizes the ultimate finding of written description as follows:
Given the breadth of tumor types, their factors which
cause migration, the evidence of immune evasion/suppression,
the sheer number of cell types, and lack of cause-and-effect for
the generic tumor and cell type and administration, the Artisan
would not have understood Applicant to have been in
possession of the invention as presently claimed.
Id. at 18.
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Analysis
To meet the initial burden of establishing a prima facie case of
unpatentability based on a lack of written description, the Examiner must
“present[] evidence or reasons why persons skilled in the art would not
recognize in the disclosure a description of the invention defined by the
claims.” In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996).
In the present case, having carefully considered the positions of the
Examiner and the Appellant, and the evidence advanced in support of those
positions, we agree with Appellant that a preponderance of the evidence
does not support the Examiner’s finding that the claims lack adequate
descriptive support.
Our reviewing court has stated that, “[f]or generic claims, we have set
forth a number of factors for evaluating the adequacy of the disclosure,
including ‘the existing knowledge in the particular field, the extent and
content of the prior art, the maturity of the science or technology, [and] the
predictability of the aspect at issue.’” Ariad Pharmaceuticals, Inc. v. Eli
Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (quoting Capon v.
Eshhar, 418 F.3d 1349, 1359 (Fed. Cir. 2005).
Accordingly:
A claim will not be invalidated on section 112 grounds
simply because the embodiments of the specification do not
contain examples explicitly covering the full scope of the claim
language. That is because the patent specification is written for
a person of skill in the art, and such a person comes to the
patent with the knowledge of what has come before. Placed in
that context, it is unnecessary to spell out every detail of the
invention in the specification; only enough must be included to
convince a person of skill in the art that the inventor possessed
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the invention and to enable such a person to make and use the
invention without undue experimentation.
Falknerv. Inglis, 448 F.3d 1357, 1366 (Fed. Cir. 2006) (quoting LizardTech,
Inc. v. Earth Resource Mapping, PTY, Inc., 424 F.3d 1336, 1345 (Fed. Cir.
2005)); see also Capon v. Eshhar, 418 F.3d at 1359 (“It is not necessary that
every permutation within a generally operable invention be effective in order
for an inventor to obtain a generic claim, provided that the effect is
sufficiently demonstrated to characterize a generic invention.”).
In the present case, as discussed above, the Specification provides an
in vivo working example in a mouse model in which systemically
administered stem cells encompassed by claim 1, and a systemically
administered somatostatin ligand-binding therapeutic agent encompassed by
claim 1, act to inhibit tumor growth. See Spec. 1262. We, thus, agree with
Appellant that the tumor treating effect required by Appellant’s claim 1 has
been shown sufficiently to characterize, generically, the invention recited in
claim 1.
As discussed above also, to the extent that certain stem cells, immune
cells, and fibroblast cells were known in the art not to localize to tumor cells,
those cells are expressly excluded from Appellant’s claim 1. See App. Br.
26 (claim 1 reciting “stem cells, immune cells or fibroblast cells having the
ability to migrate to and localize to a tumor upon parenteral administration
to a subject having a tumor”).
It might be true, as with the enablement rejection above, that not every
type of stem cell, immune cell, or fibroblast cell capable of localizing to
tumors, as required by claim 1, would have worked in accordance with the
invention as described. That one may conceive of claim-encompassed
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embodiments that might not function in accordance with the invention as
described does not, however, demonstrate a lack of written description. See,
e.g., Falkner v. Inglis, 448 F.3d at 1366 (application disclosure need not
exemplify every embodiment encompassed by claims because “the patent
specification is written for a person of skill in the art”).
In the present case, although the Examiner might advance evidence of
potentially inoperative embodiments, the Examiner does not advance
persuasive evidence showing that a skilled artisan, viewing the claims and
written disclosure in the light of the knowledge in the prior art, would have
failed to recognize that Appellant adequately described, and thereby
possessed, the claimed invention. In contrast, Appellant advances
significant evidence showing that a skilled artisan would have understood
from the Specification and prior art what subject matter encompassed by the
claims would have been part of Appellant’s invention. See App. Br. 11—13
and references cited therein as support for enablement; see also id. at 19
(expressly incorporating enablement arguments in traversing written
description rejection).
Accordingly, for the reasons discussed, Appellant persuades us that a
preponderance of the evidence does not support the Examiner’s finding of a
lack of written description in this instance. We, therefore, reverse the
Examiner’s rejection of claim 1, and its dependents, on this ground.
WRITTEN DESCRIPTION-
CELLS ENGINEERED TO LOCALIZE TO TUMORS
The Examiner’s Rejection
The Examiner’s second rejection under the written description
requirement of § 112, first paragraph, is based on a finding that the claims,
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“as seen by depending claim 65, are drawn to or specifically encompass a
generic cell engineered to localize to migrate to, and localize within, a
tumor.” Ans. 19.
The reasoning underlying the Examiner’s ultimate finding of lack of
written description is as follows:
The specification provides broad recitation of such (p. 5),
arguing that it is well within the skill of the Artisan (Id.).
However, the sole example of such “engineering” is providing a
viral vector with a ligand that binds to a cell type to alter its
natural tropism profile (e.g., p. 65). There are absolutely NO
examples of any cell type that has been modified to migrate to,
and localize within, any type of tumor.
The Art provides nothing.
Hence, given the great number of ways of “engineering”
these cells to localize, and the non-exist[e]nt showing of a
single member of this large genera, the Artisan would not have
understood Applicant to have been in possession of the
invention at the time of filing.
Ans. 19-20.
Analysis
As an initial matter, we note that the sole claim actually requiring
modification of cells to localize to tumors is claim 65, which recites “[t]he
method of claim 1, wherein the cells are cells engineered to localize to a
tumor expressing an antigen or chemoattractant.” App. Br. 28.
As noted above, moreover, Appellant’s Specification must be viewed
not only for what it expressly describes, but for what it describes when
viewed by a skilled artisan armed with all of the relevant knowledge of the
prior art. See Falkner v. Inglis, 448 F.3d at 1366.
In the present case, as Appellant points out, beyond the descriptive
disclosure acknowledged by the Examiner (see Spec. ]Hf 246—247), a skilled
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artisan would have known of a number of ways in which a cell could be
modified so as to migrate to a tumor. See App. Br. 22—24, and references
cited therein. Indeed, by acknowledging that there are a “great number of
ways of ‘engineering’ these cells to localize” (Ans. 20), the Examiner
appears to agree with Appellant’s assessment of the state of the prior art in
this regard.
We acknowledge the Examiner’s contentions that Appellant’s claims
are not limited to the specific embodiments described in the references
Appellant cites to show the state of the art. Ans. 48 49. Again, however,
that one may conceive of claim-encompassed embodiments that might not
function in accordance with the invention as described does not demonstrate
a lack of written description. See, e.g., Capon v. Eshhar, 418 F.3d at 1359
(“It is not necessary that every permutation within a generally operable
invention be effective in order for an inventor to obtain a generic claim,
provided that the effect is sufficiently demonstrated to characterize a generic
invention.”).
Thus, on the current record, the Examiner does not advance
persuasive evidence suggesting that an ordinary artisan would have failed to
recognize that, when read in light of the knowledge in the prior art,
Appellant was in possession of cells engineered as required by claim 65, that
would be generally operable within the spirit of the claimed invention. In
contrast, Appellant’s Specification, as well as the prior art advanced by
Appellant, support a finding that an ordinary artisan would have understood
Appellant as having invented a process using cells engineered as required by
claim 65, and would have been able to make such cells, based on the
knowledge in the prior art.
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Accordingly, for the reasons discussed, Appellant persuades us that a
preponderance of the evidence does not support the Examiner’s finding of a
lack of written description in this instance. We, therefore, reverse the
Examiner’s rejection of claim 1, and its dependents, on this ground.
WRITTEN DESCRIPTION-
LIGANDS AND THERAPEUTICS THAT BIND TO EACH OTHER
The Examiner’s Rejection
The Examiner’s third and final rejection under the written description
requirement of § 112, first paragraph, is based on a finding that the claims
“are generic for administrations of ligands and therapeutics that bind each
other, but are not coupled to each other, and for any timing of
administration, as seen by the amendment in Claim 1.” Ans. 20.
In reasoning that such subject matter lacks written description, the
Examiner states as follows:
The specification only describes that these are “coupled”
to each other, which the Artisan would understand to be a
chemical linkage (covalent bond), and not separate. E.g., page
3. At no point is an example provided of separate
administrations, or non-covalently-linked entities. The Art fails
to make this clear for this invention. Hence, the Artisan would
not have understood Applicant to have been in possession of
the invention as claimed at the time of filing.
Ans. 21.
Analysis
The step at issue in this ground of rejection requires “administering to
the subject a somatostatin receptor ligand and an anti-tumor therapeutic that
specifically binds the ligand and that is effective to kill the engineered cells
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and thereby effect a damage on the tumor, whereby the tumor is treated.”
App. Br. 26 (claim 1).
As noted above, as to this step, Appellant’s in vivo working example
describes administering 90Y-octreotate, which is a radioactive somatostatin
analogue which contains a chelator that binds to the 90Y atom, and thus is a
somatostatin receptor ligand to which the anti-tumor therapeutic, the
radioactive 90Y, is actually bound. See Spec. 1262. As Appellant argues,
the Specification explains more generally that therapeutic radionuclides can
be bound to somatostatin receptor ligands using chelators. Id. at 134 (“The
ligand may further comprise a chelator molecule, such as . . . DOT A ... or .
. . DTPA .... In particular embodiments, the ligand may be [90YDOTA]-
octreotate or [177Lu-DOTA]-octreotate.”).
Given these disclosures, we conclude that an ordinary artisan, giving
claim 1 its broadest reasonable interpretation consistent with the
Specification, would have understood the administration step to involve the
co-administration of the somatostatin ligand and an agent that is bound to
the ligand. That is, we agree with Appellant that “delivery of the three-way
complex (receptor ligand - chelator - radionuclide) is consistent with it being
‘a somatostatin receptor ligand and an anti-tumor therapeutic that
specifically binds the ligand’” (Reply Br. 10) as recited in claim 1.
Accordingly, because the Examiner’s written description rejection is
based on interpreting claim 1 as encompassing separate administration of the
somatostatin ligand and its therapeutic agent binding partner, whereas an
ordinary artisan, for the reasons discussed, would not have considered that
interpretation reasonable in light of Appellant’s Specification, we reverse the
Examiner’s rejection in this instance as well.
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SUMMARY
For the reasons discussed, we reverse each of the Examiner’s
rejections.
REVERSED
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