Nibaldo C. Inestrosa et al.

Patent Trials and Appeals Board

Feb 3, 2020

14761824 - (D) (P.T.A.B. Feb. 3, 2020)

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.
14/761,824 07/17/2015 Nibaldo C. INESTROSA InnoBio - 61/814445 1019
22925 7590 02/03/2020
Pharmaceutical Patent Attorneys, LLC
801 Brickell Avenue
9th Floor #9101
Miami, FL 33131-4924
EXAMINER
BARKER, MICHAEL P
ART UNIT PAPER NUMBER
1655
NOTIFICATION DATE DELIVERY MODE
02/03/2020 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):
administration@LicensingLaw.net
docket@LicensingLaw.net
mark.pohl@licensinglaw.net
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
________________

Ex parte NIBALDO C. INESTROSA and
JUAN L. HANCKE OROZCO1
________________

Appeal 2019–000509
Application 14/761,824
Technology Center 1600
________________

Before: JEFFREY N. FREDMAN, JOHN G. NEW, and
JAMIE T. WISZ, Administrative Patent Judges.

NEW, Administrative Patent Judge.

DECISION ON APPEAL

1 We use the word “Appellant” to refer to the “applicant” as defined in
37 C.F.R. § 1.142. Appellant identifies InnoBiosciences LLC as the real
party-in-interest. App. Br. 1.
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SUMMARY
Appellant files this Appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 9, 10, and 12–17 as unpatentable under
35 U.S.C. § 103(a) as being obvious over Hancke Orozco et al. (US
2006/0063831 A1, March 23, 2006) (“Hancke Orozco”).
Claims 1–9 also stand rejected as unpatentable under 35 U.S.C.
§ 103(a) as being obvious over et al. (CN 1666985 A, March 14,
2005) (“CN ’985”).2
Claims 1, 2, 5–7, and 11 stand rejected as unpatentable under 35
U.S.C. § 103(a) as being obvious over Bombardelli et al. (WO
2011/086007 A1,July 21, 2011) (“Bombardelli”).
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

NATURE OF THE CLAIMED INVENTION
Appellant’s claimed invention is directed to a method of using
andrographolide (the claimed composition) and its derivatives in the
treatment of Alzheimer’s disease. Spec. Abstr.

REPRESENTATIVE CLAIM
Independent claim 1 is representative of the claims on appeal
and recites:
1. Administering to human diagnosed with dementia, a
therapeutically effective amount of a compound of Formula (I):

2 A machine translation of CN ’985 provided by Google Patents is of
record. Neither Appellant nor the Examiner dispute its accuracy.
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wherein

R1 is selected from the group consisting of hydrogen, alkyl
or hydroxyl,

R2 is selected from the group consisting of hydroxyalkyl
or alkyl-O-L1, wherein L1 is a carbohydrate moiety,

R3 is selected from the group consisting of hydrogen or
hydroxyl,

X is selected from the group consisting of C(=CH2),
CH(OH), or a spirooxirane-2 moiety,

Z is selected from the group consisting of CH2, CH(OH)
or C(=O), and

R4 is selected from the group consisting of an optionally
substituted L2 alkyl or L2 alkenyl, wherein L2 is an optionally
substituted 3-furanyl or 3-fur-3-enyl moiety,

or a pharmaceutically acceptable salt, ester, ether or
prodrug thereof.

App. Br. 21.
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ISSUES AND ANALYSES
We agree and adopt, the Examiner’s findings, reasoning, and
conclusion that the claims on appeal are obvious over the combined cited
prior art. We address the arguments raised sequentially by Appellant below.

A. Rejection of the claims 9, 10, and 12–17 over Hancke Orozco
Issue
Appellant argues that the Examiner erred in disregarding a different
Examiner’s finding in a prior examination that Hancke Orozco does not
enable treating dementia. App. Br. 10.

Analysis
The Examiner finds that Hancke Orozco teaches an andrographolides3
composition that reduces proinflammatory cytokines and exemplifies its use
in treating Alzheimer’s disease and multiple sclerosis. Final Act. 6 (citing
Hancke Orozco ¶¶ 38, 69, 149, and 153–158 claims 53, 54, 57, 64). The
Examiner finds that Example 9 of Hancke Orozco teaches the
andrographolides composition used in the treatment of Alzheimer’s disease
and multiple sclerosis. Id. (also citing Hancke Orozco Exs. 11, 15, ¶¶ 149,
153–156). The Examiner finds that these treatments comprise 24.6%
andrographolide, 4.8% 14-deoxyandrographoilide, and 0.6%

3 Andrographolides are labdane diterpenes extracted from, and a major
component of, the plant Andrographis paniculata (family Acanthaceae).
See Spec. 1. Appellant and the Examiner do not dispute that Appellant’s
claimed compositions are andrographolides.
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neoandrographolide and further suggests a pharmaceutical form with
dosages of 1–5 mg/kg andrographolide, 0.2–1 mg/kg 14-
deoxyandrographoilide, and 0.02–0.12 mg/kg neoandrographolide. Id.
(citing Hancke Orozco 144–147).
The Examiner finds further that Hancke Orozco teaches that the
method of treating Alzheimer’s disease includes diagnosing patients with
appropriate neuropsychological tests, such as the MMSE, BNT, and TT.
Final Act. 6 (citing Hancke Orozco ¶¶ 153, 154). The Examiner finds that
Hancke Orozco differs from the present claims 9, 10, and 12–17 in that
Hancke Orozco at least explicitly suggests the methods now claimed but
fails to describe or contemplate an embodiment beyond the general teaching
and prophetic examples. Id.
Appellant argues that, in a prior examination, the Examiner found
that, given the unpredictability of pharmaceutical science, Hancke Orozco
does not enable treating dementia. App. Br. 10 (citing Office Act. re US
Appl. No. 10/516,500 at 6 (March 16, 2006) (the “’500 Examination”)).
Appellant contends that the Examiner in the present appeal can reject the
earlier fact finding in the ’500 Examination, but that, to do so, the Examiner
must first demonstrate evidence showing why the fact finding in the ‘’500
Examination was clearly error. Id. Appellant argues that the Examiner has
not done so. Id. Appellant therefore asserts that the Examiner must accept
the fact findings of the ’500 Examination, because Examiner Barker has not
provided any evidence showing clear error in that finding. Id. at 11 (citing
MPEP §§ 704.01, 706.04).
Appellant argues further that federal administrative procedure
distinguishes between fact findings and legal conclusions. App. Br. 11.
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According to Appellant, an Agency’s legal conclusions in one case do not
bind it in a later case with different facts, but Agency fact findings bind the
Agency in subsequent proceedings. Id. (citing, e.g., U.S. v. Utah Constr. &
Mining Co., 384 U.S. 394, 422 (1966) (holding that when a Federal agency
“resolve[s] disputed issues of fact properly before it which the parties have
had an adequate opportunity to litigate, the courts have not hesitated to apply
res judicata”)).
Appellant contends that, in the ’500 Examination, the Examiners
found that Hancke Orozco provides such limited disclosure, in an
unpredictable art, that Hancke Orozco failed to enable the artisan to treat
either dementia or AIDS. App. Br. 12. Appellant asserts that this is a
finding of fact, and not a legal conclusion. Id. Appellant argues that the
present Examiner’s rejection must be reversed as a matter of law because the
’500 Examination already found that Haneke Orozco fails to enable treating
dementia, and the Examiner in the present appeal provides no new evidence
showing that the ’500 Examination’s finding was clearly error. Id.
Appellant argues further that the Examiner’s alleged disregard of the
’500 Examination’s findings are in violation of the Federal Administrative
Procedure Act (the “APA”). App. Br. 12 (citing, e.g., Dickinson v. Zurko,
527 U.S. 150, 152 (1999)). Appellant alleges that the Examiner’s disregard
of the fact finding of the ’500 Examination, without providing evidence to
support a contrary position, is arbitrary and capricious in violation of 57
U.S.C. § 706(2)(A).
Appellant further argues that the APA requires the Examiner to give
“full faith and credit” to the findings of fact of the ’500 Examination. App.
Br. 13 (citing M.P.E.P. §§ 704.01; 706.04). Appellant therefore contends
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that the Examiner’s disregard of the ’500 Examination’s prior fact finding is
thus “without observance of procedure required by law.” Id. (citing 57
U.S.C. § 706(2)(D)).
We are not persuaded by Appellant’s argument. As an initial matter,
we disagree with Appellant’s contention that the ’500 Examiner’s
conclusion that: “Hancke [Orozco] failed to enable the artisan to treat either
dementia or AIDS,” is a finding of fact, rather than a conclusion of law.
App. Br. 12. “Invalidity for lack of enablement is a conclusion of law and
must be supported by facts proved by clear and convincing evidence.”
Northern Telecom, Inc. v. Datapoint Corp., 908 F.2d 931, 941 (Fed. Cir.
1990). The ’500 Examination’s conclusion that Hancke Orozco does not
enable the treatment of dementia is therefore, Appellant’s argument
notwithstanding, a conclusion of law that is not controlling in our analysis in
the present appeal.
Furthermore, Appellant’s characterization of the Examiner’s initial
Final Rejection of the ’500 application does not withstand scrutiny.
Although the Examiner initially rejected the claims under 35 U.S.C. § 112,
first paragraph, as failing to enable a “method of diagnosing in a patient a
disease selected from the group consisting of: Alzheimer’s disease; Immune
deficiency syndrome; and autoimmune disease,” this rejection was
subsequently withdrawn by the Examiner in a subsequent rejection. See
’500 Exam., Final Act., March 16, 2006 at 10–11; ’500 Exam., Final Act.,
January 19, 2007 at 2–3.
Furthermore, the claims at issue in the present appeal are not directed
to “a method of diagnosing a patient,” as claimed in the ’500 application, or
in Hancke Orozco, but rather to “[a] method comprising: administering to a
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human diagnosed with dementia…” (dependent claims 9, 10 (which depend
from claim 2)) or “[a]dministering to a human a test” and “Administering to
said human, … a daily dosage (claims 12–17). Whether the Hancke Orozco
claims enabled “diagnosing” is consequently entirely irrelevant to our
present inquiry and, in any case, that rejection was withdrawn by the
Examiner. Appellant makes no argument on the merits that the claims of
Hanck Orozco were not enabled by the Specification.
The question at hand, rather, is whether the claims are obvious over
the prior art reference cited by the Examiner. Appellant makes no
substantive argument on the merits of the Examiner’s obviousness rejection
beyond the argument that the prior art is not enabled. Because we conclude
that Appellant’s argument is not persuasive in this respect, we affirm the
Examiner’s rejection of claims 9, 10, and 12–17 upon this ground.

B. Rejection of the claims 1–9 over CN ’985
Issue
Appellant argues that the Examiner erred because the Specification of
CN ’985 does not enable the claimed treatment of dementia. App. Br. 15.

Analysis
Appellant acknowledges that CN ’985 teaches that andrographolide
affects IL-1β and TNF-α expression in vitro, and that, based upon this data,
CN ’985 teaches that andrographolide can be used to treat Alzheimer’s-
related dementia. App. Br. 13 (citing CN ’985 2, Figs. 1–2). However,
Appellant argues that CN ’985 also teaches that andrographolide can also be
used to treat a large number of other diseases that are associated with IL-1β
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and TNF-α expression. Id. at 13–14 (citing CN ’985 2, 5). Appellant argues
that the wide range of diseases that can thus be treated with andrographolide
is consequently and inherently unbelievable. Id. at 14.
Appellant argues, therefore, that CN ’985 is not enabled, and cannot
therefore stand as prior art to the present application. App. Br 15 (citing
MPEP § 2121(1); In re Morsa, 713 F.3d 104, 110 (Fed. Cir. 2013)).
Appellant points to the unpredictability of the art as further substantiating
their conclusion that CN ’985 is not enabled. Id. at 15. Appellant contends
that, given this unpredictability, the Board has already concluded that,
generally speaking, limited in vitro data standing alone does not enable
treating human dementia. Id.
We are not persuaded by Appellant’s argument. The question before
us is whether CN ’985 is enabling for the claims of the CN ’985 patent. The
claims of CN ’985 are not directed to a method of “treating human
dementia,” as argued by Appellant, but are primarily composition claims
directed to andrographolide. See CN ’985 claim 1: “A compound of the
following general formula or a prodrug thereof”; claim 5: “[t]he compound
or prodrug thereof of the following formula….”; claim 8: “[a]ndrographolide
preparing [sic] IL-1β inhibitor use….”; claim 9: “[a] compound or prodrug
thereof of the following formula”; claim 11: “the pharmaceutical
composition of claim 10….”
Claim 4 of CN ’985 recites: “Andrographolide preparation TNF-α
inhibitor use, wherein the TNF-a inhibitors useful for treating disorders
selected from the group of one or more of [various diseases including
Alzheimer’s].” Claim 10 of the CN ’985 patent recites: “A pharmaceutical
composition comprising a compound or prodrug thereof a therapeutically
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effective amount of a formula selected from the following, in a
pharmaceutically acceptable salt thereof and one or more pharmaceutically
acceptable carriers….”
All of the claims of CN ’985, with the exception of claim 4, are
therefore directed to composition claims and not to a “method of treating
human dementia” as argued by Appellant. We acknowledge that certain of
the claims of CN ’985 also recite some variation of where the claimed
compositions “are useful for the treatment of disorders selected from the
group of one or more of [various diseases including Alzheimer’s].” See, e.g.,
CN ’985 claim 8. However, these limitations recite an intended use of the
claimed compositions, and are consequently not limiting upon the claimed
composition itself. Therefore, the proper question is whether the
Specification of CN ’985 is enabling for the compositions recited in the
claims, and not whether it is enabling for “treating human dementia,” as
Appellant argues.
Our reviewing court has held that:
In patent prosecution the examiner is entitled to reject application
claims as anticipated by a prior art patent without conducting an
inquiry into whether or not that patent is enabled or whether or
not it is the claimed material (as opposed to the unclaimed
disclosures) in that patent that are at issue. The applicant,
however, can then overcome that rejection by proving that the
relevant disclosures of the prior art patent are not enabled.

Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355 (Fed. Cir.
2003) (Internal citation omitted). Appellant has made no argument that the
CN ’985 Specification is not enabled for the compositions recited in the
claims of the CN ’985 patent.
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Claim 10 of CN ’985 recites: “A pharmaceutical composition
comprising a compound or prodrug thereof a therapeutically effective
amount of a formula selected from the following, in a pharmaceutically
acceptable salt thereof and one or more pharmaceutically acceptable
carriers….” The Specification of the CN ’985 patent discloses:
A therapeutically effective amount of the compound of the
present invention, a prodrug thereof or a pharmaceutically
acceptable salt thereof and a pharmaceutical composition is
between 0.001–100mg/kg/d. Between any of the above range of
the amount of an effective amount of the present invention are
all between 0.001 mg/kg/d and 99.999 mg/kg/d which is between
the lower dose, higher doses ranged from 0.002 mg /kg/ d and
between 100 mg/kg/d.

See CN ’985, 12. We therefore conclude that, contrary to Appellant’s
argument, the CN ’985 patent is enabled for administering a therapeutically
effective dose of andrographolide.
Claim 4 of the CN ’985 patent recites: “Andrographolide preparation
TNF-α inhibitor use, wherein the TNF-α inhibitors useful for treating
disorders selected from the group of one or more of [various diseases
including Alzheimer’s].” We interpret this language to mean that the claim
recites using andrographolide as a TNF-α inhibitor, with the intended
purpose (“useful for”) of the treatment of various diseases, including
Alzheimer’s-related dementia. The CN ’985 patent discloses, in Figure 1:
“[T]he formula shown [sic] andrographolide and its derivatives, analogs in
vitro significantly inhibited the expression of precursor inflammatory
cytokines TNF-α and IL-1β….” CN ’985, 6. We therefore conclude that the
Specification of CN ’985 is enabling for its use as a TNF-α inhibitor. Id. at
7. Furthermore, CN ’985 also discloses that it was well known in the art that
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TNF-α inhibitors are useful in the treatment of TNF-α-related diseases,
including Alzheimer’s dementia. See CN ’985, 2. We consequently
conclude that the CN ’985 is enabling for claim 4.
We conclude that Appellant has failed to meet the burden of showing
that CN ’985 is not enabled. Because Appellant makes no substantive
argument addressing the Examiner’s conclusion that the claims on appeal
are obvious over CN ’985, we affirm the Examiner’s rejection of claims 1–9
on that ground.

C. Rejection of the claims 1, 2, 5–7, and 11 over Bombardelli
Issue
Appellant argues that: (1) Bombardelli fails to enable the artisan to
treat dementia; and (2) Bombardelli expressly teaches away from the
claimed method. App. Br. 18–19

Analysis
With respect to argument (1), Appellant argues that Bombardelli, like
the instant inventors, evaluates the behavior of transgenic mice in a Morris
Water Maze. App. Br. 16 (citing Bombardelli). According to Appellant,
Bombardelli teaches that treatment improved learning in the transgenic
mice, similarly to that found by the instant inventors. Id. However, argues
Appellant, Bombardelli does not provide examples of any further studies,
unlike the inventors of the present application. Id. Appellant therefore
argues that Bombardelli teaches how to improve learning, but not how to
treat dementia, because, Appellant asserts, water maze data alone does not
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“reasonably correlate” to efficacy in treating dementia in humans. Id. (citing
MPEP § 2107.03(1)).
With respect to argument (2), Appellant contends that the
administration of andrographolide without Gingko biloba extract and
phospholipids fails to “fully satisfy the therapeutic requirements.” App. Br.
19 (quoting Bombardelli 4). Appellant acknowledges the Examiner’s
finding that Appellant’s claims 1 and 2 allow for additional ingredients. Id.
However, argues Appellant, the issue is not whether a skilled artisan,
starting from claim 1, would find it obvious to add Gingko biloba extract
and phospholipids to claim 1 so as to replicate Bombardelli. Id. Rather,
Appellant asserts, the proper question is whether a skilled artisan, starting
from Bombardelli would have found it obvious to remove Gingko biloba
extract and phospholipid from the method taught by Bombardelli to arrive at
the method of claim 1. Id.
Appellant asserts that Bombardelli expressly admonishes the reader to
not do so, warning that andrographolide without Gingko biloba extract and
phospholipid fails to “fully satisfy the therapeutic requirements.” App. Br.
19 (quoting Bombardelli 4). Therefore, Appellant contends, Bombardelli
teaches away from Appellant’s claims on appeal. Id.
We are not persuaded by Appellant’s arguments. With respect to
Appellant’s argument (1) supra, Bombardelli expressly teaches that:
[T]he APPswe/PS1 transgenic mouse.…expresses the human
gene presenilin 1 (delta E9) and the chimeric mouse/human gene
of amyloid precursor protein (APP), which in turn contains the
Swedish mutation.

It has previously been demonstrated that this animal model is
characterized by abnormal amyloid deposition, with progressive
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memory loss, thus demonstrating one of the most predictive
models for the study of drugs designed to treat Alzheimer’s
disease.

See Bombardelli 8 (internal reference omitted). We agree with the Examiner
that Bombardelli thus teaches or suggests to the person of ordinary skill in
the art that the transgenic mice in question are recognized in the art as being
an accepted model for studying drugs designed to treat dementia, such as
that caused by Alzheimer’s disease, and that an aspect of this transgenic
mouse model of Alzheimer’s disease is progressive memory loss. See id.
Bombardelli further teaches that:
Treatment of 20 transgenic mice per group with the composition
described in example 1 and the individual ingredients
demonstrates that the composition according to the invention
significantly reduces memory loss induced by amyloid
accumulation in the transgenic mouse, as demonstrated in the
Morris water maze paradigm test (Morris R, J. Neurosci.
Methods 1984; 11:47-60).

Bombardelli 8 (emphasis added). Bombardelli does not thus merely teach
that treatment with its compositions improves learning, as argued by
Appellant, but rather teaches that administration of the composition, or its
individual ingredients, “significantly reduces memory loss induced by
amyloid accumulation in the transgenic mouse.” Id. We therefore agree
with the Examiner that a person of ordinary skill, comprehending the
teachings of Bombardelli, would have found it obvious to administer
andrographolide, one of the individual ingredients of Bombardelli’s
composition, to a human diagnosed with dementia.
For the same reason, we are not persuaded that Bombardelli teaches
away from Appellant’s invention. A “teaching away” requires a reference to
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actually criticize, discredit, or otherwise discourage the claimed solution.
See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). As we have
explained, Bombardelli expressly teaches that andrographolide, one of the
individual ingredients of Bombardelli’s composition, “significantly reduces
memory loss induced by amyloid accumulation in the transgenic mouse.”
Bombardelli 8. The passage of Bombardelli quoted by Appellant reads, in
its entirety: “Not all the mixtures described in the literature and present on
the market fully satisfy the therapeutic requirements.” Bombardelli 4. This
sentence is presented subsequent to a review of certain prior art compounds,
and not to the compositions taught by Bombardelli, which, as we have
explained, demonstrates that andrographolide, one of the individual
ingredients of Bombardelli’s composition, “significantly reduces memory
loss induced by amyloid accumulation in the transgenic mouse.” Id. at 8.
We do not, therefore, find persuasive Appellant’s argument that Bombardelli
teaches away from Appellant’s claimed invention.
Finally, in a footnote, Appellant also argues that Bombardelli is not
enabled because it does not teach dosage. App. Br. 18, fn.3. According to
Appellant, Bombardelli teaches making 600 mg cellulose oral capsules,
which, Appellant argues, has approximately the volume of a chick pea. Id.
(citing Bombardelli 7). Appellant argues that such capsules would be too
large for a mouse to swallow, and that Bombardelli therefore teaches
administering, not capsules, but “the composition,” Bombardelli, without
teaching how much composition is to be administered. Id.
We are not persuaded. Even if we accept Appellant’s unsupported
assertion with respect to the volume of a 600 mg oral capsule, Bombardelli
expressly teaches “[t]reatment of 20 transgenic mice per group with the
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composition described in example 1.” See Bombardelli 8. Example 1 of
Bombardelli teaches preparation of containing:
1. Andrographis paniculata extract (35% andrographolides) 150 mg
2. Ginkgo biloba extract complexed with phospholipid 250 mg
3. Evening primrose oil q.s. for 600 mg.
Id. Although Example 4 of Bombardelli is silent with respect to the means
of administration of the composition of Example 1, Bombardelli teaches that
administration of andrographolide alone, at 150 mg, “significantly reduces
memory loss induced by amyloid accumulation in the transgenic mouse.”
Id. at 8, 9, Table 1. We are consequently not persuaded by Appellant’s
argument that Bombardelli is not enabled as prior art to Appellant’s claims.

CONCLUSION
The Examiner’s rejection of claims 1–17 under 35 U.S.C.
§ 103(a) is affirmed.

AFFIRMED

Claims
Rejected
35
U.S.C.
§
Reference(s)/Basis Affirmed Reversed
9, 10, 12–17 103(a) Hancke Orozco 9, 10, 12–17
1–9 103(a) CN ’985 1–9
1, 2, 5–7, 11 103(a) Bombardelli 1, 2, 5–7, 11
Overall
Outcome 
    1–17