ITALFARMACO SPA

Patent Trials and Appeals Board

Nov 18, 2020

2020002100 (P.T.A.B. Nov. 18, 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.
15/346,926 11/09/2016 Tiziano OLDONI GPK-622-118 5553
23117 7590 11/18/2020
NIXON & VANDERHYE, PC
901 NORTH GLEBE ROAD, 11TH FLOOR
ARLINGTON, VA 22203
EXAMINER
CHONG, YONG SOO
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
11/18/2020 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):
PTOMAIL@nixonvan.com
pair_nixon@firsttofile.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte TIZIANO OLDONI, PAOLO MASCAGNI,
ALESSANDRO RAMBALDI, and TIZIANO BARBUI
____________

Appeal 2020-002100
Application 15/346,926
Technology Center 1600
____________

Before DONALD E. ADAMS, ULRIKE W. JENKS, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision to reject claims 13–15 and 18–21 (Final Act.2 2). We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as
“ITALFARMCO SPA, a corporation of Italy” (Appellant’s September 16,
2019 Appeal Brief (Appeal Br.) 3).
2 Examiner’s June 14, 2019 Final Office Action.
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STATEMENT OF THE CASE
Appellant’s disclosure relates to “[t]he use of substances capable of
inhibiting one or more enzymes of the histone deacetylase family (histone
deacetylase inhibitors) for the therapeutic treatment of Philadelphia-negative
myeloproliferative syndromes (polycythemia vera, essential
thrombocythemia or idiopathic myelofibrosis)” (Abstract3). Appellant’s
independent claim 13 is reproduced below:
13. Method of treating Philadelphia-negative
myeloproliferative syndromes in a patient suffering from said
syndromes, said method consisting of administering to said
patient an active ingredient consisting of diethyl-[6-(4-
hydroxycarbamoyl-phenylcarbamoyloxymethyl)-naphthalen-2-
yl-methyl]-ammonium chloride, or other pharmaceutically
acceptable salts and/or solvates, in a daily dosage amount of
from 50 to 150 mg per patient.
(Appeal Br. 22.)

Grounds of rejection before this Panel for review:
Claims 13–15 and 18–21 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Guerini,4 Golay,5 Wash,6 and Pinori
’355.7

3 Appellant’s November 9, 2016 Abstract of the Disclosure.
4 Guerini et al., Potent Inhibition of EEC Colony Formation in JAK2V617F PV
and ET by Low Doses of ITF2357, a New Histone Deacetylase Inhibitor,
108 BLOOD (ASH Annual Meeting Abstracts) Abstract 2702 (2006).
5 Golay et al., The histone deacetylase inhibitor ITF2357 has anti-leukemic
activity in vitro and in vivo and inhibits IL-6 and VEGF production by
stromal cells, 21 LEUKEMIA 1892–1900 (2007).
6 Wash et al., WO 2007/016354 A1, published Feb. 8, 2007.
7 Pinori et al., WO 2004/065355 A1, published Aug. 5, 2004.
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Claims 13–15 and 18–21 stand rejected under the judicially created
doctrine of obviousness-type double patenting as being unpatentable over
claims 1–2 of Pinori ’6898 in view of Wash.
Claims 13–15 and 18–21 stand rejected under the judicially created
doctrine of obviousness-type double patenting as being unpatentable over
claims 1–3, 6, 13, and 14 of Bertolini9 in view of Wash and Pinori ’355.

OBVIOUSNESS:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Appellant discloses that “[d]iethyl-[6-(4-hydroxycarbamoyl-
phenylcarbamoyloxymethyl)-naphthalen-2-yl methyl]-ammonium chloride,
which is described in WO 97 43251 (anhydrous form) and in . . . [Pinori
’355] (monohydrate crystal form), . . . is an HDAC inhibitor with good anti-
inflammatory activities; such an active principle is also known as ITF2357
and/or Givinostat” (Spec.10 3; see also Appeal Br. 7).
FF 2. Appellant discloses that it was known that “[m]yeloproliferative
syndromes are separated into four types: chronic myeloid leukaemia (CML),
polycythemia vera (PV), essential thrombocythemia (ET), and idiopathic
myelofibrosis (IM)”, wherein CML is a “Philadelphia-positive

8 Pinori et al., US 7,329,689 B2, issued Feb. 12, 2008.
9 Bertolini et al., US 6,034,096, issued Mar. 7, 2000.
10 Appellant’s November 9, 2016 Specification.
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myeloproliferative syndrome[]” and PV, ET and IM are “Philadelphia-
negative myeloproliterative syndromes” (Spec. 1).
FF 3. Guerini “investigate[d] the ability of ITF2357 . . . to inhibit the
spontaneous outgrowth of hematopoietic stem cells obtained from patients
with [Polycythemia Vera (PV), Essential Thrombocythemia (ET),] . . . and
Idiopathic Erythrocytosis” (Guerini, Abstract).
FF 4. Guerini discloses that “ITF2357, at concentration easily attained
after low oral doses of the drug, show[s] a potent inhibitory activity on the
autonomous proliferation of hematopoietic stem cells of PV and [ET]
carrying the JAK2 V617F mutation” and “[t]his may provide the framework
for a Phase II study of ITF2357 in these malignancies” (Guerini, Abstract;
see Final Act. 8; see also Final Act. 12; Ans.11 5 (Guerini discloses “that
ITF2357 shows a potent inhibitory activity on the autonomous proliferation
of hematopoietic stem cells of PV and ET carrying the JAK2V617F mutation,”
at a concentration easily attained after low oral doses of the drug)).
FF 5. Examiner finds that Guerini does not disclose “the treatment of [a
patient with] PV or ET by administering Givinostat . . . [in] a daily dosage
amount of from 50 to 100 mg per patient,” “the treatment of primary or
secondary myelfibrosis,” or “the ammonium chloride monohydrate crystal
form” of Givinostate” (Final Act. 8).
FF 6. Golay
investigated the activity of ITF2357 . . . on multiple myeloma
(MM) and acute myelogenous leukemia (AML) cells in vitro
and in vivo. ITF2357 induced apoptosis in 8/9 MM and 6/7
AML cell lines, as well as 4/4 MM and 18/20 AML freshly
isolated cases. . . . Finally, the drug significantly prolonged

11 Examiner’s November 22, 2019 Answer.
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survival of severe combined immunodeficient mice inoculated
with the AML-PS in vivo passaged cell line already at the 10
mg/kg oral dose. These data demonstrate that ITF2357 has
potent anti-neoplastic activity in vitro and in vivo through direct
induction of leukemic cell apoptosis.
(Golay, Abstract; see Final Act. 8 (“[T]he HDAC inhibitor ITF2357 . . . has
potent anti-neoplastic activity in vitro and in vivo through direct induction of
leukemic cell apoptosis in acute myelogenous leukemia and multiple
myeloma”); Ans. 5; see also Final Act. 12.)
FF 7. Wash discloses histone deacetylase (HDAC) inhibitors useful in
treating disease states including hematologic and nonhematologic cancers,
such as chronic myelogenous leukemia (CML), PV, myelofibrosis, and ET
(Wash 1:8–9; 7:8–15; 8:15–19; see Final Act. 9; see also Final Act. 12–13;
Ans. 5–6 (Examiner asserts that Wash was “relied on to teach that HDAC
inhibitors are useful for treating HDAC-related diseases, such as
[Appellant’s] claimed myeloproliferative diseases. The nexus between
IFT2357 and HDAC inhibitors are already taught by . . . Golay . . ., which
clearly state[s] that ITF2357 is a known HDAC inhibitor”)).
FF 8. Examiner relies on Pinori ’355 to disclose “the hydrochloride salt of
(6-diethylaminomethyl-naphthalen-2-yl)-methyl ester of (4-
hydroxycaramoylphenyl)-carbamic acid and the monohydrous hydrochloride
crystalline which is stable and simpler to handle than the anhydrous and
amorphous form” (Final Act. 9 (citing Pinori ’355 1–2)).
ANALYSIS
Based on the combination of Guerini, Golay, Wash, and Pinori ’355,
Examiner concludes that, at the time Appellant’s invention was made, it
would have been prima facie obvious “to treat polycythemia vera, essential
thrombocythemia, primary and secondary myelofibrosis by administering
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ITF2357 . . . or the ammonium chloride monohydrate crystal form” (Final
Act. 9; see also id. at 10–11; FF 3–8). As to the claimed dosage range,
Examiner concludes that
[o]ne skilled in the art would have found it obvious and [would
have been] motivated to administer the claimed compound in a
daily dosage amount of from 50 to 100 mg per
patient . . . because Guerini teach[es] that at [a] concentration
easily attained after low oral doses of the drug, ITF2357 show a
potent inhibitory activity on the autonomous proliferation of
hematopoietic stem cells of PV and ET carrying the JAK2V617F
mutation
(Final Act. 11; see Ans. 5 (“Guerini provides teachings and motivation for
one skilled in the art to reasonably expect that an in vivo administration
would be therapeutically effective. Furthermore, determining the amount of
the drug is well within the skill of the art through routine experimentation”);
see also FF 4). In this regard, Examiner reasons that “it is within the skill of
the art through routine experimentation to determine effective ranges and
dosing regimen” (id.). See In re Aller, 220 F.2d 454, 456 (CCPA 1955)
(“[W]here the general conditions of a claim are disclosed in the prior art, it is
not inventive to discover the optimum or workable ranges by routine
experimentation.”).
Appellant, in contrast, contends that
[a] person having ordinary skill in the art, however, would
know and understand that none of the cited documents suggests
or gives any hints to a person having ordinary skill in the art
that ITF2357 would or could be used in the treatment of
patients affected by Philadelphia-negative myeloproliferative
syndromes in the claimed dosage.
(Appeal Br. 8.) Appellant’s contention is not persuasive.
The evidence on this record establishes that, at the time of
Appellant’s claimed invention, PV, ET, and IM were known as
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“Philadelphia-negative myeloproliferative syndromes” and Appellant’s
active ingredient was known as ITF2357 (see FF 1–2; see also FF 8).
Guerini “investigate[d] the ability of ITF2357 . . . to inhibit the spontaneous
outgrowth of hematopoietic stem cells obtained from patients with
[Polycythemia Vera (PV), Essential Thrombocythemia (ET),] . . . and
Idiopathic Erythrocytosis” (FF 3). In response to this investigation, Guerini
found that ITF2357 showed potent inhibitory activity on PV and ET cells at
a concentration that those of ordinary skill in this art would recognize as
being easily attained after low oral doses of the drug (FF 4). This finding
led Guerini to conclude that its data “provide[s] the framework for a Phase II
study of ITF2357 in these malignancies” (FF 4).
Stated differently, Guerini disclosed that ITF2357 exhibits potent
inhibitory activity on the cells of Philadelphia-negative myeloproliferative
syndromes at dosages easily attained after low oral doses of the drug and
encouraged those of ordinary skill in this art to pursue a clinical trial, i.e.
Phase II study, wherein ITF2357 would be administered to patients with
Philadelphia-negative myeloproliferative syndromes (see FF 3–4; see Ans. 5
(“Guerini provides teachings and motivation for one skilled in the art to
reasonably expect that an in vivo administration would be therapeutically
effective,” which is supported by Walsh’s disclosure “that HDAC inhibitors
are useful for treating HDAC-related diseases, such as the claimed
myeloproliferative diseases”); see also FF 7).
For the foregoing reasons, we are not persuaded by Appellant’s
contention that “[n]one of the cited documents discloses, teaches, or
suggests the use of Givinostat for the treatment of Philadelphia-negative
myeloproliferative syndromes” (Appeal Br. 9; see id. at 9–11, 13–14; cf.
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Final Act. 12 (“[I]t is the combination of the art that teaches the obviousness
of the instant claims”); see generally Ans. 3–6).
As discussed above, Guerini disclosed “that ITF2357 shows a potent
inhibitory activity on the autonomous proliferation of hematopoietic stem
cells of PV and ET carrying the JAK2V617F mutation,” at a concentration
easily attained after low oral doses of the drug (FF 4). As to the art
recognized oral dosage of the drug, Golay discloses that ITF2357 has potent
anti-neoplastic activity in vitro and in vivo at an oral dose of 10 mg/kg (FF
6; see generally Ans. 5). Thus, we agree with Examiner’s conclusion that
“determining the amount of the drug is well within the skill of the art
through routine experimentation” (Ans. 5). See In re Aller, 220 F.2d at 456.
For the foregoing reasons, we are not persuaded by Appellant’s
contention that
[e]ven if an ordinarily skilled artisan could have considered
testing ITF2357 in [a] patient with Philadelphia-negative
myeloproliferative syndrome in order to see whether it would
have been effective in treating the recited diseases . . . the
ordinarily skilled artisan would certainly not have done that
with a reasonable expectation of success.
(Appeal Br. 8; see also Reply Br.12 1 (“[A] person having ordinary skill in
the art would not have had any reasonable expectation of treating patients
with Philadelphia-negative myeloproliferative syndromes by administering
ITF2357 at a daily dosage of 10-150 mg per patient”); Reply Br. 1–3.) To
the contrary, for the reasons discussed above, we find that, at the time of
Appellant’s claimed invention, a person of ordinary skill in this art would
have had a reasonable expectation of successfully treating Philadelphia-

12 Appellant’s January 21, 2020 Reply Brief.
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negative myeloproliferative syndromes, by administering a therapeutically
effective amount of ITF2357, as determined through routine
experimentation, to a patient in need of such treatment. “Obviousness does
not require absolute predictability of success . . . all that is required is a
reasonable expectation of success.” In re O’Farrell, 853 F.2d 894, 903
(Fed. Cir. 1988).

Secondary Considerations:
We acknowledge Mascagni’s discussion of Experimental Reports 1
and 2; Galli Scientific Report, Report 3; and a Phase II Clinical Study
(Mascagni Decl. ¶¶ 2–13; see also Appeal Br. 11).
Mascagni states that Experimental Reports 1 and 2 relate to clinical
studies on psoriasis (id. ¶ 3; see also id. ¶¶ 4–5; Appeal Br. 11–12, 15–16).
As Examiner explains, however, “psoriasis is a condition that does not fall
under the umbrella of Philadelphia-negative myeloproliferative syndromes
or conditions that are specifically related to the point mutation of JAK2,
particularly JAKV617F” (Ans. 6). Experimental Reports 1 and 2, therefore,
are not commensurate in scope with Appellant’s claimed invention. See In
re Huai-Hung Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) (In order to be
persuasive of non-obviousness, “[e]vidence of secondary considerations
must be reasonably commensurate with the scope of the claims.”).
Mascagni states that “[t]he Galli Scientific Report relates to the
clinical efficacy and tolerability of different doses of Givinostat in patients
with moderate to severe plaque psoriasis and in patients with Multiple
Myeloma (MM)” (Mascagni Decl. ¶ 6; see also id. ¶ 7; Appeal Br. 12, 15–
16). As discussed above, psoriasis is not a Philadelphia-negative
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myeloproliferative syndrome, in addition Examiner further explains that
“multiple myeloma, . . . is a hematologic cancer that is also not under the
scope of Philadelphia-negative myeloproliferative syndromes or conditions
that are specifically related to the point mutation of JAK2, particularly
JAKV617F” (Ans. 6). Thus, the Galli Scientific Report is not commensurate
in scope with Appellant’s claimed invention.
Mascagni states that “[t]he Phase II Clinical Study . . . relates to the
administration of Givinostat in combination with Hydroxyurea in patients
with Philadelphia-negative myeloproliferative syndromes” (Mascagni Decl.
¶ 11 (emphasis added); see also id. ¶¶ 12–13; Appeal Br. 12, 17). The
method of Appellant’s claim 13, however, “consist[s] of administering to
said patient an active ingredient consisting of [Givinostat]” (see Appeal Br.
22). Thus, the combination treatment of the Phase II clinical Study is not
commensurate in scope with Appellant’s claimed invention (see Final Act.
13 (“[T]he study teaches a combination treatment of Givinostat and
hydroxyurea, in which the current claims are not drawn to this specific
combination”)).
Mascagni states that Report 3 “relates to the clinical study described
in Example 1 of [Appellant’s] . . . application, and evaluates the efficacy and
safety of Givinostat in the treatment of patients with JAKV617K positive
myeloproliferative diseases at a daily dosage of 50 mg” (Mascagni Decl. ¶ 9;
see also id. ¶ 10; Appeal Br. 12, 16). Initially, we note that data relating to a
daily dosage of 50 mg is not commensurate in scope with the dosage range
set forth in the method of Appellant’s claim 13, which consists of “a daily
dosage amount of from 50 to 150 mg per patient” (see Appeal Br. 22; cf.
Mascagni Decl. ¶ 9).
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Thus, in sum, the evidence relied upon and testimony provided by
Mascagni are not commensurate in scope with Appellant’s claimed
invention and, therefore, are not persuasive on this record.
In addition, given the evidence relied upon by Examiner, as discussed
above, we are not persuaded by Appellant’s contention that the positive
results observed in Report 3, which relates to the clinical study disclosed in
Example 1 of Appellant’s Specification, would have been unexpected to
those of ordinary skill in this art (see Appeal Br. 15 (“[T]he recited methods
reflect unexpected results”)). In this regard, we note that Mascagni
characterizes the results observed in Report 3 as “an objective response,” not
an unexpected response (see Mascagni Decl. ¶ 10; cf. Appeal Br. 16 (“The
evidence thus show results that ITF2357 can induce an objective response in
the majority of patients. . . . This is not expected based on the cited
references”) (emphasis added)). See In re Pearson, 494 F.2d 1399, 1405
(CCPA 1974) (“Attorney’s argument in a brief cannot take the place of
evidence.”).
To be complete, we decline Appellant’s invitation to consider its new
argument relating to “contemporaneous evidence” that was submitted with
Appellant’s Reply Brief (see Reply Br. 3–4). See Ex parte Borden, 93
USPQ2d 1473, 1474 (BPAI 2010) (informative) (“[T]he reply brief [is not]
an opportunity to make arguments that could have been made in the
principal brief on appeal to rebut the Examiner’s rejections, but were not.”).
CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness. The rejection of claim 13 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Guerini, Golay, Wash, and
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Pinori ’355 is affirmed. Claims 14, 15 and 18–21 are not separately argued
and fall with claim 13.

OBVIOUSNESS-TYPE DOUBLE PATENTING:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness-type double patenting?
ANALYSIS
The rejection over claims of Pinori ’689 in view of Wash:
Pinori ’689 claims:
1. Monohydrous hydrochloride of (6-diethylaminomethyl-
naphthalen-2-yl)-methyl ester of (4-hydroxycarbamoylphenyl)-
carbamic acid of formula (I)

in crystalline form having the diffraction spectrum shown in
FIG. 3.
2. A pharmaceutical composition comprising the compound of
claim 1.
(Pinori ’689 4:1–25; see generally Final Act. 4.) Examiner finds that Pinori
’689 does not claim “the use of the compound in the treatment of
Philadelphia-negative myeloproliferative syndrome, characterized in that the
daily dosage is from 50 to 100 mg per patient or that it is administered with
other active agents” (Final Act. 4). To make up for these deficiencies,
Examiner relies on Walsh to disclose “that an HDAC inhibitor [, such as that
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set forth in Pinori ’689’s claims,] can treat HDAC-related diseases such as
the myeloproliferative disorders polycythemia vera, myelofibrosis (i.e.
primary myelofibrosis) and essential thrombocythemia” (id. (citing Walsh
claims 33, 34, 38, 40, and 53)).
Thus, based on claims 1–2 of Pinori ’689 in view of Wash, Examiner
concludes that, at the time Appellant’s invention was made, it would have
been prima facie “obvious to use the same compound or monohydrous salt
to treat Philadelphia-negative myeloproferative syndromes with the claimed
dosages and other active agents because it is the same compound and thus
inherently would treat the same condition” (Final Act. 4). In this regard,
Examiner reasons that “[i]t is within the skill of the art to determine the
optimal dosage amount [and] dosage regimens” for the administration of
Pinori ’689’s claimed compound or composition for the treatment of
Philadelphia-negative myeloproferative syndromes (see Final Act. 4–5).
Appellant contends that because the claims of Pinori ’689
do not recite a method, do not recite treating Philadelphia-
negative myeloproferative syndromes, and do not recite a daily
dosage amount of from 50 to 150 mg per patient . . . [t]here is
no reason or rationale based on the claims of . . . [Pinori ’689]
that a person having ordinary skill in the art would or could
have created the claimed subject matter.
(Appeal Br. 18–19; see generally Reply Br. 4 (“[T]he pending claims are
patentably distinct . . . for the reasons set forth in the Appeal Brief.”).) We
are not persuaded by Appellant’s contention, because Appellant fails to
address Examiner’s combination of the claims of Pinori ’689 with Wash as
discussed above.

The rejection over claims of Bertolini in view of Wash and Pinori ’355:
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Examiner finds that Bertolini claims “4-(6-diethylaminomethyl)
[-]napth-2-ylmethyloxycarbamyl)benzohydroxamide acid, its compositions
and use in the method of suppressing immune response” (Final Act. 5).
Examiner finds that Bertolini does not claim “the use of the compound in the
treatment of Philadelphia-negative myeloproliferative syndrome,
characterized in that the daily dosage is from 50 to 100 mg per patient or that
it is administered with other active agents” (Final Act. 5; see also id.
(Bertolini “also does not teach the hydrochloride salt or monohydrous
hydrochloride salt crystalline form of the compound”)). To make up for
these deficiencies, Examiner relies on Walsh to disclose “that an HDAC
inhibitor[, such as that set forth in Pinori ’689’s claims,] can treat HDAC-
related diseases such as the myeloproliferative disorders polycythemia vera,
myelofibrosis (i.e. primary myelofibrosis) and essential thrombocythemia”
(id. at 6 (citing Walsh claims 33, 34, 38, 40, and 53)). Examiner further
relies on Pinori ’355 to disclose “the hydrochloride salt of (6-
diethylaminomethyl-naphthalen-2-yl)-methyl ester of (4-
hydroxycaramoylphenyl)-carbamic acid and the monohydrous hydrochloride
crystalline which is stable and simpler to handle than the anhydrous and
amorphous form” (Final Act. 6 (citing Pinori ’355 1–2)).
Thus, based on claims 1–3, 6, 13, and 14 of Bertolini in view of Wash
and Pinori ’355, Examiner concludes that, at the time Appellant’s invention
was made, it would have been prima facie
obvious to use the hydrochloride salt or the monohydrous salt
crystalline form to treat Philadelphia-negative myeloproferative
syndromes with the claimed dosages, dosage regimen, and
other active agents because first the non-salt, salt and
monohydrate salt all have the same activity, thus inherently
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would treat the same condition (i.e. Philadelphia-negative
myeloproliferative syndromes) once administered.
(Final Act. 6.) In this regard, Examiner reasons that “[i]t is within the skill
of the art to determine the optimal dosage amount [and] dosage regimens”
for the administration of Bertolini’s claimed compound or composition for
the treatment of Philadelphia-negative myeloproferative syndromes (see id.).
Appellant contends that because the claims of Bertolini
do not recite a method, do not recite treating Philadelphia-
negative myeloproferative syndromes, and do not recite a daily
dosage amount of from 50 to 150 mg per patient [t]here is no
reason or rationale based on the claims of . . . [Bertolini] that a
person having ordinary skill in the art would or could have
created the claimed subject matter.
(Appeal Br. 19–20; see generally Reply Br. 4 (“[T]he pending claims are
patentably distinct . . . for the reasons set forth in the Appeal Brief.”).) We
are not persuaded by Appellant’s contention, because Appellant fails to
address Examiner’s combination of the claims of Bertolini with Wash and
Pinori ’355 as discussed above.
CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness-type double patenting.
The rejection of claim 13 under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over claims 1 and
2 of Pinori ’689 in view of Wash is affirmed. Claims 14, 15 and 18–21 are
not separately argued and fall with claim 12.
The rejection of claim 13 under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over claims 1–3, 6,
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13, and 14 of Bertolini in view of Wash and Pinori ’355 is affirmed. Claims
14, 15 and 18–21 are not separately argued and fall with claim 12.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
13–15, 18–21 103 Guerini, Golay,
Wash, Pinori ’355
13–15, 18–21
13–15, 18–21 Obviousness-type
Double Patenting
Pinori ’689, Wash
13–15, 18–21
13–15, 18–21 Obviousness-type
Double Patenting,
Bertolini, Wash,
Pinori ’355
13–15, 18–21
Overall
Outcome
13–15, 18–21

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