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Patent Trials and Appeals Board

Nov 7, 2019

15054899 - (D) (P.T.A.B. Nov. 7, 2019)

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.
15/054,899 02/26/2016 Karine Deffez 298046-19 5327
3705 7590 11/07/2019
ECKERT SEAMANS CHERIN & MELLOTT LLC
U.S. Steel Tower
600 Grant Street, 44th Floor
Pittsburgh, PA 15219
EXAMINER
YOUNG, MICAH PAUL
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
11/07/2019 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):
ipmail@eckertseamans.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KARINE DEFFEZ and JEAN-PIERRE CASSIERE1
Appeal 2019-004972
Application 15/054,899
Technology Center 1600
Before ERIC B. GRIMES, ULRIKE W. JENKS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
dispersible tablet, which have been rejected as obvious. We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM but designate the affirmance a new ground of rejection.
STATEMENT OF THE CASE
The Specification describes Compound I (4-[3,5-bis(2-
hydroxyphenyl)-[1,2,4]triazol-1-yl]benzoic acid). Spec. 1. “Compound I is

1 Appellant identifies the real party in interest as Novartis AG. Appeal Br. 3.
We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a).
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an orally active iron chelator that is indicated in the treatment of iron
overload in transfusion dependent anemias.” Id. Compound I is also known
as deferasirox. Appeal Br. 14.
Claims 16 and 27–31 are on appeal. Claim 16, reproduced below, is
illustrative:
16. A dispersible tablet comprising 125mg deferasirox or
a pharmaceutically acceptable salt thereof; and, at least one
disintegrant selected from the group consisting of cross-linked
polyvinylpyrrolidone, starch, CMC-Ca, CMC-Na,
microcrystalline cellulose, alginic acid, sodium alginate, and
guar gum, in a total amount of about 5 to 40% by weight based
on the total weight of the tablet.
Claims 27 and 28 are also independent, and are identical to claim 16
except for requiring 250 mg or 500 mg, respectively, of deferasirox.
OPINION
Claims 16 and 27–31 stand rejected under 35 U.S.C. § 103(a) as
obvious based on Lattmann2 and Patel.3 Ans. 3. The Examiner finds that
“Lattmann teaches a dispersible tablet formulation comprising deferasirox.”
Id. at 4. “The dosage form is administered to a patient in need thereof in a
concentration from 20–80 mg/kg. . . . The compound is an iron chelator and
can be used to treat iron overload.” Id. The Examiner finds that Lattmann
discloses that its tablets can include “excipients such as fillers like, lactose,
sucrose and mannitol, disintegrants such as starches, binders such as
polyvinylpyrrolidone,” etc. Id.

2 Lattmann et al., WO 97/49395, published Dec. 31, 1997.
3 Patel et al., US 5,698,221, issued Dec. 16, 1997.
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The Examiner finds that Lattmann “is silent to the specific
concentrations of these compounds, however their presence and
concentrations are well known in the art as seen in the Patel patent.” Id.
Specifically, “Patel discloses a dispersible tablet comprising” a different
active agent. Id. The tablets comprise, among other things, “disintegrants up
to 30%.” Id.
The Examiner concludes that “[i]t would have been obvious to combine
the specific formulation of [Patel] with the formulation of [Lattmann] since
both patents disclose dispersible tablets comprising Alzheimer’s medications.”
Id. The Examiner reasons that “the specific concentrations and ranges of the
instant claims” are “result effective parameters” and “[e]ach of them can be
manipulated and optimized in order to arrive at an optimal dispersible tablet
. . . through routine experimentation.” Id. at 5.
We agree with the Examiner that Lattmann and Patel support a prima
facie case of obviousness for the claimed tablets. Lattman discloses
compounds for treating iron overload caused by, for example, repeated
blood transfusions. Lattmann 1. Lattmann describes deferasirox in a working
example. Id. at 19, Example 5.
Lattmann states that “[p]harmaceutical preparations for enteral or
parenteral administration are, for example, those in unit dose forms, such as
sugar-coated tablets, tablets, dispersible tablets,” etc. Id. at 7. “Pharmaceutical
preparations for oral administration can thus be obtained by combining the
active ingredient with solid carriers.” Id. “Suitable carriers are, in particular,
fillers . . . , furthermore binders . . . , and, if desired, disintegrants, such as . . .
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starches, furthermore carboxymethyl starch, crosslinked polyvinylpyrrolidone,
agar or alginic acid or a salt thereof, such as sodium alginate.” Id.
“Dispersible tablets are tablets which rapidly disintegrate in a
comparatively small amount of liquid. . . . They can advantageously be
employed for the oral administration of large individual doses.” Id. at 8.
Lattmann discloses that
[t]he doses to be administered daily in the case of oral
administration are between 10 and approximately 120 mg/kg, in
particular 20 and approximately 80 mg/kg, and for a warm-
blooded animal having a body weight of approximately 40 kg,
preferably between approximately 400 mg and approximately
4,800 mg, in particular approximately 800 mg to 3,200 mg,
which is expediently divided into 2 to 12 individual doses.
Id. A dosage of 800 mg divided into 12 doses corresponds to about 67
mg/dose, and a dosage of 3200 mg divided into 2 doses corresponds to 1600
mg/dose. Lattmann thus suggests individual doses containing 67–1600 mg
of active agent.
Patel discloses a water-dispersible tablet comprising an active agent
(“AMTP”), a swellable clay disintegrating agent, and “a further
pharmaceutically acceptable disintegrating agent.” Patel 1:31–36. Patel
suggests specific further disintegrating agents and ranges of amounts for
them, including: “cross-linked povidone 0 to 10% w/w, preferably 2 to 6%
w/w, alginic acid and alginates 0 to 10% w/w, 2 to 5% w/w, pregelatinised
starch 0 to 10% w/w, preferably 0.5 to 5% w/w, . . . modified corn starch
(e.g. starch 1500 R) 0 to 20% w/w, preferably 1 to 10% w/w, starch (e.g.
potato/maize starch) 0 to 15% w/w, preferably 0.2 to 10% w/w.” Id. at 5:56
to 6:4.
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In view of the disclosures of Lattmann and Patel, the tablets of claims
16, 27, and 28 would have been prima facie obvious to a person of ordinary
skill in the art. Lattmann discloses deferasirox as being useful in
pharmaceutical compositions for treating iron overload, and suggests
dispersible tablets for oral administration of large doses. Lattmann also
suggests individual doses of 67–1600 mg, a range that encompasses the
amounts of deferasirox recited in the instant claims.
Finally, Lattmann suggests including disintegrants that include several
of those recited in the claims, and Patel discloses ranges for amounts of the
same disintegrants, also in a dispersible tablet, that include amounts within
the 5–40% range recited in the claims. It would have been obvious to a
skilled artisan to use the specific disintegrants suggested by both Lattmann
and Patel, in the amounts disclosed by Patel to be useful in dispersible
tablets, for their recognized function of promoting disintegration, in the
deferasirox dispersible tablets suggested by Lattmann.
Appellant argues that “no motivation to single out deferasirox from
the primary reference Lattmann exists.” Appeal Br. 10. Appellant argues that
Lattmann’s formula I encompasses hundreds of thousands of compounds,
and “[e]ven if considering the teaching of Example 5, deferasirox is only one
of 42 compounds exemplified.” Id. at 10–11.
This argument is unpersuasive. Lattmann’s specific description of
deferasirox, among forty-two exemplified compounds, is sufficient reason
for a skilled artisan to use deferasirox in Lattmann’s pharmaceutical
formulations. The forty-one other exemplified compounds do not make
deferasirox any less obvious. Cf. Merck & Co. v. Biocraft Labs., Inc., 874
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F.2d 804, 807 (Fed. Cir. 1989) (“[D]isclos[ing] a multitude of effective
combinations does not render any particular formulation less obvious.”).
Appellant argues that “Lattmann provides no teaching or suggestion
that among the range of formulation choices, dispersible tablets provide any
benefits or advantages for any particular . . . compounds.” Appeal Br. 11.
This argument is unpersuasive, because Lattmann states that dispersible
tablets “can advantageously be employed for the oral administration of large
individual doses.” Lattmann 8. Lattmann also suggests individual doses in
the range of 67–1600 mg of active agent, a range which includes large
amounts of an active agent. Thus, a dispersible tablet would have been
among the obvious choices for a deferasirox dosage form, based on
Lattmann’s teachings.
Appellant argues that Patel’s active agent has different properties than
deferasirox. Appeal Br. 13–14. However, the Examiner cites Patel only for
teaching the amount of excipients (e.g., disintegrants) used in dispersible
tablets. Ans. 4. Appellant has not shown that the alleged properties of Patel’s
active agent would affect the amount of disintegrant(s) used in dispersible
tablets comprising deferasirox. The argument is therefore unpersuasive.
Appellant argues that Patel requires a swellable clay disintegrant and
“[n]owhere in Patel does it teach or suggest a non-sipatrigine water-
dispersible tablet without a first swellable clay, as the current claims recite.”
Appeal Br. 15. See also id. at 16 (“The Markush group for disintegrant
selection is closed and enumerated with the swellable clay excluded.”); id. at
19 (with respect to claims 29–31, “[t]he presently claimed invention does
not involve a swellable clay as a disintegrant.”).
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The instant claims, however, use the transition term “comprising.” “In
the patent claim context, the term ‘comprising’ is well understood to mean
‘including but not limited to’.” CIAS, Inc. v. Alliance Gaming Corp., 504
F.3d 1356, 1360 (Fed. Cir. 2007). Thus, the instant claims encompass
ingredients in addition to those recited, including a swellable clay
disintegrant.
Appellant argues that “the Examiner has not articulated why a person
of ordinary skill in the art at the time of the present invention would have
had the motivation to select the specific amounts of deferasirox recited in
claims 16, 27 and 28.” Appeal Br. 17.
This argument is unpersuasive because Lattmann describes a range of
individual doses for its compounds, including the exemplified compound
deferasirox, and that range encompasses the claimed amounts. “A prima
facie case of obviousness typically exists when the ranges of a claimed
composition overlap the ranges disclosed in the prior art.” In re Peterson,
315 F.3d 1325, 1329 (Fed. Cir. 2003). “Selecting a narrow range from within
a somewhat broader range disclosed in a prior art reference is no less
obvious than identifying a range that simply overlaps a disclosed range.” Id.
at 1329–30.
For the reasons discussed above, we conclude that Lattmann and Patel
support a prima facie case of obviousness for the claims on appeal. “Once
the examiner establishes a prima facie case of obviousness, the burden shifts
to the applicant to rebut that case. . . . However, once the applicant has come
forward with rebuttal evidence, the examiner must consider the totality of
the evidence to determine whether the obviousness rejection should stand.”
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In re Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir. 2011). See also id. at
1067 (“[W]hen secondary considerations are present, though they are not
always dispositive, it is error not to consider them.”).
Appellant argues that the evidence of record shows that the claimed
invention solved a long-felt but previously unsolved need and has been a
commercial success. Appeal Br. 21. Appellant also argues that, in the Final
Action, “the Examiner made no mention of the evidence proffered by the
Appellant at all.” Id. See also Reply Br. 12 (“The Examiner neither responds
to nor acknowledges the arguments in the Appeal Brief related to the
second[ary] considerations.”).
We agree with Appellant that the Examiner erred in not addressing the
proffered evidence and re-considering the case for obviousness based on all
of the evidence. We therefore address Appellant’s evidence below and,
although we ultimately affirm the rejection, we designate the affirmance a
new ground of rejection to allow Appellant a fair opportunity to respond to
our critique of the evidence.
Long-felt but Unsolved Need
Appellant argues that “[p]rior to the approval of EXJADE®
(deferasirox) by the FDA, DESFERAL® (deferoxamine) was the principal
treatment of chronic transfusional iron overload for over forty years.”
Appeal Br. 21, citing Danko Decl.4 ¶¶ 8, 10. See also id. at 22 (“EXJADE®

4 Appellant cites to Exhibit 5 of the Appeal Brief’s Evidence Appendix, but
Exhibit 5 is an unsigned declaration that refers to a different patent
application. We understand Appellant’s citations to “Ex. 5” to instead refer
to the Declaration under 37 C.F.R. § 1.132 of Laszlo Danko submitted in the
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(deferasirox) dispersible tablets are the commercial embodiment of the
claimed subject matter.”). Appellant argues that deferoxamine “is delivered
by continuous subcutaneous infusion for 8–12 h/day, 5–7 days/week.” Id. at
21–22, citing Danko Decl. ¶ 10, Porter5 ¶ 2. Appellant argues that parenteral
administration of deferoxamine “hinders adherence (compliance), with
resultant premature deaths related to iron overload.” Id. at 22, citing Danko
Decl. ¶ 12.
Appellant cites the Danko Declaration and Cappellini6 as evidence
that EXJADE® provides “vastly improved patient compliance” or a
“substantial improvement in patient compliance.” Id. Appellant cites Jordan7
and Vichinsky8 as evidence that, among patients with sickle cell disease,
“[c]ompliance is vastly improved with EXJADE@ (deferasirox) compared
to DESFERAL® (deferoxamine) in this, mostly African American,
population.” Id. at 23.

instant application on February 26, 2016. Our discussion pertains to that
declaration, not to Exhibit 5 of the Evidence Appendix.
5 Porter et al., Health-Related Quality of Life, Treatment Satisfaction,
Adherence and Persistence in β-Thalassemia and Myelodysplastic Syndrome
Patients with Iron Overload Receiving Deferasirox: Results from the EPIC
Clinical Trial, Anemia, Article ID 297641, 10 pages (2012).
6 Cappellini et al., Patient Satisfaction with Deferasirox (Exjade®, ICL670)
an Oral Form of Chelation Therapy Versus Deferoxamine an Infused
Chelation Therapy, Blood 106: Abstract 2704 (2005).
7 Jordan et al., Persistence and compliance of deferoxamine versus
deferasirox in Medicaid patients with sickle-cell disease, Journal of Clinical
Pharmacy and Therapeutics 37:173–181 (2012).
8 Vichinsky et al., Satisfaction and Convenience of Chelation Therapy in
Patients with Sickle Cell Disease (SCD): Comparison between Deferasirox
(Exjade®, ICL670) and Deferoxamine (DFO), Blood 106: Abstract 2334
(2005).
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We find that the cited evidence supports Appellant’s position that
EXJADE® solved a long-felt need in the art for an iron chelation agent that,
unlike deferoxamine, could be conveniently administered, thereby increasing
patient compliance.
Commercial Success
Appellant also argues that “evidence of commercial success [was]
detailed in the Danko Declaration.” Appeal Br. 23. Appellant argues that
EXJADE® “is now approved in about 100 countries, [and] had global sales
exceed $870 and $893 million in 2012 and 2013, respectively.” Id., citing
Danko Decl. ¶¶ 19–22. “This accounts for over 500% increase from the sales
of DESFERAL® (deferoxamine), and proves that the market share gained
by EXJADE® (deferasirox) is based on its superior effectiveness.” Id.,
citing Danko Decl. ¶ 18.
We agree with Appellant that the Danko Declaration provides
evidence that EXJADE® is a commercially successful iron chelation
treatment agent. Mr. Danko declares that “DESFERAL® (deferoxamine) . . .
has been (was) the standard of care for transfusional iron overload for over
forty (40) years.” Danko Decl. ¶ 10. “FDA approved dispersible tablet
EXJADE® (deferasirox) as the first oral drug for chronic iron overload
November 9, 2005.” Id. ¶ 15. “EXJADE® (deferasirox) . . . now accounts
for over 500% (5x) the sales of DESFERAL® (deferoxamine).” Id. ¶ 18.
Mr. Danko also declares that global sales of EXJADE® exceeded $870
million in 2012 and $893 million in 2013. Id. ¶¶ 19, 21.
The Danko Declaration therefore provides persuasive evidence that
EXJADE® sales have increased substantially since its introduction, that at
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least as of 2013 EXJADE® sales were much greater than those of
deferoxamine, and that purchasers spent hundreds of millions of dollars to
buy EXJADE® in 2012 and 2013. The evidence thus shows that EXJADE®
is a commercially successful product.
Nexus
“[T]here is a . . . fundamental requirement that must be met before
secondary considerations can carry the day. ‘For objective evidence of
secondary considerations to be accorded substantial weight, its proponent
must establish a nexus between the evidence and the merits of the claimed
invention.’” In re Kao, 639 F.3d at 1068, quoting Wyers v. Master Lock Co.,
616 F.3d 1231, 1246 (Fed. Cir. 2010) (emphasis added by the Kao court).
With regard to commercial success, for example, “an applicant ‘need not sell
every conceivable embodiment of the claims in order to rely upon evidence
of commercial success, so long as what was sold was within the scope of the
claims.’” Id. at 1069, quoting In re DBC, 545 F.3d 1373, 1384 (Fed. Cir.
2008).
We find that Appellant’s evidence falls short with respect to the
required nexus between the evidence relating to EXJADE® and the claimed
dispersible tablets. The Danko Declaration provides evidence that
EXJADE® represents dispersible tablets comprising deferasirox, in dosages
that include 125, 250, and 500 mg. Danko Decl. ¶¶ 15, 22. However, the
instant claims are directed to specific formulations of deferasirox: dispersible
tablets comprising at least one of eight specific disintegrants, in an amount
of about 5 to 40% by weight based on the total weight of the tablet.
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Appellant has not pointed to evidence showing that EXJADE®
dispersible tablets comprise at least one of the disintegrants recited in the
instant claims, in the required amount. Thus, the evidence does not show that
EXJADE® is a deferasirox dispersible tablet formulation encompassed by
the claims.
Although Appellant states that “EXJADE® (deferasirox) dispersible
tablets are the commercial embodiment of the claimed subject matter,”
Appeal Br. 22, “[a]ttorney’s argument in a brief cannot take the place of
evidence.” In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974). Thus,
Appellant has not shown that the evidence that has been submitted
pertaining to EXJADE® is evidence of nonobviousness for the claimed
invention.
CONCLUSION
A preponderance of the evidence of record supports a conclusion of
obviousness and therefore we affirm the rejection of claims 16 and 27–31
under 35 U.S.C. § 103(a) based on Lattmann and Patel. Because the
Examiner did not address Appellant’s evidence of nonobviousness, however,
we designate our affirmance a new ground of rejection.
DECISION SUMMARY
In summary:
Claims
Rejected
35
U.S.C.
§
Reference(s)/Basis Affirmed Reversed New
Ground
16, 27–
31
103(a) Lattmann, Patel 16, 27–31 16, 27–
31

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TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 41.50(b). Section 41.50(b) provides “[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review.”
Section 41.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the prosecution will be
remanded to the examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the claims,
appellant may again appeal to the Board pursuant to this subpart.
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.

Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure § 1214.01.
AFFIRMED; 37 C.F.R. § 41.50(b)