Relypsa, Inc.

Patent Trials and Appeals Board

Jan 26, 2021

2020003411 (P.T.A.B. Jan. 26, 2021)

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.
14/415,434 01/16/2015 Linda De Young RLYS 2012F12.USN 7423
160162 7590 01/26/2021
STINSON LLP (VIT)
7700 Forsyth Boulevard
Suite 1100
St. Louis, MO 63105
EXAMINER
FALKOWITZ, ANNA R
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
01/26/2021 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):
stl.uspatents@stinson.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte LINDA DE YOUNG and STEPHEN F. CARROLL
__________

Appeal 2020-003411
Application 14/415,434
Technology Center 1600
__________

Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a dosage
form comprising a crosslinked cation-binding polymer comprising
carboxylate groups and pKa decreasing groups and a base. The Examiner
rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.

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 Vifor
(International) Ltd. (see Appeal Br. 2). We have considered the
Specification of Jan. 16, 2015 (“Spec.”); Final Office Action of Jan. 4, 2019
(“Final Action”); Appeal Brief of Aug. 6, 2019 (“Appeal Br.”); and
Examiner’s Answer of Dec. 16, 2019 (“Ans.”).
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Application 14/415,434

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Statement of the Case
Background
“Numerous diseases and disorders are associated with ion imbalances
(e.g., hyperkalemia, hypernatremia, hypercalcemia, and hypermagnesia)
and/or increased retention of fluid (e.g., heart failure and end stage renal
disease (ESRD))” (Spec. ¶ 3). “[T]reatment of diseases or disorders
associated with ion imbalances may employ the use of ion exchange resins
to restore ion balance . . . may involve the use of diuretics . . . [and] may
include restrictions on dietary consumption of electrolytes and water” (id.
¶ 3). The Specification teaches methods of using “the polymers disclosed
herein, with or without added base, to treat various diseases and disorders,
ion imbalances, and fluid imbalances” (Spec. ¶ 1644).
The Claims
Claims 60, 62–68, 74–76, and 127–133 are on appeal.2 Independent
claim 60 is representative and reads as follows:
60. A dosage form comprising:
a. a crosslinked cation-binding polymer comprising
carboxylate groups and pKa decreasing groups; and
b. a base;
wherein from about 5% to about 75% of the carboxylate
groups in said polymer have calcium counterions;
wherein the polymer comprises no more than about 5%
sodium cations as counterions to the carboxylate groups in said
polymer; and
wherein the base is present in an amount sufficient to
provide at least 0.2 equivalents of base per equivalent of
carboxylic acid groups in the polymer.

2 We note that claims 85, 87–89, 130 and 131 were withdrawn by the
Examiner in the Non-Final action mailed October 31, 2016 and as indicated
in the Amendment filed May 1, 2017.
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Application 14/415,434

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The issues
A. The Examiner rejected claims 60, 62–68, 74–76, 127–129, 132, and
133 under 35 U.S.C. § 103(a) as obvious over Mansky,3 Reddy,4 Albrecht,5
and Strickland6 (Final Act. 4–12).
B. The Examiner rejected claims 60 and 63–68 on the ground of
provisional nonstatutory obviousness-type double patenting as being
unpatentable over claims 54, 59, 60, 64–66, and 76–78 of copending
application 14/415,409 (Final Act. 17–19).

A. 35 U.S.C. § 103(a) over Mansky, Reddy, Albrecht, and Strickland
The issues with respect to this rejection are: Does a preponderance of
the evidence of record support the Examiner’s conclusion that Mansky,
Reddy, Albrecht, and Strickland render claim 60 obvious?
Findings of Fact
1. Mansky teaches “treating hyperkalemia . . . by administration
of crosslinked cation exchange polymers having combinations of particular
particle sizes” (Mansky ¶ 17).
2. Mansky teaches “the polymer can be hydrolyzed with a strong
acid (e.g., HCl) to form the carboxylate salt” (Mansky ¶ 78).
3. Mansky teaches “the crosslinked cation exchange polymer
includes a pKa-decreasing group, preferably an electron-withdrawing
substituent” where “preferred polymers result from the polymerization of

3 Mansky et al., US 2010/0104527 A1, published Apr. 29, 2010.
4 Reddy et al., WO 2010/132662 A1, published Nov. 18, 2010.
5 Albrecht et al., US 2010/0111891 A1, published May 6, 2010.
6 Strickland et al., WO 2009/029829 A1, published Mar. 5, 2009.
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alpha-fluoro acrylic acid, difluoromaleic acid, or an anhydride thereof”
(Mansky ¶¶ 42–43; cf. Mansky ¶ 70).
4. Mansky teaches “hydrolysis of the polymer having ester groups
to form a polymer having carboxylic acid groups, preferably, the polymer is
hydrolyzed with a strong base (e.g., NaOH, KOH, Mg(OH)2 or Ca(OH)2) to
remove the alkyl (e.g., methyl) group and form the carboxylate salt”
(Mansky ¶ 78).
5. Mansky teaches:
Further, it has been observed that the addition of sodium
chloride in the aqueous phase decreased coalescence and
particle aggregation. Other suitable salts for this purpose
include salts that are soluble in the aqueous phase. In this
embodiment, water soluble salts are added at a concentration of
from about 0.1 wt.% to about 10 wt.%, particularly from about
2 wt.% to about 5 wt.%, and even more particularly from about
3 wt. % to about 4 wt. %.
(Mansky ¶ 76).
6. Mansky teaches “the sodium salt of the cation exchange
polymer is converted to the calcium salt by washing with a solution that
substitutes calcium for sodium, for example, by using calcium chloride,
calcium acetate, calcium lactate gluconate, or a combination thereof”
(Mansky ¶ 79).
7. The Examiner acknowledges that:
While Mansky discloses forming the calcium bicarbonate
base and discloses wherein the product includes excipients as
described above, it is unclear if some, all, or none of the
calcium bicarbonate is washed out during the synthesis steps
[0079].
While Mansky discloses a dosage form comprising a
base and a cation binding polymer as set forth above, Mansky
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does not disclose wherein the calcium cations are from about
5% to about 75% of the carboxylate group.
(Final Act. 5).
8. Reddy teaches a “crosslinked potassium-binding polymer” with
units where “the carboxylic acid is preferably in the salt form (i.e., balanced
with a counterion such as Ca2+, Mg2+, Na+, NH4+, and the like). Preferably,
the carboxylic acid is in the salt form and balanced with a Ca2+ counterion”
(Reddy ¶ 17).
9. Reddy teaches “the powder formulation includes an
antimicrobial agent . . . . Suitable antimicrobial agents include . . . sodium
benzoate . . . in a concentration ranging from about 0 wt.% to about 1.5
wt.%” (Reddy ¶ 43).
10. Reddy teaches agents like calcium carbonate “can be present in
a concentration ranging from about 0 wt.% to about 0.1 wt.%” (Reddy ¶ 46).
11. Albrecht teaches “compositions of a stabilizing linear polyol
and a salt of a crosslinked cation exchange polymer comprising a fluoro
group and an acid group. These compositions are useful to bind potassium in
the gastrointestinal tract” (Albrecht ¶ 2).
12. Albrecht teaches “a pharmaceutical composition comprising a
crosslinked cation exchange polymer salt and from about 10 wt. % to about
40 wt. % of a linear polyol based on the total weight of the composition”
(Albrecht ¶ 8).
13. Albrecht teaches the “percent calcium in the composition is
tested after extraction with an appropriate acid . . . the amount of calcium in
the polymer is in the range of from about 8 wt. % to about 25 wt. %”
(Albrecht ¶ 59). The Examiner calculates that this would result in a range
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“wherein the calcium is about 6 to 75% of the carboxylate group” (Final
Act. 6).
Principles of Law
“The idea behind the ‘result-effective variable’ analysis is . . . that a
person of ordinary skill would not always be motivated to optimize a
parameter ‘if there is no evidence in the record that the prior art recognized
that [that] particular parameter affected the result.’” E.I. DuPont de
Nemours & Co. v. Synvina C.V., 904 F.3d 996, 1008 (Fed. Cir. 2018)
(quoting In re Antonie, 559 F.2d 618, 620 (CCPA 1977)).
Analysis
Appellant contends the Examiner’s finding that “the amounts of
calcium carbonate and sodium benzoate disclosed in Reddy overlap the
required at least 0.2 equivalents of base per equivalent of carboxylic acid
groups in the polymer is not correct and the amount of sodium benzoate or
calcium carbonate of Reddy does not meet this limitation” (Appeal Br. 6).
Appellant further contends,
at least the calcium counterion concentration of 5% to 75% and
the required 0.2 equivalents of base per equivalent of the
carboxylate groups of the polymer are not result-effective
variables based on the references of record. Mansky, Albrecht,
Reddy, and Strickland individually or in combination do not
disclose that the calcium counterion concentration is a result-
effective variable. Further, Reddy does not disclose the sodium
benzoate and calcium carbonate as a base in the formulation.
Thus, the Reddy disclosure cannot be the basis for optimization
of a base in the dosage form since the sodium benzoate and
calcium carbonate cited by the Office are present in the Reddy
composition for a different purpose (e.g., an antimicrobial agent
or a coloring agent).
(Appeal Br. 8–9).
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The Examiner finds “the amount of a specific ingredient in this
composition is clearly a result effective parameter that a person of ordinary
skill in the art would routinely optimize” (Final Act. 7). The Examiner
finds,
the prior art of record and the instant inventions are directed
towards the same type of formulations that act to bind ions in
the body, as the amount of base present is very broad with a
range of 0.2 equivalents of base per equivalent of carboxylic
acid groups in the polymer, and the claim does not recite a
function of the base the range does not appear critical.
(Ans. 5–6). The Examiner finds “the current version of the MPEP7 does not
limit optimization to only result effective variables” (Ans. 8).
We are compelled to agree with Appellant. The Examiner appears to
tacitly concede, in noting that the amount of base is “not critical,” that the
prior art amounts of base do not overlap those recited in claim 60. The
Examiner also does not appear to provide a calculation or other evidence
showing that the amounts of base disclosed in the prior art overlap or
“provide at least 0.2 equivalents of base per equivalent of carboxylic acid
groups in the polymer” as required by claim 60. Finally, the Examiner
provides no persuasive reason to optimize the amount of base to values
above the highest value of the ranges disclosed by Reddy (FF 9–10).
Therefore, while we agree with the Examiner that Appellant has
shown no criticality to the claimed base values, we agree with Appellant that
the Examiner provides no persuasive reasoning that the prior art recognized
that the amount of these base components impacts the efficacy of the

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composition in any way, much less in affecting treatment of hyperkalemia or
other ionic related condition.
As to the MPEP, it cites Antonie for the proposition that a “parameter
must first be recognized as a result-effective variable, i.e., a variable which
achieves a recognized result, before the determination of the optimum or
workable ranges of said variable might be characterized as routine
experimentation, because ‘obvious to try’ is not a valid rationale for an
obviousness finding.” MPEP § 2144.05(II)(B). The MPEP also states “after
KSR, the presence of a known result-effective variable would be one, but not
the only, motivation for a person of ordinary skill in the art to experiment to
reach another workable product or process.” Id. Thus, the MPEP does not
rule out the result-effective variable approach for motivation, but rather
states that other motivations including design need and market pressure may
motivate the solution in situations where there are “a finite number of
identified, predictable solutions.” Id.
Here, the Examiner relies upon routine optimization, not design need
or market pressure. The Examiner does not provide evidence that the
amount of base equivalents in the dosage is either finite, identified, or
predictable, or any other reason to select the recited amount of base in claim
60. Thus, the Examiner has not established a prima facie case of
obviousness consistent with the requirements of the MPEP. A prima facie
case for obviousness “requires a suggestion of all limitations in a claim,”
CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003) and
“a reason that would have prompted a person of ordinary skill in the relevant
field to combine the elements in the way the claimed new invention does.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Neither a
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suggestion of the amount of base nor a reason to use the recited amount of
base is present in this case.
Conclusion of Law
A preponderance of the evidence of record does not support the
Examiner’s conclusion that Mansky, Reddy, Albrecht, and Strickland render
claim 60 obvious.
B. Provisional obviousness-type double patenting over US 14/415,409
We decline to reach the provisional rejection. The rejection is
provisional and US Application No. 14/415,409 remains copending and not
allowed. The Examiner should process the obviousness-type double-
patenting rejection consistent with MPEP 804. See, e.g., MPEP
804(B)(1)(b)(ii); In re Moncla, 95 USPQ2d 1884, 1885 (BPAI 2010)
(precedential).
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§ 
Reference(s)/Basis Affirmed Reversed
60, 62–68,
74–76, 127–
129, 132,
133
103  Mansky, Reddy,
Albrecht, Strickland
60, 62–68,
74–76, 127–
129, 132, 133
60, 63–68   Provisional
Nonstatutory Double
Patenting

Overall
Outcome
60, 62–68,
74–76, 127–
129, 132, 133

REVERSED