Ex Parte Mansky et al

Patent Trial and Appeal Board

Oct 17, 2016

12545809 (P.T.A.B. Oct. 17, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/545,809 08/22/2009
79158 7590 10/19/2016
Senniger Powers LLP (RL Y)
100 NORTH BROADWAY
17THFLOOR
ST. LOUIS, MO 63102
FIRST NAMED INVENTOR
PaulMansky
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
RL Y 06051.301 2179
EXAMINER
CHICKOS, SARAH J
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
10/19/2016 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):
uspatents@senniger.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PAUL MANSKY, DETLEF ALBRECHT, MICHAEL BURDICK,
HAN-TING CHANG, DOMINIQUE CHARMOT,
ERIC CONNOR, SHERIN HALFON, I-ZU HUANG,
MINGJUN LIU, and WERNER STRUVER1
Appeal2015-001281
Application 12/545,809
Technology Center 1600
Before DONALD E. ADAMS, ERIC B. GRIMES,
and TIMOTHY G. MAJORS, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to methods
of removing potassium from the gastrointestinal tract of an animal, which
have been rejected as obvious, and provisionally rejected for obviousness-
type double patenting. We have jurisdiction under 35 U.S.C. § 6(b).
1 Appellants identify the Real Party in Interest as Relypsa, Inc. (App. Br. 2;
reference to "App. Br." refers to the Appeal Brief filed Nov. 26, 2013, as
supplemented by the "Summary of Claimed Subject Matter" filed on Mar.
21, 2014.)
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Application 12/545,809
We affirm.
STATEMENT OF THE CASE
Appellants' "invention is directed to methods of removing potassium
in the gastrointestinal tract, including methods of treating hyperkalemia, by
administration of crosslinked cation exchange polymers having beneficial
physical properties, including combinations of particle size, particle shape,
particle size distribution, viscosity, yield stress, compressibility, surface
morphology, and/or swelling ratio." (Spec. ,-i 2.)
Claims 1--4, 6, 7, 12, 15, 16, 19, 25, 26, 29-31, 39--41, and43--45 are
on appeal. Claim 1 is illustrative:
1. A method for removmg potassium from the
gastrointestinal tract of an animal subject in need thereof
comprising administering a potassium binding polymer to the
animal subject, the potassium binding polymer being a
crosslinked cation exchange polymer comprising acid groups in
acid or salt form, the potassium binding polymer being in the
form of substantially spherical particles having a mean diameter
of from about 20 µm to about 200 µm and less than about 4
volume percent of the particles have a diameter of less than about
10 µm, and the potassium binding polymer having a sediment
yield stress of less than about 4000 Pa, and a swelling ratio of
less than 10 grams of water per gram of polymer.
(App. Br. 13 (Claims App'x).) In response to a species election
requirement, Appellants elected a potassium binding polymer comprised of
particular monomers. More specifically, Appellants "elect[ ed] a species of
an alpha-fluoroacrylic acid for Formula 11 (R1 = R2 =hydrogen and All is
carboxylic); divinylbenzene for Formula 22 (X1 = phenylene); and 1,7,-
octadiene for Formula 33 (X2 = butylene)." (See 1/3/2012 Resp. to
Restriction Requirement 2 (see pending claim 40); see also, Final Act. 2
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("Claims 1--4, [etc.] ... are examined on their merits to the extent of the
elected species alpha-fluoroacrylic acid, divinylbenzene and 1,7-octadiene.")
We limit our analysis of claims to the patentability of the elected species. Ex
parte Ohsaka, 2 USPQ2d 1460, 1461 (BP AI 1987).
The claims stand rejected as follows:
I. Claims 1--4, 6, 7, 12, 15, 16, 19, 25, 26, 29-31, 39--41, and 43--45
under 35 U.S.C. § 103(a) over Cope et al., WO 2007/041569 Al, published
April 12, 2007 ("Cope"), as further evidenced by the Specification. (Final
Act. 4.)
II. Claims 1-4, 6, 7, 12, 15, 16, 19, 25, 26, 29-31, 39--41, and43--45
as provisionally rejected for nonstatutory obviousness-type double patenting
over claims 36-47, 49-51, 60, and 61 of copending Application No.
13/060,207 ("the '207 Application"). (Final Act. 10-12.)
I
Issue
Has the Examiner established by a preponderance of the evidence that
claims 1--4, 6, 7, 12, 15, 16, 19, 25, 26, 29-31, 39--41, and43--45 would
have been obvious over Cope, as further evidenced by the Specification?
Findings of Fact (FF)
FF 1. The Examiner's findings of fact and statement of Rejection I
may be found at pages 4-10 of the Final Action dated January 28, 2013. We
adopt those findings and provide the following for emphasis.
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FF 2. Cope teaches
methods and compositions for the treatment of ion imbalances
using core-shell composites . . . . In particular, the invention
provides core-shell particles and compositions comprising
potassium binding polymers ... [that] offer improved approaches
for treatment of hyperkalemia and other indications related to
potassium homeostasis.
(Cope Abstract.) Cope further teaches "administering a pharmaceutical
composition (such as a core-shell particle) to the mammal ... [that]
preferentially exchanges and retains potassium ion over sodium ion in a
lower colon of the gastrointestinal tract." (Id. at iJ 9; see also id. at iJ 129.)
FF 3. Cope teaches
[i]n some preferred embodiments the core-component polymer
comprises 2-fluoroacrylic acid crosslinked with a crosslinking
agent. The crosslinking agent for a polymeric core component
can be selected from the group consisting of divinylbenzene, 1, 7-
octadiene ... and combinations thereof. In some embodiments,
the core can be in its proton form, sodium form, potassium form,
calcium form, ammonium form, or combinations thereof.
(Id. at iJ 105; see also id. at iii! 30, 106, 148, 257.)
FF 4. Cope teaches "[i]n some embodiments, the size of the core-
shell particles are less than (about) 250 microns, more preferred is less than
(about) 150 microns." (Id. at iJ 150.) Cope further teaches "the particles can
be spherical." (Id. at iJ 152.)
Analysis
Claims 1 & 2
Claims 1 and 2 recite similar subject matter relating to methods of
administering a potassium binding polymer with certain properties, such as
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size, shape, and swelling ratio. (App. Br. 13 (Claims App'x).) The claims
differ in that the "mean diameter" of the polymeric particles in claim 1 is
"from about 20 µm to about 200 µm" while in claim 2 it is "less than about
250 µm." (Id.) Moreover, claim 1 recites "a sediment yield stress of less
than about 4000 Pa." (Id.) Claim 2 does not recite a sediment yield stress
and instead recites "a hydrated and sedimented mass of polymer particles
having a viscosity of less than about 1,000,000 Pa·s." (Id.)
Like Appellants, we address Rejection I and the patentability of
claims 1 and 2 together.
The Examiner finds that Cope teaches "removing potassium from the
gastrointestinal tract of an animal ... comprising administering a potassium
binding polymer." (Final Act. 4.) The Examiner finds "[o]ne disclosed
polymer [of Cope] is 2-fluoroacrylic acid and the preferred crosslinking
agent is selected from a group consisting of divinylbenzene, 1, 7-octadiene,
and combinations thereof' and Cope teaches "monomer repeat units of
alpha-fluoroacrylate in the polymers." (Id. at 5.) According to the
Examiner, "[t]hese monomers read on the three monomers instantly recited
(formulae 11, 22, and 33, respectively)" - in other words, the Examiner
finds that Cope teaches Appellants' elected species of cross-linked cation
exchange polymer formed from alpha-fluoroacrylic acid, divinylbenzene and
1,7-octadiene. (Id.)
The Examiner further finds Cope teaches the "polymer is in the form
of substantially spherical particles" and that "[t]he diameter of the
substantially spherical particles ranges from about 20 to 150 microns," thus
meeting the shape and size limitations recited in claims 1 and 2. (Id.)
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The Examiner acknowledges that Cope does not expressly disclose
certain properties of the polymer in claims 1 and 2, including sediment yield,
swelling ratio, or viscosity. (Final Act. 6-9; Adv. Act. 2.) However, in light
of the structural and functional overlap between the potassium binding
polymers disclosed in Cope and those recited in claims 1 and 2, the
Examiner reasons that Cope's polymer would exhibit the claimed properties.
(See, e.g., Final Act. at 7 ("Given that they are structurally identical, the
polymer particles taught by Cope [] necessarily have a swelling ratio from
about 1 to about 3 (which is less than 10 called for in claim l).").) The
Examiner concludes that she
has presented evidence of the structural identity of the particles
in their physical characteristics and dimensions as well as their
chemical make up (the same monomers make up the same
polymer as that claimed). The examiner has also provided
evidence that [the polymers] function in the same way. Where
the claimed and prior art products are identical or substantially
identical in structure or composition, or are produced by identical
or substantially identical processes, a prima facie case of either
anticipation or obviousness has been established. In re Best, 562
F.2d 1252, 1255 ... (CCPA 1977).
(Adv. Act. 2; see also Ans. 4 ("Cope discloses the exact monomers being
claimed and teaches a polymerization process that is nearly identical to the
polymerization process used by Appellants.").)
Appellants argue the Examiner has not met the burden to establish a
prima facie case of obviousness. (App. Br. 5.) We disagree. Cope teaches
the polymer is formed from the same monomers as the elected species. (FF
3.) Cope further teaches size and shape characteristics of the polymer
particles that overlap with the claims. (FF 4.) And the polymer particles of
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Cope are used for the same purpose as the present claims - binding of
potassium to facilitate its removal from the gastrointestinal tract of an
animal. (FF 2.) Moreover, as the Examiner determined, "a very standard
polymerization procedure is followed in the examples of the Cope reference.
This same standard polymerization procedure is followed by Appellants."
(Ans. 5 ("This [standard] procedure is followed in Examples 1, 2 and 3 of
the Cope reference and in Examples 1 and 4 of Appellants[']
specification").) Appellants, on the other hand, "have not identified
anything unique or unusual about their polymerization process that would
cause it to impart unique properties to the polymer." (Id.)
In view of the Examiner's findings and reasoning of record, we are
not persuaded the Examiner failed to establish a prima facie case. To the
contrary, under these circumstances, the Examiner appropriately shifted to
Appellants the burden to show that the polymer disclosed in Cope would not
possess the properties claimed. (Ans. 6.)
Where . . . the claimed and prior art products are identical or
substantially identical ... the PTO can require an applicant to
prove that the prior art products do not necessarily or inherently
possess the characteristics of his claimed product. . . . Whether
the rejection is based on 'inherency' under 35 U.S.C. § 102, on
"prima facie obviousness" under 35 U.S.C. § 103, jointly or
alternatively, the burden of proof is the same, and its fairness is
evidenced by the PTO's inability to manufacture products or to
obtain and compare prior art products.
In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (citations and footnote
omitted).
As further discussed below, Appellants' argument and evidence does
not overcome the Examiner's prima facie case.
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Appellants argue "Cope ... does not exemplify the synthesis of a 2-
fluoroacrylic acid polymer crosslinked with a combination of 1, 7-octadiene
and divinylbenzene." (App. Br. 5.) Appellants also cite the polymerization
method in Example 6 of the Specification, which discloses a "90:5:5 weight
ratio mixture of organic phase of monomers" and contend "[ t ]here is no
disclosure of that polymerization process in the Cope reference." (Id.)
This argument is unpersuasive. A working example in Cope that
expressly sets forth every detail of the synthesis of a polymer from the same
monomers that are claimed is not required. The Examiner finds that the
polymerization procedures described in Cope's working examples (as well
as at least Example 1 of the Specification) are "very standard" and thus
would have been known and employed by the skilled artisan. (Ans. 5.)
Appellants have not persuasively shown otherwise.
The Examiner has provided a reasoned basis for concluding that
synthesis of the relevant polymer by routine methods would produce the
same polymer or one that is substantially the same such that it would exhibit
the claimed characteristics. Appellants contend that the structure and
properties of a polymer formed from the same monomers are affected by
"varying reaction conditions" (App. Br. 5-6) and "myriad parameters" (App.
Br. 7). But Appellants have provided insufficient persuasive evidence that
the reaction conditions a skilled artisan would reasonably employ to
synthesize a polymer from the monomers relevant here - with
consideration of Cope's teachings - creates a polymer with a yield stress,
viscosity, etc. outside the scope of the claims.
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In support of their arguments, Appellants also submitted a declaration2
and a dictionary definition related to polyethylene. 3 Having considered
these materials, we are unpersuaded.
The Lees Declaration provides background on polymer rheology and
identifies multiple equations. (Lees Deel. iii! 4-11.) The Lees Declaration
also states
suspensions of polymer particles of the same chemical nature,
but with different physical properties such as particle size,
particle size distribution, particle shape, or swelling ratio/degree
of solvation (controlled by the crosslink density) can have very
different rheological properties.
(Lees Deel. iJ 12.) In applying these "principles" to the facts, however, the
Lees Declaration provides no example where a polymer formed from alpha-
fluoroacrylic acid, crosslinked with divinylbenzene and 1,7-octadiene failed
to exhibit properties within the ranges claimed. (Id. at iJ 14.) Instead, the
Lees Declaration opines that without disclosure of "all the parameters
necessary to determine the shape, size, size distribution, viscosity, yield
stress, and swelling ratio" in Cope, "a person of ordinary skill in the art
would not have been able to predict the shape, size, particle distribution,
viscosity, yield stress, or swelling ratio of these polymer particles." (Id.)
We conclude that more is required to overcome the Examiner's prima
facie case. As the Examiner points out, Cope expressly provides details for
a number of the variables cited in the Lees Declaration as affecting
2 Declaration of Inez Lees, Ph.D. dated Sept. 20, 2012 ("Lees Declaration").
3 See Reply Brief at 3--4 (citing Hawley's Condensed Chemical Dictionary
897-898 (131h ed. 1997) ("Hawley's Dictionary").
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rheological properties. (Ans. 5-6.) Cope expressly teaches the desired
shape and size of the polymer particles, in ranges that overlap with the
claims. (Ans. 5-6; FF 4.) Cope also teaches "particle size distribution is not
narrowly critical" and "can be controlled with respect to kinetics of ion
exchange for achieving a desired ion exchange kinetic profile." (Cope
iJ 151.) The desired use of Cope' s polymer particles is the same as the
desired use of the polymer particles recited in claims 1 and 2 - removing
potassium from an animal's gastrointestinal tract. (FF 2; Ans. 8-9.) And
Appellants have not persuasively rebutted the Examiner's findings that the
polymer synthesis methods described in both Cope and Appellants'
Specification are largely routine. (Ans. 5.)
We tum now to the dictionary definition of polyethylene, and
particularly low-density polyethylene (LDPE) and high-density polyethylene
(HDPE), which Appellants have cited. (Reply Brief 3--4.)4 According to
Appellants, the "dictionary entry shows that polymers having the same
repeat units can have very different[] properties." (Id. at 4.) Appellants'
discussion of unrelated polymers and monomers is not persuasive. Although
some of the properties of LDPE and HDPE are different (e.g., tensile
strength), Appellants cite to none that are the relevant rheological properties.
4 The Examiner did not consider Appellants' contentions concerning
synthesis of polyethylene at pages 5-6 of the Appeal Brief, finding that
Appellants' contentions relied on "new evidence" that was untimely under
37 C.F.R. § 41.33. (Ans. 7.) Appellants responded by submitting Hawley's
Dictionary, which Appellants argue is not "evidence." (Reply Br. 3--4.)
Although the Examiner did not address this dictionary (as it was first
submitted in the Reply Brief), it is unpersuasive in rebutting the Examiner's
prima facie case.
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(Id.) Moreover, LDPE is prepared under high temperature and pressure,
while HDPE is prepared at low temperature and pressure. (Hawley's
Dictionary 898; App. Br. 6.) Here, however, the Examiner found that
synthesis methods described in Cope and the Specification are "very
standard" and would have been carried out under similar temperatures and
other reaction conditions. (Ans. 5.)
Appellants also argue "the evidence the Office provides to support the
contention that the polymers of the claimed methods have the required
properties was gleaned only from the [Appellants'] disclosure and using this
evidence to support the rejection is improper." (App. Br. 7.) We disagree.
The Examiner cited the Specification as "extrinsic evidence" to corroborate
the Examiner's reasoning that preparation of cation-exchange polymers from
alpha-fluoroacrylic acid crosslinked with divinylbenzene and 1,7-octadiene
and employing routine synthesis methods, as taught in Cope, would have
produced polymer particles with the claimed properties. (Ans. 8-9.) In this
instance, we are not persuaded that the Examiner has misused Appellants'
disclosures - particularly where Appellants have pointed to nothing that is
unique, novel, or non-obvious about the polymer synthesis methods
identified by the Examiner in the Specification. (Id. at 5.)
Finally, Appellants argue that "without [] information or guidance in
Cope that such properties [e.g., swelling ratio, particle size distribution] are
advantageous, a person of skill would not have had a reason to develop
polymers having the claimed combination of [properties]." (App. Br. 9.) As
discussed above, however, the Examiner's determination is that preparing a
preferred polymer of Cope (with the recited monomers, shape, and size)
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through routine synthesis methods would result in a polymer having a
swelling ratio, etc. within the ranges claimed. The issue is not whether
properties such as swelling ratio, etc. were "known result-effective
variables" as contended by Appellants. (Id.) But even assuming under some
hypothetical set of reaction conditions that it was possible to synthesize a
polymer from the relevant monomers that did not exhibit the combination of
properties within the ranges claimed, Appellants have provided no evidence
that the combination of properties claimed is critical or provides unexpected
results.
The law is replete with cases in which the difference between the
claimed invention and the prior art is some range or other
variable within the claims. . . . [I]n such a situation, the applicant
must show that the particular range is critical, generally by
showing that the claimed range achieves unexpected results
relative to the prior art range.
In re Woodruff, 919 F.2d 1575, 1577 (Fed. Cir. 1990).
For all the above reasons, we conclude the Examiner established by a
preponderance of the evidence that claims 1 and 2 would have been obvious.
Claims 3, 4, 6, 7, 12, 15, 16, 25, 31, 39--41, and 43--45 have not been argued
separately and thus fall with claims 1and2. 37 C.F.R. § 41.37(c)(l)(iv).
Claim 19
Claim 19 depends from claim 1 and further requires "the polymer
particles in dry form have a compressibility index of less than about 10."
(App. Br. 14 (Claims App'x).) Appellants adopt their arguments concerning
claim 1, and further contend that "Cope [] does not provide a reason that
such a compressibility index is advantageous, so a person of ordinary skill in
would not have had [] an expectation that the Cope polymer had the required
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compressibility index." (Id. at 10.) This argument is not persuasive for the
reasons discussed above. Appellants have not persuasively shown that a
polymer prepared as proposed by the Examiner would not exhibit this
property or that it would not otherwise result from routine optimization by
the skilled artisan. We thus affirm the rejection of claim 19.
Claims 26, 29, and 30
Claims 26, 29, and 30 depend directly or indirectly from claim 1 and
relate to a subject's tolerance of dosages of the administered potassium
binding polymer. For example, claim 26 recites "[t]he method of claim 1
wherein the polymer is administered once or twice per day to the subject and
less than 25% of subjects taking the polymer once or twice per day
experience mild or moderate gastrointestinal adverse events." (Id. at 14
(Claims App'x).)
Appellants again adopt their arguments regarding claim 1 and contend
Cope "does not disclose the advantages in terms of patient tolerability of the
polymer administration that the claimed properties provide as claimed in
claims 26, 29, and 30." (Id. at 10-11.) We are not persuaded. Cope teaches
that its polymer can be administered once, twice, or three times per day.
(Cope ,-i 251; Final Act. 4.) Absent persuasive argument or evidence to the
contrary, a subject's tolerability to the polymers is an inherent characteristic
and thus does not patentably distinguish claims 26, 29, or 30 over Cope. In
re Woodruff, 919 F.2d at 1578 ("merely discovering a new benefit of an old
process cannot render the process again patentable.") We thus affirm the
rejection of claims 26, 29, and 30.
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II
The Examiner provisionally rejected claims 1--4, 6, 7, 12, 15, 16, 19,
25, 26, 29-31, 39--41, and 43-45 for obviousness-type double patenting over
claims 36--47, 49-51, and 60-61 of the '207 Application. (Final Act. 11-
12.) Appellants did not argue this rejection. It is thus summarily affirmed.
SUMMARY
We affirm the rejection claims 1-4, 6, 7, 12, 15, 16, 19, 25, 26, 29-31,
39--41, and 43--45 under 35 U.S.C. § 103(a).
We affirm the provisional rejection of claims 1--4, 6, 7, 12, 15, 16, 19,
25, 26, 29-31, 39--41, and 43--45 for obviousness-type double patenting.
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. § l.136(a).
AFFIRMED
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