Ex Parte Dohmen et al

Patent Trial and Appeal Board

Feb 2, 2018

13576674 (P.T.A.B. Feb. 2, 2018)

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.
13/576,674 08/02/2012 Marianne Dohmen MERCK-3973 2959
23599 7590 02/06/2018
MILLEN, WHITE, ZELANO & BRANIGAN, P.C.
2200 CLARENDON BLVD.
SUITE 1400
ARLINGTON, VA 22201
EXAMINER
HAGOPIAN, CASEY SHEA
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
02/06/2018 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):
docketing@mwzb.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARIANNE DOHMEN, RALF FIELDER,
HEIKE MUELLER, JENS KLATY, HANS KURT PETH,
GUENTER MODDELMOG, and THORSTEN WEDEL1
Appeal 2017-001713
Application 13/576,674
Technology Center 1600
Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and
JOHN G. NEW, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
appellants state that the real party-in-interest is Merck Patent GmbH. App.
Br. 1.
Appeal 2017-001713
Application 13/576,674
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 13—30. Specifically, claims 13—17,
20-23, and 29 stand rejected as unpatentable under 35 U.S.C. § 103(a) as
being obvious over Morifuji (EP 0460923 A2, December 11, 1991)
(“Morifuji”).
Claims 18—19 and 24—28 stand rejected as unpatentable under
35 U.S.C. § 103(a) as being obvious over the combination of Morifuji,
Haines-Nutt (GB 1 422 176 A, January 21, 1976) (“Haines-Nutt”), and
Lewis (US 5,838,571, November 17, 1998) (“Lewis”).
Claims 28 and 30 stand rejected as unpatentable under 35 U.S.C.
103(a) as being obvious over the combination of Morifuji and Kabaradjian
(WO 2009/112156 Al, September 17, 2009) (“Kabaradjian”).
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
REPRESENTATIVE CLAIM
Claim 13 is representative of the claims on appeal and recites:
13. Directly compressible magnesium hydroxide carbonate,
which magnesium hydroxide carbonate:
is classified as heavy in accordance with the
requirements of the PhEur, BP, USP and E 504 standards,
has a BET surface area of 44 to 70 m2/g,
has a bulk density of 0.40 to 0.60 g/ml,
has a tapped density of 0.50 to 0.80 g/ml, and
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is capable of providing tablets with a hardness of from 80
N to 492.2 N and a friability < 0.2% by weight when tableted
by compression with a pressing force in the range from 10 kN
to 30 kN.
App. Br. 19.
ISSUES AND ANALYSES
A. Rejection of claims 13—17, 20-23, and 29 over Morifuji
Issue 1
Appellants argue that the Examiner erred in finding that the claims are
obvious over Morifuji because the objectives properties taught or suggested
Morifuji are allegedly distinct from the objectives and properties of the
claimed invention. App. Br. 7.
Analysis
The Examiner finds Morifuji teaches basic magnesium carbonate
having an average particle size of 1 to 50 pm and a specific surface area of
10—70 m2/g which abuts the endpoint of the claimed range. Final Act. 3
(citing Morifuji Abstr.). The Examiner finds Morifuji also teaches that basic
magnesium carbonate is, preferably, heavy magnesium carbonate having a
bulk density of 0.2 to 0.9 g/cc which overlaps with the claimed amounts. Id.
(citing Morifuji 3). The Examiner notes that Appellants’ Specification
describes
“magnesium hydroxide carbonate” as a synonym of “basic heavy
magnesium carbonate.” Id. (citing Spec. 1 84).
With respect to the limitation of claim 13 reciting: “is capable of
providing tablets with a hardness of from 80 N to 492.2 N and a friability of
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less than 0.2% by weight when tableted by compression with a pressing
force in the range from 10 kN to 30 kN,” the Examiner finds the limitation is
a recitation of intended use and, as such, does not have patentable weight.
Final Act. 3—4. The Examiner notes that a recitation reciting the intended
use of a claimed invention must exhibit a structural difference between the
claimed invention and the prior art in order to patentably distinguish the
claimed invention from the prior art. Id. at 4.
Appellants argue that the objective of the teachings of Morifuji is to
obtain magnesium hydroxide carbonate having improved powder properties,
such as better adsorption, filling, dispersability, and flowability. App. Br. 4
(citing Morifuji 3). According to Appellants, Morifuji teaches a “specific
preparation process” particularly designed to achieve these objectives by
enhancing the amount of smaller size particles. Id. Appellants contend that
the composition taught by Morifuji has a higher volume occupied by fine
o
pores having a radius smaller than 100 A. Id.
In contrast, Appellants argue, the claimed composition discloses a
different special process designed to yield a magnesium hydroxide carbonate
composition with good compressibility (i.e., being directly compressible)
and particular tableting properties, specifically those expressly recited in
claim 13. App. Br. 4 (citing, e.g., Spec. 3—4). Appellants assert that
Morifuji discloses nothing regarding compressibility or tableting for its
magnesium hydroxide carbonate. To the contrary, Appellants contend, one
of ordinary skill in the art would reasonably expect that the Morifuji
material, which is optimized for improved powder properties, would not
have good compressibility and tableting properties. Id.
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Appellants argue further that the teachings of Morifuji are broad and
generic with respect to specific surface area. App. Br. 4. Specifically,
Appellants contend, the Examples taught by Morifuji do not disclose any
composition having a BET surface area as high as the 44 to 70 m2/g range
recited in the claims. Id. (citing Morifuji 8, Table 1). Furthermore, argue
Appellants, the average particle size for the Morifuji magnesium hydroxide
carbonate products, from 3.8 to 6.0 pm additionally demonstrate that the
Morifuji compositions are distinct from the claimed products, which
preferably have an average particle diameter, measured by laser, Do.so, as
being between 20 and 60 pm. Id. (citing claims 14 and 29).
Appellants assert that the teachings of Morifuji would not have led a
person of ordinary skill in the art to the magnesium hydroxide carbonate
claimed by Appellants. Id. at 5. To the contrary, Appellants argue, Morifuji
would have directed one of ordinary skill in the art to a different magnesium
hydroxide carbonate having different properties that are distinct from the
claimed magnesium hydroxide carbonate. Id.
Appellants further dispute the Examiner’s finding that the recitation
regarding the tableting properties of the claimed composition is directed to
an intended use and carries no patentable weight. App. Br. 5. Rather,
Appellants argue, claim 13 recites that the composition has specific tableting
properties, and Morifuji suggests that its magnesium hydroxide carbonate
composition would not have these properties. Id.
The Examiner responds that Morifuji teaches a specific/BET surface
area of 10 to 70 m2/g, a range that subsumes Appellants’ claimed 44 to 70
m2/g range. Ans. 9 (citing Morifuji Abstr. 5). Similarly, the Examiner finds,
Morifuji teaches an average particle size of 1 to 50 pms, which significantly
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overlaps Appellants’ claimed 20 to 60 pm range (see claim 14). Id. (citing
Morifuji Abstr.). The Examiner also finds that Morifuji teaches a generally
preferred bulk density is in the range of from 0.2 to 0.9 g/cc, and especially
from 0.3 to 0.7 g/cc. Final Act. 3 (see Morifuji 3). The Examiner finds that
this also overlaps with the recited bulk density of 0.40 to 0.60 g/ml. Ans.
10. 12.
With respect to the Examples disclosed by Appellants’ Specification,
the Examiner finds that Examples B-E of the Specification, which are
representative of the claimed invention, correspond to the teachings of
Morifuji. Ans. 15.
We are not persuaded by Appellants’ arguments. As an initial matter,
we disagree with the Examiner’s finding that the limitation of claim 13
reciting: “is capable of providing tablets with a hardness of from 80 N to
492.2 N and a friability < 0.2% by weight when tableted by compression
with a pressing force in the range from 10 kN to 30 kN” is directed to an
intended use of the composition. See Final Act. 4. To the contrary, we find
that the language of the limitation in dispute is directed to a capability or
property of the composition and must therefore be accorded patentable
weight.
Nevertheless, we agree with the Examiner that Morifuji teaches the
compound claimed, viz., magnesium hydroxide carbonate, in a formulation
that suggests the claimed compound with respect to specific/BET surface
area, average particle size, and bulk density. We agree with both Appellants
and the Examiner that Morifuji is silent with respect to being “capable of
providing tablets with a hardness of from 80 N to 492.2 N and a friability
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< 0.2% by weight when tableted by compression with a pressing force in the
range from 10 kN to 30 kN,” as well as a “a tapped density of 0.5 to 0.8
g/ml” as required by claim 13. Nevertheless, because Appellants’ claimed
composition falls within the range of characteristics taught by Morifuji, the
burden falls upon Appellants to demonstrate that the composition of
Morifuji does not possess those qualities not recited by Morifuji. As the
predecessor to our reviewing court held:
Where, as here, the claimed and prior art products are
identical or substantially identical, or are produced by identical
or substantially identical processes, 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 (C.C.P.A. 1977). Appellants argue that
Morifuji teaches a broadly generic composition of magnesium hydroxide
carbonate and would not have directed a person of ordinary skill in the art to
their claimed composition which, they argue, is directed to a formulation
suitable for tableting. However, Appellants have adduced no objective
evidence, beyond attorney argument to which we accord little probative
value, that the compositions taught by Morifuji which corresponds generally
to Appellants’ claimed formulation, do not possess the remaining claimed
properties. Absent such objective evidence of record, we conclude that
Appellants have failed to meet their prescribed burden, and we consequently
affirm the Examiner’s rejection upon this ground.
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Issue 2
Appellants argue claims 20-23 separately. App. Br. 11. Claim 20
recites:
20. Process for the preparation of a directly compressible
magnesium hydroxide carbonate according to Claim 13
comprising:
a) continuously pumping a warmed solution of a magnesium salt
and a warmed solution of an alkali-metal or alkaline-earth
metal carbonate into a tubular reactor so that they are mixed
with one another, where the solution of the magnesium salt
has a magnesium content of 2—11% by weight and the
solution of the alkali-metal or alkaline-earth metal carbonate
has a carbonate content of 2—18% by weight, so that a
temperature of 60 to 70°C and a pH in the range 8.5—9.0
become established in the reaction solution, to form a
magnesium hydroxide carbonate product-containing reaction
mixture, and
b) precipitating out magnesium hydroxide carbonate product
from the product-containing reaction mixture, optionally after
being allowed to settle for some time, and filtering off and
drying the product.
Id. at 20. Appellants argue that the claimed method is patentably distinct
from the method taught by Morifuji. Id. at 11.
Analysis
According to Appellants, Morifuji teaches a “specific preparation
process” for making its compositions that is particularly suited to obtaining a
magnesium hydroxide carbonate having a fine pore size distribution of
particles. App. Br. 12 (citing Morifuji 2, 3). Appellants argue that Morifuji,
teaches that the: “smaller average particle size is preferable for increasing
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o
the volume occupies [sic] by fine pores having a radius smaller than 100 A
in the pore size distribution of particles.” Id. (citing, e.g., Morifuji 3). The
method taught by Morifuji is to combine a water-soluble magnesium salt and
a water-soluble carbonate, preferably both in a solid state (rather than in the
form of aqueous solutions), in a reaction vessel at a temperature above 40°C.
Id. (citing Morifuji 4, lines 3—46). Appellants also note that Morifuji prefers
addition of a crystallizing assistant and teaches that such is necessary if the
starting water-soluble magnesium salt and water-soluble carbonate are not
brought together in the solid state. Id. (citing Fujimori 5).
However, Appellants argue, Morifuji fails to teach their claimed
process in which a warmed solution of a magnesium salt and a warmed
solution of an alkali-metal or alkaline-earth metal carbonate are continuously
pumped into a tubular reactor so that they are mixed with one another. App.
Br. 12. According to Appellants, the Examples taught by Morifuji do not
disclose the use of a tubular reactor. Id. Furthermore, Appellants assert, the
starting materials are added in solid powder form, with the exception of Run
5 of Example 3, in which the resulting product is inferior. Id. Appellants
assert further that Morifuji also fails to disclose the specific conditions of the
claimed methods, i.e., that the solution of the magnesium salt has a
magnesium content of 2—11% by weight, that the solution of the alkali-metal
or alkaline-earth metal carbonate has a carbonate content of 2—18% by
weight, and that a temperature of 60 to 70°C and a pH in the range 8.5—9.0 is
required in the reaction solution. Id.
The Examiner responds that Morifuji expressly states that “the
preparation process in not particularly critical”, and in fact teaches several
different methods of preparation. Ans. 18 (citing Morifuji 4).
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The Examiner finds Morifuji teaches, in one embodiment, that the
starting materials are in aqueous form and are maintained at a warm
temperature between 40°C and boiling, which overlaps Appellants’ claimed
temperature range. Ans. 18 (citing Morifuji 4—5). The Examiner notes that
the open-ended “comprising” language allows for other unrecited
ingredients or steps in the preparation method. Id.
With respect to the other conditions required by the claims, the
Examiner finds that Morifuji also teaches stirring the reaction mixture in a
reaction vessel and that the shape of the reaction vessel is not particularly
critical except in figuring out the amount of stirring time. App. Br. 18
(citing Morifuji 4). The Examiner further finds that Morifuji teaches the
water-soluble salt is used in an amount of 0.1 to 0.8 mol/L, consequently, the
Examiner finds, if magnesium chloride (MW 203.3) is used as the water-
soluble salt, the molar concentration range can be converted to a
concentration percentage of approximately 2—16% which overlaps
Appellants’ claimed range of 2—11%. Id.
The Examiner further finds that Morifuji teaches that it is preferred
that the mixing ratio between the water-soluble magnesium salt and water-
soluble carbonate be such that the concentration of the water-soluble
carbonate is equivalent to, or slightly in excessive of, the concentration of
the water-soluble magnesium salt. App. Br. 18—19 (citing Morifuji 4). The
Examiner therefore, finds that Morifuji suggests that the percentage of
water-soluble carbonate should be approximately 2—16% with some possible
margin at the upper end of the percentage range, which again overlaps
Appellants’ claimed range of 2—18%. Id. at 19.
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The Examiner admits that Morifuji is silent with respect to the pH,
however the Examiner finds that the ingredients and amounts aught by
Morifuji are nearly identical and that the addition of a crystallizing agent in
an amount as low as 0.5% will be likely not to drastically alter the pH. Id.
We are not persuaded by Appellants’ arguments. We agree with the
Examiner’s arguments that Morifuji teaches with respect to rejected claim
13: (1) an overlapping temperature range; and (2) directly comparable
concentrations of water-soluble magnesium salt and water-soluble
carbonate. Furthermore, Morifuji teaches:
The time of stirring the reaction mixture depends on the shape of
the reaction vessel, the reaction volume, the shape and size of
stirring blades and the stirring intensity, but it is generally
preferred that the stirring time be the same as the time required
for adding the water-soluble magnesium salt and/or the water-
soluble carbonate or stirring be stopped within 5 minutes from
the completion of the addition.
Morifuji 4. Morifuji thus contemplates conducting the reaction in a variety
of vessel shapes and types and we agree with the Examiner that a person of
ordinary skill would understand that vessels of different shapes require
different routinely optimizable reaction regimes. Appellants have not
provided evidence that the choice of a tubular vessel would have been non
obvious when Morifuji expressly teaches that any shape may be used.
Indeed, the Specification admits that any vessel is suitable (Spec. 7),
consistent with Morifuji’s teachings.
We agree with Appellants that Morifuji is silent with respect to the
limitation reciting: “a pH in the range 8.5—9.0.” Nevertheless, Morifuji
teaches the use of: “water-soluble magnesium salt and water-soluble
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carbonate” in the preparation of the claimed product. Morifuji 4. Morifuji
further teaches that:
As the water-soluble carbonate, there can be mentioned alkali
metal carbonates such as sodium carbonate and potassium
carbonate, and ammonium carbonate. Each of the water-soluble
magnesium salt and water-soluble carbonate is preferably
supplied in the solid state into an aqueous medium maintained at
a temperature of from 40°C to the boiling point, that is, the
reaction temperature.
Id. (emphasis added). We find that a person of ordinary skill in the art
would understand that such an aqueous solution containing alkaline/basic
constituents, such as alkali metal carbonates, would have a pH greater than
7, and thus be basic in nature, and would routinely optimize the amounts of
such components. Furthermore, we agree with the Examiner that Morifuji
teaches synthesis of Appellants’ claimed product by essentially the same
claimed by Appellants (excepting determination of the pH), as explained
above. Appellants have not adduced any evidence that their claimed pH
range of 8.5 to 9.0 is essential to the successful synthesis of magnesium
hydroxide carbonate. We conclude that the balance of evidence supports the
Examiner’s prima facie conclusion of obviousness and we consequently
affirm the Examiner’s rejection.
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B. Rejection of claims 18—19 and 24—28 over Morifuji, Haines-Nutt, and
Lewis
Issue
Appellants argue that a person of ordinary skill in the art would not
have been motivated to modify Morifuji to alter the properties in a way that
arrives at the properties recited in the claims. App. Br. 15.
Analysis
Claim 18 is representative of these dependent claims and recites:
“Tablets which have a hardness of from 80 N to 492.2 N and a friability <
0.2% by weight and which have been produced using a magnesium
hydroxide carbonate of Claim 13 by compression with a pressing force in
the range from 10 kN to 30 kN.”
Appellants argue that Morifuji teaches magnesium hydroxide
carbonate having distinct properties prepared by a special process to meet
objectives distinct from those of the claimed invention, and that modifying
the Morifuji materials in a way to meet the objectives of Haines-Nutt or to
achieve the specific recited properties of the claimed invention would be
contrary to, and render inoperative, the objectives sought by Morifuji. Id.
According to Appellants, the objectives of Morifuji and Haines-Nutt are
different. Id.
Specifically, Appellants argue that Haines-Nutt discloses directly
compressible pharmaceutical tablets which contain heavy magnesium
carbonate. App. Br. 15. However, Appellants contend, Haines-Nutt offers
neither teaching nor suggestion regarding the specific properties of the
heavy magnesium carbonate used therein. Id. Furthermore, Appellants
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argue, there is no teaching in Haines-Nutt concerning any specific hardness
or friability properties of the compressible tablets other than that they have
desirable hardness and friability properties. Id. (citing Haines-Nutt 4).
Consequently, Appellants assert, no conclusion can be made from the
teachings of Haines-Nutt that the tablets have a hardness of from 80 N to
492.2 N and a friability less than 0.2% by weight when tableted by
compression with a pressing force in the range from 10 kN to 30 kN, as
required by the claims. Id.
Furthermore, Appellants argue, Haines-Nutt does not teach that the
heavy magnesium carbonate taught therein is, by itself, directly
compressible. App. Br. 16. According to Appellants, Haines-Nutt teaches
that its compositions as a whole, which comprise the heavy magnesium
carbonate as a partial ingredient, are directly compressible. Id. Appellants
assert that, in the Examples of Haines-Nutt, the content of the heavy
magnesium carbonate is, at most, 40%. Id.
Appellants further argue that the Examiner relies upon Lewis as
teaching that a pressing force in the range from 18 kN to 27 kN is common
for preparing tablets. App. Br. 16. Appellants do not dispute the
Examiner’s finding, but argues that Lewis teaches nothing with respect to
the properties of the tablets obtained when using such pressing force. Id.
Appellants summarize that the Examiner’s proposed combination of
Morifuji, Haines-Nutt, and Lewis provides no teaching or suggestion of a
magnesium hydroxide carbonate capable of providing tablets have a
hardness of from 80 N to 492.2 N and a friability of less than 0.2% by
weight when tableted with such a pressing force. Id.
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The Examiner responds that Morifuji teaches that magnesium
carbonate, preferably heavy magnesium carbonate, is useful as a carrier in
pharmaceuticals and that it can be more effectively and conveniently used in
known application fields, because of its improved powder characteristics
Ans. 19—20 (citing Morifuji 2, 3, 4). The Examiner finds that Haines-Nutt
demonstrates the use of heavy magnesium carbonate as an excipient/carrier
in pharmaceutical tablets, and that such tablets are produced by direct
compression using conventional pressures. Id. at 20 (citing Haines-Nutt 1—
2). The Examiner cites Lewis as teaching that conventional pressures in
tablet production are known to be between 18 to 27 kN. Id. (citing Lewis
col. 13,11. 1-3).
The Examiner concludes that it would have been prima facie obvious
to one of ordinary skill in the art at the time the invention was made to
combine the heavy magnesium carbonate of Morifuji into the tablet of
Haines-Nutt, with a reasonable expectation of success based on the evidence
of Lewis. Ans. 6. The Examiner concludes that a person of ordinary skill in
the art would have been motivated to combine the references because
Morifuji teaches heavy magnesium carbonate for the use in medicine as a
carrier and Haines-Nutt specifically uses heavy magnesium carbonate as a
carrier in a tablet that is made via direct compression. Id. The Examiner
also concludes that Haines-Nutt would have provided further motivation
because Haines-Nutt teaches that direct compression tablet formulations
comprising heavy magnesium carbonate “greatly improves the tableting
properties of the formulation and increases the dissolution rate.” Id. at 6—7
(citing Haines-Nutt 4,11. 42-47).
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We agree with the Examiner. We incorporate by reference our
explanation supra of why we conclude that Morifuji teaches the composition
of claim 13. Furthermore, Haines-Nutt expressly teaches that the use of
heavy magnesium carbonate, as claimed by Appellants, has long been
known in the art. Haines-Nutt Abstr. (“[T]his invention relates to
pharmaceutical tablets containing high proportions of heavy magnesium
carbonate”). Lewis is relied upon by the Examiner as teaching that it
conventional in the art that pressures in tablet production were generally
between 18 to 27 kN, which is within the range recited by Appellants’
claims. We consequently agree with the Examiner that a person of ordinary
skill in the art would have understood, from the teachings of the combined
cited prior art, that there would have been a reasonable expectation of
success in synthesizing tablets “which have a hardness of from 80 N to
492.2 N and a friability less than 0.2% by weight and which have been
produced using a magnesium hydroxide carbonate of claim 13 by
compression with a pressing force in the range from 10 kN to 30 kN, as
recited in the claims. Appellants did not provide objective evidence to the
contrary to undermine the Examiner’s conclusion. We therefore affirm the
Examiner’s rejection of the claims.
C. Rejection of claims 28—30 over Morifuji and Kabaradiian
Appellants rely upon the same arguments presented supra with
respect to issue A1 and argue that Kabaradjian fails to cure the alleged
deficiencies of the Examiner’s combined cited prior art. App. Br. 16—17.
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For the reasons we have explained supra, we do not find Appellants’
arguments persuasive, and we consequently affirm the Examiner’s rejection
of the claims.
DECISION
The Examiner’s rejection of claims claims 13—30, as unpatentable
under 35 U.S.C. § 103(a) is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED
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