Karim Amighi et al.

Patent Trials and Appeals Board

Nov 14, 2019

13122134 - (D) (P.T.A.B. Nov. 14, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/122, 134 03/31/2011
74275 7590 11/25/2019
DILWORTH IP, LLC
2 CORPORATE DRIVE, SUITE 206
TRUMBULL, CT 06611
FIRST NAMED INVENTOR
Karim Amighi
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.
230-00lUS 6105
EXAMINER
BECKHARDT, LYNDSEY MARIE
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
11/25/2019 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):
docketing@dilworthip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KARIM AMIGHI and
ANTONIO SERENO GUERRA1
Appeal 2019-000134
Application 13/122, 134
Technology Center 1600
Before JOHN G. NEW, RYAN H. FLAX, and JAMIE T. WISZ,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 We use the word "Appellant" to refer to the "applicant" as defined in
37 C.F.R. § 1.142. Appellant identifies Laboratorios Linconsa, S.A. as the
real party-in-interest. App. Br. 3.
Appeal 2019-000134
Application 13/122, 134
SUMMARY
Appellant files this appeal under 35 U.S.C. § I34(a) from the
Examiner's Final Rejection of claims 1, 34--41, 45, and 46 as unpatentable
under 35 USC§ I03(a) as being obvious over the combination of Woolfe et
al. (US 2002/0081266 Al, June 27, 2002) ("Woolfe") and Zeng (US
2010/0326437 Al, December 30, 2010) ("Zeng").
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellant's invention is directed to inhalable particles comprising a
stabilized amorphous form of tiotropium with a stabilizing agent. Abstr.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. Inhalable particles consisting of a stabilized anhydrous
amorphous form of tiotropium bromide and a stabilizing agent,
the stabilizing agent being lactose, wherein the percentage (%)
of tiotropium bromide in weight relative to the weight of
tiotropium bromide and stabilizing agent is comprised between
4-8%, wherein the tiotropium bromide present in the inhalable
particles contains less than 10% crystalline fractions, the
inhalable particles being spray dried, and the stabilized
anhydrous amorphous form of tiotropium bromide with the
stabilizing agent comprises a matrix in which the tiotropium
bromide is dispersed in a molecular state.
App. Br. 18.
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ISSUES AND ANALYSES
We adopt the Examiner's findings, reasoning, and conclusion that the
claims on appeal are prima facie obvious over the cited prior art. Arguments
made by Appellant in the Appeal Brief and properly presented in the Reply
Brief have been considered; arguments not so-presented are waived. See
37 C.F.R. § 4I.37(c)(l)(iv) (2017); see also Ex parte Borden, 93 USPQ2d
14 73, 14 7 4 (BP AI 2010) (informative) ("Any bases for asserting error,
whether factual or legal, that are not raised in the principal brief are
waived."). We address the arguments raised by Appellant below.
Issue 1:
Appellant argues the Examiner erred in finding that Woolfe teaches or
suggests the combination of a sugar derivative as a stabilizer with
tiotropium. App. Br. 10-11.
Analysis
The Examiner finds that W oolfe teaches a formulation comprising a
mixture of particle of drugs and excipients spray dried for administration, in
which the drugs include amorphous tiotropium and the excipient is lactose.
Final Act. 4 (citing Woolfe Abstr., ,r,r 41, 94, claim 12). The Examiner finds
that Woolfe teaches that the particles are spray dried. Id. (citing Woolfe
Abstr.). The Examiner finds that Woolfe further teaches the optional use of
additional excipients in preferred formulations. Id. (citing Woolfe ,r 50).
The Examiner further finds that Woolfe teaches that the stabilized
anhydrous amorphous form of tiotropium with the stabilizing agent
comprises a matrix in which tiotropium is dispersed in a molecular state in
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which the particles are a pharmaceutical composition. Final Act. 4 ( citing
Woolfe Abstr., ,r,r 40-41). The Examiner finds that Woolfe teaches that its
compositions may be synthesized by spray drying, and that combining the
two constituents in solution before spray drying would result in a dispersion
of the two ingredients. Id. (citing Woolfe ,r,r 16, 72).
However, the Examiner finds that Woolfe does not expressly teach:
(1) that the inhalable medicament is tiotropium bromide; or (2) that the
percentage (%) of tiotropium bromide in weight relative to the weight of
tiotropium bromide and stabilizing agent is comprised between 4--8%. Final
Act. 6.
The Examiner finds that Zeng teaches an inhalable medicament of
tiotropium bromide in the form of solid amorphous particles in combination
with a sugar, the sugar being lactose. Final Act. 6 (citing Zeng Abstr. ,r 14).
The Examiner finds that Zeng teaches that the percentage of tiotropium
bromide in weight relative to the weight of tiotropium bromide and
stabilizing agent is between 1:10 to 1:500 (which equates to about 0.1 to 50
wt%), which encompasses the claimed range of 4--8 wt%. Id. ( citing Zeng
i123).
The Examiner concludes that it would have been prima facie obvious
to a person of ordinary skill in the art to use tiotropium bromide, as taught
by Zeng, in the pharmaceutical preparation taught by Woolfe, because
Woolfe teaches the use of tiotropium and salts thereof and Zeng teaches
tiotropium bromide, a tiotropium salt, which is known to be used in
inhalation pharmaceutical formulations. Final Act. 7 (citing Zeng Abstr.).
The Examiner concludes that a skilled artisan would have a reasonable
expectation of success in combining the references, because Woolfe teaches
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amorphous tiotropium salt-lactose compositions, and Zeng teaches
amorphous tiotropium bromide-lactose particles in the claimed
concentrations. Id. (citing Woolfe ,r 94; Zeng Abstr.).
Appellant argues that Woolfe neither teaches nor suggests that the
sugar derivatives can have the function of stabilizing agents. App. Br. 10.
Rather, Appellant argues, a careful reading of Woolfe reveals that the sugar
is not used as a stabilizer. Id. According to Appellant, Woolfe specifically
discloses that, in addition to sugars, the formulations described may also
include further excipients selected from pH stabilizers (paragraph [0044])
and that preferred formulations may also include a stabilizer an as excipient,
including antioxidants, pH modifiers, or buffers. Id. (citing Woolfe ,r,r 44,
50). Appellant asserts that the reference is not directed to the combination
of tiotropium with a sugar, much less lactose as a stabilizing agent. Id.
Appellant contends that the Examiner is confusing the teachings of
Woolfe with the discovery of the present invention, in which the lactose
functions as both a stabilizing agent for the tiotropium bromide, and also in
which the lactose can be further and separately formulated as an excipient
for the stabilized amorphous tiotropium bromide/lactose particles. App. Br.
10-11. Appellant argues that the claimed invention describes at length the
necessity of a stabilizing agent for preventing the desirable amorphous form
of the tiotropium bromide drug active from transforming into the undesirable
crystalline form. Id. at 11 ( citing Spec. ,r,r 29, 31, 32, 43). 2
Appellant contends that the claimed invention also discloses the
desirability, in some embodiments, of further incorporating an excipient,
2 We note that the Specification as filed lacks numbered paragraphs.
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such as lactose, for flow and delivery properties for inhalation therapy of the
drug active. Id. (citing Spec. ,r 39, claim 35). Appellant cites paragraph
[0043] of the Specification, which, Appellant argues, explains that the
stabilizing agent can be selected from chemically identical or chemically
different substances. Id. Therefore, Appellant contends, when lactose is
selected as both the stabilizing agent and the excipient, the lactose then
exists in two separate components of the formulation: (1) as a stabilizing
agent in intimate contact with the tiotropium bromide as part of the inhalable
amorphous drug active particles; and (2) externally and separately from
those drug active particles as a delivery medium excipient. Id. ( citing Spec.
,r,r 3 8, 39).
Appellant argues that, because of this alleged distinction between the
dual and separate formulation and functional aspects of the lactose
constituent, Woolfe is no longer relevant. App. Br. 11. According to
Appellant, Woolfe does not teach lactose as a stabilizer for intimate
admixture with the drug active component, but rather as an excipient
external to the drug active component. Id. (citing Woolfe ,r 56). Appellant
contends that W oolfe nowhere teaches or suggests a formulation or process
in which the active ingredient is intimately admixed with either a solution or
suspension of a stabilizing agent prior to spray drying. Id. Rather,
Appellant asserts, W oolfe teaches that the active ingredient is directly spray
dried without such a stabilizer. Id. Appellant contends that, because Woolfe
is allegedly inapposite and irrelevant, the Examiner is allegedly "cherry
picking" unrelated passages from throughout the reference in an attempt to
make a case of obviousness. Id.
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Appellant argues further that all of the examples of Woolfe are
directed to spray-dried particles made of drugs other than tiotropium and
without any excipients. App. Br. 11. Appellant contends that none of the
specific particles disclosed in the reference contain sugar derivatives. App.
Br. 11. Appellant notes that the X-ray powder diffraction analysis on some
of the examples in W oolfe strongly suggests that the spray-dried products
are at least partly crystalline. Id. (citing Woolfe ,r,r 91, 92, 146). Appellant
further observes that, although tiotropium is listed as a possible drug, and
sugar derivatives are mentioned as possible excipients, Woolfe teaches that
the disclosed particles do not need to contain any excipients and that they are
not necessarily amorphous. Id. at 11-12. To summarize, Appellant argues,
Woolfe does not teach or suggest an anhydrous amorphous stable form of
tiotropium bromide or how to prepare such a form. Id. at 12.
Appellant next points to paragraph [0094] of Woolfe, which teaches
production of amorphous ipratropium (an anti-cholinergic drug having a
different chemical structure from tiotropium), but only in the presence of an
additional drug active, salbutamol, and using water as a solvent. App. Br.
12. In contrast, Appellant asserts, when using ipratropium alone (without
the salbutamol) in water or ethanol, crystalline material was obtained. Id.
( citing Woolfe ,r,r 92, 93). Appellant therefore contends that the very
specific components, additional drug actives, and excipients play a key role
in determining the final nature of the product obtained. Id. Appellant
asserts that one cannot merely pick and choose ingredient teachings from the
cited art references in an attempt to achieve the present invention, when
seemingly slight modifications can shift the final product from the
amorphous to the crystalline form. Id.
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We are not persuaded by Appellant's arguments. Woolfe teaches
spray-dried powders for pulmonary or nasal administration. W oolfe Title.
Woolfe teaches that: "The component or components may be an excipient
designed to stabilise the drug or give better content uniformity of the drug or
product." Woolfe ,r 3.
Specifically, Woolfe teaches that:
Any combination of drugs and excipients including mixtures of
drugs and excipients, for example as referred to above may be
used. . . . Preferred muscarine bronchial dilating agents include
ipatropium, oxitropium, tiotropium, and salts thereof
The particles may comprise a single drug or a combination of
two or more drugs together with one or more excipients suitable
for nasal of pulmonary delivery. Excipients may be sugars, for
example selected from; lactose, mannitol, xylitol, trehalose,
dextrose and other pharmaceutically acceptable sugars.
Woolfe ,r,r 40-41 (emphases added). Woolfe thus teaches a combination of
a tiotropium salt ( e.g., tiotropium bromide) and lactose as an excipient.
Woolfe further teaches that excipients can act as either stabilizing agents or
to give better content uniformity. Id. at ,r 3.
We agree with Appellant that Woolfe also teaches other optional
excipients that can act as pH stabilizers, pH modifiers, and antioxidants.
Woolfe ,r,r 44, 50. However, the addition of such optional excipients does
not change the fact that lactose functions as a stabilizer when used as an
excipient, whether this property was recognized in the prior art or not.
More importantly, Woolfe expressly teaches the inclusion of lactose
as an excipient and tiotropium as an active compound. It is Appellant's
burden, therefore, to demonstrate that the inclusion of lactose as an excipient
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in the compositions of Woolfe did not act as a stabilizer in those
compositions.
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, or "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). Appellant adduces no
evidence to show that the lactose added as an excipient in the compositions
of Woolfe acts as a stabilizing excipient.
Appellant argues that Woolfe nowhere teaches or suggests a
formulation or process in which the active ingredient is intimately admixed
with either a solution or suspension of a stabilizing agent prior to spray
drying. See App. Br. 11. However, Appellant's claims do not require that
the active agent and the excipient be "intimately admixed," but rather
require that the "stabilizing agent comprises a matrix in which the tiotropium
bromide is dispersed in a molecular state." See claim 1. Appellant's
Specification defines the claim term "dispersed in a molecular state," as
meaning: "inhalable particles obtained by drying a solution containing both
the stabilizing agent and tiotropium." Spec. 9.
Woolfe teaches producing particles by spray drying mixtures of drugs
or excipients. Specifically, Woolfe teaches that "[ a ]ccording to a first aspect
to a present invention there is provided a formulation for pulmonary or nasal
administration comprising a mixture of particles of two or more drugs or
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excipients produced by spray drying and suitable for administration without
further processing of the particles." Woolfe ,r 36. Woolfe thus teaches that
this produces "inhalable particles obtained by drying a solution containing
both the stabilizing agent and tiotropium," corresponding to the
Specification's definition of "dispersed in a molecular state." See Spec. 9.
Woolfe ,r 38). Further, Woolfe teaches that the two or more drugs,
including, preferably, tiotropium, or excipients, including lactose, are used
to form particles by spray drying. Id. (citing Woolfe Abstr., ,r,r 40-41).
Woolfe therefore teaches that the drug and lactose are taught to be in
admixture when spray dried together to form the particles, with the drug
dispersed in a molecular state with the lactose. Id.
Woolfe further teaches lactose can be a excipient provided to improve
flow characteristics of the drug containing particles. Specifically, Woolfe
teaches that "[a] dosage form in accordance with the fourth to sixth aspects
of this invention may incorporate an external excipient to improve flow
characteristics. Examples of suitable external excipients include lactose,
mannitol, trehalose or other sugars or mixtures thereof." Woolfe ,r 56
( emphasis added). W oolfe thus teaches that lactose can be used both as an
excipient in admixture with the drug when spray dried to form the particles,
and additionally as an external excipient in the form of lactose particles for
administration of the drug particles. Id.
With respect to Appellant's argument that Woolfe does not teach
specific examples of a tiotropium-lactose combination, the examples of
Woolfe do not provide the sole teachings of the reference upon which a
person of ordinary skill may rely. Rather, in an obviousness analysis, "the
proper test is whether the references, taken as a whole, would suggest the
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invention to one of ordinary skill in the art." In re McLaughlin, 443 F.2d
1392, 1395, (C.C.P.A. 1971) (emphasis added); see also Merck & Co., Inc.
v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (holding that "all
disclosures of the prior art, including unpreferred embodiments, must be
considered") ( emphasis added). As we have explained supra, Wolfe
expressly teaches the use of tiotropium salts as the active agent and the use
of lactose as an excipient, the latter being both used in a spray-dried
admixture with the active agent and as an external excipient.
With respect to Appellant's argument that the X-ray powder
diffraction analysis on some of the examples in Woolfe strongly suggests
that the spray-dried products are at least partly crystalline (see App. Br. 11 ),
we note that the examples of Woolfe cited by the Examiner are directed to a
mixture of salbutamol sulfate or salbutamol BP and ipratropium bromide
(which Appellant acknowledges has different chemical properties than
tiotropium). See Woolfe ,r 78. Woolfe teaches that: "Salbutamol sul[fJate
as supplied was a crystalline material by XRD. When spray dried from
aqueous solution it was amorphous[,] as evidenced by XRD[.] The
amorphous material was relatively stable on heating. There was no obvious
exotherm in the DSC thermo gram, reflective of recrystallisation from the
glass." Id. at ,r 89. Woolfe further teaches that: "Spray drying from
ethanolic solution also resulted in an amorphous material by XRD. Again
the DSC showed no obvious exotherm indicative ofrecrystalli[z]ation." Id.
at ,r 90. Although some active agents did show evidence of some
crystallization (see id. at ,r,r 91-93), others expressly did not (see id. at ,r 94),
and none of the examples of Woolfe is directed to a tiotropium-lactose
mixture.
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In sum, we are not persuaded by Appellant's argument that the
techniques of Woolfe necessarily teach that a tiotropium lactose necessarily
crystallizes more than 10% upon spray drying. Indeed, Appellant discloses
in their Specification that: "the presence of lactose in the spray-dried
powders permitted to stabilize tiotropium as a tiotropium-lactose amorphous
form even after storage." Spec. 20. Appellant adduces no evidence to show
that this stability was not inherently a property of the spray-dried tiotropium-
lactose compositions taught by Woolfe. See in re Best, 562 F.2d at 1255.
As such, we do not find Appellant's argument in this respect persuasive.
Issue 2
Appellant argues that Zeng does not cure the alleged deficiencies of
Woolfe. App. Br. 12.
Analysis
Appellant argues that Zeng discloses a medicament in the form of
solid amorphous particles containing an intimate admixture of tiotropium
bromide together with a pharmaceutically acceptable co-solid having a glass
transition temperature of at least -50°C, such as a sugar and/or a sugar
alcohol. App. Br. 12 (citing Zeng Abstr.). Appellant points out that these
medicaments are in the form of freeze-dried (i.e., lyophilized) compositions,
in contrast to the compositions of the present invention, which are in the
form of spray-dried compositions. Id. at 12-13 (citing Zeng, e.g., ,r,r 16, 18,
Exs. 1, 2). According to Appellant, a person of ordinary skill in the art
would have recognized the difference between compositions prepared via
freeze-drying versus spray drying. Id. at 13. Appellant asserts that Zeng
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teaches the particles as containing an intimate "admixture" of the tiotropium
bromide and a co-solid, but that there is no teaching of the dispersion of the
tiotropium bromide in a molecular state, as required by Claim 1. Id.
Appellant next points to the Declaration of Antonio Sereno Guerra,
filed March 31, 2015 ( the "Guerra Declaration") which, argues Appellant,
demonstrates the undesired crystalline nature of the compositions taught by
Zeng. App. Br. 13. Appellant states that the Guerra Declaration describes a
direct comparison of tiotropium bromide/lactose compositions made
according to the present patent application with those made according to
Examples 1 and 2 of Zeng. Id. Appellant states that the Guerra Declaration
states that Example 1 of Zeng describes a vacuum drying procedure at -20°C
and Example 2 of Zeng describes a freeze-drying technique whereby a
solution is sprayed into liquid nitrogen. Id. Appellant contends that the
experiments described in the Guerra Declaration were conducted at the
request of and under the responsibility of Mr. Guerra in the Laboratory of
Pharmaceutics and Biopharmaceutics of the Universite Libre de Bruxelles
(ULB). Id. Based on the experimental results, argues Appellant, the
tiotropium bromide/lactose particle samples in a 100: 1 ( w/w lactose-
tiotropium bromide) ratio were 100% amorphous when prepared according
to the present invention, however, the same ratio, when prepared according
to either Example 1 or 2 of Zeng, demonstrated at most between 10.5% to
54% amorphous characteristics. Id. ( citing Guerra Deel. Table 1 ).
Appellant argues that, as stated in the Guerra Declaration, because the
sample produced according to Example 1 of Zeng produces particles that are
not of a suitable size for use in an inhalable product, the resultant product
was further micronized. App. Br. 14. Appellants assert that the Guerra
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Declaration discloses, however, that micronization provided only a modest
improvement in the amorphous character of the resultant product, increasing
it from 10.5% to only 38%. Id. Therefore, Appellant contends, a
micronized product based on Zeng still does not demonstrate the amorphous
character of the product of the present invention. Id.
Appellant next points to the Guerra Declaration's disclosure that an
additional formulation was prepared and tested having a lactose to
tiotropium bromide ratio of 12.4: 1 (weight/weight), which correspond to
approximately 7.5% of the tiotropium bromide by weight. App. Br. 14.
Appellant states that such a formulation is a typical formulation within the
weight range of compositions of the present invention. Id. ( citing Spec.
,r 35). Appellant asserts that, even at this relatively low ratio of lactose to
tiotropium bromide, the resultant product prepared according to the present
invention resulted in particles of 100% amorphous character. Id.
Furthermore, argues Appellant, the tiotropium bromide/lactose
particle samples of the present invention retained all their amorphous
characteristics upon storage at 25°C, 40°C, 50°C, and 75°C for two and four
weeks, except for a sample stored under the most extreme of the storage
conditions, namely 75°C and ambient relative humidity for four weeks.
App. Br. 14. In contrast, Appellant contends, the Guerra Declaration shows
that samples prepared according to either Example 1 or 2 of Zeng,
demonstrated highly variable and undesirable amorphous content. Id. at 14--
15 ( citing Guerra Deel. Table 2).
We are not persuaded by Appellant's arguments. Furthermore,
conclude the Guerra Declaration does not persuasivley address the
determinations of the Examiner's rejection. Zeng teaches methods of
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preparing a tiotropimn bromide-lactose composition via lyophilizing the
preparation. However, the Examiner relies upon W oolfe as teaching that the
composition is spray-dried, as in Appellant's claimed invention. See Final
Act. 4; Woolfe ,r 15. Similarly, the Guerra Declaration compares the freeze-
drying preparation taught by Zeng with Appellant's composition formed by
spray drying, and claims that the methods taught by Zeng do not reliably
form the claimed percentage of amorphous tiotropium-lactose particles.
Guerra Deel. ,r,r 5-21.
However, if Appellant is asserting that their claimed composition
possesses properties that are substantially different than those of the prior
art, then Appellant must compare their results with those of the closest prior
art. See In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). In
this case, the closest prior art is Woolfe, which also teaches tiotropium salt-
lactose compositions formed by spray drying. Notably, Appellant produces
no evidence, either in the Guerra Declaration or elsewhere, that the methods
taught by Woolfe do not produce the claimed stable greater than 90%
amorphous formulation.
The Examiner relies upon Woolfe as teaching spray-dried tiotropium
salt-lactose compositions. See Final Act. 4. Zeng is relied upon by the
Examiner as teaching, inter alia, the claimed concentrations of tiotropium
bromide and lactose. Id. at 6. Because Appellant does not demonstrate that
the claimed composition is substantially different from the compositions of
the combined cited prior art, we are not persuaded by Appellant's arguments
in this respect.
Issue 3
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Appellant argues that a person of ordinary skill would not have been
motivated to combine Woolfe with Zeng to arrive at the present invention.
App. Br. 15.
Analysis
Appellant argues that there is no teaching or suggestion in Woolfe to
combine its teachings and suggestions with Zeng. App. Br. 15-16.
Appellant repeats the argument supra that W oolfe neither teaches nor
suggests a combination of tiotropium bromide and lactose, much less a
stabilized amorphous form, and that Zeng is directed to compositions that
are generally crystalline or that are not sufficiently stabilized, and thus that
revert to a crystalline form. Id. at 16. Therefore, Appellant contends, a
skilled artisan not have been motivated to select Zeng to remedy the
deficiencies of Woolfe. Id.
We are not persuaded by Appellant's argument. As we have
explained, both Woolfe and Zeng are directed to compounds containing a
tiotropium salt (specifically tiotropium bromide, in the teachings of Zeng).
Woolfe teaches spray dried compositions of this compound, and Zeng
teaches the relative concentrations that are effective. We conclude that a
person of ordinary skill in the art would have been motivated to combine the
teachings of the two references because Zeng expressly teaches
therapeutically effective concentrations of tiotropium bromide and lactose
that could be incorporated into the spray-dried compositions ofWoolfe. See
Zeng ,r 23.
Issue 4
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Appellant argues that the claimed invention would not have been
prima facie obvious to a person of ordinary skill in the art over the combined
teachings and suggestions ofWoolfe and Zeng. App. Br. 16.
Analysis
Appellant alleges that the Examiner is improperly picking and
choosing, piecemeal, specific teachings from each of the cited references in
an attempt to build a case of obviousness, selecting at least ten separate and
unrelated paragraphs in each ofWoolfe and Zeng. App. Br. 16. Appellant
asserts that the Examiner's allegedly selectively picking and choosing
specific teachings from each reference with no motivation, except the
hindsight of the present invention, for attempting to combine them together
is impermissible. Id.
We are not persuaded. We have explained supra why we agree with
the Examiner that it would have been obvious for a person of ordinary skill
in the art to combine the teachings of Woolfe and Zeng to arrive at
Appellant's claimed invention.
Furthermore, with respect to Appellant's allegation that the Examiner
impermissibly relied upon hindsight reasoning:
Any judgment on obviousness is in a sense necessarily a
reconstruction based upon hindsight reasoning, but so long as it
takes into account only knowledge which was within the level of
ordinary skill at the time the claimed invention was made and
does not include knowledge gleaned only from applicant's
disclosure, such a reconstruction is proper.
In re McLaughlin, 443 F.2d at 1395. Appellant points to no evidence that
the Examiner relied upon knowledge other than from the teachings of the
cited references or knowledge which was within the level of ordinary skill at
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the time the claimed invention was made. Consequently, we affirm the
Examiner's rejection of the claims.
DECISION
The Examiner's rejection of claims 1, 34--41, 45, and 46 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)(l )(iv).
1, 34--41, 45, 103(a)
46
Overall
Outcome
Woolfe, Zeng 1, 34--41, 45,
46
18
1, 34--41, 45,
46