Application/Control Number:
`13/967,168
`Application/Control Number: 13/967,168 (cid:9)
`Art Unit: 1658
`Art Unit: 1658
`
`Page 3
`Page 3
`
`goods associated with
`the
`trademark
`or
`trade In the present case, name.
`
`
`goods associated with the trademark or trade name. In the present case, the
`
`the
`
`trademark/trade name is used
`to
`
`identify/describe 10-30 alkyl acrylate cross-acrylate/C
`
`trademark/trade name is used to identify/describe acrylate/C10-30 alkyl acrylate cross-
`
`polymers, or high molecular weight co-polymers of acrylic acid and a
`long
`chain
`polymers, or high molecular weight co-polymers of acrylic acid and a long chain alkyl
`
`alkyl
`
`methacrylate cross-linked with
`allyl
`
`ethers pentaerythritol (see paragraph of
`
`bridging
`methacrylate cross-linked with allyl ethers of pentaerythritol (see paragraph bridging
`
`pages 19-20 of the disclosure) and, accordingly,
`the
`identification/description
`pages 19-20 of the disclosure) and, accordingly, the identification/description is
`
`is
`
`indefinite.
`indefinite.
`
`Claim Rejections - 35 USC §103
`Claim Rejections - 35 USC § 103
`
`4.
`4.
`
`The following
`is a
`quotation
`of 35
`
`U.S.C. which forms the basis 103(a)
`
`for all
`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
`
`obviousness rejections set
`forth
`in
`this
`obviousness rejections set forth in this Office action:
`
`Office
`
`action:
`
`is
`
`sought
`
`(a) A patent may not
`be
`obtained
`
`though not identically the
`
`invention disclosed or
`
`
`described
`(a) A patent may not be obtained though the invention is not identically disclosed or described as
`set forth
`in section
`102 this title,
`
`of if the differences
`
`between
`the
`subject
`matter
`set forth in section 102 of this title, if the differences between the subject matter sought to be
`patented and
`the
`
`prior are such art that
`
`
`the
`
`subject matter as a whole
`would
`have
`patented and the prior art are such that the subject matter as a whole would have been obvious
`at the time
`
`the invention was made
`to
`a
`person ordinary skill
`
`in
`
`having the
`art
`to
`at the time the invention was made to a person having ordinary skill in the art to which said
`subject matter
`pertains. Patentability shall
`not
`be
`negatived
`by which the
`
`the invention
`
`subject matter pertains. Patentability shall not be negatived by the manner in which the invention
`was made.
`was made.
`
`been
`which
`
`manner
`
`5.
`
`Claims 37-60 are
`rejected
`under 35
`
`U.S.C. as being unpatentable over 103(a)
`
`Claims 37-60 are rejected under 35 U.S.C. 103(a) as being unpatentable over
`
`Ding et al. (US 5,474,979,
`cited
`in
`the
`IDS
`Ding et al. (US 5,474,979, cited in the IDS dated 12/27/2004).
`
`dated
`
`12/27/2004).
`
`Ding et al. disclose
`topical ophthalmic
`
`emulsions for treating an eye of human
`Ding et al. disclose topical ophthalmic emulsions for treating an eye of human
`
`having KCS (dry eye disease),
`and
`a
`method
`comprising topically
`having KCS (dry eye disease), and a method comprising topically administering to the
`
`administering
`
`eye the human emulsion
`(see
`next
`eye the human emulsion (see next page):
`
`page):
`
`0178
`
`TEVA - EXHIBIT 1004 (PART 2 OF 4)
`
`

`

`Application/Control Number:
`13/967,168
`Application/Control Number: 13/967,168 (cid:9)
`Art Unit: 1658
`Art Unit: 1658
`
`Page 4
`Page 4
`
`Exatapte I
`ample
`
`A
`
`B
`B
`
`c
`C
`
`D:
`D:
`
`E
`E
`
`0.40® G.m
`0.05%
`OJOR
`0.20%
`0.410%
`0.20%
`0.05%
`0„10%
`0.20%
`5.m%
`125%
`5.00%
`5,00%
`1.25% U25%
`2.50%
`<X625*
`L0096
`L00%
`L00»
`1.00%
`L00%
`LOU%
`L.00%
`1.00%
`LOSfSr
`1.00%
`0,05% msm
`Q,05%
`0,65%
`aoss.
`0.05%
`0,05%
`0.05%
`0,05%
`0.05%
`2,20%
`2^0%
`2.20%
`2.20%
`2.20%
`2.20%
`120%
`220%
`2,20%
`220%
`qt
`qs
`cs
`qs
`tiE
`qs
`qs
`qs
`as
`qs
`qs
`qs
`q:s
`qs
`qs
`qs
`qs
`qs
`qs
`7,2-7,5 7.2-7M 7.2-7.6 7,2-7,6 7.2-7,6
`7.2-7;6
`7,2-7,5
`72-7.6
`7.2-7.d
`7.2-7,6
`
`Cp-.1Gsparin A
`CydoBpo-rin A
`Caslcr oil
`Caster cti1
`Polysothate g0
`Polygctrbate 16
`PtiSfelktf ®
`Pezw.len ®
`GIj^eriRS
`Glycerisla
`NaOH
`NaOH
`FusiSsd waKr
`Plaited water
`pH
`Pli
`
`Thus, a comparison of the
`instantly
`claimed
`
`and Ding et al. some
`
`Thus, a comparison of the instantly claimed and some of the Ding et al.
`
`of
`
`the
`
`embodiments
`is presented
`below:
`embodiments is presented below:
`
`DINGetal.
`1-D
`DING et al. 1-D
`
`instant invention DINGetal.
`1-E
`instant invention DING et al. 1-E
`
`Cyclosporin
`Cyclosporin
`
`Castor oil
`Castor oil
`
`0.10%
`0.10%
`
`1.25%
`1.25%
`
`Polysorbate 80
`Polysorbate 80
`
`1.00%
`1.00%
`
`Pemulen
`Pemulen
`
`Glycerine
`Glycerine
`
`NaOH
`NaOH
`
`Purified water
`Purified water
`
`0.05%
`0.05%
`
`2.20%
`2.20%
`
`qs
`qs
`
`qs
`qs
`
`0.05%
`0.05%
`
`1.25%
`1.25%
`
`1.00%
`1.00%
`
`0.05%
`0.05%
`
`2.20%
`2.20%
`
`qs
`qs
`
`qs
`qs
`
`0.05%
`0.05%
`
`0.625%
`0.625%
`
`1.00%
`1.00%
`
`0.05%
`0.05%
`
`2.20%
`2.20%
`
`qs
`qs
`
`qs
`qs
`
`PH
`pH
`
`7.2-7.6
`7.2-7.6
`
`7.2-7.6
`7.2-7.6
`
`7.2-7.6
`7.2-7.6
`
`
`Furthermore, the claims of Ding et al. disclose
`ranges
`for
`the
`components
`Furthermore, the claims of Ding et al. disclose ranges for the components (e.g.,
`
`(e.g.,
`
`claims 1-8). For example, Ding et al. discloses a
`pharmaceutical
`emulsion
`claims 1-8). For example, Ding et al. discloses a pharmaceutical emulsion comprising
`
`comprising
`
`0179
`
`

`

`Application/Control Number:
`13/967,168
`Application/Control Number: 13/967,168 (cid:9)
`Art Unit: 1658
`Art Unit: 1658
`
`Page 5
`Page 5
`
`cyclosporin A, castor oil, Pemulen, glycerine, polysorbate
`80,
`water in amounts
`
`cyclosporin A, castor oil, Pemulen, glycerine, polysorbate 80, water in amounts
`
`
`sufficient to prevent crystallization cyclosporin A for a period of up to about nine of
`
`sufficient to prevent crystallization of cyclosporin A for a period of up to about nine
`
`months, said pharmaceutical
`emulsion
`being
`suitable
`for
`topical
`months, said pharmaceutical emulsion being suitable for topical application to ocular
`
`application
`
`tissue, wherein
`
`the cyclosporin is present in an amount between A
`
`
`about and
`tissue, wherein the cyclosporin A is present in an amount between about 0.05 to and
`
`0.05
`
`to
`
`about 0.40%, by weight,
`the
`
`
`
`castor is present in an amount oil between about of
`
`about 0.40%, by weight, the castor oil is present in an amount of between about
`
`0.625%, by weight, and about 5.0%, by weight,
`the
`polysorbate
`80
`0.625%, by weight, and about 5.0%, by weight, the polysorbate 80 is present in an
`
`is
`
`present
`
`amount of about 1.0%, by weight,
`the Pemulen
`is
`present
`
`in about 0.05%, an
`
`amount of about 1.0%, by weight, the Pemulen is present in an amount of about 0.05%,
`
`amount
`
`by weight, and
`the glycerine
`is
`present
`
`in about 2.2%, by weight an amount
`
`
`of (e.g.,
`by weight, and the glycerine is present in an amount of about 2.2%, by weight (e.g.,
`
`
`
`claims 7-8).
`claims 7-8).
`
`The formulations set
`forth
`
`in Examples -4 were made 1
`
`for treatment
`The formulations set forth in Examples 1-4 were made for treatment of
`
`of
`
`keratoconjunctivitis sicca
`
`(dry eye) syndrome with Examples 2, 3
`and
`4
`keratoconjunctivitis sicca (dry eye) syndrome with Examples 2, 3 and 4 without the
`
`without
`
`active ingredient cyclosporin
`utilized
`to
`determine
`the the
`
`active ingredient cyclosporin utilized to determine the toxicity of the
`
`toxicity
`
`of
`
`emulsified components.
`emulsified components.
`
`Ding et al. teach
`that
`the
`formulations
`in
`Examples -4 were applied
`
`1 to rabbit
`
`Ding et al. teach that the formulations in Examples 1-4 were applied to rabbit
`
`eyes eight times a
`day
`for seven
`days
`and
`were
`eyes eight times a day for seven days and were found to cause only slight to mild
`
`found
`
`to
`
`discomfort and slight hyperemia
`in
`the
`rabbit eyes. Slit lamp examination
`
`revealed
`discomfort and slight hyperemia in the rabbit eyes. Slit lamp examination revealed no
`
`no
`
`changes in the surface
`
`tissue. In addition, the cyclosporin containing
`castor
`changes in the surface tissue. In addition, the cyclosporin containing castor oil
`
`oil
`
`emulsion, as hereinabove
`set
`forth in Examples 1A-1D, was
`
`also
`tested
`emulsion, as hereinabove set forth in Examples 1A-1D, was also tested for ocular
`
`for
`
`ocular
`
`bioavailability in rabbits;
`and
`the
`
`therapeutic cyclosporin was level
`
`bioavailability in rabbits; and the therapeutic level of cyclosporin was
`
`of
`
`found in the
`
`
`tissues of interest after dosage. Ding et al. go on to teach that this
`found in the tissues of interest after dosage. Ding et al. go on to teach that this
`
`substantiates that cyclosporin
`in
`an ophthalmic
`delivery
`system for treating dry
`
`substantiates that cyclosporin in an ophthalmic delivery system is useful for treating dry
`
`is
`
`useful
`
`eye.
`eye.
`
`0180
`
`

`

`Application/Control Number:
`13/967,168
`Application/Control Number: 13/967,168 (cid:9)
`Art Unit: 1658
`Art Unit: 1658
`
`Page 6
`Page 6
`
`One of ordinary
`
`skill the art at in
`
`the
`time
`the
`invention
`was
`One of ordinary skill in the art at the time the invention was made would have
`
`made
`
`been motivated
`to modify
`the
`invention Ding et al., e.g., Example of
`
`
`1E, making any by
`
`been motivated to modify the invention of Ding et al., e.g., Example 1 E, by making any
`
`
`
`composition
`(and method
`thereof)
`encompassed
`by
`composition (and method thereof) encompassed by the ranges disclosed in Ding et al.
`
`the
`
`One of ordinary
`
`skill the art at in
`
`the
`time
`the
`invention
`was
`One of ordinary skill in the art at the time the invention was made would have been
`
`made
`
`motivated
`to do
`so
`given the guidance provided
`
`by
`Ding
`et
`al., castor
`
`motivated to do so given the guidance provided by Ding et al., i.e., the amount of castor
`
`i.e.,
`
`oil in the emulsions
`is
`taught
`to
`be castor oil
`
`cyclosporin is between
`
`0.12
`to
`oil in the emulsions is taught to be cyclosporin to castor oil is between 0.12 and 0.02,
`
`and
`
`0.02,
`
`which, for 0.05%
`corresponds
`to
`
`0.4% castor oil (which encompasses to 2.5%
`
`
`which, for 0.05% corresponds to 0.4% to 2.5% of castor oil (which encompasses
`
`of
`
`1.25%). See, e.g.,
`col. 3. One of ordinary
`
`skill the art, at in
`
`the
`time
`the
`invention
`1.25%). See, e.g., col. 3. One of ordinary skill in the art, at the time the invention was
`
`made, would have
`had
`a
`reasonable
`expectation
`made, would have had a reasonable expectation of success for doing so because
`
`of
`
`success
`
`1.25% was known
`to
`be
`non-irritating
`as
`shown
`1.25% was known to be non-irritating as shown in Example 1 D, because such
`
`in
`
`modifications are
`routinely
`determined
`and in the art
`
`optimized through routine
`
`
`modifications are routinely determined and optimized in the art through routine
`
`experimentation [see MPEP
`
`2144.05 (I) regarding optimization of ranges] and because
`experimentation [see MPEP 2144.05 (I) regarding optimization of ranges] and because
`
`the active
`ingredients,
`
`cyclosporin and castor oil were present A
`
`at
`the active ingredients, cyclosporin A and castor oil were present at overlapping
`
`overlapping
`
`concentrations between
`the
`instant
`invention
`and
`the [see MPEP
`concentrations between the instant invention and the invention of Ding et al. [see MPEP
`
`
`
`2144.05 (I) regarding overlapping
`ranges].
`Moreover,
`differences
`2144.05 (I) regarding overlapping ranges]. Moreover, differences in concentration or
`
`in
`
`temperature will not
`support
`the
`patentability subject matter encompassed of
`
`
`temperature will not support the patentability of subject matter encompassed by the
`
`by
`
`the
`
`prior art unless
`there
`is
`evidence
`indicating
`such
`critical
`prior art unless there is evidence indicating such concentration or temperature is critical
`
`concentration
`
`[see MPEP 2144.05
`(II)]. Furthermore,
`to establish
`unexpected
`results
`[see MPEP 2144.05 (II)]. Furthermore, to establish unexpected results over a claimed
`
`range, applicants
`should
`compare
`a
`sufficient
`number
`range, applicants should compare a sufficient number of tests both inside and outside
`
`of
`
`the daimed
`range
`to
`
`the of the claimed criticality range
`
`
`
`(MPEP 716.02).
`show
`the claimed range to show the criticality of the claimed range (MPEP 716.02).
`
`Furthermore, one
`of ordinary skill
`
`in
`the
`art
`would
`have
`been
`Furthermore, one of ordinary skill in the art would have been motivated to determinf.-?,
`
`motivated
`
`adequate daily
`
`frequency administration of
`
`in
`order
`to
`find
`suitable
`adequate daily frequency of administration in order to find suitable administration
`
`administration
`
`0181
`
`

`

`Application/Control Number:
`13/967,168
`Application/Control Number: 13/967,168 (cid:9)
`Art Unit: 1658
`Art Unit: 1658
`
`Page 7
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`
`
`regimes (e.g., once, twice, thrice, etc.),
`
`one ordinary skiii in of
`
`the
`
`art the time the at
`
`regimes (e.g., once, twice; thrice, etc.), one of ordinary skill in the art at the time the
`
`invention was made would
`have
`had
`
`reasonable success given
`
`expectation that the
`
`invention was made would have had reasonable expectation of success given that the
`
`0.1% containing cyclosporin
`emulsion
`was
`effective
`in
`0.1% containing cyclosporin emulsion was effective in treating KC S (see Examples).
`
`treating
`
`Claim scope
`is
`not limited
`by
`claim
`
`language makes optional but that
`
`Claim scope is not limited by claim language that suggests or makes optional but
`
`suggests
`
`does not require
`steps
`to
`be
`performed,
`or
`by
`does not require steps to be performed, or by claim language that does not limit a claim
`
`claim
`
`to a particular structure.
`However,
`
`examples claim language, although of
`
`to a particular structure. However, examples of claim language, although not
`
`not
`
`exhaustive,
`that may
`raise
`a
`question
`as the language
`
`
`to in a
`exhaustive, that may raise a question as to the limiting effect of the language in a claim
`
`
`
`the claim
`
`are:
`are:
`
`(A) "adapted
`to"
`or
`"adapted
`(A) "adapted to" or "adapted for" clauses;
`
`for"
`
`clauses;
`
`(B) "wherein" clauses;
`(B) "wherein" clauses; and
`
`and
`
`(C) "whereby" clauses.
`(C) "whereby" clauses.
`
`The determination
`of whether each of these clauses
`is
`a
`limitation
`The determination of whether each of these clauses is a limitation in a claim
`
`in
`
`depends on
`the
`specific
`facts
`of
`the
`case.
`[..] the
`depends on the specific facts of the case. In the instant case, the limitations ", [..] the
`
`In
`
`the
`
`blood of
`the human
`has
`substantially
`no
`detectable
`blood of the human has substantially no detectable concentration of cyclosporin A",
`
`concentration
`
`"wherein the emulsion
`breaks
`down
`more
`quickly a human, once
`
`"wherein the emulsion breaks down more quickly in the eye of a human, once
`
`in
`
`administered
`to
`the
`eye
`of
`the
`human,
`thereby
`administered to the eye of the human, thereby reducing vision distortion in the eye of
`
`reducing
`
`the human as
`compare
`to
`an
`emulsion
`that
`contains
`the human as compare to an emulsion that contains only 50% as much castor oil",
`
`only
`
`"wherein
`the ophthalmic
`emulsion,
`when
`
`administered a human,
`"wherein the ophthalmic emulsion, when administered to the eye of a human,
`
`to
`
`the
`
`demonstrates a
`reduction
`in
`
`adverse in the human", events "wherein
`
`
`the
`adverse
`demonstrates a reduction in adverse events in the human", "wherein the adverse events
`
`events
`
`include side effects"
`and
`"wherein
`the
`emulsion
`is
`include side effects" and "wherein the emulsion is effective in increasing tear production
`
`effective
`
`in the human having
`KCS",
`it
`is
`
`noted effects would necessarily that such
`
`
`in the human having KCS", it is noted that such functional effects would necessarily flow
`
`flow
`
`functional
`
`0182
`
`

`

`Application/Control Number:
`13/967,168
`Application/Control Number: 13/967,168 (cid:9)
`Art Unit: 1658
`Art Unit: 1658
`
`Page 8
`Page 8
`
`from the compositions
`of Ding et al. and methods
`
`thereof which comprise administration
`from the compositions of Ding et al. and methods thereof which comprise administration
`
`of all the claimed components
`and
`amounts
`in
`the
`of all the claimed components and amounts in the claimed method, as set forth above.
`
`claimed
`
`From the
`teaching
`of the reference,
`
`it
`is
`apparent
`that
`one skill in the
`
`From the teaching of the reference, it is apparent that one of ordinary skill in the
`
`of
`
`art would have had
`a
`reasonable
`expectation
`of
`art would have had a reasonable expectation of success in producing the claimed
`
`success
`
`invention. Therefore,
`the
`invention
`as
`a
`whole
`invention. Therefore, the invention as a whole was prima facie obvious to one of
`
`was
`
`ordinary skill
`in
`the
`art
`at
`the
`time
`the evidenced by
`
`ordinary skill in the art at the time the invention was made, as evidenced by the
`
`
`
`invention the
`
`references, especially
`in
`the
`absence evidence to
`
`
`the
`
`of contrary.
`references, especially in the absence of evidence to the contrary.
`
`Double Patenting
`Double Patenting
`
`6.
`6. (cid:9)
`
`The nonstatutory
`double
`patenting
`
`rejection is judicially created based
`
`The nonstatutory double patenting rejection is based on a judicially created
`
`on
`
`doctrine grounded
`in
`public
`policy
`(a
`policy
`reflected to prevent the
`
`
`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
`
`unjustified or
`improper
`timewise
`extension
`of
`the
`unjustified or improper timewise extension of the "right to exclude" granted by a patent
`
`"right
`
`and to prevent possible
`harassment
`by
`multiple assignees. A nonstatutory double
`
`and to prevent possible harassment by multiple assignees. A nonstatutory double
`
`patenting rejection
`is
`appropriate
`where the
`claims
`at
`patenting rejection is appropriate where the claims at issue are not identical, but at least
`
`issue
`
`one examined application
`claim
`is
`not
`patentably
`one examined application claim is not patentably distinct from the reference claim(s)
`
`distinct
`
`because
`the examined
`application
`claim
`is
`either
`because the examined application claim is either anticipated by, or would have been
`
`anticipated
`
`obvious over,
`the
`reference
`
`claim(s). In re Berg, 140 F.3d See, e.g.,
`
`
`
`1428, USPQ2d
`obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d
`
`46
`
`
`1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d
`1046, USPQ2d 2010 29
`
`
`(Fed. Cir.
`1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir.
`
`1993); In re Longi,
`759
`
`F.2d USPQ 645 (Fed. Cir. 1985); 887, 225
`
`
`In
`re Van Ornum,
`1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum,
`
`
`686 F.2d 937, 214 USPQ (CCPA 1982); 761
`
`
`Vogel, F.2d 438, 164 USPQ 422
`
`In
`re
`686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619
`
`619
`
`(CCPA 1970);
`and
`418
`
`F.2d 1969).
`In
`re
`Thorington,
`(CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
`
`528,
`
`A timely filed
`terminal
`disclaimer
`in
`
`compliance (c) or 1.321 (d) with
`
`A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d)
`
`37
`
`may be used
`to overcome
`an
`actual
`or
`provisional
`may be used to overcome an actual or provisional rejection based on a nonstatutory
`
`rejection
`
`0183
`
`

`

`Application/Control Number:
`13/967,168
`Application/Control Number: 13/967,168 (cid:9)
`Art Unit: 1658
`Art Unit: 1658
`
`Page 9
`Page 9
`
`double patenting
`ground
`provided
`the
`reference
`application
`double patenting ground provided the reference application or patent either is shown to
`
`be commonly owned
`with
`this
`application,
`or made as a claims result
`
`
`
`be commonly owned with this application, or claims an invention made as a result of
`
`of
`
`an
`
`activities undertaken within
`the
`scope a joint research agreement. of
`
`
`A
`activities undertaken within the scope of a joint research agreement. A terminal
`
`terminal
`
`disclaimer must be
`signed
`in
`compliance
`(b).
`disclaimer must be signed in compliance with 37 CFR 1.321(b).
`
`with
`
`37
`
`CFR
`
`The USPTO
`internet Web
`site
`contains
`terminal
`The USPTO internet Web site contains terminal disclaimer forms which may be
`
`disclaimer
`
`used. Please visit http://www.uspto.gov/forms/. The filing date
`of the
`application
`used. Please visit http://www.uspto.gov/forms/. The filing date of the application will
`
`determine what
`form
`should
`be A web-based eTerminal used.
`
`
`Disclaimer
`may
`determine what form should be used. A web-based eTerminal Disclaimer may be filled
`
`will
`
`be
`
`out completely online
`using
`web-screens.
`An
`eTerminal that meets all
`
`out completely online using web-screens. An eTerminal Disclaimer that meets all
`
`Disclaimer
`
`requirements
`is
`auto-processed
`and
`approved
`
`immediately For more
`requirements is auto-processed and approved immediately upon submission. For more
`
`upon
`
`information about
`eTerminal Disclaimers,
`information about eTerminal Disclaimers, refer to
`
`refer
`
`to
`
`http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-l.jsp.
`http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
`
`7.
`7. (cid:9)
`
`Claims 37-60 are
`rejected
`on
`the nonstatutory obviousness-type ground of
`
`
`
`Claims 37-60 are rejected on the ground of nonstatutory obviousness-type
`
`double patenting
`as
`being
`unpatentable
`
`over Patent No. 5,474,979. claims
`
`double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 5,474,979.
`
`1-8
`
`Although
`the conflicting
`claims
`are
`not
`identical,
`Although the conflicting claims are not identical, they are not patentably distinct from
`
`they
`
`each other because
`Ding
`et
`al.
`(US
`5,474,979)
`each other because Ding et al. (US 5,474,979) claims pharmaceutical emulsions
`
`claims
`
`comprising of cyclosporine A, castor oil, Pemulen ® (crosslinked polyacrylate
`stabilizer),
`comprising of cyclosporine A, castor oil, Pemulen ® (crosslinked polyacrylate stabilizer),
`
`glycerine and water
`as
`instantly
`claimed
`(see Ding et al.)
`
`
`for claims topical
`
`glycerine and water as instantly claimed (see claims 6-8 of Ding et al.) for topical
`
`6-8
`
`application comprising
`to
`ocular tissue wherein
`
`the
`cyclosporine
`A
`is
`application comprising to ocular tissue wherein the cyclosporine A is presents in an
`
`presents
`
`amount of between about 0.05
`to
`
`and 0.40% by weight about
`
`(which
`encompasses
`amount of between about 0.05 to and about 0.40% by weight (which encompasses
`
`about 0.05% cyclosporin
`
`A), oil from about 0.625% castor
`
`to
`about
`about 0.05% cyclosporin A), castor oil from about 0.625% to about 5.0% (which
`
`5.0%
`
`(which
`
`encompasses 1.25%
`
`of castor Pemulen ® at about oil),
`
`0.05%,
`and
`encompasses 1.25% of castor oil), Pemulen ® at about 0.05%, and glycerin at about
`
`glycerin
`
`2.2%. (see, e.g.,
`
`claim Additionally, a 8).
`
`different
`emulsifier,
`i.e.,
`2.2%. (see, e.g., claim 8). Additionally, a different emulsifier, i.e., polysorbate 80, is
`
`polysorbate
`
`0184
`
`

`

`Application/Control Number:
`13/967,168
`Application/Control Number: 13/967,168 (cid:9)
`Art Unit: 1658
`Art Unit: 1658
`
`Page 10
`Page 10
`
`taught at about 1.0%
`
`(see claim 8). The also
`
`emulsion
`contains
`water
`taught at about 1.0% (see also claim 8). The emulsion contains water as set forth in
`
`as
`
`claims 6-8 of Ding et al. The specification of Ding et al. was used
`as
`dictionary
`claims 6-8 of Ding et al. The specification of Ding et al. was used as dictionary and it
`
`and
`
`was determined
`that
`the
`
`compositions to treat dry eye were
`
`
`
`used (KCS) and that the
`was determined that the compositions were used to treat dry eye (KCS) and that the
`
`compositions encompassed
`Examples
`1A-E,
`wherein
`1E
`compositions encompassed Examples 1A-E, wherein 1 E comprises all the components
`
`comprises
`
`and ranges
`instantly
`claimed
`except
`for
`the
`castor
`and ranges instantly claimed except for the castor oil, which is encompassed by the
`
`oil,
`
`claimed ranges
`to
`cyclosporin
`to oil.
`
`claimed ranges to cyclosporin to castor oil.
`
`castor
`
`One of ordinary
`
`skill the art at in
`
`the
`time
`the
`invention
`was
`One of ordinary skill in the art at the time the invention was made would have
`
`made
`
`been motivated
`to modify
`the
`invention Ding et al. by making of
`
`
`any
`compositions
`been motivated to modify the invention of Ding et al. by making any compositions
`
`encompassed by
`the
`ranges taught
`by
`Ding ordinary skill
`
`et al. in the
`
`
`encompassed by the ranges taught by Ding et al. One of ordinary skill in the art would
`
`art
`
`
`
`One would
`
`have been motivated
`to
`do
`
`so create nonirritating in order emulsions
`
`
`to
`
`of
`cyclosporin
`have been motivated to do so in order to create nonirritating emulsions of cyclosporin
`
`suitable for
`topical
`
`
`
`application ocular tissue. One to ordinary skill of
`
`in
`the
`art,
`suitable for topical application to ocular tissue. One of ordinary skill in the art, at the time
`
`at
`
`the
`
`the invention was made,
`would
`have
`had
`
`a success for doing reasonable
`
`the invention was made, would have had a reasonable expectation of success for doing
`
`so because such modifications
`are
`routinely
`determined
`so because such modifications are routinely determined and optimized in the art
`
`and
`
`through routine experimentation [see
`
`MPEP (I) regarding optimization of 2144.05
`
`through routine experimentation [see MPEP 2144.05 (I) regarding optimization of
`
`ranges] and because
`the
`active
`ingredients,
`cyclosporin oil were present
`
`ranges] and because the active ingredients, cyclosporin A and castor oil were present at
`
`at
`
`A
`
`overlapping concentrations
`between
`the
`instant
`
`invention Ding et al.
`overlapping concentrations between the instant invention and the invention of Ding et al.
`
`and
`
`[see MPEP 2144.05 (I) regarding overlapping
`ranges]. Moreover,
`differences
`[see MPEP 2144.05 (I) regarding overlapping ranges]. Moreover, differences in
`
`in
`
`concentration or
`temperature
`will
`not the patentability of subject matter support
`
`
`concentration or temperature will not support the patentability of subject matter
`
`encompassed by
`the
`prior
`art
`unless
`there
`is
`encompassed by the prior art unless there is evidence indicating such concentration or
`
`evidence
`
`temperature is critical [see MPEP 2144.05 (II)]. Furthermore, to establish unexpected
`temperature
`is
`critical
`[see
`
`MPEP (II)]. Furthermore, 2144.05
`
`to establish unexpected
`
`results over a claimed range, applicants should compare a sufficient number of tests
`results over a claimed
`range,
`applicants should
`compare
`a
`
`sufficient
`
`both inside and
`outside
`the
`claimed
`range
`to the claimed
`
`show range
`
`both inside and outside the claimed range to show the criticality of the claimed range
`
`0185
`
`

`

`Application/Control Number:
`13/967,168
`Application/Control Number: 13/967,168 (cid:9)
`Art Unit: 1658
`Art Unit: 1658
`
`Page 11
`Page 11
`
`(MPEP 716.02). Furthermore,
`one ordinary skill of
`
`
`
`in the art wouid have
`been
`(MPEP 716.02), Furthermore, one of ordinary skill in the art would have been motivated
`
`motivated
`
`to determine adequate
`daily
`
`frequency administration of
`
`(e.g.,
`once,
`twice, thrice, etc.)
`
`to determine adequate daily frequency of administration (e,g,, once, twice, thrice, etc,)
`
`in order to find suitable administration
`regimes,
`one ordinary skiii
`
`of in
`
`
`the at the time art
`
`in order to find suitable administration regimes, one of ordinary skill in the art at the time
`
`the invention was made
`would
`have
`had
`reasonable success given
`
`that
`the invention was made would have had reasonable expectation of success given that
`
`expectation
`
`the 0.1% containing cyclosporin
`emulsion
`was
`effective
`the 0,1% containing cyclosporin emulsion was effective in treating KCS (see Examples),
`
`in
`
`Claim scope
`is
`not limited
`by
`claim
`
`language makes optional but that
`
`Claim scope is not limited by claim language that suggests or makes optional but
`
`suggests
`
`does not require
`steps
`to
`be
`performed,
`or
`by
`does not require steps to be performed, or by claim language that does not limit a claim
`
`claim
`
`to a particular structure.
`However,
`
`examples claim language, although of
`
`to a particular structure. However, examples of claim language, although not
`
`not
`
`exhaustive,
`that may
`raise
`a
`question
`as the language
`
`
`to in a
`exhaustive, that may raise a question as to the limiting effect of the language in a claim
`
`
`
`the claim
`
`are:
`are:
`
`(A) "adapted
`to"
`or
`"adapted
`(A) "adapted to" or "adapted for" clauses;
`
`for"
`
`clauses;
`
`(B) "wherein" clauses;
`(B) "wherein" clauses; and
`
`and
`
`(C) "whereby" clauses.
`(C) "whereby" clauses.
`
`The determination
`of whether each of these clauses
`is
`a
`limitation
`The determination of whether each of these clauses is a limitation in a claim
`
`in
`
`a
`
`depends on
`the
`specific
`facts
`of
`the
`case.
`depends on the specific facts of the case. In the instant case, the limitations "wherein
`
`In
`
`the
`
`the topical ophthalmic
`emulsion
`is
`therapeutically
`effective
`the topical ophthalmic emulsion is therapeutically effective in treating KCS", "wherein,
`
`in
`
`when the
`topical
`ophthalmic
`emulsion
`is
`
`
`administered a human, [..]
`when the topical ophthalmic emulsion is administered to an eye of a human, [..] the
`
`the
`
`to
`
`blood of
`the human
`has
`substantially
`no
`detectable
`blood of the human has substantially no detectable concentration of cyclosporin A",
`
`concentration
`
`"wherein
`the emulsion
`breaks
`down
`more the eye of a human, quickly
`
`
`"wherein the emulsion breaks down more quickly in the eye of a human, once
`
`
`
`in once
`
`administered
`to
`the
`eye
`of
`the
`human,
`thereby
`administered to the eye of the human, thereby reducing vision distortion in the eye of
`
`reducing
`
`the human as
`compare
`to
`an
`emulsion
`that
`contains
`the human as compare to an emulsion that contains only 50% as much castor oil",
`
`"wherein
`the ophthalmic
`emulsion,
`when
`administered
`"wherein the ophthalmic emulsion, when administered to the eye of a human,
`
`to
`
`only
`
`the
`
`0186
`
`

`

`Application/Control Number:
`13/967,168
`Application/Control Number: 13/967,168 (cid:9)
`Art Unit: 1658
`Art Unit: 1658
`
`Page 12
`Page 12
`
`demonstrates a
`reduction
`in
`adverse
`events
`in
`the
`demonstrates a reduction in adverse events in the human", "wherein the adverse events
`
`human",
`
`include side effects"
`and
`"wherein
`the
`emulsion
`is
`include side effects" and "wherein the emulsion is effective in increasing tear production
`
`effective
`
`in the human having
`KCS";
`it
`is
`noted
`that
`such
`in the human having KCS"; it is noted that such functional effects would necessarily flow
`
`from the compositions
`and
`methods
`claimed
`and
`from the compositions and methods claimed and exemplified by Ding et al. which
`
`exemplified
`
`comprise all
`the
`claimed
`components,
`amounts
`and
`comprise all the claimed components, amounts and methods as set forth above.
`
`methods
`
`From the
`teaching
`of the reference,
`
`it
`is
`apparent
`that ordinary skill one in
`
`
`
`From the teaching of the reference, it is apparent that one of ordinary skill in the
`
`
`
`of the
`
`art would have had
`a
`reasonable
`expectation success in producing
`
`
`of the claimed
`art would have had a reasonable expectation of success in producing the claimed
`
`invention. Therefore,
`the
`invention
`as
`a
`whole
`invention. Therefore, the invention as a whole was prima facie obvious to one of
`
`was
`
`ordinary skill
`in
`the
`art
`at
`the
`time
`the
`ordinary skill in the art at the time the invention was made, as evidenced by the
`
`invention
`
`references, especially
`in
`the
`absence evidence to
`
`
`the
`
`of contrary.
`references, especially in the absence of evidence to the contrary.
`
`8.
`8. (cid:9)
`
`Claims 37-60 are
`provisionally
`rejected
`on
`the
`Claims 37-60 are provisionally rejected on the ground of nonstatutory double
`
`ground
`
`patenting as being
`unpatentable
`over
`claims copending Application No. 37-60
`
`
`patenting as being unpatentable over claims 37-60 of copending Application No.
`
`of
`
`13/961,818. Although
`the
`claims
`at
`issue
`are
`13/961,818. Although the claims at issue are not identical, they are not patentably
`
`not identical,
`
`distinct from each
`other
`because
`US
`'818 a method which
`
`
`is encompasses drawn
`distinct from each other because US '818 is drawn to a method which encompasses
`
`
`
`a method comprising
`topically
`administering
`to the human
`
`
`the in need
`eye thereof
`
`a method comprising topically administering to the eye of the hum