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`for the components of the active phase, taking into account evaporation of the heavy
`
`solvent (see pp. 262-263).
`
`Le Person teaches the limitations of the instant claims, other than the differences
`
`discussed below.
`
`Le Person does not teach the viscosity of its wet mixture of ingredients, whereas
`
`the instant claims require a viscosity from about 400 to about 100,000 cps. It would
`
`have been obvious to one of ordinary skill in the art at the time the invention was made
`
`to have prepared Le Person's coating mixture of acrylic polymer, solvents and active
`
`with an appropriate viscosity so that it can be spread on a substrate and dried to form a
`
`film useful for transdermal delivery of the active (seep. 257). The claimed viscosity
`
`from about 400 to about 1 00,000 cps corresponds to a viscosity ranging from thin castor
`
`oil to mincemeat. It would been obvious to one of ordinary skill in the art at the time the
`
`invention was made to prepare Le Person's mixture such that the viscosity is not too
`
`low, and thus, the mixture doesn't run like water, but not too high so the mixture is
`
`spreadable on a substrate; and so as to ultimately form a transdermal delivery film
`
`which is a quality product with physical and chemical homogeneity and an appropriate
`
`distribution of active substance (see the paragraph bridging the left and right columns
`
`on p. 257 of Le Person).
`
`The claimed percent variation of active of no more than 10%, less than 5%, less
`
`than 2%, less than 1% and less than 0.5%, and thus also the claimed substantially
`
`uniform distribution and locking-in or substantially preventing migration are inherent in
`
`Le Person's films in view of the fact that, as noted above, Le Person's active material
`
`Page 1134
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`Application/Control Number: 95/002,170
`Art Unit: 3991
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`Page 68
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`homogenizes and a quasi-equilibrium is obtained for the components of the active
`
`phase, taking into account evaporation of the heavy solvent. Accordingly, Le Person's
`
`films are suitable for regulatory approval by the FDA and commercialization, as here
`
`claimed.
`
`Alternatively, to the extent the claimed percent variation of active is no inherent
`
`from Le Person's process, then such would have been obvious. Le Person also differs
`
`from the instant claims in that while Le Person teaches the active material homogenizes
`
`and a quasi-equilibrium is obtained for the components of the active phase, taking into
`
`account evaporation of the heavy solvent, Le Person does not perform "analytical
`
`chemical tests" on the equal sized dosage units.
`
`However, Le Person's films are intended for human use for delivery of
`
`pharmaceuticals, such as transdermal drug delivery (seep. 257). It is well-known in the
`
`art that world regulatory authorities do not permit dosage forms to vary by more than
`
`1 0% in the amount of active present. It is also well-known in the art that to verify such
`
`uniformity, the actual content of active in individual dosages is measured, i.e.,
`
`conventional analytical testing is used.
`
`It would have been obvious to one of ordinary skill in the art at the time the
`
`invention was made to minimize the active content variation among Le Person's
`
`dosages, as measured by analytical chemical tests, as close to zero as possible,
`
`including the instantly claimed no more than 10%, less than 5%, less than 2%, less than
`
`1 %, and less than 0.5%, in view of the well-known goal of a skilled artisan to prepare
`
`dosages that do not vary by more than 1 0% in active, in view of the fact that Le
`
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`Page 69
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`Person's active material homogenizes and a quasi-equilibrium is obtained for the
`
`components of the active phase, taking into account evaporation of the heavy solvent,
`
`and a desire to obtain FDA approval and commercialize the product. A skilled artisan
`
`would minimize active content variation by optimizing the available parameters in Le
`
`Person's process, which are the same as or similar to those in the '080 patent. These
`
`include drying temperature, drying time, air velocity, humidity etc (see pp. 258-259 of Le
`
`Person).
`
`Further, it would have been obvious to one of ordinary skill in the art at the time
`
`the invention was made to have performed known analytical chemical tests on Le
`
`Person's dosages so as to determine the actual amount of active in the dosages and
`
`thus, assure active content uniformity.
`
`With respect to claim 82 and 315, Le Person does not specifically teach
`
`repeating its process and said analytical chemical tests. Further, Le Person does not
`
`specifically teach that the active content of the first film obtained from the process and
`
`additional films prepared by repeating the process varies no more than 10% from a
`
`desired amount as indicated by analytical chemical tests.
`
`However, it would have been obvious to one of ordinary skill in the art at the time
`
`the invention was made to have repeated Le Person's process and the analytical
`
`chemical tests for each film prepared by the process so as to prepare more films and
`
`dosages, seek regulatory approval and commercialize the product. It further would
`
`have been obvious to a skilled artisan at the time the invention was made to have
`
`prepared the multiple films such that the active content in each film does not vary by
`
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`Page 70
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`more than 1 0% from the amount of active the dosages are supposed to contain as
`
`required by various world regulatory authorities, in order to minimize dosage variation
`
`and commercialize the product. A skilled artisan would obtain the variation of no than
`
`10% from the desired amount by optimizing said available parameters in Le Person's
`
`process.
`
`With respect to claims 90 and 172, Le Person teaches that its coating mixture
`
`contains three light solvents (Sii) (see p. 258, section 2.1 ). Table 1 indicates that
`
`solvent Sl2 has a molecular weight of 46, which is the molecular weight of ethanol.
`
`While dimethyl ether also has a molecular weight of 46, it cannot be used as a solvent
`
`due to its low boiling point of -24 'C. Accordingly, the Le Person's light solvent of
`
`molecular weight 46 is either the same as or renders obvious ethanol as here claimed.
`
`With respect to claims 274 and 292, which require that the resulting film contains
`
`less than about 6% by weight solvent, the solvent content in Le Person's dried films is
`
`far under about 6% as evidenced by Figs. 2 and 5. Le Person teaches that using a
`
`short-infrared drying process, in 10 minutes 99% of the initial water content from a 100
`
`11m thick coating is evaporated (see§ 3.1 at pp. 260-261, in particular Fig. 5 and the
`
`second paragraph of right col. at page 260). In view of the water and heavy solvent
`
`content in Fig. 5, the total solvent content is well under about 6%.
`
`Le Person does not teach the pharmaceutical or drug active materials listed in
`
`claims 92 and 174. However, these materials are conventional pharmaceuticals and
`
`drugs.
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`Page 71
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`Accordingly, it would have been obvious to one of ordinary skill in the art at the
`
`time the invention was made to have used the conventional pharmaceutical or drug
`
`materials here claimed as the pharmaceutical or drug material in Le Person's film so as
`
`to take advantage of the intended function of the pharmaceutical or drug, and because
`
`of a reasonable expectation of success.
`
`With respect to claims 317 and 318, while Le Person does not specifically teach
`
`using air currents which have forces below the yield value of the polymer matrix such is
`
`either inherent or obvious. It's inherent because Le Person teaches air velocities of 2
`
`m/s and 4 m/s (Table 2), which correspond to 4.5 miles/hr and 8.9 miles/hr,
`
`respectively. These are light winds that even with water (viscosity 1 cp) would produce
`
`only small wavelets.
`
`Alternatively, since Le Person's resulting, dried films are homogeneous with
`
`respect to active material, it would have been obvious to one of ordinary skill in the art
`
`at the time the invention was made to have adjusted Le Person's air velocity so that the
`
`film is not excessively blown and thus, a consistent product can be obtained.
`
`8.
`
`On pages 45-46 of the Comments filed 04/12/13, Third Party Requester
`
`proposes that claims 1, 5, 7-10, 13, 14, 23, 63, 64, 82, 84,86-89,92,93, 102, 142,
`
`143, 161, 166, 168-171, 174, 175, 184,224,225,249,267,285 and 300-317 be
`
`rejected under 35 U.S.C. 102(b) as anticipated by or, in the alternative, under 35
`
`U.S.C. 1 03(a) as obvious over Horstmann.
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`Page 72
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`9.
`
`On page 46 of the Comments filed 04/12/13, Third Party Requester
`
`proposes that claim 318 be rejected under 35 U.S.C. 1 03(a) as being unpatentable
`
`over the combined teachings of Horstmann and Arter.
`
`10. On pages 46-47 of the Comments filed 04/12/13, Third Party Requester
`
`proposes that claim 318 be rejected under 35 U.S.C. 1 03(a) as being unpatentable
`
`over the combined teachings of Horstmann and Strobush.
`
`These proposed rejection Nos. 8 to 1 0 are not adopted for the reasons that
`
`follow.
`
`Independent claims 1, 82 and 161 have been amended to require, and new
`
`independent claims 315-318 require, performing analytical chemical tests for uniformity
`
`of content of said active in substantially equal sized individual dosage units sampled
`
`from different locations of said resulting film, said tests indicating that uniformity of
`
`content in the amount of the active varies by no more than 1 0%. This requirement is
`
`similar to the imitation set forth in patented dependent claims 255, 273 and 291 (now
`
`canceled), which depended from claims 1, 82 and 161, respectively, and required the
`
`step of forming a plurality of individual dosage units of substantially the same size,
`
`wherein the active content of individual dosage units varies no more than 1 0%. Neither
`
`in the request for reexamination nor in the Comments filed 04/12/13 has Third Party
`
`Requester shown how Horstmann teaches or renders said requirement. Further,
`
`Horstmann is discussed in the Background of the Related Technology section of the
`
`'080 patent, where difficulty in achieving a uniform film after drying is discussed (col. 1,
`
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`line 52 through col. 4, line 23). Neither Arter nor Strobush solves Horstmann's
`
`deficiency.
`
`Response to Arguments
`
`Patent Owner's arguments filed March 13, 2013 have been fully considered but
`
`they are not persuasive.
`
`It is noted that p. 61 of the Remarks filed 03/13/13 refers to " ... the Bogue
`
`Declaration and the Fuller Declaration". There is no Fuller Declaration of record in the
`
`reexamination proceeding. As noted on p. 46 of the Remarks filed 03/13/13, the
`
`declarations accompanying Patent Owner's response of 03/13/13 are the Bogue
`
`Declaration and Lin Declaration.
`
`General Arguments and the Bogue Declaration:
`
`Patent Owner compares the claimed process to making bread on different days
`
`of the week (Remarks of 03/13/13, pp. 48-49). In particular, Patent Owner argues slices
`
`of bread from a loaf baked on a Monday would differ in taste by only 1 0%, and that
`
`slices from a Monday loaf and a Friday loaf have a difference in taste of about 1 0% from
`
`what the baker believes all his/her bread should be expected to taste like (Remarks of
`
`03/13/13, pp. 48-49). Patent Owner cites the Bogue Declaration and argues that the
`
`"recipe" of Patent Owner's process keeps the difference between individual dosage
`
`units from one manufactured lot at smaller than 1 0% in amount of pharmaceutical active
`
`in claims 1, 82, 161 and 316-318, and keeps the difference between individual dosage
`
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`units between different manufactured lots smaller than 10% from a desired amount in
`
`claim 315 (Remarks of 03/13/13, pp. 48-52). The Bogue Declaration is cited in other
`
`portions of the Remarks of 03/13/13, including pp. 46, 60, 61, 63 and 64.
`
`Patent Owner's arguments and the Bogue Declaration are unpersuasive. While
`
`a baker can follow a specific recipe with specific ingredients to bake the bread loaf, the
`
`instant claims are not so specific, but rather are broad and general. As noted above in
`
`the rejections, the prior art either explicitly, inherently and/or obviously performs the
`
`claimed generic manufacturing steps using the claimed generic ingredients.
`
`In fact, as also noted above, Chen analyzes its resulting film using the same
`
`criteria exemplified in the '080 patent specification for evaluation of substantial uniform
`
`distribution, i.e., weight of dosages and visual inspection (see col. 31, line 37 through
`
`col. 32, line 34, and col. 37, lines 61-63 of the '080 patent). In particular, Chen's dried
`
`film product of Example 1 is cut into equal sized dosage units ready for packing (p. 17,
`
`lines 31-32; Table 4) and has a weight of 0.028 ± 0.001 g/dosage film, a density of
`
`1.0485 ± 0.009 g/cm2
`
`, a water content of 1. 7 ± 0.24%, a thickness of 2.1 ± 0.12 mil (see
`
`Table 4); and the dried films are glossy and substantially transparent (p. 17, line 15),
`
`i.e., they are visually free of aggregation. The 0.028 ± 0.001 g/dosage film has variation
`
`of (0.001/0.028) x 100 = 3.6%. When film weight is rounded to two decimal places as in
`
`Table 2 at col. 31 of the '080 patent, then the weight is 0.03 gram/dosage film with a
`
`variation of 0%. Such small variation when following Chen's process was confirmed in
`
`the Reitman Declaration submitted by Third Party Requester.
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`Likewise, in the Example at cols. 11-12, Staab prepares a four-foot wide film
`
`which is then cut into two inch by two inch films each weighing 190 mg and containing
`
`19 mg of benzalkonium chloride as the active agent (see col. 11, line 52 through col. 12,
`
`line 3). Le Person teaches the active material homogenizes and a quasi-equilibrium is
`
`obtained for the components of the active phase, taking into account evaporation of the
`
`heavy solvent (p. 263, col. 1 , I ines 8-13),
`
`The Bogue Declaration is unpersuasive for several reasons. It does not make a
`
`comparison with the prior art of record, and thus, does not show anything unexpected
`
`with respect to the prior art of record. Other than the general process steps in the
`
`claims, which are performed by the prior art either explicitly, inherently or obviously, the
`
`Bogue Declaration lacks specific details about the film production. For example, it is not
`
`clear in the Bogue Declaration which materials, e.g., the specific polymers, actives and
`
`solvent, are used; it is not clear if other materials are present when preparing the films;
`
`it is not clear exactly what is done to form the flowable polymer matrix or how and on
`
`what it is casted, or how the controlled drying is performed and for what exact amount of
`
`time the drying is done, or which analytical chemical tests are used, etc. Accordingly, a
`
`definitive conclusion cannot be reached form the Bogue Declaration.
`
`Patent Owner argues that "[a]s defined in the '080 patent, a visco-elastic film is
`
`one that has been controllably dried to lock its components into a substantially uniform
`
`distribution throughout the film while avoiding problems associated with conventional
`
`drying methods." (Remarks of 03/13/13, p. 53).
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`Page 1142
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`Page 76
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`This argument is unpersuasive. Nowhere does the '080 patent provide a special
`
`definition for the term "visco-elastic film". As noted above in the Scope of Claims
`
`section, the matrix prior to evaporating the solvent (water) may be viscoelastic, and the
`
`viscoelasticity is present due, for example, to the fact that a hydrocolloid has been
`
`added. The instant claims have been amended to require "controlled drying ... to form
`
`a visco-elastic film having said active substantially uniformly distributed throughout ... ".
`
`However, as noted in the rejections, Chen, Staab and Le Person use controlled drying
`
`and obtain the claimed substantial uniformity of active in a viscoelastic film.
`
`Patent Owner argues that physical properties such as product film weight and
`
`appearance do not establish uniformity of content of components, and that in the Scope
`
`of Claims section of the Office action mailed 11/29/12, the Specialist mistakenly
`
`included physical uniformity type tests with chemical uniformity type tests (Remarks of
`
`03/13/13, pp. 53-59). In particular, Patent Owner cites the following passage from the
`
`Scope of Claims:
`
`An alternative means for evaluating uniformity is to cut the film into individual
`doses and measure the weight of the doses (col. 31, line 46 through col. 32, line
`45). The '080 patent notes that "films of substantially similar size cut from
`different locations of the same film contain substantially the same amount of
`active." (col. 32, lines 37-39).
`
`and argues that the two sentences are not related to each other, other than that both
`
`deal with examples of cutting the film into dosage forms (Remarks of 03/13/13, pp. 57-
`
`58). Patent Owner cites col. 32, lines 35-40 of the '080 patent and argues that the '080
`
`patent "discloses essentially that to demonstrate uniformity of content for active, the
`
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`Page 77
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`amount of active in each substantially similarly sized sample must be determined."
`
`(Remarks of 03/13/13, pp. 58-59). Patent Owner argues that "it is one thing to have
`
`films which appear to be substantially free of aggregation and rely on that to say there is
`
`substantially no disparity among the amount of active in any portion of the film, and it is
`
`a totally different thing to demonstrate the presence of the required level of uniformity of
`
`content in the amount of active by analytical chemical testing and determining the actual
`
`amount of active in samples." (Remarks of 03/13/13, p. 58). Patent Owner argues that
`
`"[i]n one example, in the '080 Patent analytical chemical testing was used to test for the
`
`amount of one component, a red dye, and in so doing established that the uniformity of
`
`content of the component fell well within the 10% level, particularly, it was 4%. See,
`
`'080 Patent, col. 33, I. 10 through col. 34, I. 24 (example M)." (Remarks of 03/13/13, p.
`
`59).
`
`Patent Owner's arguments are unpersuasive. First, it is noted that the issued
`
`claims in the '080 patent do not recite "analytical chemical tests". This requirement was
`
`added by Patent Owner in the amendment dated 03/13/13 in response to the Office
`
`action mailed 11/29/12. Accordingly, in discussing the distribution of active in the Scope
`
`of Claims section in the first Office action, the Specialist was not mistaken in citing those
`
`portions of the '080 patent that deal with distribution of the active. In particular, the '080
`
`patent teaches at col. 31, lines 37-44, that a "uniform distribution of components" can be
`
`determined by examination by either the naked eye or under slight magnification, and
`
`that "by viewing the films it was apparent that they were substantially free of
`
`aggregation, i.e. the carrier and the actives remained substantially in place and did not
`
`Page 1144
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`Page 78
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`move substantially from one portion of the film to another ... [t]herefore, there was
`
`substantially no disparity among the amount of active in any portion of the film." An
`
`alternative means for evaluating uniformity is to cut the film into individual doses and
`
`measure the weight of the doses (col. 31, line 46 through col. 32, line 45). The '080
`
`patent notes that "films of substantially similar size cut from different locations of the
`
`same film contain substantially the same amount of active." (col. 32, lines 37-39).
`
`Further, contrary to Patent Owner's argument, said two sentences are related to
`
`each other, i.e., cutting the film into individual doses and measuring the weight of the
`
`doses is an analytical technique for determining uniformity of active, as discussed at col.
`
`31, line 46 through col. 32, line 39 of the '080 patent. In particular, col. 31, line 46
`
`through col. 32, line 39 of the '080 patent discusses measuring uniformity by cutting the
`
`film into individual dosage units and weighing them.
`
`In this example, i.e., Example E
`
`bridging cols. 30-32, the individual dosages weighed 0.04 grams, i.e., 40 mg, "which
`
`shows that the distribution of the components within the film was consistent and
`
`uniform. This is based on the simple principle that each component has a unique
`
`density. Therefore, when the components of different densities are combined in a
`
`uniform manner in a film, as in the present invention, individual dosages [sic] forms from
`
`the same film of substantially equal dimensions, will contain the same mass." (See col.
`
`31, line 46 through col. 32, line 33). The '080 patent then goes on to teach that "[a]n
`
`alternative method of determining uniformity of the active is to cut the film into individual
`
`doses ... [which are then] dissolved and tested for the amount of active in films of
`
`particular size." (See col. 32, lines 34-39).
`
`Page 1145
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`Page 79
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`In fact, Patent Owner's Lin Declaration notes in ,-r16 that "[t]esting to establish
`
`uniformity of dosage is defined in the USP under the general chapter <905>." As noted
`
`by Third Party Requester on pp. 13-14 of the Comments filed 04/12/13, "[i]f the amount
`
`of active is high enough, a Weight Variation Test is acceptable. See Exhibit Kat pp. 6-
`
`7, Q&A5." Exhibit J of the Comments filed 04/12/13, which is the 2011 version of
`
`general chapter <905>, shows that weight variation involves weight measurement of
`
`dosages.
`
`Further, in the example in the '080 patent cited by Patent Owner, i.e., Example M
`
`at cols. 33-34, analytical chemical testing is used to test for the amount of one
`
`component, a red dye. However, red dye, which footnote 4 of Table 4 notes is available
`
`from McCormick, is not a bioactive active or pharmaceutical active here claimed. In the
`
`examples of the '080 patent containing bioactive or pharmaceutical active, visual
`
`inspection and/or weight of dosage films are used as in Chen. In the '080 patent's
`
`Example E, which contains loratadine as an active, visual inspection is used, and so is
`
`weight of dosage films, which are consistently found to be 0.04 gm (see col. 31, line 37
`
`through col. 32, line 33). In the example at col. 37, lines 52-67, loratadine is added to
`
`composition AA and a dried film is formed and then cut into 1 in. x 0.75 in. pieces. The
`
`pieces are measured to weigh 70 mg ± 0.7 mg "demonstrating the uniformity of the
`
`composition of the film."
`
`Patent Owner argues the following on pp. 54-55 of the Remarks filed 03/13/13:
`
`Importantly, the process of forming a proper film product with the claimed
`levels of uniformity of content in, for example, the amount of active does not end
`
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`at the mixing stage. Patentee has discovered that the various steps post-mixing
`play a very important role in ensuring that the resulting product complies with the
`stringent requirements for uniformity of content. For example, one key step in
`the formation of a film product is the drying step, particularly when heat and/or
`radiation is used to dry the film. Patentee has discovered that controlled drying
`methods is essential in meeting these claimed requirements. Controlled drying
`includes methods that avoid, for example, the formation of bubbles, or
`uncontrolled air currents that may cause movement of particles within the visco(cid:173)
`elastic film forming matrix. Controlled drying, as required by the invention as
`claimed, may be effectuated through evaporating at least a portion of said
`solvent to form a visco-elastic film, having said active substantially uniformly
`distributed throughout, within about the first 4 minutes by rapidly increasing the
`viscosity of said polymer matrix upon initiation of drying to maintain said
`substantially uniform distribution of said active by locking-in or substantially
`preventing migration of said active within said visco-elastic film wherein the
`polymer matrix temperature is 1 00 oc or less.
`
`This argument is unpersuasive since, as noted above in the rejections, each of
`
`Chen, Staab and Le Person performs the claimed controlled drying. Using Chen as an
`
`example, it is the Specialist's position that Chen's mixture before drying is viscoelastic.
`
`In particular, as noted above, the '080 patent teaches that "[t]he addition of
`
`hydrocolloids to the aqueous phase of the suspension increases viscosity, may produce
`
`viscoelasticity, and can impart stability depending on the type of hydrocolloid, its
`
`concentration and the particle composition, geometry, size and volume fraction (see col.
`
`8, lines 42-46). Chen adds the same hydrocolloid as in the '080 patent, i.e. said HPMC,
`
`to water, and Chen's wet matrix before drying has a viscosity of 500-15,000 cps (p. 15,
`
`line 26), which is within the '080 patent's disclosed range of about 400-100,000 cps and
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`overlaps the most preferred range of about 1 ,000-40,000 cps (see the paragraph
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`bridging cols. 16 and 17 of the '080 patent). Accordingly, Chen's films in Examples 1, 2
`
`and 5-8 and the Example in Tables 7 and 8 are inherently viscoelastic before drying.
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`Page 1147
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`TEVA EXHIBIT 1007
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`

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`Application/Control Number: 95/002,170
`Art Unit: 3991
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`Page 81
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`Within 4 minutes of the 9 minutes of drying in Chen's Examples 1, 2 and 5-8 and the
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`Example in Tables 7 and 8, a more dry viscoelastic film is obtained.
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`Alternatively, to the extent that Chen's wet film in Examples 1, 2 and 5-8 and the
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`example in Tables 7 and 8 before drying are not viscoelastic, then within about the first
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`4 minutes of the 9 minute drying in a hot air circulating oven at 50°C, a viscoelastic film
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`is inherently formed. In particular, in order to arrive at a dried film product as in Chen,
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`which is made using the same materials as disclosed in the '080 patent and the same
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`basic process steps here claimed, wherein the dried film is glossy and substantially
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`transparent and has the gram per dosage, thickness, density and water content in
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`Chen's Table 4 for Example 1, then a viscoelastic film is inherently formed within about
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`4 minutes. The remaining time after the viscoelastic film is formed further dries the
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`viscoelastic film.
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`As an even further alternative, if Chen's viscoelastic film is formed after about the
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`first 4 minutes but within Chen's 9 minute drying time, then a skilled artisan would
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`recognize that with a higher drying temperature, a shorter drying time than 9 minutes
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`can be used. In other words, a higher drying temperature than the 50°C exemplified by
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`Chen would result in formation of Chen's viscoelastic film product sooner. In fact, Chen
`teaches that its drying temperature can be in the range of 40-1 oooc (seep. 15, line 28).
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`It would have been obvious to one of ordinary skill in the art at the time the invention
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`was made to have used a higher drying temperature than the 50°C exemplified by Chen
`because Chen teaches that the drying temperature can be as high as 1 oooc, and the
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`resulting expectation of a shorter drying time using a higher temperature.
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`Page 1148
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`TEVA EXHIBIT 1007
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`

`
`Application/Control Number: 95/002,170
`Art Unit: 3991
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`Page 82
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`Further, before controlled drying, Chen's mixture of ingredients, i.e., the instant
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`flowable polymer matrix, which Chen teaches has a viscosity of 500 to 15,000 cps, is
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`degassed in a vacuum chamber until trapped air bubbles are removed, and then coated
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`on the non-siliconized side of a polyester film (seep. 15, lines 24-29; and p. 17, lines
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`13-15). Chen controls drying and evaporates water from the cast matrix in 9 minutes of
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`drying in a hot air circulating oven at 50°C (seep. 17, lines 13-15 and Fig. 2). As seen
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`schematically in the drying apparatus of Chen's Fig. 2, the air flow is less direct at the
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`film surface at the beginning of the drying and becomes more direct as the film
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`proceeds through the drying oven, which has an aeration controller (see also p. 5, line
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`31 through p. 6, line 3). According, Chen takes into account air bubbles and control of
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`air currents.
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`Patent Owner argues that having a glossy surface does not equate to a uniform
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`film, because the bottom side of a film product formed on a substrate will take the
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`surface features of the substrate (Remarks of 03/13/13, p. 55).
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`This argument is unpersuasive. Apparently, this argument is referring to Chen,
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`which teaches that its film is glossy (seep. 17, line 15). The argument ignores the fact
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`that Chen further teaches its film is substantially transparent, has a weight of 0.028 ±
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`0.001 g/dosage film when cut into dosages, has a thickness of 2.1 ± 0.12 mil, has a
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`density of 1.0485 ± 0.009 g/cm2
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`, and has a water content of 1.7 ± 0.24% (seep. 17,
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`lines 15-16 and Table 4). The argument also ignores the fact that Chen uses
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`essentially the same production steps, e.g., forming a masterbatch premix, adding
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`Page 1149
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`TEVA EXHIBIT 1007
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`

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`Application/Control Number: 95/002,170
`Art Unit: 3991
`
`Page 83
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`active, casting the flowable polymer matrix, controlled drying, and forming a resulting
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`film, as in instant claim 1.
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`Patent Owner argues they were the first to identify and solve the problems
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`associated with manufacture of commercially and pharmaceutically viable active
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`containing film dosage units or forms (Remarks of 03/13/13, pp. 59-61 ).
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`In particular,
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`Patent Owner argues they discovered that conventional drying methods are not
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`commercially viable to manufacture therapeutic-active-containing films, and argues they
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`solved the problem by controlling polymer matrix viscosity and controlling the drying
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`process (Remarks of 03/13/13, pp. 60-61 ).
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`These arguments are not persuasive. While the '080 patent states at col. 3, lines
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`33-37 that "[c]onventional drying methods generally include the use of forced hot air
`
`using a drying oven, drying tunnel, and the like" and that "[t]he difficulty in achieving a
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`uniform film is directly related to the rheological properties and the process of water
`
`evaporation in the film-forming process", it is noted that none of the processes of Chen,
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`Staab or Le Person, which are essentially the same as here claimed, with the exception
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`of running conventional "analytical chemical tests", is addressed in the '080 patent.
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`Patent Owner argues the Cohen Declaration is "dead wrong on its face or does
`
`not apply to the '080 patent" because "Dr. Cohen does not discuss the degree of
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`uniformity of content"; argues that Dr. Cohen provides no support for any prescribed
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`Page 1150
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`TEVA EXHIBIT 1007
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`

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`Application/Control Number: 95/002,170
`Art Unit: 3991
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`Page 84
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`degree of uniformity; and cites case law for the proposition that inherency requires more
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`than probabi