EXHIBIT 1015 
`
`Coalition For Affordable Drugs XI LLC
`Exhibit 1015
`Coalition For Affordable Drugs XI LLC v Insys Pharma, Inc.
`IPR2015-01797
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`

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`INSl0763P00l0lUS
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Application of:
`
`S. George Kottayil
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`Serial No.:
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`13/895,111
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`Filed: May 15, 2013
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`)
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`Sublingual Fentanyl Spray
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`Examiner:
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`Robert S Landsman
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`Group Art Unit:
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`1647
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`Confirmation No.:
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`1050
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`AMENDMENT
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`Commissioner for Patents
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`P.O. Box 1450
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`Alexandria, VA 223 13-1450
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`Madam:
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`Responsive to the Office Action mailed November 21, 2013, please amend the above-
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`identified application as indicated below.
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`Amendments to the Specification begin on page 2 of this paper.
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`Listing of the Claims begin on page 9 of this paper.
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`Remarks begin on page 10 of this paper.
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`Page 1 of 15
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`Response to Office Action mailed November 21, 2013
`Serial No. 13/895,111
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`Amendments to the Specification
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`Please replace paragraph [0001] with the following paragraph:
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`[0001] This application is a continuation of U.S. Patent Application No. 12/21,333 filed August
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`1, 2008 gnow U.S. Patent No. 8,486,973 issued July 16, 20131, which claims the benefit of U.S.
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`Provisional Application Nos. 60/963,076, filed on August 2, 2007 and 60/963,253 filed August
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`3, 2007; the disclosures of which are hereby incorporated by reference in their entireties.
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`Please replace paragraph [0006] with the following paragraph:
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`[0006] Fentanyl is currently available in injectable form, as a lozenge (e.g. Actiq®; fentanyl
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`citrate; Actig is a registered trademark of Anesta, LLC), and as a transderrnal patch (e.g.
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`Duragesic® 25, 50, 75, and 100 ug of fentanyl per hour; Duragesic is a registered trademark of
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`Johnson & Johnson Corporation). Duragesic® provides continuous systemic delivery of fentanyl
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`for approximately 72 hours. Duragesic
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`® is indicated in the management of chronic pain in
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`patients requiring continuous opioid analgesia for pain that is not optimally managed with lesser
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`means such as acetaminophen-opioid combinations, non-steroidal analgesics, or pm (as needed)
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`dosing with short-acting opioids. Duragesic
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`® is typically not suitable for patients experiencing
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`acute pain due to the delay in absorption of the fentanyl through the patch, or postoperative pain
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`because serious or life-threatening hypoventilation could result.
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`Please replace paragraph [00119] with the following paragraph:
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`[00119] In certain embodiments, the compositions comprise a C2_g alcohol such as propylene
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`glycol, or a polyethylene glycol and/or polypropylene glycol of an average molar weight of 200
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`to 4000, or a mixture thereof, in addition to the organic solvent described above. The C2_g
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`alcohol may act as a cosolvent in combination with the organic solvent. Polyethylene glycols
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`commercially available as Carbowax®®(Carbowax is a registered trademark of Union Carbide
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`Corporation; e.g., Carbowax@ 300 of a molar weight of 300), can be used.
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`Please replace paragraph [00159] with the following paragraph:
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`Response to Office Action mailed November 21, 2013
`Serial No. 13/895,111
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`[00159] Droplet size distribution can be determined by utilizing any reliable method known to
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`one of skill in the art. One such method uses laser diffraction devices, such as, for example, the
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`Malvern® §Malvern is a registered trademark of Malvern Instruments Limited} Spraytec® with
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`RT Sizer Software. A Malvem@ Mastersizer® gMastersizer is a registered trademark of Malvern
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`Instruments Limited) S, by Malvem@ Instruments Limited (U.K.), device may also be used to
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`determine size distribution. A Malvern@ Mastersizer® S is a modular particle size
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`analyzer offering measurement versatility. It can measure spray droplet size as well as wet and
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`dry samples. Particles from sub-micron to a few millimeters may be measured with the
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`Malvern@ Mastersizer@ S.
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`Please replace paragraph [00160] with the following paragraph:
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`[00160] Further, automated actuation stations for comparative in vitro bioequivalence tests or
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`other testing to decrease the variability associated with manual actuation may also be used when
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`determining the droplet size distribution. Any such automated actuation stations known to one of
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`skill may be applicable in practicing the present invention. An example of one such device is the
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`MightyRunt Actuation Station by Innova Systems, Inc. In a preferred embodiment, a
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`MightyRunt is equipped with an exhaust fan attachment. In a further embodiment, the
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`MightyRunt is further equipped with a Mettler Toledo® 1Mettler Toledo is a registered trademark
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`of Mettler-Toledo AG) balance Model AT20l.
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`Please replace the paragraph titled Preparation of Formulations (Examples 1 - 5) which follows
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`Table 5 with the following paragraph:
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`Preparation of Formulations §Examples 1-51
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`1. Calculated amount of Fentanyl base or Fentanyl citrate was weighed in a tared glass
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`container.
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`2. Calculated amount of alcohol was added to the container and mixed to dissolve fentanyl.
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`3. Propylene glycol was weighed and added to the fentanyl solution.
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`4. Water or Buffer or Miglyol® ]Miglyol is a registered trademark of Cremer Oleo GmbH &
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`Co. KG Limited Liability Partnership 1 was weighed, added to the fentanyl solution and
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`mixed for 2 mm.
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`5.
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`Inactive ingredients (Mannitol, Triacetin, or TW80) were added at the end and mixed
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`well.
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`6. The final solution was vortexed for 3 min. After mixing, the formulations were stored in
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`refrigerator for further studies.
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`Please replace paragraph [00213] with the following paragraph:
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`[00213] The EpiOral tissues, grown on cell culture inserts with Teflon®_(Teflon is a registered
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`trademark of E.I. Du Pont De Nemours and Company) backing membrane, were shipped by
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`MatTek Corp on Monday for delivery on Tuesday morning. All the tissues were used in the
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`permeability experiments within 72 hours of shipment. The inserts containing the tissues were
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`rinsed with distilled water before the start of permeation experiments. The tissue area for the
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`ORL-100 is 0.6 cn12.
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`Please replace Table 20 with the following table:
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`EXAMPLE #*
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`CONC. OF
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`@ %
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`FENTANYL HOL 5%) YOL PERMEATED
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`BASE
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`"
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`"
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`"
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`IN 2 HOURS
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`Fentanyl
`Base
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`8—a (b)
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`1 mg/ml
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`20
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`5
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`—
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`17.33
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`Fentanyl
`Base
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`Fentanyl
`Citrate
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`Fentanyl
`Citrate
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`
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`1 mg/ml
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`0.646 mg/ml
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`(b)-buffer, (w)-water
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`Please replace paragraph [00220] with the following paragraph:
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`[00220] In Example 12, several ingredients including hydroxypropyl beta cyclodextrin
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`(HPBCD), mannitol, polyvinyl pyrrolidone (PVP), propylene carbonate (PC), sodium
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`glycocholate (SG), sodium lauryl sulphate (SLS), triacetin, triethyl citrate and tween Tween® 80
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`(Tween is a registered trademark of Unig ema Americas LLC; TW 80) were added to the
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`formulations either individually or in combination and studied for their effect on permeability
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`and solution stability. Table 24 to 36 summarizes the formulations and permeation results of
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`buffered and water formulations containing the above excipients.
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`Please replace paragraph [00221] with the following paragraph:
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`[00221] The results in Table 24 indicate that all the buffered formulations had similar
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`permeability characteristics as that of control formulations except the buffered formulation
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`containing 0.3% Tween@ 80 which showed lower permeability. All water formulations exhibited
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`lower permeability than buffered formulations.
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`Please replace paragraph [00222] with the following paragraph:
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`[00222] The results indicate that addition of individual excipients including HPBCD (Table 25),
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`PVP (Table 27), PC (Table 28), Triethyl citrate (Table 31) and Tween@ 80 (Table 32) to the
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`formulation decreased the permeability of fentanyl across MatTek buccal membranes
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`irrespective of excipient concentration. As shown in Table 26 and Table 30, formulations
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`containing 0.3% Mannitol and 0.5% Triacetin showed similar permeability characterisitics as
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`that of control formulation but the permeability decreased as the concentrations of these
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`individual excipients were increased in the formulations. Stability studies indicated that a
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`minimum of 0.45% and 0.5% mannitol concentration should be added to buffer and water
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`formulations, respectively, to keep them stable. In case of Triacetin, formulations containing
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`0.5% or higher concentrations of triacetin were found to be stable.
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`Please replace paragraph [00224] with the following paragraph:
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`[00224] The results of fentanyl permeation across MatTek-buccal tissues from formulations
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`containing combination of excipients are shown in Tables 33-36. Addition of Labrasol@
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`gLabrasol is a registered trademark of Gattefosse SAS[ to the formulation improved the stability
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`but decreased fentanyl permeation across MatTek buccal tissues. Similar results were observed
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`with formulations containing la-braselLabrasol® and SLS. Among all the formulations containing
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`combination of excipients, two formulations, Example 12-uu (0.l5% mannitol, 0.4% triacetin)
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`and Example 12-bbb (0.2% mannitol, 0.2% TW80), showed higher permeability compared to
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`control formulation. We observed that the presence of mannitol in triacetin formulations did not
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`show any improvement in the permeation. Hence, the formulation containing 0.5% triacetin
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`(Table 30) was selected for further studies. Though the formulation, Example 12-bbb, showed
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`good permeability mannitol concentration was increased to 0.3% to improve the stability of the
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`product.
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`Please replace paragraph [00225] with the following paragraph:
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`[00225] Both fentanyl citrate and fentanyl base formulations were stable at all temperatures
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`studied. The data from in-vitro tissue permeation studies, as shown in Table 3, showed that
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`permeation of fentanyl from fentanyl base formulations was about 10-fold higher than from
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`fentanyl citrate formulations. Water and buffer formulations did not show any significant
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`difference in fentanyl base permeation across buccal tissue. Our studies also showed that
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`fentanyl base formulation containing Miglyol@ had very low permeability. Among the
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`excipients, triacetin at 0.5% and mannitol at 0.3% in combination with 0.2% TW 80 showed
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`good permeability and stability.
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`Please replace paragraph [00228] with the following paragraph:
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`[00228] The formulation was sprayed using a 0.10 ml multidose nasal spray pump by Pfeiffer®
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`of America, Princeton, N.J. [Pfeiffer is a registered trademark of Ing. Erich Pfeiffer GmbH[ and
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`the droplets were measured using a Malvem@ Mastersizer@ S device, by Malvem@ Instruments
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`Ltd. A single depression of the sublingual spray pump generated a plume which was then
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`analyzed for spray particles. The sample size for the dose volume, spray pattern, and droplet size
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`distribution was 25 sprays.
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`Please replace paragraph [00234] with the following paragraph:
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`[00234] The formulation was sprayed using a 0.10 ml multidose nasal spray pump by Pfeiffer®
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`of America, Princeton, N.J. and the droplets were measured using a Malvem@ Mastersizer® S
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`device, by Malvem® Instruments Ltd. A single depression of the sublingual spray pump
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`generated a plume which was then analyzed for spray particles. The sample size for the dose
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`volume, spray pattern, and droplet size distribution was 25 sprays.
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`Please replace paragraph [00239] with the following paragraph:
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`[00239] The equipment and supplies utilized in this process included an HPLC system equipped
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`with a pump, variable wavelength detector, and autosampler, or equivalent, a Waters Symmetry
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`HPLC column (C18, 4.6><75 mm, 3.5 um particle size), 0.45 um, 47 mm nylon filters (Gelman
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`N-yl-afle® Nylafio® P/N 66608 or equivalent; Nylafio is a registered trademark of Membrana
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`Inc.), acetonitrile (HPLC Grade), potassium phosphate monobasic (ACS Grade), phosphoric acid
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`(ACS Grade), deionized water, alcohol (ethanol, absolute), and fentanyl base reference standard.
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`Please replace paragraph [00255] with the following paragraph:
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`[00255] In Example 16 the method for determination of droplet size distribution by laser
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`diffraction for fentanyl sublingual spray using the Spraytec device by Malvem@ was performed.
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`Please replace paragraph [00259] with the following paragraph:
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`[00259] Samples were prepared using Pfeiffer@ unit dose glass vials, Pfeiffer@ unit dose v1
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`stoppers, Pfeiffer® vial holder, and Pfeiffer® unit dose applicator. The instrumentation utilized in
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`the study include a Spraytec with 200 mm lens by Malvem® Instruments, Inc, a MightyRunt
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`Actuation Station by Innova Systems Inc. equipped with an exhaust fan attachment, and a
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`Mettler Toledo® balance Model AT201.
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`Please replace paragraph [00291] with the following paragraph:
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`[00291] The HPLC process was consistent with the process described in Example 15 above. The
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`materials and supplies utilized in the study included acetonitrile (HPLC Grade), potassium
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`phosphate monobasic (ACS Grade), phosphoric acid (ACS Grade), deionized water, alcohol
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`(ethanol, absolute), Short Stack Andersen Cascade Impactor set-up consisting of a 5-liter
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`expansion chamber, induction port, stages 0, 1, 2, and after filter, a vacuum source, in-line flow
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`meter (Sierra Top-Track or equivalent), VWR® [VWR is a registered trademark of VWR
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`International, Inc.) Sterile sampling bags, glass fiber filter, 8.1 cm, external calibrated flow meter
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`(Dry-Cal Flow Meter or equivalent), and a pneumatic actuator (Innova Systems Mighty Runt or
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`equivalent).
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`Please replace paragraph [00316] with the following paragraph:
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`[00316] Data from 21 subjects who completed the study was subjected to pharrnacokinetic and
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`statistical analyses. Concentration-time data was transferred from Watson LIMS directly to
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`WinNonlin Enterprise Edition (Version 4.0, Pharsight@Corporation; Pharsight is a registered
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`trademark of Tripos L.P. [ using the Custom Query Builder option for analysis. Data was
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`analyzed by noncompartmental methods in WinNonlin. Concentration-time data that were
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`below the limit of quantification (BLQ) were treated as zero (0.00 ng/mL) in the data
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`summarization and descriptive statistics.
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`Please replace paragraph [00325] with the following paragraph:
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`[00325] The preliminary data appears to support the conclusion that Fentanyl SL has faster onset
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`(60% Tmax in 10 minutes) and therefore pain relief than analgesic products currently available
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`commercially (i.e., Actiq®, Fentora®; fentanyl buccal tablet, Fentora is a registered trademark of
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`Fentora Cima Labs Inc., Rapinyl®; fentanyl citrate, Rapinyl is a registered trademark of Endo
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`Pharmaceuticals Inc., BEMA Fentanyl). The preliminary data also indicates that Fentanyl SL
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`stays close to Tmax for 100 minutes translating to pain relief for a longer time.
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`Please add the following paragraph directly after paragraph [00333]:
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`ABSTRACT
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`[00334] The present invention is directed to sublingual formulations containing fentanyl, a
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`pharrnaceutically acceptable sale thereof, or derivative thereof, suitable for administration to a
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`patient, and methods for treatment with the formulations.
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`Listing of the Claims
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`1.
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`(Original) A sublingual formulation comprising an effective amount of fentanyl and at
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`least one pharrnaceutically acceptable excipient, the formulation providing a mean Tmax of about
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`1.28+/-0.60 hours when a dose is administered sublingually to humans.
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`2.
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`(Original) The sublingual formulation of claim 1, which provides a plasma concentration
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`after administration to humans selected from the group consisting of: about 60% of the mean
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`Cmax in about 10 minutes, about 86% of the mean Cmax by about 20 minutes and a combination
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`thereof
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`3.
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`(Original)The sublingual formulation of claim 1, that when administered to humans
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`provides a plasma concentration that is greater than about 80% of the mean Cmax for about 2
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`hours.
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`4.
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`(New) A sublingual spray formulation comprising 400 mcg dose of fentanyl which
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`provides one or more mean pharmacokinetic values selected from the group consisting of:
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`AUC1ast 4.863 +/-1.70821 hr*ng/mL, AUCjnfS.761 +/- 1.916 hr*ng/mL, and AUCeX[rap 10.26 +/-
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`5.66%, when administered to humans.
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`5.
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`(New) A sublingual spray formulation comprising a dose of fentanyl which provides a
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`substantially dose proportional mean AUC1ast based on a mean AUC1ast of about 4.863 +/-1.70821
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`hr*ng/mL for a 400 mcg fentanyl dose when administered to humans.
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`6.
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`(New) A sublingual spray formulation comprising a 400 mcg dose of fentanyl which
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`provides a mean F(AUC1ast) of about 0.721 +/- 0.199 ng/mL when administered to humans.
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`Response to Office Action mailed November 21, 2013
`Serial No. 13/895,111
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`REMARKS
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`I. Specification
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`The specification has been amended to: (1) update the status of the parent application; (2)
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`properly respect the proprietary nature of the trademarks contained therein; and (3) add an
`Abstract.
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`2. Claims
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`Claims 1-3 are pending. Claims 4-6 are new.
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`35 U.S.C. § 112 Rejections
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`Claims 1-3 stand rejected under 35 U.S.C. § 112, first paragraph, as failing to comply
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`with the enablement requirement because the specification does not reasonably provide
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`enablement for all sublingual formulations “(1) which are formulated for a spray and (2) which
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`have the desired properties (and also limited to a size of 10 microns)”. The Office Action admits
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`that the specification is enabling for sublingual formulations of Table 50. Specifically, the
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`Office Action asserts that the “breadth of the claims is excessive with regard to claiming all
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`sublingual formulations having a Tmax of 1.28 +/- 0.60 hrs as well as the claimed Cmax” and
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`that the “[a]pplicants have only provided guidance and working examples that the formulations
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`disclosed in Table 50 (10 micron droplet size for use as a spray) act as claimed.”
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`Applicants respectfully traverse this rejection. MPEP § 2164.01(a) state that “[i]t is
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`improper to conclude that a disclosure is not enabling based on an analysis of only one of the
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`above factors while ignoring one or more of the others. The examiner’s analysis must consider
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`all the evidence related to each of these factors, and any conclusion of nonenablement must be
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`based on the evidence as a whole.” citing, In re Wands, 858 F.2d 731 at 737, 740. Those other
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`factors include:
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`“(B) The nature of the invention; (C) The state of the prior art; (D) The level of
`one of ordinary skill; (E) The level of predictability in the art...and (H) The
`quantity of experimentation needed to make or use the invention based on the
`content of the disclosure.”
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`MPEP § 2164.01(a), citing, 858 F.2d at 737. The guidance provided by the Applicants is
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`not limited to Table 50 which describes the working examples. Applicants have also
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`provided Cmax and Tmax values for other formulations that were administered to rabbits
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`(see examples 1-6). A PHOSITA would be able to extrapolate this data to aid in the
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`formulation of doses to administer to humans that would provide the claimed Tmax and
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`Cmax. Additionally a PHOSITA is a highly trained formulation chemist, well-versed in
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`developing formulations. Assuming, for the sake of the analysis, that the number of
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`experiments based on the claim breadth was high, the experiments themselves would be
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`routine given the guidance and working examples of the instant specification. see MPEP
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`§ 2164.06, citing 858 F.2d at 73 7 ([t]he test is not merely quantitative, since a
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`considerable amount of experimentation is permissible, if it is merely routine, or if the
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`specification in question provides a reasonable amount of guidance with respect to the
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`direction in which the experimentation should proceed. ’) Based on these additional
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`factors, the instant specification provides the PHOSITA with sufficient guidance and
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`working examples such that the routine experimentation necessary to enable the claims
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`would not be undue.
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`Claims 1-3 are provisionally rejected under 35 U.S.C. § 112, first paragraph, as
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`failing to describe in the specification in such a way as to reasonably convey to a
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`PHOSITA that the inventors, at the time the application was filed, had possession of the
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`claimed invention. The Office Action asserts that the Applicants have only provided
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`adequate written description that the formulations disclosed in Table 50 act as claimed
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`and do not provide what distinguishing characteristics are shared by the members of the
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`claimed genus. The Office Action further asserts that specific, not general, guidance is
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`needed for the PHOSITA to reasonably conclude that the Applicants had possession of
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`the claimed invention at the time of filing.
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`Applicants respectfully traverse this rejection. In the instant application, the
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`Applicants have claimed a sublingual formulation comprising an effective amount of
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`fentanyl which provides a very specific Tmax and Cmax upon administration to humans.
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`These limitations themselves narrow the claims a great deal and provide distinguishing
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`characteristics that are shared by the members of the claimed genus. As mentioned
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`above, the PHOSITA is a formulation chemist well versed in developing formulations for
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`administration to humans and measuring the resulting Tmax and Cmax. This high level
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`of skill of the PHOSITA and knowledge in the art sets a low bar for “the specificity of the
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`disclosure necessary to satisfy the written description requirement” see MPEP §
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`2l63(II)(A)(2) (“[g]enerally, there is an inverse correlation between the level of skill and
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`knowledge in the art and the specificity of disclosure necessary to satisfy the written
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`description requirement.”) Thus, the description set forth in the instant specification
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`gives adequate guidance to the PHOSITA for the PHOSITA to determine that the
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`inventors had possession of the claimed invention at the time of filing.
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`35 U.S.C. § 102/103 Rejections
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`Claims 1-3 stand rejected under l02(e) as anticipated by or in the alternative under l03(a)
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`as obvious over McCarty (US 2007/0071806). The Office Action asserts that McCarty teaches
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`sublingual fentanyl formulations which comprise Xylitol and propylene glycol as well as other
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`alcohols. The Office Action admits that McCarty is silent with regard to Tmax and Cmax
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`values. The Office Action asserts that the burden is on the Applicants to show a novel or
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`unobvious difference between the claimed product and the product of the prior art, citing In re
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`Best, 562 F.2d 1252 (CCPA 1977).
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`Applicants respectfully traverse this rejection.
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`In In re Best, the court found that the later
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`filed application was anticipated and obvious over an earlier patent despite the fact that the
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`application’s claims had an additional element not taught by the earlier patent, namely a cooling
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`rate. The court found that removing the heat source would necessarily lead to the cooling rate
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`claimed and that the applicants failed to show that normal cooling rates were not sufficient for
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`the process described in the application.
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`In re Best, does not apply to the instant application because the situation is not analogous.
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`The additional element claimed in the instant application’s claim 1, namely Tmax, Cmax, and
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`area under the curve (“AUC”) values, do not necessarily result from the product taught in
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`McCarty. McCarty teaches that a fentanyl formulation could contain Xylitol, propylene glycol
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`and other alcohols. However, McCarty does not teach that these formulations are limited to
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`those that are capable of producing the claimed Tmax, Cmax and AUC values in humans. Any
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`fentanyl formulation containing Xylitol, propylene glycol and other alcohols will not necessarily
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`result in the claimed Tmax, Cmax and AUC values when administered to humans.
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`The Office Action contends that even if McCarty does not meet the limitations of the
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`instant invention under 10[2], it would still have been obvious at the time of the instant invention
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`to have optimized the conditions to provide a formulation with a rapid/desired onset of action to
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`reduce pain quickly as possible.
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`McCarty does not teach or suggest that a fentanyl formulation of any particular Tmax,
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`Cmax or AUC value would be useful for treating pain. Thus, a PHOSITA would not have found
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`it obvious to optimize the conditions taught in McCarty, namely sublingual/buccal tablets, to
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`provide the instantly claimed invention of a sublingual fentanyl formulation with the claimed
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`Tmax, Cmax and AUC values.
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`Claims 1-3 stand rejected under 102(b) as anticipated by or in the alternative under
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`103(a) as obvious over Ross (US 2003/0190290) (“Ross 2003”). The Office Action asserts that
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`Ross 2003 teaches sublingual fentanyl formulations. The Office Action admits that Ross 2003 is
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`silent with regard to Tmax and Cmax values. The Office Action asserts that the burden is on the
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`Applicants to show a novel or unobvious difference between the claimed product and the product
`
`of the prior art, citing In re Best, 562 F.2d 1252 (CCPA 1977).
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`Applicants respectfully traverse this rejection.
`
`In In re Best, the court found that the later
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`filed application was anticipated and obvious over an earlier patent despite the fact that the
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`application’s claims had an additional element not taught by the earlier patent, namely a cooling
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`rate. The court found that removing the heat source would necessarily lead to the cooling rate
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`claimed and that the applicants failed to show that normal cooling rates were not sufficient for
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`the process described in the application.
`
`In re Best, does not apply to the instant application because the situation is not analogous.
`
`The additional element claimed in the instant application’s claim 1, namely Tmax, Cmax, and
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`area under the curve (“AUC”) values, do not necessarily result from the product taught in Ross
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`2003.
`
`Ross 2003 simply teaches a fentanyl
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`formulation and does not
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`teach that
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`these
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`formulations are limited to those that are capable of producing the claimed Tmax, Cmax and
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`AUC values in humans. Any fentanyl formulation will not necessarily result in the claimed
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`Tmax, Cmax and AUC values when administered to humans.
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`Page 13 of 15
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`

`
`Response to Office Action mailed November 21, 2013
`Serial No. 13/895,111
`
`The Office Action contends that even if Ross 2003 does not meet the limitations of the
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`instant invention under l0[2], it would still have been obvious at the time of the instant invention
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`to have optimized the conditions to provide a formulation with a rapid/desired onset of action to
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`reduce pain quickly as possible.
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`Ross 2003 does not teach or suggest that a fentanyl formulation of any particular Tmax,
`
`Cmax or AUC value would be useful for treating pain. Thus, a PHOSITA would not have found
`
`it obvious to optimize the conditions taught in Ross 2003, to provide the instantly claimed
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`invention of a sublingual fentanyl formulation with the claimed Tmax, Cmax and AUC values.
`
`Double Patenting
`
`The Office Action rejected claims 1-3 on the ground of nonstatutory obviousness-type
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`double patenting over claims 1-3 of U.S. Patent No. 8,486,973 and/or claims 1-20 of U.S. Patent
`
`No. 8,486,973.
`
`In response, Applicants respectfully request that this rejection be held in abeyance until
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`the instant application is deemed to have allowable subject matter but for the double-patenting
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`rej ection.
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`Page 14 of 15
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`

`
`Response to Office Action mailed November 21, 2013
`Serial No. 13/895,111
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`Conclusion
`
`Neither McCarty nor Ross 2003 teaches or makes obvious a sublingual
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`fentanyl
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`formulation having the claimed Tmax, Cmax and AUC values. Applicants respectfully submit
`
`that the pending claims 1-3 and the newly added claims 4-6 are patentable. Accordingly,
`
`reconsideration of the rejections and allowance of the application are requested. Applicants
`
`request a One-Month Extension of Time to respond to the Office Action. The Commissioner is
`
`hereby authorized to charge any appropriate fees under 37 C.F.R. §l .16, 1.17, and 1.21 that may
`
`be required by this paper, and to credit any overpayment, to Deposit Account No. 23-0785.
`
`Should the Examiner have any questions concerning the above, he is respectfully requested to
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`contact the undersigned at the telephone number listed below.
`
`Respectfully submitted,
`
`Date: March 6, 2014
`
`/Steven F. Weinstock/
`Steven F. Weinstock, Registration No. 30,117
`
`WOOD, PHILLIPS, KATZ,
`CLARK & MORTIMER
`
`500 West Madison Street, Suite 1130
`Chicago, IL 60662-2511
`Tel.: (312) 876-2110
`Fax.: (312) 876-2020
`
`Page 15 of 15
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`

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`Electronic Patent Application Fee Transmittal
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`Filing Date:
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`15-May-2013
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`Title of Invention:
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`SUBLINGUAL FENTANYL SPRAY
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`;
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`Utility under 35 USC111(a) Filing Fees
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`Description
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`Fee Code
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`Quantity
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`Sub-Total in
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`USD($)
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`Basic Filing:
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`Miscellaneous Filing
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`Patent Appeals and Interference:
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`Post-Allowance-and-Post Issuance
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`Extension-of-Time:
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`Extension -1 rnonth
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`

`
`Miscellaneous:
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` S“:-S1-;(t$a)| in
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`Total in USD (S)
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`

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`Electronic Acknowledgement Receipt
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`m—
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`Title of Invention:
`
`SUBLINGUAL FENTANYL SPRAY
`
`I
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`Payment information:
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`yes—
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`Charge any Additional Fees required under 37 C.F.R. Section 1.17 (Patent application and reexamination processing fees)
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