TN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicants: Nachiappan Chidambaram and Aqeel Fatmi
`
`Serial No.:
`
`Continuation of 11/367,238
`
`Art Unit:
`
`Not yet assigned
`
`Filed:
`
`December 22, 2015
`
`Examiner:
`
`Not yet assigned
`
`For:
`
`SOLVENT SYSTEM FOR ENHANCING THE SOLUBILITY OF
`PHARMACEUTICAL AGENTS
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`DECLARATION UNDER37 C.F.R. § 1.132
`
`The undersigned, Robert Edward Kalkreuter, do hereby declare and state that:
`
`1.
`
`2.
`
`I am currently a chemistry PhD candidate at North Carolina State University.
`
`I have a Bachelor of Science in Chemistry from Emory University and have
`
`studied chemistry for seven years, including the last three in a. Chemistry PhD program.
`
`3.
`
`I have read U.S. Patent No. 6,383,515 to Sawyer eta!. ("Sawyer"), which was
`
`cited by the Examiner during the prosecution of U.S. Patent Application No. 11/367,238
`
`('238 Application).
`
`4.
`
`Sawyer describes solutions suitable for encapsulation in softgel capsules (col. 1,
`
`lines 6-7). Sawyer describes formulations containing a low molecular weight polymer,
`
`an active agent, and the salt of an organic acid containing at least three carbon atoms (col.
`
`3, lines 23-26). The active agent is generally in the form of the free acid or base, and the
`
`45211536
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`BAN 102 CON
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`
`Petitioner - Catalent Pharma Solutions
`Ex. 1006, Pg. 1 of 257
`
`

`

`Continuation ofU.S.S.N. 11/367,238
`, 2015
`Filed: December
`Declaration Under 37 CFR 1.132
`
`salt of the organic acid is a base which serves to ionize the active agent, when the active
`
`agent is an acid (Col. 4, lines 22-24).
`
`5.
`
`Example 17 of Sawyer describes a solution containing naproxen sodium,
`
`polyethylene glycol, potassium hydroxide, and sodium propionate. Potassium hydroxide
`
`and sodium propionate are bases, i.e., ionizing agents, which function to maintain
`
`naproxen as the sodium salt. The Examiner alleged during prosecution of the '238
`
`Application that because the formulation disclosed in Sawyer contains sodium propionate
`
`in aqueous solution, the formulation would inherently contain propionic acid.
`
`6.
`
`The Examiner provided no evidence to demonstrate that propionic acid is present
`
`in an amount between 0.2 to 1.0 mole equivalents of the active agent(s), as required by
`
`the claimed subject-matter.
`
`7.
`
`Propionic acid is a weak acid. Propionate is the corresponding conjugate base of
`
`propionic acid. The equilibrium reaction is as follows:
`
`8
`C3H 50 2 + H 20
`Propionate
`
`HC3H 50 2 + OH8
`propionic acid
`
`8.
`
`Acid-base chemistry teaches that the Ka of a weak acid and the Kb of its conjugate
`
`base are related according to the equation:
`
`where Kw is the ionic constant of water and has a value of approximately LOx 10"1
`-l at
`
`room temperature. Therefore, the Kb of propionate can be calculated to be 7.46x 10"10
`
`based solely upon the equation above and the Ka of propionic acid of~ 1.34x 10"5
`
`.
`
`Accordingly, when calculating either the propionic acid concentration or the propionate
`
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`Petitioner - Catalent Pharma Solutions
`Ex. 1006, Pg. 2 of 257
`
`

`

`Continuation ofUS.S.N. 11/367,238
`Filed: December , 2015
`Declaration Under 37 CFR 1.132
`
`concentration present in Example 17 of Sawyer, one may use either the Ka ofthe acid or
`
`the Kb of the conjugate base as long as the equations are set up appropriately such that:
`
`The equation for determining the concentration of propionic acid based upon the Kb or Ka
`
`using the equations shown below:
`
`Kb =[propionic acid][OH"]
`[propionate]
`
`or
`
`(2) Ka= [propionate][H+]
`Ipropionic acid]
`
`8.
`
`Example 17 of Sawyer, in part, reads as follows:
`
`A formulation was prepared with the ingredients set forth in Table 17. The
`ingredients were mixed and the sample was heated in a steam bath and swirled
`until dissolved. The potassium hydroxide was added as a solution of 6.8 g KOH in
`100 mls ofwater. The sodium propionate was added as a solution of500 g sodium
`propionate in 700 mls of water. A clear solution was obtained.
`
`TABLE 17
`
`Fonnulation of Exmnple 17
`
`Ing1edient
`
`~aproxen sodium
`Polyethylene Glycol 300
`Potassium hydroxide
`SodiLtm propionul<'
`
`Amo:.1nt
`
`3.0033 g
`10.0332 g
`6.66 mg
`0.8153 g
`
`\Vtig~lt l-'trct"-Ut
`(%)
`
`21.(17
`72.40
`0.05
`5.88
`
`Based on the information provided in Example 17, the amount of water present from the
`
`potassium hydroxide solution can be calculated by:
`
`(6.66 mg KOH) x (100 mL H20 I 6.8 g KOH) x (1 g I 1000 mg) = 0.0979mL ofwater
`
`The volume of water added from the sodium propionate solution is calculated by:
`
`45211536
`
`3
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`BAN 102 CON
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`
`Petitioner - Catalent Pharma Solutions
`Ex. 1006, Pg. 3 of 257
`
`

`

`Continuation ofU.S.S.N. ll/367,238
`Filed: December
`, 2015
`Declaration Under 37 CFR 1.132
`
`(0.8153 g sodium propionate) x (700 mL H20 I 500 g sodium propionate)= 1.14142 mL
`
`of water
`
`Therefore, the total volume of water present in the formulation of Sawyer was 1.23932
`
`mL.
`
`9.
`
`In Example 17 of Sawyer both a strong base (6.66 mg KOH) and a weak base
`
`(0.8153 g sodium propionate) were added to the formulation having a volume of water
`
`equal to 1.23932 mL. KOH is a strong base that will completely dissociate in water.
`
`Therefore, to a first approximation the pH can be determined from the concentration of
`
`KOH, wherein KOH has a molecular weight of 56.1056 glmol. Thus, the molar
`
`concentration ofKOH dissolved in solution is calculated as:
`
`(6.66 mg KOH I 1.23932 mL H 20) x (1 mol KOH/56.1056 g KOH) x (1000 mg/lg) x
`
`(1000 mL I 1 L) = 0.09578 M.
`
`Thus, the pH of the solution is calculated as follows:
`
`pH= 14.0- pOH = 14.0 +log [OH"] = 14.0 +log (0.09578) = 14.0- 1.02 = 12.98.
`
`with the pH of the solution being strongly basic.
`
`10.
`
`In order to calculate the concentration of propionic acid present in the formulation
`
`one further requires knowing the amount of sodium propionate added to the solution in
`
`Example 17. As only sodium propionate was added, conservation of mass requires that
`
`the sum of the concentration of sodium propionate and the concentration of propionic
`
`45211536
`
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`
`BAN 102 CON
`095161/00060
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1006, Pg. 4 of 257
`
`

`

`Continuation ofU.S.S.N. 11/367,238
`Filed: December , 2015
`Declaration Under 37 CFR 1.132
`
`acid, which may form in equilibrium in solution, must be equal to the initial
`
`concentration of sodium propionate that was dissolved.
`
`11.
`
`The initial concentration of sodium propionate dissolved in the solution is
`
`calculated using the 0.8153 g of sodium propionate dissolved in 1.23932 mL of water
`
`wherein sodium propionate has a molecular weight of 96.060 g/mol. Accordingly, this
`
`gives a concentration of sodium propionate added of 6.84844 M.
`
`12.
`
`Using the relationship that the sum of concentrations of [propionic acid] +
`
`[propionate] 6. 84844 M and either the equation for Ka of propionic acid or the equation
`
`for Kb of propionate it is then possible to calculate the concentration of propionic acid in
`
`solution.
`
`13.
`
`Using the equation for Kb, one finds:
`
`Kb =[propionic acidl[OH"]
`[propionate]
`
`7.46xl0- 10= [propionic acid] [0.09578] I (6.84844
`
`[propionic acid])
`
`[propionic acid] = 5.3Xl0"8 M
`
`Alternatively, using the equation for Ka, one finds:
`
`Ka = [pro pi on ate] [H+]
`[propionic acid]
`
`1.34x 10"5=(6. 84844- [propionic acid])[! 0"12 98]/[propionic acid]
`
`[propionic acid] = 5.3xl0-8 M
`
`14.
`
`Therefore, in a volume of 1.23932 mL of solution having a molar concentration of
`
`5.3xl0"8 M propionic acid the solution only contains about 6.5x10"11 moles ofpropionic
`
`acid. This concentration of propionic acid accounts for the effect of potassium hydroxide
`
`present in the formulation.
`
`45211536
`
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`BAN 102 CON
`095161/00060
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1006, Pg. 5 of 257
`
`

`

`Continuation ofU.S.S.N. 11/367,238
`Filed: December , 2015
`Declaration Under 37 Cf.l< 1.132
`
`15.
`
`Based on the 6.5x 10"11 moles of propionic acid present and 0.0119 moles of
`
`naproxen sodium present, this gives a ratio of propionic acid to active agent of only
`
`S.Sxl0-9
`
`, well below the mole equivalent value required by the claims.
`
`15.
`
`Although Sawyer indicates that the pH of the propionate solution may be adjusted
`
`by the addition of propionic acid in an amount of 1-2% by weight of the propionate
`
`solution (Sawyer, para. [0032]) the addition of such small amounts of propionic acid
`
`would not at all be expected to significantly affect the amount of propionic acid present
`
`in a manner which would be sufficient to meet the claimed mole equivalents of a
`
`deionizing agent.
`
`16.
`
`I declare that all statements made herein of my own knowledge are tme and that
`
`all statements made on information and belief are believed to be tme; and further that
`
`these statements were made with the knowledge that willful false statements and the like
`
`so made are punishable by fine or imprisonment, or both, under Section 1001 of Title 18
`
`of the United States Code and that such willful false statements may jeopardize the
`
`validity of the application or any patent issued thereon.
`
`W_f1AJt011;:-_
`
`Rober! Edward Kalkreuter
`
`~52ll536
`
`6
`
`BAN 102 CON
`095161/00060
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1006, Pg. 6 of 257
`
`

`

`Electronic Acknowledgement Receipt
`
`EFS ID:
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`Application Number:
`
`24438565
`
`14977808
`
`International Application Number:
`
`Confirmation Number:
`
`1747
`
`Title of Invention:
`
`SOLVENT SYSTEM FOR ENHANCING THE SOLUBILITY OF PHARMACEUTICAL
`AGENTS
`
`First Named Inventor/Applicant Name:
`
`Customer Number:
`
`23579
`
`Filer:
`
`Patrea L. Pabst/Cindy Phillips
`
`Filer Authorized By:
`
`Patrea L. Pabst
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`Attorney Docket Number:
`
`BAN 102CON
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`lc. 9ad 3cb 15130ad 6e 7a7f2ee75e299aa24d
`9e8bc
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`Petitioner - Catalent Pharma Solutions
`Ex. 1006, Pg. 7 of 257
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`

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`Total Files Size (in bytes)
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`Petitioner - Catalent Pharma Solutions
`Ex. 1006, Pg. 8 of 257
`
`

`

`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicants: Banner Life Sciences, LLC
`
`Inventors:
`
`Nachiappan Chidambaram and Aqeel Fatmi
`
`Serial No.
`
`Continuation ofU.S.S.N. 11/367,238
`
`Art Unit:
`
`Not yet assigned
`
`Filed:
`
`December 22, 2015
`
`Examiner:
`
`Not yet assigned
`
`For:
`
`SOLVENT SYSTEM FOR ~ENHANCING THE SOLUBILITY OF PHARMACF,UTJCAL
`AGENTS
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`REQUEST FOR FILING A CONTINUATION APPLICATION
`UNDER 37 C.F.R. § 1.53(b)
`
`Sir:
`
`Pursuant to 35 U.S. C.§ 21(a), as amended by Public Law 97-247 and 1.53(b),
`
`Applicants enclose for filing the attached new patent application entitled "SOLVENT SYSTEA1
`
`FOR ENHANCING THE SOLUBILI1Y OFPHARN!AC}.'UTICAL AGENT'S". This application is
`
`a continuation of pending Application No. 11/367,238, filed March 3, 2006, entitled "SOLVENT
`
`SYSTEl'v! FOR ENHANCING THE SOLUBILITY OF PHARlvJACEUTICAL AGENTS" by
`
`Nachiappan Chidambaram and Aqeel Fatmi, which claims priority to and benefit of U.S.
`
`Provisional Application No. 60/659,679 filed on March 8, 2005.
`
`The inventorship for the claims in the new application is the same as in parent
`
`Application No. 11/367,238.
`
`45212274
`
`BAN 102 CON
`095161/00060
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1006, Pg. 9 of 257
`
`

`

`Continuation of 11/367,238
`Filed: December 22, 2015
`REQUEST FOR FILING A CONTINUATION Al'l'LICATION UNDER 37 C.li.R. § 1.5J(b)
`
`Enclosed is a Preliminary Amendment. Please amend the application in accordance with
`
`the Preliminary Amendment.
`
`Also enclosed are an (a) Application Data Sheet; (b) Utility Patent Application
`
`Transmittal; and, (c) Fee Transmittal.
`
`Information Disclosure Statement
`
`Pursuant to 37 C.F.R. § 1.56 and 37 C.F.R. § 1.97, Applicant submits an Information
`
`Disclosure Statement, including one (1) page of Form PT0-1449. The non-patent and foreign
`
`documents cited on the enclosed pages of Form PT0-1449 were submitted to the Patent Office in
`
`Application Serial No. 11/367,238. Pursuant to 37 C.F.R. §I .98(d), Applicant is not enclosing
`
`copies of these publications. Pursuant to the waiver in the notice entitled "Information
`
`Disclosure Statements May Be Filed Without Copies of U.S. Patents and Published Applications
`
`in Patent Applications Filed After June 30, 2003" published on August 5, 2003 in 1273 OG 55,
`
`copies of the U.S. Patents and Published Applications are not enclosed. Copies of any of the
`
`cited documents can be provided upon request.
`
`This Information Disclosure Statement is being filed under 37 C.P.R.§ 1.97(b) prior to a
`
`f1rst Office Action on the merits. It is believed that no fee is required with this submission.
`
`However, should a fee be required, the Commissioner is hereby authorized to charge any
`
`required fees to Deposit Account No. 50-3129.
`
`This statement should not be interpreted as a representation that an exhaustive search has
`
`been conducted or that no better art exists. Moreover, Applicant invites the Examiner to make an
`
`independent evaluation of the cited art to determine its relevance to the subject matter of the
`
`45212274
`
`2
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`BAN 102 CON
`095161/00060
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`Petitioner - Catalent Pharma Solutions
`Ex. 1006, Pg. 10 of 257
`
`

`

`Continuation of 11/367,238
`Filed; December22, 2015
`REQUEST IIOR FILING A CONTINUATION Al'PLICATION UNDER 37 C.~F.R. § 1.53(b)
`
`present application. Applicant is ofthe opinion that their claims patentably distinguish over the
`
`art referred to herein, either alone or in combination.
`
`A credit card payment is being made electronically in the amount of $8,840.00 to cover
`
`the filing fees, search fees, examination fees, Request for Prioritized Examination and surcharge
`
`for a large entity. It is believed that this is the proper filing fee since the application includes 20
`
`total pages, six (6) independent claims and a total of 43 claims upon entry of the enclosed
`
`Preliminary Amendment.
`
`The Commissioner is authorized to charge any additional fees which may be required, or
`
`credit any overpayment to Deposit Account No. 50-3129.
`
`All correspondence concerning this application should be mailed to:
`
`Customer No. 23579
`PABST PATENT GROUP LLP
`1545 Peachtree Street
`Suite 320
`Atlanta, Georgia 30309
`(404) 879-2151 (Telephone)
`( 404) 879-2160 (Fax)
`
`Respectfully submitted,
`
`/Patrea L. Pabst/
`Patrea L. Pabst
`Reg. No. 31,284
`
`Date: December 22, 2015
`
`PABST PATENT GROUP LLP
`1545 Peachtree Street, NE
`Suite 320
`Atlanta, Georgia 30309
`(404) 879-2151
`(404) 879-2160 (Facsimile)
`
`45212274
`
`3
`
`BAN 102 CON
`095161/00060
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1006, Pg. 11 of 257
`
`

`

`Continuation of ll/367 ,238
`Filed: December 22, 2015
`REQUEST FOR FILING A CONTINUATION APPLICATION UNDER 37 C.F.R. § 1.53(b)
`
`CERTIFICATE OF ELECTRONIC TRANSMISSION UNDER 37 C.F.R. § 1.8
`
`I hereby certify that this correspondence, including any items indicated as attached or included, is
`being transmitfe(l via electronic transmission via EFS-Web on the date indicated below.
`
`Date:
`
`Decembet· 22, 2015
`
`/Cindv Phillips
`Cindy Philips
`
`45212274
`
`4
`
`BAN 102 CON
`095161/00060
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`Petitioner - Catalent Pharma Solutions
`Ex. 1006, Pg. 12 of 257
`
`

`

`Electronic Patent Application Fee Transmittal
`
`Application Number:
`
`Filing Date:
`
`Title of Invention:
`
`SOLVENT SYSTEM FOR ENHANCING THE SOLUBILITY OF PHARMACEUTICAL
`AGENTS
`
`First Named Inventor/Applicant Name:
`
`Nachiappan Chidambaram
`
`Filer:
`
`Patrea L. Pabst/Cindy Phillips
`
`Attorney Docket Number:
`
`BAN 102 CON
`
`Filed as Large Entity
`
`Filing Fees for Track I Prioritized Examination- Nonprovisional Application under 35 USC 111 (a)
`
`Description
`
`Fee Code
`
`Quantity
`
`Amount
`
`Sub-Total in
`USD($)
`
`Basic Filing:
`
`Pages:
`
`Claims:
`
`Utility application filing
`
`Utility Search Fee
`
`Utility Examination Fee
`
`Request for Prioritized Examination
`
`Claims in Excess of 20
`
`Independent claims in excess of 3
`
`1011
`
`1111
`
`1311
`
`1817
`
`1202
`
`1201
`
`1
`
`1
`
`1
`
`1
`
`23
`
`3
`
`280
`
`600
`
`720
`
`280
`
`600
`
`720
`
`4000
`
`-4000
`
`80
`
`420
`
`1840
`
`1260
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1006, Pg. 13 of 257
`
`

`

`Description
`
`Fee Code
`
`Quantity
`
`Amount
`
`Sub-Total in
`USD($)
`
`Miscellaneous-Filing:
`
`PROCESSING FEE, EXCEPT PROV. APPLS.
`
`1830
`
`1
`
`140
`
`140
`
`Petition:
`
`Patent-Appeals-and-Interference:
`
`Post-Allowance-and-Post-Issuance:
`
`Extension-of-Time:
`
`Miscellaneous:
`
`Total in USD ($)
`
`8840
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1006, Pg. 14 of 257
`
`

`

`Electronic Acknowledgement Receipt
`
`EFS 10:
`
`Application Number:
`
`24430367
`
`14977808
`
`International Application Number:
`
`Confirmation Number:
`
`1747
`
`Title of Invention:
`
`SOLVENT SYSTEM FOR ENHANCING THE SOLUBILITY OF PHARMACEUTICAL
`AGENTS
`
`First Named Inventor/Applicant Name:
`
`Nachiappan Chidambaram
`
`Customer Number:
`
`23579
`
`Filer:
`
`Patrea L. Pabst/Cindy Phillips
`
`Filer Authorized By:
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`Patrea L. Pabst
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`Attorney Docket Number:
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`BAN 102CON
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`Receipt Date:
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`22-DEC-2015
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`Filing Date:
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`TimeStamp:
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`11:06:59
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`Application Type:
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`Utility under 35 USC 111 (a)
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`Submitted with Payment
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`Payment was successfully received in RAM
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`RAM confirmation Number
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`yes
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`Credit Card
`
`$8840
`
`10920
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`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpayment as follows:
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1006, Pg. 15 of 257
`
`

`

`File listing:
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`1
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`TrackOne Request
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`BAN_1 02_CON_Track_One_Re
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`124623
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`no
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`2
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`2
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`Information Disclosure Statement (IDS)
`Form (SBOB)
`
`BAN_1 02_CON_1449.pdf
`
`no
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`1
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`25309
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`Bf"2a8a3 ZdZall e402fBacad25604138bb9a
`da19c
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`3
`
`BAN_1 02_CON_Application.pd
`
`yes
`
`21
`
`704431
`
`Multipart Description/PDF files in .zip description
`
`914eS 1 ee3 755 :JSL f2adc77ee 17a e0272620
`oObdd
`
`Document Description
`
`Start
`
`End
`
`Miscellaneous Incoming Letter
`
`Specification
`
`Claims
`
`Abstract
`
`Warnings:
`
`Information:
`
`1
`
`17
`
`20
`
`21
`
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`
`2
`
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`
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`BAN_1 02_ CON_ADS.pdf
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`no
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`
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`Warnings:
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`5
`
`BAN_l 02_CON_Preliminary_A
`mendment.pdf
`
`156247
`
`daa519d989480352a46e4t:.9216403c0c6c6
`d6a6c
`
`yes
`
`17
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1006, Pg. 16 of 257
`
`

`

`Multipart Description/PDF files in .zip description
`
`Document Description
`
`Start
`
`End
`
`Preliminary Amendment
`
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`Claims
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`Applicant Arguments/Remarks Made in an Amendment
`
`Warnings:
`
`Information:
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`1
`
`2
`
`11
`
`17
`
`1
`
`2
`
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`
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`6
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`Transmittal of New Application
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`BAN_l 02_CON_Transmittal.pd
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`no
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`4
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`
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`eb22bd6b34r6535di!Pilli!00b04~9b;v:\9
`befdcB
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`41802
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`7
`
`Fee Worksheet (SB06)
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`fee-info.pdf
`
`no
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`2
`
`6800B23e33c50372.003f300e12ad613a898
`8cb91
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`Information:
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`Total Files Size (in bytes)
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`2975462
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`This Acknowledgement Receipt evidences rece.ipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`New Agglications Under 35 U.S.C. 111
`If a new application is being filed and the application includes the necessary components for a filing date (see 37 CFR
`1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shown on this
`Acknowledgement Receipt will establish the filing date of the application.
`
`National Stage of an International Agglication under 35 U.S.C. 371
`If a timely submission to enter the national stage of an international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCT/DO/E0/903 indicating acceptance of the application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`New International Agglication Filed with the USPTO as a Receiving Office
`If a new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP 181 0), a Notification of the International Application Number
`and oft he International Filing Date (Form PCT/R0/1 OS) will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this Acknowledgement Receipt will establish the international filing date of
`the application.
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1006, Pg. 17 of 257
`
`

`

`Electronic Acknowledgement Receipt
`
`EFS ID:
`
`Application Number:
`
`24430367
`
`14977808
`
`International Application Number:
`
`Confirmation Number:
`
`1747
`
`Title of Invention:
`
`SOLVENT SYSTEM FOR ENHANCING THE SOLUBILITY OF PHARMACEUTICAL
`AGENTS
`
`First Named Inventor/Applicant Name:
`
`Nachiappan Chidambaram
`
`Customer Number:
`
`23579
`
`Filer:
`
`Patrea L. Pabst/Cindy Phillips
`
`Filer Authorized By:
`
`Patrea L. Pabst
`
`Attorney Docket Number:
`
`BAN 102 CON
`
`Receipt Date:
`
`22-DEC-2015
`
`Filing Date:
`
`TimeStamp:
`
`11:06:59
`
`Application Type:
`
`Utility under 35 USC 111 (a)
`
`Payment information:
`
`Submitted with Payment
`
`Payment Type
`
`Payment was. successfully received in RAM
`
`RAM confirmation Number
`
`Deposit Account
`
`Authorized User
`
`yes
`
`Credit Card
`
`$8840
`
`10920
`
`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpayment as follows:
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1006, Pg. 18 of 257
`
`

`

`File listing:
`
`Document
`Number
`
`Document Description
`
`File Name
`
`1
`
`TrackOne Request
`
`BAN_1 02_CON_Track_One_Re
`quest.pdf
`
`Warnings:
`
`Information:
`
`File Size( Bytes)/
`Message Digest
`
`Multi
`Part /.zip
`
`Pages
`(ifappl.}
`
`124623
`
`9a4a07 4ac079aaeac7 e5aOBdd f3518c8ba 1
`
`"''
`
`no
`
`2
`
`2
`
`Information Disclosure Statement (IDS)
`Form (SB08)
`
`BAN_1 02_CON_1449.pdf
`
`no
`
`1
`
`25309
`
`8f2aBa32d2a11 e402fBaGJd15604138bb9a
`da29c
`
`Warnings:
`
`Information;
`
`This is not an USPTO supplied IDS fillable form
`
`3
`
`BAN_1 02_CON_Application.pd
`
`yes
`
`21
`
`704431
`
`Multipart Description/PDF files in .zip description
`
`914e81 eeJ75S ::JSC flad c77ee 17ae027ZU20
`::~Obdd
`
`Document Description
`
`Start
`
`End
`
`Miscellaneous Incoming Letter
`
`Specification
`
`Claims
`
`Abstract
`
`Warnings:
`
`Information:
`
`1
`
`17
`
`20
`
`21
`
`1
`
`2
`
`18
`
`21
`
`1822737
`
`4
`
`Application Data Sheet
`
`BAN_1 02_CON_ADS.pdf
`
`no
`
`8
`
`7e:1eebn58t075f3db953ddd2r<~d7Bf!ee53
`48328
`
`Warnings:
`
`Information:
`
`5
`
`BAN_1 02_CON_Preliminary_A
`mendment.pdf
`
`156247
`
`daaS 19d9B94B03 5 2a<!6e4c.9216,J OJc Oc6c6
`d6a5c
`
`yes
`
`17
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1006, Pg. 19 of 257
`
`

`

`Multipart Description/PDF files in .zip description
`
`Document Description
`
`Start
`
`End
`
`Preliminary Amendment
`
`Specification
`
`Claims
`
`Applicant Arguments/Remarks Made in an Amendment
`
`Warnings:
`
`Information:
`
`1
`
`2
`
`11
`
`17
`
`1
`
`2
`
`3
`
`12
`
`100313
`
`6
`
`Transmittal of New Application
`
`BAN_1 02_CON_ Transmittal.pd
`
`no
`
`4
`
`Warnings:
`
`Information:
`
`t>b22hd6b34c6 5 35 d aea 1 a00b04eca9ba49
`befdcB
`
`41802
`
`7
`
`Fee Worksheet (SB06)
`
`fee-info.pdf
`
`no
`
`2
`
`60808 21 e 33 tiS 03 7200 3 f3 DOe 12ad 513 a898
`Bcb9l
`
`Warnings:
`
`Information:
`
`Total Files Size (in bytes)
`
`2975462
`
`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO oft he indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`New A~~lications Under 35 U.S.C. 111
`If a new application is being filed and the application includes the necessary components for a filing date (see 37 CFR
`1.53(b)-(d) and MPEP 506}, a Filing Receipt (37 CFR 1.54} will be issued in due course and the date shown on this
`Acknowledgement Receipt will establish the filing date of the application.
`
`National Stage of an International A~~lication under 35 U.S.C. 371
`If a timely submission to enter the national stage of an international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCT/DO/E0/903 indicating acceptance of the application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`New International A~~lication Filed with the USPTO as a Receiving Office
`If a new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP 1 81 0}, a Notification of the International Application Number
`and of the International Filing Date (Form PCT/R0/1 OS) will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this Acknowledgement Receipt will establish the international filing date of
`the application.
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1006, Pg. 20 of 257
`
`

`

`Doc Code: TRACK1.REQ
`Document Description: TrackOne Request
`
`PTO/AIA/424 (04-14)
`
`CERTIFICATION AND REQUEST FOR PRIORITIZED EXAMINATION
`UNDER 37 CFR 1.102(e) (Page 1 of1)
`
`N h.
`ac Iappan
`SOLVENT SYSTEM FOR ENHANCING THE SOLUBILITY OF PHARMACEUTICAL AGENTS
`
`b
`Ch'd
`I am aram known):
`
`I Nonprovisional Application Number (if I
`
`First Named
`Inventor:
`Title of
`Invention:
`
`APPLICANT HEREBY CERTIFIES THE FOLLOWING AND REQUESTS PRIORITIZED EXAMINATION FOR
`THE ABOVE-IDENTIFIED APPLICATION.
`
`1. The processing fee set forth in 37 CFR 1.17(i)(1) and the prioritized examination fee set forth in
`37 CFR 1.17(c) have been filed with the request. The publication fee requirement is met
`because that fee, set forth in 37 CFR 1.18(d), is currently $0. The basic filing fee, search fee,
`and examination fee are filed with the request or have been already been paid. I understand
`that any required excess claims fees or application size fee must be paid for the application.
`
`2.
`
`I understand that the application may not contain, or be amended to contain, more than four
`independent claims, more than thirty total claims, or any multiple dependent claims, and that
`any request for an extension of time will cause an outstanding Track I request to be dismissed.
`
`i.
`
`3. The applicable box is checked below:
`I. 0 Original Application (Track One)- Prioritized Examination under§ 1.102(e)(1)
`(a) The application is an original nonprovisional utility application filed under 35 U.S.C. 111 (a).
`This certification and request is being filed with the utility application via EFS-Web.
`---OR---
`( b) The application is an original nonprovisional plant application filed under 35 U.S. C. 111 (a).
`This certification and request is being filed with the plant application in paper.
`
`ii. An executed inventor's oath or declaration under 37 CFR 1.63 or 37 CFR 1.64 for each
`inventor, Q! the application data sheet meeting the conditions specified in 37 CFR 1.53(f)(3)(i) is
`filed with the application.
`0 Reguest for Continued Examination -Prioritized Examination under§ 1.1 02(e)(2}
`
`II.
`
`i. A request for continued examination has been filed with, or prior to, this form.
`ii.
`If the application is a utility application, this certification and request is being filed via EFS-Web.
`iii. The application is an original nonprovisional utility application filed under 35 U.S.C. 111 (a), or is
`a national stage entry under 35 U.S.C. 371.
`iv. This certification and request is being filed prior to the mailing of a first Office action responsive
`to the request for continued examination.
`v. No prior request for continued examination has been granted prioritized examination status
`under 37 CFR 1.1 02(e)(2).
`
`Signature/Patrea L. Pabst/
`~p~~~yped) Patrea L. Pabst
`
`oate December 22, 2015
`31 284
`
`Practitioner
`Registration Number
`
`'
`
`Note: This form must be signed in accordance with 37 CFR 1.33. See 37 CFR 1.4(d) for signature requirements and certifications.
`Submit multiple farms if mare than one signature is required. •
`
`D *Total of ___ forms are submitted.
`
`Petitioner - Catalent Pharma Solutions
`Ex. 1006, Pg. 21 of 257
`
`

`

`Privacy Act Statement
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your
`submission of the attached form related to a patent application or patent. Accordingly, pursuant to the requirements of
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`
`The information provided by you in this form will be subject to the following routine uses:
`
`1. The information on this form will be treated confidentially to the extent allowed under the Freedom of
`Information Act (5 U.S.C. 552) and the Privacy Act (5 U.S.C 552a). Records from this system of records may
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