`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313- 1450
`wwwnsptogov
`
`APPLICATION NO.
`
`
`
`
` F ING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`
`
`
`CONF {MATION NO.
`
`11/225,741
`
`09/13/2005
`
`Chih—Ming Chen
`
`141—596 B
`
`3874
`
`12/04/2008
`7590
`47888
`HEDMAN & COSTIGAN PC.
`1185 AVENUE OF THE AMERICAS
`NEW YORK, NY 10036
`
`EXAMINER
`
`YOUNG, MICAH PAUL
`
`ART UNIT
`
`1618
`
`MAIL DATE
`
`12/04/2008
`
`PAPER NUMBER
`
`DELIVERY MODE
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL—90A (Rev. 04/07)
`
`AUROBINDO EX. 1017, 1
`
`AUROBINDO EX. 1017, 1
`
`

`

`
`
`Application No.
`
`Applicant(s)
`
`
` _ 11/225,741 CHEN ET AL.
`
`Interwew Summary
`Examiner
`Art Unit
`
`MICAH-PAUL YOUNG
`
`1618
`
`All participants (applicant, applicant’s representative, PTO personnel):
`
`(1) MlCAH-PAUL YOUNG.
`
`(2) Martin Endres.
`
`Date of Interview: 02 December 2008.
`
`(3)
`
`.
`
`(4)_-
`
`Type:
`
`b)I:I Video Conference
`a)IZI Telephonic
`c)I:I Personal [copy given to: 1)I:I applicant
`
`2)I:I applicant’s representative]
`
`Exhibit shown or demonstration conducted:
`
`If Yes, brief description:
`
`d)I:I Yes
`
`e)I:I No.
`
`Claim(s) discussed:
`
`Identification of prior art discussed:
`
`Agreement with respect to the claims f)I:I was reached. g)I:I was not reached.
`
`h)IZI N/A.
`
`Substance of Interview including description of the general nature of what was agreed to if an agreement was
`reached, or any other comments: The Application has been abandoned.
`
`(A fuIIer description, if necessary, and a copy of the amendments which the examiner agreed would render the claims
`allowable, if available, must be attached. Also, where no copy of the amendments that would render the claims
`allowable is available, a summary thereof must be attached.)
`
`THE FORMAL WRITTEN REPLY TO THE LAST OFFICE ACTION MUST INCLUDE THE SUBSTANCE OF THE
`
`If a reply to the last Office action has already been filed, APPLICANT IS
`INTERVIEW. (See MPEP Section 713.04).
`GIVEN A NON-EXTENDABLE PERIOD OF THE LONGER OF ONE MONTH OR THIRTY DAYS FROM THIS
`
`INTERVIEW DATE, OR THE MAILING DATE OF THIS INTERVIEW SUMMARY FORM, WHICHEVER IS LATER, TO
`FILE A STATEMENT OF THE SUBSTANCE OF THE INTERVIEW. See Summary of Record of Interview
`requirements on reverse side or on attached sheet.
`
`
`
`iMICAH-PAUL YOUNG/
`Examiner, Art Unit 1618
`U.S. Patent and Trademark Office
`
`PTOL-413 (Rev. 04-03)
`
`Interview Summary
`
`Paper No. 20081202
`
`AUROBINDO EX. 1017, 2
`
`AUROBINDO EX. 1017, 2
`
`

`

`
`
`Notice of Abandonment
`
`11/225,741
`Examiner
`
`CHEN ET AL.
`Art Unit
`
`Application No.
`
`Applicant(s)
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address--
`
`MICAH-PAUL YOUNG
`
`1618
`
`This application is abandoned in view of:
`
`1. X Applicant’s failure to timely file a proper reply to the Office letter mailed on 29 April 2008.
`(a) El A reply was received on
`(with a Certificate of Mailing or Transmission dated
`period for reply (including a total extension oftime of
`month(s)) which expired on
`
`), which is after the expiration of the
`
`(b) I] A proposed reply was received on
`
`, but it does not constitute a proper reply under 37 CFR 1.113 (a) to the final rejection.
`
`(A proper reply under 37 CFR 1.113 to a final rejection consists only of: (1) a timely filed amendment which places the
`application in condition for allowance; (2) a timely filed Notice of Appeal (with appeal fee); or (3) a timely filed Request for
`Continued Examination (RCE) in compliance with 37 CFR 1.114).
`
`but it does not constitute a proper reply, or a bona fide attempt at a proper reply, to the non-
`(c) I] A reply was received on
`final rejection. See 37 CFR 1.85(a) and 1.111. (See explanation in box 7 below).
`
`(d) X No reply has been received.
`
`2. D Applicant’s failure to timely pay the required issue fee and publication fee, if applicable, within the statutory period of three months
`from the mailing date of the Notice of Allowance (PTOL-85).
`
`(with a Certificate of Mailing or Transmission dated
`(a) I] The issue fee and publication fee, if applicable, was received on
`), which is after the expiration of the statutory period for payment of the issue fee (and publication fee) set in the Notice of
`Allowance (PTOL-85).
`
`(b) D The submitted fee of $
`
`is insufficient. A balance of $
`
`is due.
`
`The issue fee required by 37 CFR 1.18 is $
`
`. The publication fee, if required by 37 CFR 1.18(d), is $
`
`.
`
`(c) D The issue fee and publication fee, if applicable, has not been received.
`
`3.|:| Applicant’s failure to timely file corrected drawings as required by, and within the three-month period set in, the Notice of
`Allowability (PTO-37).
`
`(a) I] Proposed corrected drawings were received on
`after the expiration of the period for reply.
`
`(b) I:I No corrected drawings have been received.
`
`(with a Certificate of Mailing or Transmission dated
`
`_)
`
`, which is
`
`4. I] The letter of express abandonment which is signed by the attorney or agent of record, the assignee of the entire interest, or all of
`the applicants.
`
`5. I] The letter of express abandonment which is signed by an attorney or agent (acting in a representative capacity under 37 CFR
`1.34(a)) upon the filing of a continuing application.
`
`6. |:| The decision by the Board of Patent Appeals and Interference rendered on
`of the decision has expired and there are no allowed claims.
`
`and because the period for seeking court review
`
`7. D The reason(s) below:
`
`
`
`/Michael G. Hartley/
`Supervisory Patent Examiner, Art Unit 1618
`
`/M|CAH-PAUL YOUNG/
`Examiner, Art Unit 1618
`
`Petitions to revive under 37 CFR 1.137(a) or (b), or requests to withdraw the holding of abandonment under 37 CFR 1.181, should be promptly filed to
`minimize an neative effects on oatent term.
`U.S. Patent and Trademark Office
`
`PTOL-1432 (Rev. 04-01)
`
`Notice of Abandonment
`
`Part of Paper No. 20081202
`
`AUROBINDO EX. 1017, 3
`
`AUROBINDO EX. 1017, 3
`
`

`

`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313- 1450
`wwwnsptogov
`
`APPLICATION NO.
`
`
`
`
` F ING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`
`
`
`CONF {MATION NO.
`
`11/225,741
`
`09/13/2005
`
`Chih—Ming Chen
`
`141—596 B
`
`3874
`
`04/29/2008
`7590
`47888
`HEDMAN & COSTIGAN PC.
`1185 AVENUE OF THE AMERICAS
`NEW YORK, NY 10036
`
`EXAMINER
`
`YOUNG, MICAH PAUL
`
`ART UNIT
`
`1618
`
`MAIL DATE
`
`04/29/2008
`
`PAPER NUMBER
`
`DELIVERY MODE
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL—90A (Rev. 04/07)
`
`AUROBINDO EX. 1017, 4
`
`AUROBINDO EX. 1017, 4
`
`

`

`
`
`Application No.
`
`11/225,741
`
`Applicant(s)
`
`CHEN ET AL.
`
`Office Action Summary
`
`Examiner
`
`MICAH-PAUL YOUNG
`
`Art Unit
`
`1618 -
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE _MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMU—NICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a).
`In no event however may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1)I:I Responsive to communication(s) filed on
`
`2a)IZI This action is FINAL.
`
`2b)I:I This action is non-final.
`
`3)I:I Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`
`closed in accordance with the practice under EX parte Quayle, 1935 CD. 11, 453 O.G. 213.
`
`
`
`Disposition of Claims
`
`4)I:I Claim(s)
`
`is/are pending in the application.
`
`4a) Of the above Claim(s)
`
`is/are withdrawn from consideration.
`
`5)I:I Claim(s) _ is/are allowed.
`
`6)I:I Claim(s) _ is/are rejected.
`
`7)I:I Claim(s) _ is/are objected to.
`
`8)I:I Claim(s) _ are subject to restriction and/or election requirement.
`
`Application Papers
`
`9)I:I The specification is objected to by the Examiner.
`
`10)I:I The drawing(s) filed on
`
`is/are: a)I:I accepted or b)I:I objected to by the Examiner.
`
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
`
`11)I:I The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
`
`Priority under 35 U.S.C. § 119
`
`12)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)—(d) or (f).
`
`a)I:I All
`
`b)I:I Some * c)I:I None of:
`
`Certified copies of the priority documents have been received.
`
`Certified copies of the priority documents have been received in Application No.
`
`Copies of the certified copies of the priority documents have been received in this National Stage
`
`application from the International Bureau (PCT Rule 17.2(a)).
`
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attach ment(s)
`
`1) IZI Notice of References Cited (PTO-892)
`2) D Notice of Draftsperson‘s Patent Drawing Review (PTO-948)
`3) |:| Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mai| Date
`.
`U.S. Patent and Trademark Office
`
`4) D Interview Summary (PTO-413)
`Paper No(s)/Mai| Date. _
`5) I:I Notice of Informal Patent Application
`6) D Other:
`
`PTOL-326 (Rev. 08-06)
`
`Office Action Summary
`
`PartKU’fiia flow/Baffiwéffiifi’ 5
`
`AUROBINDO EX. 1017, 5
`
`

`

`Application/Control Number: 11/225,741
`
`Art Unit: 161 8
`
`Page 2
`
`DETAILED ACTION
`
`Acknowledgment of Papers Received: Amendment/Response dated 2/6/08
`
`Claim Rejections - 35 USC § 1 03
`
`1.
`
`The following is a quotation of 35 USC. 103(a) which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in
`section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are
`such that the subject matter as a whole would have been obvious at the time the invention was made to a person
`having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the
`manner in which the invention was made.
`
`2.
`
`The factual inquiries set forth in Graham v. John Deere C0., 383 US. 1, 148 USPQ 459
`
`(1966), that are applied for establishing a background for determining obviousness under 35
`
`USC. 103(a) are summarized as follows:
`
`.-'>S’°.'\’.H
`
`Determining the scope and contents of the prior art.
`Ascertaining the differences between the prior art and the claims at issue.
`Resolving the level of ordinary skill in the pertinent art.
`Considering objective evidence present in the application indicating obviousness
`or nonobviousness.
`
`3.
`
`Claims 43-78, 80 and 82-88 are rejected under 35 USC. 103(a) as being unpatentable
`
`over the disclosures of Elger et a1 (USPN 4,834,985 hereafter “985). The claims are drawn to a
`
`controlled release ora1 dosage form comprising a metformin in a matrix with a controlled release
`
`carrier and a controlled release coating.
`
`4.
`
`The ‘985 patent discloses a controlled release formulation comprising metformin (col. 3,
`
`1m. 9), various carriers (col. 4, 1m. 54-69) and a coating (col. 5, 1m. 23-28, example 9).
`
`Regarding claim 75, the ‘985 patent discloses that the formulation can be granulated into
`
`individual granules/pellets or microparticles comprising the active agents and a carrier polymer
`
`constituting multiple dosage forms (col. 5, 1m. 20-27). Regarding claim 77, the ‘985 patent
`
`AUROBINDO EX. 1017, 6
`
`AUROBINDO EX. 1017, 6
`
`

`

`Application/Control Number: 11/225,741
`
`Art Unit: 161 8
`
`Page 3
`
`discloses that the dosage from comprises binders such as polyvinylpyrrolidone (example 17).
`
`Regarding claim 78, the ‘985 patent discloses that the dosage from comprises components used
`
`as absorption enhancers such as various polyethylene glycols and cetostearyl alcohol (examples).
`
`Regarding claim 80 which recite specific carrier polymers, the ‘985 patent discloses that the
`
`dosage form comprises cellulose ethers such as hydroxypropylcellulose (col. 2, lin. 24-33).
`
`5.
`
`Regarding the specific dissolution profile recited in the claims, it is the position of the
`
`Examiner that such limitations are functional and same compositions must have the same
`
`properties. The limitations of claims 43-74 are encompassed inherently by the disclosures of the
`
`‘985 patent. The configuration of the carrier polymers, concentration of the drug present in the
`
`core and the presence of a membrane coating determine the dissolution profile. The tablets of
`
`the ‘985 patent disclose each of these components. Further these components can be modified in
`
`order to achieve a desired release rate. For disorders that require faster acting active agents, the
`
`carrier materials can be chosen and provided in the proper concentrations to achieve a faster or
`
`slower release. In the instant case 0-30% of the drug is to be released at a 2-hour mark with a
`
`plasma concentration of 1500 ng/ml. The compositions of the ‘985 patent can be configured to
`
`release 0-27% at the 2 hour mark with a plasma concentration of approximately 1600 ng/ml
`
`(examples and table 12). However through routine experimentation these dissolution profiles
`
`can be altered. It is the position of the Examiner that the dissolution profiles of the instant claims
`
`are obvious variations and can be determined through routine experimentation. For these reasons
`
`dissolution profile limitation do not impart patentability on the claims.
`
`6.
`
`Regarding the Cmax values recited in the claims, it is the position of the Examiner that
`
`such limitations are functional and same compositions must have the same properties. These
`
`AUROBINDO EX. 1017, 7
`
`AUROBINDO EX. 1017, 7
`
`

`

`Application/Control Number: 11/225,741
`
`Art Unit: 161 8
`
`Page 4
`
`limitations are seen as future intended uses for known formulations. Further, the claims recite
`
`that they are based on varying concentrations of the metformin, meaning the Cmax values are
`
`hypothetical at best. It is the position of the Examiner that any formulation matching the
`
`physical components as that of the instant claims, namely a metformin compound in a matrix
`
`with a controlled release carrier would be capable of achieving these Cmax values, and would
`
`inherently achieve these values. Also the claims recite that the formulation only be suitable for
`
`once-a-day administration, which is again a future intended use for the formulation. Any
`
`formulation can be made suitable for any type of administration. It is the position of the
`
`Examiner that such a limitation does not impart patentability.
`
`7.
`
`Specifically regarding the Cmax values that are dependent on a specific hypothetical
`
`release concentration, the Office does not have the facilities for examining and comparing
`
`applicant’s product with the product of the prior art in order to establish that the product of the
`
`prior art does not possess the same material structural and functional characteristics of the
`
`claimed product. In the absence of evidence to the contrary, the burden is upon the applicant to
`
`prove that the claimed products are functionally different than those taught by the prior art and to
`
`establish patentable differences. See Ex parte Phillips, 28 U.S.P.Q.2d 1302, 1303 (PTO Bd. Pat.
`
`App. & Int. 1993), Ex parte Gray, 10 USPQ2d 1922, 1923 (PTO Bd. Pat. App. & Int.) and In re
`
`Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977).
`
`8.
`
`With these things in mind it would have been obvious to follow the suggestions of the
`
`‘985 patent in order arrive at the controlled release formulation of the instant claims. It would
`
`have been obvious to produce a controlled release formulation as disclosed in the ‘985 patent
`
`AUROBINDO EX. 1017, 8
`
`AUROBINDO EX. 1017, 8
`
`

`

`Application/Control Number: 11/225,741
`
`Art Unit: 161 8
`
`Page 5
`
`with an expected result of a tablet useful in treating various disorders including serum glucose
`
`regulation.
`
`9.
`
`Claims 43-88 rejected under 35 U.S.C. 103(a) as being unpatentable over the combined
`
`disclosures of Elger et al (USPN 4,834,985 hereafter “985) in view of Chen et al (USPN
`
`5,837,379 hereafter “379). The claims are drawn to a controlled release dosage form comprising
`
`a passageway through the membrane and a plasticizer.
`
`10.
`
`As discussed above the ‘985 patent obviates many aspects of the instantly claimed
`
`invention. The reference is silent however to a specific passageway out of the membrane coating
`
`or a specific plasticizer. These components are however well known in the art and would be
`
`obvious additions to the formulation of the ‘985 patent. They can bee seen in the ‘379 patent.
`
`11.
`
`The ‘379 patent discloses a controlled release formulation comprising various active
`
`agents combined with controlled release carriers in a matrix surrounded by a membrane coating
`
`(abstract). The carrier polymers include cellulose ethers such as hydroxypropylcellulose (col. 4,
`
`lin. 25-30). The formulation further includes a plasticizer such as rapeseed oil, triacetin and
`
`glycerol sorbitol (col. 5, lin. 44-55). The formulation includes absorption enhancers such as
`
`sodium lauryl sulfate (examples) and binders such as povidone (examples). The formulation
`
`includes an opening in the membrane through which the core active agents are released (col. 3,
`
`lin. 50-60). The active agents include chlorporpamide a commonly associated compound useful
`
`in reducing serum glucose levels (col. 2, lin. 60). It would have been obvious to include the
`
`passageway forming polymers into the coating of the ‘985 patent in order to provide an
`
`improved for prolonged release of the active agents.
`
`AUROBINDO EX. 1017, 9
`
`AUROBINDO EX. 1017, 9
`
`

`

`Application/Control Number: 11/225,741
`
`Art Unit: 161 8
`
`Page 6
`
`12.
`
`It would have been obvious to include the plasticizers and passageway-forming polymers
`
`of the “379 patent into the formulation of the “985 patent in order to maintain the integrity of the
`
`coating while releasing a steady stream of active agent over a longer period of time. It would
`
`have been obvious to one of ordinary skill in the art to combine the disclosures as such with an
`
`expected result of a sustained release composition capable of reducing serum glucose levels over
`
`an extended period of time.
`
`Response to Arguments
`
`Applicant's arguments filed 2/6/08 have been fully considered but they are not
`
`persuasive. Applicant argues that:
`
`a. The “985 patent alone or in combination does not teach or suggest the “unique”
`
`in vitro or in viva properties taught in the instant claims.
`
`b. The combination of the “985 and “379 patent do not obviate the claims since
`
`the '3 79 patent does not overcome the deficiencies of the '985 patent and does not teach
`
`or suggest the "unique" in vitro or in viva properties taught by the instant claims.
`
`Regarding argument a., it remains the position of the Examiner that the “985 patent
`
`continues to obviate the claims. Applicant argues that the “985 patent does not disclose the
`
`“unique” release profile however it remains the position of the Examiner that as long as the
`
`formulation is capable for performing or achieving the desired result the “985 patent would read
`
`on the instant claims. In order for the formulation to be capable of the release profile it must
`
`meet the compositional limitations of the claims. By meeting the compositional limitations of
`
`AUROBINDO EX. 1017, 10
`
`AUROBINDO EX. 1017, 10
`
`

`

`Application/Control Number: 11/225,741
`
`Art Unit: 161 8
`
`Page 7
`
`the formulation the compound of the prior art would inherently be capable of the "unique" in
`
`vivo or in vitro properties. The claims recite a controlled release formulation comprising
`
`metformin, a controlled release carrier, and a controlled release coating. The ‘985 patent
`
`discloses a controlled release matrix formulation comprising the same drug, combined with the
`
`same controlled release carriers and controlled release coating materials as the instant claims.
`
`Since a composition and its properties cannot be separated and the composition of the ‘985
`
`patent is fiJndamentally the same as the instant claims, the formulation must have the same
`
`release profile. Applicant argues that the '985 patent does not disclose the unique physical, or
`
`metabolic properties of metformin that must be considered when making a controlled release
`
`formulation. These considerations would have been obvious to one of ordinary skill in the art
`
`and are the definition of routine experimentation. The '985 patent provides a wide range of
`
`active ingredients all with their specific formulating parameters, and it remains the potion of the
`
`Examiner that the modification and appreciation of the specific formulating parameters for each
`
`active compound would be well within the level of skill in the art and obvious to one of ordinary
`
`skill in the art. For these reasons the claims remain obviated.
`
`Regarding argument b., it remains the position the Examiner that the combination of the
`
`'985 and the 379 patent obviates the claims. As discussed above the '985 patent meets the
`
`compositional limitations of the instant claims, and thereby would also meet the inherent release
`
`characteristics as well. The reference however is silent to the specific plasticizer or passageway
`
`through the surrounding membrane. The ‘379 patent provides these components, establishing
`
`the level of skill in the art. The ‘985 patent disclose the use of a plasticizer, though different than
`
`that of the instant claims. The '3 79 patent provides the specific compound. It would have been
`
`AUROBINDO EX. 1017, 11
`
`AUROBINDO EX. 1017, 11
`
`

`

`Application/Control Number: 11/225,741
`
`Art Unit: 161 8
`
`Page 8
`
`obvious to include them into the '985 patent in order to provide a more precise release rate or
`
`modify it completely. These modifications would have been obvious to one of ordinary skill in
`
`the art since the “985 and ‘379 patents provide similar carrier formulations comprising cellulose
`
`ethers, and active compound useful in treating patients with NIDDM. For these reasons the
`
`composition of the combination would have obviated the instant claims.
`
`Conclusion
`
`Applicant's amendment necessitated the new ground(s) of rejection presented in this
`
`Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a).
`
`Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
`
`A shortened statutory period for reply to this final action is set to expire THREE
`
`MONTHS from the mailing date of this action. In the event a first reply is filed within TWO
`
`MONTHS of the mailing date of this final action and the advisory action is not mailed until after
`
`the end of the THREE-MONTH shortened statutory period, then the shortened statutory period
`
`will expire on the date the advisory action is mailed, and any extension fee pursuant to 37
`
`CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event,
`
`however, will the statutory period for reply expire later than SIX MONTHS from the date of this
`
`final action.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to MICAH-PAUL YOUNG whose telephone number is (571)272-
`
`0608. The examiner can normally be reached on Monday-Friday 7:00-4:30; every other Monday
`
`off.
`
`AUROBINDO EX. 1017, 12
`
`AUROBINDO EX. 1017, 12
`
`

`

`Application/Control Number: 11/225,741
`
`Art Unit: 161 8
`
`Page 9
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Michael G. Hartley can be reached on 571-272-0616. The fax phone number for the
`
`organization where this application or proceeding is assigned is 571-273-8300.
`
`Information regarding the status of an application may be obtained from the Patent
`
`Application Information Retrieval (PAIR) system. Status information for published applications
`
`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
`
`applications is available through Private PAIR only. For more information about the PAIR
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`system, see http://pair-direct.uspto. gov. Should you have questions on access to the Private PAIR
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`system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would
`
`like assistance from a USPTO Customer Service Representative or access to the automated
`
`information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`/Michael G. Hartley/
`Supervisory Patent Examiner, Art Unit 1618
`
`/MICAH-PAUL YOUNG/
`
`Examiner, Art Unit 1618
`
`AUROBINDO EX. 1017, 13
`
`AUROBINDO EX. 1017, 13
`
`

`

`
`
`Application/Control No.
`
`11/225,741
`Examiner
`
`MlCAH-PAUL YOUNG
`U.S. PATENT DOCUMENTS
`
`Applicant(s)/Patent Under
`Reexamination
`CHEN ET AL.
`Art Unit
`
`1618
`
`Page 1 0“
`
`Notice of References Cited
`
`Document Number
`Country Code-Number-Kind Code
`
`Date
`MM-YYYY
`
`Classification
`
`
`ccccccccccccc
`‘P‘P‘P‘P‘P‘P‘P‘P‘P‘P‘P
`
`
`
`NON-PATENT DOCUMENTS
`
`Include as applicable: Author, Title Date, Publisher, Edition or Volume, Pertinent Pages)
`
`- U
`
`S—4,834,985
`
`86,837,379
`
`05-1989
`
`11-1998
`
`Elger et aI.
`Chen et aI.
`
`424/488
`
`424/465
`
`Document Number
`Country Code-Number-Kind Code
`
`Um,_..(D
`MM-YYYY
`
`Country
`
`FOREIGN PATENT DOCUMENTS
`
`Classification
`
`
`
`
`
`*A copy of this reference is not being furnished with this Office action. (See MPEP § 707.05(a).)
`Dates in MM-YYYY format are publication dates. Classifications may be US or foreign.
`U.S. Patent and Trademark Office
`
`PTO-892 (Rev. 01-2001)
`
`Notice of References Cited
`
`Part of Paper No. 20080417
`
`AUROBINDO EX. 1017, 14
`
`AUROBINDO EX. 1017, 14
`
`

`

`Application/Control No.
`
`1618
` MICAH-PAUL YOUNG
`
`
`
`Applicant(s)lPatent Under
`Reexamination
`
`Index Of Claims
`CHEN ET AL.
`11225741
`
`
`
`Art Unit
` Examiner
`
`
`
`
`
`Appeal II— a
`
`Rejected I Cancelled
`Allowed
`fl Restricted
`
`fl
`
`n Non-Elected
`
`El Claims renumbered in the same order as presented by applicant
`
`El CPA
`
`El T.D.
`
`El R.1.47
`
`DATE
`CLAIM
`
`
` N1
`
`_
`
`(II-[>60
`
`_—_______
`_—_______
`_—_______
`n————————
`_—_______
`
`
`
`8 9 1
`
`
`
`
`
`0 _
`
`—_______
`_—_______
`_—_______
`_—_______
`_—_______
`
`16
`
`17
`18
`
`_—_______
`_—_______
`_—_______
`_—_______
`_—_______
`
`24
`
`25
`26
`
`_—_______
`_—_______
`_—_______
`_—_______
`_—_______
`
`32
`33
`34
`
`_—_______
`_—_______
`U.S. Patent and Trademark Office
`Part of Paper No. : 20080417
`
`AUROBINDO EX. 1017, 15
`
`AUROBINDO EX. 1017, 15
`
`

`

`Application/Control No.
`
`1618
` MICAH-PAUL YOUNG
`
`
`
`Applicant(s)lPatent Under
`Reexamination
`
`Index Of Claims
`CHEN ET AL.
`11225741
`
`
`
`Art Unit
` Examiner
`
`
`
`
`
`Appeal II— a
`
`Rejected I Cancelled
`Allowed
`fl Restricted
`
`fl
`
`n Non-Elected
`
`El Claims renumbered in the same order as presented by applicant
`
`El CPA
`
`El T.D.
`
`El R.1.47
`
`DATE
`CLAIM
`
`Final
`Original
`04/21/2008
`
`37
`-
`38
`-
`
`_—_______
`_—_______
`_—_______
`_—_______
`<\
`_________
`
`44
`45
`46
`
`_________
`_________
`_________
`_________
`_________
`
`52
`53
`54
`
`
`
`xxx
`xxxxx
`xxx
`xxxxx
` xxxxxx
`
`_________
`_________
`_________
`_________
`_________
`
`60
`61
`62
`
`_________
`_________
`_________
`n————————
`xx
`_________
`
`68
`69
`70
`
` xxxxx
`
`_________
`_________
`U.S. Patent and Trademark Office
`Part of Paper No. : 20080417
`
`
`
`AUROBINDO EX. 1017, 16
`
`AUROBINDO EX. 1017, 16
`
`

`

`Applicant(s)lPatent Under
`Reexamination
`
`
`Index Of Claims
`11225741
`CHEN ET AL.
`
`Art Unit
` Examiner
`
`
`Application/Control No.
`
`MICAH-PAUL YOUNG
`1618
`
`
`
`
`
`
`
`
`II— a
`
`Rejected I Cancelled
`Allowed
`fl Restricted
`
`fl
`
`n Non-Elected
`
`Appeal
`
`El Claims renumbered in the same order as presented by applicant
`
`El CPA
`
`El T.D.
`
`El R.1.47
`
`DATE
`CLAIM
`
`Final
`Original
`04/21/2008
`
`73
`\/
`74
`
`xxxxxx
`
`
`
`
`
`_________
`_________
`_________
`_________
`_________
`
`80
`81
`82
`
`xxx
`
`_________
`_________
`_________
`“________
`_________
`88
`
`xxxxxx
`
`U.S. Patent and Trademark Office
`
`Part of Paper No. : 20080417
`
`AUROBINDO EX. 1017, 17
`
`AUROBINDO EX. 1017, 17
`
`

`

`
`
`Application/Control No.
`
`Applicant(s)lPatent Under
`Reexamination
`
`Search Notes
`
`11225741
`
`CHEN ET AL.
`
`
`
`
`||||||||||||
`"NIH"
`H
`"mm
`Examiner
`Art unit
`
`
`MlCAH-PAUL YOUNG
`
`1618
`
`
`
`SEARCHED
`
`
`Examiner
`Date
`Subclass
`Class
`
`424
`464, 469, 450, 484
`12/8/05
`MPY
`514
`414, 415
`above
`to date
`above
`to date
`above
`to date
`above
`to date
`
`——
`
`MPY
`
`
`
`6/17/06
`2/27/07
`9/25/07
`4/ 18/08
`
`INTERFERENCE SEARCH
`
`SEARCH NOTES
`
`mum
`Search Notes
`
`east brs search, all databases searched odp with 11/224,784
`12/8/05
`MPY
`search updated 6/21/06, 2/27/07, odp with 11/224,784 and 10/796, 411
`
`search updated 9/25/07 and 4/18/08 odp droppped with abn of copending
`
`apps
`
`4/18/08 _
`
`US. Patent and Trademark Office
`
`Part of Paper No. : 20080417
`
`AUROBINDO EX. 1017, 18
`
`AUROBINDO EX. 1017, 18
`
`

`

`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Docket No. 141-596B
`
`In re Application of:
`
`Chen et a1.
`
`I
`
`Serial N0.: 11 / 225,741
`
`Group Art Unit: 1618
`
`Filed: September 13, 2005
`
`Examiner: Micah Paul Young
`
`For: CONTROLLED RELEASE METFORMIN COMPOSITIONS
`
`New York, New York 10036
`February 4, 2008
`
`Mail Stop Amendment
`Hon. Commissioner of Patents
`
`PO. Box 1450
`
`Alexandria, VA 22313-1450
`
`Sir:
`
`AMENDMENT
`
`In response to the Office Action dated October 2, 2007,
`
`in the above-
`
`identified application, Applicants respectfully request amendment and reconsideration.
`
`In accordance with the provisions of 37 C.F.R. § 1.121 attached hereto on
`
`separate sheets are: a) an amendment to the claims and b) a remark section.
`
`I hereby certify that this paper or fee is
`being deposited with the United States Postal
`Service as first class mail on February 4,
`2008 in an envelope addressed to:
`
`02/06/200800HOU1
`
`02 FC:1202
`
`Commissioner for Trademarks
`' ., Box
`'Hl
`Alexandr‘ .- ,/ VA
`
`2
`
`
`00000021 11225741
`/ 1
`A”ar in P. Endres,
`350.00 UP 35,498
`
`Reg. No.
`
`
`
`AUROBINDO EX. 1017, 19
`
`AUROBINDO EX. 1017, 19
`
`

`

`AMENDMENTS TO THE CLAIMS
`
`Please amend claims 43 and 47 as indicated below.
`
`Please add new claims 82-88.
`
`A complete list of claims as currently amended follows:
`
`1-42 (cancelled).
`
`43. (currently amended) A controlled release oral dosage form for the reduction
`
`of serum glucose levels in human patients with NIDDM, comprising (a) an active agent
`
`consisting of metformin or a pharmaceutically acceptable salt thereof and (b) a
`
`controlled-release carrier which is incorporated into a matrix along with the metformin,
`
`or which is applied as a controlled release coating, said dosage form (i) providing an in-
`
`vitro dissolution of metformin or salt thereof of from 0-30% at 2 hours when tested in a
`
`USP type II apparatus at 75 rpm in 900 mL of pH 7.5 phosphate buffer and at 37 degrees
`
`C; and (ii) being suitable for providing once-a-day oral administration of the metformin
`
`or pharmaceutically acceptable salt thereof and providing a mean maximum plasma
`
`concentration (Cmax) of metformin from about 1500 ng/ ml to about 3000 ng/ ml, based
`
`on administration of a 2000 mg once-a-day dose of metformin to human patients and
`
`(iii) providing a width at 50% of the height of a mean plasma concentration time curve
`
`of the metformin from about 4.5 to about 13 hours.
`
`44. (previously presented) The controlled release oral dosage form of claim 43,
`
`which provides a mean maximum plasma concentration (Cmax) of metformin from
`
`about 750 ng/ ml to about 1500 ng/ ml upon administration of a 1000 mg once—a—day
`
`dose of metformin.
`
`AUROBINDO EX. 1017, 20
`
`AUROBINDO EX. 1017, 20
`
`

`

`45. (previously presented) The controlled release oral dosage form of claim 43,
`
`which provides a mean maximum plasma concentration (Cmax) of metformin from
`
`about 1125 ng/ ml to about 2250 ng/ ml upon administration of a 1500 mg once-a-day
`
`dose of metformin.
`
`46. (previously presented) The controlled release oral dosage form of claim 43,
`
`which provides a mean maximum plasma concentration (Cmax) of metformin from
`
`about 1875 ng/ ml to about 3750 ng/ ml upon administration of a 2500 mg once-a—day
`
`dose of metfor