~~! UNITED STA ms PATENT AND TRADEMARK OFFICE
`~~OJ~
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`13/901,830
`
`05/24/2013
`
`Giorgio Calderari
`
`23278.2.US.9
`
`3806
`
`11/22/2013
`7590
`53449
`PATENT CORRESPONDENCE
`ARNALL GOLDEN GREGORY LLP
`171 17TH STREET NW
`SUITE 2100
`A1LANTA, GA 30363
`
`EXAMINER
`
`GEMBEH, SHIRLEY V
`
`ART UNIT
`
`1628
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`11/22/2013
`
`ELECTRONIC
`
`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.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`patents@ agg.com
`
`PTOL-90A (Rev. 04/07)
`
`Dr. Reddy’s Laboratories, Ltd., et al.
`v.
`Helsinn Healthcare S.A., et al.
`U.S. Patent No. 9,(cid:20)(cid:26)(cid:22),(cid:28)(cid:23)(cid:21)
`Reddy Exhibit 1022
`
`Exh. 1022
`
`

`
`Application No.
`13/901,830
`
`App|icant(s)
`CALDERARI ET AL.
`
`Office Action Summary
`
`AIA (First lnventorto File)
`Art unit
`Examiner
`E*;*”S
`1628
`SHIRLEY v. GEMBEH
`— 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 COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR1.136(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 bythe 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
`
`HE Responsive to communication(s) filed on 5/24/13.
`I:l A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2b) This action is non-final.
`2a)I:l This action is FINAL.
`3)I:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
`; the restriction requirement and election have been incorporated into this action.
`
`4)D 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 C.D. 11,453 O.G. 213.
`
`Disposition of Claims
`5) Claim(s) Lids/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`j is/are allowed.
`s) gm/are rejected.
`) Z is/are objected to.
`
`are subject to restriction and/or election requirement.
`)
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`hit
`:/:’vvww.u:sbto. cw atents/ii‘-.it events/' Ea/'incie><.‘s,orsend an inquiry to i-‘Pl--lfeedback-’<%, usr_>tc.c1ov.
`
`Application Papers
`
`10)I:I The specification is objected to by the Examiner.
`11)|:| The drawing(s) filed on Z 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( ).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`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( )—(d) or (f).
`Certified copies:
`
`a)|:l All
`b)I:l Some * c)I:l None of the:
`1.D Certified copies of the priority documents have been received.
`.
`2.l:l Certified copies of the priority documents have been received in Application No.
`3.I:I 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( )).
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attach ment(s)
`
`1) El Notice of References Cited (PTO-892)
`
`Information Disclosure Statement(s) (PTO/SB/08)
`2)
`Paper No(s)/Mail Date 5/24/13.
`U.S. Patent and Trademark Office
`PTOL—326 (Rev. 08-13)
`
`3) E jnterview summary (pTo-413)
`Paper No(s)/Mail Date. 11/7/13 _
`4 D O h
`_
`I
`I 9“ :-
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20131107
`
`Exh. 1022
`
`

`
`Application/Control Number: 13/901,830
`Art Unit: 1628
`
`DETAILED ACTION
`
`1.
`
`The present application is being examined under the pre—AlA first to invent
`
`provisions.
`
`Information Disclosure Statement
`
`2.
`
`The information disclosure statement (IDS) submitted on 5/24/13 is
`
`acknowledged and has been reviewed.
`
`Double patenting Rejection
`
`Examiner acknowledges the filing of the terminal disclaimers.
`
`Claim Rejections - 35 USC § 103
`
`4.
`
`In the event the determination of the status of the application as subject to AIA 35
`
`U.S.C. 102 and 103 (or as subject to pre—AlA 35 U.S.C. 102 and 103) is incorrect, any
`
`correction of the statutory basis for the rejection will not be considered a new ground of
`
`rejection if the prior art relied upon, and the rationale supporting the rejection, would be
`
`the same under either status.
`
`The following is a quotation of pre—AlA 35 U.S.C. 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.
`
`The following is a quotation of pre—A|A 35 U.S.C. 103(a) which forms the basis
`
`for all obviousness rejections set forth in this Office action:
`
`Exh. 1022
`
`

`
`Application/Control Number: 13/901,830
`Art Unit: 1628
`
`Page 3
`
`(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.
`
`The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148
`
`USPQ 459 (1966), that are applied for establishing a background for determining
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`obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
`
`1. Determining the scope and contents of the prior art.
`
`2. Ascertaining the differences between the prior art and the claims at issue.
`
`3. Resolving the level of ordinary skill in the pertinent art.
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`4. Considering objective evidence present in the application indicating
`
`obviousness or nonobviousness.
`
`This application currently names joint inventors. In considering patentability of the
`
`claims under pre—AlA 35 U.S.C. 103(a), the examiner presumes that the subject matter
`
`of the various claims was commonly owned at the time any inventions covered therein
`
`were made absent any evidence to the contrary. Applicant is advised of the obligation
`
`under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was
`
`not commonly owned at the time a later invention was made in order for the examiner to
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`consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre—A|A 35 U.S.C.
`
`102( ), (f) or (g) prior art under pre—A|A 35 U.S.C. 103(
`
`).
`
`Claims 10-18 are rejected under pre—AlA 35 U.S.C. 103(a) as being unpatentable
`
`over Berger et al. (US 5,202,333) in view of Barton (Citrate Buffer Calculation, 2000,
`
`Exh. 1022
`
`

`
`Application/Control Number: 13/901,830
`Art Unit: 1628
`
`Page 4
`
`2pgs and Castillo et al., US 6,284,749 further in view of Gambhir, US 5,854,270 and as
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`evidenced by Matsumoto (All references have already been made of record).
`
`Berger et al. teaches a pharmaceutical solution for reducing emesis, comprising
`
`palonosetron in a pharmaceutical acceptable carrier. See col. 2, lines 20 to 25 and col.
`
`12, lines 41 -52 and col. 3, lines 17-21). Palonosetron is (as shown) is represented by
`
`formula I, at col. 8, lines 35 to 40). The reference also discloses that the
`
`pharmaceutically acceptable salt is hydrochloride and can be in an injectable form (see
`
`col. 12, lines 25-29).. See col. 5, lines 2-3. With regard to the concentration
`
`palonosetron, the reference discloses the concentration is from 0.000001% w to 10%
`
`weight. Interpreting that assuming 100 °/o is 100 ml, therefore in 1 ml (1000 mg) the
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`equivalent of 0.03mg/ml is 0.00003 wt % which is within the disclosed range, see col.
`
`12, lines 65-67 (claims 10) in a preferred single unit dosage form (see col. 13, lines 1-5).
`
`Berger also teaches the addition of citric acid buffer (see col. 28, lines 62-67, as
`
`required by instant claim 16)
`
`However Berger fails to teach that the composition comprises mannitol
`
`(from 10
`
`— 80 mg/ml) and EDTA (from 0.005-1.0 mg/ml) wherein the formulation is stable for 24
`
`months in a 5 ml sterile aqueous solution (as required by instant claims 12-15)
`
`Barton is introduced for the teaching of the use of buffers in solution
`
`therefore in order to buffer solution that that is close to the desired ranges. In the instant
`
`claim the pH is 4-6, the pK's used for citric acid are 3.15, 4.50 and 5.75, therefor it is
`
`best to buffer at a pH close to one of the pK's, therefore use citrate buffers only in the
`
`pH range 3-6, since the required pH is from 4.0-6.0 (claim 4). Additionally Barton
`
`Exh. 1022
`
`

`
`Application/Control Number: 13/901,830
`Art Unit: 1628
`
`Page 5
`
`teaches buffers are used to adjust the pH of liquid drugs to keep the solubility and
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`chemical stability and to decrease the irritation of the drugs. Thus the concentration of
`
`the citric acid will depend on the buffering condition of the solution.
`
`Castillo et al. teach the most preferred chelating agent in pharmaceuticals
`
`composition is EDTA. The chelating agents can be added to pharmaceutical
`
`compositions in the form of a pharmaceutically acceptable salt. For example, EDTA
`
`may be added in the form of edetate disodium. In general, the amount of chelating
`
`agent present in the compositions is from about 0.001 to about 1%, preferably about
`
`0.01 to about 0.2%, and most preferably about 0.01 to about 0.1%, which is within the
`
`claimed concentration in instant claim 7. See col. 3, lines 1-16. Therefore it would have
`
`been obvious to one of ordinary skill in the art to substitute citric acid for EDTA as the
`
`chelating agent since substituting one for another will have the same effect, stabilizing
`
`the formulation. Castillo teaches unit dose of their composition in the range of 1- 15 ml
`
`(see col. 4, lines 65-67). Thus it would have been obvious to one of ordinary skill in the
`
`art to formulate the unit dose formulation in 5 ml as required by the instant claim.
`
`Additionally Berger specifically teach that their formulations can be in a preferred unit
`
`dosage form, therefore, since the concentration can be at the dosage range/ml thus can
`
`be formulated in any amount as a single dosage use with a reasonable expectation of
`
`success.
`
`Gambhir et al. teach that the liquid composition for oral administration comprises
`
`ondansetron and a sweetener wherein the sweetener comprises one or more polyhydric
`
`Exh. 1022
`
`

`
`Application/Control Number: 13/901,830
`Art Unit: 1628
`
`Page 6
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`alcohol (see column 2 lines 11-16). Column 2 line 40 of Gambhir lists mannitol as one
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`species of polyhydric alcohol for use in the invention.
`
`Gambhir further teaches (column 2 lines 44-48) that the total polyhydric alcohol
`
`content of the liquid composition conveniently lies in the range of 20 to 85% weight by
`
`volume. Gambhir discloses a liquid composition for oral administration comprising
`
`another 5HT3 receptor antagonist, ondansetron, wherein the pH of the composition lies
`
`in the range of 2.0 to 5.0 (see column 2 lines 11-16 and abstract as required by instant
`
`claim 6). The composition disclosed in Gambhir is also generally used to treat emesis
`
`regardless of the cause (see column 4 lines 23-26). Therefore it would be obvious to an
`
`ordinary skilled artisan to formulate the composition of Berger et al. at a pH of about 2.0
`
`to 5.0 which overlaps with the ranges of pH claimed in the instant application since
`
`palonosetron and ondansetron (claim 1 of Gambhir) have similar structures that both
`
`block 5HT3 receptors and have the same utility of treating emesis.
`
`It would have been obvious to one of ordinary skill in the art to have used the
`
`teaching of Berger et al. administer the 5-HT3 receptor antagonist -palonosetron for the
`
`treatment of emesis because the reference teaches palonosetron is used in treating
`
`emesis.
`
`Also, it would have been obvious to one of ordinary skill in the art to substitute
`
`glucose (Berger's reference) to mannitol because absent factual evidence mannose is
`
`identical to glucose except for the orientation of the H and OH on carbon 2. Therefore
`
`one of ordinary skill in the art would be motivated to substitute glucose for mannose or
`
`vis--versa and would expect the same result. Although, the reference do not teach
`
`Exh. 1022
`
`

`
`Application/Control Number: 13/901,830
`Art Unit: 1628
`
`Page 7
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`EDTA, it is known in the art that EDTA is a chelating agent, one of ordinary skill in the
`
`art would have been motivated to use the teaching of Castillo et al. add a concentration
`
`of EDTA that will be capable of stabilizing the solution, therefore, one of ordinary skill in
`
`the art would be motivated to add a carrier salt of EDTA to a pharmaceutical solution for
`
`stability and its antioxidant action as taught (see above discussion). Optimization of the
`
`concentration is within the purview of one of ordinary skill in the art, since it is known
`
`that these salts aid in stability one of ordinary skill in the art would be motivated to
`
`optimize and use the range or concentration that will s prolong stability.
`
`One of ordinary skill in the art would be motivated to use citric acid in buffering a
`
`solution to obtain the a pH of 4.0-6.0 because the art teaches its best to buffer at a pH
`
`close to one of the pK's, so use citrate buffers only in the pH range 3-6. See underlining.
`
`Based on the teaching it is well within the level of one of ordinary skill in the art to
`
`incorporate citrate buffer to a pharmaceutical composition having the pH in the range of
`
`4-6 because it is known in the art.
`
`With regards to a single unit dosage form, although Berger did not per say teach
`
`a single dosage form, nonetheless Berger specifically teach that the amount of
`
`Palonosetron may vary widely depending upon the type of formulation, size of the unit
`
`dosage etc., therefore based on Berger’s teaching alone, it would have been obvious to
`
`one of ordinary skill in the art to have formulated a single, unit dosage form having a
`
`volume of 5 ml comprising 0.05 mg/ml with a reasonable expectation of success
`
`because Berger makes it obvious to do so (see col. 12, lines 60-68).
`
`Exh. 1022
`
`

`
`App|icationlControl Number: 13/901,830
`Art Unit: 1628
`
`Page 8
`
`As to the limitations to reduce the likelihood of cancer chemotherapy—induced
`
`nausea and vomiting and is stable for 24 months and 18 months is given no patentable
`
`weight because the claimed structure is already known. See In re Schreiber, 128 F.3d
`
`1473, 1477 (Fed. Cir.1997). While features of an apparatus may be recited either
`
`structurally or functionally, claims directed to an apparatus must be distinguished from
`
`the prior art in terms of structure rather than function. Id. at 1477-78; see also Hewlett-
`
`Packard Co. v. Bausch & Lomb lnc., 909 F.2d 1464, 1468 (Fed. Cir. 1990). “[A]pparatus
`
`claims cover what a device is, not what a device does.”
`
`Therefore the claim invention is prima facie obvious at the time of filing.
`
`Double Patenting
`
`The nonstatutory double patenting rejection is based on a judicially created
`
`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
`
`unjustified or improper timewise extension of the “right to exclude” granted by a patent
`
`and to prevent possible harassment by multiple assignees. A nonstatutory double
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`patenting rejection is appropriate where the claims at issue are not identical, but at least
`
`one examined application claim is not patentably distinct from the reference c|aim(s)
`
`because the examined application claim is either anticipated by, or would have been
`
`obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d
`
`1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir.
`
`1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum,
`
`Exh. 1022
`
`

`
`Application/Control Number: 13/901,830
`Art Unit: 1628
`
`Page 9
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`686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619
`
`(CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
`
`A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321 (d)
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`may be used to overcome an actual or provisional rejection based on a nonstatutory
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`double patenting ground provided the reference application or patent either is shown to
`
`be commonly owned with this application, or claims an invention made as a result of
`
`activities undertaken within the scope of a joint research agreement. A terminal
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`disclaimer must be signed in compliance with 37 CFR 1.321 (b).
`
`The USPTO internet Web site contains terminal disclaimer forms which may be
`
`used. Please visit http://www.uspto.gov/forms/. The filing date of the application will
`
`determine what form should be used. A web-based eTermina| Disclaimer may be filled
`
`out completely online using web—screens. An eTerminal Disclaimer that meets all
`
`requirements is auto—processed and approved immediately upon submission. For more
`
`information about eTerminal Disclaimers, refer to
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`http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
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`Claims 1-9 are provisionally rejected under the judicially created doctrine of
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`obviousness-type double patenting as being unpatentable over claims 56-58 of US
`
`patent application 14/052,925.
`
`Although the conflicting claims are not identical, they are not patentably distinct
`
`from each other. The reasons are as follows:
`
`Bothe application recites the same pharmaceutical composition comprising the
`
`same agents for reducing emesis and is stable for 18 to 245 months.
`
`Exh. 1022
`
`

`
`Application/Control Number: 13/901,830
`Art Unit: 1628
`
`Page 10
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`In view of the foregoing, the copending application claims and the current
`
`application claims are obvious variations.
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`5.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to SHIRLEY V. GEMBEH whose telephone number is
`
`(571)272-8504. The examiner can normally be reached on 8:30 -5:00, Monday— Friday.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, BRANDON FETTEROLF can be reached on 571-272-2919. 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 system, see http://pair-direct.uspto.gov. Should
`
`you have questions on access to the Private PAIR 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.
`
`/SHIRLEY V GEMBEH/
`
`Primary Examiner, Art Unit 1628
`11/8/13
`
`Exh. 1022