U NITED S TATES P ATENT AND T RADEMARK O FFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States J>atent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. So., 1450
`Alexandria, Virgin.i.a 223L3·l450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAJ\.ffiD INVENTOR
`
`ATIORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`I3/902, 132
`
`05/24/2013
`
`Giorgio Calderari
`
`2327&.2.US.I 0
`
`2532
`
`08108/20 I3
`7590
`53449
`PATENT CORRESPONDENCE
`ARNALL GOLDEN GREGORY LLP
`17117TH STREET NW
`SUITE2100
`ATLANTA, GA 30363
`
`EXAl\III!'fER
`
`GEMDEH, SHIRLEY V
`
`ART UNIT
`
`1628
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`0&/0&/2013
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time petiod 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. 8,729,094
`Reddy Exhibit 1038
`
`Exh. 1038
`
`

`
`Application No.
`13/902,132
`
`Examiner
`SHIRLEY V. GEMBEH
`
`Applicant{s)
`CALDERARI ET AL.
`Art Unit
`1628
`
`Office Action Summary
`
`AlA (First Inventor to File)
`Status
`Yes
`- The MAILING DATE 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 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 olthis communication.
`Failure to repl y within the set or extended period l or reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § t 33).
`Any reply received by the Ollice later than three months after the mailing date of this communication, even if timely filed, may reduce any
`eamed patent term adjustment. See 37 CFR i . 704(b).
`
`Status
`1 )[8] Responsive to communication(s) filed on 24 Mav 2013.
`0 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on _ ____,
`2a)0 This action is FINAL.
`2b)[8] This action is non-final.
`3)0 An election was madle 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)0 Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`close·d in accordance with the practice under Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims
`5)[8] Claim(s) 10-15 is/are pending in the application.
`5a) Of the above claim(s) __ is/are withdrawn from consideration.
`6)0 Claim(s) __ is/are allowed.
`7)~ Claim(s) 10-15 is/are rejected.
`8)0 Claim(s) __ is/are objected to.
`9)0 Claim(s) __ 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
`http:/NMNl.uspto.gov/patents/init eventsippt1iindex.jsp or send an inquiry to PPHfeedback@uspto.gov.
`Application Papers
`1 0)0 The specification is objected to by the Examiner.
`11 )0 The drawing(s) filed on __ is/are: a)O accepted or b)O 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).
`Priority under 35 U.S.C. § 119
`12)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`a)O All
`b)O Some* c)O None of the:
`Certified copies of the priority documents have been received.
`1.0
`Certified copies of the priority documents have been received in Application No. __ .
`2.0
`Copies of the certified copies of the priority documents have been received in this National Stage
`3.0
`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.
`
`Attachment(s)
`1) [8] Notice of References Cited (PT0-892)
`
`2) [8]1nformation Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date 5124113.
`U.S. Patent and Trademark Office
`PTOL·326 (Rev. 05-13)
`
`Office Action Summary
`
`Interview Summary (PT0-413)
`3) 0
`Paper No(s)/Mail Date. __ .
`4) 0 Other: __ .
`
`Part of Paper No./Mail Date 20130717
`Exh. 1038
`
`

`
`Application/Control Number: 13/902,132
`Art Unit: 1628
`
`Page 2
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`DETAILED ACTION
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`Status of Claims
`
`Claims 10-15 are pending and are under examination in this office action.
`
`Information Disclosure Statement
`
`The information disclosure statement (IDS) submitted on 5/24/13 is
`
`acknowledged and has been reviewed.
`
`Claim Rejections - 35 USC § 112
`
`The following is a quotation of 35 U.S.C. 112(b):
`(b) CONCLUSION.-The specification shall conclude with one or more claims particularly
`pointing out and distinctly claiming the subject matter which the inventor or a joint inventor
`regards as the invention.
`
`The following is a quotation of 35 U.S.C. 112 (pre-AlA), second parag~raph:
`The specification shall conclude with one or more claims particularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
`
`Claims 10-15 are rejected under 35 U.S. C. 112(b) or 35 U.S.C. 112 (pre-AlA),
`
`second paragraph, as being indefinite for failing to particularly point out and distinctly
`
`claim the subject matter which the inventor or a joint inventor, or for pre-AlA the
`
`applicant regards as the invention.
`
`Regarding claim 10, the word "means" is preceded by the word(s) "making" in an
`
`attempt to use a "means" clause to recite a claim element as a means for performing a
`
`specified function. However, since no function is specified by the word(s) preceding
`
`"means," it is impossible to determine the equivalents of the element, as required by
`
`Exh. 1038
`
`

`
`Application/Control Number: 13/902,132
`Art Unit: 1628
`
`Page 3
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`35 U.S.C. 112(f) or 35 U.S. C. 112 (pre-AlA), sixth paragraph. See Ex parte Klumb, 159
`
`USPQ 694 (Bd. App. 1967).
`
`The term "making" has no functional meaning, therefore it is confusing what
`
`Applicant is refereeing to.
`
`However to accelerate prosecution Examiner has interpreted the claim as a
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`formulation comprising palonosetron.
`
`The present application, filed on or after March 16, 2013, is being examined
`
`under the first inventor to file provisions of the AlA.
`
`In the event the determination of the status of the application as subject to AlA 35
`
`U.S. C. 102 and 103 (or as subject to pre-AlA 35 U.S. C. 102 and 1 03) is incorrect, any
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`correction of the statutory basis for the rejection will not be considered a new ground of
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`rejectijon if the prior art relied upon, and the rationale supporting the rejection, would be
`
`the same under either status
`
`Claim Rejections - 35 USC§ 102
`
`The following is a quotation of the appropriate paragraphs of 35 U.S. C. 102 that
`
`form the basis for the rejections under this section made in this Office action.:
`
`A person shall be entitled to a patent unless -
`
`Claims 10-11 are rejected under 35 U.S.C. 102(b) as being anticipated by
`
`Baroni et al. (WO 2004/073714).
`
`Exh. 1038
`
`

`
`Application/Control Number: 13/902,132
`Art Unit: 1628
`
`Page4
`
`Baroni et al. teach a Palonosetron has surprisingly been found to exhibit an
`
`efficacy plateau as a single dose (see pg 8, lines 20+) and can be in a concentration of
`
`0.25 mg (see pgs 11, lines 14-16 and 13, lines 20-25) for the treatment of emesis
`
`induced by chemotherapy (see pg 13, lines 18-20, as required by instant claims1 0-11)
`
`in a single intravenous unit (see pg 13, lines 3-5).
`
`With regards to the limitations means for making said formulation stable for 24
`
`months or 18 months, Baroni teaches their formulation prepared as shown in Example
`
`3, Table 8, therefore it is expected that the aqueous formulation of palonosetron will be
`
`stable for 24 or 18 months. Additionally Baroni teaches that their formulation is stable
`
`for extended times ranging from 1 yr, 18 months , 6 months (see pg 18, lines 21 -24, as
`
`required by instant claim 1 0)
`
`Therefore Baroni anticipates instant claims 10-11.
`
`Claim Rejections - 35 USC§ 103
`
`The following is a quotation of 35 U.S.C. 103 which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`A patent for a claimed invention may not be obtained, notwithstanding that the claimed
`invention is not identically disclosed as set forth in section 102 of this title, if the differences
`between the claimed invention and the prior art are such that the claimed invention as a whole
`would have been obvious before the effective filing date of the claimed invention to a person
`having ordinary skill in the art to which the claimed invention pertains. Patentability shall not
`be negated 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
`
`obviousness under 35 U.S.C. 103 are summarized as follows:
`
`1. Determining the scope and contents of the prior art.
`
`Exh. 1038
`
`

`
`Application/Control Number: 13/902,132
`Art Unit: 1628
`
`Page 5
`
`2. Ascertaining the differences between the prior art and the claims at issue.
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`3. Resolving the level of ordinary skill in the pertinent art.
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`4. Considering objective evidence present in the application indicating
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`obviousness or nonobviousness.
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`This application currently names joint inventors. In considering patentability of the
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`claims the examiner presumes that the subject matter of the various claims was
`
`commonly owned at the time any inventions covered therein were effectively filed
`
`absent any evidence to the contrary. Applicant is advised of the obligation under 37
`
`CFR 1.56 to point out the inventor and effective filing dates of each claim that was not
`
`commonly owned at the time a later invention was effectively filed in order for the
`
`examiner to consider the applicability of 35 U.S.C. 1 02(b)(2)(C) for any potential 35
`
`U.S. C. 1 02(a)(2) prior art against the later invention.
`
`Claims 12-15 are rejected under 35 U.S.C. 103 as being obvious over Baroni et
`
`al. (WO 2004/073714).
`
`The applied reference has a common inventor with the instant application. Based
`
`upon the earlier effective filing date of the reference, it constitutes prior art under 35
`
`U.S.C. 1 02(a)(2).
`
`This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under
`
`37 CFR 1.130(a) tlhat the subject matter disclosed in the reference was obtained directly
`
`or indirectly from the inventor or a joint inventor of this application and is thus not prior
`
`art in accordance with 35 U.S. C. 1 02(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of
`
`a prior public disclosure under 35 U.S. C. 1 02(b)(2)(B); or (3) a statement purrsuant to 35
`
`Exh. 1038
`
`

`
`Application/Control Number: 13/902,132
`Art Unit: 1628
`
`Page 6
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`U.S.C. 1 02(b)(2)(C) establishing that, not later than the effective filing date of the
`
`claimed invention, the subject matter disclosed and the claimed invention were either
`
`owned by the same person or subject to an obligation of assignment to the same
`
`person or subject to a joint research agreement. See generally MPEP § 706.02(1)(1)
`
`and § 706.02(1)(2).
`
`With regards to instant claims 12, Baroni also teaches treating emesis (i.e.,
`
`vomiting) induced by chemotherapy administering palonosetron in its free base form,
`
`wherein it was palonosetron was administered over 30 seconds (see pgs 14, lines 3-6
`
`and pg 20, lines 9-12, as required by instant claim 13). Baroni teaches their
`
`formulation is used for reducing vomiting (see pg 8, lines 11-19 , as required by instant
`
`claims 14-15). The claims (14-15) do not recite additional steps or products to be
`
`administered, but rather recite effects which will necessarily occur upon intravenously
`
`admitting the composition.
`
`However Baroni fails to teach that the intravenous administration to humans
`
`occurs before the start of chemotherapy. Nonetheless Baroni teaches that
`
`administration of palonosetron before an operation (see pg 15, lines 1-5).1t would have
`
`been obvious to one of ordinary skill in the art to have been motivated to administer
`
`palonosetron with a reasonable expectation of success before the effective filing day of
`
`the claimed invention because Baroni makes it obvious.
`
`This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under
`
`37 CFR 1.130(a) tlhat the subject matter disclosed in the reference was obtained directly
`
`or indirectly from the inventor or a joint inventor of this application and is thus not prior
`
`Exh. 1038
`
`

`
`Application/Control Number: 13/902,132
`Art Unit: 1628
`
`Page 7
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`art in accordance with 35 U.S.C. 1 02(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of
`
`a prior public disclosure under 35 U.S. C. 1 02(b)(2)(B); or (3) a statement pursuant to 35
`
`U.S.C. 1 02(b)(2)(C) establishing that, not later than the effective filing date of the
`
`claimed invention, the subject matter disclosed and the claimed invention were either
`
`owned by the same person or subject to an obligation of assignment to the same
`
`person or subject to a joint research agreement. See generally MPEP § 706.02(1)(1)
`
`and § 706.02(1)(2).
`
`No claims allowed.
`
`Note that COER (Clinical Pharmacology and Biopharmaceutics Review
`
`(September 2002)) can also be used to form a rejection
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`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
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`number for the org1anization where this application or proceeding is assigned is 571-
`
`273-8300.
`
`Exh. 1038
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`

`
`Application/Control Number: 13/902,132
`Art Unit: 1628
`
`Page 8
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`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`published applicatiions 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
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`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`/SHIRLEY V GEMBEH/
`Primary Examiner, Art Unit 1628
`7/23/13
`
`Exh. 1038