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
`
`12106/20 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
`
`12106/2013
`
`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 a l.
`U.S. Patent No. 8,729,094
`Reddy Exhibit 1008
`
`Exh. 1008
`
`

`
`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 9 October 2013.
`0 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on _ ____,
`2a)[8] This action is FINAL.
`2b)0 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) 12-41 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) 12-41 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) 0 Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date __ .
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 05·13)
`
`3) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`4) 0 Other: __ .
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20131127
`Exh. 1008
`
`

`
`Application/Control Number: 13/902,132
`Art Unit: 1628
`
`Page 2
`
`DETAILED ACTION
`
`The present application, filed on or after March 16, 2013, is being examined
`
`under the first inventor to file provisions of the AlA.
`
`Status of Claims
`
`Claims 12-41 are pending and are under examination in this office action. Claims
`
`1-11 have been cancelled. Claims 16-41 are newly added.
`
`Information Disclosure Statement
`
`The information disclosure statement (IDS) submitted on 11/25/13 is
`
`acknowledged and has been reviewed.
`
`1 .
`
`The response filed on 10/9/13 has been entered.
`
`2.
`
`Applicant's arguments filed 10/9/13 have been fully considered but they are not
`
`deemed to be persuasive.
`
`3.
`
`The text of those sections of Title 35, U.S. Code not included in this action can
`
`be found in a prior Office action.
`
`4.
`
`The rejection of claims 1 0-15 under 35 U.S. C. 112, second paragraph, as being
`
`indefinite is withdrawn due to the amendment of the claims.
`
`Exh. 1008
`
`

`
`Application/Control Number: 13/902,132
`Art Unit: 1628
`
`Page 3
`
`The rejection of Claims 10-11 under 35 U.S.C. 1 02(b) as being anticipated by
`
`Baroni et al. (WO 2004/073714 ). Is withdrawn due to Applicant's amendment to the
`
`claims.
`
`The rejection of Claims 12-15 under 35 U.S.C. 103 as being obvious over Baroni
`
`et al. (WO 2004/073714) is withdrawn due to Applicant's amendment to the claims.
`
`Claim Objections
`
`Claim 27 is objected to because of the following informalities: claim 2:7 is a
`
`duplicate of claim 26. Appropriate correction is required.
`
`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.
`
`2. Ascertaining the differences between the prior art and the claims at issue.
`
`Exh. 1008
`
`

`
`Application/Control Number: 13/902,132
`Art Unit: 1628
`
`Page4
`
`3. Resolving the level of ordinary skill in the pertinent art.
`
`4. Consider'ing objective evidence present in the application indicating
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`obviousness or nonobviousness.
`
`This application currently names joint inventors. In considering patentability of the
`
`claims the examiner presumes that the subject matter of the various claims was
`
`commonly owned as of the effective filing date of the claimed invention(s) 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 as of the effective filing date of the later invention in order for the examiner to
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`consider the applicability of 35 U.S. C. 102(b)(2)(C) for any potential 35 U.S.C. 1 02(a)(2)
`
`prior art against the later invention.
`
`Claims 12, 14-16, 18-24, 26-33, 35-41 are rejected under pre-AlA 35 U.S.C.
`
`1 03(a) as being unpatentable over Berger et al. (US 5,202,333) in view of Barton
`
`(Citrate Buffer Calculation, 2000, 2pgs and Castillo et al., US 6,.284,749 further in view
`
`of Gambhir, US 5,854,270 and as evidenced by Matsumoto (All references have
`
`already been made of record).
`
`With regards to claims 12, 16, 24 and 33, Berger et al. teaches a method of
`
`treating and or reducing chemotherapy induced nausea and vomiting with a
`
`pharmaceutical solution for reducing emesis in cancer patients (see col. 1, lines 33-40,
`
`as required by instant claims 14, 18, 26-26, 35), comprising palonosetron in a
`
`pharmaceutical acceptable carrier (see col. 2, lines 20 to 25 and col. 12, lines 41-52 and
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`col. 3, lines 17-21) in a single unit dosage form (see col. 13, lines 1-5) for intravenous
`
`Exh. 1008
`
`

`
`Application/Control Number: 13/902,132
`Art Unit: 1628
`
`Page 5
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`use (see col. 12, lines 25-35) wherein the concentration of palonosetron is from
`
`0.000001% w to 1 0% weight. Interpreting that assuming 1 00 % is 1 00 ml, therefore in 1
`
`ml (1 000 mg) the equivalent of 0.03mg/ml is 0.00003 wt% which is within the disclosed
`
`range, see col. 12, lines 65-67 (as required by the claims). (as shown) is represented
`
`by formula I, at col. 8, lines 35 to 40. The reference also discloses that the
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`pharmaceutically acceptable salt is hydrochloride and can be in an injectable form (i.e.,
`
`intravenous see col. 12, lines 25- 29) .. See col. 5, lines 2-3. Berger nonetheless teaches
`
`addition of citric acid. Citric acid is a chelating agent is citric acid monohydrate is used;
`
`see col. 28, lines 62-67 wherein the concentration of the citric acid is about 0.5
`
`millimoles. Berger also teaches that the amount of palonesetron may vary widely
`
`depending upon the type of formulation, size of the unit dosage, therefore based on
`
`Berger's teaching alone (see col. 12, lines 60-68), additionally, Berger makes it obvious
`
`that the formulation can be prepared in any volume from 1 ml to 100 ml (see col.s 28-
`
`29), matter of optimizations within the purview of the skilled artisan.it would have been
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`obvious to one of ordinary skill in the art to formulate single unit dosage form having a
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`volume of 5 ml in a free base amount of 0.25 mg which is equivalent to its free base
`
`0.05.
`
`However Berger fails to teach that there formulation comprises 0.005 EDTA,
`
`mannitol, 10 millimoles of citric acid and the PH of the formulation. As required by the
`
`claims. Although Berger fails to teach addition of EDTA, It is known in the art that
`
`chelators are known to stabilize pharmaceutical product (see as evidenced by
`
`Matsumoto, already of record). Berger also fails to teach that the formulation is stable
`
`Exh. 1008
`
`

`
`Application/Control Number: 13/902,132
`Art Unit: 1628
`
`Page 6
`
`for 24 months when stored at room temperature as required by the claims. The
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`limitation wherein said intravenous administration to the patient occurs before the start
`
`of the cancer therapy is taught wherein the formulation is administered before
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`administration of the cancer therapy (see col. 31 , lines 1-15). Additionally the wherein
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`clause in a method claim is not given weight when it simply expresses the intended
`
`result of a process step positively recited." Minton v. Nat't Ass'n of Securitfes Dealers,
`
`tnc., 336 F.3d 1373, 1381,67 USPQ2d 1614, 1620 (Fed. Cir. 2003).
`
`Barton is introduced for the teaching of the use of buffers, 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 (as required by claims 12, 16 24, 29 and 33) ..
`
`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 (required by instant claims 1216, 22, 24. 32-33 and 40 (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.
`
`Exh. 1008
`
`

`
`Application/Control Number: 13/902,132
`Art Unit: 1628
`
`Page 7
`
`Gambhir et al. teach that the liquid composition for oral administration comprises
`
`ondansetron and a sweetener wherein the sweetener comprises one or more polyhydric
`
`alcohol (see column 2 lines 11-16). Column 2 line 40 of Gambhir lists mannitol as one
`
`species of polyhydlric alcohol for use in the invention (as required by claims 12, 1624,
`
`and 33).
`
`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 (as required by instant claims112, 1620-22, 30-33 and 41 ). Gambhir (U.S.
`
`Patent 5,854,270) 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). 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
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`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. and formulate a pharmaceutical stable formulation comprising
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`the 5-HT3 receptor antagonist -palonosetron for the treatment of emesis because the
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`reference teaches palonosetron is used in treating emesis and substitute the glucose of
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`Berger for mannose/mannitol with a reasonable expectation of success because
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`Exh. 1008
`
`

`
`Application/Control Number: 13/902,132
`Art Unit: 1628
`
`Page 8
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`mannose and glucose differ only at the orientation of the Hand OH on carbon 2.
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`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 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 wills 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 tl1e range of
`
`4-6 because it is known in the art.
`
`With regards to the providing a room comprising one or more containers,
`
`adjusting the temperature of the room at greater than ten degrees Celsius and storing
`
`the formulation plays no patentable weight because it is evident that all pharmaceutical
`
`formulation is stored in a room is obvious and stored in a container is obvious because
`
`Exh. 1008
`
`

`
`Application/Control Number: 13/902,132
`Art Unit: 1628
`
`Page 9
`
`Berger teaches placing the formulation in a single unit dosage form for intravenous use
`
`as already discussed above. Thus the formulation would have been in a container/vial
`
`ready for intravenous use and kept in a room for a longer period of 24 months.
`
`Additionally as stated supra it is not convincing because the claimed system 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. ld. at 1477-78; see also Hewlett-Packard Co. v. Bausch & Lomb
`
`Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990). "[A]pparatus claims cover what a device is,
`
`not what a device does." See Supra ..
`
`Additionally, "Where the claimed and prior art products are identical or
`
`substantially identical in structure or composition, or are produced by identical or
`
`substantially identical processes, a prima facie case of either anticipation or
`
`obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430,
`
`433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products
`
`of the applicant and the prior art are the same, the applicant has the burden of showing
`
`that they are not." See MPEP 2144.04. Generally, differences in concentration or
`
`temperature will not support the patentability of subject matter encompassed by the
`
`prior art unless there is evidence indicating such concentration or temperature is critical.
`
`"[W]here the general conditions of a claim are disclosed in the prior art, it is not
`
`inventive to discover the optimum or workable ranges by routine experimentation." In re
`
`Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1955).
`
`Exh. 1008
`
`

`
`Application/Control Number: 13/902,132
`Art Unit: 1628
`
`Page 10
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`Claims 13, 17 and 25 are rejected under 35 U.S.C. 103 as being unpatentable
`
`over Berger et al. (US 5,202,333) in view of Castillo et al., US 6,284,749 further in view
`
`of Gambhir, US 5,854,270 and as evidenced by Matsumoto (All references have
`
`already been made of record) as it relates to claims 12, 14-16, 18-24, 26-33, 35-41 and
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`further in view of Landau et al. (US 2004/014751 0) and Perez et al. (cancer J. Sci Am.
`
`(1998) 4® 1 ):52
`
`The references are applied here as above,
`
`However they fail to teach intravenous administration in a human occurred over a
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`period of time of 1 0-60 seconds.
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`Landau teaches treating nausea administering palonesetron (see abstract and
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`0104-1 05) formulated for intravenous use (0206) for bolus administration.
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`Peres et al. teach administering a bolus antiemetic formulation in a single 30
`
`second intravenous bolus infusion (see entire article).
`
`It would have been obvious to one of ordinary skill in the art to have been
`
`motivated to modify the cited references (i.e., Berger, Castillo, Gambhir) to include the
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`method of treating emesis caused by chemotherapy taught by Landau and Perez by
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`intravenously administering a bolus formulation comprising palonesetron with a
`
`reasonable expectation because claimed invention as a whole would have been
`
`obvious before the effective filing date of the claimed invention of success because
`
`Landau and Perez specifically teach that drugs for treating chemotherapeutic induced
`
`emesis for 30 second ..
`
`Exh. 1008
`
`

`
`Application/Control Number: 13/902,132
`Art Unit: 1628
`
`Page 11
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`Thus the claimed invention would have been obvious to modify before the
`
`effective filing date of the claimed invention.
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`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 claim(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 USPQ.2d 2010 (Fed. Cir.
`
`1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re VanOrnum,
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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)
`
`may be used to overcome an actual or provisional rejection based on a nonstatutory
`
`double patenting g1round 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).
`
`Exh. 1008
`
`

`
`Application/Control Number: 13/902,132
`Art Unit: 1628
`
`Page 12
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`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 eTerminal 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.gJov/patents/process/file/efs/guidance/eTD-info-l.jsp.
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`Claims 12-41 are provisionally rejected on the ground of nonstatutory
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`obviousness-type double patenting as being unpatentable over claims 1 0-18 of
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`copending Application No 14/052925.
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`Although the conflicting claims are not identical, they are not patentably distinct
`
`from each other. The reasons are as follows:
`
`The claims of the instant application refers to a method of treating or reducing
`
`chemotherapy-induced nausea ... and the claims O'f the copending application refers to a
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`pharmaceutical formulation for reducing emesis formulated comprising palonosetron in
`
`a pharmaceutically acceptable carrier. Both applications recite using the same
`
`compositions and/or derivatives thereof. See copending application claims 56 and
`
`instant application claims 1 0. The compositions recited in the claims are anticipatory of
`
`each other and would have been used in the method of reducing emesis ..
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`In view of thle foregoing, the copending application claims and the current
`application claims are obvious variations.
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`No claims allowed.
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`Exh. 1008
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`

`
`Application/Control Number: 13/902,132
`Art Unit: 1628
`
`Page 13
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`Applicant's amendment necessitated the new ground(s) of rejection presented in
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`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
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`TWO MONTHS of the mailing date of this final action and the advisory action is not
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`mailed until after the end of the THREE-MONTH shortened statutory period, then the
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`shortened statutory period will expire on the date the advisory action is mailed, and any
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`extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of
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`the advisory action. In no event, however, will the statutory period for reply expire later
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`than SIX MONTHS from the date of this final action.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to SHIRLEY V. GEMBEH whose telephone number is
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`(571 )272-8504. The examiner can normally be reached on 8:30 -5:00, Monday- Friday.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
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`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-
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`273-8300.
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`Exh. 1008
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`

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`Application/Control Number: 13/902,132
`Art Unit: 1628
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`Page 14
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`Information regarding the status of an application may be obtained from the
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`Patent Application Information Retrieval (PAIR) system. Status information for
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`published applicatiions may be obtained from either Private PAIR or Public PAIR.
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`Status information for unpublished applications is available through Private PAIR only.
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`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
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`you have questions on access to the Private PAIR system, contact the Electronic
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`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
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`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.
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`/SHIRLEY V GEMBEH/
`Primary Examiner, Art Unit 1628
`11/27/13
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`Exh. 1008