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`

`
`LEN 'E‘Ii*iE UNETEEE3 STATES PATENT ANB TRADEMARK OFE<‘§CE
`
`App}. N0.
`Applicant
`Filed
`TCfA.U.
`
`Examiner
`Docket No.
`
`Custeiner N0.
`
`Confirmation Ne.
`
`: 12l811,73’7
`: Federice STROPFOLG, et ai.
`: July 6, 2019
`: 161’?
`
`: Genevieve S.A1iey
`: 3504-108
`
`2 Q6449
`
`: 1929
`
`
`
`ANB
`UNBER 37 C.F.R. 4:: 1.114
`
`
`
`
`
`
`Directer ef the United States F‘atent
`
`and Trademark Gffice
`
`R0. Box 145$}
`
`Atexandria, VA 22313-1450
`
`In response tn the firtai Qffiee Action matted September 12, 2012, Applicants tespeetfuliy
`
`request entry and consideration ef the amendments and retnsrks contained on the t‘e1Eew‘i_rtg
`
`pages. Appiieants are filing eenenttentty herewith a Request for Continued Examinatien
`
`(“RC5”). Anthorizetieti is hereby given to eherge Deposit Aeeennt Ne. C92—2135 fer any fees
`
`deemed necessary. Applicants respeetfuity request ennsiderntion of the remarks centaiiiett en the
`
`following gages.
`
`Anteneinients te the Ctairns begin on page 2 ef this paper.
`
`Remarks begin en page 4 of this paper.
`
`

`
`US. Serini No. i2;i8l 1,737
`Response to Office Action dated 9/12ii2';
`Page 2
`
`mmnnsmsrrs T8 TEE QEAEMS
`
`Tlie foilewing iisting of claims replaces and superseiies ail previous listings,
`
`Listing of Cinirns:
`
`i. (Currently Amended) An orally disintegrating tablet with speckled appearance
`
`comprising gs: sgecides comprising coicred granules of s. water—soinl31e sugar and
`
`as
`
`
`
` . ‘ ' a pharrnaceuticaily acceptable carrier.
`
`2. {Previously Preseriteri) The orally disintegrating tablet according to claim 1 ‘wherein
`
`the watenscinisie sugar is selected from the group consisting of sucrose and poiysicohois.
`
`3. (Previously Presented) The orally ciisintcgrnting tablet according to claim 2 wherein
`
`the wstensoiuiile sugar is seiecteti from the group consisting of sucrose, sorliitol, nisnnitoi,
`
`xylitoi, and fructose.
`
`4. (Previously Presented) The oreiiy disintegrating tablet according to claim 3 wherein
`
`the weter~solu‘olc sugar is mannitol.
`
`5. (Previously Presented} The orally disintegrating tabict acccrding to ciaim 1 wherein
`
`the eoicred granules have a particle size from about l0 cm. to about 1200 inn.
`
`6. (Previously Presented) The orally disintegrating tsbiet according to claim 5 wherein
`
`the coiorcrl grannies have a particle size from about 20% rim to about 890 um.
`
`

`
`US. Seriai No. i2!8.i.i.,73"?
`Response to Office Action dated 9:12/12
`?age 3
`
`7. (Previously Presented) The orally disintegrating tabiet according to ciaim 6 wherein
`
`the colored granules have 21 particle size from about 300 em to about 50G gm.
`
`8. (Pteviousiy Presented) The oraiiy disimtegratiiig tablet according to claim i wherein
`
`the colored granules are present in an amount. from about 0.1% wiw to about 50% w/W per tabiet.
`
`9. (Previeueiy Presented) The oraiiy disintegrating tablet according to claim 1 wherein
`
`the colored grannies are present iii an amount from about 1% wfw to about 30% wiw per tablet.
`
`10. (Withdrawn) A metiioai for the id$if1iZ’ifiCa€i0i1Qf an orally disintegrating iabiet
`
`comprising the use of an orally disiniegratiiig tablet with speckled appearance according to eiaim
`
`1.
`
`11. (Withdrawn) A method according to claim 10 whereiii the oraiiy disiiitegratiiig tabiet
`
`is scored and embossed with one or more eymbois, letters, numbers or oenibiiiation thereof.
`
`

`
`US. Serial No. 1.2f811,737
`Response to Qffice Actien dated 9X12/1?.
`
`Page 4
`
`REMARKS
`
`The finai Office Action rnaiied September 12, 12012, has been received and carefuiiy
`
`reviewed. Tire preceding arnendrnents and the foiiewing remarks ferrn a fuii and cornpiete
`
`response thereto.
`
`in the Qffice Actien, eiairns L11 are pending. Ciaiuts 1()—11 have been
`
`witiidrawn. Ciairn 1 is curreritiy amended. Support far this arnendrnent can be feund, inter aim,
`
`in the uriginai claims and tirrougiieut the specification. inciuding but net iirnited to page 2, iines
`
`25433. No new matter has been added by this arnendnrent. Reconsideration of die outstanding
`
`rejections is respectfuiiy requested in View ef the abeve arnendrnents and the foiicwirig remarks.
`
`
`Reectiens Under 35 13.3.13.
`
`
`;;
`
`Ciairris L4 and 8 were rejected under 35 U.S.C. § 162th) as being anticipated by US.
`
`Patent Puiaiicatien Ne. 21303/'(318€1357 tn Martirio, et a1. {"‘1\/1artine”). Appiicants respectfuiiy
`
`subrnit that Martino does net describe each and every element of amended independent claim 1.
`
`in response tn Applicants’ previous arguments, the tuttstanding Office Action stated that
`
`“as written, the eiaini eriiy requires a specified appearance and does net require the speciries to
`
`comprise ceiered sugar grannies.” See Office Actien, page 7?. Ciairn I has been amended tc
`
`eiarify that the speciries comprise ceiered granules cf a water~seiui:i1e sugar. As amended, claim
`
`1 provides that the specides are attribtttabie tn the colored grannies ef watepseiubie sugar.
`
`Appiieants traverse the rejection because Martino faiis to describe “speciries eorriprisin.g eeiored
`
`grannies of a waterwseiubie sugar.”
`
`In Martino, rnarinitoi and a dye are biended in a 1iigti—s1rear mixer. See Martino,
`
`paragraph {@085}. The resuit of the precess in Martirie is a. “iietnogencus mixture at“ niarrnitni
`
`and dye,” not entered granules at’ a waternsoiubte sugar. Id.
`
`in Martina, tire specified appearance
`
`is attributed tn enter “bleeding” into the casting attire ioeus of each dye particie. See Martino,
`
`

`
`US, Serial No. l2/811,737
`Response to Office Action dated 91 l2.’ l2
`Page 5
`
`paragraph Etltllfll. The specirletl appearance is, thus, attrlltiutahle to the aqueous coating;
`
`composition comprising gellan gum? not colored granules of a watensoluhle sugar.
`
`Id‘.
`
`In contrast, the present invention provitles for “speclrles comprising colored granules of a
`
`watensoluhle sugar” and does not require a coating for a speeltletl appearance. As described in
`
`the specification, the protittctiou of these speclrles involves “granulation of the water—solul'3le
`
`sugar with an aqueous suspension or solution of the coloring agent in a suitable fluid hetl
`
`granulator.” See Specification, page 9, line l5. Thus, it is clear hoth from the claim language
`
`and the specification of the present inverition that the speclrles comprise granules of colored
`
`watensoluble sugar. Accordingly, Applicants submit that Martino does not describe each and
`
`every element of claim 1. Since claims 24 and El depend on claim l, these claims are not
`
`anticipated by hlaitiuo for at least the same reason as claim l. Tlierefore, Applicants
`
`respectfully reqiiest that the rejection be withdrawn.
`
`lleeetions linder 35 ll.S.C. 1:: lot? a
`
`
`
`
`ln the outstanding Office Action, claims l~4 and 84;? were rejected under 35 l_l.S.€."I. §
`
`l03(a) as being obvious over Martino. Additionally, claims 1-9 were rejected under 35 ll.S.C. §
`
`l03(a) as being obvious over Martino in View of US. Patent l’ul)licati.on No. 2904/G2l3855 to
`
`Pettersson, et al. (“l’ettersson”§. Applicants respectfully submit that a primufacie conclusion of
`
`clwiousness is not warranted because all of the elements of arnentletl. claim l are not in the prior
`
`art, either alone or in comhirration.
`
`As discussed altove, Martino fails to tlescrilae (or otherwise teach or suggest) “soecltles
`
`comprising colored granules of a watensoluhle sugar.” Furthermore, it/lartino fails to teach or
`
`suggest “specirles comprising colored granules of a water—soluble sugar.” As claims 2-4 and 343
`
`depend on claim 1, all of the previously rejected claims include the feature, “speclrles comprising
`
`

`
`US. Serial No. 121811337
`Response to Gffice Aeticri dated 9/ 12! 12
`Page 6
`
`coiored grannies of a water»sei’ubie sugar.” As this feature is not taught or described in the cited
`
`art, Appiicants submit that the cieirns are not ebvieus ever Martino fer at least for this reason.
`
`Aeccrdingiy, Applicants submit that the rejection of claims 1-4 and tie‘) based on Martino stone
`
`is untenable and shettiti be withdrawn.
`
`Moreover, Pettersscn fails to remedy the deficiencies of Msrtinc. Pettersseh is directed
`
`to tsbiets with rrianriitei having 3. particle size from 250 to 450 grin. Petterssen, however, does
`
`not describe, teach, er suggest “entered grannies ci’ 3 water»sohtbie sugar.” Therefore, amended
`
`ciainis 1-9 are net ehvious in View of the cited art. Accerdingiy, Applicants respectfully request
`
`that the rejection be withdrawn.
`
`Cettchision
`
`Ail of the stated greuneis cf objection and rej ecticri have been properiy traversed,
`
`accemrnedated, or rendered rnoott Appiicents therefore respectfuhy request that the Examiner
`
`reconsider ah preseiitiy outstanding rej eetions, and that they be withdrawn. Appiicarits
`
`respectfully submit that present ciairris 1—9 are new in coiiditicn fer eiiowtince.
`
`Piesse charge any required fee in connection with this submission, iiieiudirig an extension
`
`of time fee in the event this submission is uritiirieiy, er any additional fees or credits to Deposit
`
`Account Ne. 32-2135.
`
`

`
`US. Seria1Ne. I.2i81.t.,73’7
`Response te Qffiee Actien dated 9/12/12
`Page 7
`
`if fer any teaser: the Examiner determines that the application is not new in ezmditien fer
`
`aiiewanee, it is respeetfuiiy requested that the Examiner contact, by teiephene, the Applicants’
`
`untiersigned attorney at the indieateti teiephene number to arrange for an interview te expedite
`
`the disposition of this appiieatien.
`
`Respeetfuiiy submitted,
`
`
`
`Glenn
`
`Kama
`
`Attemey fmr Applicant
`Registratien No. 30,549
`RGTEFWELL, FEGG, ERNST & MANBECK
`
`6537 14th Street, Suite 800
`
`Washington, DC. 2{3(}i}5
`Teiephone: (20?) 733-6940
`
`?.O893f§5v3.
`
`

`
`Electronic Patent Application Fee Transmittal
`
`Title of Invention:
`
`ORALLY DISINTEGRATING TABLETS WITH SPECKLED APPEARANCE
`
`First Named Inventor/Applicant Name:
`
`Federico Stroppolo
`
`Attorney Docket Number:
`
`3504-108
`
`U.S. National Stage under 35 USC 371 Filing Fees
`
`Description
`
`Fee Code
`
`Quantity
`
`Sub-Total in
`
`USD($)
`
`
`
`

`
`Description
`
`Fee Code
`
`Quantity
`
`Miscellaneous:
`
`930
`
`Total in USD ($)
`
`Sub-Total in
`
`USD($)
`
`

`
`Electronic Acknowledgement Receipt
`
`m—
`
`Title of Invention:
`
`ORALLY DISINTEGRATING TABLETS WITH SPECKLED APPEARANCE
`
`I
`
`Payment information:
`
`yes—
`Submitted with Payment
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.17 (Patent application and reexamination processing fees)
`
`—Auth°“zedUser
`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpayment as follows:
`
`Charge any Additional Fees required under 37 C.F.R. 1.492 (National application filing, search, and examination fees)
`
`

`
`Charge any Additional Fees required under 37 C.F.R. Section 1.19 (Document supply fees)
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`Charge any Additional Fees required under 37 C.F.R. Section 1.20 (Post Issuance fees)
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`Multi
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`_
`_
`_
`Request for Continued Examination
`(RCE)
`
`3504 108RCE. df
`-
`'°
`
`238622
`
`9463a498084c10e43b92eea59914f8a021f
`e930
`
`This is not a USPTO supplied RCE SB30 form.
`
`3504_108AmendmentAF.pdf
`
`c3d551f68b6e37a58c000509113ae1bb3e4
`
`256021
`
`Multipart Description/PDF files in .zip description
`
`Amendment After Final
`
`Fee Worksheet (SB06)
`
`fee-info.pdf
`
`3e18de4909640ab1eb0ada173b1a8c21cf2
`7b699
`
`

`
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`New International Application Filed with the USPTO as a Receiving Office
`lfa new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP 1810), a Notification of the International Application Number
`and ofthe International Filing Date (Form PCT/R0/105) will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this Acknowledgement Receipt will establish the international filing date of
`the application.
`
`

`
`PTO/SB/06 (07-06)
`Approved for use through 1/31/2007. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paerwork Reduction Act of 1995, no ersons are reuired to resond to a collection of information unless it disla s avalid OMB control number.
`
`PATENT APPLICATION FEE DETERMINATION RECORD
`substitute for Form PTo-375
`
`Application or Docket Number
`12/811,737
`
`Filing Date
`07/06/2010
`
`III To be Mailed
`
`APPLICATION AS FILED — PART I
`
`OTHER THAN
`
`FO
`
`D BASIC FEE
`37CFR1.16a, b,or c
`
`D SEARCH EEE .
`37CFR1.16k, I,or m
`
`El EXAMINATION FEE
`(37 CFR1.16( ), (p), or (q))
`TOTAL CLAIMS
`37 CFR1.16i
`INDEPENDENT CLAIMS
`37 CFR1.16h
`
`DAPPLICATION sIzE PE
`(37 CFR 1 “W5”
`
`(Column 1)
`NUMBER FILED
`
`(Column 2)
`NUMBER EXTRA
`
`SMALL ENTITY D OR
`RATE (515)
`FEE ($)
`
`SMALL ENTITY
`RATE (515)
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`‘A’
`
`.
`”"““5 2°=
`.
`”"”“53=
`
`If the specification and drawings exceed 100
`h
`t
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`'
`f
`d
`1‘: $§§o‘1$i’Z‘;eI;. s§.§i";I.°$iy'§°?of':§cfie
`“Q
`additional 50 sheets or fraction thereof. See
`35 U.S.C. 41 a 1 G and 37 CFR 1.16 s.
`
`I:I MULTIPLE DEPENDENT CLAIM PRESENT (37 CFR1.16(j))
`* If the difference in column 1 is less than zero, enter “0" in column 2.
`
`APPLICATION AS AMENDED — PART II
`
`(Column 1)
`CLAIMS
`
`2‘E¥”é‘.l”'”G
`
`AMENDMENT
`
`(Column 2)
`HIGHEST
`
`Etiéliiéfisty
`
`PAID FOR
`
`-2o
`
`(Column 3)
`
`SMALL ENTITY
`
`SEELEBON“
`
`X519
`
`X$
`
`=
`
`=
`
`OTHER THAN
`
`SMALL ENTITY
`
`ADDITIONAL
`FEE (515)
`
`I:I Application Size Fee (37 CFR1.16(s))
`
`D FIRST PRESENTATION OF MULTIPLE DEPENDENT CLAIM (37 CFR1.16(j))
`
`I-
`
`ZU
`
`J EDZU
`
`J E<
`
`CLAIMS
`
`REMAINING
`AFTER
`AMENDMENT
`
`HIGHEST
`
`NUMBER
`PREVIOUSLY
`PAID FOR
`
`1.16 i
`Total (37 CFR
`Independent
`37 CFR 1.16 h
`
`,
`*
`
`Minus
`Minus
`
`,,
`H,
`
`I:I Application Size Fee (37 CFR1.16(s))
`
`PRESENT
`EXTRA
`
`RATE ($)
`
`ADDITIONAL
`FEE ($)
`
`ADDITIONAL
`FEE ($)
`
`X519
`
`X$
`
`=
`
`=
`
`>< %
`X %
`
`II
`
`II
`
`D FIRST PRESENTATION OF MULTIPLE DEPENDENT CLAIM (37 CFR1.16(j))
`
`- or
`OR
`
`ADD‘L
`FEE
`
`AMENDMENT
`
`Legal lnstrument Examiner.
`* If the entry in column 1 is less than the entry in column 2, write “0" in column 3.
`/William Phi”ipS/
`I
`** If the “Highest Number Previously Paid For” IN THIS SPACE is less than 20, enter “20".
`*** If the “Highest Number Previously Paid For" IN THIS SPACE is less than 3, enter
`The “Highest Number Previously Paid For" (Total or Independent) is the highest number found in the appropriate box in column 1.
`This collection of information is required by 37 CFR 1.16. The information is required to obtain or retain a benefit bythe public which is to file (and bythe USPTO to
`process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 12 minutes to complete, including gathering,
`preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the individual case. Any comments on the amount of time you
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