Bass and Spangenberg
`Exhibit 1009
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`Page 1 of 9
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`Exhibit 1009
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`Page 1 of 9
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`U.S. Serial No. 12/811,737
`Response to Office Action dated 2/14/12
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`Page 2
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`Al\/IENDMCENTS TO THE CLAIMS
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`The following listing of claims replaces and supersedes all previous listings.
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`Listing of Claims:
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`1. (Currently Amended) An orally Gsally disintegrating tablets tablet with
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`speckled appearance comprising colored granules of a water—soluble sugar in admixture
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`with a pharmaceutically acceptable carrier.
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`2. (Currently Amended) The orally Gtally disintegrating tablets tablet according
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`to claim 1 wherein the water—soluble sugar is selected from the group consisting of
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`sucrose and polyalcohols.
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`3. (Currently Amended) The orally Gtally disintegrating tablets tablet according
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`to claim 2 wherein the water—soluble sugar is selected from the group consisting of
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`sucrose, sorbitol, rnannitol, Xylitol, and fructose.
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`4. (Currently Amended) The orally Gra-lly disintegrating tablets tablet according
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`to claim 3 wherein the water—soluble sugar is mannitol.
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`5. (Currently Amended) The orally Qrall-y disintegrating tablets tablet according
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`to claim 1 wherein the colored granules have a particle size from about 10 mm to about
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`1200 um.
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`Page 2 of 9
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`Page 2 of 9
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`U.S. Serial No. 12/811,737
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`Response to Office Action dated 2/14/12
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`Page 3
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`6. (Currently Amended) The orally Qtally disintegrating tablets tablet according
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`to claim 5 wherein the colored granules have a particle size from about 200 mm to about
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`800 um.
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`7. (Currently Amended) The orally Qtally disintegrating tablets tablet according
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`to claim 6 wherein the colored granules have a particle size from about 300 mm to about
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`500 um.
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`8. (Currently Amended) The orally Qtally disintegrating tablets tablet according
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`to claim 1 wherein the colored granules are present in an amount from about 0.1% w/w to
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`about 50% w/w per tablet.
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`9. (Currently Amended) The orally Grttl-l—y disintegrating tablets tablet according
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`to claim 1 wherein the colored granules are present in an amount from about 1% w/w to
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`about 30% w/w per tablet.
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`10.
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`(Withdrawn———Currently Amended) A method for the identification of Q
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`orally disintegrating tablets tablet comprising the use of an orally disintegrating tablet
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`with speckled appearance according to claim 1.
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`11. (Withdrawn) A method according to claim 10 wherein the orally
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`disintegrating tablet is scored and embossed with one or more symbols, letters, numbers
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`or combination thereof.
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`Page 3 of 9
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`Page 3 of 9
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`U.S. Serial No. 12/811,737
`Response to Office Action dated 2/14/12
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`Page 4
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`REMARKS
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`The Office Action mailed February 14, 2012, has been received and carefully
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`reviewed. The preceding amendments and the following remarks form a full and
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`complete response thereto. In the Office Action, claims 1-9 are pending and stand
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`rejected. Claims 10-11 have been withdrawn. Claims 1-10 are currently amended.
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`Support for these amendments can be found, inter alia, in the original claims and the
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`specification. No new matter has been added. Reconsideration of the outstanding
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`rejections is respectfully requested in view of the above amendments and the following
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`remarks.
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`Objection to Claims 1-9 for Informalities
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`Claims 1-9 were objected to because of informalities. More specifically, claims
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`1—9 were objected to for failing to recite an article at the beginning of each claim. Claims
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`1-9 have been amended such that an article, either “an” or “the” precedes each claim.
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`Accordingly, Applicants respectfully request that the rejection be withdrawn.
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`Claim 9 was objected to for reciting an incomplete unit. Per the Examiner’s
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`suggestion, claim 9 has been amended to recite that “the colored granules are present in
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`an amount from about 1% w/w to about 30% w/w per tablet.” Accordingly, Applicants
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`respectfully request that the rejection be withdrawn.
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`Page 4 of 9
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`Page 4 of 9
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`U.S. Serial No. 12/811,737
`Response to Office Action dated 2/14/12
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`Page 5
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`35 U.S.C. §_ 1021b:
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`Claims 1-4 and 8 were rejected under 35 U.S.C. § 102(b) as being anticipated by
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`U.S. Patent Publication No. 2003/0180357 to Martino, et al. (“Martino”). Applicants
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`respectfully submit that Martino does not describe each and every element of independent
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`claim 1. Specifically, Applicants submit that Martino fails to describe “colored granules
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`of a water~soluble sugar.”
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`In Martino, mannitol and a dye are blended in a high—shear mixer. See Martino,
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`paragraph [OO85]. The result of the process in Martino is a “homogenous mixture of
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`mannitol and dye,” not colored granules of a water~soluble sugar. Id. Furthermore, the
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`speckled appearance of the tablet is due to the coating with an aqueous coating
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`composition comprising gellan gum. See Martino, paragraph [OO13].
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`In contrast, the present invention does not require a coating for a speckled
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`appearance, but rather is speckled due to the presence of “colored granules of a water-
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`soluble sugar.” As described in the specification, the production of “colored granules of
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`a water—soluble sugar” involves “granulation of the water—soluble sugar with an aqueous
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`suspension or solution of the coloring agent in a suitable fluid bed granulator.” Thus, it is
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`clear both from the claim language and the specification of the present invention, that the
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`granules of colored water—soluble sugar are distinct from Martino’s description of a
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`mixture of an uncolored water—soluble sugar and a dye. Accordingly, Applicants submit
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`that Martino does not describe each and every element of claim 1. Since claims 2-4 and 8
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`depend on claim 1 and thus include the same claim element, Applicants respectfully
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`request that the rejection be withdrawn.
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`Page 5 of 9
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`Page 5 of 9
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`U.S. Serial No. 12/811,737
`Response to Office Action dated 2/14/12
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`Page 6
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`35 U.S.C. § 1031a!
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`In the outstanding Office Action, claims 1-4 and 8-9 were rejected under 35
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`U.S.C. § 103(a) as being obvious over Martino. Additionally, claims 1-9 were rejected
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`under 35 U.S.C. § 103(a) as being obvious over Martino in view of U.S. Patent
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`Publication No. 2004/0213855 to Pettersson, et al. (“Pettersson”). Applicants
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`respectfully submit that a primafacie conclusion of obviousness is not warranted because
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`all of the elements of amended claim 1 are not in the prior art, either alone or in
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`combination.
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`As discussed above, Martino fails to describe “colored granules of a water-soluble
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`sugar.” Furthermore, Martino fails to teach or suggest “colored granules of a water-
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`soluble sugar.” Therefore, the rejection of claims 1-4 and 8-9 based on Martino alone is
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`untenable and should be withdrawn. Moreover, Pettersson fails to remedy the
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`deficiencies of Martino. Pettersson is directed to tablets with mannitol having a particle
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`size from 250 to 450 um. Pettersson, however, does not describe, teach, or suggest
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`“colored granules of a water-soluble sugar.”
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`For the above—identified reasons, amended claims 1-9 would not have been
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`‘ obvious in view of the cited art. Accordingly, Applicants respectfully request that the
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`rejection be withdrawn.
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`CONCLUSION
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`All of the stated grounds of objection and rejection have been properly traversed,
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`accommodated, or rendered moot. Applicants therefore respectfully request that the
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`Page 6 of 9
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`Page 6 of 9
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`U.S. Serial No. 12/811,737
`Response to Office Action dated 2/14/12
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`Page 7
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`Examiner reconsider all presently outstanding rejections, and that they be withdrawn.
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`Applicants respectfully submit that present claims 1-9 are now in condition for
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`allowance.
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`Please charge any required fee in connection with this submission, including an
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`extension of time fee in the event this submission is untimely, or any additional fees or
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`credits to Deposit Account No. 02-2135.
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`If for any reason the Examiner determines that the application is not now in
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`condition for allowance, it is respectfully requested that the Examiner contact, by
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`telephone, the Applicants’ undersigned attorney at the indicated telephone number to
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`arrange for an interview to expedite the disposition of this application.
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`Respectfully submitted,
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`%\§~%L/*
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`
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`Glenn E. Karta
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`Attorney for Applicant
`Registration No. 30,649
`ROTHWELL, FIGG, ERNST & MANBECK
`1425 K. Street, Suite 800
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`Washington, D.C. 20005
`Telephone: (202) 783-6040
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`200l986vl
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`Page 7 of 9
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`Page 7 of 9
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`Electronic Acknowledgement Receipt
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`12766782
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`Application Number:
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`12811737
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`International Application Number:
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`Confirmation Number:
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`Title of Invention:
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`ORALLY DISINTEGRATING TABLETS WITH SPECKLED APPEARANCE
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`First Named Inventor/Applicant Name:
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`Federico Stroppolo
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`Customer Number:
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`6449
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`Glenn E. Karta/Jessica Fu
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`Filer Authorized By:
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`Glenn E. Karta
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`Attorney Docket Number:
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`3504-108
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`Receipt Date:
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`14—MAY-201 2
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`Filing Date:
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`06-JUL—201 0
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`Time Stamp:
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`12:58:43
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`Application Type:
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`U.S. National Stage under 35 USC 371
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`Payment information:
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`Submitted with Payment
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`File Listing:
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`Document
`Number
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`Document Description
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`File Size(Bytes)/
`Message Digest
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`Pages
`Multi
`Part /.zip (if appl.)
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`998a4
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`Amendment.pdf
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`e7385306eea3b0d18d75d6efa696f3217eb
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`Page 8 of 9
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`Page 8 of 9
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`Multipart Description/PDF files in .zip description
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`Document Description
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`Amendment/Req. Reconsideration-After Non-Final Reject
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`ApplicantArguments/RemarksMadeinanAmendment
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`Total Files Size (in bytes)
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`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO ofthe indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
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`New Applications Under 35 U.S.C. 111
`lfa new application is being filed and the application includes the necessary components for a filing date (see 37 CFR
`1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shown on this
`Acknowledgement Receipt will establish the filing date of the application.
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`National Stage of an International Application under 35 U.S.C. 371
`lfa timely submission to enter the national stage of an international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCT/DO/E0/903 indicating acceptance of the application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
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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.
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`Page 9 of 9
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`Page 9 of 9
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