Exhibit 1003
`
`‘183 Patent File History (“FH183”)
`Office Action 12/20/2006
`
`

`
`__ D_E_M_A_RK ___ O_F_FI_C_E ______
`UNITED ST A TES DEPARTMENT OF COMMERCE
`United States Patent and Trndemork Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alcxandrio, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`10/741,592
`
`FILING DATE
`12/22/2003
`
`FIRST NAMED INVENTOR
`John R. Plachetka
`
`ATTORNEY DOCKET NO.
`7569/80923
`
`CONFIRMATION NO.
`2525
`
`12/20/2006
`7590
`66991
`LAW OFFICE OF MICHAEL A. SANZO, LLC
`15400 CALHOUN DR..
`.
`SUITE 125
`ROCKVILLE, MD 20855
`
`EXAMINER
`KENNEDY, SHARON E
`ART UNIT
`1615
`
`PAPER NUMBER
`
`SHORTENED STATUTORY PERIOD OF RESPONSE
`MAIL DATE
`DELIVERY MODE
`3 MONTHS
`12/20/2006
`PAPER
`Please find below and/or attached an Office communication concerning this application or proceeding.
`IfNO period for reply is specified above, the maximum statutory period will apply and will expire 6 MONTHS
`from the mailing· date of this communication.
`
`PTOL-90A (Rev. 10/06)
`
`

`
`Office Action Summary
`
`Application No.
`Applicant(s)
`10/741,592
`PLACHETKA ET AL.
`Examiner
`Art Unit
`Sharon E. Kennedy
`1615
`•• 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 ;i. 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 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 by the 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
`1)0 Responsive to communication(s) filed on __ .
`2a)0 This action is FINAL.
`This action is non-final.
`3)0 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 parle Quayle, 1935 C. D. 11, 453 O.G. 213.
`Disposition of Claims
`Claim(s) 1-20 is/are pending in the application.
`4a) Of the above claim(s) __ is/are withdrawn from consideration.
`5)0 Claim(s) __ is/are allowed.
`Claim(s) 1-20 is/are rejected.
`7)0 Claim(s) __ is/are objected to.
`8)0 Claim(s) __ are subject to restriction and/or election requirement.
`Application Papers
`9)0 The specification is objected to by the Examiner.
`The drawing(s) filed on 1212212003 is/are:
`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).
`11 )0 The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PT0-152.
`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).
`a)O All b)O Some* c)O None of:
`1.0 Certified copies of the priority documents have been received.
`2.0 Certified copies of the priority documents have been received in Application No. __ .
`3.0 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(a)).
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PT0-948)
`3)
`Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date See Continuation Sheet.
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 08-06)
`
`4) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`5) 0 Notice of Informal Patent Application
`6) 0 Other: __ .
`Office Action Summary
`
`Part of Paper No./Mail Date 12082006
`
`

`
`Continuation Sheet (PTOL-326)
`
`Application No. 10/741,592
`
`Continuation of Attachment(s) 3). Information Disclosure Statement(s) (PTO/SB/08), Paper No(s)/Mail Date :05/21/2004;
`06/18/2004; 08/30/2005; 11 /29/2005; 05/12/2006.
`
`2
`
`

`
`Application/Control Number: 10/741,592
`Art Unit: 1615
`
`Page 2
`
`DETAILED ACTION
`The text of those sections of Title 35, U.S. Code not included in this action can
`be found in a prior Office action or the MPEP.
`
`Claim Rejections· 35 USC§ 112
`Claims 1-20 are rejec:;ted under 35 U.S.C. 112, second paragraph, as being
`indefinite for failing to particularly point out and distinctly claim the subject matter which
`applicant regards as the invention. Claim 1 is cqnfusing because there is insufficient
`antecedent basis for "said NSAID" in part b) of the claim. It appears that applicant
`intended to write "said naproxen" and the claim will be examined with this interpretation
`in mind.
`
`Claim Rejections· 35 USC§ 103
`Claims 1-20 are rejected under 35 U.S.C. 103(a) as being unpatentable over
`Plachetka, US 5,872, 145 in view of Swintosky, US 2,951,792. Plachetka discloses the
`migraine combination naproxen and triptan in the amounts claimed. Plachetka does not
`disclose separating the ingredients into different layers. Swintosky is cited to exemplify
`that the concept of separating tablet ingredients into various layers to control delivery
`rates, prevent interference between the two compounds, etc., is notoriously old.
`Accordingly, it would be obvious to one of ordinary skill in the art at the time the.
`Plachetka invention was made to separate the naproxen and triptan medicaments into
`different layers if a better delivery rate could be achieved in that matter. Note is made
`
`

`
`Application/Control Number: 10/741,592
`Art Unit: 1615
`
`Page 3
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`of applicant's allegations of surprising benefits from separating the drugs, however, it is
`well-known to form various tablet formulations to achieve the type that provides the
`greatest results. Regarding the claimed intermediate layer, see Swintosky figure 2,
`showing the three layered tablet. Regarding the claimed coating, these coatings are
`commonly provided a smooth, swallowable surface on the tablet, provide a specific
`colored tablet, provide a surface where the manufacturer can print their name, etc., and
`are within the skill of the ordinary artisan.
`
`Conclusion
`The prior art made of record and not relied upon is considered pertinent to
`applicant's disclosure. The patent to Whyte, US 701,438, is cited to exemplify that
`tablets with different layers of separated incompatible agents have been known in the
`·art since at least 1902, the issue date of the Whyte patent.
`
`Contact Information
`Any inquiry concerning this communication or earlier communications from the
`examiner should be directed to Sharon E. Kennedy whose telephone number is
`571/272-4948. The examiner can normally be reached on Monday-Thursday.
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`supervisor, Michael Woodward, can be reached on 571/272-8373.
`Information regarding the status of an application may be obtained from the
`Patent Application Information Retrieval (PAIR) system. Status information for
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`

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`Application/Control Number: 10/7 41,592
`Art Unit: 1615
`
`Page 4
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`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).
`
`Sharon E. Kennedy
`Primary Examiner
`Art Un it 1615