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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria1 Virginia 22313— 1450
`wwwnsptogov
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`11/273,575
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`11/15/2005
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`Paul Jonathan Harrison
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`2476.0060000/RWE/JSO
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`3339
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`26111
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`7590
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`04/15/2009
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`stNE, KESSLER, Gomsmmmx 1311c.
`1100 NEW YORK AVENUE, N.W.
`WASHINGTON, DC 20005
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`ART UNIT
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`1618
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`MAIL DATE
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`04/ 1 5/2009
`
`VU, JAKE MINH
`PAPER NUMBER
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`DELIVERY MODE
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`PAPER
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`PTOL—90A (Rev. 04/07)
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`

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`Office Action Summary
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`Application No.
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`Applicant(s)
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`11/273,575
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`Examiner
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`HARRISON ET AL.
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`Art Unit
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`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 1 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).
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`Status
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`1)IXI Responsive to communication(s) filed on 15 November 2005.
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`2a)I:I This action is FINAL.
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`2b)I:I This action is non-final.
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`3)I:I Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
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`closed in accordance with the practice under EX parte Quayle, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims
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`4)IZI Claim(s) fl is/are pending in the application.
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`4a) Of the above Claim(s)
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`is/are withdrawn from consideration.
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`5)I:I Claim(s) _ is/are allowed.
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`6)I:I Claim(s) _ is/are rejected.
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`7)I:I Claim(s)
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`is/are objected to.
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`8)IXI Claim(s) Q are subject to restriction and/or election requirement.
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`Application Papers
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`9)I:I The specification is objected to by the Examiner.
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`
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`10)I:I The drawing(s) filed on
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`is/are: a)I:I accepted or b)I:I objected to by the Examiner.
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`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
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`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
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`11)I:I The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
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`Priority under 35 U.S.C. § 119
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`12)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)—(d) or (f).
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`a)I:I All
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`b)I:I Some * c)I:I None of:
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`Certified copies of the priority documents have been received.
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`Certified copies of the priority documents have been received in Application No.
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`Copies of the certified copies of the priority documents have been received in this National Stage
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`application from the International Bureau (PCT Rule 17.2(a)).
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`* See the attached detailed Office action for a list of the certified copies not received.
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`Attach ment(s)
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`1) D Notice of References Cited (PTO-892)
`2) D Notice of Draftsperson‘s Patent Drawing Review (PTO-948)
`3) |:| Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mai| Date
`.
`U.S. Patent and Trademark Office
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`4) D Interview Summary (PTO-413)
`Paper No(s)/Mai| Date. _
`5) I:I Notice of Informal Patent Application
`6) D Other:
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`PTOL-326 (Rev. 08-06)
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`Office Action Summary
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`Part of Paper No./Mai| Date 2009041 1
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`

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`Application/Control Number: 11/273,575
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`Page 2
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`Art Unit: 1618
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`DETAILED ACTION
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`Election/Restrictions
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`Restriction to one of the following inventions is required under 35 U.S.C. 121:
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`Claims 1-9, drawn to a composition that is basic, classified in class 514,
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`subclass 412.
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`Claims 10-17, drawn to a composition that displays a major degradation to
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`ramiprilat, classified in class 548, subclass 401.
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`Claims 18-22, drawn to a composition that demonstrates no degradation
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`to ramipril diketopiperazine during storage, classified in class 424,
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`subclass 400.
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`IV.
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`Claim 23, drawn to a method of treating or preventing a disease, classified
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`in class 514, subclass 412.
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`Claim 24, drawn to a therapeutic package, classified in class 424,
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`subclass 464.
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`VI.
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`Claims 25-29, drawn to a method of manufacturing ramipril formulation,
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`classified in class 548, subclass 401.
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`The inventions are distinct, each from the other because of the following reasons:
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`Inventions H” and V are unrelated.
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`Inventions are unrelated if it can be shown
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`that they are not disclosed as capable of use together and they have different designs,
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`modes of operation, and effects (MPEP § 802.01 and § 806.06).
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`In the instant case, the
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`Application/Control Number: 11/273,575
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`Page 3
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`Art Unit: 1618
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`different inventions have different effects, such as basic, degrades to ramiprilat, and no
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`degradation to ramipril diketopiperazine, a therapeutic kit.
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`Inventions HM and IV are related as product and process of use. The inventions
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`can be shown to be distinct if either or both of the following can be shown: (1) the
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`process for using the product as claimed can be practiced with another materially
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`different product or (2) the product as claimed can be used in a materially different
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`process of using that product. See MPEP § 806.05(h).
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`In the instant case the product
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`could be used for materially different processes, such as treating kidney or treating
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`hypertension.
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`Inventions H”, V and VI are related as process of making and product made.
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`The inventions are distinct if either or both of the following can be shown: (1) that the
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`process as claimed can be used to make another and materially different product or (2)
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`that the product as claimed can be made by another and materially different process
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`(MPEP § 806.05(f)).
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`In the instant case the product could be made by materially
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`different processes, such as wet granulation, or dry granulation.
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`Restriction for examination purposes as indicated is proper because all these
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`inventions listed in this action are independent or distinct for the reasons given above
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`fl there would be a serious search and examination burden if restriction were not
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`required because one or more of the following reasons apply:
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`(a) the inventions have acquired a separate status in the art in view of their
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`different classification;
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`Application/Control Number: 11/273,575
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`Page 4
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`Art Unit: 1618
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`(b)
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`the inventions have acquired a separate status in the art due to their
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`recognized divergent subject matter;
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`(c) the inventions require a different field of search (for example, searching
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`different classes/subclasses or electronic resources, or employing different
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`search queries);
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`(d) the prior art applicable to one invention would not
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`likely be applicable to
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`another invention;
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`(e) the inventions are likely to raise different non-prior art issues under 35 U.S.C.
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`101 and/or 35 U.S.C. 112, first paragraph.
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`Applicant is advised that the reply to this requirement to be complete must
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`include (i) an election of a invention to be examined even though the requirement
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`may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing
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`the elected invention.
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`The election of an invention may be made with or without traverse. To reserve a
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`right to petition, the election must be made with traverse. If the reply does not distinctly
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`and specifically point out supposed errors in the restriction requirement, the election
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`shall be treated as an election without traverse. Traversal must be presented at the time
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`of election in order to be considered timely. Failure to timely traverse the requirement
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`will result in the loss of right to petition under 37 CFR 1.144.
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`If claims are added after
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`the election, applicant must indicate which of these claims are readable on the elected
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`invenflon.
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`Application/Control Number: 11/273,575
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`Page 5
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`Art Unit: 1618
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`If claims are added after the election, applicant must indicate which of these
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`claims are readable upon the elected invention.
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`Should applicant traverse on the ground that the inventions are not patentably
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`distinct, applicant should submit evidence or identify such evidence now of record
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`showing the inventions to be obvious variants or clearly admit on the record that this is
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`the case.
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`In either instance,
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`if the examiner finds one of the inventions unpatentable
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`over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C.
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`103(a) of the other invention.
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`This application contains claims directed to the following patentably distinct
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`species of: arginine, ethanolamine, sodium lauryl sulphate, talc, magnesium stearate,
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`sodium carbonate, sodium bicarbonate, calcium carbonate and citrate salts.
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`The species are independent or distinct because claims to the different species
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`recite the mutually exclusive characteristics of such species.
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`In addition, these species
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`are not obvious variants of each other based on the current record.
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`Applicant is required under 35 U.S.C. 121 to elect a single disclosed species for
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`prosecution on the merits to which the claims shall be restricted if no generic claim is
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`finally held to be allowable. Currently, claims 1 and 11 are generic.
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`This application contains claims directed to the following patentably distinct
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`species of: hypertension, heart failure, stroke, myocardial
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`infarction, diabetes and
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`Application/Control Number: 11/273,575
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`Page 6
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`Art Unit: 1618
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`cardiovascular disease or for reducing the risk of further strokes, heart attacks and
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`cognitive impairment among stroke patients.
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`The species are independent or distinct because claims to the different species
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`recite the mutually exclusive characteristics of such species.
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`In addition, these species
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`are not obvious variants of each other based on the current record.
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`Applicant is required under 35 U.S.C. 121 to elect a single disclosed species for
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`prosecution on the merits to which the claims shall be restricted if no generic claim is
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`finally held to be allowable. Currently, claim 23 is generic.
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`This application contains claims directed to the following patentably distinct
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`species of: wet granulation, dry granulation or direct compression.
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`The species are independent or distinct because claims to the different species
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`recite the mutually exclusive characteristics of such species.
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`In addition, these species
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`are not obvious variants of each other based on the current record.
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`Applicant is required under 35 U.S.C. 121 to elect a single disclosed species for
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`prosecution on the merits to which the claims shall be restricted if no generic claim is
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`finally held to be allowable. Currently, claim 25 is generic.
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`There is an examination and search burden for these patentably distinct species
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`due to their mutually exclusive characteristics. The species require a different field of
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`search (e.g.,
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`searching different classes/subclasses or electronic resources, or
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`employing different search queries); and/or the prior art applicable to one species would
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`Page 7
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`Art Unit: 1618
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`not likely be applicable to another species; and/or the species are likely to raise different
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`non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
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`Applicant is advised that the reply to this requirement to be complete must
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`include (i) an election of a species to be examined even though the requirement
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`may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing
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`the elected species, including any claims subsequently added. An argument that a
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`claim is allowable or that all claims are generic is considered nonresponsive unless
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`accompanied by an election.
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`The election of the species may be made with or without traverse. To preserve a
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`right to petition, the election must be made with traverse. If the reply does not distinctly
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`and specifically point out supposed errors in the election of species requirement, the
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`election shall be treated as an election without traverse. Traversal must be presented at
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`the time of election in order to be considered timely. Failure to timely traverse the
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`requirement will result in the loss of right to petition under 37 CFR 1.144.
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`If claims are
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`added after the election, applicant must indicate which of these claims are readable on
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`the elected species.
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`Should applicant traverse on the ground that the species are not patentably
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`distinct, applicant should submit evidence or identify such evidence now of record
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`showing the species to be obvious variants or clearly admit on the record that this is the
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`case. In either instance, if the examiner finds one of the species unpatentable over the
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`prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103(a)
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`of the other species.
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`Application/Control Number: 11/273,575
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`Page 8
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`Art Unit: 1618
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`Upon the allowance of a generic claim, applicant will be entitled to consideration
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`of claims to additional species which depend from or otherwise require all the limitations
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`of an allowable generic claim as provided by 37 CFR 1.141.
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`Applicant
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`is reminded that upon the cancellation of claims to a non-elected
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`invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one
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`or more of the currently named inventors is no longer an inventor of at least one claim
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`remaining in the application. Any amendment of inventorship must be accompanied by
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`a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
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`The examiner has required restriction between product and process claims.
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`Where applicant elects claims directed to the product, and the product claims are
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`subsequently found allowable, withdrawn process claims that depend from or otherwise
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`require all the limitations of the allowable product claim will be considered for rejoinder.
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`fl claims directed to a nonelected process invention must require all the limitations of
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`an allowable product claim for that process invention to be rejoined.
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`In the event of rejoinder,
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`the requirement for restriction between the product
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`claims and the rejoined process claims will be withdrawn, and the rejoined process
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`claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to
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`be allowable, the rejoined claims must meet all criteria for patentability including the
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`requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product
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`are found allowable, an othenNise proper restriction requirement between product
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`claims and process claims may be maintained. Withdrawn process claims that are not
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`Page 9
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`Art Unit: 1618
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`commensurate in scope with an allowable product claim will not be rejoined. See MPEP
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`§ 821 .04(b). Additionally,
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`in order to retain the right to rejoinder in accordance with the
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`above policy, applicant is advised that the process claims should be amended during
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`prosecution to require the limitations of the product claims. Failure to do so may result
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`in a loss of the right to rejoinder. Further, note that the prohibition against double
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`patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement
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`is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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`Telephonic Inquiries
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to JAKE M. VU whose telephone number is (571)272-
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`8148. The examiner can normally be reached on Mon-Tue and Thu-Fri 8:30AM-
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`5:00PM.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Michael Hartley can be reached on (571) 272-0616. The fax phone number
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`for the organization where this application or proceeding is assigned is 571-273-8300.
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`Application/Control Number: 11/273,575
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`Page 10
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`Art Unit: 1618
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`Information regarding the status of an application may be obtained from the
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`Patent Application Information Retrieval
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`(PAIR) system.
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`Status
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`information for
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`published applications 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).
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`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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`/Jake M. Vu/
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`Examiner, Art Unit 1618
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`