UNITED STA 1ES p A 1ENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`111620,986
`
`01108/2007
`
`Mary Jane He1enek
`
`30015730-0043
`
`1325
`
`26263
`7590
`10/23/2008
`SONNENSCHEIN NATH & ROSENTHAL LLP
`P.O. BOX 061080
`WACKER DRIVE STATION, SEARS TOWER
`CHICAGO, IL 60606-1080
`
`EXAMINER
`
`LAU, JONATHAN S
`
`ART UNIT
`
`PAPER NUMBER
`
`1623
`
`MAIL DATE
`
`DELIVERY MODE
`
`10/23/2008
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL-90A (Rev. 04/07)
`
`Pharmacosmos, Exh. 1040, p. 1
`
`

`

`Office Action Summary
`
`Application No.
`
`Applicant(s)
`
`11/620,986
`
`Examiner
`
`HELENEK ET AL.
`
`Art Unit
`
`1623
`Jonathan S. Lau
`-- 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 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).
`
`Status
`
`1)0 Responsive to communication(s) filed on __ .
`2a)0 This action is FINAL.
`2b)~ 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 parte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`4)~ Claim(s) 1-60 is/are pending in the application.
`4a) Of the above claim(s) __ is/are withdrawn from consideration.
`5)0 Claim(s) __ is/are allowed.
`6)0 Claim(s) __ is/are rejected.
`7)0 Claim(s) __ is/are objected to.
`8)~ Claim(s) 1-60 are subject to restriction and/or election requirement.
`
`Application Papers
`
`9)0 The specification is objected to by the Examiner.
`10)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).
`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)
`1) 0 Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PT0-948)
`3) 0 Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date __ .
`
`4) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`5) 0 Notice of Informal Patent Application
`6) 0 Other: __ .
`
`U.S. Patent and Trademark Off1ce
`PTOL-326 (Rev. 08-06)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20081017
`
`Pharmacosmos, Exh. 1040, p. 2
`
`

`

`Application/Control Number: 11/620,986
`Art Unit: 1623
`
`Page 2
`
`DETAILED ACTION
`
`Election of Species Requirement
`
`This application contains claims directed to the following patentably distinct First
`
`species of disease, disorder or condition; Second species of iron carbohydrate complex
`
`and Third species of route of administration. The species are independent or distinct
`
`because claims to the different species recite the mutually exclusive characteristics of
`
`such species. In addition, these species are not obvious variants of each other based
`
`on the current record.
`
`Examples of a First specie of disease, disorder or condition are:
`
`1 a) chronic blood loss, disclosed in claim 4,
`
`1 b) surgery or acute trauma, disclosed in claim 4,
`
`1 c) inflammatory bowel disease, disclosed in claim 6, and
`
`1 d) restless leg syndrome, disclosed in claim 9.
`
`Examples of a Second specie of iron carbohydrate complex are:
`
`2a) iron mannitol complex, disclosed in claim 25,
`
`2b) iron polymaltose complex, disclosed in claim 25,
`
`2c) iron carboxymaltose complex, disclosed in claims 25 and 26, and
`
`2d) iron polyglucose sorbitol carboxymethyl ether complex, disclosed in claim 31.
`
`Examples of a Third specie of route of administration are:
`
`Pharmacosmos, Exh. 1040, p. 3
`
`

`

`Application/Control Number: 11/620,986
`Art Unit: 1623
`
`3a) parenterally, disclosed in claim 44,
`
`3b) intravenously infused, disclosed in claim 46, and
`
`3c) intravenously injected as a bolus, disclosed in claim 50.
`
`Page 3
`
`Applicant is required under 35 U.S.C. 121 to elect a single disclosed species for
`
`prosecution on the merits to which the claims shall be restricted if no generic claim is
`
`finally held to be allowable. Currently, all claims are generic to the First specie of
`
`disease, disorder or condition, claims 1-25 and 33-57 are generic to the Second specie
`
`of iron carbohydrate complex and claims 1-43 and 57-60 are generic to the Third specie
`
`of route of administration.
`
`There is an examination and search burden for these patentably distinct species
`
`due to their mutually exclusive characteristics. The species require a different field of
`
`search (e.g., searching different classes/subclasses or electronic resources, or
`
`employing different search queries); and/or the prior art applicable to one species would
`
`not likely be applicable to another species; and/or the species are likely to raise different
`
`non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
`
`Applicant is advised that the reply to this requirement to be complete must
`
`include (i) an election of a species to be examined even though the requirement
`
`may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing
`
`the elected species, including any claims subsequently added. An argument that a
`
`claim is allowable or that all claims are generic is considered nonresponsive unless
`
`accompanied by an election.
`
`Pharmacosmos, Exh. 1040, p. 4
`
`

`

`Application/Control Number: 11/620,986
`Art Unit: 1623
`
`Page 4
`
`The election of the species may be made with or without traverse. To preserve a
`
`right to petition, the election must be made with traverse. If the reply does not distinctly
`
`and specifically point out supposed errors in the election of species requirement, the
`
`election shall be treated as an election without traverse. Traversal must be presented at
`
`the time of election in order to be considered timely. Failure to timely traverse the
`
`requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are
`
`added after the election, applicant must indicate which of these claims are readable on
`
`the elected species.
`
`Should applicant traverse on the ground that the species are not patentably
`
`distinct, applicant should submit evidence or identify such evidence now of record
`
`showing the species to be obvious variants or clearly admit on the record that this is the
`
`case. In either instance, if the examiner finds one of the species unpatentable over the
`
`prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 1 03(a)
`
`of the other species.
`
`Upon the allowance of a generic claim, applicant will be entitled to consideration
`
`of claims to additional species which depend from or otherwise require all the limitations
`
`of an allowable generic claim as provided by 37 CFR 1 .141.
`
`Applicant is reminded that upon the cancellation of claims to a non-elected
`
`invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one
`
`or more of the currently named inventors is no longer an inventor of at least one claim
`
`remaining in the application. Any amendment of inventorship must be accompanied by
`
`a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
`
`Pharmacosmos, Exh. 1040, p. 5
`
`

`

`Application/Control Number: 11/620,986
`Art Unit: 1623
`
`Page 5
`
`Conclusion
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Jonathan S. Lau whose telephone number is 571-270-
`
`3531. The examiner can normally be reached on Monday- Thursday, 9 am - 4 pm
`
`EST.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Shaojia Anna Jiang can be reached on 571-272-0627. The fax phone
`
`number for the organization where this application or proceeding is assigned is 571-
`
`273-8300.
`
`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`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). If you would like assistance from a
`
`USPTO Customer Service Representative or access to the automated information
`
`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`Jonathan Lau
`Patent Examiner
`Art Unit 1623
`
`/Shaojia Anna Jiang, Ph.D./
`Supervisory Patent Examiner
`Art Unit 1623
`
`Pharmacosmos, Exh. 1040, p. 6
`
`

`

`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Application No.: 11/620,986
`
`Examiner: LAU, Jonathan S
`
`Group Art Unit: 1623
`
`Confirmation No.: 1325
`
`Customer No.: 26263
`
`Applicant: HELENEK, MARY JANE
`
`Filed: January 1, 2007
`
`Docket No.: 30015730-0043
`
`Title: METHODS AND COMPOSITIONS
`FOR ADMINISTRATION OF IRON
`
`November 21, 2008
`
`FILED ELECTRONICALLY FILED VIA EFS-WEB
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`RESPONSE TO RESTRICTION AND ELECTION REQUIREMENTS
`
`Sir:
`
`In response to the Restriction and Election Requirments of October 23, 2008,
`
`Applicants request the Office consider the following remarks.
`
`Page 1 of 3
`
`Pharmacosmos, Exh. 1040, p. 7
`
`

`

`Application No. 11/620,986
`Response dated November 21, 2008
`Reply to Office Action dated October 23, 2008
`
`Election of Invention
`
`Species Restriction
`
`In the Action of October 23, 2008, the Office required under 35 U.S.C. 121 an
`
`election of a first species of disease, disorder, or condition; a second species of iron
`
`carbohydrate complex; and a third species of route of adminstration. The Office
`
`acknowledges that at all claims are generic to the first specie of disease, disorder, or
`
`condition; claims 1-25 and 35-57 are generic to the second specie of iron carbohydrate
`
`complex; and claims 1-43 and 57-60 are generic to the third specie of route of
`
`administration.
`
`Election of Species
`
`For the first species, Applicants elect iron deficiency anemia. Claims readable on
`
`the elected species of iron deficiency anemia include claims 1-4 and 10-60.
`
`For the second species, Applicants elect iron carboxymaltose complex. Claims
`
`readable on the elected species of iron carboxymaltose complex include claims 1-30
`
`and 33-60.
`
`The Office requires election of a third species from: parenteral, intravenosuly
`
`infused, and intravenously injected. For the third species, Applicants elect parenteral
`
`administration. Claims readable on the elected species of parenteral administration
`
`include claims 1-60. Applicants note that parenteral administration is defined by the
`
`Specification to include both intravenous and intramuscular injection (see ,-r0036).
`
`Intravenous injection is defined to include both bolus and infusion (see ,-r0036). As
`
`such, the Office appears to have misunderstood the genus/species organization. If so
`
`required, Applicants would elect intravenous injection as a sub-species (readable on
`
`claims 1-60), and intravenous infusion as a sub-sub-species (readable on claims 1-49
`
`anf 54-60). Applicants request clarification from the Office regarding the third species
`
`election requirement of record.
`
`Page 2 of 3
`
`23222550\V -1
`
`Pharmacosmos, Exh. 1040, p. 8
`
`

`

`Application No. 11/620,986
`Response dated November 21, 2008
`Reply to Office Action dated October 23, 2008
`
`Rejoinder
`
`In electing the above species, Applicants reserve the right to request
`REJOINDER, under MPEP § 821.04, and examination of the non-elected species upon
`
`allowance of any claims generic to the non-elected species.
`
`Conclusion
`
`Applicants believe that the claims as presented represent allowable subject
`
`matter. If the Examiner desires, Applicants welcome a telephone interview to expedite
`
`prosecution. As always, the Examiner is free to call the undersigned at the number
`
`below. Applicants believe there are no additional fees due at this time. However, the
`
`Commissioner is hereby authorized to charge any applicable fees to Deposit Account
`
`No. 19-3140.
`
`Respectfully submitted,
`
`SONNENSCHEIN NATH & ROSENTHAL LLP
`
`By:
`
`/G. Harley Blosser/ (Reg. 33,650}
`G. Harley Blosser
`SONNENSCHEIN NATH & ROSENTHAL LLP
`P.O. Box 061080
`Wacker Drive Station, Sears Tower
`Chicago, IL 60606-1080
`Telephone: 314.259.5806
`Fax: 312.876.7934
`
`Page 3 of 3
`
`23222550\V -1
`
`Pharmacosmos, Exh. 1040, p. 9
`
`

`

`! UNITED STATES pATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`Unitl'd StatE's Pat('nt and Trademark Offic('
`Address: COMMISSIONER FOR P A lENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`111620,986
`
`01/08/2007
`
`Mary Jane Helenek
`
`30015730-0043
`
`1325
`
`02/23/2009
`7590
`26263
`SONNENSCHEIN NATII & ROSENTHAL LLP
`P.O. BOX 061080
`WACKER DRIVE STATION, SEARS TOWER
`CHICAGO, IL 60606-1080
`
`EXAMINER
`
`LAU, JONATHAN S
`
`ART UNIT
`
`PAPER NUMBER
`
`1623
`
`MAIL DATE
`
`DELIVERY MODE
`
`02/23/2009
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL-90A (Rev. 04/07)
`
`Pharmacosmos, Exh. 1040, p. 10
`
`

`

`Office Action Summary
`
`Application No.
`
`Applicant(s)
`
`11/620.986
`
`Examiner
`
`HELENEK ET AL.
`
`Art Unit
`
`1623
`Jonathan S. Lau
`-- 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 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).
`
`Status
`
`1 )1:2:1 Responsive to communication(s) filed on 21 November 2008.
`2a)0 This action is FINAL.
`2b)[2J 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 parte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`4)1:2:1 Claim(s) 1-60 is/are pending in the application.
`4a) Of the above claim(s) __ is/are withdrawn from consideration.
`5)0 Claim(s) __ is/are allowed.
`6)0 Claim(s) __ is/are rejected.
`7)0 Claim(s) __ is/are objected to.
`8)1:2:1 Claim(s) 1-60 are subject to restriction and/or election requirement.
`
`Application Papers
`
`9)0 The specification is objected to by the Examiner.
`1 0)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).
`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 )0 All b )0 Some * c )0 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)
`1) 0 Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PT0-948)
`3) 0 Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date __ .
`
`4) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`5) 0 Notice of Informal Patent Application
`6) 0 Other: __ .
`
`U.S. Patent and Trademark Off1ce
`PTOL-326 (Rev. 08-06)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20090211
`
`Pharmacosmos, Exh. 1040, p. 11
`
`

`

`Application/Control Number: 11/620,986
`Art Unit: 1623
`
`Page 2
`
`DETAILED ACTION
`
`This Office Action is Responsive to Applicant's Amendment and Remarks, mailed
`
`21 Nov 2008.
`
`Response to Amendment
`
`The reply filed on 21 Nov 2008 is not fully responsive to the prior Office Action
`
`because of the following omission(s) or matter(s): Applicant's election of First species of
`
`"iron deficiency anemia" is deemed to be the non-responsive election of a subgenus
`
`encompassing multiple species. See 37 CFR 1 .111. For example, the First species of
`
`iron deficiency anemia associated with chronic blood loss, iron deficiency anemia
`
`associated with parasitic infections and anemia of the chronic disease inflammatory
`
`bowel disease each possess a distinct etiology, associated symptoms and patient
`
`population, and are not obvious variants of each other based on the current record.
`
`However, in view of the election of a subgenus deemed non-responsive and confusion
`
`regarding the Third species of route of administration, the previous Office Action, mailed
`
`23 Oct 2008, is withdrawn and a new Election of Species Requirement is detailed
`
`below.
`
`Withdrawal of Previous Office Action
`
`Responsive to Applicant's Remarks, filed 21 Nov 2008, the previous Office
`
`Action, mailed 23 Oct 2008, is withdrawn in order to clarify the Election of Species
`
`Pharmacosmos, Exh. 1040, p. 12
`
`

`

`Application/Control Number: 11/620,986
`Art Unit: 1623
`
`Page 3
`
`requirement and more clearly indicate and explain what constitutes a non-responsive
`
`election of a subgenus.
`
`Election of Species Requirement
`
`This application contains claims directed to the following patentably distinct First
`
`species of disease, disorder or condition; Second species of iron carbohydrate complex
`
`and Third species of route of administration. The species are independent or distinct
`
`because claims to the different species recite the mutually exclusive characteristics of
`
`such species. In addition, these species are not obvious variants of each other based
`
`on the current record.
`
`Examples of a First specie of disease, disorder or condition are:
`
`1 a) iron deficiency anemia associated with chronic blood loss, disclosed in claim
`
`4,
`
`1 b) iron deficiency anemia associated with surgery or acute trauma, disclosed in
`
`claim 4,
`
`1 c) iron deficiency anemia associated with parasitic infections, disclosed in claim
`
`4,
`
`1 d) anemia of the chronic disease inflammatory bowel disease, disclosed in
`
`claim 6,
`
`1 e) anemia of the chronic disease rheumatoid arthritis, disclosed in claim 6, and
`
`1 e) restless leg syndrome, disclosed in claim 9.
`
`Pharmacosmos, Exh. 1040, p. 13
`
`

`

`Application/Control Number: 11/620,986
`Art Unit: 1623
`
`Page 4
`
`Examples of a Second specie of iron carbohydrate complex are:
`
`2a) iron mannitol complex, disclosed in claim 25,
`
`2b) iron polymaltose complex, disclosed in claim 25,
`
`2c) iron carboxymaltose complex, disclosed in claims 25 and 26, and
`
`2d) iron polyglucose sorbitol carboxymethyl ether complex, disclosed in claim 31.
`
`Examples of a Third specie of route of administration are:
`
`3a) intravenously infused, disclosed in claim 46,
`
`3b) intravenously injected as a bolus, disclosed in claim 50, and
`
`3c) intramuscularly, disclosed in claim 54.
`
`Applicant is required under 35 U.S.C. 121 to elect a single disclosed species for
`
`prosecution on the merits to which the claims shall be restricted if no generic claim is
`
`finally held to be allowable. Applicant is cautioned that election of a subgenus, such as
`
`iron deficiency anemia or anemia of a chronic disease, will be considered non-
`
`responsive. Currently, all claims are generic to the First specie of disease, disorder or
`
`condition, claims 1-25 and 33-57 are generic to the Second specie of iron carbohydrate
`
`complex and claims 1-43 and 57-60 are generic to the Third specie of route of
`
`administration.
`
`There is an examination and search burden for these patentably distinct species
`
`due to their mutually exclusive characteristics. For example, iron deficiency anemia
`
`associated with chronic blood loss, iron deficiency anemia associated with parasitic
`
`Pharmacosmos, Exh. 1040, p. 14
`
`

`

`Application/Control Number: 11/620,986
`Art Unit: 1623
`
`Page 5
`
`infections and anemia of the chronic disease inflammatory bowel disease each possess
`
`a distinct etiology, associated symptoms and patient population, and are not obvious
`
`variants of each other based on the current record. The species require a different field
`
`of search (e.g., employing different search queries for methods of treating different
`
`patient populations); and/or the prior art applicable to one species would not likely be
`
`applicable to another species; and/or the species are likely to raise different non-prior
`
`art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
`
`Applicant is advised that the reply to this requirement to be complete must
`
`include (i) an election of a species to be examined even though the requirement
`
`may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing
`
`the elected species, including any claims subsequently added. An argument that a
`
`claim is allowable or that all claims are generic is considered nonresponsive unless
`
`accompanied by an election.
`
`The election of the species may be made with or without traverse. To preserve a
`
`right to petition, the election must be made with traverse. If the reply does not distinctly
`
`and specifically point out supposed errors in the election of species requirement, the
`
`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. If claims are
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`added after the election, applicant must indicate which of these claims are readable on
`
`the elected species.
`
`Pharmacosmos, Exh. 1040, p. 15
`
`

`

`Application/Control Number: 11/620,986
`Art Unit: 1623
`
`Page 6
`
`Should applicant traverse on the ground that the species are not patentably
`
`distinct, applicant should submit evidence or identify such evidence now of record
`
`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. 1 03(a)
`
`of the other species.
`
`Upon the allowance of a generic claim, applicant will be entitled to consideration
`
`of claims to additional species which depend from or otherwise require all the limitations
`
`of an allowable generic claim as provided by 37 CFR 1 .141.
`
`Applicant 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
`
`remaining in the application. Any amendment of inventorship must be accompanied by
`
`a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
`
`Conclusion
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Jonathan S. Lau whose telephone number is 571-270-
`
`3531. The examiner can normally be reached on Monday- Thursday, 9 am - 4 pm
`
`EST.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Shaojia Anna Jiang can be reached on 571-272-0627. The fax phone
`
`Pharmacosmos, Exh. 1040, p. 16
`
`

`

`Application/Control Number: 11/620,986
`Art Unit: 1623
`
`Page 7
`
`number for the organization where this application or proceeding is assigned is 571-
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`273-8300.
`
`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`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). If you would like assistance from a
`
`USPTO Customer Service Representative or access to the automated information
`
`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`Jonathan Lau
`Patent Examiner
`Art Unit 1623
`
`/Shaojia Anna Jiang/
`Supervisory Patent Examiner
`Art Unit 1623
`
`Pharmacosmos, Exh. 1040, p. 17
`
`

`

`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Application No.: 11/620,986
`
`Examiner: LAU, Jonathan S
`
`Group Art Unit: 1623
`
`Confirmation No.: 1325
`
`Customer No.: 26263
`
`Applicant: HELENEK, MARY JANE
`
`Filed: January 1, 2007
`
`Docket No.: 30015730-0043
`
`Title: METHODS AND COMPOSITIONS
`FOR ADMINISTRATION OF IRON
`
`March 3, 2009
`
`FILED ELECTRONICALLY FILED VIA EFS-WEB
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`RESPONSE TO RESTRICTION AND ELECTION REQUIREMENTS
`
`Sir:
`
`In response to the Restriction and Election Requirments of February 23, 2009,
`
`Applicants request the Office consider the following remarks.
`
`Page 1 of 3
`
`Pharmacosmos, Exh. 1040, p. 18
`
`

`

`Application No. 11/620,986
`Response dated March 3, 2009
`Reply to Office Action dated February 23, 2009
`
`REMARKS
`
`Applicants acknowledge withdrawal of the Action of October 23, 2008 and the
`
`entry of the present Action, which the Office provides to clarify the Election of Species
`
`requirement as requested by Applicant in the prior Response.
`
`Election of Species
`
`In the Action of February 23, 2009, the Office required under 35 U.S.C. 121 an
`
`election of a first species of disease, disorder, or condition; a second species of iron
`
`carbohydrate complex; and a third species of route of administration. The Office
`
`acknowledges that at all claims are generic to the first specie of disease, disorder, or
`
`condition; claims 1-25 and 35-57 are generic to the second specie of iron carbohydrate
`
`complex; and claims 1-43 and 57-60 are generic to the third specie of route of
`
`administration.
`
`Election of Species
`
`For the first species, Applicants elect iron deficiency anemia associated with
`
`chronic blood loss. Claims readable on the elected species of iron deficiency anemia
`
`include claims 1-4 and 1 0-60.
`
`For the second species, Applicants elect iron carboxymaltose complex. Claims
`
`readable on the elected species of iron carboxymaltose complex include claims 1-30
`
`and 33-60.
`
`For the third species, Applicants elect intravenous infusion. Claims readable on
`
`the elected species of intravenous infusion include claims 1-49 and 54-60.
`
`Rejoinder
`
`In electing the above species, Applicants reserve the right to request
`REJOINDER, under MPEP § 821.04, and examination of the non-elected species upon
`
`allowance of any claims generic to the non-elected species.
`
`Page 2 of 3
`
`23222550\V -1
`
`Pharmacosmos, Exh. 1040, p. 19
`
`

`

`Application No. 11/620,986
`Response dated March 3, 2009
`Reply to Office Action dated February 23, 2009
`
`Conclusion
`
`Applicants believe that the claims as presented represent allowable subject
`
`matter. If the Examiner desires, Applicants welcome a telephone interview to expedite
`
`prosecution. As always, the Examiner is free to call the undersigned at the number
`
`below. Applicants believe there are no additional fees due at this time. However, the
`
`Commissioner is hereby authorized to charge any applicable fees to Deposit Account
`
`No. 19-3140.
`
`Respectfully submitted,
`
`SONNENSCHEIN NATH & ROSENTHAL LLP
`
`By:
`
`/G. Harley Blosser/ (Reg. 33,650}
`G. Harley Blosser
`SONNENSCHEIN NATH & ROSENTHAL LLP
`P.O. Box 061080
`Wacker Drive Station, Sears Tower
`Chicago, IL 60606-1080
`Telephone: 314.259.5806
`Fax: 312.876.7934
`
`Page 3 of 3
`
`23222550\V -1
`
`Pharmacosmos, Exh. 1040, p. 20
`
`

`

`UNITED STA 1ES p A 1ENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`111620,986
`
`01108/2007
`
`Mary Jane He1enek
`
`30015730-0043
`
`1325
`
`26263
`7590
`05/29/2009
`SONNENSCHEIN NATH & ROSENTHAL LLP
`P.O. BOX 061080
`WACKER DRIVE STATION, SEARS TOWER
`CHICAGO, IL 60606-1080
`
`EXAMINER
`
`LAU, JONATHAN S
`
`ART UNIT
`
`PAPER NUMBER
`
`1623
`
`MAIL DATE
`
`DELIVERY MODE
`
`05/29/2009
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL-90A (Rev. 04/07)
`
`Pharmacosmos, Exh. 1040, p. 21
`
`

`

`Office Action Summary
`
`Application No.
`
`Applicant(s)
`
`11/620,986
`
`Examiner
`
`HELENEK ET AL.
`
`Art Unit
`
`1623
`Jonathan S. Lau
`-- 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 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