UNITED STA IBS p A IBNT AND TRADEMARK OFFICE
`
`UNITED STA TES 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.
`
`121787,283
`
`05/25/2010
`
`Mary Jane Helenek
`
`30015730-0053
`
`4251
`
`26263
`7590
`SNR DENTON US LLP
`P.O. BOX 061080
`CHICAGO, IL 60606-1080
`
`03/23/2012
`
`EXAMINER
`
`LAU, JONATHAN S
`
`ART UNIT
`
`PAPER NUMBER
`
`1623
`
`MAILDATE
`
`DELIVERY MODE
`
`03/23/2012
`
`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. 1043, p. 1
`
`

`
`Office Action Summary
`
`Application No.
`
`Applicant(s)
`
`12/787,283
`
`Examiner
`
`HELENEK ET AL.
`
`Art Unit
`
`1623
`Jonathan S. Lau
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address -(cid:173)
`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 )IZ! Responsive to communication(s) filed on 25 Mav 2010.
`2a)0 This action is FINAL.
`2b)[8J This action is non-final.
`3)0 An election was made by the applicant in response to a restriction requirement set forth during the interview on
`__ ;the restriction requirement and election have been incorporated into this action.
`4)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
`
`5)[8J Claim(s) 1-20 is/are pending in the application.
`5a) Of the above claim(s) __ is/are withdrawn from consideration.
`6)0 Claim(s) __ is/are allowed.
`7)0 Claim(s) __ is/are rejected.
`8)0 Claim(s) __ is/are objected to.
`9)[8J Claim(s) 1-20 are subject to restriction and/or election requirement.
`
`Application Papers
`
`10)0 The specification is objected to by the Examiner.
`11 )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).
`12)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
`
`13)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 Office
`PTOL-326 (Rev. 03·11)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20120321
`
`Pharmacosmos, Exh. 1043, p. 2
`
`

`
`Application/Control Number: 12/787,283
`Art Unit: 1623
`
`Page 2
`
`DETAILED ACTION
`
`This Office Action details three Election of Species requirements.
`
`Election of Species
`
`This application contains claims directed to the following patentably distinct First
`
`species of disease, disorder or condition treated, Second species of iron carbohydrate
`
`complex, and Third species of route of administration. The species are independent or
`
`distinct because a different disease, disorder or condition defines a different patient
`
`population, symptoms and causes, the species of methods administer a different
`
`complex having different chemical components by different routes. In addition, these
`
`species are not obvious variants of each other based on the current record.
`
`Examples of First species of disease, disorder or condition treated are:
`
`1 a) iron deficiency anemia associated with blood chronic or acute blood loss
`
`disclosed in claim 6,
`
`1 b) iron deficiency anemia associated with idiopathic pulmonary siderosis
`
`disclosed in claim 6,
`
`1 c) anemia of the chronic disease rheumatoid arthritis disclosed in claim 6, and
`
`1 d) restless leg syndrome disclosed in claim 7.
`
`Examples of Second species of iron carbohydrate complex are:
`
`2a) iron hydrogenated dextran complex disclosed in claim 1,
`
`2b) iron carboxymaltose complex having the formula disclosed in (i) in claim 14,
`
`Pharmacosmos, Exh. 1043, p. 3
`
`

`
`Application/Control Number: 12/787,283
`Art Unit: 1623
`
`Page 3
`
`2c) iron carboxymaltose complex having the formula disclosed in (ii) in claim 14,
`
`and
`
`2d) iron polyglucose sorbitol carboxymethyl ether complex disclosed in claims 15
`
`and 16.
`
`Examples of Third species of route of administration are:
`
`3a) intravenous infusion disclosed in claim 19,
`
`3b) intramuscular injection disclosed in claim 19, and
`
`3c) bolus injection that is not intramuscular implicitly disclosed in claim 19.
`
`Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or
`
`a single grouping of patentably indistinct 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 or subgeneric to the first and third species, and claims 1-12, 14
`
`and 17-20 are generic or subgeneric to the second species.
`
`There is a search and/or examination burden for the patentably distinct species
`
`as set forth above because at least the following reason(s) apply:
`
`(c) the species require a different field of search (for example, employing different
`
`search queries for treating a specific patient population or by specific methods of
`
`administration).
`
`Applicant is advised that the reply to this requirement to be complete must
`
`include (i) an election of a species or a grouping of patentably indistinct species
`
`Pharmacosmos, Exh. 1043, p. 4
`
`

`
`Application/Control Number: 12/787,283
`Art Unit: 1623
`
`Page 4
`
`to be examined even though the requirement may be traversed (37 CFR 1.143) and
`
`(ii) identification of the claims encompassing the elected species or grouping of
`
`patentably indistinct 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 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 or grouping of patentably indistinct species.
`
`Should applicant traverse on the ground that the species, or groupings of
`
`patentably indistinct species from which election is required, are not patentably distinct,
`
`applicant should submit evidence or identify such evidence now of record showing them
`
`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. 103(a) of the other
`
`species.
`
`Pharmacosmos, Exh. 1043, p. 5
`
`

`
`Application/Control Number: 12/787,283
`Art Unit: 1623
`
`Page 5
`
`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.
`
`Due to the complexity of the species election requirements, no telephone
`
`communication was made. See MPEP 812.01.
`
`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).
`
`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.
`
`Pharmacosmos, Exh. 1043, p. 6
`
`

`
`Application/Control Number: 12/787,283
`Art Unit: 1623
`
`Page 6
`
`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. 1043, p. 7
`
`

`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Application No.: 12/787,283
`
`Examiner: Johnathan S. Lau
`
`Group Art Unit: 1623
`
`Confirmation No.: 4251
`
`Customer No.: 26263
`
`Applicant: Mary Jane Helenek
`
`Filed: May 25, 2010
`
`Docket No.: 30015730-0053
`
`Title: METHODS AND COMPOSITIONS
`FOR ADMINISTRATION OF IRON
`
`April 19, 2012
`
`FILED VIA EFS-WEB
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`RESPONSE TO ELECTION REQUIREMENTS
`
`Sir:
`
`In response to the Election Requirements of March 23, 2012, Applicants request
`
`the Office consider the following remarks.
`
`Page 1 of 4
`
`Pharmacosmos, Exh. 1043, p. 8
`
`

`
`Application No. 12/787,283
`Response dated April 19, 2012
`to Action dated March 23, 2012
`
`REMARKS
`
`Upon entry of this amendment, claims 1-20 are pending. No claims have been
`
`amended. No claims have been added. No claims have been withdrawn. No claims
`
`have been canceled.
`
`Election of Species
`
`The Office requires a series of species elections as follows:
`
`(i) species of disease, disorder or condition;
`
`(ii) species of iron carbohydrate complex; and
`
`(iii) species of route of administration.
`
`The Office acknowledges that all claims are generic to (i) and (iii) and at least
`
`claims 1-12 and 17-20 are generic to (ii).
`
`In response to the Office's restriction of species of disease, disorder or condition,
`
`Applicants elect to prosecute: iron deficiency anemia associated with chronic blood
`
`loss or acute blood loss, as recited in claim 6. At least claims 1-6 and 8-20 read on
`
`the elected species. By the Office's required species election, the Office acknowledges
`
`that each specie of disease, disorder or condition is independent, distinct, and a
`
`nonobvious variant over other species (MPEP 806.04; 37 CFR 1.146).
`
`In response to the Office's restriction of species of iron carbohydrate complex,
`
`Applicants elect to prosecute: iron polyisomaltose, as recited in claim 1. At least
`
`claims 1-12 and 17-20 read on the elected species. By the Office's required species
`
`election, the Office acknowledges that each specie of iron carbohydrate complex is
`
`independent, distinct, and a nonobvious variant over other species (MPEP 806.04; 37
`
`CFR1.146).
`
`In response to the Office's restriction of species of route of administration,
`
`Applicants elect to prosecute intravenous infusion, as recited in claim 19. All claims
`
`read on the elected species. By the Office's required species election, the Office
`
`Page 2 of 4
`
`23222550\ V-1
`
`Pharmacosmos, Exh. 1043, p. 9
`
`

`
`Application No. 12/787,283
`Response dated April 19, 2012
`to Action dated March 23, 2012
`
`acknowledges that each specie of route of administration is independent, distinct, and a
`
`nonobvious variant over other species (MPEP 806.04; 37 CFR 1.146).
`
`To the extent necessary to do so, it appears that claims 1-6 and 17-19 are
`
`generic to all of the elected species, and thus are designated for examination in
`
`connection therewith.
`
`In electing the above species, Applicants reserve the right to request
`REJOINDER, under MPEP § 821.04, and examination of non-elected species upon
`allowance of any claims generic to the non-elected species.
`
`Page 3 of 4
`
`23222550\ V-1
`
`Pharmacosmos, Exh. 1043, p. 10
`
`

`
`Application No. 12/787,283
`Response dated April 19, 2012
`to Action dated March 23, 2012
`
`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,
`
`By:
`
`/David R. Metzger/ (Reg. 32.919)
`
`SNR Denton US LLP
`P.O. Box 061080
`Wacker Drive Station, Willis Tower
`Chicago, IL 60606-1080
`Telephone: 312-876-8000
`Fax: 312/876-7934
`
`ATTORNEYS FOR APPLICANT
`
`Page 4 of 4
`
`23222550\ V-1
`
`Pharmacosmos, Exh. 1043, p. 11
`
`

`
`UNITED STA IBS p A IBNT AND TRADEMARK OFFICE
`
`UNITED STA TES 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.
`
`121787,283
`
`05/25/2010
`
`Mary Jane Helenek
`
`30015730-0053
`
`4251
`
`26263
`7590
`SNR DENTON US LLP
`P.O. BOX 061080
`CHICAGO, IL 60606-1080
`
`06/06/2012
`
`EXAMINER
`
`LAU, JONATHAN S
`
`ART UNIT
`
`PAPER NUMBER
`
`1623
`
`MAILDATE
`
`DELIVERY MODE
`
`06/06/2012
`
`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. 1043, p. 12
`
`

`
`Office Action Summary
`
`Application No.
`
`Applicant(s)
`
`12/787,283
`
`Examiner
`
`HELENEK ET AL.
`
`Art Unit
`
`1623
`Jonathan S. Lau
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address -(cid:173)
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE ;J. 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 )IZ! Responsive to communication(s) filed on 19 April 2012.
`2a)0 This action is FINAL.
`2b)[8J This action is non-final.
`3)0 An election was made by the applicant in response to a restriction requirement set forth during the interview on
`__ ;the restriction requirement and election have been incorporated into this action.
`4)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 G.D. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`5)[8J Claim(s) 1-20 is/are pending in the application.
`5a) Of the above claim(s) 7 and 13-16 is/are withdrawn from consideration.
`6)0 Claim(s) __ is/are allowed.
`7)[8J Claim(s) 1-6.8-12 and 17-20 is/are rejected.
`8)0 Claim(s) __ is/are objected to.
`9)0 Claim(s) __ are subject to restriction and/or election requirement.
`
`Application Papers
`
`10)0 The specification is objected to by the Examiner.
`11 )IZ! The drawing(s) filed on 25 Mav 2010. 6 Jul 2010 is/are: a)IZ! 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).
`12)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
`
`13)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) [8J Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PT0-948)
`3) [8J Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date 17 Jun 2010. 20 Jan 2012.
`
`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 Office
`PTOL-326 (Rev. 03-11)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20120601
`
`Pharmacosmos, Exh. 1043, p. 13
`
`

`
`Application/Control Number: 12/787,283
`Art Unit: 1623
`
`Page 2
`
`DETAILED ACTION
`
`This application is a domestic application, filed 25 May 201 O; and claims benefit
`
`as a CON of 11/620,986, filed 8 Jan 2007, issued as PAT 7,754,702, which claims
`
`benefit of provisional application 60/757, 119, filed 6 Jan 2006.
`
`Claims 1-20 are pending in the current application. Claims 7 and 13-16, drawn to
`
`non-elected species, are withdrawn. Claims 1-6, 8-12 and 17-20 are examined on the
`
`merits herein.
`
`Election/Restrictions
`
`Applicant's election of species of iron deficiency anemia associated with chronic
`
`blood loss or acute blood loss, iron polyisomaltose, and intravenous infusion, in the
`
`reply filed on 19 Apr 2012 is acknowledged.
`
`Claims 7 and 13-16 are withdrawn from further consideration pursuant to 37 CFR
`
`1.142(b) as being drawn to a nonelected species, there being no allowable generic or
`
`linking claim. Election of species was made in the reply filed on 19 Apr 2012. Upon
`
`finding of an allowable generic or linking claim, species will be rejoined.
`
`Claim Rejections - 35 USC § 112
`
`The following is a quotation of the first paragraph of 35 U.S.C. 112:
`
`The specification shall contain a written description of the invention, and of the manner and process of
`making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the
`
`Pharmacosmos, Exh. 1043, p. 14
`
`

`
`Application/Control Number: 12/787,283
`Art Unit: 1623
`
`Page 3
`
`art to which it pertains, or with which it is most nearly connected, to make and use the same and shall
`set forth the best mode contemplated by the inventor of carrying out his invention.
`
`Claims 2 and 3 are rejected under 35 U.S.C. 112, first paragraph, because the
`
`specification does not reasonably provide enablement for iron polyisomaltose complex
`
`having substantially non-immunogenic carbohydrate complex and substantially no cross
`
`reactivity with anti-dextran antibodies (instant claims 2 and 3). The specification does
`
`not enable any person skilled in the art to which it pertains, or with which it is most
`
`nearly connected, to use the invention commensurate in scope with these claims.
`
`The Applicant's attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988)
`
`at 1404 where the court set forth eight factors to consider when assessing if a
`
`disclosure would have required undue experimentation. Citing Ex parte Forman, 230
`
`USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
`
`(1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of
`
`those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the
`
`claims; (6) the amount of direction or guidance presented; (7) the presence or absence
`
`of working examples; and (8) the quantity of experimentation necessary.
`
`Nature of the invention: A method of treating a disease, disorder, or condition
`
`characterized by iron deficiency or dysfunctional iron metabolism comprising
`
`administering to a subject in need thereof an iron carbohydrate complex in a single
`
`dosage unit of at least about 0.6 grams of elemental iron wherein the iron carbohydrate
`
`complex is selected from the group consisting of an iron carboxymaltose complex, iron
`
`mannitol complex, iron polyisomaltose complex, iron polymaltose complex, iron
`
`gluconate complex, iron sorbitol complex and iron hydrogenated dextran complex
`
`Pharmacosmos, Exh. 1043, p. 15
`
`

`
`Application/Control Number: 12/787,283
`Art Unit: 1623
`
`Page 4
`
`having substantially non-immunogenic carbohydrate complex (instant claim 2) and
`
`substantially no cross reactivity with anti-dextran antibodies (instant claim 3).
`
`The state of the prior art: Cisar et al. (Journal of Experimental Medicine, 1975,
`
`142, p435-459, provided by Applicant in IDS mailed 17 Jun 2010) discloses that while
`
`dextrans are branched polymers, anti-dextran antibodies recognize both terminal and
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`non-terminal a(1-6) chains of dextran binding to a trisaccharide to hexasaccharide sized
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`site (page 436, paragraphs 2-3). Cisar et al. discloses an antibody that binds to dextran
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`binding with synthetic dextran that reacts as a completely linear molecule (paragraph
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`spanning bottom of page 436 and top of page 437), or polyisomaltose. Therefore one
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`of skill in the art would expect anti-dextran antibodies to cross react with polyisomaltose,
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`which is a linear a(1-6) chain of dextran.
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`The relative skill of those in the art: The relative skill of those in the art is high.
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`The predictability or unpredictability of the art: One of skill in the art would expect
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`anti-dextran antibodies to cross react with polyisomaltose, which is a linear a(1-6) chain
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`of dextran. The prior art predicts anti-dextran antibodies recognize both terminal and
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`non-terminal a(1-6) chains of dextran.
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`The Breadth of the claims: The scope of the claims encompasses iron
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`polyisomaltose complex having substantially non-immunogenic carbohydrate complex
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`and substantially no cross reactivity with anti-dextran antibodies (instant claims 2 and
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`3).
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`The amount of direction or guidance presented: The specification speaks
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`generally about certain characteristics of iron carbohydrate complexes that make them
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`Pharmacosmos, Exh. 1043, p. 16
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`

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`Application/Control Number: 12/787,283
`Art Unit: 1623
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`Page 5
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`amenable to administration at doses high than contemplated by current administration
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`protocols, such as a non-immunogenic carbohydrate component and no cross reactivity
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`with anti-dextran antibodies at page 17, paragraph 60. The specification provides that it
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`is within the skill in the art to test for said characteristics. The specification discloses the
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`preferred embodiment of iron carboxy-maltose complex at page 18, paragraph 62.
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`However the specification does not provide specific guidance as to what structural
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`features other than those necessarily present in the disclosed embodiment give rise to
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`said characteristics.
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`The presence or absence of working examples: No working example is provided
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`of an iron polyisomaltose complex having substantially non-immunogenic carbohydrate
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`complex and substantially no cross reactivity with anti-dextran antibodies.
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`The quantity of experimentation necessary: In order to practice the invention
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`with the full range of all possible methods of administration beyond those known in the
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`art, (such as those causing significant adverse reaction or cross reactivity with anti-
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`dextran antibodies) one skilled in the art would undertake a novel and extensive
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`research program into what specific structural features are recognized by each anti-
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`dextran antibody and how to remove such structural recognition from iron
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`polyisomaltose complex. Because this research would have to be exhaustive, and
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`because it would involve such a wide and unpredictable scope of patient populations
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`having anti-dextran antibodies, it would constitute an undue and unpredictable
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`experimental burden.
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`Genentech, 108 F.3d at 1366, sates that, "a patent is not a hunting license. It is not a reward for
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`search, but compensation for its successful conclusion." And "patent protection is granted in
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`Pharmacosmos, Exh. 1043, p. 17
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`

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`Application/Control Number: 12/787,283
`Art Unit: 1623
`
`Page 6
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`return for an enabling disclosure of an invention, not for vague intimations of general ideas that
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`may or may not be workable."
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`Therefore, in view of the Wands factors, as discussed above, particularly the
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`breadth of the claims, Applicants fail to provide information sufficient to practice the
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`claimed invention for the full scope of the claim wherein iron polyisomaltose complex
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`has a substantially non-immunogenic carbohydrate complex and substantially no cross
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`reactivity with anti-dextran antibodies.
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`Claim Rejections - 35 USC § 103
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`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
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`obviousness rejections set forth in this Office action:
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`(a) A patent may not be obtained though the invention is not identically disclosed or described as set
`forth in section 102 of this title, if the differences between the subject matter sought to be patented and
`the prior art are such that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the invention was made.
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`This application currently names joint inventors. In considering patentability of
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`the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of
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`the various claims was commonly owned at the time any inventions covered therein
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`were made absent any evidence to the contrary. Applicant is advised of the obligation
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`under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was
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`not commonly owned at the time a later invention was made in order for the examiner to
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`consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g)
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`prior art under 35 U.S.C. 103(a).
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`Pharmacosmos, Exh. 1043, p. 18
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`

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`Application/Control Number: 12/787,283
`Art Unit: 1623
`
`Page 7
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`Claims 1, 4-6, 8-12 and 18-20 are rejected under 35 U.S.C. 103(a) as being
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`unpatentable over Hamstra et al. (JAMA, 1980, 243(17), p1726-1731, cited in PT0-892)
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`in view of Muller et al. (US Patent 3, 100,202, issued 6 Aug 1963, cited in PT0-892).
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`Hamstra et al. teaches intravenous injection of iron dextran, usually 250 to 500
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`mg at less than 100 mg/min (page 1726, abstract), implying an intravenous infusion.
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`Hamstra et al. teaches parenteral iron therapy in the treatment of iron deficiency anemia
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`(page 1726, left column, paragraph 1 ), and teaches the patient population selected from
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`patients having chronic and acute blood loss (page 1726, right column, paragraph 1 ).
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`Hamstra et al. teaches injections wherein the iron content per injection includes 501-999
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`mg, 1,000 mg, and> 1,000 mg (page 1726, Table 2 at bottom of right column). Hamstra
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`et al. teaches the total amount of iron given ranges to > 15,000 mg (page 1723, Table 3
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`at top of left column). Hamstra et al. teaches the intravenous injection diluted in 250 ml
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`5% dextrose in water or in normal saline and teaches optimizing the rate at which the
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`injection is administered, such as 100 to 400 ml/hr or the undiluted drug at 1 to 5
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`ml/min (page 1727, left column, paragraph 1 ). Hamstra et al. teaches it is routine for
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`one of ordinary skill in the art to perform treatment including subsequent iron dextran
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`therapy as needed (page 1728, table 6 at top of page).
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`Hamstra et al. teaches does not specifically teach the iron carbohydrate complex
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`is an iron polyisomaltose complex (instant claim 1 ). Hamstra et al. teaches does not
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`specifically teach the single dosage unit of elemental iron is at least about 1.5 grams
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`(instant claim 9) or 2.0 grams (instant claim 10).
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`Pharmacosmos, Exh. 1043, p. 19
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`

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`Application/Control Number: 12/787,283
`Art Unit: 1623
`
`Page 8
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`Muller et al. teaches an iron-polyisomaltose complex which is parenterally
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`injectible (column 1, lines 10-15). Muller et al. teaches a known treatment for iron
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`deficiency anemia is the iron dextran complex (column 1, lines 45-50). Muller et al.
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`teaches the improvement of the iron-polyisomaltose complex is more heterogeneous in
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`particle size, surprisingly lower toxicity, better pharmacological properties, and higher
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`therapeutic efficacy than the iron dextran complexes hitherto known (column 2, lines 25-
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`30).
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`It would have been obvious to one of ordinary skill in the art at the time of the
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`invention to combine Hamstra et al. in view of Muller et al. Both Hamstra et al. and
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`Muller et al. are drawn to iron carbohydrate complexes for treatment of iron deficiency
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`anemia. One of ordinary skill in the art at the time of the invention would have been
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`motivated to combine Hamstra et al. in view of Muller et al. with a reasonable
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`expectation of success because Hamstra et al. teaches administration of iron dextran
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`complexes to treat iron deficiency anemia and Muller et al. teaches improvements of the
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`iron-polyisomaltose complex compared to iron dextran complexes. It would have been
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`routine for one of ordinary skill in the art to optimize the iron dosage per injection and
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`the rate of administration because Hamstra et al. teaches intravenous injection of iron
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`dextran, usually 250 to 500 mg at less than 100 mg/min but also teaches embodiments
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`wherein the iron content per injection includes 501-999 mg, 1,000 mg, and> 1,000 mg,
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`to a total amount of> 15,000 mg iron given, as well as suggesting optimizing the rate at
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`which the injection is