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.
`
`141100,717
`
`12/09/2013
`
`Mary Jane Helenek
`
`30015730-0065
`
`2813
`
`26263
`7590
`DENTONS US LLP
`P.O. BOX 061080
`CHICAGO, IL 60606-1080
`
`02/07/2014
`
`EXAMINER
`
`LAU, JONATHAN S
`
`ART UNIT
`
`PAPER NUMBER
`
`1673
`
`MAILDATE
`
`DELIVERY MODE
`
`02/07/2014
`
`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. 1042, p. 1
`
`

`
`Application No.
`14/100,717
`
`Applicant(s)
`HELENEK ET AL.
`
`Office Action Summary
`
`AIA (First Inventor to File)
`Status
`No
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address -(cid:173)
`Period for Reply
`
`Examiner
`Jonathan S. Lau
`
`Art Unit
`1673
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE ;J. MONTHS 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 )~ Responsive to communication(s) filed on 9 Dec 2013.
`0 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on __ .
`2a)0 This action is FINAL.
`2b)~ 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)~ 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)~ Claim(s) 1-20 is/are rejected.
`8)0 Claim(s) __ is/are objected to.
`9)0 Claim(s) __ are subject to restriction and/or election requirement.
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`http:ilwww.uspto.gov/patents/init events/pph/index.jsp or send an inquiry to PPHfeedback(wuspto.aov.
`
`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).
`
`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).
`Certified copies:
`a)O All b)O Some** c)O None of the:
`Certified copies of the priority documents have been received.
`1.0
`Certified copies of the priority documents have been received in Application No. __ .
`2.0
`Copies of the certified copies of the priority documents have been received in this National Stage
`3.0
`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) ~ Notice of References Cited (PT0-892)
`2) 0 Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date __ .
`
`3) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`4) 0 Other: __ .
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20140204
`
`Pharmacosmos, Exh. 1042, p. 2
`
`

`
`Application/Control Number: 14/100, 717
`Art Unit: 1673
`
`Page 2
`
`DETAILED ACTION
`
`The present application is being examined under the pre-AIA first to invent
`
`provisions.
`
`This application is made special as a Track I application.
`
`This application is a domestic application, filed 9 Dec 2013; and claims benefit as
`
`a CON of 13/847,254, filed 19 Mar 2013; which claims benefit as a CON of 12/787,283,
`
`issued as Patent 8,431,549, filed 25 May 201 O; which claims benefit as a CON of
`
`11/620,986, issued as Patent 7,754,702, filed 8 Jan 2007; which claims benefit of
`
`provisional application 60/757, 119, filed 6 Jan 2006.
`
`Claims 1-20 are pending in the current application and are examined on the
`
`merits herein.
`
`Claim Rejections - 35 USC § 102
`
`The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C.
`
`102 that form the basis for the rejections under this section made in this Office action:
`
`A person shall be entitled to a patent unless -
`
`(b) the invention was patented or described in a printed publication in this or a foreign country
`or in public use or on sale in this country, more than one year prior to the date of application
`for patent in the United States.
`
`Claims 1, 3-5, 8, 13, 14 and 18 are rejected under pre-AIA 35 U.S.C. 102(b) as
`
`being anticipated by Geisser et al. (WI PO Publication WO 2004/037865 A 1, published 6
`
`Pharmacosmos, Exh. 1042, p. 3
`
`

`
`Application/Control Number: 14/100, 717
`Art Unit: 1673
`
`Page 3
`
`May 2004, cited in PT0-892, English language equivalent US Patent 7,612, 109
`
`provided, cited in PT0-892). As WO 2004/037865 A 1 is not in English, US Patent
`
`7,612, 109 is provided as an English language equivalent and is cited as Geisser et al.
`
`hereafter.
`
`Geisser et al. discloses an iron carbohydrate complex of iron and the oxidation
`
`product of maltodextrins as a medicament for treatment of iron deficiency conditions
`
`(abstract). Geisser et al. discloses the iron carbohydrate complex for treatment of iron
`
`deficiency anemia and especially useful for parenteral application (column 1, lines 15-
`
`20), meeting limitations of instant claims 4, 5 and 18. Geisser et al. discloses the
`
`complexes shall have reduced toxicity and shall avoid dangerous anaphylactic shocks
`
`which can be induced by dextran (column 1, lines 35-40), meeting limitations of instant
`
`claim 3. Geisser et al. discloses in the complexes theoretically it is assumed that the
`
`oxidation occurs mainly at the terminal aldehyde group (acetal or semiacetal group
`
`respectively) of the maltodextrin molecules (column 2, lines 25-30), implying the iron
`
`carbohydrate complex is an iron carboxymaltose complex, meeting limitations of instant
`
`claim 13. Geisser et al. discloses the complexes are prepared from an iron (Ill) salt and
`
`a strong base such as a potassium, calcium or magnesium hydroxide (column 3, lines
`
`1-15), implying the iron carbohydrate complex is a polynuclear iron (111)-hydroxide
`
`carboxymaltose complex and implicitly meeting limitations of instant claim 14. Geisser
`
`et al. discloses the advantage that the LD50 lies at over 2000 mg Fe/kg and it is possible
`
`to apply the medicaments of the invention parenterally in the form of a single dose of,
`
`Pharmacosmos, Exh. 1042, p. 4
`
`

`
`Application/Control Number: 14/100, 717
`Art Unit: 1673
`
`Page 4
`
`for example, 500 to 1000 mg iron; and it can be applied, for example, during the course
`
`of one hour (column 4, lines 50-65), meeting limitations of instant claim 1 and 8.
`
`Claims 1-3, 7-12 and 18-20 are rejected under pre-AIA 35 U.S.C. 102(b) as
`
`being anticipated by Helenek et al. (US Patent Application Publication 2004/0180849
`
`A 1, published 16 Sep 2004, cited in PT0-892).
`
`Helenek et al. discloses a method of treating restless leg syndrome by
`
`administering to a subject an iron complex (abstract), meeting limitations of instant claim
`
`7. Helenek et al. discloses the iron carbohydrate complexes administered include iron
`
`polyisomaltose (iron dextran), iron polymaltose (iron dextrin), iron gluconate, iron
`
`sorbital and iron hydrogenated dextran (page 3, paragraph 0021 ), meeting limitations of
`
`instant claim 1. Helenek et al. discloses the iron carbohydrate complexes avoid the risks
`
`of anaphylaxis associated with IOI when administered intravenously due to antibodies
`
`against the dextran moiety not being present in other iron complexes (page 3,
`
`paragraph 0017), meeting limitations of instant claims 2 and 3. Helenek et al. discloses
`
`the appropriate dosage level will generally be about 10 mg to 1000 mg of elemental iron
`
`per dose, which can be administered in single or multiple doses, for example particularly
`
`at least 600.0, 750.0, 800.0, 900.0, 1000.0, and 2000.0 milligrams of elemental iron,
`
`and furthermore up to the maximal tolerated dose (MTD) per administration (page 5,
`
`paragraph 0051 ), meeting limitations of instant claims 1 and 8-10. Helenek et al.
`
`discloses the embodiments of 1000 mg of elemental iron administered in an injectable
`
`Pharmacosmos, Exh. 1042, p. 5
`
`

`
`Application/Control Number: 14/100, 717
`Art Unit: 1673
`
`Page 5
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`intravenous as a single dose as a 1.5-5 mg iron/ml in normal saline (page 5, paragraph
`
`0052), implying a volume of 666 ml-200 ml normal saline, or diluent, meeting
`
`limitations of instant claim 18 and 19. Helenek et al. discloses the iron complexes may
`
`be administered ad hoc, that is, as symptoms reappear (page 5, paragraph 0053),
`
`meeting limitations of instant claim 20. Helenek et al. discloses embodiments of direct
`
`injection over 2 minutes and over 5 minutes (page 7, paragraph 0097), meeting
`
`limitations of instant claims 11 and 12.
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis
`
`for all obviousness rejections set forth in this Office action:
`
`(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.
`
`This application currently names joint inventors. In considering patentability of the
`
`claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter
`
`of the various claims was commonly owned at the time any inventions covered therein
`
`were made absent any evidence to the contrary. Applicant is advised of the obligation
`
`under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was
`
`not commonly owned at the time a later invention was made in order for the examiner to
`
`consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C.
`
`102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
`
`Pharmacosmos, Exh. 1042, p. 6
`
`

`
`Application/Control Number: 14/100, 717
`Art Unit: 1673
`
`Page 6
`
`Claims 1, 4-6, 8-12 and 18-20 are rejected under pre-AIA 35 U.S.C. 103(a) as
`
`being unpatentable over Hamstra et al. (JAMA, 1980, 243(17), p1726-1731, cited in
`
`PT0-892) in view of Muller et al. (US Patent 3, 100,202, issued 6 Aug 1963, cited in
`
`PT0-892).
`
`Hamstra et al. teaches intravenous injection of iron dextran, usually 250 to 500
`
`mg at less than 100 mg/min (page 1726, abstract), implying an intravenous infusion.
`
`Hamstra et al. teaches parenteral iron therapy in the treatment of iron deficiency anemia
`
`(page 1726, left column, paragraph 1 ), and teaches the patient population selected from
`
`patients having chronic and acute blood loss (page 1726, right column, paragraph 1 ).
`
`Hamstra et al. teaches injections wherein the iron content per injection includes 501-999
`
`mg, 1,000 mg, and> 1,000 mg (page 1726, Table 2 at bottom of right column). Hamstra
`
`et al. teaches the total amount of iron given ranges to > 15,000 mg (page 1723, Table 3
`
`at top of left column). Hamstra et al. teaches the intravenous injection diluted in 250 ml
`
`5% dextrose in water or in normal saline and teaches optimizing the rate at which the
`
`injection is administered, such as 100 to 400 ml/hr or the undiluted drug at 1 to 5
`
`ml/min (page 1727, left column, paragraph 1 ). Hamstra et al. teaches it is routine for
`
`one of ordinary skill in the art to perform treatment including subsequent iron dextran
`
`therapy as needed (page 1728, table 6 at top of page).
`
`Hamstra et al. teaches does not specifically teach the iron carbohydrate complex
`
`is an iron polyisomaltose complex (instant claim 1 ). Hamstra et al. teaches does not
`
`specifically teach the single dosage unit of elemental iron is at least about 1.5 grams
`
`(instant claim 9) or 2.0 grams (instant claim 10).
`
`Pharmacosmos, Exh. 1042, p. 7
`
`

`
`Application/Control Number: 14/100, 717
`Art Unit: 1673
`
`Page 7
`
`Muller et al. teaches an iron-polyisomaltose complex which is parenterally
`
`injectible (column 1, lines 10-15). Muller et al. teaches a known treatment for iron
`
`deficiency anemia is the iron dextran complex (column 1, lines 45-50). Muller et al.
`
`teaches the improvement of the iron-polyisomaltose complex is more heterogeneous in
`
`particle size, surprisingly lower toxicity, better pharmacological properties, and higher
`
`therapeutic efficacy than the iron dextran complexes hitherto known (column 2, lines 25-
`
`30).
`
`It would have been obvious to one of ordinary skill in the art at the time of the
`
`invention to combine Hamstra et al. in view of Muller et al. Both Hamstra et al. and
`
`Muller et al. are drawn to iron carbohydrate complexes for treatment of iron deficiency
`
`anemia. One of ordinary skill in the art at the time of the invention would have been
`
`motivated to combine Hamstra et al. in view of Muller et al. with a reasonable
`
`expectation of success because Hamstra et al. teaches administration of iron dextran
`
`complexes to treat iron deficiency anemia and Muller et al. teaches improvements of the
`
`iron-polyisomaltose complex compared to iron dextran complexes. It would have been
`
`routine for one of ordinary skill in the art to optimize the iron dosage per injection and
`
`the rate of administration because Hamstra et al. teaches intravenous injection of iron
`
`dextran, usually 250 to 500 mg at less than 100 mg/min but also teaches embodiments
`
`wherein the iron content per injection includes 501-999 mg, 1,000 mg, and> 1,000 mg,
`
`to a total amount of> 15,000 mg iron given, as well as suggesting optimizing the rate at
`
`which the injection is administered.
`
`Pharmacosmos, Exh. 1042, p. 8
`
`

`
`Application/Control Number: 14/100, 717
`Art Unit: 1673
`
`Page 8
`
`Claim 17 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over
`
`Hamstra et al. (JAMA, 1980, 243(17), p1726-1731, cited in PT0-892) in view of Muller
`
`et al. (US Patent 3, 100,202, issued 6 Aug 1963, cited in PT0-892) as applied to claims
`
`1, 4-6, 8-12 and 18-20 above, and further in view of Lawrence et al. (US Patent
`
`5,624,668, issued 29 Apr 1997, provided by Applicant in IDS mailed 17 Jun 2010).
`
`Hamstra et al. in view of Muller et al. teaches as above.
`
`Hamstra et al. in view of Muller et al. does not specifically teach the method
`
`wherein the mean iron core size is at least about 1 nm but no greater than about 9 nm;
`
`or mean size of a particle of the iron carbohydrate complex is no greater than about 35
`
`nm (instant claim 17).
`
`Lawrence et al. teaches iron dextran composition for treating iron deficiency
`
`(abstract). Lawrence et al. teaches a greater degree of homogeneity is desired, such as
`
`a uniform molecular weight distribution (column 4, lines 45-55). Lawrence et al. teaches
`
`DEXFERRUM particles typically range in length from about 31.5 to about 36.5 nm and
`
`are approximately 4.5 nm in width (column 3, lines 60-65 and column 9, lines 10-15).
`
`It would have been obvious to one of ordinary skill in the art at the time of the
`
`invention to combine Hamstra et al. in view of Muller et al. further in view of Lawrence et
`
`al. All of Hamstra et al., Muller et al. and Lawrence et al. are drawn to iron carbohydrate
`
`complexes for treatment of iron deficiency. One of ordinary skill in the art would have
`
`been motivated to combine Hamstra et al. in view of Muller et al. further in view of
`
`Lawrence et al. because Lawrence et al. teaches the new improvment of a greater
`
`degree of homogeneity is desired, such as a uniform molecular weight distribution, and
`
`Pharmacosmos, Exh. 1042, p. 9
`
`

`
`Application/Control Number: 14/100, 717
`Art Unit: 1673
`
`Page 9
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`suggests the improvement by optimizing the particle size of the iron carbohydrate
`
`complex.
`
`Double Patenting
`
`The nonstatutory double patenting rejection is based on a judicially created
`
`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
`
`unjustified or improper timewise extension of the "right to exclude" granted by a patent
`
`and to prevent possible harassment by multiple assignees. A nonstatutory double
`
`patenting rejection is appropriate where the claims at issue are not identical, but at least
`
`one examined application claim is not patentably distinct from the reference claim(s)
`
`because the examined application claim is either anticipated by, or would have been
`
`obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d
`
`1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir.
`
`1993); In re Langi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum,
`
`686 F.2d 937, 214 USPQ 761(CCPA1982); In re Vogel, 422 F.2d 438, 164 USPQ 619
`
`(CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644(CCPA1969).
`
`A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321 (d)
`
`may be used to overcome an actual or provisional rejection based on a nonstatutory
`
`double patenting ground provided the reference application or patent either is shown to
`
`be commonly owned with this application, or claims an invention made as a result of
`
`activities undertaken within the scope of a joint research agreement. A terminal
`
`disclaimer must be signed in compliance with 37 CFR 1.321 (b).
`
`Pharmacosmos, Exh. 1042, p. 10
`
`

`
`Application/Control Number: 14/100, 717
`Art Unit: 1673
`
`Page 1 O
`
`The USPTO internet Web site contains terminal disclaimer forms which may be
`
`used. Please visit http://www.uspto.gov/forms/. The filing date of the application will
`
`determine what form should be used. A web-based eTerminal Disclaimer may be filled
`
`out completely online using web-screens. An eTerminal Disclaimer that meets all
`
`requirements is auto-processed and approved immediately upon submission. For more
`
`information about eTerminal Disclaimers, refer to
`
`http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-l.jsp.
`
`Claims 1-20 are rejected on the ground of nonstatutory double patenting over
`
`claims 1-57 of U.S. Patent No. 7,754,702 since the claims, if allowed, would improperly
`
`extend the "right to exclude" already granted in the patent.
`
`The subject matter claimed in the instant application is fully disclosed in the
`
`patent and is covered by the patent since the patent and the application are claiming
`
`common subject matter, as follows: Independent claim 1 of U.S. Patent No. 7,754,702
`
`recites a method of treating a disease, disorder, or condition characterized by iron
`
`deficiency or dysfunctional iron metabolism resulting in reduced bioavailability of dietary
`
`iron comprising administering 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, an iron mannitol
`
`complex, an iron polymaltose complex, an iron gluconate complex, and an iron sorbitol
`
`complex; and the iron carbohydrate complex has a substantially non-immunogenic
`
`carbohydrate component and substantially no cross reactivity with anti-dextran
`
`antibodies wherein said disease, disorder or condition is not Restless Leg Syndrome.
`
`Pharmacosmos, Exh. 1042, p. 11
`
`

`
`Application/Control Number: 14/100, 717
`Art Unit: 1673
`
`Page 11
`
`Independent claim 55 of U.S. Patent No. 7,754,702 recites a method of treating a
`
`disease, disorder, or condition characterized by iron deficiency or dysfunctional iron
`
`metabolism resulting in reduced bioavailability of dietary iron comprising administering
`
`an iron carboxymaltose complex. Claims 2-9 of U.S. Patent No. 7,754,702 are drawn to
`
`the disease or conditions of instant claims 4-7. Claims 10-16 of U.S. Patent No.
`
`7,754,702 are drawn to the dosage unit of elemental iron corresponding to instant
`
`claims 8-10. Claims 17-20 of U.S. Patent No. 7,754,702 are drawn to the duration of
`
`administration corresponding to instant claims 11 and 12. Claims 23, 26, 27 and 57 are
`
`drawn to the iron carboxymaltose complex corresponding to instant claims 13 and 14.
`
`Claims 28 and 29 are drawn to the iron carbohydrate complex corresponding to instant
`
`claims 15 and 16. Claims 30-40 of U.S. Patent No. 7,754,702 are drawn to the particle
`
`size corresponding to instant claim 17. Claims 41-52 of U.S. Patent No. 7,754,702 are
`
`drawn to the route of administration corresponding to instant claim 19. Claim 53 is
`
`drawn to a second administration corresponding to instant claim 20.
`
`Furthermore, there is no apparent reason why applicant was prevented from
`
`presenting claims corresponding to those of the instant application during prosecution of
`
`the application which matured into a patent. See In re Schneller, 397 F.2d 350, 158
`
`USPQ 210 (CCPA 1968). See also MPEP § 804.
`
`Claims 1-12 and 15-20 are rejected on the ground of nonstatutory double
`
`patenting over claims 1-23 of U.S. Patent No. 8,431,549 since the claims, if allowed,
`
`would improperly extend the "right to exclude" already granted in the patent.
`
`Pharmacosmos, Exh. 1042, p. 12
`
`

`
`Application/Control Number: 14/100, 717
`Art Unit: 1673
`
`Page 12
`
`The subject matter claimed in the instant application is fully disclosed in the
`
`patent and is covered by the patent since the patent and the application are claiming
`
`common subject matter, as follows: Independent claim 1 of U.S. Patent No. 8,431,549 is
`
`drawn to a method of treating a disease, disorder, or condition characterized by iron
`
`deficiency or dysfunctional iron metabolism resulting in reduced bioavailability of dietary
`
`iron comprising administering 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 mannitol complex, an iron polymaltose
`
`complex, an iron gluconate complex, and an iron sorbitol complex; and the iron
`
`carbohydrate complex has a substantially non-immunogenic carbohydrate component
`
`wherein said disease, disorder or condition is not Restless Leg Syndrome. Claim 2 of
`
`U.S. Patent No. 8,431,549 is drawn to said complex having substantially no cross
`
`reactivity with anti-dextran antibodies corresponding to instant claim 3. Claims 3-6 of
`
`U.S. Patent No. 8,431,549 are drawn to the disease or conditions of instant claims 4-7.
`
`Claims 7-9 and 19 of U.S. Patent No. 8,431,549 are drawn to the dosage unit of
`
`elemental iron corresponding to instant claims 8-10. Claims 10, 11 and 18 of U.S.
`
`Patent No. 8,431,549 are drawn to the duration of administration corresponding to
`
`instant claims 11 and 12. Claims 12 and 13 are drawn to the iron carbohydrate complex
`
`corresponding to instant claims 15 and 16. Claim 14 of U.S. Patent No. 8,431,549 is
`
`drawn to the particle size corresponding to instant claim 17. Claims 15-16 of U.S. Patent
`
`No. 8,431,549 are drawn to the route of administration corresponding to instant claims
`
`Pharmacosmos, Exh. 1042, p. 13
`
`

`
`Application/Control Number: 14/100, 717
`Art Unit: 1673
`
`Page 13
`
`18 and 19. Claim 17 of U.S. Patent No. 8,431,549 is drawn to a second administration
`
`corresponding to instant claim 20.
`
`Furthermore, there is no apparent reason why applicant was prevented from
`
`presenting claims corresponding to those of the instant application during prosecution of
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`the application which matured into a patent. See In re Schneller, 397 F.2d 350, 158
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`USPQ 210 (CCPA 1968). See also MPEP § 804.
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`Conclusion
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`No claim is found to be allowable.
`
`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
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`supervisor, Shaojia Anna Jiang can be reached on 571-272-0627. The fax phone
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`number for the organization where this application or proceeding is assigned is 571-
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`273-8300.
`
`Pharmacosmos, Exh. 1042, p. 14
`
`

`
`Application/Control Number: 14/100, 717
`Art Unit: 1673
`
`Page 14
`
`Information regarding the status of an application may be obtained from the
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`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 S Lau/
`Examiner, Art Unit 1673
`
`Pharmacosmos, Exh. 1042, p. 15
`
`

`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Application No.: 14/100,717
`
`Examiner: LAU, JONATHAN S
`
`Group Art Unit: 1673
`
`Confirmation No.: 2813
`
`Customer No.: 26263
`
`Applicant: HELENEK, MARY JANE
`
`Filed: 09 December 2013
`
`Title: METHODS AND COMPOSITIONS
`FOR ADMINISTRATION OF IRON
`
`Docket No.: 30015730-0065
`
`09 June 2014
`
`FILED ELECTRONICALLY VIA EFS-WEB
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`AMENDMENT AND RESPONSE TO OFFICE ACTION
`
`UNDER 37 C.F.R. § 1.111
`
`Sir:
`
`In response to the Office Action of 07 February 2014, Applicants request the
`
`Office to enter the following amendments and consider the remarks set forth below.
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`Because 07 June 2014, falls on a weekend, this Response is being filed on the
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`next following business day, 09 June 2014, and is, therefore, timely filed as of the four
`
`month date.
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`Page 1 of 19
`
`Pharmacosmos, Exh. 1042, p. 16
`
`

`
`Application No. 14/100,717
`Response dated 09 June 2014
`to Action of 07 February 2014
`
`FILED VIA EFS-Web
`
`IN THE CLAIMS
`
`1. (currently amended) A method of treating a disease, disorder, or condition
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`characterized by iron deficiency or dysfunctional iron metabolism resulting in reduced
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`bioavailability of dietary iron, comprising
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`administering to a subject in need thereof an iron carbohydrate complex in
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`a single dosage unit of at least about 0.6 grams of elemental iron;
`
`wherein
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`the iron carbohydrate complex is selected from the group consisting
`
`of an iron carboxymaltose complex, an iron mannitol complex, an iron polyisomaltose
`
`complex, an iron polymaltose complex, ar-t--iro,r.t--9,lt,H:K}Fh::.<tH--GOH-"lf.Jl·HK;--·an iron sorbitol
`
`hydrogenated dextran complex_;
`
`2. (canceled)
`
`3. (original) The method of claim 1, wherein the iron carbohydrate complex has
`
`substantially no cross reactivity with anti-dextran antibodies.
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`4. (original) The method of claim 1, wherein the disease, disorder, or condition
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`comprises anemia.
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`5. (original) The method of claim 4, wherein the anemia comprises iron
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`deficiency anemia.
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`6. (original) The method of claim 4, wherein:
`
`Page 2 of 19
`
`Pharmacosmos, Exh. 1042, p. 17
`
`

`
`Application No. 14/100,717
`Response dated 09 June 2014
`to Action of 07 February 2014
`
`FILED VIA EFS-Web
`
`(i) the anemia comprises an iron deficiency anemia associated with chronic blood
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`loss; acute blood loss; pregnancy; childbirth; childhood development; psychomotor and
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`cognitive development in children; breath holding spells; heavy uterine bleeding;
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`menstruation; chronic recurrent hemoptysis; idiopathic pulmonary siderosis; chronic
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`internal bleeding; gastrointestinal bleeding; parasitic infections; chronic kidney disease;
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`dialysis; surgery or acute trauma; and chronic ingestion of alcohol, chronic ingestion of
`
`salicylates, chronic ingestion of steroids; chronic ingestion of non-steroidal anti(cid:173)
`
`inflammatory agents, or chronic ingestion of erythropoiesis stimulating agents;
`
`(ii) the anemia is of a chronic disease selected from the group consisting of
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`rheumatoid arthritis; cancer; Hodgkins leukemia; non-Hodgkins leukemia; cancer
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`chemotherapy; inflammatory bowel disease; ulcerative colitis thyroiditis; hepatitis;
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`systemic lupus erythematosus; polymyalgia rheumatica; scleroderma; mixed connective
`tissue disease; Sojgren's syndrome; congestive heart failure I cardiomyopathy; and
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`idiopathic geriatric anemia;
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`(iii) the anemia is due to impaired iron absorption or poor nutrition;
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`(iv) the anemia is associated with Crohn's Disease; gastric surgery; ingestion of
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`drug products that inhibit iron absorption; or chronic use of calcium.
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`7. (original) The method of claim 1 wherein the disease, disorder, or condition is
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`selected from the group consisting of restless leg syndrome; blood donation; hair loss;
`
`and attention deficit disorder.
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`8. (original) The method of claim 1 wherein the single dosage unit of elemental
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`iron is at least about 1 .0 grams.
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`9. (original) The method of claim 1 wherein the single dosage unit of elemental
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`iron is at least about 1 .5 grams.
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`10. (original) The method of claim 1 wherein the single dosage unit of elemental
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`iron is at least about 2.0 grams.
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`Page 3 of 19
`
`Pharmacosmos, Exh. 1042, p. 18
`
`

`
`Application No. 14/100,717
`Response dated 09 June 2014
`to Action of 07 February 2014
`
`11. (canceled)
`
`FILED VIA EFS-Web
`
`12. (original) The method of claim 1 wherein the single dosage unit of elemental
`
`iron is administered in about 5 minutes or less.
`
`13. (original) The method of claim 1 wherein the iron carbohydrate complex is
`
`an iron carboxymaltose complex.
`
`14. (original) The method of claim 13, wherein
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`(i) the iron carboxymaltose complex has a chemical formula of [FeOx (OH)y
`
`(H20)z ]n [{(C5H100s)m (C5H1207 )}1 ]k, where n is about 103, m is about 8, I is about 11,
`and k is about 4; contains about 28% elemental iron; and has a molecular weight of
`
`about 150,000 Da; or
`
`(ii) the iron carboxymaltose complex is a polynuclear iron (111)-hydroxide 4(R)(cid:173)
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`(poly-(1-A )-O-a-glucopyranosyl)-oxy-2(R),3(S),5(R),6-tetrahydroxy-hexanoate.
`
`15. (original) The method of claim 1, wherein the iron carbohydrate complex is
`
`an iron polyglucose sorbitol carboxymethyl ether complex.
`
`16. (original) The method of claim 15, wherein the iron polyglucose sorbitol
`
`carboxymethyl ether complex is a polyglucose sorbitol carboxymethyl ether-coated non(cid:173)
`
`stoichiometric magnetite complex.
`
`17. (original) The method of claim 1, wherein
`
`mean iron core size is at least about 1 nm but no greater than about 9 nm; or
`mean size of a particle of the iron carbohydrate complex is no greater than about
`
`35 nm.
`
`Page 4 of 19
`
`Pharmacosmos, Exh. 1042, p. 19
`
`

`
`Application No. 14/100,717
`Response dated 09 June 2014
`to Action of 07 February 2014
`
`FILED VIA EFS-Web
`
`18. (original) The method of claim 1, wherein the iron carbohydrate complex is
`
`administered parenterally.
`
`19. (original) The method of claim 18, wherein
`
`(i) pa