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Amag Pharmaceuticals, Inc. v. Sandoz, Inc.

United States District Court, D. New Jersey

July 19, 2017

AMAG PHARMACEUTICALS, INC., Plaintiff/Counterclaim-Defendant,
v.
SANDOZ, INC., Defendant/Counterclaim-Plaintiff.

          MEMORANDUM AND ORDER

          PETER G. SHERIDAN, U.S.D.J.

         This matter comes before the Court on Joint Claim Construction submitted by Amag Pharmaceuticals, Inc. (“AMAG” or “Plaintiffs”) and Sandoz, Inc. (“Sandoz” or “Defendant”) pursuant to L. Pat. R. 4.3 (see D.I. 38).

         In order to market and sell pharmaceutical drug Feraheme®, AMAG has listed the following U.S. Patents-6, 599, 498 (the “'498 patent); 7, 553, 479 (the “'479 patent); 7, 871, 597 (the “'597 patent”); 8, 591, 864 (the “'864 patent”); and 8, 926, 947 (the “'947 patent”) (collectively “Patents-in-Suit”)-in Food and Drug Association's (“FDA”) Approved Drug Products with Therapeutic Equivalence Applications, commonly known as the Orange Book. See 21 U.S.C. § 355(B)(1). Feraheme® is used to treat iron deficiencies in people with chronic kidney disease.

         Thereafter, Sandoz filed an Abbreviated New Drug Application (“ANDA”) with the FDA in order to seek approval to market a generic version of Feraheme®. See 21 U.S.C. § 355(j)(1). Accordingly, pursuant to 21 U.S.C. § 355(j)(5)(B)(iii), AMAG initiated this suit against Sandoz because Sandoz's request to market the generic version of Feraheme® was done prior to the expiration of the Patents-in-Suit.

         On April 26-27, 2017, pursuant to L. Pat. R. 4.6, a Markman hearing was conducted before the Court for multiple claim terms recited in the Patents-in-Suit. These terms are construed below.

         BACKGROUND

         Feraheme® (ferumoxytol) is an FDA approved pharmaceutical drug approved for the use of treating iron deficiencies in people with chronic kidney disease (“CKD”). Feraheme® is administered either as a bolus or as an intravenous solution. (See the '498 patent, col. 3, ll. 17-19 and 29).

         I. The Patent Family

         Amongst the Patents-in-Suit, the '498 patent is the parent patent as it issued from the first-filed patent application. The '479 and '597 patents claim priority to the '498 patent as their respective patent applications are continuation-in-part patent applications of the '498 patent.[1] As such, the disclosure of the '479 and '597 patents include additional subject matter that is not disclosed in the '498 matter.

         Further, the patent application of the '864 patent is a continuation application[2] of the U.S. Patent 8, 501, 158, whose patent application is a divisional application[3] of the '597 patent. As such, the disclosure of the '864 patent is the same as the disclosure of the '597 patent because no new matter is added to the '864 patent. Likewise, the '947 patent shares the same disclosure as the '864 and '597 patent because it is a continuation application of the '864 patent.

         In short, the three patents with three distinct, non-overlapping, disclosures are-the '498 patent, the '479 patent, and the '597 patent. The disclosures of the '864 and '947 patents are the same as the '597 patent.

         II. The '498 Patent A. Disclosure of the '498 Patent

         The '498 patent is directed towards pharmaceutical compositions that are used for providing enhanced magnetic resonance imaging (“MRI”) of a patient's internal organs, such as liver, spleen, or lymph nodes, during an MRI scan. The compositions are imaging agents that comprise carboxyalklayed reduced polysaccharides coated ultra-small superparamagnetic iron oxides. (See Abstract of the '498 patent).

         The '498 patent identifies that the conventional contrast agents are distributed into two classes of imaging agents-namely, low molecular weight gadolinium complexes such as Magnevist® and colloidal iron oxides. The conventional contrast agents face the following problems-expense, inefficiency, loss of coating of sterilized agent by autoclaving, narrow range of organ uptake for purposes of imaging. (Id. at col. 1, ll. 25-35). During the autoclaving process, for example, the polymer coating becomes dissociated from the iron oxide cores due to exposure to heat. The polymer dissociation results in functional consequences, such as, physical changes in the material (i.e., clumping), bio-distribution changes (i.e., changes in plasma half-life), and changes in toxicity profile (i.e., potential increases in adverse events). (Id. at col. 7, ll. 60-65).

         In order to mitigate dissociation of the coating from the iron oxide when the material is subject to heat stress, the '498 patent discloses a method for the synthesis of a colloid of an iron oxide that is associated with a water soluble polysaccharide coating. (Id. at col. 10, ll. 30-35). The term “heat stress” being defined as “heating the colloid to approximately 121°C or higher for about 30 minutes at neutral pH […] that are well known in the art to autoclave (or terminally sterilize) an injectable drug.” (Id. at col. 10, ll. 35-40).

         In an example embodiment, the '498 patent discloses that a coated colloid may be prepared by adding a polysaccharide to an iron oxide sol (a colloidal dispersion in a liquid). Wherein the term “colloid” includes “any macromolecule or particle having a size less than about 250 nm [(nanometer)]”. The iron oxide polysaccharide colloids of the invention have improved physical characteristics and manufacturability such as ability to withstand heat stress and show less evidence of polysaccharide dissociation under stress. (Id. at col. 11, ll. 5-20).

         The colloids of the '498 patent can be used as contrast agents for MRI scanning or in other applications such as magnetic fraction of cells, immunoassays, magnetically targeted drug delivery, and as therapeutic injectable iron supplements. (Id. at col. 11, ll. 40-45). In particular, the colloids are suited for parenteral administration because the final sterilization is autoclaving. Autoclaving being a preferred method because it eliminates viability of all cellular life forms including bacterial spores and viruses. (Id. at col. 11, ll. 45-50).

         Accordingly, the improvements provided in these colloids that can be used as contrast agents over the prior art include-(i) heat sterilization by autoclaving that optimizes long-term storage at ambient temperatures; (ii) being non-toxic to mammals, including humans, at higher doses; and (iii) ability to obtain additional images during a single clinical visit and use of the imaging apparatus due to successive doses being administered after a brief interval after administration of a first dosage. (Id. at col. 11, ll. 60-67-col. 12, ll. 1-5).

         According to the various example embodiments, the '498 patent discloses that a reduced polysaccharide iron oxide complex or a derivatized reduced polysaccharide iron oxide complex, which is a reduced polymer of glucose, is produced by sterilizing the same by autoclaving. An example of a reduced polymer of glucose is a reduced dextran. (Id. at col. 2, ll. 1-15). In another example embodiment, the '498 patent discloses that a complex such as a reduced derivatized polysaccharide iron oxide complex may be stable at a temperature of at least approximately 100°C or 121°C. (Id. at col. 5-20).

         The '498 patent includes a total of 26 claims, wherein claims 1, 13, 23 and 25 are independent claims. Claims 1 and 23 being method claims and claims 13 and 25 being product claims.

         B. Prosecution History of the '498 Patent

         i. Applicant's Arguments/Remarks filed October 9, 2001.

         In its response to the July 5, 2001 non-final Office action, the Applicant responded by arguing that none of the cited references disclosed a “reduced polysaccharides” or “carboxyalkylated polysaccharides” such as reduced carboxymethylated dextran as required in then pending claims 1-13, 18-29-35-36, 39-52 and 57-66. (See Image File Wrapper[4] of the '498 Patent; Applicant's Arguments/Remarks at 6-7, filed October 9, 2001). Additionally, with respect to a particular reference cited against the claimed invention, Applicant argued that there was no disclosure of autoclavability of the MRI contrast agents. (Id. at 8). With respect to then claims 18-20 and 29, the Applicant argued that the methods and compositions are “stable after autoclaving, with respect to certain physical and chemical properties (e.g., stability at particular elevated temperatures, or stability of colloidal suspensions without aggregation), ” which were not disclosed by any of the prior art references. (Id. at 9).

         Further, in the same response, in order to distinguish the claimed invention over the cited art, the Applicant equates the term “complex” to “polysaccharide, ” by arguing that “Golman et al. neither teaches nor suggests autoclaving, either of a polysaccharide or of a complex.” (Id. at 11).

         ii. Applicant's Arguments/Remarks filed April 25, 2002.

         Next, in response statements made on April 25, 2002, the Applicant noted that preamble “for administration to a mammalian subjection, ” would be understood by one of ordinary skill in the art to mean that “the iron oxide complex must have an acceptable profile with respect to stability and risk of adverse reaction, and if the mammal is a human, must typically be approved by a regulatory authority such as the Food and Drug administration.” (See Applicant's Arguments/Remarks at 4, filed April 25, 2002). Further, in order to distinguish over the cited art, the Applicant primarily relies on an affidavit of one of the co-inventors of the '498 patent.

         Pursuant to 37 C.F.R. § 1.132, in support of its response, the Applicant submitted an affidavit of Dr. Jerome Lewis. Dr. Lewis is a co-inventor of polysaccharide superparamagnetic iron oxide complexes and related materials and methods. (Id. at Declaration of Jerome Lewis (“Decl. of Lewis”) at ¶ 1). Dr. Lewis noted that from a regulatory and commercial perspective, to have a “polysaccharide superparamagnetic iron oxide complex as a pharmaceutical that when terminally sterilized (autoclaved) does not form particulates and that has minimal edematous response.” (Id. at ¶ 3). Terminal sterilization (autoclaving) being favored over filter sterilization because-(i) terminal sterilization provides a much higher level of sterility assurance; and (ii) their opaque nature prevents ordinary visual inspection by the physician during administering the drug, thereby making terminal sterilization more desirable. (Id. at ¶¶ 4-5 (internal citations omitted)).

         In his declaration, Dr. Lewis provides a background on the development of these types of pharmaceutical drugs. In particular, he notes that the drug disclosed in the present application is a third generation drug. The two previous generation drugs had issues. The first generation drug was Feridex® disclosed in U.S. Patent 4, 827, 945. The material used in Feridex® had issues such as particulate formulation and adverse reactions such as edematous response (i.e., accumulation of an excessive amount of watery fluid in cells, tissues, or body cavities). (Id. at ¶ 7). The second generation drug being Combidex®, a complex of ultra-small particles. This drug is filtered by a process of filtration, instead of terminal sterilization, at the time it is administered to the patient. The risks with this drug being-edematous response, administration of the material only after dilution, and slow administration.

         Unlike the first and second generation drugs, this third generation drug, which is a complex of ultra-small particles and has a favorable bio-distribution, has sufficiently small risk of particulate formulation such that no filtration is required during administration. (Id. at ¶¶ 7-9). And, because of low risk of adverse reaction, the drug disclosed in the '498 patent can be administered more rapidly and without dilution. (Id. at ¶ 10). In short, Dr. Lewis notes that the new material disclosed in the '498 patent is sterilized using the autoclaving method. And, unlike the conventional drugs, Combidex® and Feridex®, the new material does not require filtration during administration, no dilution, no slow administration, and no edematous response. Accordingly, noting that such properties are commercially and medically desirable in an iron based colloidal MRI contrast agent. (Id. at ¶ 11).

         In distinguishing the third generation agent disclosed in the '498 patent from the conventional drugs, Dr. Lewis states that “autoclaving normally requires temperatures of at least 121 degrees [C] (see, for example, Exhibit C), and in any event at least 115 degrees C.” (Id. at ¶ 15). Dr. Lewis notes that the material disclosed in the prior art references, noted in the Office action dated November 2, 2001, namely, Lewis and Groman references, are autoclaved in the presence of citrate. Doing so has a risk of particulate formulation requiring administration through a filter, and an adverse reaction risk requiring dilution and slow administration. (Id. at ¶ 15). In other words, the cited references fail to teach anything about creating a material without degradation or decreased risk of adverse reactions. (Id.)

         Under the section titled “Consideration of Certain Terms in the Patent Application, ” Dr. Lewis notes, “[i]n the present invention, the reduced polysaccharide is a poly alcohol compound; thus, it contains multiple OH groups. All the OH groups are functional groups and thus potential reactive sites to form derivatives of the original compound.” (Id. at ¶ 16). With respect to “ultrasmall” term, Dr. Lewis relied on a publication to define this term as a new class of contrast agents “small enough to migrate across the capillary wall, a prerequisite in the design of targetable particulate pharmaceuticals.” (Id. at ¶ 19 (internal citations omitted)).

         In support of Dr. Lewis' declaration, Applicant submits multiple exhibits to the Patent Office. One of these exhibits, Exhibit D, is entitled “European Pharmacopoeia, 3rd Edition, 1997.” Exhibit D states, “[s]terility is the absence of viable micro-organisms […] [which] is assured by the application of a suitably validated production process.” As such, failure to follow a meticulously validated process involves the risk of a non-sterile product or of a deteriorated product. Wherever possible, “a process in which the product is sterilized in its final container (terminal sterilization) is chosen.” For terminal sterilization, it is essential to take into account the non-uniformity of the physical and chemical conditions within the sterilizing chamber. By establishing a terminal sterilization process, knowledge of its performance in routine use is gained wherever possible, by monitoring and suitably recording the physical and chemical conditions achieved within the load in the chamber throughout each sterilizing cycle.

         Additionally, attached Exhibits H and I, note that ultrasmall superparamagnetic iron oxide (USPIO) are small enough to migrate across the capillary wall, a prerequisite in the design of targetable particulate pharmaceuticals. As such, the applications of USPIO being-(i) used as an intravenous contrast agent for the lymphatic system, (ii) a bone marrow contrast agent, (iii) a long-half-life perfusion agent for brain and heart, and (iv) the magnetic moiety in organ-targeted superparamagnetic contrast agents for magnetic resonance imaging. (Id. at Exhibit I, “Radiology”).

         iii. Applicant's Arguments/Remarks filed June 4 2002, October 8, 2002 and November 13, 2002.

         With respect to the remarks filed June 4, 2002, no significant comments were made by the Applicant.

         However, with respect to the remarks filed October 8, 2002, the Applicant noted “[t]he change in claims such as 53 and 54 from ‘colloid' to ‘complex' is intended to be a broadening amendment; similar language already appeared in numerous claims.” (See Applicant's Arguments/Remarks at 6, filed October 8, 2002). Additionally, Dr. Lewis' attached declaration notes that the material in the patent application of the '498 patent employs a synthetic method that “does not require a reflux step or centrifugation. And the resulting material falls apart upon autoclaving - i.e., heating at 121°C for 30 min. does not result in an increase in particulate formulation.” (Decl. of Lewis at ¶ 11, dated September 25, 2002). In addition, Dr. Lewis notes that his experimental data indicates that such “autoclaved materials are stable (as measured by no increase in particulate level per mL of material) for up to 3 years.” (Id. at ¶ 12).

         Whereas, in the remarks filed November 13, 2002, Applicant again noted that the changing of claim terms from “colloid” to “complex” is intended to be a broadening amendment.

         iv. Notice of Allowance mailed on January 22, 2003.

         Under the reasons for allowance, the Examiner noted that the claimed subject matter was novel and nonobvious because the prior art references did not disclose-(i) a reduced carboxyalkylated polysaccharide iron oxide complex wherein the complex is stable at a temperature of about 121°C; and (ii) a method of providing an iron oxide complex for administration to a mammalian subject consisting of producing a carboxyalkylated reduced polysaccharide iron oxide complex and sterilizing the complex by autoclaving. The Examiner further noted that the declaration filed by Dr. Lewis on October 8, 2002, was sufficient and persuasive to overcome the prior art references because the material disclosed in the prior art was “not stable upon autoclaving (heating at 121 C for 30 minutes), ” unlike the material of the patent application of the '498 patent.

         III. The '479 Patent

         A. Disclosure of the '479 Patent

         The Court notes that the patent application for the '479 patent is a continuation-in-part patent application for the patent application for the '498 patent. As such, a substantial portion of the disclosure in the '479 patent is recited in the '498 patent. (See supra fn. 1).

         Based on a review of the disclosure of the '479 patent, additional disclosure regarding the colloid particles is made in the '479 patent. The '479 patent explains that unlike the conventional drugs, Combidex® and Feridex®, the colloid particles disclosed in this patent application show less evidence of polysaccharide dissociation under stress, and exhibiting no appreciable change in size. The '479 patent identifies the shortcomings with the conventional drugs such as loss of dextran coating when subjected to heat stress, increase in particle diameter size, and clumping of material. (See the '479 patent, col. 11, ll. 5-20).

         The '479 patent discloses an improved method of administration, which comprises injection of an autoclaved reduced polysaccharide iron oxide complex in a volume of 15 mL or less. In another aspect of the embodiment the injected volume is injected as a bolus. (See the '479 patent, col. 3, ll. 20-25).

         The '479 patent includes two (2) claims wherein claim 1 is in independent form, and is directed to a pharmaceutical composition in a vial. Claim 1 of the '479 patent, unlike the claims of the '498 patent, recites carboxymethylated dextran iron oxide complex, which comprises at least 750 micromole and less than 1500 micromole of carboxyl groups per gram of dextran. (See the '479 patent, col. 38, ll. 25-30).

         B. Prosecution History of the '479 Patent

         i. Applicant's Arguments/Remarks filed December 14, 2006.

         In responding to the rejections set forth in the outstanding Office action issued by the patent examiner, the Applicant argued, “[w]hether a composition, or in this case a complex, is terminally sterilizable - i.e. autoclavable - depends on the chemical composition of the disclosed complex, it does not describe a purpose or intended use.” (See Applicant's Arguments/Remarks at 9, filed December 14, 2006). The Applicant further states that “[a]utoclavability is a physical property that reflects a chemical property and thus chemical composition.” (Id. at 10).

         The Applicant further notes that the term “terminally sterilizable” also “adds patentable weight to the claimed iron oxide composition, because not all reduced carboxyalkylated polysaccharide iron oxide complexes are terminally sterilizable and stable at temperatures of at least 100°C.” As such, the term “terminally sterilizable” imparts essential chemical structure via this physical property because a composition that is “terminally sterilizable” is chemically different from one that is not. (Id. at 10). The Applicant argued that they have developed “unexpectedly and surprisingly” developed a process that prepares reduced carboxyalkylated polysaccharide iron oxide complexes that can be autoclaved without precipitating or degrading.

         In support of its arguments, the Applicant submitted a declaration by one of the inventors', Dr. Jerome Lewis. Generally, the declaration of Dr. Lewis submitted with the Applicant's remarks was substantially similar to the declaration by Dr. Lewis in the '498 patent.

         ii. Applicant's Arguments/Remarks filed February 23, 2007.

         In its remarks, the Applicant addressed indefiniteness rejections under 35 U.S.C. § 112, first paragraph by making certain amendments. Next, the Applicant addressed obviousness rejection by asserting that the cited art failed to disclose “an injectable complex in a vial that is stable at a temperature of about 100°C, or an injectable complex in a vial that is terminally sterilizable (autoclavable) within the vial.” (See Applicant's Arguments/Remarks at 4, filed February 23, 2007).

         iii. Applicant's Arguments/Remarks filed May 4, 2007.

         In its remarks, relying on the declaration by Dr. Lewis and Dr. Timothy Frigo, the Applicant argued that unlike the conventional drugs, PCU-USPIO iron oxide complex, showed an insignificant change in size upon autoclaving. (See Applicant's Arguments/Remarks at 5, filed May 4, 2007). Dr. Timothy Frigo is an assignee of the '479 patent and one of the senior scientists who prepared and analyzed the substances disclosed in this patent. Dr. Frigo's declaration indicates that the size of PCU-USPIO after autoclaving did not change drastically, as it did for the conventional drugs. (See Declaration of Dr. Frigo (“Decl. of Frigo) at ¶¶ 10-11, filed May 4, 2007).

         iv. Notice of Allowance mailed on April 10, 2009.

         In its reasons for allowance, the Examiner indicated that the claimed subject matter is patentable over the cited art because the compositions disclosed in the references are not stable when subjected to autoclaving. As such, the compositions in the claimed subject matter do “not form into a gel or form substantial particulates and remains clear and can be micro-filtered.” (See Notice of Allowance at 3, mailed on April 10, 2009).

         IV. The '597 Patent

         A. Disclosure of the '597 Patent

         The '597 patent is directed towards administrating an effective amount of a pharmacological composition that uses an iron oxide complex with a polyol or polyether. The complex is formulated in a biocompatible liquid that provides minimal detectable free iron in a subject and minimal incidence of anaphylaxis (i.e., allergic reaction). (See the '479 patent, col. 2, ll. 5-10). The '479 patent notes that unlike the existing iron oxide complexes, polyol or polyether iron oxide complexes disclosed herein, when administered parenterally to a patient for use as a pharmacological agent, provides minimal detectable free iron and anaphylaxis in a patient. (Id. at col. 11, ll. 15-20).

         Accordingly, the improvement comprising that of parenteral administration to a mammalian subject of an effective dose of the complex formulated in a biocompatible liquid delivered at a rate substantially greater than 1 mL/min. (Id. at col. 3, ll. 40-45). The method of administration comprising-injection of an autoclaved reduced polysaccharide iron oxide complex in a volume of 15 mL or less. (Id. at col. 6, ll. 60-67).

         Further, this patent notes that four of the conventional types of iron oxide compounds used as MRI contrast agents and/or hematinic agents (i.e., agents for increasing the amount of hemoglobin in the blood) have serious drawbacks. (Id. at col. 15, ll. 45-65 and col. 16, ll. 1-25). Accordingly, the embodiments of the '597 patent are directed to polyol or polyether iron oxide complex, when administered to a patient, provides both minimal detectable free iron in a subject and minimal anaphylaxis in a patient. For example, as discussed in examples 6 and 7 and examples 8 and 9 of the '597 patent. (Id. at col. 19, ll. 45-50). The polyol or polyether iron oxide complex of the '597 patent are administered parenterally by bolus injection at a dosage of from about 1 mg to about 4 mg of iron/kg of body weight. (Id. at col. 26, ll. 30-35).

         The '597 patent identifies autoclave or terminally sterilize as synonyms. (Id. at col. 10, ll. 65-67). “Terminal sterilization (autoclaving) is a preferred method of sterilizing drugs for injection.” (Id. at col. 13, ll. 4-5). “These colloids are particularly suited to parenteral administration, because the final sterilization typically is autoclaving, a preferred method since it eliminates viability of all cellular life forms including bacterial spores, and viruses.” (Id. at col. 18, 35-40).

         In example 62, the '597 patent discloses that following autoclaving for 30 minutes at 121°C, USPIO coated with reduced dextran maintained its small size. Whereas, USPIO coated with native dextran increased in size 28-fold following autoclaving. (Id. at col. 45, ll. 35-45). Additionally, a second type of increased stability was achieved by use of reduced dextran to coat USPIO is the property of pH of the bulk solvent. (Id. at col. 45, ll. 50-55). The data in both Tables 12 and 13 show that the particles coated with reduced dextran had significantly improved pH stability upon autoclaving, compared to those coated with native dextran. As such, the effect of autoclaving on pH, size, and bound polysaccharide of colloids coated with native and reduced dextran was observed. (Id. at col. 45, ll. 55-col. 46, ll. 1-30).

         An example embodiment disclosed in the '597 patent is that of a method that comprises mixing the polyol, reduced polysaccharide, or polyether with iron salts in an acidic solution selected from the group comprising ferric salts, ferrous salts, or a mixture of ferrous and ferric salts, cooling the solution, neutralizing the solution with a base, and recovering the coated iron oxide colloid. (Id. at col. 17, ll. 30-35). Cooling the solution to 5°C as noted in example 5 or cooled to a room temperature as noted in example 36. (Id. at col. 25, ll. 40-45; col. 37, ll. 25-35).

         B. Prosecution History of the '597 Patent

         i. Applicant's Arguments/Remarks filed July 3, 2006.

         In responding to the rejections set forth in the outstanding Office action, the Applicant argued that the claimed subject matter is directed to ‘pharmacological compositions, ' which requires a composition that will be acceptable for use in humans. That is, the aforementioned term informs a person of ordinary skill in the art that the iron oxide complex must have an acceptable profile with respect to stability and risk of adverse reaction in humans. (See Applicant's Arguments/Remarks at 7, filed July 3, 2006). Applicant further goes onto indicate that those skilled in the art recognize that in the art of contrast agents, use of terminal sterilization (autoclaving) over filter sterilization is preferred because terminal sterilization provides a much higher level of sterility assurance. (Id. at 7). As such, being desirable to have polyol/polyether superparamagnetic iron oxide complex as pharmacological composition that is capable of being autoclaved and that can be administered after autoclaving to provide minimal detectable free iron and minimal incidence of anaphylaxis. (Id. at 8).

         The Applicant further identifies that the drug disclosed in the patent application is better than the conventional drugs, Combidex® and Feridex®, because it has a sufficiently small risk of particulate formulation after autoclaving that no filtration is required during administration of the drug. Thereby, providing minimal free iron to the subject upon administration. And, the risk of adverse reaction is lower compared to the conventional drugs, which results in more rapid administration of this new drug without dilution. (Id. at 9).

         Next, the Applicant argues that the prior art cited did not disclose a pharmacological composition that is “capable of being parenterally administered (composition), or actually administered (method), at a rate substantially greater than 1mL/min.” (Id. at 11). Further, the Applicant argues that the reduced carboxyalkylated polysaccharide iron oxide complexes claimed in the instant application can be autoclaved, and the claims require that they be autoclaved or autoclavable. (Id. at 14).

         ii. Applicant's Arguments/Remarks filed January 29, 2007.

         In support of its remarks, Applicant submitted a declaration of Dr. Lewis, one of the inventors of this patent. In order to distinguish over the cited art, the Applicant amended the claims to include claim term “autoclavable” in the body of the claim in order to give patentable weight to this claim term. The Applicant asserted that “[a]utoclavability is a physical property that reflects a chemical property and thus limits the chemical composition.” (See Applicant's Arguments/Remarks at 8, filed January 29, 2007). And, because not all reduced carboxyalkylated polysaccharide iron oxide complexes are autoclaved and thus stable, the term “autoclavable” adds patentable weight. (Id. at 9). Dr. Lewis points out that that the “distinguishing property of the complexes of the present application compared to the previous generation complexes Feridex and Combidex, and the [reference] Maruno EP compound, is autoclavability.” (Id. at 10).

         iii. Applicant's Arguments/Remarks filed May 18, 2007.

         In support of its remarks, Applicant submitted a declaration of Dr. Timothy Frigo, an assignee and one of the senior scientists who prepares and analyzes the substances disclosed in the this patent. Dr. Frigo noted that PSC-USPIO proprietary iron oxide complex showed an insignificant change in ...


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