Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 16, 19, and 27-43 of T. Christensen et al., US 18/421,494 (Jan. 24, 2024) are pending, under examination, and are rejected.
Provisional Election of Species Requirement
Applicant’s representative, Robin Teskin, provisionally elected without traverse by telephone on April 7, 2025, iron chloride as the species of iron and hydrogenated oligoisomaltose as the species of carbohydrate. Pending claims 16, 19, and 27-43 read on the elected species. The elected species was searched and determined to by unpatentable pursuant to § 103. The search was not further extended. Applicant has confirmed the elected species in the Reply. Reply at pages 6-7. The provisional election of species is given effect. No claims are withdrawn from consideration by the examiner, 37 CFR 1.142(b), as not reading on the elected species.
Claim Interpretation
During examination, a claim must be given its broadest reasonable interpretation consistent with the specification as it would be interpreted by one of ordinary skill in the art. MPEP § 2173.01(I); § 2111.01. Under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. The plain meaning of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the time of the invention. MPEP § 2173.01(I). Claim interpretation is updated/modified from the previous Office action in view of the claim amendments and withdrawal of the § 102 rejections.
Summary of Claim 16 with Reference to the Specification
Claim 16 recites as follows:
16. An aqueous preparation comprising a carbohydrate and iron,
wherein the carbohydrate is oligoisomaltose or hydrogenated oligoisomaltose and
the iron is in the form of iron chloride
wherein
- the amount of arsenic in the preparation does not exceed 4.5 μg per g iron
and the amount of lead in the iron preparation does not exceed 1.5 μg per g iron.
The specification teaches that the amounts of non-iron metals are preferably determined using Inductively Coupled Plasma (ICP) methods such as inductively coupled plasma mass spectrometry (ICPMS). Specification at page 6, lines 4-6. The specification teaches that in step (ii), the iron complex compounds of the invention can be prepared by contacting the iron preparation that is low in arsenic and lead, and optionally is also low in chromium, mercury, cadmium and/or aluminum with a ligand in the presence of water. Specification at page 12, lines 9-12.
The specification example teaches preparation of FeCl3 (ferric chloride) from iron carbonyl as follows:
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where residual ferrous chloride (FeCl2) remaining after step 2 was converted to ferric chloride (FeCl3) by step-wise addition of hydrogen peroxide until no more ferrous iron was detected. Specification at page 42.
Specification Example 2 (directed to an embodiment of instant claim 16) teaches preparation of Iron isomaltoside 1000, which involves forming an aqueous preparation comprising iron chloride (FeCl3) (elected iron species) and hydrogenated oligoisomaltose (elected carbohydrate species). Example 2 teaches that the procedure used is that described in WO 2010/108493 A11, but using the FeCl3 produced from carbonyl iron by the process described in instant specification Example 1 and employing hydrogenated oligoisomaltose instead of WO 2010/108493’s dextran. Instant specification Example 2 is reproduced below.
FeCl3 produced from carbonyl iron by the process described in example 1 was used. An amount of FeCl3 containing 240 kg Fe3+ was combined with 560 kg of a hydrogenated oligoisomaltose (oligoisomaltoside, i.e. isomaltoside 1000) preparation having a weight 30 average molecular weight of 1,097 Da and a content of mono- and disaccharides of 0.8 wt-% [in an aqueous medium comprising Na2CO3 and NaOH]2.
Specification at page 42, lines 26-31.
This Example 2 reaction, based on WO2010/108493, is summarized by the Examiner below.
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Specification at pages 42-43.
Specification Example 3 is similar to Example 2, but employs aqueous ferric chloride solution that was obtained during the processing of an iron-containing nickel ore for nickel production and extracting the aqueous ferric chloride solution using an organic solvent. Specification at page 43.
Specification Example 4 reports the amounts of non-iron metals in several iron complex compounds were determined by ICP-MS are summarized in Table 1. Specification at pages 43-44.
Interpretation of the Structure of Claim 16
The plain language of claim 16 indicates that the iron species and carbohydrate may exist individually (unreacted) within the aqueous preparation or as a complex between the iron species and the carbohydrate (i.e., where by the iron species reacts with the carbohydrate to form an iron-carbohydrate complex existing in the aqueous preparation).
Interpretation of “hydrogenated oligoisomaltose”
Claim 16 recites:
16 . . . wherein the carbohydrate is oligoisomaltose or hydrogenated oligoisomaltose . . .
Applicant elected hydrogenated oligoisomaltose as the species of carbohydrate. The specification does not specifically define “hydrogenated oligoisomaltose”. The term “hydrogenated oligoisomaltose” is reasonably interpreted based on its plain lagnauge, consistently with the specification as an oligoisomaltose subjected to a reduction reaction, whereby aldehyde groups are reduced or partially reduced. Specification at page 12, lines 32-33. See also, WO 2010/108493 at page 10, lines 10-16 (discussing hydrogenation of the terminal aldehyde groups to alcohols).
It is noted here that H. Andreasen, WO 2010/108493 (2010) (“Andreasen”) (cited in the § 103 rejection below) hydrogenates dextran to produced hydrogenated dextran.3 Andreasen at page 14, lines 1-24. The hydrogenated dextran prepared by Andreasen is (per claim 1) a “hydrogenated oligoisomaltose”.4 See, Andreasen at page 5, lines 8-12.
Note also that the tradename product isomaltoside 1000 is a “hydrogenated oligoisomaltose” because it is a hydrogenated dextrin/oligoisomaltose. See e.g., J. Stein et al., 18 Expert Opinion on Pharmacotherapy 1721-1737 (2017) (stating at page 1730, col. 1 -- “iron isomaltoside 1000 (a very low molecular weight hydrogenated dextran of 3–5 glucose units)”). The specification acknowledges that isomaltoside 1000 can be prepared by the above-discussed Andreasen prior art process. Specification at page 42, lines 24-25. It was also known in the prior art that Isomaltoside 1000 is the carbohydrate employed in the commercial product Monofer®.5
Withdrawal Claim Rejections – 35 USC § 102 (AIA )
Withdrawal § 102(a)(1) Rejection over Uniferon Offered for Sale on or before September 10, 2016
Rejection of claims 16-19 and 29-37 under 35 U.S.C. 102(a)(1) as being anticipated by Uniferon® on sale or otherwise available to the public on or before September 10, 2016 is withdrawn in view of Applicant’s amendments. The rejection is withdrawn because claim 16 has been amended to replace “wherein the iron is in a form selected from a water-soluble iron salt, an iron hydroxide, an iron oxidehydroxide, and a mixture thereof” with “iron chloride”. As such, Uniferon®, which is an aqueous preparation comprising the carbohydrate dextran and ferric oxide cannot meet the amended claim 16 limitation of iron chloride.
As stated in the previous Office action and as argued by Applicant (Reply at page 12), Uniferon® contains iron dextran (where the dextrin is, per Claim Interpretation above, a hydrogenated oligoisomaltose). However, there is no evidence of record that Uniferon® comprises iron chloride as required by amended claim 16. Therefore, Uniferon® on sale or otherwise available to the public on or before September 10, 2016 cannot be said to meet each and every limitation of claim 16 as amended.
Withdrawal § 102(a)(1) Rejection over Monofer® Offered for Sale on or before September 10, 2016
Rejection of claims 16-19, 27, and 29-37 and the elected species under 35 U.S.C. 102(a)(1) as being anticipated by Monofer® on sale or otherwise available to the public on or before September 10, 2016 is withdrawn in view of Applicant’s amendments for the same reasons as above. That is, there is no evidence of record that Monofer® on sale or otherwise available to the public on or before September 10, 2016 comprises iron chloride as required by independent claim 16, as amended. 6
Claim Rejections – 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 16, 19, and 27-43 are rejected under AIA 35 U.S.C. 103 as being unpatentable over either H. Andreasen, WO 2010/108493 (2010) (“Andreasen”) or K. Nordfjeld et al. Drug Design, Development and Therapy, 43-51 (2012) and/or Jahn et al., 78 European Journal of Pharmaceutics and Biopharmaceutics, 480-491 (2011) (“Jahn”), in view of secondary references W. McEwan et al., US 4,056,386 (1977) (“McEwan”); E. Ladd, US 2,096,855 (1937), L. Sklokin et al., WO 02/02833 (2002) (“Sklokin”); S. Wadhawan et al., WO 99/43408 (1999) (“Wadhawan”); M. Bauer et al., 6 European Journal of Pharmaceutical Sciences, 331-335 (1998) and/or US Pharmacopeia, <232> Elemental Impurities—Limits (USP 39) (2015) (“USP-232”).
Amended and new claims 28 and 43 are obvious, as above, in further view of H. Andreasen et al., US 6,291,440 (2001) (“Andreasen-2”)
H. Andreasen, WO 2010/108493 (2010) (“Andreasen”)
Andreasen teaches an iron oligosaccharide compound with enhanced stability suitable for entering into compositions for the treatment or prophylaxis of iron deficiency anemia. Andreasen at page 3, lines 26-29.
Andreasen teaches that preparation of an iron oligosaccharide comprises combining a fractionated hydrogenated oligosaccharide as an aqueous solution with at least one water-soluble ferric salt, adding base to the resulting aqueous solution to form ferric hydroxide, and heating the resultant basic solution to transform the ferric hydroxide into ferric oxyhydroxide in association with said oligosaccharide. Andreasen at page 8, lines 1-10. Andreasen teaches that a preferred water-soluble ferric salt is ferric chloride. Andreasen at page 10, lines 31-33.
Andresen’s Two Working Examples
In the first working example, Andresen teaches hydrolysis and hydrogenation of dextran by a first hydrolysis at pH 1.5 and a temperature of 95°C, followed by reduction with sodium borohydride. Andreasen at page 14, lines 1-24. Andresen’s dextrin is, per Claim Interpretation above, a “hydrogenated oligoisomaltose” as required by claim 16.
In the second working example, Andreasen teaches preparation of iron dextran powder by mixing the above hydrogenated dextran with FeCl3 and Na2CO3/NaOH. Andreasen at page 15 (“Synthesis of iron-dextran”). The Andreasen working example synthesis of iron dextran powder7 is summarized by the Examiner as follows.
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Andreasen at page 15 (“Synthesis of iron-dextran”).
Most relevant to the instant § 103 rejection is Andreasen’s following step of this preparation:
Synthesis of iron-dextran
120 kg dextran as produced above is mixed as an 18% solution with 150 kg FeCl3, 6 H2O. To the agitated mixture, 93 kg Na2CO3 as a saturated aqueous solution is added, whereupon the pH is raised to 10.5 5 using 24 litres of concentrated aqueous NaOH (27 %(w/v)).
Andreasen at page 15, lines 1-5. Andreasen’s above aqueous preparation of FeCl3 and dextran (which is a hydrogenated oligoisomaltose) clearly meets all claim 16 limitations, except that it is not clear whether or not Andreasen meets the claim 16 purity limitations in strikeout text below:
16. An aqueous preparation comprising a carbohydrate and iron,
wherein the carbohydrate is oligoisomaltose or hydrogenated oligoisomaltose and
the iron is in the form of iron chloride
Differences between Andreasen and Claims
As noted above, Andreasen’s working Example aqueous preparation of FeCl3 and dextran (which is a hydrogenated oligoisomaltose) differs from claim 16 only in that it is not clear whether or not the following claim 16 purity limitations are met.
Claim 16 . . . wherein
- the amount of arsenic in the preparation does not exceed 4.5 μg per g iron
and the amount of lead in the iron preparation does not exceed 1.5 μg per g iron.
K. Nordfjeld et al. Drug Design, Development and Therapy, 43-51 (2012)
Nordfjeld teaches that iron isomaltoside 1000 (Monofer®; Pharmacosmos A/S, Holbaek, Denmark) is a new chemical structure developed by complexing ferric hydroxide with isomaltoside 1000”. Nordfjeld at pages 43-44. Nordfjeld teaches that Monofer is useful to treat patients with either chronic kidney disease or chronic heart failure suffering from iron-deficiency anemia. Nordfjeld at page 50, col. 1. As discussed in detail above, Monofer comprises ferric hydroxide (i.e., Fe(OH)3) and the elected species hydrogenated oligoisomaltose (elected carbohydrate species).
Jahn et al., 78 European Journal of Pharmaceutics and Biopharmaceutics, 480-491 (2011) (“Jahn”)
Jahn teaches the structural identity of isomaltoside 1000. Jahn teaches that:
The carbohydrate isomaltoside 1000 is a pure linear chemical structure of repeating a1-6 linked glucose units, with an average size of 5.2 glucose units and an average molecular weight of 1000 Da, respectively. It is a nonbranched, nonanaphylactic carbohydrate [16,17], structurally different from branched polysaccharides used in iron dextran (Cosmofer).
Jahn at page 481, col. 1. Note that specification acknowledges that isomaltoside 1000 can be prepared according to H. Andreasen, WO 2010/108493 (2010) (“Andreasen”). Specification at page 42, lines 24-25.
W. McEwan et al., US 4,056,386 (1977) (“McEwan”)
W. McEwan et al., US 4,056,386 (1977) (“McEwan”) teaches that when iron pentacarbonyl is decomposed into free iron and carbon monoxide, the resulting iron is of very high purity and because of the high purity, the iron is in demand for use wherever very pure iron is needed. McEwan at col. 1., lines 14-17. McEwan teaches decomposition of iron pentacarbonyl by heating and contacting with a catalytic gas mixture. Ewan at Example 2. McEwan teaches that if extremely pure iron is desired it may be preferable to use either H2 or NH3 as the catalytic gas. McEwan at col. 4, lines 6-8. This is the same procedure taught in the instant specification for preparation of the iron used as a starting material for FeCl3. Specification at page 8, lines 30-35.
E. Ladd, US 2,096,855 (1937)
E. Ladd, US 2,096,855 (1937) teaches preparation of ferric chloride (FeCl3) by reaction of iron with chlorine gas continuously by the addition of iron, water and chlorine; that the process can be economically carried out in a simple and compact apparatus of large capacity. Ladd at page 1, col. 1, lines 5-15.
L. Sklokin et al., WO 02/02833 (2002) (“Sklokin”) and S. Wadhawan et al., WO 99/43408 (1999) (“Wadhawan”) – High purity FeCl3
Sklokin teaches preparing high-purity ferric chloride from hydrochloric solutions containing impurities. Abstract. Sklokin teaches that As an extracting agent use is made of aliphatic alcohol, predominantly octanol-1, octanol-2, 2-ethylgexanol, and decanol-1 or their mixtures. Abstract. In working Example 1, Sklokin teaches preparing ferric chloride solution from a feed hydrochloric acid solution of ferric chloride produced as a result of leaching an iron-containing concentrate by hydrochloric acid. Sklokin at pages 19-20 (Example 1). The feed solution contains in kg/m3: 243.25 FeCl3, 75.0 HCI and impurities in g/m3 : 308 Al, 53.7 Ca, 1.6 Cu, 1.9 Cr, 34.3 Mn, 170 Na, 1.1 Ni, 9.1 P, 83 Si, 10.9 Zn. Id. The total content of impurity chlorides is in an amount of 1.633 kg/m3. Sklokin at page 19, last paragraph. As an extracting agent a commercial octanol-1 is used with alcohol content of 98%. Sklokin teaches that the ferric chloride recovery into the first stage liquor, as an end product, is 97.5%, FeCl3 content being 400 kg/m3. Id. Sklokin teaches that the residual content in the product of each impurity element is below sensibility limit of the ICP measuring device. Id.
Wadhawan teaches a process to purify ferrous or ferric chloride solutions with high amounts of impurities, especially impurities such as Ca, Na, Ma, V, Cr, Ni, and the like based on using a selective organic solvent that will selectively extract ferric chloride and leave the impurities in the raffinate. Wadhawan at page 5, lines 1-10. Wadhawan teaches that ferric chloride solution is transported to an extraction apparatus and the organic solvent that is preferably N-octanol is introduced to the extraction apparatus. Wadhawan at page 7, lines 5-10. Wadhawan teaches that solvent is removed from stripping apparatus 16 in line 28 and a pure solution of ferric chloride is removed in liquor line 30. Wadhawan at page 7, lines 10-15.
M. Bauer et al., 6 European Journal of Pharmaceutical Sciences, 331-335 (1998) (“Bauer”)
Bauer teaches that purity of pharmaceuticals is an important issue and that pharmaceuticals and that impurity profiles impart major consequences, in particular for the interpretation of toxicological and clinical studies. See Bauer at page 331, col. 1; page 332, col. 2.
US Pharmacopeia, <232> Elemental Impurities—Limits (USP 39) (2015) (“USP-232”)
The United States Pharmacopeia (USP) is a non-profit organization that sets and publishes quality standards for medicines, dietary supplements, and healthcare products in the United States, ensuring their identity, strength, quality, and purity.
USP-232 specifies limits for the amounts of elemental impurities in drug products. Elemental impurities include catalysts and environmental contaminants that may be present in drug substances, excipients, or drug products. USP-232, page 1. USP-232 teaches that due to the ubiquitous nature of arsenic, cadmium, lead, and mercury, they (at the minimum) must be considered in the risk assessment. USP-232, page 1.
USP-232 recommends consideration of the permissible daily exposures (PDEs) in Table 1. USP-232, page 1. USP-232, Table 1 indicates permissible parenteral daily doses of arsenic (15 μg/day), lead (5 μg/day), mercury (3 μg/day), cadmium (2 μg/day), and chromium (1100 μg/day). USP-232, page 2, Table 1.
USP-232 motivates one of ordinary skill to seek low to zero levels of arsenic, lead, mercury, cadmium, and chromium.
Obviousness Rationale -- Claims 16, 19, and 27-43
Claims 16, 19, and 27-43 and the elected species are obvious for the following reasons. One of ordinary skill is motivated to combine high-purity iron chloride (FeCl3), with either of the carbohydrates/ oligosaccharides: (1) hydrogenated dextran (as taught by Andreasen); or (2) isomaltoside 1000 (structure/composition taught by Jahn), according to Andreasen’s procedure:
Synthesis of iron-dextran
120 kg dextran as produced above is mixed as an 18% solution with 150 kg FeCl3, 6 H2O. To the agitated mixture, 93 kg Na2CO3 as a saturated aqueous solution is added, whereupon the pH is raised to 10.5 5 using 24 litres of concentrated aqueous NaOH (27 %(w/v)).
(Andreasen at page 15, lines 1-5) thereby forming the claim 16 “aqueous preparation”. One of ordinary skill is so motivated to combine the high-purity iron chloride (FeCl3) and carbohydrate with the goal that the FeCl3 reacts in situ to form high purity ferric oxyhydroxide, which then associates with the carbohydrate leading to either of the products: (1) ferric oxyhydroxide in association with the hydrogenated dextran as taught by Andreasen (Andreasen at page 8, lines 1-10); or (2) the product iron isomaltoside 1000 (Monofer®) as taught by Nordfjeld, in high purity. Since both of hydrogenated dextran and isomaltoside 1000 are (per claim 16) a “hydrogenated oligoisomaltose”, each and every limitation of independent claim 16 is met.
Respecting the purity limitations of claims 16, 29-35, and 38-42, one of ordinary skill is directly motivated to obtain low concentrations of the non-iron elements arsenic, lead, cadmium, mercury, aluminum, and chromium, as per claims 16, 29-35, and 38-42, because the end use is therapeutic administration and USP-232 specifies limits for the amounts of elemental impurities in drug products and teaches that due to the ubiquitous nature of arsenic, cadmium, lead, and mercury, they (at the minimum) must be considered in the risk assessment. 8 USP-232, page 1. Further, M. Bauer et al., 6 European Journal of Pharmaceutical Sciences, 331-335 (1998) teaches that purity of pharmaceuticals is an important issue and that pharmaceuticals and that impurity profiles impart major consequences, in particular for the interpretation of toxicological and clinical studies. See Bauer at page 331, col. 1; page 332, col. 2. Per above footnote 8, one of ordinary skill has suitable methods of obtaining high purity FeCl3, for example, as taught by McEwan, Ladd, Sklokin and Wadhawan for use in Andreasen as a suitable source of high-purity FeCl3. Note that McEwan’s synthesis of Fe0 is the same procedure taught in the instant specification for preparation of the iron used as a starting material for FeCl3 that in fact achieves the claimed purity levels. Specification at page 8, lines 30-35; see MPEP § 2112(IV). In sum, the instantly claimed purified form of Andreasen’s prior art product is obvious over the cited art because the claimed chemical compound or composition has the same utility as closely related materials in the prior art, and the prior art suggests the particular form or structure of the claimed material or suitable methods of obtaining that form or structure. MPEP § 2144.04(VIII) (se footnote 8 above). Alternatively, the instantly claimed levels of non-iron elements arsenic, lead, cadmium, mercury, aluminum, and chromium as claimed in 16, 29-35, and 38-42 are inherently met by the above proposed § 103 rationale because one of ordinary skill is directly motivated by USP-232 to employ high purity reagents in the first place. MPEP 2112(I) (citing Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999) (“[t]he discovery of a previously unappreciated property of a prior art composition . . . does not render the old composition patentably new to the discoverer")).
The limitations of claim 19 are met because the proposed FeCl3 is ferric chloride.
The limitations of claim 27 are met because the alternatively proposed carbohydrates (i.e., hydrogenated dextran or isomaltoside 1000) are both a hydrogenated oligoisomaltose. See Claim Interpretation above.
Claim 28 requiring “wherein the carbohydrate has a weight average molecular weight (Mw) of from 700 Dato 1,400 Da” is obvious for the following reasons. H. Andreasen et al., US 6,291,440 (2001) (“Andreasen-2”) teaches that the molecular weight of dextrans is an important consideration (i.e., a result-effective variable) relevant to the risk for anaphylactic reactions when infusing clinical dextrans. Andreasen-2 at col. 3, lines 49-56 (emphasis added). Andreasen-2 teaches iron-dextran compounds having an extremely low frequency of non-desired side effects and being satisfactory stable, also during sterilization and storage as aqueous solutions, which iron-dextran compound can be used as component in a therapeutical composition for prophylaxis or treatment of iron-deficiency in animal or human Subjects by parenteral administration, the iron-dextran compound being characterized in that it comprises hydrogenated dextran having a weight average molecular weight (Mw) between 700 and 1,400 Daltons, preferably approximately 1,000 Daltons. Andreasen-2 at col. 4, lines 54-65. In working Example 1, Andreasen-2 teaches hydrolysis and hydrogenation of dextran, which appears to be the same procedure cited above in Andreasen-1 (although more detailed) to give the dextran product where Mw is found to be 1,217 Daltons. Thus claim 28 is obvious because one of ordinary skill is motivated to optimize the carbohydrate molecular weight to within the claim 28 range because this is the same range taught by Andreasen-2. MPEP § 2144.05(I) (in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art a prima facie case of obviousness exists). Further, Andreasen-2 clearly teaches one of ordinary skill that carbohydrate molecular weight is a result-effective variable. MPEP § 2144.04(II)(A). One of ordinary skill is motivated to develop workable or optimum ranges for result-effective parameters. MPEP § 2144.04(II)(A). See In re Boesch, 617 F.2d 272,276 (CCPA 1980); In re Aller, 220 F.2d 454, 456 (CCPA 1955).
The further purity limitations of claims 29-35 are obvious for the reasons discussed in detail above.
Claims 36 and 37 are claimed using ‘nested’ product-by-process language. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. MPEP § 2113(I); Biogen MA Inc. v. EMD Serono, Inc., 976 F.3d 1326, 1334 (Fed. Cir. 2020) (“[t]he nesting of the product-by-process limitation within a method . . . claim does not change the proper construction of the product-by-process limitation itself”); see also non-binding, non-precedential opinion in Ex parte Wohaibi, Appeal No. 2024-004112, 17/750,212 (PTAB 2025) discussing this Federal Circuit decision. Claims 36 and 37 are therefore obvious over the cited art because the product-by-process limitation of how the iron is obtained (or prepared) cannot distinguish from the cited art. MPEP § 2113(I). Alternatively, one of ordinary skill is motivated to obtain the iron from iron pentacarbonyl (per claim 36) because McEwan teaches that when iron pentacarbonyl is decomposed into free iron and carbon monoxide, the resulting iron is of very high purity and because of the high purity, the iron is in demand for use wherever very pure iron is needed. McEwan at col. 1., lines 14-17. And (per claim 37) one of ordinary skill is motivated to purify the FeCl3 by extracting an aqueous iron salt solution with 1-octanol because Sklokin/ Wadhawan teach one of ordinary skill that such method is suitable to obtain high-purity FeCl3, where Sklokin teaches that such extraction procedure results in high purity FeCl3 where the residual content in the product of Al, Ca, Cu, Cr, Mn, Na, Ni, P, Si, and Zn is below sensibility limit of the ICP measuring device. Sklokin at page 20, last two lines of Example 1.
The further purity limitations of claims 38-42 are obvious for the reasons discussed in detail above.
Claim 43 is obvious for the same reasons discussed for claim 28 above. That is, H. Andreasen et al., US 6,291,440 (2001) (“Andreasen-2”) teaches that the molecular weight of dextrans is an important consideration (i.e., a result-effective variable) relevant to the risk for anaphylactic reactions when infusing clinical dextrans. Andreasen-2 at col. 3, lines 49-56 (emphasis added). Andreasen-2 teaches iron-dextran compounds having an extremely low frequency of non-desired side effects and being satisfactory stable, also during sterilization and storage as aqueous solutions, which iron-dextran compound can be used as component in a therapeutical composition for prophylaxis or treatment of iron-deficiency in animal or human Subjects by parenteral administration, the iron-dextran compound being characterized in that it comprises hydrogenated dextran having a weight average molecular weight (Mw) between 700 and 1,400 Daltons, preferably approximately 1,000 Daltons. Andreasen-2 at col. 4, lines 54-65. Thus, Andreasen-2 directly suggest the claim 43 limitation of “wherein the carbohydrate has a weight average molecular weight (Mw) of about 1,000 Da”. Claim 28 43 obvious because one of ordinary skill is motivated to optimize the carbohydrate molecular weight to within the claim 43 range because this is the same range taught by Andreasen-2. MPEP § 2144.05(I) (in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art a prima facie case of obviousness exists).
APPLICANT’S ARGUMENT RESPECTING THE § 103 REJECTION
Applicant’s arguments, directed to the claims as amended, are addressed in the § 103 analysis above, which required supplementation in view of the amendments. The following points are noted.
Applicant’s Argument that the Cited Art Does Not Teach Each and Every Claim Limitation
Applicant argues that the § 103 rejection is deficient because the cited references fail to disclose or suggest the recited levels of lead and arsenic. Applicant argues that the only cited document which even mentions lead and arsenic at all is U.S.P-232, which permits significantly higher levels of lead and arsenic than those claimed. Reply at page 18, last paragraph. Applicant agues that a proper prima facie case of obviousness requires identification of reference disclosures that actually teach or suggest all elements and limitations of the claims at issue.
This argument is not persuasive because factors to be considered in determining whether a purified form of an old product is obvious over the prior art include whether the claimed chemical compound or composition has the same utility as closely related materials in the prior art, and whether the prior art suggests the particular form or structure of the claimed material or suitable methods of obtaining that form or structure. MPEP § 2144.04(VIII) (citing Ex parte Stern, 13 USPQ2d 1379 (Bd. Pat. App. & Inter. 1987). The instantly claimed purified form of Andreasen’s prior art product is obvious over the cited art because the claimed “aqueous preparation” is the staring material for a product having the same utility as closely related materials in the prior art, and the prior art suggests the particular form or structure of the claimed material or suitable methods of obtaining that form or structure. MPEP § 2144.04(VIII) (see footnote 8 above). Here, although USP-232 U.S.P-232, may permit higher levels of lead and arsenic than those claimed, one of ordinary skill is motivated to achieve lower levels approaching zero. When making a determination of obviousness should be on what a person of ordinary skill in the pertinent art would have known at the relevant time, and on what such a person would have reasonably expected to have been able to do in view of that knowledge; regardless of whether the source of that knowledge and ability was documentary prior art, general knowledge in the art, or common sense. MPEP § 2141(II) (discussing the flexible approach of KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007)).
Applicant argues that even assuming they would have been so incentivized (for which Applicant strongly disagrees), the references do not provide a reasonable expectation that such combined methods would necessarily or predictably have resulted in iron chloride containing the specific low levels of arsenic and lead required by Applicant's claims. Reply at paragraph bridging pages 19-20.
This argument is not persuasive because the motivation is not to achieve the specific levels of non-iron elements claimed, but rather reduce these levels to as low as possible (approaching zero) in view of the utility of therapeutic administration. One of ordinary skill has a reasonable expectation that such can be accomplished because McEwen teaches “highly pure iron”. McEwan at col. 4, lines 6-8. Further, this is the same procedure taught in the instant specification for preparation of the iron used as a starting material for FeCl3. Specification at page 8, lines 30-35. Thus, the instantly claimed levels of non-iron elements arsenic, lead, cadmium, mercury, aluminum, and chromium as claimed in 16, 29-35, and 38-42 are inherently met by the above proposed § 103 rationale because one of ordinary skill is directly motivated by USP-232 to employ McEwen’s highly pure iron and thereafter use highly pure reagents to covert the iron to FeCl3 (for example, use highly purified chlorine and FeCl3 --where highly pure FeCl3 is taught by Sklokin/Wadhawan-- in the process of Ladd). Although Applicant may have determined the prior art processes for arriving at pure FeCl3, in fact, achieve in the claimed purity levels, this property of an old product does not render the old product patentably new. MPEP 2112(I) (citing Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999) (“[t]he discovery of a previously unappreciated property of a prior art composition . . . does not render the old composition patentably new to the discoverer")).
Applicant argues that in fact, in the absence of any teaching to the contrary, the reagents used in Ladd could function oppositely, i.e., by providing a further source of additional non-iron metals, including lead and/or arsenic.
This argument is not persuasive because one of ordinary skill is directly motivated by USP-232 to employ McEwen’s highly pure iron and thereafter use highly pure reagents to covert the iron to FeCl3 (for example, use highly purified chlorine and FeCl3 --where highly pure FeCl3 is taught by Sklokin/Wadhawan-- in the process of Ladd).
Applicant’s Argument that the Cited Art does not Motivate One of Ordinary Skill to Arrive at the Claimed Invention
Applicant argues that Bauer also does not mention any of the claimed non-iron metals as possible impurities, therefore, in the absence of any mention of the claimed non-iron metals, or a permitted daily human dose of these non-iron metals, Bauer would not motivate a skilled person to limit the levels of arsenic and lead to the levels defined in claim 16. Reply at page 24, first paragraph.
This argument is not persuasive because one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. MPEP § 2145 (IV). Bauer was cited as a general reference, one of ordinary skill is directly motivated to obtain low concentrations of the non-iron elements arsenic, lead, cadmium, mercury, aluminum, and chromium, as per claims 16, 29-35, and 38-42, because the end use is therapeutic administration and USP-232 specifies limits for the amounts of elemental impurities in drug products and teaches that due to the ubiquitous nature of arsenic, cadmium, lead, and mercury, they (at the minimum) must be considered in the risk assessment. USP-232, page 1.
Applicant argues that view of then-accepted guidance regarding arsenic and lead levels, as e.g., established by the British Pharmacopoeia, and the U.S.P-232 guidance document cited above, absent any evidence of toxicity issues, a skilled person would not have had any motivation to exceed the levels of the claimed non-iron metals specified in then-accepted regulatory agency guidance, and most certainly would have had no reason to seek a level thereof much lower than the maximum then-accepted by drug regulators and manufacturers, which (as noted above) greatly exceeded the maximum levels required by Applicant's claims. Reply at page 27, 3rd paragraph.
This argument is not persuasive because the motivation is not to achieve the specific levels of non-iron elements claimed, but rather reduce these levels to as low as possible (approaching zero) in view of the utility of therapeutic administration. One of ordinary skill has a reasonable expectation that such can be accomplished because McEwen teaches “highly pure iron”. McEwan at col. 4, lines 6-8. Further, this is the same procedure taught in the instant specification for preparation of the iron used as a starting material for FeCl3. Specification at page 8, lines 30-35. Thus, the instantly claimed levels of non-iron elements arsenic, lead, cadmium, mercury, aluminum, and chromium as claimed in 16, 29-35, and 38-42 are inherently met by the above proposed § 103 rationale because one of ordinary skill is directly motivated by USP-232 to employ McEwen’s highly pure iron and thereafter use highly pure reagents to covert the iron to FeCl3 (for example, use highly purified chlorine and FeCl3 --where highly pure FeCl3 is taught by Sklokin/Wadhawan-- in the process of Ladd). Although Applicant may have determined the prior art processes for arriving at pure FeCl3, in fact, achieve in the claimed purity levels, this property of an old product does not render the old product patentably new. MPEP 2112(I) (citing Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999) (“[t]he discovery of a previously unappreciated property of a prior art composition . . . does not render the old composition patentably new to the discoverer")).
Applicant’s Argument that the Claimed Aqueous Preparation Achieves Unexpected Results
Applicant argues that as of the effective filing date, as evidenced by "Q3D Elemental Impurities Guidance for Industry", 15 December 2014, pg. 40 (hereinafter "Q3D"), submitted herewith, the permissible daily exposure of lead was 5μg per day, which dosage was estimated to result in a target blood level of 1-2 μg/dl of lead. Reply at page 28. Accordingly, the accepted view by drug regulators was that this dosage was acceptable and posed a minimal risk. Reply at page 28. However, Applicant argues that Fig. 1 in Lanphear et al. (Lancet Public Health, 2017, 3:e177-184 (hereinafter "Lanphear"), published after the effective filing date of the subject application, shows that even blood lead levels of lead as low as 1-2 μg/dL may be associated with an enhanced hazard ratio for (A) all-cause mortality, (B) cardiovascular disease mortality, and (C) ischemic heart disease. Reply at page 29. Applicant argues that accordingly, the present invention addresses this then-unappreciated problem. Id.
This argument is not persuasive for the following reasons. Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. MPEP § 716.02(b)(III). Further, an affidavit or declaration under 37 CFR 1.132 also must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. MPEP § 716.02(e). The burden is on Appellant to establish that the evidence relied upon demonstrates that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance. MPEP § 716.02(b). Here, Applicant has not presented a comparison of the claimed aqueous preparation with the closest prior art. Rather, Applicant proffers that the claimed invention achieves lower lead values than suggested by "Q3D Elemental Impurities Guidance for Industry", 15 December 2014, pg. 40. Applicant has not addressed whether this result is unexpected, and therefore has not met its burden MPEP § 716.02(b). Further, Lanphear et al. (Lancet Public Health, 2017, 3:e177-184 cannot be considered in an analysis of unexpected results. Per MPEP § 716, the patent rules (i.e., 37 CFR 1.68) permit a declaration to be used instead of an affidavit. MPEP § 716. The declaration must include an acknowledgment by the declarant that willful false statements and the like are punishable by fine or imprisonment, or both (18 U.S.C. 1001) and may jeopardize the validity of the application or any patent issuing thereon. MPEP § 716. The declarant must set forth in the body of the declaration that all statements made of the declarant’s own knowledge are true and that all statements made on information and belief are believed to be true. MPEP § 716. Lanphear does not meet these requirements. Further, Lanphear cannot be considered in any obviousness analysis because it is a post-filing date reference.
Non-Statutory 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 conflicting claims 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 Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
Nonstatutory Double Patenting Rejection over T. Christensen et al., US 11,111,261 (2021)
Claims 16-19, 27 and 29-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over conflicting claim 24 of T. Christensen et al., US 11,111,261 (2021) for the following reasons. The product recited in conflicting claim 24 (as prepared by the process of its conflicting base claim 1), which is the elected species of the current application, clearly anticipates instant claims 19, 27 and 29-37, including the purity limitations.
Provisional Nonstatutory Double Patenting Rejection over C. Strom et al., US 17/421,481 (2020)
Claims 16-19, 27 and 29-37 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over conflicting claim 1 of C. Strom et al., US 17/421,481 (2020), published as US 2022/0062331 (2022) for the following reasons. Conflicting claim 1 teaches treating iron deficiency comprising administering an amount of iron isomaltoside. As discussed above, iron isomaltoside 1000 (i.e., Monofer®), includes hydrogenated oligoisomaltose as the carbohydrate.
Conflicting claim 1’s disclosure of iron isomaltoside meets each and every limitation of instant claims16-19, 27 and 29-37 except the claimed levels of non-iron metal species of arsenic, aluminum, lead, mercury, cadmium, and chromium as claimed in 16-19, 27 and 29-37; for example, per claim 16:
16 . . . wherein the amount of arsenic in the preparation does not exceed 4.5 μg per g iron
and the amount of lead in the iron preparation does not exceed 1.5 μg per g iron,
or the amount of aluminum in the iron preparation does not exceed 200 μg per g iron.
Instant claims 16-19, 27 and 29-37 are patentably indistinct from conflicting claim 1 because one of ordinary skill is motivated by conflicting claim 1 to prepare iron isomaltoside meeting the instantly claimed purity limitations in view of secondary references H. Andreasen, WO 2010/108493 (2010) (“Andreasen”) or K. Nordfjeld et al. Drug Design, Development and Therapy, 43-51 (2012); W. McEwan et al., US 4,056,386 (1977) (“McEwan”); E. Ladd, US 2,096,855 (1937), M. Bauer et al., 6 European Journal of Pharmaceutical Sciences, 331-335 (1998) and/or US Pharmacopeia, <232> Elemental Impurities—Limits (USP 39) (2015) (“USP-232”), for the same reasons discussed above in the § 103 rejection.
Nonstatutory Double Patenting Rejection over T. Christensen et al., US 11,020,369 (2021)
Claims 16-19, 27 and 29-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over conflicting claim 1 of T. Christensen et al., US 11,020,369 (2021) for the following reasons. Conflicting claim 1 claims a method to treat iron deficiency comprising administering ferric carboxymaltose. Ferric carboxymaltose consists of a polynuclear Fe(III)-oxyhydroxide core surrounded by carboxymaltose which is derived from maltodextrin, an oligosaccharide produced from starch.
Conflicting claim 1’s disclosure of ferric carboxymaltose meets each and every limitation of instant claims16-19, 27 and 29-37 except the claimed levels of non-iron metal species of arsenic, aluminum, lead, mercury, cadmium, and chromium as claimed in 16-19, 27 and 29-37; for example, per claim 16:
16 . . . wherein the amount of arsenic in the preparation does not exceed 4.5 μg per g iron
and the amount of lead in the iron preparation does not exceed 1.5 μg per g iron,
or the amount of aluminum in the iron preparation does not exceed 200 μg per g iron.
Instant claims 16-19, 27 and 29-37 are patentably indistinct from conflicting claim 1 because one of ordinary skill is motivated by conflicting claim 1 to prepare ferric carboxymaltose meeting the instantly claimed purity limitations in view of secondary references H. Andreasen, WO 2010/108493 (2010) (“Andreasen”) or K. Nordfjeld et al. Drug Design, Development and Therapy, 43-51 (2012); W. McEwan et al., US 4,056,386 (1977) (“McEwan”); E. Ladd, US 2,096,855 (1937), M. Bauer et al., 6 European Journal of Pharmaceutical Sciences, 331-335 (1998) and/or US Pharmacopeia, <232> Elemental Impurities—Limits (USP 39) (2015) (“USP-232”), for the same reasons discussed above in the § 103 rejection.
Nonstatutory Double Patenting Rejection over T. Christensen et al., US 11,806,329 (2023)
Claims 16-19, 27 and 29-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over conflicting claim 1 of T. Christensen et al., US 11,806,329 (2023) for the following reasons. Conflicting claim 1 claims a method to treat iron deficiency comprising administering ferric carboxymaltose. Ferric carboxymaltose consists of a polynuclear Fe(III)-oxyhydroxide core surrounded by carboxymaltose which is derived from maltodextrin, an oligosaccharide produced from starch.
Conflicting claim 1’s disclosure of ferric carboxymaltose meets each and every limitation of instant claims16-19, 27 and 29-37 except the claimed levels of non-iron metal species of arsenic, aluminum, lead, mercury, cadmium, and chromium as claimed in 16-19, 27 and 29-37; for example, per claim 16:
16 . . . wherein the amount of arsenic in the preparation does not exceed 4.5 μg per g iron
and the amount of lead in the iron preparation does not exceed 1.5 μg per g iron,
or the amount of aluminum in the iron preparation does not exceed 200 μg per g iron.
Instant claims 16-19, 27 and 29-37 are patentably indistinct from conflicting claim 1 because one of ordinary skill is motivated by conflicting claim 1 to prepare ferric carboxymaltose meeting the instantly claimed purity limitations in view of secondary references H. Andreasen, WO 2010/108493 (2010) (“Andreasen”) or K. Nordfjeld et al. Drug Design, Development and Therapy, 43-51 (2012); W. McEwan et al., US 4,056,386 (1977) (“McEwan”); E. Ladd, US 2,096,855 (1937), M. Bauer et al., 6 European Journal of Pharmaceutical Sciences, 331-335 (1998) and/or US Pharmacopeia, <232> Elemental Impurities—Limits (USP 39) (2015) (“USP-232”), for the same reasons discussed above in the § 103 rejection.
Provisional Nonstatutory Double Patenting Rejection over T. Christensen et al., US 18/370,926 (2023)
Claims 16-19, 27 and 29-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over conflicting claim 1 of T. Christensen et al., US 18/370,926 (2023), published as US 2024/0058295 (2024). The rejection is provisional because the conflicting claims have not been patented. Conflicting claim 1 claims a method to treat iron deficiency comprising administering ferric carboxymaltose. Ferric carboxymaltose consists of a polynuclear Fe(III)-oxyhydroxide core surrounded by carboxymaltose which is derived from maltodextrin, an oligosaccharide produced from starch.
Conflicting claim 1’s disclosure of ferric carboxymaltose meets each and every limitation of instant claims16-19, 27 and 29-37 except the claimed levels of non-iron metal species of arsenic, aluminum, lead, mercury, cadmium, and chromium as claimed in 16-19, 27 and 29-37; for example, per claim 16:
16 . . . wherein the amount of arsenic in the preparation does not exceed 4.5 μg per g iron
and the amount of lead in the iron preparation does not exceed 1.5 μg per g iron,
or the amount of aluminum in the iron preparation does not exceed 200 μg per g iron.
Instant claims 16-19, 27 and 29-37 are patentably indistinct from conflicting claim 1 because one of ordinary skill is motivated by conflicting claim 1 to prepare ferric carboxymaltose meeting the instantly claimed purity limitations in view of secondary references H. Andreasen, WO 2010/108493 (2010) (“Andreasen”) or K. Nordfjeld et al. Drug Design, Development and Therapy, 43-51 (2012); W. McEwan et al., US 4,056,386 (1977) (“McEwan”); E. Ladd, US 2,096,855 (1937), M. Bauer et al., 6 European Journal of Pharmaceutical Sciences, 331-335 (1998) and/or US Pharmacopeia, <232> Elemental Impurities—Limits (USP 39) (2015) (“USP-232”), for the same reasons discussed above in the § 103 rejection.
Provisional Nonstatutory Double Patenting Rejection over T. Christensen et al., US 18/502,240 (2023)
Claims 16-19, 27 and 29-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over conflicting claim 1 of T. Christensen et al., US 18/502,240 (2023), published as US 2024/0075007 (2024). The rejection is provisional because the conflicting claims have not been patented. Conflicting claim 1 claims a method to treat iron deficiency comprising administering ferric carboxymaltose. Ferric carboxymaltose consists of a polynuclear Fe(III)-oxyhydroxide core surrounded by carboxymaltose which is derived from maltodextrin, an oligosaccharide produced from starch.
Conflicting claim 1’s disclosure of ferric carboxymaltose meets each and every limitation of instant claims16-19, 27 and 29-37 except the claimed levels of non-iron metal species of arsenic, aluminum, lead, mercury, cadmium, and chromium as claimed in 16-19, 27 and 29-37; for example, per claim 16:
16 . . . wherein the amount of arsenic in the preparation does not exceed 4.5 μg per g iron
and the amount of lead in the iron preparation does not exceed 1.5 μg per g iron,
or the amount of aluminum in the iron preparation does not exceed 200 μg per g iron.
Instant claims 16-19, 27 and 29-37 are patentably indistinct from conflicting claim 1 because one of ordinary skill is motivated by conflicting claim 1 to prepare ferric carboxymaltose meeting the instantly claimed purity limitations in view of secondary references H. Andreasen, WO 2010/108493 (2010) (“Andreasen”) or K. Nordfjeld et al. Drug Design, Development and Therapy, 43-51 (2012); W. McEwan et al., US 4,056,386 (1977) (“McEwan”); E. Ladd, US 2,096,855 (1937), M. Bauer et al., 6 European Journal of Pharmaceutical Sciences, 331-335 (1998) and/or US Pharmacopeia, <232> Elemental Impurities—Limits (USP 39) (2015) (“USP-232”), for the same reasons discussed above in the § 103 rejection.
Nonstatutory Double Patenting Rejection over L. Thomsen et al., US 10,960,081 (2021)
Claims 16-19, 27 and 29-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over conflicting claim 1 of L. Thomsen et al., US 10,960,081 (2021) for the following reasons. Conflicting claim 1 claims a method to treat iron deficiency comprising administering a pharmaceutical composition comprising an iron carbohydrate complex comprising an iron hydrogenated oligoisomaltoside.
Conflicting claim 1’s disclosure of iron carbohydrate complex comprising an iron hydrogenated oligoisomaltoside meets each and every limitation of instant claims16-19, 27 and 29-37 except the claimed levels of non-iron metal species of arsenic, aluminum, lead, mercury, cadmium, and chromium as claimed in 16-19, 27 and 29-37; for example, per claim 16:
16 . . . wherein the amount of arsenic in the preparation does not exceed 4.5 μg per g iron
and the amount of lead in the iron preparation does not exceed 1.5 μg per g iron,
or the amount of aluminum in the iron preparation does not exceed 200 μg per g iron.
Instant claims 16-19, 27 and 29-37 are patentably indistinct from conflicting claim 1 because one of ordinary skill is motivated by conflicting claim 1 to prepare an iron carbohydrate complex comprising an iron hydrogenated oligoisomaltoside meeting the instantly claimed purity limitations in view of secondary references H. Andreasen, WO 2010/108493 (2010) (“Andreasen”) or K. Nordfjeld et al. Drug Design, Development and Therapy, 43-51 (2012); W. McEwan et al., US 4,056,386 (1977) (“McEwan”); E. Ladd, US 2,096,855 (1937), M. Bauer et al., 6 European Journal of Pharmaceutical Sciences, 331-335 (1998) and/or US Pharmacopeia, <232> Elemental Impurities—Limits (USP 39) (2015) (“USP-232”), for the same reasons discussed above in the § 103 rejection.
Nonstatutory Double Patenting Rejection over L. Thomsen et al., US 11,633,489 (2023)
Claims 16-19, 27 and 29-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over conflicting claim 1 of L. Thomsen et al., US 11,633,489 (2023) for the following reasons. Conflicting claim 1 claims a method to treat iron deficiency comprising administering a pharmaceutical composition comprising an iron carbohydrate complex comprising an iron hydrogenated oligoisomaltoside.
Conflicting claim 1’s disclosure of iron carbohydrate complex comprising an iron hydrogenated oligoisomaltoside meets each and every limitation of instant claims16-19, 27 and 29-37 except the claimed levels of non-iron metal species of arsenic, aluminum, lead, mercury, cadmium, and chromium as claimed in 16-19, 27 and 29-37; for example, per claim 16:
16 . . . wherein the amount of arsenic in the preparation does not exceed 4.5 μg per g iron
and the amount of lead in the iron preparation does not exceed 1.5 μg per g iron,
or the amount of aluminum in the iron preparation does not exceed 200 μg per g iron.
Instant claims 16-19, 27 and 29-37 are patentably indistinct from conflicting claim 1 because one of ordinary skill is motivated by conflicting claim 1 to prepare an iron carbohydrate complex comprising an iron hydrogenated oligoisomaltoside meeting the instantly claimed purity limitations in view of secondary references H. Andreasen, WO 2010/108493 (2010) (“Andreasen”) or K. Nordfjeld et al. Drug Design, Development and Therapy, 43-51 (2012); W. McEwan et al., US 4,056,386 (1977) (“McEwan”); E. Ladd, US 2,096,855 (1937), M. Bauer et al., 6 European Journal of Pharmaceutical Sciences, 331-335 (1998) and/or US Pharmacopeia, <232> Elemental Impurities—Limits (USP 39) (2015) (“USP-232”), for the same reasons discussed above in the § 103 rejection.
Nonstatutory Double Patenting Rejection over L. Thomsen et al., US 11,040,064 (2021)
Claims 16-19, 27 and 29-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over conflicting claim 9 of L. Thomsen et al., US 11,040,064 (2021) for the following reasons. Conflicting claim 9 claims a method to treat restless leg syndrome comprising administering to the patient an effective amount of a pharmaceutical composition comprising an iron carbohydrate complex, where the carbohydrate is (1[Symbol font/0xAE]6)- α-D-glycopyranan-(1[Symbol font/0xAE]6)-α-D-glycitol (which is a hydrogenated oligoisomaltose).
Conflicting claim 9’s disclosure of the iron carbohydrate complex meets each and every limitation of instant claims16-19, 27 and 29-37 except the claimed levels of non-iron metal species of arsenic, aluminum, lead, mercury, cadmium, and chromium as claimed in 16-19, 27 and 29-37; for example, per claim 16:
16 . . . wherein the amount of arsenic in the preparation does not exceed 4.5 μg per g iron
and the amount of lead in the iron preparation does not exceed 1.5 μg per g iron,
or the amount of aluminum in the iron preparation does not exceed 200 μg per g iron.
Instant claims 16-19, 27 and 29-37 are patentably indistinct from conflicting claim 9 because one of ordinary skill is motivated by conflicting claim 9 to prepare an iron carbohydrate complex (where the carbohydrate is a hydrogenated oligoisomaltose) meeting the instantly claimed purity limitations in view of secondary references H. Andreasen, WO 2010/108493 (2010) (“Andreasen”) or K. Nordfjeld et al. Drug Design, Development and Therapy, 43-51 (2012); W. McEwan et al., US 4,056,386 (1977) (“McEwan”); E. Ladd, US 2,096,855 (1937), M. Bauer et al., 6 European Journal of Pharmaceutical Sciences, 331-335 (1998) and/or US Pharmacopeia, <232> Elemental Impurities—Limits (USP 39) (2015) (“USP-232”), for the same reasons discussed above in the § 103 rejection.
Nonstatutory Double Patenting Rejection over L. Thomsen et al., US 11,471,483 (2022)
Claims 16-19, 27 and 29-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over conflicting claim 8 of L. Thomsen et al., US 11,471,483 (2022) for the following reasons. Conflicting claim 8 claims a method to treat restless leg syndrome comprising administering to the patient an effective amount of a pharmaceutical composition comprising an iron carbohydrate complex, where the carbohydrate is (1[Symbol font/0xAE]6)- α-D-glycopyranan-(1[Symbol font/0xAE]6)-α-D-glycitol (which is a hydrogenated oligoisomaltose).
Conflicting claim 8’s disclosure of the iron carbohydrate complex meets each and every limitation of instant claims16-19, 27 and 29-37 except the claimed levels of non-iron metal species of arsenic, aluminum, lead, mercury, cadmium, and chromium as claimed in 16-19, 27 and 29-37; for example, per claim 16:
16 . . . wherein the amount of arsenic in the preparation does not exceed 4.5 μg per g iron
and the amount of lead in the iron preparation does not exceed 1.5 μg per g iron,
or the amount of aluminum in the iron preparation does not exceed 200 μg per g iron.
Instant claims 16-19, 27 and 29-37 are patentably indistinct from conflicting claim 8 because one of ordinary skill is motivated by conflicting claim 8 to prepare an iron carbohydrate complex (where the carbohydrate is a hydrogenated oligoisomaltose) meeting the instantly claimed purity limitations in view of secondary references H. Andreasen, WO 2010/108493 (2010) (“Andreasen”) or K. Nordfjeld et al. Drug Design, Development and Therapy, 43-51 (2012); W. McEwan et al., US 4,056,386 (1977) (“McEwan”); E. Ladd, US 2,096,855 (1937), M. Bauer et al., 6 European Journal of Pharmaceutical Sciences, 331-335 (1998) and/or US Pharmacopeia, <232> Elemental Impurities—Limits (USP 39) (2015) (“USP-232”), for the same reasons discussed above in the § 103 rejection.
Nonstatutory Double Patenting Rejection over C. von der Recke et al., US 11,040,059 (2021)
Claims 16-19, 27 and 29-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over conflicting claim 7 of C. von der Recke et al., US 11,040,059 (2021) for the following reasons. Conflicting claim 7 claims a method of increasing the blood haemoglobin concentration comprising administering iron carbohydrate complex, where the carbohydrate is a hydrogenated polymaltose.
Conflicting claim 7’s disclosure of the iron carbohydrate complex meets each and every limitation of instant claims16-19, 27 and 29-37 except the claimed levels of non-iron metal species of arsenic, aluminum, lead, mercury, cadmium, and chromium as claimed in 16-19, 27 and 29-37; for example, per claim 16:
16 . . . wherein the amount of arsenic in the preparation does not exceed 4.5 μg per g iron
and the amount of lead in the iron preparation does not exceed 1.5 μg per g iron,
or the amount of aluminum in the iron preparation does not exceed 200 μg per g iron.
Instant claims 16-19, 27 and 29-37 are patentably indistinct from conflicting claim 7 because one of ordinary skill is motivated by conflicting claim 7 to prepare an iron carbohydrate complex (where the carbohydrate is a hydrogenated polymaltose) meeting the instantly claimed purity limitations in view of secondary references H. Andreasen, WO 2010/108493 (2010) (“Andreasen”) or K. Nordfjeld et al. Drug Design, Development and Therapy, 43-51 (2012); W. McEwan et al., US 4,056,386 (1977) (“McEwan”); E. Ladd, US 2,096,855 (1937), M. Bauer et al., 6 European Journal of Pharmaceutical Sciences, 331-335 (1998) and/or US Pharmacopeia, <232> Elemental Impurities—Limits (USP 39) (2015) (“USP-232”), for the same reasons discussed above in the § 103 rejection.
Nonstatutory Double Patenting Rejection over H. Andreasen et al., US 8,815,301 (2014)
Claims 16-19, 27 and 29-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over conflicting claim 19 of H. Andreasen et al., US 8,815,301 (2014) for the following reasons. Conflicting claim 19 claims a method of preventing or treating iron-deficiency anaemia comprising administering an iron oligosaccharide compound comprising a hydrogenated oligosaccharide in stable association with ferric oxyhydroxide.
Conflicting claim 19’s disclosure of the iron carbohydrate complex meets each and every limitation of instant claims16-19, 27 and 29-37 except the claimed levels of non-iron metal species of arsenic, aluminum, lead, mercury, cadmium, and chromium as claimed in 16-19, 27 and 29-37; for example, per claim 16:
16 . . . wherein the amount of arsenic in the preparation does not exceed 4.5 μg per g iron
and the amount of lead in the iron preparation does not exceed 1.5 μg per g iron,
or the amount of aluminum in the iron preparation does not exceed 200 μg per g iron.
Instant claims 16-19, 27 and 29-37 are patentably indistinct from conflicting claim 19 because one of ordinary skill is motivated by conflicting claim 19 to prepare an iron carbohydrate complex (where the carbohydrate is a hydrogenated polymaltose) meeting the instantly claimed purity limitations in view of secondary references M. Bauer et al., 6 European Journal of Pharmaceutical Sciences, 331-335 (1998); W. McEwan et al., US 4,056,386 (1977) (“McEwan”); E. Ladd, US 2,096,855 (1937).
The rational is obviousness for the same reasons discussed above in the § 103 rejection. That is, one of ordinary skill is motivated to use the Iron (Fe0) as taught by McEwan, and thereafter convert the McEwan Fe0 to FeCl3 as taught by Ladd for use in synthesis of the conflicting claim 19 iron oligosaccharide simply as a suitable source of FeCl3. One of ordinary skill thereby necessarily achieves the instantly claimed levels of non-iron elements arsenic, aluminum, lead, mercury, cadmium, and chromium as claimed in 16-19 and 29-37. The rational is combining prior art elements according to known methods to yield predictable results. MPEP § 2143(I)(A). The motivation to combine the cited references need not be to specifically to reduce trace metal impurities. Rather, the more general motivation to combine the cited art is to employ pure reagents/starting materials (e.g., the pure iron as disclosed by McEwan) in pharmaceutical compositions prepared according well-established prior art procedures. For example, M. Bauer et al., 6 European Journal of Pharmaceutical Sciences, 331-335 (1998) teaches that purity of pharmaceuticals is an important issue and that pharmaceuticals and that impurity profiles impart major consequences, in particular for the interpretation of toxicological and clinical studies. See Bauer at page 331, col. 1; page 332, col. 2. Here, the reference combination necessarily results in the claimed purity levels. See MPEP § 2144(IV) (the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem and it is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant; citing, In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention).
Nonstatutory Double Patenting Rejection over H. Andreasen et al., US 10,414,831 (2019)
Claims 16-19, 27 and 29-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over conflicting claim 2 of H. Andreasen et al., US 10,414,831 (2019) for the following reasons. Conflicting claim 2 claims iron oligosaccharide compound comprising a hydrogenated oligosaccharide in stable association with ferric oxyhydroxide, wherein said hydrogenated oligosaccharide comprises a mixture of hydrogenated dextran oligosaccharides.
Conflicting claim 2’s disclosure of the iron carbohydrate complex meets each and every limitation of instant claims16-19, 27 and 29-37 except the claimed levels of non-iron metal species of arsenic, aluminum, lead, mercury, cadmium, and chromium as claimed in 16-19, 27 and 29-37; for example, per claim 16:
16 . . . wherein the amount of arsenic in the preparation does not exceed 4.5 μg per g iron
and the amount of lead in the iron preparation does not exceed 1.5 μg per g iron,
or the amount of aluminum in the iron preparation does not exceed 200 μg per g iron.
Instant claims 16-19, 27 and 29-37 are patentably indistinct from conflicting claim 2 because one of ordinary skill is motivated by conflicting claim 2 to prepare an iron carbohydrate complex (where the carbohydrate is a hydrogenated dextran oligosaccharide) meeting the instantly claimed purity limitations in view of secondary references M. Bauer et al., 6 European Journal of Pharmaceutical Sciences, 331-335 (1998); W. McEwan et al., US 4,056,386 (1977) (“McEwan”); E. Ladd, US 2,096,855 (1937).9
The rational is obviousness for the same reasons discussed above in for US 8,815,301 (2014).
Nonstatutory Double Patenting Rejection over H. Andreasen et al., US 11,851,504 (2023)
Claims 16-19, 27 and 29-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over conflicting claim 1 of H. Andreasen et al., US 11,851,504 (2023) for the following reasons. Conflicting claim 1 claims iron oligosaccharide compound comprising a hydrogenated oligosaccharide in stable association with ferric oxyhydroxide, wherein said hydrogenated oligosaccharide is derived from dextran.
Conflicting claim 1’s disclosure of the iron carbohydrate complex meets each and every limitation of instant claims16-19, 27 and 29-37 except the claimed levels of non-iron metal species of arsenic, aluminum, lead, mercury, cadmium, and chromium as claimed in 16-19, 27 and 29-37; for example, per claim 16:
16 . . . wherein the amount of arsenic in the preparation does not exceed 4.5 μg per g iron
and the amount of lead in the iron preparation does not exceed 1.5 μg per g iron,
or the amount of aluminum in the iron preparation does not exceed 200 μg per g iron.
Instant claims 16-19, 27 and 29-37 are patentably indistinct from conflicting claim 1 because one of ordinary skill is motivated by conflicting claim 1 to prepare an iron carbohydrate complex (where the carbohydrate is a hydrogenated dextran oligosaccharide) meeting the instantly claimed purity limitations in view of secondary references M. Bauer et al., 6 European Journal of Pharmaceutical Sciences, 331-335 (1998); W. McEwan et al., US 4,056,386 (1977) (“McEwan”); E. Ladd, US 2,096,855 (1937). See footnote 9.
The rational is obviousness for the same reasons discussed above in for US 8,815,301 (2014) and US 10,414,831 (2019).
Nonstatutory Double Patenting Rejection over H. Andreasen et al., US 12,030,962 (2024)
Claims 16-19, 27 and 29-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over conflicting claim 10 of H. Andreasen et al., US 12,030,962 (2024) for the following reasons. Conflicting claim 10 claims iron oligosaccharide compound comprising a hydrogenated oligosaccharide in stable association with ferric oxyhydroxide, wherein said hydrogenated oligosaccharide is derived from dextran.
Conflicting claim 10’s disclosure of the iron carbohydrate complex meets each and every limitation of instant claims16-19, 27 and 29-37 except the claimed levels of non-iron metal species of arsenic, aluminum, lead, mercury, cadmium, and chromium as claimed in 16-19, 27 and 29-37; for example, per claim 16:
16 . . . wherein the amount of arsenic in the preparation does not exceed 4.5 μg per g iron
and the amount of lead in the iron preparation does not exceed 1.5 μg per g iron,
or the amount of aluminum in the iron preparation does not exceed 200 μg per g iron.
Instant claims 16-19, 27 and 29-37 are patentably indistinct from conflicting claim 10 because one of ordinary skill is motivated by conflicting claim 10 to prepare an iron carbohydrate complex (where the carbohydrate is a hydrogenated dextran oligosaccharide) meeting the instantly claimed purity limitations in view of secondary references M. Bauer et al., 6 European Journal of Pharmaceutical Sciences, 331-335 (1998); W. McEwan et al., US 4,056,386 (1977) (“McEwan”); E. Ladd, US 2,096,855 (1937). See footnote 9.
The rational is obviousness for the same reasons discussed above in for US 8,815,301 (2014) and US 10,414,831 (2019).
Nonstatutory Double Patenting Rejection over H. Andreasen et al., US 6,977,249 (2005)
Claims 16-19, 27 and 29-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over conflicting claim 11 of H. Andreasen et al., US 6,977,249 (2005) for the following reasons. Conflicting claim 11 claims pharmaceutical composition for prophylaxis or treatment of iron-deficiency by parental administration comprising an iron-dextran compound.
Conflicting claim 11’s disclosure of the iron-dextran compound meets each and every limitation of instant claims16-19, 27 and 29-37 except the claimed levels of non-iron metal species of arsenic, aluminum, lead, mercury, cadmium, and chromium as claimed in 16-19, 27 and 29-37; for example, per claim 16:
16 . . . wherein the amount of arsenic in the preparation does not exceed 4.5 μg per g iron
and the amount of lead in the iron preparation does not exceed 1.5 μg per g iron,
or the amount of aluminum in the iron preparation does not exceed 200 μg per g iron.
Instant claims 16-19, 27 and 29-37 are patentably indistinct from conflicting claim 11 because one of ordinary skill is motivated by conflicting claim 11 to prepare an iron carbohydrate complex (where the carbohydrate is a hydrogenated dextran oligosaccharide) meeting the instantly claimed purity limitations in view of secondary references M. Bauer et al., 6 European Journal of Pharmaceutical Sciences, 331-335 (1998); W. McEwan et al., US 4,056,386 (1977) (“McEwan”); E. Ladd, US 2,096,855 (1937).
The rational is obviousness for the same reasons discussed above in for US 8,815,301 (2014).
Nonstatutory Double Patenting Rejection over H. Andreasen et al., US 6,291,440 (2001)
Claims 16-19, 27 and 29-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over conflicting claim 5 of H. Andreasen et al., US 6,291,440 (2001) for the following reasons. Conflicting claim 5 claims a therapeutic composition for prophylaxis or treatment of iron deficiency in an animal or human and suitable for parenteral administration consisting essentially of a pharmaceutically effective amount of an iron-dextran compound.
Conflicting claim 11’s disclosure of the iron-dextran compound meets each and every limitation of instant claims16-19, 27 and 29-37 except the claimed levels of non-iron metal species of arsenic, aluminum, lead, mercury, cadmium, and chromium as claimed in 16-19, 27 and 29-37; for example, per claim 16:
16 . . . wherein the amount of arsenic in the preparation does not exceed 4.5 μg per g iron
and the amount of lead in the iron preparation does not exceed 1.5 μg per g iron,
or the amount of aluminum in the iron preparation does not exceed 200 μg per g iron.
Instant claims 16-19, 27 and 29-37 are patentably indistinct from conflicting claim 5 because one of ordinary skill is motivated by conflicting claim 5 to prepare an iron carbohydrate complex (where the carbohydrate is a hydrogenated dextran oligosaccharide) meeting the instantly claimed purity limitations in view of secondary references M. Bauer et al., 6 European Journal of Pharmaceutical Sciences, 331-335 (1998); W. McEwan et al., US 4,056,386 (1977) (“McEwan”); E. Ladd, US 2,096,855 (1937). See footnote 9.
The rational is obviousness for the same reasons discussed above in for US 8,815,301 (2014).
Terminal Disclaimer
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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
APPLICANT’S ARGUMENT RESPECTING THE § DOUBLE PATENTING REJECTIONS
Applicant traverses and submits that certain ODP rejections in U.S. Application No.: 17/421,481; U.S. Patent No.: 11,020,369; U.S. Patent No.: 11,826,329; U.S. Patent No.: 12,295,934); and U.S. Patent No.: 12,303,486 are improper as they are based on patents and applications having later effective filing dates than the subject application. Reply at page 32. Applicant these rejections should be withdrawn for the same reasons as the recent PTAB decision Ex Parte Baurin, Appeal 2024-002920, Appl. No. 17/135,529 (PTAB Nov. 6, 2024), which reversed an ODP rejection because the rejection was made over a patent having a later effective filing date than the patent application whose claims were at issue. Id. Specifically, Applicant notes that in Baurin, the PTAB reversed an obviousness-type double patenting (ODP) rejection based on a later-filed, later-expiring unrelated U.S. Patent No. 10,882,922, because this ODP rejection was based on patents and applications having later effective filing dates than the patent application at issue. Id.
It response, it is true that the board in Ex Parte Baurin found that in light of the terminal disclaimers that have been filed in the application on appeal, any patent claims issuing from the application on appeal will have a term that cannot extend beyond March 28, 2032, which is well before the expiration of the '922 patent claims. Ex Parte Baurin at page 7. The board found that, notably, in both of the foregoing cases, the reference patent claims had an earlier filing date than the patent against which they were applied in the nonstatutory double patenting analysis and an earlier expiration date. Ex Parte Baurin at page 7.
This argument is not persuasive because even if the reasoning in Ex Parte Baurin facially could be construed to support Applicant’s position, it is noted that Ex Parte Baurin is non-published/non-precedential and non-binding on the Examiner in this matter. See discussion in https://www.uspto.gov/patents/ptab/precedential-informative-decisions. In this regard, it is noted that the Office did not agree with the board’s decision and filed a Request for Rehearing Under MPEP § 1214.04. See, Request for Rehearing, filed on January 3, 2025. The Request for Rehearing argues the decision in Ex Parte Baurin is inconsistent with USPTO guidance which does not instruct examiners to compare filing dates and expiration dates. Request for Rehearing at page 2 (citing MPEP § 804 and 804.02). As such, the Examiner cannot withdraw the double patenting rejections based on the reasoning of Ex Parte Baurin at this time. To be fair, the Examiner will revisit this issue, upon allowance of the claim(s) by conferring with Patent Legal. Similarly, Applicant has requested that the double patenting rejection of U.S. Patent No.: 11,111,261 be held in abeyance until this application is otherwise in condition for allowance. Reply at page 31.
Conclusion
Applicant's amendment and/or submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) (i.e., WO 99/43408) necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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ALEXANDER R. PAGANO
Examiner
Art Unit 1692
/ALEXANDER R PAGANO/Primary Examiner, Art Unit 1692
1 It appears that the instant specification is referring to the procedure of WO 2010/108493 disclosed at page 15 “Synthesis of iron-dextran”, which employs an aqueous reaction medium. WO 2010/108493 at page 15.
2 The “[in an aqueous medium comprising Na2CO3 and NaOH]” is added by the Examiner because it is inferred from WO 2010/108493 at page 15 upon which instant specification Example 2 states that the Example 2 procedure is based. See footnote 1. In this regard, claim 16 requires an “aqueous preparation”.
3 In the first working example, Andresen teaches hydrolysis and hydrogenation of dextran by a first hydrolysis at pH 1.5 and a temperature of 95°C, followed by reduction with sodium borohydride. Andreasen at page 14, lines 1-24.
4 This fact is also acknowledged in Applicants Reply of 10/15/2017. See Reply at page 15, lines 9-12 (“the examples in this document describe the production of an iron hydrogenated oligoisomaltose”); Id. at page 10, lines 1-2.
5 For example, Jahn teaches that:
Iron isomaltoside 1000 (Monofer®) (e.g., iron oligo isomaltoside (1000) as generic name) is developed and manufactured by Pharmacosmos in Denmark and was introduced in Europe in 2010.
Jahn et al., 78 European Journal of Pharmaceutics and Biopharmaceutics, 480-491 (2011) (“Jahn”) (see Jahn at page 481, col. 1).
6 Note that searches conducted did not identify any reference that teaches the specific experimental details of how Monofer is actually synthesized. For example, K. Nordfjeld et al. Drug Design, Development and Therapy, 43-51 (2012) teaches that “Iron isomaltoside 1000 (Monofer®; Pharmacosmos A/S, Holbaek, Denmark) is a new chemical structure developed by complexing ferric hydroxide with isomaltoside 1000” but does not give the specific synthetic details. Nordfjeld at pages 43-44. All identified references employing Monofer simply cite Pharmacosmos as the source. See e.g., J. Dahlerup et al., 51 Scandinavian Journal of Gastroenterology, 1332-1338 (2016) (“Dahlerup”); C. Holm et al., VoxSanguinis, 122-131 (2017).
7 As discussed above in the previous Office action, iron dextran is marketed by Pharmacosmos under the name Uniferon. See e.g., S. Andersen et al., 310 Am J Physiol Regul Integr Comp Physiol, 481-492 (2016) (see page 482, col. 2).
8 Factors to be considered in determining whether a purified form of an old product is obvious over the prior art include whether the claimed chemical compound or composition has the same utility as closely related materials in the prior art, and whether the prior art suggests the particular form or structure of the claimed material or suitable methods of obtaining that form or structure. MPEP § 2144.04(VIII) (citing Ex parte Stern, 13 USPQ2d 1379 (Bd. Pat. App. & Inter. 1987) (Claims to interleukin-2 (a protein with a molecular weight of over 12,000) purified to homogeneity were held unpatentable over references which recognized the desirability of purifying interleukin-2 to homogeneity in a view of a reference which taught a method of purifying proteins having molecular weights in excess of 12,000 to homogeneity wherein the prior art method was similar to the method disclosed by appellant for purifying interleukin-2).
9 It is proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. MPEP § 804(II)(B)(1) (citing AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014); Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003)). Here the disclosed utility in US 10,414,831 is treatment or prophylaxis of iron deficiency anaemia. See US 10,414,831 at col. 2, lines 59-62.