Detailed Action
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 .
Claim Status
Claims 3-5, 7-9, 11-14, 16-18, 20-22, 24, 26, 28, 30, and 31 have been amended.
Claims 1-31 are pending.
Claims 1-31 are being examined herein.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. CN 202011055787.3 and CN202011055789.2, filed on 2020-09-29.
Information Disclosure Statement
The IDS filed on 02/04/2023,10/25/2024, and 04/16/2025 have been fully considered with all the references. IDS filed on 09/02/2025 have been considered, however NPL reference cited “Setkina et al.,” was not considered because copy of the reference was not provided. See the attached PTO 1449 forms.
Election/Restrictions
Applicant’s election without traverse of Group I, i.e., claims 1-30 in the reply filed on 09/02/2025 is acknowledged.
Claims 22-27 and 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention group and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/02/2025.
Applicant elected the method that includes mixing polynuclear iron hydroxide suspension with an additional ingredient. Applicant pointed out that Claims 1-30 encompass the elected species. Further, for the required election of a specific additional ingredient such as any of the ingredients recited in claims 9-30, applicant elected a carbohydrate as the additional ingredient. Claims 1-21, 28, and 29 encompass the elected species of additional ingredient.
Claim 30 is not drawn to elected species of additional ingredient and therefore only claims 1-21, 28, and 29 will be further examined on the merits.
Claim Objections
Claim 17 is objected because of following informality:
Claim 17 recites “a weight average molecular weight of …” should be rewritten as “an average molecular weight of…”
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 6, 8-15, 19, and 28 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad temperature between 15 °C and 50 °C, and the claim also recites between 20 °C and 40 °C and further between 22 °C and 27 °C which are the narrower statement of the range/limitation. Claim 6 recites mass range of 1 % to 25%, and the claim also recites 3% to 20%, and further 5% to 15% which are the narrower statement of the range/limitation. Claim 8 recites mass range of 5 % to 60% and the claim also recites 15% to 25%, which is the narrower statement of the range/limitation. Claim 9 recites temperature range of 60 °C - 125 °C and the claim also recites 80 °C - 95 °C which is the narrower statement of the range/limitation. Claim 11 recites mass percentage of 5% to 50% and also recites 10% to 25% which is the narrower statement of the range/limitation. Claim 12 recites temperature range of 80 °C - 125 °C and the claim also recites 85 °C - 95 °C which is the narrower statement of the range/limitation. Claim 13 recites mass ratio of 1: (10-20) and the claim also recites 1: (13-17) which is the narrower statement of the range/limitation. Claim 14 recites pH range of 5.5-11.1 and 10.5-11.2 and the claim also recites 6.5-7.5 which are the narrower statement of the range/limitation. Claim 19 recites temperature range of 65 °C - 121 °C and the claim also recites 80 °C - 95 °C which is the narrower statement of the range/limitation. Claim 28 recites mass range of 65 °C - 125 °C and the claim also recites 65 °C - 75 °C which is the narrower statement of the range/limitation.
The claims 3, 6, 8, 9, 12-14, 19, and 28 are indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 6 is rejected as being indefinite because it recites first, second, and third base solution is an aqueous solution of Na2CO3 while it depends on claim 5 which recites each of the first, second, and the third base solutions are independently different chemical solutions of a carbonate salt selected from the group consisting of NaHCO3, Na2CO3, (NH4)2CO3, and K2CO3. There is a conflict between claims 5 and 6 thus renders the claim indefinite.
Claims 10, 11, and 15 are rejected because they depend on claims that are indefinite as discussed above, and they do not clarify the issues, and thus are also rejected under 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, 5-8, 10-13, 15-18 and 21 are rejected under 35 U.S.C. 102 (a)(1)/(a)(2) as being unpatentable by WO2005/094202 A2 (Newton et. al., published 10/13/2005; filed on 03/16/2004; cited in IDS filed on 10/25/2024).
Regarding Claim 1
Claim 1: A method of preparing an iron hydroxide product, the method comprising the steps of:
adding a first base solution to a solution of a ferric salt to obtain Mixture A having a pH value of 2.7-2.8,
adding a second base solution to Mixture A to prepare a crude iron hydroxide suspension having a pH value of 2.8-3.8, and
adding a third base solution to adjust the pH of the crude iron hydroxide suspension to 5-9, followed by purification and concentration, thereby obtaining a purified polynuclear iron hydroxide suspension containing polynuclear iron hydroxide.
Newton, throughout the reference, teaches making ferric hydroxide complex. (e.g. Abstract).
Newton teaches preparation of ferric hydroxide (reads as iron hydroxide of instant claim 1) consisting steps of: dissolving ferric salt in aqueous medium (e.g. pg. 14, line 9-10+), adding first base (e.g. Pg.14, line 4-10+) to obtain pH 2-2.5 (Pg.14, line 26-27+). In general, given the ordinary and customary meaning of the term “about” in this art, it would be roughly ± 10% which would make the end point of pH 2.5 to pH 2.7. therefore, pH 2.75 anticipates the claimed genus of range 2.7-2.8 of the instant claim 1.
Newton also teaches adding second base to form a suspension (Pg. 14, lines 15-16+; Pg.15, lines 9-13+) to obtain pH 3.5-9 (Pg.15, line 10-11+). Here, the amount of second base added until pH 3.5 according to Newton, reads on second base of instant claim 1 and the additional amount of second base added above pH 3.5 according to Newton, reads on addition of third base of instant claim 1. The pH 3.5 reached by addition of second base taught by Newton anticipates the claimed genus of pH 2.8-3.8 in instant claim 1. Similarly, the end point pH 9 reached by adding additional second base above pH 3.5, anticipates the claimed genus of pH 5-9 in the instant claim 1. (See MPEP § 2131.03) Newton also teaches the resultant ferric hydroxide precipitate (reads as polynuclear iron hydroxide of instant claim 1) is filtered and washed (reads as purified) (Pg.15, lines 20-25+).
Regarding Claim 3
Claim 3: The method of claim 1, wherein each of the first base solution, the second base solution, and the third base solution, independently, is added at a temperature between 15 °C and 50 °C, preferably between 20 °C and 40 °C, and more preferably between 22 °C and 27 °C.
Newton teaches all the bases were added while maintaining temperature from about 20 ̊ to 30 ̊C (pg.15, line 1) which reads as all the bases were added at temperature from about 20 ̊ to 30 ̊C. The temperature range taught by Newton anticipates the claimed temperature range of between 20 °C and 40 °C in the instant claim 3. (See MPEP § 2131.03)
Regarding Claim 5
Claim 5: The method of claim 1, wherein each of the first base solution, the second base solution, and the third base solution, independently, is an aqueous solution of a carbonate salt selected from the group consisting of NaHCO3, Na2CO3, (NH4)2CO3, and K2CO3.
Newton teaches sodium carbonate as first and second base (Pg.14, lines 4-8; exemplary preparation on pg.23, lines 5, 12-15). Second base taught by Newton also reads on third base of instant claim 5, as explained supra.
Regarding Claim 6
Claim 6: The method of claim 5, wherein each of the first base solution, the second base solution, and the third base solution is an aqueous solution of Na2CO3 having a mass percentage of 1 % to 25%, preferably 3% to 20%, more preferably 5% to 15%.
Newton teaches first and second bases are (30% W/V solution) sodium carbonate (Pg.14, lines 4-8+; exemplary preparation on pg.23, lines 5, 12-15+) and further in the exemplary preparation, teaches first base can be aqueous solution of 25% W/V Na2CO3 (Pg.26, lines 20-23+). The mass percent of 25% W/V Na2CO3 anticipates the claimed range of 1 % to 25% Na2CO3 of instant claim 6. (See MPEP § 2131.03)
Regarding Claim 7
Claim 7: The method of claim 1, wherein the ferric salt is selected from the group consisting of Fe2(SO4)3, Fe (NO3)3, and FeCl3.
Newton teaches ferric salt is selected from Fe (NO3)3 and FeCl3. (Pg.14, lines 1-3)
Regarding Claim 8
Claim 8: The method of claim 1, wherein the ferric salt is FeCl3 having a mass percentage of 5% to 60%, preferably 15% to 25%.
Newton teaches solution of 5 g of ferric chloride hexahydrate (reads as ferric salt) dissolved in 20 mL water which is calculated as 25% W/V (Pg.34, lines 25-26). The mass percentage of 25% W/V taught by Newton anticipates claimed genus of mass percentage of 5% to 60% in the instant claim 8. (See MPEP § 2131.03)
Regarding claim 9
Claim 9: The method of claim 1, further comprising the steps of:
mixing the purified polynuclear iron hydroxide suspension and a carbohydrate to obtain a carbohydrate mixture,
adjusting the pH value of the carbohydrate mixture to 7 .5-13 or 10-13 .5, and
heating the pH-adjusted carbohydrate mixture to a temperature of 60°C - 125°C, preferably 80°C - 95°C, thereby producing an iron hydroxide-carbohydrate complex suspension, the mass ratio between iron and carbohydrate being (1-1100): 100,
wherein the iron hydroxide product is the iron hydroxide-carbohydrate complex.
Newton teaches mixing purified ferric hydroxide (reads as iron hydroxide) and sucrose (reads as carbohydrate, pg.16, lines1-2+). Newton teaches that pH of mixture of ferric hydroxide and sucrose can be adjusted to between 6.5-13 (Pg.47, claim 42). The pH range of 6.5-13 taught by Newton anticipates the claimed range of pH 7.5-13. Newton also teaches heating the mixture at 100-105°C (exemplary preparation on pg.23, lines 25-26+). The temperature range of 100-105°C anticipates the claimed genus of temperature range of 60°C - 125°C in the instant claim 9. Newton teaches the process of mixing ferric hydroxide and sucrose at pH and temperature taught by Newton as above, produces iron sucrose complex containing 1 to 60% ferric ion by Wt. (Pg.49-50, claims 54-57) which is calculated as 1:99 to 60:40. The ratio of 60:40 translates to 1.5 of Ferric ion to Sucrose which is same as 150:100. Thus, calculated mass ratio of 150:100 anticipates the claimed mass ratio between iron and carbohydrate of (1-1100): 100 in the instant claim 9(See MPEP § 2131.03 I).
Regarding Claim 10
Claim 10: The method of claim 9, wherein the carbohydrate is selected from the group consisting of monosaccharides, disaccharides, oligosaccharides, polysaccharides, hydrolyzed polysaccharides, and any combinations thereof.
Newton further teaches use of sucrose which is monosaccharides (Pg.16, lines 1-2)
Regarding Claim 11
Claim 11: The method of claim 9, wherein the pH value of the carbohydrate mixture is adjusted by adding a fourth base that is a hydroxide solution selected from the group consisting of a NH4OH solution, a KOH solution, and a NaOH solution, and the hydroxide solution has a mass percentage of 5% to 50%, preferably 10% to 25%.
Newton teaches 20% W/V of NaOH solution is added to carbohydrate mixture (exemplary preparation on pg.23, lines 26-27+). The 20% concentration of NaOH taught by Newton anticipates the claimed genus of 10% to 25% and 5% to 50% NaOH in the instant claim 11. (See MPEP § 2131.03)
Regarding Claim 12
Claim 12: The method of claim 9, wherein the pH value of the carbohydrate mixture is adjusted to 10-13.5 and the pH adjusted carbohydrate mixture is heated at 80°C - 125°C and preferably 85°C - 95°C for 1 hour to 50 hours.
Newton teaches pH of the carbohydrate mixture is adjusted with 20% W/V sodium hydroxide (exemplary preparation on pg. 23, lines 26-27), in range of pH 6.5-13 (claim 42), the mixture is heated at 100-105°C for 2 hours (exemplary preparation onpg.23, lines 25-26). The higher point of pH 13 taught by Newton anticipates the claimed genus of pH 10-13.5 in the instant claim 12. The temperature range of 100-105°C as taught by Newton anticipates the claimed temperature range 80°C - 125°C in the instant claim 12. The heating time of 1-50 hours of the claimed invention is anticipated by the heating time of 2 hours taught by Newton. (See MPEP § 2131.03)
Regarding Claim 13
Claim 13: The method of claim 9, wherein the carbohydrate is sucrose and the mass ratio between Fe3+ and sucrose is 1: (10-20), preferably 1: (13-17).
Newton teaches molar ratio of sucrose to ferric hydroxide is 1:2 to 1:50 (claim 28). Molar ratio of 1:50 is calculated as 1:15.6 by mass which anticipates the claimed ratio of 1: (13-17) in instant claim 13. (See MPEP § 2131.03)
Claim 14: The method of claim 9, wherein the pH value of the iron hydroxide-carbohydrate complex suspension is adjusted, using a pH modifier, to 5.5-11.1, preferably 10.5-11.2, more preferably 6.5-7.5.
Newton teaches mixing purified ferric hydroxide (same as iron hydroxide) and sucrose (carbohydrate) (Pg.16, lines1-2), adjusting pH with 20% W/V sodium hydroxide (exemplary preparation on pg.23, lines 26-27), in range of 6.5-13 (Pg. 46, claim 42). The lower end-point of pH 6.5 as taught by Newton anticipates the claimed genus of pH range of 5.5-11 in the instant claim 14. (See MPEP § 2131.03)
Regarding Claim 15
Claim 15: The method of claim 14, wherein the pH modifier is HCl, NaOH, citric acid, oxalic acid, fumaric acid, tartaric acid, succinic acid, malic acid, ascorbic acid, phosphoric acid, pyrophosphoric acid, or glycophosphoric acid.
Newton teaches pH modifier used for adjusting pH of ferric hydroxide-sucrose complex is NaOH (exemplary preparation on pg. 23, lines 26-27).
Regarding Claim 16
The method of claim 9, further comprising the step of drying the iron hydroxide-carbohydrate complex suspension.
Newton teaches drying of purified iron sucrose complex suspension at 25-140°C temperature (pg. 18, lines 8-12)
Regarding Claim 17
The method of claim 9, wherein the iron hydroxide-carbohydrate complex has a weight average molecular weight of 30000-60000 Daltons, and has a reaction rate T75 against ascorbic acid of 35 minutes or less, and is absent of free ferric ions.
Newton teaches preparation of iron sucrose complex where the average molecular weight is about 55,000 Daltons and does not explicitly teach presence of free ferric ions which reads on absence of free ferric ions (exemplary preparation on pg. 23-24, lines 2-4). Newton also teaches weight average molecular weight of the sucrose complex is in range of 30,000 to about 60,000 Daltons (pg. 4, lines 10-13). T75 reaction rate is intrinsic chemical property of complex dependent on it size or molecular weight, therefore, complex prepared by newton method in molecular weight range of 30k to 60 k would exhibit predictable T75 rates of 35 min or less.
Regarding Claim 18
The method of claim 9, wherein the pH value of the carbohydrate mixture is adjusted to 7.5-13 and the pH adjusted carbohydrate mixture is heated for 0.2 hours to 30 hours.
Newton teaches that pH of carbohydrate mixture is adjusted with 20% W/V sodium hydroxide (exemplary preparation on pg. 23, lines 26-27), where in the pH value is in range of 6.5-13 (claim 42), heating the mixture at 100-105°C for 2 hours (exemplary preparation on pg.23, lines 25-26). The range of pH 6.5-13 taught by Newton anticipates the claimed pH 7.5-13 in the instant claim 18. The heating time of the mixture of the claimed invention is anticipated by the heating time of 2 hours as taught by Newton. (See MPEP § 2131.03)
Regarding Claim 21
The method of claim 9, further comprising the step of formulating the iron hydroxide-carbohydrate complex into drops, oral liquid, suspension, injection, powder, capsule, tablet, or lozenge for treating iron deficiency anemia in humans or animals.
Newton teaches that pharmaceutical composition of invention may be formulated as tablet, capsule, powder (pg. 19, lines 10-11). Newton also teaches exemplary injectable parenteral formulation of iron sucrose complex (pg. 19, lines 1-5).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 2, 3, 5-8, 9, 10-13, 14, 15-18, 19-20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable by WO 2005/094202 A2 (Newton, published 10/13/2005; filed on 03/16/2004; cited in IDS filed on 10/25/2024)
Newton teaches a process of making ferric hydroxide product as discussed supra.
Regarding Claim 2
Claim 2: The method of claim 1, wherein before adding the second base, Mixture A is allowed to equilibrate for 1 minute to 15 minutes; and, before adding the third base, the crude iron hydroxide suspension is allowed to equilibrate for 2 minutes to 60 minutes.
Newton teaches that the reaction mixture was allowed to equilibrated for about 10 minutes before adding the second base (Pg.14, lines 9-17+). Equilibration time of 10 minutes taught by Newton anticipates claimed genus of equilibration time 1 minute to 15 minutes of instant claim 2.
Newton does not explicitly teach the equilibration duration after adding the second base as recited in claim 2.
As discussed supra, the amount of second base added until pH 3.5 according to Newton reads on second base of instant claim 1 and the amount of base added above pH 3.5 according to Newton reads on addition of third base of instant claim 1. Newton also teaches that the second base is added at suitable addition rates from about 0.02 to 0.2 equivalents of base per minute (Pg.15, lines 5-8+).
Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the instant application to equilibrate the reaction mixture for a desired duration to achieve the pH of interest as Newton taught that equilibration after addition of base can be 10 to 120 mins and the equilibration is routine and known procedure for chemical reactions to achieve the result effective end product.
Regarding Claim 19
The method of claim 18, wherein the pH value of the carbohydrate mixture is adjusted to 9-12.5, the pH-adjusted carbohydrate mixture is heated at a temperature of 65°C - 121 °C, preferably 80°C - 95°C, for 0.2 hours to 30 hours, and the mass ratio between iron and carbohydrate is (1-264): 24.
Newton teaches that pH of carbohydrate mixture is adjusted with 20% W/V sodium hydroxide (exemplary preparation on pg.23, lines 26-27) to 6.5-13 (claim 42) and the mixture is heated at 100-105°C for 2 hours (exemplary preparation on pg.23, lines 25-26). The higher end point of pH 13 taught by newton is prima facie obvious over the claimed pH range 9-12.5 in the instant claim 19. (See MPEP § 2144.05 I) The temperature range of 100-105°C and heating time of 2 hours taught by Newton anticipates the claimed temperature range of 65°C - 121 °C and the heating time of 0.2 hours to 30 hours respectively, in the instant claim 19. (See MPEP § 2131.03). Newton teaches molar ratio of sucrose to ferric hydroxide is 1:2 to 1:50 (claim 28) which is calculated as 1.59:1 to 1:15.6 by mass. The calculated ratio of sucrose to ferric hydroxide (1:15.6) in the prior art is prima facie obvious over the mass ratio (1:24) of the claimed invention. (See MPEP § 2144.05 II(A))
Regarding Claim 20
The method of claim 9, wherein the iron hydroxide-carbohydrate complex, having a water solubility of 20 wt% or more, contains, by dry weight, iron 10% - 47% and chloride ion less than 1 %, preferably less than 0.1 %.
Newton teaches exemplary parenteral formulation of iron sucrose complex dissolved in 20% aqueous solution (pg. 19, lines 25-30). Newton also teaches iron concentration in the iron-carbohydrate complex is 1-50% (claim 55) which overlaps with the claimed range of 10% - 47% in the instant claim 20. Prima facie obviousness exists for the range taught by Newton over the claimed range (See MPEP § 2144.05 (I)). Newton further teaches the sodium salts such as sodium chloride less than 10% wt/wt (Pg.18, lines 15-17) which is prima facie obvious over chloride ion less than 1% and 0.1% as claimed in the instant claim 20. (See MPEP § 2144.05)
"[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Claims 1, 2, 3, 4, 5-8, 9, 10-13, 14, 15-18, 19-20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable by WO 2005/094202 A2 (Newton, published 10/13/2005; filed on 03/16/2004; cited in IDS filed on 10/25/2024) as evidenced by lab procedures in University of Richmond lab manual (Vacuum Filtration/Organic Chemistry I Lab, CHEM-205, Spring 2023)
Claim 4: The method of claim 1, wherein the crude iron hydroxide suspension is purified by washing with water and concentrated by removing water to an iron hydroxide concentration of 3 wt% to 16 wt%, and the purified iron hydroxide suspension has a chlorine content of less than 1 %, preferably less than 0.1 %.
Newton teaches a process of making ferric hydroxide product as discussed supra.
Newton teaches ferric hydroxide suspension was washed with water using vacuum filtration system e.g., for example through a Buchner funnel. (Pg.15, line 20-25+). The removal of water is resultant action of vacuum filtration process. Therefore the purification steps taught by Newton inherently teaches removing water and concentrating ferric hydroxide suspension. It is evidenced by chemistry lab procedures in University of Richmond lab manual (Vacuum Filtration/Organic Chemistry I Lab, Spring 2023; hereinafter referred to as CHEM205), that when using vacuum filtration system with Buchner funnel to purify the chemical reaction product, the product is washed and subsequently dried (concentrated) by allowing to sit on the filter while vacuum is on. (CHEM205, page 2, paragraph 3). It would have been obvious for a person of ordinary skills in the art before the effective filing date of the instant application to concentrate the iron hydroxide suspension after washing by removing water to determine the concentration.
Newton does not explicitly teach the concentration of iron hydroxide of 3 wt% to 16 wt%. However, the resulting concentration of iron hydroxide produced from a reaction is dependent on the amount of the reactant used. It would be obvious to a person of ordinary skills in the art to carry out routine experiments and reach to the instantly claimed concentrations.
Newton does not disclose formation of any residual chlorine when iron hydroxide is prepared. Therefore, it reads on “less than 1% or 0.1%” in instant claim 4.
Claims 1-21 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2005/094202 A2 (Newton et. al., published 10/13/2005; filed on 03/16/2004; cited in IDS filed on 10/25/2024) as applied to claims 1-21 above, and further in view of US 2003/0216566 A1 (Durga et.al) published 11/20/2003.
Claim 28 The method of claim 1, further comprising the steps of:
mixing the purified polynuclear iron hydroxide suspension with a carboxylated carbohydrate, or a mixture thereof to obtain a carboxylated carbohydrate mixture, and
heating the carboxylated carbohydrate mixture at a temperature of 65°C - 125°C. preferably 65°C - 75°Cfor 5 minutes to 10 hours, preferably 25 minutes to 55 minutes, thereby producing a ferric carboxylated carbohydrate suspension, the molar ratio between iron and the carboxylated carbohydrate being 1: (0.3 - 5), preferable 1: (0.5-1.5), wherein the iron hydroxide product is an iron hydroxide-carboxylated carbohydrate.
Claim 29 The method of claim 28, wherein the carboxylated carbohydrate
is gluconate.
Newton, throughout the reference, teaches making ferric oxide complexed with carbohydrate, as discussed supra.
Newton teaches mixing purified ferric hydroxide (reads as iron hydroxide) and sucrose (carbohydrate) (Pg.16, lines1-2) and heating the mixture at 100-105°C (which anticipates temperature range of 65°C - 125°C of instant claim 28) for 2 hours which anticipates heating time of 5 minutes to 10 hours in instant claim 28 (exemplary preparation on pg.23, lines 25-33). Newton further teaches molar ratio between iron and sucrose (reads as carbohydrates) is from 1: 2 to about 1: 50 (Pg.44, claim 28). The molar ratio between iron and sucrose of 1:2 taught by Newton anticipates the ratio of 1:(0.3-5) in the instant claim 28.
Newton does not explicitly teach mixing carboxylated carbohydrate with iron hydroxide claimed in instant claim 28. Newton also does not teach gluconate as claimed in instant claim 29.
Durga teaches preparation of sodium ferric gluconate by mixing ferric oxyhydroxide with sodium gluconate and heating up to about 70-80°C for 2 hours (pg. 2, [0044], lines 7-13). Durga also teaches the ratio of ferric oxyhydroxide to sodium gluconate is 2:1 (Pg. 2, [0044], lines 11-13).
Durga discloses in the background of invention that ferric gluconate complex is known for 40 years and been used as an injectable for treating iron deficiencies in humans. Durga also discloses that ferric gluconate complex has several advantages over other iron complexes including low toxicity, low adverse reaction, and satisfactory rate of absorption ([0002]).
Newton discloses in the background of invention iron complexes such as iron dextran complex has been associated with significant side effects. (pg.1, lines 29-31) and proposed iron sucrose complex comprising narrower molecular weight distribution to achieve safe and efficient therapy.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the instant application to substitute carbohydrate in the iron carbohydrate complex preparation of Newton et.al., with the carboxylated carbohydrate specifically gluconate used in the iron carbohydrate complex preparation by Durga et.al. to obtain the iron gluconate complex of invention claimed in the instant application, because both Newton and Durga teach complexing different carbohydrates with ferric oxide or ferric hydroxide are routine and known in the art. In addition, Durga teaches the advantage of using gluconate (a carboxylated carbohydrate) to complex with the ferric oxyhydroxide such as provide low toxicity low adverse reaction, and satisfactory rate of absorption. Thus, one of skilled in the art would be motivated to using gluconate to complex with ferric hydroxide for the desired pharmaceutical application.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Newton have demonstrated making ferric hydroxide complex with carbohydrate is routine and known in the art.
No claims are allowed.
Conclusion
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/VIJAY D PATEL/ Examiner, Art Unit 1616
/SUE X LIU/ Supervisory Patent Examiner, Art Unit 1616