Prosecution Insights
Last updated: April 19, 2026
Application No. 18/011,951

Manufacturing Method for Polynuclear Iron Compounds Stabilized by Carbohydrates and/or Humic Acid

Final Rejection §103
Filed
Dec 21, 2022
Examiner
XU, JIANGTIAN
Art Unit
1762
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Vifor Fresenius Medical Care Renal Pharma Ltd.
OA Round
2 (Final)
66%
Grant Probability
Favorable
3-4
OA Rounds
3y 3m
To Grant
99%
With Interview

Examiner Intelligence

Grants 66% — above average
66%
Career Allow Rate
211 granted / 321 resolved
+0.7% vs TC avg
Strong +33% interview lift
Without
With
+33.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
64 currently pending
Career history
385
Total Applications
across all art units

Statute-Specific Performance

§101
0.9%
-39.1% vs TC avg
§103
55.0%
+15.0% vs TC avg
§102
14.4%
-25.6% vs TC avg
§112
23.1%
-16.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 321 resolved cases

Office Action

§103
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 . Response to Amendment The amendment filed on 2/23/2026 has been entered. Claim(s) 18-25 and 30 is/are currently amended. Claim(s) 1-17 and 31-37 has/have been cancelled. Claims 38-43 are new. Claim(s) 18-30 and 38-43 is/are pending and is/are under examination in this office action. Response to Arguments Applicant's argument filed on 2/23/2026, with respect to 112(b) rejection has been fully considered and is persuasive. The 112(b) rejection is withdrawn. Applicant's argument, filed on 2/23/2026, with respect to 102 rejection has been fully considered but is moot in view of the new grounds of rejection presented below. Applicant's argument filed on 2/23/2026, with respect to 103 rejection has been fully considered but is not persuasive. Applicant argued that Salaet Ferre Fails to Teach the Claimed "Agitation": Salaet Ferre only teaches mechanical stirring during filtration of the solution in a "reactor" or "feed reservoir," upstream of its tangential-flow filtration, not the claimed agitation within the filtration apparatus. In response, whether the agitation is carried out in a reactor, feed reservoir, or within the filtration apparatus depends on the specific filtration apparatus employed in the process; and the common goal is to achieve efficient mixing of the ingredients. Salaet Ferre’s example discloses agitation in a reactor, but never teaches away from other agitation configuration. One of ordinary skill in the art at the time of filing would carry out agitation in a reactor, feed reservoir, or within the filtration apparatus depending on different design of the process and apparatus (e.g., using multishaft disk system in place of the tangential-flow filtration system), with the final goal of achieving efficient mixing of the ingredients. Rearrangement of parts was held unpatentable (see MPEP 2144.04.VI). Applicant argued that the Cited Art Fails to Render Obvious the Claimed "Disk Membrane": not only does Salaet Ferre fail to teach use of a disk filtration system, but its use of tubular tangential-flow filtration is taught as a fundamental aspect of its invention; there would have been no motivation to have replaced the integral tangential-flow filtration system of Salaet Ferre with a disk membrane filtration apparatus. Moreover, whatever Ding may teach about a multishaft disk system, it fails to teach anything about the use of a multishaft disk system within the particular context of the filtration of an iron (III) salt suspension, as claimed. In response, even though Salaet Ferre teaches tubular tangential-flow filtration, it never teaches away from using other filtration systems. Ding teaches the benefit (high permeate flux etc.) of using multishaft disk (MSD) system for mineral suspension filtration. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to substitute Salaet Ferre’s tangential-flow filtration with Ding’s MSD filtration in order to gain the benefit. Ding does not have to teach the particular context of the filtration of an iron (III) salt suspension because Ding teaches mineral suspension filtration which is in the same field of endeavor or reasonably pertinent to the same problem faced by the inventor and Salaet Ferre. Applicant argued that a multishaft disk filtration system unexpectedly led to less filter cake build-up, better filter membrane sustainability, and better retentate concentration than tangential-flow filtration. See the comparison of the use of a tubular tangential-flow filtration system as in Salaet Ferre (page 13, line 8 to page 14, line 5) vs a multishaft disk filtration system in accordance with the pending claims (page 14, line 6 to page 15, line 2). In response, the comparison of a tubular tangential-flow filtration system as in Salaet Ferre vs a multishaft disk filtration system in accordance with the pending claims is not conclusive. It is known that filtration result depends on the specific suspension and its solids content, the membrane type, pore size and diameter, flow rate and pressure, etc. The tubular tangential-flow filtration system and the multishaft disk filtration system used for comparison have different membrane material, different total surface area, etc. Therefore, the results are not comparable. In addition, whether unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980); MPEP 716.02(d). In the instant case, the examples are not commensurate in scope with the claims. For instance, claim 18 recites “at least one disk membrane”, which covers a wide variety of membranes of different material and pore size, etc.; but the example only uses one ceramic membrane of a pore size of 50 nm. It is not known if other disk membrane will give the same result. Since the examples are not reasonably commensurate with the full scope of claimed materials, and the Applicant has not provided any additional information that would allow one skilled in the art to extend the results associated with the data to the full scope of the claim, the examples cannot be relied upon to establish non-obviousness of the claimed invention. 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. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claim(s) 18-30 and 38 and 40-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salaet Ferre et al (WO 2020025552 A1) in view of Ding et al (“Investigation of performances of a multishaft disk (MSD) system with overlapping ceramic membranes in microfiltration of mineral suspensions”, Journal of Membrane Science 276 (2006) 232–240). Regarding claims 18-19 and 22-24, Salaet Ferre teaches process for producing an adsorbent comprising polynuclear iron (III) oxyhydroxide stabilized by one or more carbohydrates and humic acid [abstract, P3L35-37], said process comprises the following steps [P3L22-38]: a) reacting an alkali metal compound with iron (III) chloride in water to yield a suspension of a pH of at least 3 of precipitated iron (III) oxyhydroxide, wherein the suspension is either allowed to stand or it is submitted to intervals of stirring; b) submitting the suspension of precipitated iron (III) oxyhydroxide of step a) to a desalinization process through tangential-flow filtration which comprises the steps of: b1 ) pumping the suspension to a tubular filtration membrane, thereby interfering ions are removed from the suspension with the permeate; b2) flowing back the remainder suspension to the feed reservoir; b3) adding fresh deionized water to the feed reservoir; b4) repeat the steps b1 )-b3) until the conductivity of the resulting suspension is equal to or less than 3.5 mS/cm; The concentration of the iron (III) oxy-hydroxide in the suspension increases when eliminating the permeate through the membrane [P7L22-23]. c) contacting the resulting aqueous suspension of step b) with at least one constituent that inhibits ageing of the iron oxy-hydroxide selected from the group consisting of one or more carbohydrates and/or humic acid; and d) drying the suspension obtained in step c). The examiner submits that the polynuclear iron (III) oxyhydroxide reads on the claimed polynuclear iron compound. The one or more carbohydrates and humic acid reads on the claimed at least one carbohydrates and humic acid. The step a) reads on the claimed step a) and b), with the alkali metal compound with iron (III) chloride in water reads on the claimed basic aqueous solution with an iron (III) salt solution. The suspension reads on the claimed suspension. The recited “the suspension is either allowed to stand or it is submitted to intervals of stirring” reads on the claimed leaving said suspension to stand, optionally with occasional stirring, to obtain a permeate. The step b) reads on the claimed steps c) and d), with “pumping the suspension to a tubular filtration membrane” corresponding to the claimed washing the suspension by pressure-driven filtration across at least one membrane; and with “interfering ions are removed from the suspension with the permeate” corresponding to the claimed removing a halide salt by-product contained in said permeate. The recited “the concentration of the iron (III) oxyhydroxide in the suspension increases when eliminating the permeate through the membrane” indicates concentrating a remaining suspension. The filtration and concentrating are carried out simultaneously with continuous agitation of the suspension, as recited in the instant claim. Since Salaet Ferre teaches the identical composition and process, the claimed hydrogel is necessarily formed. Salaet Ferre teaches mechanical stirring during filtration [Example 1, P13L6 and L14-15], which reads on the claimed agitation “by accelerating the solution with moving objects introduced into the suspension”. Salaet Ferre is silent about “within the filtration apparatus”. However, whether the agitation is carried out in a reactor, feed reservoir, or within the filtration apparatus depends on the specific filtration apparatus employed in the process; and the common goal is to achieve efficient mixing of the ingredients. One of ordinary skill in the art at the time of filing would carry out agitation within the filtration apparatus depending on different design of the process and apparatus (e.g., using multishaft disk system in place of the tangential-flow filtration system), with the final goal of achieving efficient mixing of the ingredients. Rearrangement of parts was held unpatentable (see MPEP 2144.04.VI). The step c) reads on the claimed step e). The step d) reads on the claimed step f). Salaet Ferre teaches that the membrane is a ceramic membrane [P6L30]. Salaet Ferre teaches does not teach a disk membrane within a filtration apparatus, a ceramic disk membrane or multishift disk filtration system. Ding teaches multishaft disk (MSD) system with rotating ceramic membrane for mineral suspension filtration, which gives benefit of high permeate flux, as compared with a single rotating disk module, using an identical stationary ceramic membrane[abstract, Introduction]. It would have been obvious to one of ordinary skill in the art at the time of filing to select the MSD system as disclosed by Ding in order to achieve high permeate flux. This system meets the claimed disk membrane within a filtration apparatus, a ceramic disk membrane or multishift disk filtration system. Regarding claim 20, Salaet Ferre teaches that the membrane has pore size in the range of 0.2 µm [P7L5] (200 nm), which meets the claimed range of 50-200 nm. Regarding claim 21, Salaet Ferre teaches that the mixture after step a) has pH 6.5 [Example 1, P13L12]. Since this mixture is carried out in the filtration step, the membrane is necessarily stable at pH 6.5, which meets the claimed range of 1 to 14. Regarding claim 25, Salaet Ferre teaches that after filtration, the conductivity of the mixture is 1.7 mS/cm [Example 1, P13L22-23], meeting the claimed range of ≤ 2 mS/cm. Regarding claim 26, Salaet Ferre teaches b2) flowing back the remainder suspension to the feed reservoir; b3) adding fresh deionized water to the feed reservoir; and b4) repeat the steps b1 )-b3) as stated above. Since concentration occurs during b1 ) pumping the suspension to a tubular filtration membrane, additional concentration is anticipated because of steps b2) through b4). Regarding claim 27, Salaet Ferre teaches that a mixture of 0.9 wt% of iron was concentrated to a mixture of 3.23 wt% of iron [Example 1, P13L14-L25]. Thus, the concentration occurred by a factor of 3.6, meeting the claimed range of at least 1.5. Regarding claim 28, Salaet Ferre teaches spray drying [P9L25]. Regarding claim 29, Salaet Ferre teaches sodium carbonate and sodium bicarbonate as the alkali metal compound [P5L25]. Salaet Ferre teaches iron (III) chloride as stated above (equivalent to the claimed FeCl3). Regarding claims 30 and 38, Salaet Ferre teaches sucrose, potato starch and pregelatinized starch [P9L16 and L20]. Regarding claim 40, Salaet Ferre teaches that the suspension is submitted to intervals of stirring as stated above. Regarding claim 41, Salaet Ferre’s Examples 1 and 2 illustrate formation of a product in the form of a powder which is obtained after concentrating and drying [p. 13, lines 26-29; p. 14, lines 11-14]. A product in powder form is understood to be granulated; therefore, Salaet Ferre’s process steps of concentrating and drying also read on the claimed step of granulating. Regarding claims 42 and 43, Ding’s MSD system provides shearing of a fluid between overlapping disks mounted on parallel shafts rotating in the same direction [Abstract]. This reads on providing agitation by rotary acceleration (i.e. “other movements”) of the apparatus. Allowable Subject Matter Claim 39 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is an examiner' s statement of reasons for allowance: Dependent claim 39 is directed to method of preparing: (i) a polynuclear iron compound stabilized by at least one of carbohydrates and humic acid or (ii) a complex comprising a polynuclear iron compound and at least one of carbohydrates and humic acid, said method comprising the steps of: a) mixing a basic aqueous solution with an iron (III) salt solution comprising halide ions to form a suspension, b) leaving said suspension to stand, optionally with occasional stirring, to obtain a permeate, c) washing the suspension and removing, by pressure-driven filtration across at least one membrane, a halide salt by-product contained in said permeate, d) concentrating a remaining suspension to form a hydrogel, e) adding at least one of carbohydrates and humic acid to the hydrogel to afford a stabilized or complexed polynuclear iron compound, f) drying the stabilized or complexed polynuclear iron compound and g) optionally granulating the dried stabilized or complexed polynuclear iron compound, wherein steps c) and d) are carried out simultaneously with continuous agitation of the suspension, wherein a weight ratio of Fe: sucrose: potato starch: pre-gelatinized starch is 1.0:1.5:1.0:0.5. There is no prior art that teaches or makes obvious the aforementioned limitations as claimed. The closest prior art is the disclosure of Salaet Ferre et al (WO 2020025552 A1). The prior art teaches recited method as stated in the 103 rejection, except the limitation of “wherein a weight ratio of Fe: sucrose: potato starch: pre-gelatinized starch is 1.0:1.5:1.0:0.5”. Nothing the prior art teach or suggest the claimed ratio. Conclusion Applicant's amendment 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 extension fee 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 date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANGTIAN XU whose telephone number is (571)270-1621. The examiner can normally be reached Monday-Thursday. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Jones can be reached on (571) 270-7733. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JIANGTIAN XU/Primary Examiner, Art Unit 1762
Read full office action

Prosecution Timeline

Dec 21, 2022
Application Filed
Oct 21, 2025
Non-Final Rejection — §103
Feb 23, 2026
Response Filed
Mar 23, 2026
Final Rejection — §103 (current)

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Prosecution Projections

3-4
Expected OA Rounds
66%
Grant Probability
99%
With Interview (+33.3%)
3y 3m
Median Time to Grant
Moderate
PTA Risk
Based on 321 resolved cases by this examiner. Grant probability derived from career allow rate.

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