FINAL 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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/18/2026 has been considered by the examiner and initialed copies of the IDS are included with the mailing of this office action.
Status of the Claims
This action is in response to papers filed 01/27/2026 in which the specification was amended; claims 14-18 were withdrawn; and claims 1-5, 7-10, and 12-13 were amended. All the amendments have been thoroughly reviewed and entered.
Claims 1-13 are under examination.
Withdrawn Objections/Rejections
The Examiner has re-weighted all the evidence of record. Any rejection and/or objection not specifically addressed below is hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show “asv2” in Figure 6G as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
New Objections
Claim 1 is objected to because of the following informalities: to clearly identify the purpose of the claimed method, please amend the preamble of claim 1 from “A method of treatment” to “A method of treating gastrointestinal inflammation.” Appropriate correction is required.
New Rejection
Necessitated by Applicant’s Claim Amendments
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4, 7, and 8 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 4, the limitation of “said administering reduces said gastrointestinal inflammation” as recited in claim 4 is not further limiting from claim 1 because claim 1 already recited that “the administering ..decreases gastrointestinal inflammation in the treated subject.”
Regarding claim 7, the limitation of “said iron (III) formulation further comprises (d) a gelatinized or pre-gelatinised starch of plant origin” as recited in claim 7 is not further limiting from claim 1 because claim 1 already recites “a pre-gelatinised rice starch” in the iron (III) formulation and thus, “a gelatinized or pre-gelatinised starch of plant origin” as recited in claim 7 has broaden from the scope of “a pre-gelatinised rice starch” from claim 1.
Regarding claim 8, the limitation of “said (b) at least one phospholipid consists of a lecithin” as recited in claim 8 is not further limiting from claim 1 because claim 1 already limit the phospholipid to sunflower lecithin and thus, “at least one phospholipid consists of a lecithin” as recited in claim 8 has broadened from the scope of “sunflower lecithin” from claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Modified Rejections
Necessitated by Applicant’s Claim Amendments
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 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.
Claim(s) 1-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gómez-Ramírez et al (Pharmaceuticals, 2018, 11(97): 1-23) in view of Nagao-Kitamoto et al (Immune Network, 2017, 17(1): 1-12) and Lacorte et al (US 2015/0250885 A1; hereafter as “Lacorte 2015”).
Regarding claim 1, Gómez-Ramírez teaches iron deficiency (ID) is usually treated with oral iron salts but up to 50% of patients complain of gastrointestinal side effects, leading to reduced compliance with treatment (Abstract). Gómez-Ramírez teaches the use Sucrosomial® Iron (SI) as an alternative for effective treatment of ID while also reducing gastrointestinal side effects (Abstract; pages 4-11 and 16-17). Gómez-Ramírez teaches Sucrosomial® Iron (SI) is an oral iron containing carrier, in which ferric pyrophosphate is protected with a phospholipid bilayer membrane, mainly from sunflower lecithin, plus a sucrester matrix (sucrester E473) (page 5). Gómez-Ramírez teaches Sucrosomial® Iron has high iron bioavailability and excellent gastrointestinal tolerance, and is more efficacious and tolerable than oral iron salts (pages 4-5, 8-9, 11 and 17). Gómez-Ramírez teaches Sucrosomial® Iron is used for treating ID, especially for subjects with intolerance to iron salts or those whom iron salts are inefficacious (Abstract; pages 4-5 and 17). Gómez-Ramírez teaches Sucrosomial® Iron is formulated with tricalcium phosphate and starch to allow the Sucrosomial® Iron to be gastro-resistant and carried through the intestinal tract, without side effects from the interaction between iron and intestinal mucosa (page 5). Gómez-Ramírez teaches Sucrosomial® Iron is useful in inflammatory bowel disease (IBD) patient with iron deficiency (ID), as Sucrosomial® Iron has been shown to be efficacious in said IBD patient with rising Hb concentration, as well as, ferritin and TSAT levels and said IBD patients also had very few gastrointestinal side effects (Abstract; pages 4-11 and 16-17).
While Gómez-Ramírez does not expressly teach the Sucrosomial® Iron reduces the amount of pathogenic bacteria pathogen belonging to the phylum Proteobacteria present in the gut microbiota of the treated subject, it would have been obvious that the administered Sucrosomial® Iron in said patient of Gómez-Ramírez would implicitly reduce the amount of pathogenic bacteria pathogen belonging to the phylum Proteobacteria present in the gut microbiota of said patient of Gómez-Ramírez because Nagao-Kitamoto establishes that pathobionts are known to be enriched in IBD patients, as several microbiome analyses have revealed there is an expansion of the Proteobacteria phylum in IBD patients, and such enrichment of pathobionts induces intestinal inflammation of said IBD patients (Nagao-Kitamoto: Abstract; pages 2-7). Gómez-Ramírez teaches that malabsorption due to IBD is one of the main causes of iron deficiency. As discussed above, Sucrosomial® Iron was established by Gómez-Ramírez to be useful in inflammatory bowel disease (IBD) patient with iron deficiency (ID) due to Sucrosomial® Iron has been shown to be efficacious in said IBD patient. Thus, it would have been obvious with reasonable expectation that the that the administered Sucrosomial® Iron in said patient of Gómez-Ramírez would result in reducing the amount of pathogenic bacteria pathogen belonging to the phylum Proteobacteria present in the gut microbiota of said patient because Gómez-Ramírez established that the use of Sucrosomial® Iron reduces gastrointestinal side effects, where IBD with iron deficiency whom were administered Sucrosomial® Iron had very few gastrointestinal side effects.
It is noted that the subject to be treated with Sucrosomial® Iron from Gómez-Ramírez is the identified subject as claimed in claim 1 because as discussed above, Gómez-Ramírez has identified the subject to be treated with Sucrosomial® Iron as a patient having iron deficiency and said patient was previously administered oral iron salts and had gastrointestinal side effects due to the administered oral iron salts, particularly said patient include inflammatory bowel disease (IBD) patient with iron deficiency (ID) (Gómez-Ramírez: Abstract; pages 2-3, 5, 8-11, and 16-17). As discussed above, Nagao-Kitamoto established that inflammatory bowel disease (IBD) patient with iron deficiency (ID) of Gómez-Ramírez is known to be enriched in pathobionts (Nagao-Kitamoto: Abstract; pages 2-7). Thus, the subject (patient) that was administered Sucrosomial® Iron in Gómez-Ramírez is the same identified subject from instant claimed method of claim 1.
With respect to the pre-gelatinised rice starch in the iron(III) formulation as recited in claim 1, Lacorte 2015 teaches a solid composition comprising iron (III) pyrophosphate, sucrose ester or sucresters E473, and lecithin, wherein the solid composition is used for treating disorders or diseases related to or derived from iron deficiency (Abstract; [0001]-[0144]; claims 1-20). Lacorte 2015 teaches the solid composition further contains a starch, preferably, pre-gelatinized rice starch ([0058]-[0102]; claims 7-8). Lacorte 2015 teaches sucrester E473 contains 70% of monoesters, being obtained by sucrose esterification with vegetable fatty acids (stearic and palmitic) ([0048]-[0051]). Lacorte 2015 teaches said sucrose ester or sucrester and said lecithin are in the composition in a weight ratio from 20:1 to 15:1 ([0083]-[0084]; claim 17).
It would have been obvious to one of ordinary skill in the art to use pre-gelatinized rice starch as the starch material in the iron formulation of Gómez-Ramírez, and achieve the claimed invention. One of ordinary skill in the art would have been motivated to do so because as discussed above, Lacorte 2015 provides for the use of pre-gelatinized rice starch as the starch material in the iron formulation of Gómez-Ramírez containing iron (III) pyrophosphate, sucrose ester or sucresters E473, and sunflower lecithin. One of ordinary skill in the art would have reasonable expectation of success in using pre-gelatinized rice starch as the starch material in the iron formulation of Gómez-Ramírez because as discussed above, Gómez-Ramírez and Lacorte 2015 are drawn to teaching the same iron formulation containing iron (III) pyrophosphate, sunflower lecithin, sucrester or sucrose esters and pre-gelatinized rice starch, and Lacorte 2015 is also drawn to using the iron formulation for treating disorders or diseases related to or derived from iron deficiency.
Regarding claims 2 and 3, Gómez-Ramírez teaches the patient is also anemic and had previously been treated with iron salts that was inefficacious (Abstract; pages 4-5 and 16-17).
Regarding claim 4, Gómez-Ramírez teaches one of the main causes of iron deficiency in said patients was due to malabsorption from Helicobater pylori infection, and the use of Sucrosomial® Iron (SI) was an effective treatment of ID while also reducing gastrointestinal side effects (Abstract; pages 2, 4-11 and 16-17).
Regarding claim 5, Nagao-Kitamoto teaches the pathogenic bacteria in the phylum Proteobacteria include E coli and Salmonella (Nagao-Kitamoto: pages 4-5).
Regarding claim 6, as discussed above, Gómez-Ramírez established that the use of Sucrosomial® Iron reduces gastrointestinal side effects, where IBD with iron deficiency whom were administered Sucrosomial® Iron had very few gastrointestinal side effects, thereby the Sucrosomial® Iron has modified the gut microbiota of said patient.
Regarding claim 7, Gómez-Ramírez teaches Sucrosomial® Iron is formulated with tricalcium phosphate and starch to allow the Sucrosomial® Iron to be gastro-resistant and carried through the intestinal tract, without side effects from the interaction between iron and intestinal mucosa (page 5).
Regarding claim 8, as discussed above, Gómez-Ramírez teaches Sucrosomial® Iron (SI) is an oral iron containing carrier, in which ferric pyrophosphate is protected with ap phospholipid bilayer membrane, mainly from sunflower lecithin, plus a sucrester matrix.
Regarding claim 9, as discussed above, both Gómez-Ramírez and Lacorte 2015 teaches sucrester 473 in their iron formulation.
Regarding claim 10, Lacorte 2015 teaches a solid composition comprising iron (III) pyrophosphate, sucrose ester or sucresters E473, and lecithin, wherein the solid composition is used for treating disorders or diseases related to or derived from iron deficiency (Abstract; [0001]-[0144]; claims 1-20). Lacorte 2015 teaches the solid composition further contains pre-gelatinized rice starch ([0058]-[0102]; claims 7-8). Lacorte 2015 teaches sucrester E473 contains 70% of monoesters, being obtained by sucrose esterification with vegetable fatty acids (stearic and palmitic) ([0048]-[0051]). Lacorte 2015 teaches said sucrose ester or sucrester and said lecithin are in the composition in a weight ratio from 20:1 to 15:1 ([0083]-[0084]; claim 17). It would have been obvious to one of ordinary skill in the art to optimize the weight ratio of the sucrester and lecithin from 50:1 to 10:1 and achieve the claimed invention. One of ordinary skill in the art would have been motivated to do so because Gómez-Ramírez and Lacorte 2015 are drawn to teaching the same iron formulation containing iron (III) pyrophosphate, sunflower lecithin, sucrester or sucrose esters and pre-gelatinized rice starch, and as discussed above, Lacorte 2015 provides for the weight ratio of the sucrester and lecithin in the iron formulation to be from 20:1 to 15:1, which is a weight ratio that fall within or reads on the claimed range as recited in claim 10. One of ordinary skill in the art would have reasonable expectation of success of optimizing the weight ratio of the sucrester and lecithin from 50:1 to 10:1 because as discussed above, Gómez-Ramírez and Lacorte 2015 are drawn to teaching the same iron formulation containing iron (III) pyrophosphate, sunflower lecithin, sucrester or sucrose esters and pre-gelatinized rice starch, and Lacorte 2015 is also drawn to using the iron formulation for treating disorders or diseases related to or derived from iron deficiency.
Regarding claim 11, Gómez-Ramírez and Nagao-Kitamoto teaches gastrointestinal infection includes intestinal inflammations (Gómez-Ramírez: Abstract; pages 2, 4-11 and 16-17; Nagao-Kitamoto: Abstract; pages 2-7).
Regarding claim 12, as discussed above, Gómez-Ramírez teaches Sucrosomial® Iron is useful in inflammatory bowel disease (IBD) patient with iron deficiency (ID), as Sucrosomial® Iron has been shown to be efficacious in said IBD patient with rising Hb concentration, as well as, ferritin and TSAT levels and said IBD patients also had very few gastrointestinal side effects. Furthermore, Gómez-Ramírez also teaches that the main causes of iron deficiency are due to inappropriate diet and malabsorption due to bariatric surgery, IBD, and celiac disease (Gómez-Ramírez: page 2).
Regarding claim 13, as discussed above, Gómez-Ramírez teaches Sucrosomial® Iron is formulated with tricalcium phosphate and starch to allow the Sucrosomial® Iron to be gastro-resistant and carried through the intestinal tract, without side effects from the interaction between iron and intestinal mucosa.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 1-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gómez-Ramírez et al (Pharmaceuticals, 2018, 11(97): 1-23) in view of Nagao-Kitamoto et al (Immune Network, 2017, 17(1): 1-12) and Lacorte et al (WO 2019/025922 A1; hereafter as “Lacorte 2019”).
Regarding claim 1, Gómez-Ramírez teaches iron deficiency (ID) is usually treated with oral iron salts but up to 50% of patients complain of gastrointestinal side effects, leading to reduced compliance with treatment (Abstract). Gómez-Ramírez teaches the use Sucrosomial® Iron (SI) as an alternative for effective treatment of ID while also reducing gastrointestinal side effects (Abstract; pages 4-11 and 16-17). Gómez-Ramírez teaches Sucrosomial® Iron (SI) is an oral iron containing carrier, in which ferric pyrophosphate is protected with a phospholipid bilayer membrane, mainly from sunflower lecithin, plus a sucrester matrix (sucrester E473) (page 5). Gómez-Ramírez teaches Sucrosomial® Iron has high iron bioavailability and excellent gastrointestinal tolerance, and is more efficacious and tolerable than oral iron salts (pages 4-5, 8-9, 11 and 17). Gómez-Ramírez teaches Sucrosomial® Iron is used for treating ID, especially for subjects with intolerance to iron salts or those whom iron salts are inefficacious (Abstract; pages 4-5 and 17). Gómez-Ramírez teaches Sucrosomial® Iron is formulated with tricalcium phosphate and starch to allow the Sucrosomial® Iron to be gastro-resistant and carried through the intestinal tract, without side effects from the interaction between iron and intestinal mucosa (page 5). Gómez-Ramírez teaches Sucrosomial® Iron is useful in inflammatory bowel disease (IBD) patient with iron deficiency (ID), as Sucrosomial® Iron has been shown to be efficacious in said IBD patient with rising Hb concentration, as well as, ferritin and TSAT levels and said IBD patients also had very few gastrointestinal side effects (Abstract; pages 4-11 and 16-17).
While Gómez-Ramírez does not expressly teach the Sucrosomial® Iron reduces the amount of pathogenic bacteria pathogen belonging to the phylum Proteobacteria present in the gut microbiota of the treated subject, it would have been obvious that the administered Sucrosomial® Iron in said patient of Gómez-Ramírez would implicitly reduce the amount of pathogenic bacteria pathogen belonging to the phylum Proteobacteria present in the gut microbiota of said patient of Gómez-Ramírez because Nagao-Kitamoto establishes that pathobionts are known to be enriched in IBD patients, as several microbiome analyses have revealed there is an expansion of the Proteobacteria phylum in IBD patients, and such enrichment of pathobionts induces intestinal inflammation of said IBD patients (Nagao-Kitamoto: Abstract; pages 2-7). Gómez-Ramírez teaches that malabsorption due to IBD is one of the main causes of iron deficiency. As discussed above, Sucrosomial® Iron was established by Gómez-Ramírez to be useful in inflammatory bowel disease (IBD) patient with iron deficiency (ID) due to Sucrosomial® Iron has been shown to be efficacious in said IBD patient. Thus, it would have been obvious with reasonable expectation that the that the administered Sucrosomial® Iron in said patient of Gómez-Ramírez would result in reducing the amount of pathogenic bacteria pathogen belonging to the phylum Proteobacteria present in the gut microbiota of said patient because Gómez-Ramírez established that the use of Sucrosomial® Iron reduces gastrointestinal side effects, where IBD with iron deficiency whom were administered Sucrosomial® Iron had very few gastrointestinal side effects.
It is noted that the subject to be treated with Sucrosomial® Iron from Gómez-Ramírez is the identified subject as claimed in claim 1 because as discussed above, Gómez-Ramírez has identified the subject to be treated with Sucrosomial® Iron as a patient having iron deficiency and said patient was previously administered oral iron salts and had gastrointestinal side effects due to the administered oral iron salts, particularly said patient include inflammatory bowel disease (IBD) patient with iron deficiency (ID) (Gómez-Ramírez: Abstract; pages 2-3, 5, 8-11, and 16-17). As discussed above, Nagao-Kitamoto established that inflammatory bowel disease (IBD) patient with iron deficiency (ID) of Gómez-Ramírez is known to be enriched in pathobionts (Nagao-Kitamoto: Abstract; pages 2-7). Thus, the subject (patient) that was administered Sucrosomial® Iron in Gómez-Ramírez is the same identified subject from instant claimed method of claim 1.
With respect to the pre-gelatinised rice starch in the iron(III) formulation as recited in claim 1, Lacorte 2019 teaches a composition comprising iron (III) pyrophosphate, sucrose ester or sucresters E473, and lecithin, wherein the solid composition is used in a method for the treatment of an iron deficiency or anaemia of inflammation in a subject affected by at least one pathology selected from among chronic kidney disease (CKD), nephropathy, neoplasms, chronic inflammatory intestinal diseases, ulcerous colitis, Crohn's Disease, and celiac disease (Abstract; pages 3-14). Lacorte 2019 teaches the solid composition further contains pre-gelatinized rice starch (pages 9-11). Lacorte 2019 teaches sucrester E473 contains 70% of monoesters, being obtained by sucrose esterification with vegetable fatty acids (stearic and palmitic) (page 9). Lacorte 2019 teaches the composition contains from 0.1 to 1.5% by weight of lecithin and 10 to 20% by weight of sucrose ester or sucresters E473 (pages 8-9). Lacorte 2019 teaches the composition further contains a starch, preferably, pre-gelatinized rice starch (pages 9-10; claims 1-5).
It would have been obvious to one of ordinary skill in the art to use pre-gelatinized rice starch as the starch material in the iron formulation of Gómez-Ramírez, and achieve the claimed invention. One of ordinary skill in the art would have been motivated to do so because as discussed above, Lacorte 2019 provides for the use of pre-gelatinized rice starch as the starch material in the iron formulation of Gómez-Ramírez containing iron (III) pyrophosphate, sucrose ester or sucresters E473, and sunflower lecithin. One of ordinary skill in the art would have reasonable expectation of success in using pre-gelatinized rice starch as the starch material in the iron formulation of Gómez-Ramírez because as discussed above, Gómez-Ramírez and Lacorte 2019 are drawn to teaching the same iron formulation containing iron (III) pyrophosphate, sunflower lecithin, sucrester or sucrose esters and pre-gelatinized rice starch, and Lacorte 2019 is also drawn to using the iron formulation for treatment of an iron deficiency or anaemia of inflammation in a subject affected by at least one pathology selected from among chronic kidney disease (CKD), nephropathy, neoplasms, chronic inflammatory intestinal diseases, ulcerous colitis, Crohn's Disease, and coeliac disease.
Regarding claims 2 and 3, Gómez-Ramírez teaches the patient is also anemic and had previously been treated with iron salts that was inefficacious (Abstract; pages 4-5 and 16-17).
Regarding claim 4, Gómez-Ramírez teaches one of the main causes of iron deficiency in said patients was due to malabsorption from Helicobater pylori infection, and the use of Sucrosomial® Iron (SI) was an effective treatment of ID while also reducing gastrointestinal side effects (Abstract; pages 2, 4-11 and 16-17).
Regarding claim 5, Nagao-Kitamoto teaches the pathogenic bacteria in the phylum Proteobacteria include E coli and Salmonella (Nagao-Kitamoto: pages 4-5).
Regarding claim 6, as discussed above, Gómez-Ramírez established that the use of Sucrosomial® Iron reduces gastrointestinal side effects, where IBD with iron deficiency whom were administered Sucrosomial® Iron had very few gastrointestinal side effects, thereby the Sucrosomial® Iron has modified the gut microbiota of said patient.
Regarding claim 7, Gómez-Ramírez teaches Sucrosomial® Iron is formulated with tricalcium phosphate and starch to allow the Sucrosomial® Iron to be gastro-resistant and carried through the intestinal tract, without side effects from the interaction between iron and intestinal mucosa (page 5).
Regarding claim 8, as discussed above, Gómez-Ramírez teaches Sucrosomial® Iron (SI) is an oral iron containing carrier, in which ferric pyrophosphate is protected with ap phospholipid bilayer membrane, mainly from sunflower lecithin, plus a sucrester matrix.
Regarding claim 9, as discussed above, both Gómez-Ramírez and Lacorte 2019 teaches sucrester 473 in their iron formulation.
Regarding claim 10, Lacorte 2019 teaches a composition comprising iron (III) pyrophosphate, sucrose ester or sucresters E473, and lecithin, wherein the solid composition is used in a method for the treatment of an iron deficiency or anaemia of inflammation in a subject affected by at least one pathology selected from among chronic kidney disease (CKD), nephropathy, neoplasms, chronic inflammatory intestinal diseases, ulcerous colitis, Crohn's Disease, and celiac disease (Abstract; pages 3-14). Lacorte 2019 teaches the solid composition further contains pre-gelatinized rice starch (pages 9-11). Lacorte 2019 teaches sucrester E473 contains 70% of monoesters, being obtained by sucrose esterification with vegetable fatty acids (stearic and palmitic) (page 9). Lacorte 2019 teaches the composition contains from 0.1 to 1.5% by weight of lecithin and 10 to 20% by weight of sucrose ester or sucresters E473 (pages 8-9). Lacorte 2019 teaches the composition further contains a starch, preferably, pre-gelatinized rice starch (pages 9-10; claims 1-5). It would have been obvious to one of ordinary skill in the art to optimize the weight ratio of the sucrester and lecithin from 50:1 to 10:1, and achieve the claimed invention. One of ordinary skill in the art would have been motivated to do so because Gómez-Ramírez and Lacorte 2019 are drawn to teaching the same iron formulation containing iron (III) pyrophosphate, sunflower lecithin, sucrester or sucrose esters and pre-gelatinized rice starch, and as discussed above, Lacorte 2019 provides for the composition to contain from 0.1 to 1.5% by weight of lecithin and 10 to 20% by weight of sucrose ester or sucresters E473, which encompassed weight ratios that falls within or read on the claimed weight ratios ranges of claim 10. One of ordinary skill in the art would have reasonable expectation of success of optimizing the weight ratio of the sucrester and lecithin from 50:1 to 10:1 because as discussed above, Gómez-Ramírez and Lacorte 2019 are drawn to teaching the same iron formulation containing iron (III) pyrophosphate, sunflower lecithin, sucrester or sucrose esters and pre-gelatinized rice starch, and Lacorte 2019 is also drawn to using the iron formulation for treatment of an iron deficiency or anaemia of inflammation in a subject affected by at least one pathology selected from among chronic kidney disease (CKD), nephropathy, neoplasms, chronic inflammatory intestinal diseases, ulcerous colitis, Crohn's Disease, and celiac disease.
Regarding claim 11, Gómez-Ramírez and Nagao-Kitamoto teaches gastrointestinal infection includes intestinal inflammations (Gómez-Ramírez: Abstract; pages 2, 4-11 and 16-17; Nagao-Kitamoto: Abstract; pages 2-7).
Regarding claim 12, as discussed above, Gómez-Ramírez teaches Sucrosomial® Iron is useful in inflammatory bowel disease (IBD) patient with iron deficiency (ID), as Sucrosomial® Iron has been shown to be efficacious in said IBD patient with rising Hb concentration, as well as, ferritin and TSAT levels and said IBD patients also had very few gastrointestinal side effects. Furthermore, Gómez-Ramírez also teaches that the main causes of iron deficiency are due to inappropriate diet and malabsorption due to bariatric surgery, IBD, and celiac disease (Gómez-Ramírez: page 2).
Regarding claim 13, as discussed above, Gómez-Ramírez teaches Sucrosomial® Iron is formulated with tricalcium phosphate and starch to allow the Sucrosomial® Iron to be gastro-resistant and carried through the intestinal tract, without side effects from the interaction between iron and intestinal mucosa.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 01/27/2026 have been fully considered but they are not persuasive.
Below is the Examiner’s response to Applicant’s arguments as they pertain to the pending 103 rejections.
Applicant argues “[n]either Gómez-Ramirez nor Nagao-Kitamoto provide any teaching or suggestion that bacteria of the Proteobacteria phylum may be increased in IBD patients following iron supplementation, let alone that administration of an iron (Ill) formulation to such patients would reduce the level of bacteria belonging to the phylum Proteobacteria in those patients.” Thus, Applicant alleges “the combination of G6mez-Ramirez and Nagao-Kitamoto fail to establish a link between an increase in bacteria of the Proteobacteria phylum and the specific patient population defined by Claim 1.” (Remarks, pages 8-9).
In response, the Examiner disagrees. As discussed above in the pending 103 rejections, the subject to be treated with Sucrosomial® Iron from Gómez-Ramírez is the identified subject as claimed in claim 1 because as discussed above, Gómez-Ramírez has identified the subject to be treated with Sucrosomial® Iron as a patient having iron deficiency and said patient was previously administered oral iron salts and had gastrointestinal side effects due to the administered oral iron salts, particularly said patient include inflammatory bowel disease (IBD) patient with iron deficiency (ID) (Gómez-Ramírez: Abstract; pages 2-3, 5, 8-11, and 16-17). As discussed above, Nagao-Kitamoto established that inflammatory bowel disease (IBD) patient with iron deficiency (ID) of Gómez-Ramírez is known to be enriched in pathobionts (Nagao-Kitamoto: Abstract; pages 2-7). Thus, the subject (patient) that was administered Sucrosomial® Iron in Gómez-Ramírez is the same identified subject from instant claimed method of claim 1. Thus, as discussed above in the 103 rejection, it is maintained that it would have been obvious that the administered Sucrosomial® Iron in said patient of Gómez-Ramírez would implicitly reduce the amount of pathogenic bacteria pathogen belonging to the phylum Proteobacteria present in the gut microbiota of said patient of Gómez-Ramírez because Nagao-Kitamoto establishes that pathobionts are known to be enriched in IBD patients, as several microbiome analyses have revealed there is an expansion of the Proteobacteria phylum in IBD patients, and such enrichment of pathobionts induces intestinal inflammation of said IBD patients (Nagao-Kitamoto: Abstract; pages 2-7). Gómez-Ramírez teaches that malabsorption due to IBD is one of the main causes of iron deficiency. As discussed above, Sucrosomial® Iron was established by Gómez-Ramírez to be useful in inflammatory bowel disease (IBD) patient with iron deficiency (ID) due to Sucrosomial® Iron has been shown to be efficacious in said IBD patient. Thus, it would have been obvious with reasonable expectation that the that the administered Sucrosomial® Iron in said patient of Gómez-Ramírez would result in reducing the amount of pathogenic bacteria pathogen belonging to the phylum Proteobacteria present in the gut microbiota of said patient because Gómez-Ramírez established that the use of Sucrosomial® Iron reduces gastrointestinal side effects, where IBD with iron deficiency whom were administered Sucrosomial® Iron had very few gastrointestinal side effects.
As a result, for at least the reason discussed above, claims 1-13 remain rejected as being obvious and unpatentable over the combined teachings of the cited prior arts in the pending 103 rejections as set forth in this office action.
Conclusion
No claim is allowed.
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOAN THI-THUC PHAN whose telephone number is (571)270-3288. The examiner can normally be reached 8-5 EST Monday-Friday.
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/DOAN T PHAN/Primary Examiner, Art Unit 1613
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