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 .
Election/Restrictions
Applicant’s election without traverse of polyallylamine, 2,3-dihydroxybenzoic acid, and a PEG cross-linker in the reply filed on 05/27/2026 is acknowledged. An additional telephone call with Applicant’s attorney, Richard Brown, was conducted on 07/15/2026 to further narrow down the cross-linker to a single specific species. Attorney selected the polyethylene glycol diglycidyl ether of claim 60. Accordingly, claims 57 and 58 are withdrawn as being drawn to non-elected species.
Status of Claims
Receipt of Remarks/Amendments filed on 05/27/2026 is acknowledged. Claims 49-50, 56-58, 60, 62, and 67 are amended and claims 1-48, 51, 53, 59, and 66 are canceled. Claims 69-72 are new. Claims 57 and 58 are withdrawn as discussed above. Claims 49-50, 52, 54-56, 60-65, and 67-72 are examined on the merits herein.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/21/2024, 12/01/2025, and 01/07/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Priority
The instant application filed 02/12/2024, is a 371 filing of PCT/US22/40250, filed 08/12/2022, which claims benefit to Provisional Application No. 63/316,831, filed 03/04/2022, and Provisional Application No. 63/233,024, filed 08/13/2021.
Claim Rejections - 35 USC § 112(b)
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 60-65 are 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.
Applicant has elected poly(ethylene glycol) diglycidyl ether as the crosslinker and several of the claims and working examples of the instant specification define it by name (i.e., claim 72, para. [00112]). Poly(ethylene glycol) diglycidyl ether has the following structure as evidenced by Sigma Aldrich:
PNG
media_image1.png
161
433
media_image1.png
Greyscale
, which reads on a structure defined in claim 56. However, the structures of claims 60-62 do not appear to define such a structure, instead defining the crosslinker as
PNG
media_image2.png
86
161
media_image2.png
Greyscale
, with L3 being polyethylene glycol. Polyethylene glycol has the following structure:
PNG
media_image3.png
200
400
media_image3.png
Greyscale
, meaning a crosslinker according to the structure of claims 60-62 would have a structure of
PNG
media_image4.png
200
400
media_image4.png
Greyscale
, where the epoxides are bound directly to the oxygens of the polyethylene glycol. The known structure of poly(ethylene glycol) diglycidyl ether, on the other hand, contains CH2 groups between the polyethylene glycol chain and the epoxides:
PNG
media_image5.png
106
285
media_image5.png
Greyscale
. Thus, the structure of claims 60 and 61 should contain an additional CH2 group between L3 and the epoxide connection if applicant intends to define poly(ethylene glycol) diglycidyl ether as the crosslinker. For the sake of compact prosecution the claims will be interpreted as defining poly(ethylene glycol) diglycidyl ether and its known structure as the crosslinker.
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 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.
Claims 49-50, 52, 56, 67, and 69-71 are rejected under 35 U.S.C. 103 as being unpatentable over Berkland C. et al. (US 20130056211 A1, 03/07/2013, IDS dated 01/07/2026), hereinafter Berkland, in view of Sherrington R. et al. (WO 2010005851 A1, 01/14/2010, PTO-892), hereinafter Sherrington, as evidenced by Fisher Scientific (2026). N,N’-Methylenebisacrylamide, 99+%, Elecrophoresis Grade. Thermo Scientific Chemicals (PTO-892), hereinafter Fisher Scientific.
Berkland discloses a composition comprising a polymer and one or more chelators covalently coupled to the polymer (abstract).
Regarding claim 49: Berkland teaches a composition comprising a polymeric chelator, the polymeric chelator including a polymer coupled with a metal chelator ([0074]; claim 1). The polymer includes a polyamine (claim 4), with specific examples synthesized from precursor PAAm (polyallylamine) chains (Ex. 1, [0097]). The chelators are covalently coupled to the polymer (abstract; claim 1). Specifically, the iron chelator 2,3-DHBA is coupled with the reactive primary amine side groups of a PAAm polymer ([0081]; Ex. 1, [0097]). The polymer may be a cross-linked polymer, with specific examples utilizing a cross-linked PAAm hydrogel synthesized by cross-linking the precursor PAAm chains with a N,N'-methylenebis-acrylamide (MBA) cross-linker ([0076]; Ex. 1, [0097]; Ex. 3, [0111]-[0113]; [0126]; Ex. 4, [0135]; [0160]; Ex. 5, [0176]; Ex. 7, [0223]).
Regarding claim 52: The polyamine includes polyallylamine (PAA) (claim 8; Ex. 1, 3-5, and 7).
Regarding claim 56: The N,N'-methylenebisacrylamide (MBA) cross-linker used by Berkland (Ex. 1, 3-5, and 7) has the following structure as evidenced by Fisher Scientific:
PNG
media_image6.png
250
250
media_image6.png
Greyscale
(p. 1), which reads on the instantly claimed structure wherein R1 and R2 are acrylamides having a R’ of H, n is 0, and L3 is a bond.
Regarding claim 67: The N,N'-methylenebisacrylamide (MBA) cross-linker (Ex. 1, 3-5, and 7) is water soluble as evidenced by Fisher Scientific, meaning it is a hydrophilic cross-linker as claimed.
Regarding claims 69-71: The chelator coupled to the polymer (i.e., polyamine backbone below) is 2,3-dihydrobenzoic acid (DHBA) ([0077]; [0079]; Ex. 1-6), which comprises a phenyl group substituted with at least two hydroxyl groups as shown below in the “metal binding domain” below. The structure below also reads on the structure of claim 71:
PNG
media_image7.png
358
481
media_image7.png
Greyscale
(Fig. 1B).
Regarding the polyamine molecular weight, poly(allylamine hydrochloride) (PAAm) having an average molecular weight of 56 kDa is used in Examples 3 through 5. However, the polymeric chelator can be configured to have any appropriate molecular weight for injection, ingestion, inhalation or for topical application ([0091]) and the plasma half-life of these polymeric agents can be optimized based on the initial molecular weight of the polymer ([0093]).
Overall, the polymeric chelators of Berkland can be included in oral therapeutics for use in iron overload disease patients. The chelating polymers can selectively bind iron and remove it from the GI tract before it is absorbed into the blood stream ([0087]).
The teachings of Berkland differ from that of the instantly claimed invention in the that Berkland does not explicitly teach the composition to comprise an agent selected from an antacid, a histamine H2-receptor antagonist, or a proton pump inhibitor, as recited in claim 1, nor wherein the polyamine polymer has a weight average molecular weight of 1-50 kDa, as recited in claim 50.
Sherrington discloses combination therapies for the treatment of iron overload disorders utilizing inhibitors of divalent metal transporter-1 (DMT1 ), proton pump inhibitors (PPIs), iron chelators and calcium channel blockers (p. 1, para. 1). It is proposed that a PPI would work additively with chelation therapy to remove the excess iron that is in the body by blocking the uptake of iron from the intestine into the body or by increasing the urinary iron output from the kidney. This combination may increase efficacy and improve iron serum and tissue control in iron-overloaded patients or could lead to reduction in the dosage or frequency of dosing chelators which could lead to safer treatments for patients by reducing the chelation treatment-induced side effects (p. 3, para. 1).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to incorporate a PPI into the composition of Berkland since PPIs are known and routine actives for treating iron overload disorders as taught by Sherrington. The composition of Berkland comprises an iron chelator for treating an iron overload disease. As such, one of ordinary skill in the art would have been motivated to include a PPI in combination with said iron chelator, as suggested by Sherrington, in order to improve efficacy and reduce the dosage/frequency of administration. One of ordinary skill in the art would have had a reasonable expectation of success in adding a PPI into the composition of Berkland since the formulation of iron chelators and PPIs together is encouraged by Sherrington.
Regarding claim 50, it would have been further prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to optimize the molecular weight of the polyamine polymer to fall within the instantly claimed rang of 1-50 kDa since adjusting molecular weight is known and routine in the art according to Berkland. While the 56 kDa polyallylamine of the examples does not fall within the instantly claimed range of 1-50 kDa, it is well within the abilities of an ordinary artisan to optimize the polymer’s molecular weight depending on the desired mode of administration and half-life of the final product, as reasonably suggested by Berkland. As such, one of ordinary skill in the art would have arrived at the instantly claimed range of claim 50 through no more than routine experimentation. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 49-50, 52, 54-56, 67, and 69-71 are rejected under 35 U.S.C. 103 as being unpatentable over Berkland and Sherrington as applied to claims 49-50, 52, 56, 67, and 69-71 above, and further in view of Milman N (2020). A Review of Nutrients and Compounds, Which Promote or Inhibit Intestinal Iron Absorption: Making a Platform for Dietary Measures That Can Reduce Iron Uptake in Patients with Genetic Haemochromatosis, Journal of Nutrition and Metabolism, 7373498, 15 pages (PTO-892), hereinafter Milman.
The combined teachings of Berkland and Sherrington are discussed above.
The combined teachings of Berkland and Sherrington differ from that of the instantly claimed invention in that neither explicitly teach an antacid as defined in claim 54 and 55.
Milman provides an overview of nutrients and compounds which influence human intestinal iron absorption, thereby making a platform for elaboration of dietary recommendations that can reduce iron uptake in patients with genetic haemochromatosis (abstract). Genetic haemochromatosis is characterized by an increased intestinal dietary iron uptake, which in the long term may lead to the gradual accumulation of excess iron in the body and clinical symptoms of iron overload (Intro, para. 1). Specifically, Milman discloses antacids as inhibitors of iron absorption (Table 1; section 4.2), which read on the antacid of claim 54. Many preparations contain calcium carbonate and magnesium oxide, magnesium hydroxide, or magnesium trisilicate. If taken in close association with a meal, this kind of medicine can inhibit iron uptake from the food in three ways: (i) by neutralizing the gastric acid pH, (ii) by calcium-induced inhibition of iron absorption, and (iii) by a possible inhibition of magnesium compounds on iron absorption (section 4.2). Calcium carbonate, magnesium oxide, and magnesium hydroxide all read on the antacid of claim 55. Milman also teaches proton pump inhibitors as known inhibitors of iron absorption (Section 4.1).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to incorporate an antacid into the combined composition of Berkland and Sherrington since antacids are known and routine iron absorption inhibitors in the art as taught by Milman. One of ordinary skill in the art would have been motivated to substitute or add in the antacids of Milman into the combined composition of Berkland and Sherrington since the combination of iron chelators and iron uptake inhibitors allows for increased efficacy and decreased dosage/frequency of administration, as taught by Sherrington, and antacids are known and effective iron uptake inhibitors as taught by Milman. As such, one of ordinary skill in the art would have recognized an antacid as a beneficial ingredient in a composition for treating iron overload disorders which also comprises an iron chelator.
It would have been further prima facie obvious to one of ordinary skill in the art to select any one of calcium carbonate, magnesium oxide, or magnesium hydroxide as the antacid above since it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07.
One of ordinary skill in the art would have had a reasonable expectation of success in making the above modifications since Berkland, Sherrington, and Milman all teach compounds useful for treating iron overload.
Claims 49-50, 52, 56, 60-65, 67-68, and 69-72 are rejected under 35 U.S.C. 103 as being unpatentable over Berkland and Sherrington as applied to claims 49-50, 52, 56, 67, and 69-71 above, and further in view of Wood C. et al. (WO 2022183244 A1, 09/09/2022, effectively filed 03/03/2021, PTO-829), hereinafter Wood, as evidenced by Sigma Aldrich (2026). Poly(ethylene glycol) diglycidyl ether. Millipore Sigma Product (PTO-829), hereinafter Sigma Aldrich.
The combined teachings of Berkland and Sherrington are discussed above.
Berkland further teaches wherein other crosslinking or coupling reagents can be included in the polymer and chelator system in order to prepare a polymeric chelator having the ability to chelate iron ([0078]).
The combined teachings of Berkland and Sherrington differ from that of the instantly claimed invention in that neither explicitly teach the elected crosslinker of claims 56, 60-65, 68, and 72.
Wood discloses functionalized polyamine hydrogels that can be used for capturing one or more acidic gases from gaseous streams and atmospheres (abstract). The hydrogel comprises a cross-linked polyamine or a copolymer thereof. The cross-linked poly amine or copolymer thereof comprises one or more amine groups. The one or more amine groups may be primary (1°), secondary (2°) and/or tertiary (3°) amine groups (p. 2, para. 3). The polyamine, derivative or copolymer thereof is a polyalkylenimine selected from polyallylamine (p. 28, para. 4; claim 19). The cross-linking agent may be selected from various diglycidyl ethers including poly(ethylene glycol) diglycidyl ether average (<Mn 1000) (p. 41, para. 2). Poly(ethylene glycol) diglycidyl ether has the following structure as evidenced by Sigma-Aldrich:
PNG
media_image1.png
161
433
media_image1.png
Greyscale
(p. 1), which reads on the elected structure of claim 56 wherein R1 and R2 are epoxides, n is 1, and L3 is polyethylene glycol. Such a compound also reads on the crosslinker of claims 60 and 72 and would result in the polymer structure of claims 61 and 62 upon crosslinking, as best interpreted given the 112(b) issue above. An average molecular weight of <1000 Da overlaps with the average molecular weight of claim 68. The CH2-epoxide end groups make up approximately 114 g/mol of the crosslinker’s total weight (2 x [(3 x 12) + 16 + (5 x 1)]), meaning a 1000 Da crosslinker has a PEG chain of approximately 886 Da (1000 – 114). A PEG molecular weight of 886 Da or less overlaps with the ranges of claims 63-65. PEGs are also well known in the art as very hydrophilic, meaning the PEG diglycidyl ether also reads on the crosslinker of claim 67.
The cross-linking agent of Wood may alternatively be a divinyl cross-linking agent, such as N, N- methylenebisacrylamide (p. 41, para. 4). The swelling ability of the hydrogel is dependent on the nature of the cross-linked polyamine. For example, a hydrogel with long hydrophilic cross-links may swell more than an analogous cross-linked polymer network with shorter hydrophobic cross-links (p. 39, para. 3).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to use the poly(ethylene glycol) diglycidyl ether (<Mn 1000) crosslinker of Wood as a crosslinker in the polymeric chelator of Berkland since such a cross linker is known and routine in the art as taught by Wood. One of ordinary skill in the art could have performed simple substitution of one known crosslinker for another by replacing the N,N-methylenebisacrylamide of Berkland with the PEG diglcyidyl ether of Wood, to predictably yield the instant invention. One of ordinary skill in the art would have had a reasonable expectation of success in making such a modification since both crosslinkers are known and routine in the art of crosslinking polyamines as taught by Wood and Berkland welcomes other crosslinking agents. Such a combination yields the elected crosslinker of claims 56, 60-62, 67, and 72 obvious.
Regarding the molecular weights of the PEG chain and the entire crosslinker as recited in claims 63-65 and 68, it is established above that the molecular weight range taught by Wood overlaps with those claimed. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05.
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).
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.
Claims 49-50, 52, 54-56, 60-65, and 67-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5-7 of U.S. Patent No. 9,402,861 in view of Berkland and Sherrington. The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Berkland and Sherrington.
Conflicting claim 1 recites a composition comprising: a polymeric chelator comprising a plurality of polyamine polymer backbone chains and one or more chelators, wherein the one or more chelators are covalently coupled to one or more primary amines, respectively, of at least one of the plurality of polyamine polymer backbone chains through one or more amide bonds, respectively, and wherein the plurality of polyamine polymer backbone chains are cross-linked to one another independent of any cross-linking that may result from interactions with the one or more chelators. The chelator is capable of chelating a metal such as iron (conflicting claims 5-7).
The conflicting claims differ from the instant claims in that they do not explicitly define a crosslinking agent nor an agent selected from an antacid, a histamine H2-receptor antagonist, or a proton pump inhibitor.
Berkland discloses a composition comprising a polymer and one or more chelators covalently coupled to polymer (abstract).The polymer may be a cross-linked polymer, with specific examples utilizing a cross-linked PAAm hydrogel synthesized by cross-linking the precursor PAAm chains with a N,N'-methylenebis-acrylamide (MBA) cross-linker ([0076]; Ex. 1, [0097]; Ex. 3, [0111]-[0113]; [0126]; Ex. 4, [0135]; [0160]; Ex. 5, [0176]; Ex. 7, [0223]). The chelating polymers can selectively bind iron and remove it from the GI tract before it is absorbed into the blood stream ([0087]).
Sherrington discloses combination therapies for the treatment of iron overload disorders utilizing inhibitors of divalent metal transporter-1 (DMT1 ), proton pump inhibitors (PPIs), iron chelators and calcium channel blockers (p. 1, para. 1). It is proposed that a PPI would work additively with chelation therapy to remove the excess iron that is in the body by blocking the uptake of iron from the intestine into the body or by increasing the urinary iron output from the kidney. This combination may increase efficacy and improve iron serum and tissue control in iron-overloaded patients or could lead to reduction in the dosage or frequency of dosing chelators which could lead to safer treatments for patients by reducing the chelation treatment-induced side effects (p. 3, para. 1).
It would have been prima facie obvious to one of ordinary skill in the art to crosslink the polyamine polymer backbone of the conflicting claims with the cross-linker of Berkland, since such a cross-linker is known and routine in the art for cross-linking polyamines. One of ordinary skill in the art could have combined the known polymeric chelator of the conflicting claims with the known cross-linker of Berkland according to known methods to predictably yield the instantly claimed invention. One of ordinary skill in the art would have had a reasonable expectation of success since the conflicting claims define the polymeric chelator as crosslinked and Berkland teaches crosslinking agents for similar polymeric chelators.
It would have been further prima facie obvious to one of ordinary skill in the art to incorporate a PPI into the composition of the conflicting claims since PPIs are known and routine actives for treating iron overload in combination with an iron chelator as taught by Sherrington. The conflicting composition comprises a polymeric chelator capable of chelating iron which one of ordinary skill in the art would have been motivated to use in combination with a PPI in order to synergistically treat an iron overload disease, as suggested by Sherrington. One of ordinary skill in the art would have had a reasonable expectation of success in adding a PPI into the composition of the conflicting claims since Sherrington explicitly teaches the combination of iron chelators and PPIs for treating iron overload disease.
Claims 49-50, 52, 54-56, 60-65, and 67-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-4 of U.S. Patent No. 9,974,863 in view of Berkland and Sherrington. The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Berkland and Sherrington.
Conflicting claim 1 recites a method for removing a metal from a medium containing the metal, the method comprising; applying a polymeric chelator to the medium, wherein the polymeric chelator comprises a plurality of polyamine polymer backbone chains and one or more chelators, wherein the one or more chelators are covalently coupled to one or more primary amines, respectively, of at least one of the plurality of polyamine polymer backbone chains through one or more amide bonds, respectively, and wherein the plurality of polyamine polymer backbone chains are cross-linked to one another independent of any cross-linking that may result from interactions with the one or more chelators. The metal is iron (conflicting claims 3-4).
The conflicting claims differ from the instant claims in that they do not explicitly define a crosslinking agent nor an agent selected from an antacid, a histamine H2-receptor antagonist, or a proton pump inhibitor.
Berkland discloses a composition comprising a polymer and one or more chelators covalently coupled to polymer (abstract).The polymer may be a cross-linked polymer, with specific examples utilizing a cross-linked PAAm hydrogel synthesized by cross-linking the precursor PAAm chains with a N,N'-methylenebis-acrylamide (MBA) cross-linker ([0076]; Ex. 1, [0097]; Ex. 3, [0111]-[0113]; [0126]; Ex. 4, [0135]; [0160]; Ex. 5, [0176]; Ex. 7, [0223]). The chelating polymers can selectively bind iron and remove it from the GI tract before it is absorbed into the blood stream ([0087]).
Sherrington discloses combination therapies for the treatment of iron overload disorders utilizing inhibitors of divalent metal transporter-1 (DMT1 ), proton pump inhibitors (PPIs), iron chelators and calcium channel blockers (p. 1, para. 1). It is proposed that a PPI would work additively with chelation therapy to remove the excess iron that is in the body by blocking the uptake of iron from the intestine into the body or by increasing the urinary iron output from the kidney. This combination may increase efficacy and improve iron serum and tissue control in iron-overloaded patients or could lead to reduction in the dosage or frequency of dosing chelators which could lead to safer treatments for patients by reducing the chelation treatment-induced side effects (p. 3, para. 1).
It would have been prima facie obvious to one of ordinary skill in the art to crosslink the polyamine polymer backbone of the conflicting claims with the cross-linker of Berkland, since such a cross-linker is known and routine in the art for cross-linking polyamines. One of ordinary skill in the art could have combined the known polymeric chelator of the conflicting claims with the known cross-linker of Berkland according to known methods to predictably yield the instantly claimed invention. One of ordinary skill in the art would have had a reasonable expectation of success since the conflicting claims define the polymeric chelator as crosslinked and Berkland teaches crosslinking agents for similar polymeric chelators.
It would have been prima facie obvious to one of ordinary skill in the art to incorporate a PPI into the composition of the conflicting claims since PPIs are known and routine actives for treating iron overload in combination with an iron chelator as taught by Sherrington. The composition in the conflicting claims comprises a polymeric chelator capable of chelating iron which one of ordinary skill in the art would have been motivated to use in combination with a PPI in order to synergistically treat an iron overload disease, as suggested by Sherrington. One of ordinary skill in the art would have had a reasonable expectation of success in adding a PPI into the composition of the conflicting claims since Sherrington explicitly teaches the combination of iron chelators and PPIs for treating iron overload disease.
Claims 49-50, 52, 54-56, 60-65, and 67-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-7, and 11 of U.S. Patent No. 10,039,836 in view of Berkland and Sherrington. The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Berkland and Sherrington.
Conflicting claim 1 recites a composition comprising: a polymeric chelator comprising a plurality of polyamine polymer backbone chains and one or more chelators; wherein the one or more chelators are covalently coupled to one or more primary amines, respectively, of at least one of the plurality of polyamine polymer backbone chains through one or more amide bonds, respectively; wherein the plurality of polyamine polymer backbone chains are cross-linked to one another independent of any cross-linking that may result from interactions with the one or more chelators. The chelators are capable of chelating a metal such as iron (conflicting claims 5-7 and 11).
The conflicting claims differ from the instant claims in that they do not explicitly define a crosslinking agent nor an agent selected from an antacid, a histamine H2-receptor antagonist, or a proton pump inhibitor.
Berkland discloses a composition comprising a polymer and one or more chelators covalently coupled to polymer (abstract).The polymer may be a cross-linked polymer, with specific examples utilizing a cross-linked PAAm hydrogel synthesized by cross-linking the precursor PAAm chains with a N,N'-methylenebis-acrylamide (MBA) cross-linker ([0076]; Ex. 1, [0097]; Ex. 3, [0111]-[0113]; [0126]; Ex. 4, [0135]; [0160]; Ex. 5, [0176]; Ex. 7, [0223]). The chelating polymers can selectively bind iron and remove it from the GI tract before it is absorbed into the blood stream ([0087]).
Sherrington discloses combination therapies for the treatment of iron overload disorders utilizing inhibitors of divalent metal transporter-1 (DMT1 ), proton pump inhibitors (PPIs), iron chelators and calcium channel blockers (p. 1, para. 1). It is proposed that a PPI would work additively with chelation therapy to remove the excess iron that is in the body by blocking the uptake of iron from the intestine into the body or by increasing the urinary iron output from the kidney. This combination may increase efficacy and improve iron serum and tissue control in iron-overloaded patients or could lead to reduction in the dosage or frequency of dosing chelators which could lead to safer treatments for patients by reducing the chelation treatment-induced side effects (p. 3, para. 1).
It would have been prima facie obvious to one of ordinary skill in the art to crosslink the polyamine polymer backbone of the conflicting claims with the cross-linker of Berkland, since such a cross-linker is known and routine in the art for cross-linking polyamines. One of ordinary skill in the art could have combined the known polymeric chelator of the conflicting claims with the known cross-linker of Berkland according to known methods to predictably yield the instantly claimed invention. One of ordinary skill in the art would have had a reasonable expectation of success since the conflicting claims define the polymeric chelator as crosslinked and Berkland teaches crosslinking agents for similar polymeric chelators.
It would have been prima facie obvious to one of ordinary skill in the art to incorporate a PPI into the composition of the conflicting claims since PPIs are known and routine actives for treating iron overload in combination with an iron chelator as taught by Sherrington. The composition in the conflicting claims comprises a polymeric chelator capable of chelating iron which one of ordinary skill in the art would have been motivated to use in combination with a PPI in order to synergistically treat an iron overload disease, as suggested by Sherrington. One of ordinary skill in the art would have had a reasonable expectation of success in adding a PPI into the composition of the conflicting claims since Sherrington explicitly teaches the combination of iron chelators and PPIs for treating iron overload disease.
Claims 49-50, 52, 54-56, 60-65, and 67-72 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/683,230 in view of Sherrington. The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Sherrington.
The copending claims recite a composition comprising: a plurality of polymeric chelator particles each comprising a plurality of polyamine polymer backbone chains and one or more chelators, wherein the one or more chelators are covalently coupled to one or more primary and/or secondary amines of at least one of the plurality of polyamine polymer backbone chains; and wherein the plurality of polyamine polymer backbone chains are cross-linked with a plurality of cross-linkers (copending claim 1).
The copending claims differ from the instant claims in that they do not explicitly recite an agent selected from an antacid, a histamine H2-receptor antagonist, or a proton pump inhibitor.
Sherrington discloses combination therapies for the treatment of iron overload disorders utilizing inhibitors of divalent metal transporter-1 (DMT1 ), proton pump inhibitors (PPIs), iron chelators and calcium channel blockers (p. 1, para. 1). It is proposed that a PPI would work additively with chelation therapy to remove the excess iron that is in the body by blocking the uptake of iron from the intestine into the body or by increasing the urinary iron output from the kidney. This combination may increase efficacy and improve iron serum and tissue control in iron-overloaded patients or could lead to reduction in the dosage or frequency of dosing chelators which could lead to safer treatments for patients by reducing the chelation treatment-induced side effects (p. 3, para. 1).
It would have been prima facie obvious to one of ordinary skill in the art to incorporate a PPI into the composition of the copending claims since PPIs are known and routine actives for treating iron overload in combination with an iron chelator as taught by Sherrington. The copending composition comprises a polymeric chelator which one of ordinary skill in the art would have been motivated to use in combination with a PPI in order to synergistically treat an iron overload disease, as suggested by Sherrington. One of ordinary skill in the art would have had a reasonable expectation of success in adding a PPI into the copending composition since Sherrington explicitly teaches the combination of chelators and PPIs for treating iron overload disease.
This is a provisional nonstatutory double patenting rejection.
Claims 49-50, 52, 54-56, 60-65, and 67-72 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/683,241 in view of Sherrington. The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Sherrington.
The copending claims recite a composition comprising: a polymeric chelator comprising a plurality of polyamine polymer backbone chains and one or more chelators, wherein the one or more chelators are covalently coupled to one or more primary and/or secondary amines of at least one of the plurality of polyamine polymer backbone chains; and wherein the plurality of polyamine polymer backbone chains are cross-linked with a plurality of cross-linkers (copending claim 1).
The copending claims differ from the instant claims in that they do not explicitly recite an agent selected from an antacid, a histamine H2-receptor antagonist, or a proton pump inhibitor.
Sherrington discloses combination therapies for the treatment of iron overload disorders utilizing inhibitors of divalent metal transporter-1 (DMT1 ), proton pump inhibitors (PPIs), iron chelators and calcium channel blockers (p. 1, para. 1). It is proposed that a PPI would work additively with chelation therapy to remove the excess iron that is in the body by blocking the uptake of iron from the intestine into the body or by increasing the urinary iron output from the kidney. This combination may increase efficacy and improve iron serum and tissue control in iron-overloaded patients or could lead to reduction in the dosage or frequency of dosing chelators which could lead to safer treatments for patients by reducing the chelation treatment-induced side effects (p. 3, para. 1).
It would have been prima facie obvious to one of ordinary skill in the art to incorporate a PPI into the composition of the copending claims since PPIs are known and routine actives for treating iron overload in combination with an iron chelator as taught by Sherrington. The copending composition comprises a polymeric chelator which one of ordinary skill in the art would have been motivated to use in combination with a PPI in order to synergistically treat an iron overload disease, as suggested by Sherrington. One of ordinary skill in the art would have had a reasonable expectation of success in adding a PPI into the copending composition since Sherrington explicitly teaches the combination of chelators and PPIs for treating iron overload disease.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNAH S ARMSTRONG whose telephone number is (571)272-0112. The examiner can normally be reached Mon-Fri 7:30-5 (Flex).
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, Sue X Liu can be reached at (571)272-5539. 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.
/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
Prosecution Insights