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 .
Priority
The instant application was filed 17 October 2022, claims priority to provisional application 63/010,850 filed 16 April 2020, and is the national stage entry of PCT/US2021/027741 filed 16 April 2021. The effective filing date of the instant application is 16 April 2020.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-18) in the reply filed on 24 March 2025 is acknowledged.
Claims 19-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 24 March 2025.
Examiner’s Note
The Applicant's amendments and arguments filed 14 November 2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 14 November 2025, it is noted that claim 1 has been amended, no new claims have been added, and claims 2, 9, and 14 are canceled. Support for the amendment can be found from previously canceled claims. No new matter has been added.
Claim Objections
Claim 15 is objected to because of the following informalities: Claim 15 depends from canceled claim 14. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4-8, 12, 13, 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nageswaran (US 2008/0213392 A1).
Nageswaran teaches a composition that includes crystalline NZP-type structures, such as M1M2A2VIP3IVO12 (para. 31), addressing claims 1, 4 and 5. Nageswaran teaches different embodiments using the formula, where the M variables may be Hydrogen and Zirconium and A may be niobium (paras. 31-37). X is interpreted as 1 and Hydrogen is interpreted as addressing monovalent ion in Nagewaran’s formula, addressing claims 1 and 15. Claims 6-8 are interpreted as intended use and are given minimal patentable weight (see MPEP 2111.02(II)). Claims 12 and 13 are interpreted as product-by-process limitations and are given minimal patentable weight (see MPEP 2113(I)).
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.
Claim(s) 1, 3-8, 12, 13, 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nageswaran (US 2008/0213392 A1).
Nageswaran teaches a composition that includes crystalline NZP-type structures, such as M1M2A2VIP3IVO12 (para. 31), addressing claims 1, 4 and 5. The compound trapping an ion is interpreted as intended use and is given minimal patentable weight (see MPEP 2111.02(II)). Nageswaran teaches different embodiments using the formula, where the M variables may be Hydrogen and Zirconium and A may be niobium (paras. 31-37). X is interpreted as 1 and Hydrogen is interpreted as addressing monovalent ion in Nagewaran’s formula, addressing claims 1 and 15. Claims 6-8 are interpreted as intended use and are given minimal patentable weight (see MPEP 2111.02(II)). The formulation may be used in dentistry and as disinfectants for drinking water (para. 47), where water is interpreted as a carrier, addressing claims 3 and 17. Dental cements are interpreted as a form of suspension or heterogeneous mixture, addressing claim 16. Claims 12 and 13 are interpreted as product-by-process limitations and are given minimal patentable weight (see MPEP 2113(I)).
Claim(s) 1, 3-8, 12, 13, 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goto et al. (US 2003/0092782 A1) and Nageswaran (US 2008/0213392 A1).
Goto et al. teach a crosslinked anion exchange resin composition (entire teaching; abs) made of a reaction of polymers that work by trapping phosphate ions (para. 49) and may be used to treat hyperphosphatemia through oral administration (para. 3), addressing claims 7, 8, 17, and partially claim 1. Anion exchange is interpreted as a chemical reaction of capturing ions, addressing claims 12 and 13. The formulation may be in the form of a suspension (para. 54), addressing claims 5, 6, and 16. In some embodiments, the pH was adjusted (paras. 73, 83), which is interpreted as using a buffer solution or that a buffer solution would be helpful to adjust to the proper pH level, addressing claim 18. Solvents (para. 15), diluents, fillers, or binders (para. 52) may be used, which is interpreted as a pharmaceutical carrier, addressing claim 3. The composition may also be used for renal function disorders, chronic renal failure, or dialysis (para. 56).
Goto does not specifically teach the formula of claim 1 and the microscopic cubic crystals or hydrogen zirconium phosphate in claims 4, 14, and 15. Goto does not teach an exact combination of an ion-capture compound with a carrier, suspension, and buffer in at least claim 1.
Nageswaran teaches a composition that may comprise crystalline NZP-type structures, such as M1M2A2VIP3IVO12 (para. 31), addressing claims 1 and 4. Nageswaran teaches different embodiments using the formula, where the M variables may be Hydrogen and Zirconium and A may be niobium (paras. 31-37). X is interpreted as 1 and Hydrogen is interpreted as addressing monovalent ion in Nagewaran’s formula, addressing claims 1 and 15.
In regards to selecting the combination of an ion-capture compound with a carrier, suspension, and buffer, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various
combination of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Goto et al. teach a crosslinked anion exchange resin composition (abs) made of a reaction of polymers that work by trapping phosphate ions (para. 49) and may be used to treat hyperphosphatemia through oral administration, whereas the claimed invention is directed towards a composition comprising an ion-capture compound that traps at least one ion from a sample. Since Goto teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
Since Goto does not teach microscopic cubic crystals or hydrogen zirconium phosphate in claims 1, 4, 14, and 15, one of ordinary skill in the art would have been motivated to use Nageswaran’s teaching of a composition comprising crystalline NZP structures to address the deficiencies in Goto’s teaching. One of ordinary skill in the art would have been motivated to combine the teachings because Nageswaran’s ion exchange composition is chemically inert, stable at high temperatures (para. 49), non-toxic, and resistant to corrosion against acids, alkalis, and salts (paras. 49, 62). A skilled artisan would have been motivated to combine the teachings since Goto’s pharmaceutical composition may utilize acidic components and high processing temperatures that would be stable with a crystalline NZP structure comprising hydrogen and zirconium from Nageswaran’s teaching.
Claim(s) 1, 3-8, 10-13, 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goto et al. (US 2003/0092782 A1), Nageswaran (US 2008/0213392 A1), and Pudil et al. (US 2014/0158623 A1).
In regards to claim(s) 1, 3-8, 12, 13, 15-18, Goto and Nageswaran, as applied supra, is herein applied in its entirety for its teachings of a crosslinked anion exchange resin composition made of a reaction of polymers that trap phosphate ions and may be used to treat hyperphosphatemia through oral administration.
Goto does not specifically teach trapping a monovalent or sodium ion in claims 10 and 11.
Pudil et al. teach a composition that may be an ion-exchange resin (para. 189) and a layer comprising zirconium phosphate (para. 195). The composition may be used to bind sodium (para. 290) during hemodialysis therapy, but Pudil also mentions using this ion-exchange material to remove other ions, such as phosphate (para. 188), addressing claims 10 and 11.
Since Goto does not teach trapping a monovalent ion or sodium ion in claims 10 and 11, one of ordinary skill in the art would have been motivated to use Pudil’s teaching of a composition used to trap sodium. One of ordinary skill in the art would have been motivated to combine all of the teachings because Nageswaran’s ion exchange composition is chemically inert (para. 49), non-toxic, and resistant to corrosion (para. 62), which would be helpful in Goto’s teaching for capturing various ions. Additionally, as Goto teaches an ion exchange resin system that may be used to for dialysis, and Pudil teaches a composition for binding sodium and phosphate ions during hemodialysis, one of ordinary skill in the art would have been motivated to combine the teachings with a reasonable expectation of success.
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 1, 3, 5-8, 10-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-6, 8, 9, 12, 21, 22 of copending Application No. 17/593,670 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims a ion capturing substance comprising a compound with formula M’M”xA2B3O12 in NZP form (claim 1) that may be ingested through food or beverage (claims 21 and 22), which corresponds to instant claims 1, 7, 8, and 17 (composition comprising the claimed compound is interpreted as a pharmaceutical composition). In the reference application, the ion captured may be monovalent or polyvalent (claims 2-4), which corresponds to instant claims 10 and 11. The reference application claims capturing an ion through chemical or physical means (claims 5 and 6), which corresponds to instant claims 12 and 13. Reference application claims hydrogen zirconium phosphate (claim 8) and the instant application also claims the same compound (claims 14 and 15). The reference application claims a substance in the form of a suspension (claim 9), and the instant application claims a suspension (claims 5, 6, and 16). Reference application claims a buffer (claim 12) and the instant application also claims a buffer (claim 18). It is obvious to include a pharmaceutically acceptable carrier in the reference application, which corresponds to instant claim 3.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Double Patenting Arguments
Applicant's arguments filed 14 November 2025 have been fully considered but they are not persuasive.
The Applicant has requested the above double-patenting rejections be held in abeyance until patentable subject matter is identified. In response, in any future response the Applicant must address the double patenting grounds of rejection, either by presenting arguments why the rejection is not applicable or by the filing of a terminal disclaimer. The Applicant is required to reply to every ground of rejection in the prior office action per 37 CFR 1.111(b). It is noted that only claim objections or requirements as to form not necessary to further considerations of the claims may be requested to be held in abeyance until allowable subject matter is indicated. Applicant is cautioned that further requests to hold this rejection in abeyance will not be considered responsive; such a request does not comply with CFR 1.111 (b).
Response to Arguments
Applicant's arguments filed 14 November 2025 have been fully considered but they are not persuasive.
The rejections stated above are maintained since applicant has (effectively) not responded to the rejection in a substantive manner. See 37 CFR § 1.111(b) and MPEP § 714.02.
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 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 Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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