DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Amendments, Remarks, and Declaration under 37 CFR §1.132 (herein “Rule 132”), filed 13 February 2026, in the matter of Application N° 18/238,665. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
No claims have been added or canceled.
Claims 118 and 120 have been amended.
No new matter has been added.
Thus, claims 116-140 continue to represent all claims currently under consideration.
Information Disclosure Statement
No new Information Disclosure Statements (IDS) have been filed for consideration.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 20 October 2025 since the art that was previously cited continues to read on the recited limitations.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. Applicants are 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 116-140 are rejected under 35 U.S.C. 103 as being unpatentable over Inoue et al. (US Pre-Grant Publication Nº 2010/0189679 A1; IDS reference).
The instantly claimed invention is directed to a pharmaceutical composition comprising a crosslinked amine polymer, wherein the polymer comprises residues of a monoallylamine (i.e., allylamine), a multifunctional allylamine (i.e., diallylpropyldiamine), and dichloroethane. Instant claim 134 recites the same subject matter as instant claim 128 with the added limitation of steps for preparing the polymer. The limitations of claim 134 are thus considered recite the same subject matter. See MPEP §2113.
Inoue discloses a pharmaceutical composition comprising as an effective ingredient the crosslinked polyallylamine or an acid addition salt thereof according to claim 1 (claim 6). Claim 1 discloses a crosslinked polyallylamine obtained by copolymerizing allylammonium dihydrogen phosphate with an acid addition salt of N,N’-diallyl-1,3-diaminopropane. Claim 2 discloses that crosslinking is carried out using a compound that has two or more amino group-reactive functional groups. Claim 3 further defines these compounds as including dihalogenated hydrocarbons. Paragraph [0050] defines the dihalogenated hydrocarbons as including 1,2-dichloroethane.
Claims 123, 129, and 136 each recite that the polymer has a chloride binding capacity in Simulated Small Intestine Inorganic Buffer (“SIB”) of at least 4 mmol/g.
Claims 124, 130, and 137 each recite that the crosslinked amine polymer has a ratio of chloride binding capacity to phosphate ion binding capacity in SIB of at least 2.3:1, respectively.
Claims 125, 131, and 138 each recite that the crosslinked amine polymer has (i) a proton-binding capacity and a chloride binding capacity of at least 5 mmol/g in Simulated Gastric Fluid; and (ii) a chloride ion binding capacity of at least 4 mmol/g at 1 hour in SIB.
Claims 126, 132, and 139 each recite that the crosslinked amine polymer has (i) a proton-binding capacity and a chloride binding capacity of at least 5 mmol/g in Simulated Gastric Fluid; and (ii) a chloride ion binding capacity of at least 4 mmol/g, and a phosphate ion binding capacity of less than 2 mmol/g in SIB.
Claims 127, 133, and 140 each recite that the crosslinked amine polymer has (i) a proton-binding capacity and a chloride binding capacity of at least 5 mmol/g in Simulated Gastric Fluid; and (ii) a chloride to phosphate ion binding ratio of at least 2.3:1, respectively, in SIB.
MPEP §2112.01(I) states that “[w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” “Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product.”
In the instant case, the Examiner has provided a showing in the prior art whereby the composition as claimed is disclosed and/or produced.
Therein, claim 1 discloses combining:
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with a dihalogenated hydrocarbon such as 1,2-dichloroethane.
Based on the foregoing teachings of the reference, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed pharmaceutical composition and the recited properties thereto. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
Response to Arguments
Applicants’ arguments with regard to the rejection of claims 116-140 under 35 USC 103(a) as being unpatentable over the combined teachings of Inoue et al. have been fully considered but, they are not persuasive.
At the outset, the Examiner recognizes that Applicants’ Rule 132 Declaration is one that was relied upon for a different application (14/311,852), but used to traverse the teachings of the reference at issue. The Examiner also notes that the declaration and remarks discuss the same points of argument. As such, the following response addresses both documents simultaneously.
Applicants initially traverse the rejection on the grounds that the claimed composition and Inoue are directed to different therapeutic objectives.
The Examiner, in response, respectfully submits that neither the use of the practiced composition nor the instantly claimed composition is at issue. The instantly claimed invention is directed to a composition.
Applicants next discuss providing evidence that is meant to distinguish Inoue’s binding properties from those of the instantly claimed polymers.
Here, Applicants replicate Inoue’s Examples 7 and 15-17 produce polymers that are selective for phosphate instead of chloride as tested in the SSIIB assay in accordance with the instant specification.
As discussed above, the Examiner notes that Inoue discloses a crosslinked polyallylamine obtained by copolymerizing allylammonium dihydrogen phosphate with an acid addition salt of N,N’-diallyl-1,3-diaminopropane in the presence of a dihalogenated hydrocarbons such as 1,2-dichloroethane.
Example 7 of the reference more specifically discloses combining allylammonium dihydrogen phosphate with N,N’-diallyl-1,3-diaminopropane bis(dihydrogen phosphate) in the presence of 2,2’-azobis(2-amidinopropane)dihydrochloride.
Examples 15-17 crosslink 2-hydroxyethyl acrylate with polyallylamine obtained in Example 7.
MPEP §2123(I) states that “[a] reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments.” MPEP §2123(II) states further that “[d]isclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments.”
In the instant case, having considered the relied upon Examples of Inoue and the data obtained from the polymers that result, the Examiner argues that these polymers, while presenting evidence of possessing additional properties distinct from those that are claimed, are not representative of the full disclosure of the reference. The broader compositional disclosure of the reference continues to meet the limitations of the instantly claimed compositions as discussed above. As such, Applicants’ remarks and evidence are not commensurate in scope with the claimed invention.
Applicants’ arguments, for the above reasons, are found unpersuasive. Said rejection is therefore maintained.
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 116-140 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6, 10, 11, 13, 14, and 27 of Klaerner et al. (USPN 9,205,107 B2). Although the claims at issue are not identical, they are not patentably distinct from each other.
The limitations of the instant claims are discussed above.
Klaerner ‘107 discloses a pharmaceutical composition comprising a crosslinked amine polymer prepared by radical polymerization with a polyfunctional crosslinker (see claims 1 and 10). Claims 11 and 27 further define the polyfunctional crosslinker as being a dihaloalkane, such as dichloroethane.
Claims 13 and 14 define the crosslinked amine polymer as comprising a residue of a monoallylamine and a residue of a multiallylamine such as allylamine or a salt thereof, and 1,3-bis(allylamino)propane or a salt thereof, respectively.
Compositionally, the foregoing teaches the limitations of instant claims 116-122, 128, 134, and 135.
Claim 3 discloses that the practiced composition will have a chloride binding capacity of at least 10 mmol/g in simulated gastric fluid. Claim 6 discloses the composition as having a molar ratio of chloride ions to phosphate ions of at least 1.5:1.
The foregoing is considered to teach and suggest the limitations of the instantly claimed composition and properties thereto. Were the reference available as prior art it would anticipate the instantly claimed invention.
Claims 116-140 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6, 10, 11, 13, 14, and 28 of Klaerner et al. (USPN 9,993,500 B2). Although the claims at issue are not identical, they are not patentably distinct from each other.
The limitations of the instant claims are discussed above.
Klaerner ‘500 discloses a pharmaceutical composition comprising a crosslinked amine polymer prepared by radical polymerization with a polyfunctional crosslinker (see claims 1 and 10). Claims 11 and 28 further define the polyfunctional crosslinker as being a dihaloalkane, such as dichloroethane.
Claims 13 and 14 define the crosslinked amine polymer as comprising a residue of a monoallylamine and a residue of a multiallylamine such as allylamine or a salt thereof, and 1,3-bis(allylamino)propane or a salt thereof, respectively.
Compositionally, the foregoing teaches the limitations of instant claims 116-122, 128, 134, and 135.
Claim 3 discloses that the practiced composition will have a chloride binding capacity of at least 10 mmol/g in simulated gastric fluid. Claim 6 discloses the composition as having a molar ratio of chloride ions to phosphate ions of at least 1.5:1.
The foregoing is considered to teach and suggest the limitations of the instantly claimed composition and properties thereto. Were the reference available as prior art it would anticipate the instantly claimed invention.
Claims 116-140 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, 10, and 11 of Klaerner et al. (USPN 11,197,887 B2). Although the claims at issue are not identical, they are not patentably distinct from each other.
The limitations of the instantly claimed invention are discussed above.
Klaerner ‘887 discloses a pharmaceutical composition comprising a crosslinked amine polymer prepared by radical polymerization with a crosslinker agent, such as dichloroethane (see claims 1 and 6).
The crosslinked amine polymer is disclosed as comprising a residue of a monoallylamine and a residue of a multiallylamine such as allylamine or a salt thereof, and 1,3-bis(allylamino)propane (DAPDA) or a salt thereof, respectively (see claim 1).
Compositionally, the foregoing teaches the limitations of instant claims 116-122, 128, 134, and 135.
Claims 2 and 3 discloses that the practiced composition will have a chloride binding capacity of at least 5 mmol/g and at least 10 mmol/g in simulated gastric fluid, respectively. Claims 10 and 11 disclose the composition as having a molar ratio of chloride ions to interfering ions of at least 2:1, with claim 1 defining the “interfering ions” as being phosphate ions.
The foregoing is considered to teach and suggest the limitations of the instantly claimed composition and properties thereto. Were the reference available as prior art it would read on and minimally render the instantly claimed invention prima facie obvious.
Claims 116-140 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 10 of Klaerner et al. (USPN 11,738,041 B2). Although the claims at issue are not identical, they are not patentably distinct from each other.
The limitations of the instant claims are discussed above.
Klaerner ‘041 discloses a composition comprising a crosslinked amine polymer comprising residues of 2-propen-1-ylamine (aka allylamine) or a salt thereof and 1,3-bis(allylamino)propane (aka DAPDA) or a salt thereof, crosslinked with 1,2-dichloroethane (see claims 1 and 10).
The foregoing is considered to teach the compositional merits recited by instant claims 116-122, 128, 134, and 135.
The recited chloride ion binding capacity of at least 4 mmol/g in SIB is disclosed in claim 1. Claim 3 discloses a chloride ion binding capacity of at least 5 mmol/g in SGF. Claim 5 discloses a chloride ion binding capacity of at least 10 mmol/g in SGF.
Claim 1 additionally discloses a phosphate ion binding capacity of less than 2 mmol/g, which is considered to teach a chloride binding capacity to phosphate binding capacity ratio of at least 2:1 in SIB. Such is considered to teach and suggest the recited ratio of at least 2.3:1.
The foregoing is considered to teach and suggest the recited properties of claims 123-127, 129-133, and 136-140.
The foregoing is thus considered to teach and suggest the limitations of the instantly claimed composition and properties thereto. Were the reference available as prior art it would read on and minimally render the instantly claimed invention prima facie obvious.
Response to Arguments
Applicants’ filed response to the rejection of claims 116-140 on the grounds of nonstatutory double patenting over the cited patented teachings of has been fully considered, but is not persuasive.
At issue are the cited teachings of USPNs: 9,205,107; 9,993,500; 11,197,887; and 11,738,041.
Regarding USPN 11,197,887, Applicants traverse this rejection on the grounds that the ‘887 is directed to a process and not a composition.
Applicants’ response to this rejection is not persuasive since the disclosed and practiced process of the ‘887 patent would provide the ordinarily skilled artisan with a reasonable expectation of achieving the instantly claimed composition. Thus, if the ‘887 reference were available as prior art, it would anticipate, if not render the instantly claimed composition prima facie obvious.
Review of the prosecution history of the application for the ‘887 patent (16/542,969) also reveals that Applicants’ changed the statutory category of the originally claimed composition to a process for preparing the composition. This change was initiated by Applicants and not the Examiner (e.g., negotiated in order to advance the case to allowance).
The rejection is thus maintained.
Further, regarding all of the above rejections, a request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an OBJECTION or REQUIREMENTS AS TO FORM (see MPEP §714.02 and 37 CFR 1.111(b)). Thus, the double patenting rejection(s) of record has/have been maintained as no action regarding these rejections has been taken by Applicants at this time.
All claims under consideration remain rejected; no claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicants are reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615
Prosecution Insights