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. Claims filed 6/10/2024 are made of record. Claims 1-22 are cancelled; and claims 23-37 are added. Accordingly, claims 23-37 are currently pending in the application. Claim Objections Claim 23 , 25 and 28 are objected to because of the following informalities: Claim 23 recites “wherein the packaged pharmaceutical product comprises one or more of a laminate film with an oxygen transfer rate of 0.05 CC/m 2 /day or less, an oxygen scavenger, or an inert environment within the packaged pharmaceutical product” (lines 10-12). For clarity, applicant is advised to delete this from the end portion of claim and place it in the beginning such that claim 1 reads as “A packaged pharmaceutical product comprising (a) a crosslinked poly(allylamine) polymer, and (b) one or more of a laminate film with an oxygen transfer rate of 0.05 CC/m 2 /day or less, an oxygen scavenger, or an inert environment within the packaged pharmaceutical product, wherein a is a residue ... sp2 allyl carbons”. Claim 25 recites “ZN … Zn … gallic acid, gallic acid” (lines 3 and 5). The recitation of “Zn /ZN and gallic acid” twice is redundant. For consistency and clarity, applicant is advised to delete “ZN” and one instance of “gallic acid”. Claim 28 recites “further comprises an oxygen scavenger and/or an inert environment within the packaged pharmaceutical product” (lines 2-3). For clarity, consistency and given that there is a reference to these in independent claim 23, applicant is advised to rephrase it as “comprises an oxygen scavenger and/or an inert environment within the packaged pharmaceutical product”. Appropriate correction and/or clarification are required. Claim Rejections - 35 USC § 112 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 appl icant regards as his invention. Claim 23-37 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. Claim 23 recites “c is a residue of 1,2-dichloroethane” (line 7). The crosslinked poly(allylamine) polymer of formula I in claim 23 comprising unit “c” appears to be an example of ethylene linkage between two allylamine groups obtained from crosslinking using 1,2-dichloroethane as a crosslinker (see paragraph 0014 of present specification). The recitation “c is a residue of 1,2-dichloroethane” is not consistent with the formula I. Hence, metes and bounds of present claims cannot be ascertained by one of ordinary skill in art prior to the filing of present application. Claims 24- 3 7 are subsumed by this rejection because of the dependence either directly or indirectly on independent claim 23. Claim 32 recites the limitation "the poly(allylamine) polymer" in 2. There is insufficient antecedent basis for this limitation in the claim. For Examination purposes, it is interpret ed as a poly(allylamine) polymer that is used to make crosslinked poly(allylamine) polymer (see paragraph 00127 of specification). 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. Claim 31 is 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. Claim 31 recites “ wherein more than 0.3% of the total number of carbon atoms present in the crosslinked poly(allylamine) polymer are sp2 allyl carbon atoms” and fails to further limit the scope of independent claim 23 on which it is dependent. Specifically, claim 23 requires the total number of carbon atoms present in the crosslinked poly(allylamine) polymer as sp2 allyl carbons to be less than 1.0% while more than 0.3% can include values above 1.0% . 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. 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. Claim s 23- 24, and 26- 37 are rejected under 35 U.S.C. 103 as being unpatentable over Klaerner et al (US 2019/0134076 A1) in view of Buurman et al ( WO 2013/087237 A1) . Regarding claims 23 and 29-31, Klaerner et al disclose pharmaceutical compositions (abstract). See embodiment 836, wherein a polymer is formed from allylamine hydrochloride (i.e., reads on the residue of allylamine in present claim 23) and diallylpropyldiamine (see Table C and reads on residue of N.N’-diallyl-1,3-diamino propane in present claim 23). To dry preformed amine polymer beads is added 1,2-dichloroethane (i.e., reads on the residue of 1,2-dicholorethane in present claim 23) and reaction mixture held at 70 0 C. The beads were purified until the pH of solution was 7 (paragraph 0873). Exemplary crosslinking agents include 1,2-dichloroethane (paragraph 0175). Hence, the polymer formed in embodiment 836 is implicitly a crosslinked poly(allylamine) polymer. The composition is within a sealed package (i.e., reads on packaged pharmaceutical product in present claim 23). The head space may be filled with an inert gas such as nitrogen (paragraph 0268) which reads on inert environment in present claim 23. In one embodiment, the container includes one or more oxygen scavenging layers (paragraph 0269) which reads on an oxygen scavenger in present claim 23. Klaerner et al are silent with respect to total number of sp2 allyl carbon atoms in the crosslinked poly(allylamine) polymer. However, Buurman et al in the same field of endeavor teach a process of separation of crosslinked polyallylamine from allylamine and to a process of determination of the content of allylamine in the crosslinked polyallylamine (abstract). To comply with requirements of pharmaceutical quality, it must be essentially free from residual allylamine which is a seriously toxic compound (page 2, lines 9-10). The process involves treating, under agitation, the crosslinked polyallylamine with an aqueous buffer solution. The process provides a crosslinked polyallylamine with a residual allylamine of less than 5 ppm (page 3, lines 14-25) which is equivalent to 0.0005% of allylamine (i.e., overlaps with the total number of carbon atoms present in the crosslinked poly(allylamine) as sp2 allyl carbons, since number of sp2 carbon atoms are dependent on the amount of unreacted allyl amine in the crosslinked poly(allylamine)). Therefore, in light of the teachings in Buurman et al, it would have been obvious to one skilled in art prior to the filing of present application, to purify the crosslinked poly(allylamine), of Klaerner et al, based on the teachings in Buurman et al, to obtain a crosslinked poly(allylamine) having total number of carbon atoms of sp2 allyl carbons in overlapping ranges (such as less than 1.0% as in present claims 23, less than 0.9% as in present claim 29 and less than 0.8% as in present claim 30), and optimize to any desired level including more than 0.3% as in present claim 31, for above mentioned advantages. Since PTO cannot conduct experiments, the burden of proof is shifted to the applicants to establish an unobviousness difference, see In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977). Regarding claim 24, Klaerner et al teach that composition is within a sealed package. In one embodiment, the container includes one or more oxygen scavenging layers (paragraph 0269). Regarding claims 26-28, Klaerner et al teach that composition is within a sealed package. The head space may be filled with an inert gas such as nitrogen (paragraph 0268). In one embodiment, the container includes one or more oxygen scavenging layers (paragraph 0269). Regarding claim 32, given that carbon to nitrogen ratio is dependent on the amount of free allylamine in the crosslinked poly(allylamine) polymer and the degree of crosslinking; and hence their ratio in relation to that in the starting poly(allylamine) polymer, it is the Office’s position that it is within the scope of one skilled in art prior to the filing of present application to optimize the degree of crosslinking based on the disclosure in Klearner et al combined with the teachings in Buurman to reduce the amount of free allylamine to a desired level, and obtain the claimed ratio of about 0.9, absent evidence to the contrary. Regarding claims 33-34, Buurman et al teach that extraction process provides apart from the crosslinked allylamine, an aqueous solution comprising essentially the entire original amount of allylamine in the starting material. This solution may be subjected to a suitable method of determination of the content of allylamine and the amount of allylamine in the original sample may be then easily calculated (page 9, lines 4-8). However, given that the residual amount of allylamine in the crosslinked polyallylamine is as low as less than 5 ppm, one skilled in art prior to the filing of present application would have a reasonable basis to expect the % sp2 allyl carbons to fall in the presently claimed range when measured using the claimed method, absent evidence to the contrary. Since PTO cannot conduct experiments, the burden of proof is shifted to the applicants to establish an unobviousness difference, see In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977). Regarding claim 35, Buurman et al teach a process that provides crosslinked polyallylamine with a content of residual allylamine of less than 5 ppm (page 3, lines 24-25). Regarding claim 36, given that free residual amine can be as low as less than 5 ppm based on the teachings in Buurman , one skilled in in art prior to the filing of present application would have a reasonable basis to expect the allylamine content of the crosslinked poly(allylamine) polymer to increase by less than 1.5 ppm/day allylamine, absent evidence to the contrary. Regarding claim 37, Klaerner et al teach a method of treating metabolic acidosis (paragraph 0029). Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Klaerner et al (US 2019/0134076 A1) in view of Buurman et al (WO 2013/087237 A1) and Barshied (US 2006/0076536 A1) . The discussion with respect to Klaerner et al and Buurman et al in paragraph 12 above is incorporated here by reference. Klaerner et al and Buurman et al are silent with respect to the species of oxygen scavenger. However, Barshied in the same filed of endeavor teaches pharmaceutical packaging for increasing product shelf life, reducing degradation of pharmaceuticals by reducing oxygen levels present in the pharmaceutical package (abstract). Non-limiting examples of oxygen scavenging elements include Mn and Co(II) (paragraph 0035) which read on the oxygen scavenger in present claim 25. Case law holds that selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Therefore, in light of the teachings in Barshied and case law, it would have been obvious to one skilled in art prior to the filing of present application to include oxygen scavenger, of Barshied , in the pharmaceutical package, of Klaerner et al in view of Buurman et al, for above mentioned advantages. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT KARUNA P REDDY whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-6566 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT 8:30 AM to 5:00 PM M-F . 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, FILLIN "SPE Name?" \* MERGEFORMAT Arrie (Lanee) Reuther can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-7026 . 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. /KARUNA P REDDY/ Primary Examiner, Art Unit 1764