DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/17/2025 has been considered by the examiner.
Status of the Claims
The response and amendment filed 12/30/2025 is acknowledged.
Claims 19-25 and 27-39 are pending.
Claims 19, 25, and 27 are independent
Applicant’s election without traverse of Group I, claims 19-24 in the reply filed on 07/16/2025 is acknowledged.
Applicant’s election without traverse of “human”, in the reply filed on 07/16/2025 is acknowledged.
Claims 25 and 27-39 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/16/2025.
Claims 21-22 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/16/2025.
Claims 19-20 and 23-24 are treated on the merits in this action.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Response to Arguments
Applicant’s arguments with respect to claim(s) 19-20 and 23-24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Diaz, Biomacromolecules, 11, 2010 teaches zirconium phosphates are layered materials which are non-toxic and safe for oral administration.
Clearfield, Journal of Physical Chemistry, 1973 teaches layered, crystalline zirconium phosphate was known and effective for exchanging ions such as sodium and ammonium.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 19-20 and 24 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Muller, WO 2021212006 A1 as evidenced by Diaz, Biomacromolecules, 11, 2010.
WO 2021212006 A1 claims priority to US 63010850 which was filed on 16 April, 2020, and which fully supports the facts relied upon in this rejection. The priority document, US 63010850, is available from the WIPO website as a certified copy.
Muller teaches a method comprising orally administering a composition comprising a compound having a sodium zirconium phosphate (NZP) form (Muller, e.g., claims 20 and 2), wherein the compound having a sodium zirconium phosphate form is zirconium phosphate (Muller, e.g., claim 15, 0132-0137, 0149, and Figs. 3-4), and wherein the zirconium phosphate is crystalline (Muller, e.g., 0007, 0010, 0012, 0037, 0040, 0042, 0045, 0132, claim 4, and claim 5) and wherein the subject is a human (Muller, e.g., 0048 and 0058 and 0089). Muller teaches treating subjects having chronic kidney disease and/or kidney failure (Muller, e.g., 0097 and claim 29) which requires selecting a patient capable of deriving benefit from lower levels of one or more serum toxins (Muller, e.g., 0140 and 0144) including those listed in claim 24 as evidenced by the specification at ¶ 0064. Moreover, Muller teaches practicing the method for patients having hypertension (Muller, e.g., 0049, 0093, 0095, 0140, and 0142) which requires selecting patients suffering from hypernatremia, i.e., high blood sodium levels (Muller, e.g., 0005).
Claim 19 has been amended to include the limitation of orally administering to said patient a crystalline zirconium phosphate having a layered structure.
Muller teaches crystalline zirconium phosphate, e.g., hydrogen zirconium phosphate HZr2(PO4)3 (Muller, e.g., 0132). Muller does not expressly characterize zirconium phosphate as layered. As evidenced by Diaz, e.g., introduction, zirconium phosphates were considered layered materials by those skilled in the art: among the most studied inorganic layered nanomaterials (ILN) are zirconium phosphates which are inorganic cation exchange materials.
Muller anticipates the subject matter of instant claims 19-20 and 24.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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.
Claims 19-20 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Gardner, Applied Biochemistry Biotechnology, 10, 27, 1984 (cited previously and presented on Applicant’s IDS dated 10/10/2023) in view of Clearfield, Journal of Physical Chemistry, 1973 and Diaz, Biomacromolecules, 11, 2010.
Gardner teaches methods comprising orally administering compositions comprising adsorbents for uremic metabolites, e.g., for the treatment of uremia (Gardner, entire document, e.g., Abstract), wherein the composition comprises zirconium phosphate (Gardner, entire document, e.g., Abstract), wherein the zirconium phosphate is effective to adsorb ammonium (Gardner, entire document, e.g., abstract), which requires selecting patients suffering from hyperammonemia, and having renal insufficiency, e.g., chronic renal failure (Gardner, entire document, e.g., abstract). Gardner teaches practicing the method on a human, i.e., pointing out that large amounts of urea are available for binding in the human small intestine (Gardner, e.g., ¶ spanning pp. 35-38).
Gardner does not expressly teach wherein the zirconium phosphate is crystalline and layered.
However, Clearfield teaches a crystalline, layered zirconium phosphate which exchanges ammonium ions, e.g., α-ZrP (Clearfield, entire document, e.g., Abstract, and ¶ spanning pp. 243-244).
Diaz teaches crystalline, layered zirconium phosphates, e.g., alpha-zirconium phosphate (α-ZrP) was known and used for oral administration (Diaz, entire document, e.g., Title and Abstract). Crystalline, layered, zirconium phosphates, e.g., α-ZrP (Diaz, e.g., pg. 2467c2, ¶ 2), is not toxic or harmful and appears safe for administration to humans (Diaz, e.g., Abstract and conclusion).
It would have been obvious before the effective filing date of the presently claimed invention to modify methods for treating humans suggested by Gardner by orally administering a layered, crystalline zirconium phosphate with a reasonable expectation of success. Since Gardner teaches zirconium phosphate is an adsorbent, for, e.g., ammonium, the skilled artisan would have been prompted to select known zirconium phosphate forms effective for absorbing ammonium ions such as alpha-zirconium phosphate as known from Clearfield and Diaz with a reasonable expectation of success. The skilled artisan may have seen this modification as the substitution of one zirconium phosphate for another where each were known as useful to absorb ammonium ions. Since Clearfield teaches alpha-zirconium phosphate absorbs ammonium ions and Diaz teaches alpha zirconium phosphate is safe for oral administration the skilled artisan would have had a reasonable expectation of successfully using this known zirconium phosphate absorbent to achieve predictable results, i.e., ammonium absorption, when administered orally.
Accordingly, the subject matter of claims 19-20 and 24 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Gardner, Applied Biochemistry Biotechnology, 10, 27, 1984 (cited previously and presented on Applicant’s IDS dated 10/10/2023) in view of Clearfield, Journal of Physical Chemistry, 1973 and Diaz, Biomacromolecules, 11, 2010 as applied to claims 19-20 and 24, and further in view of Ash, US 20040105895.
The combined teachings of Gardner, Clearfield and Diaz teach a method according to claim 19, wherein the method is practiced for subjects having renal insufficiency, e.g., chronic renal failure (Gardner, e.g., Title). However, the combined teachings of Gardner and Clearfield do not expressly teach for treatment of renal and hepatic insufficiency. To the extent that this limitation extends to treating subjects having hepatic insufficiency, Ash teaches oral sorbent therapy is effective for treating subjects having renal and/or liver (hepatic) dysfunction (Ash, e.g., Abstract), since subjects suffering from kidney and liver dysfunction are in need of removal of toxins from the body (Ash, e.g., 0002), e.g., elevated blood level ammonium (Ash, e.g., 0007).
It would have been obvious before the effective filing date of the presently claimed invention to practice a method suggested by the combined teachings of Gardner, Clearfield and Diaz which comprises orally administering a layered, crystalline zirconium phosphate as a sorbent for ions and uremic toxins in the intestine by administering the composition to subjects having both renal and liver dysfunction as suggested by Ash with a reasonable expectation of success. The skilled artisan would have been motivated to practice the method on subjects having both renal and liver dysfunction since these patients suffer from removal of toxins form the body like those suffering from renal dysfunction alone. The skilled artisan would have had a reasonable expectation of success because Ash clearly suggests subjects having both renal and liver dysfunction will benefit from oral administration of sorbents.
Accordingly, the subject matter of claim 23 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 19-20 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Ash, US 20190008894 A1 (presented on Applicant’s IDS dated 10/10/2023) in view of Clearfield, Journal of Physical Chemistry, 1973 and Diaz, Biomacromolecules, 11, 2010.
Ash teaches methods for removing uremic toxins from the gut comprising orally administering a sorbent (Ash, e.g., claim 1 and 0185), wherein the sorbent comprises zirconium phosphate (Ash, e.g., claim 1, and 0046-0048, and 0116, and 0185 “zp”). Ash teaches treating subject having chronic kidney disease (CKD) and/or end stage renal disease (ESRD) (Ash, e.g., 0194-0195). Ash teaches treating humans (Ash, e.g., 0060-0061 with table). Ash teaches treating subjects suffering from hyperkalemia and CKD (Ash, e.g., 0173), hyperammonemia, hyperphosphatemia, hypernatremia, hypermagnesemia, hypercalcemia and in need of binding uremic toxins (Ash, e.g., 0051-0056, 0089-0092,0171-0173, and 0185).
Ash does not expressly teach the zirconium phosphate is crystalline and layered.
However, Clearfield teaches a crystalline, layered zirconium phosphate which exchanges ammonium ions, e.g., α-ZrP (Clearfield, entire document, e.g., Abstract, and ¶ spanning pp. 243-244).
Diaz teaches crystalline, layered zirconium phosphates, e.g., alpha-zirconium phosphate (α-ZrP) was known and used for oral administration (Diaz, entire document, e.g., Title and Abstract). Crystalline, layered, zirconium phosphates, e.g., α-ZrP (Diaz, e.g., pg. 2467c2, ¶ 2), is not toxic or harmful and appears safe for administration to humans (Diaz, e.g., Abstract and conclusion).
It would have been obvious before the effective filing date of the presently claimed invention to modify methods for treating humans suggested by Ash by orally administering crystalline zirconium phosphate having a layered structure as known from Clearfield and Diaz with a reasonable expectation of success. Since Ash teaches zirconium phosphate is an adsorbent, for, e.g., ammonium, the skilled artisan would have been prompted to select known zirconium phosphate forms effective for absorbing ammonium ions such as alpha-zirconium phosphate as known from Clearfield and Diaz with a reasonable expectation of success. The skilled artisan may have seen this modification as the substitution of one zirconium phosphate for another where each were known as useful to absorb ammonium ions. Since Clearfield teaches alpha-zirconium phosphate absorbs ammonium ions and Diaz teaches alpha-zirconium phosphate is non-toxic and safe for oral administration the skilled artisan would have had a reasonable expectation of successfully using this known zirconium phosphate absorbent to achieve predictable results, i.e., ammonium absorption when administered orally.
Accordingly, the subject matter of claims 19-20 and 24 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Ash, US 20190008894 A1 (presented on Applicant’s IDS dated 10/10/2023) in view of Clearfield, Journal of Physical Chemistry, 1973 and Diaz, Biomacromolecules, 11, 2010 as applied to claims 19-20 and 24 above, and further in view of Ash, US 20040105895.
The combined teachings of Ash, Clearfield, and Diaz teach a method according to claim 19, wherein the method is practiced for subjects having renal insufficiency. However, the combined teachings of Ash, Clearfield, and Diaz do not expressly teach for treatment of renal and hepatic insufficiency. To the extent that this limitation extends to treating subjects having hepatic insufficiency, Ash teaches oral sorbent therapy is effective for treating subjects having renal and/or liver (hepatic) dysfunction (Ash, e.g., Abstract), since subjects suffering from kidney and liver dysfunction are in need of removal of toxins from the body (Ash, e.g., 0002), e.g., elevated blood level ammonium (Ash, e.g., 0007).
It would have been obvious before the effective filing date of the presently claimed invention to practice a method suggested by the combined teachings of Ash, Clearfield, and Diaz which comprises orally administering crystalline zirconium phosphate as a sorbent for ions and uremic toxins in the intestine by administering the composition to subjects having both renal and liver dysfunction as suggested by Ash with a reasonable expectation of success. The skilled artisan would have been motivated to practice the method on subjects having both renal and liver dysfunction since these patients suffer from removal of toxins form the body like those suffering from renal dysfunction alone. The skilled artisan would have had a reasonable expectation of success because Ash clearly suggests subjects having both renal and liver dysfunction will benefit from oral administration of sorbents.
Accordingly, the subject matter of claim 23 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claim 19-20 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Muller, WO 2021212006 A1 in view of Clearfield, Journal of Physical Chemistry, 1973 and Diaz, Biomacromolecules, 11, 2010.
This rejection is made in the alternative in the event it can be shown that the zirconium phosphates exemplified by Muller are not necessarily layered.
As enumerated under the 102(a)(2) rejection, Muller teaches a method according to claim 19 which includes orally administering a crystalline zirconium phosphate to a subject to adsorb unwanted ions in the gastrointestinal tract, e.g., sodium (Muller, e.g., 0116) and wherein the subject suffers from kidney disease (Muller, e.g., 0144 and claim 29). Muller does not expressly characterize zirconium phosphate as layered.
To the extent that Muller’s crystalline zirconium phosphates are not necessarily layered, it would have been obvious to practice Muller’s method with a crystalline layered phosphate such as those known from Clearfield and Diaz to achieve predictable results.
Clearfield teaches a crystalline, layered zirconium phosphate which exchanges ammonium ions, e.g., α-ZrP (Clearfield, entire document, e.g., Abstract, and ¶ spanning pp. 243-244).
Diaz teaches crystalline, layered zirconium phosphates, e.g., alpha-zirconium phosphate (α-ZrP) was known and used for oral administration (Diaz, entire document, e.g., Title and Abstract). Crystalline, layered, zirconium phosphates, e.g., α-ZrP (Diaz, e.g., pg. 2467c2, ¶ 2), is not toxic or harmful and appears safe for administration to humans (Diaz, e.g., Abstract and conclusion).
It would have been obvious before the effective filing date of the presently claimed invention to practice a method suggested by the teachings of Muller which comprises orally administering crystalline zirconium phosphate as a sorbent for ions in the intestine by selecting a layered, crystalline zirconium phosphate such as that known from Clearfield and Diaz with a reasonable expectation of success. The skilled artisan may have seen this modification as the substitution of one zirconium phosphate for another where each were known as useful to absorb sodium and ammonium ions. Since Clearfield teaches alpha-zirconium phosphate absorbs ammonium and sodium ions, and since Diaz teaches alpha-zirconium phosphate is non-toxic and safe for oral administration the skilled artisan would have had a reasonable expectation of successfully using this known zirconium phosphate absorbent to achieve predictable results, i.e., ammonium and sodium absorption, when administered orally.
Accordingly, the subject matter of claims 19-20 and 24 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Muller, WO 2021212006 A1 in view of Clearfield, Journal of Physical Chemistry, 1973 and Diaz, Biomacromolecules, 11, 2010 as applied to claims 19-20 and 24 above, and further in view of Ash, US 20040105895.
Muller in view of Clearfield and Diaz teaches a method according to claim 19 which includes orally administering a layered, crystalline zirconium phosphate to a subject to adsorb unwanted ions in the gastrointestinal tract, e.g., sodium (Muller, e.g., 0116) and wherein the subject suffers from kidney disease (Muller, e.g., 0144 and claim 29). Muller does not expressly teach practicing the method on subjects having renal and hepatic dysfunction.
To the extent that this limitation extends to treating subjects having hepatic insufficiency, Ash teaches oral sorbent therapy is effective for treating subjects having renal and/or liver (hepatic) dysfunction (Ash, e.g., Abstract), since subjects suffering from kidney and liver dysfunction are in need of removal of toxins from the body (Ash, e.g., 0002), e.g., elevated blood level ammonium (Ash, e.g., 0007).
It would have been obvious before the effective filing date of the presently claimed invention to practice a method suggested by the teachings of Muller, Clearfield, and Diaz which comprises orally administering a layered, crystalline zirconium phosphate as a sorbent for ions in the intestine by administering the composition to subjects having both renal and liver dysfunction as suggested by Ash with a reasonable expectation of success. The skilled artisan would have been motivated to practice the method on subjects having both renal and liver dysfunction since Ash reports these patients require removal of toxins from the body like those suffering from renal dysfunction. The skilled artisan would have had a reasonable expectation of success because Ash clearly suggests subjects having both renal and liver dysfunction will benefit from oral administration of sorbents.
Accordingly, the subject matter of claim 23 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
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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/WILLIAM CRAIGO/Examiner, Art Unit 1615
/SUSAN T TRAN/Primary Examiner, Art Unit 1615