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
This application, filed 07/24/2023 is a National Stage entry of PCT/EP2022/051694, International Filing Date: 01/26/2022, and claims foreign priority to 21153605.7, filed 01/26/2021. A certified copy of the foreign priority application is of record.
Status of Claims
Claims 1-6 are currently pending.
Claims 1-6 were examined and are rejected.
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 applicant regards as his invention.
Claim 4 is 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.
Regarding claim 4, the phrase "particularly" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
To provide compact prosecution, the claims were interpreted with respect to the broader claim scope, not just the limitations following “particularly”.
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, 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.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ivarsson et. al., WO 2017098047 A1, publ. 6/15/2017 (cited in an IDS), in view of Perello Bestard, US 20140271915 A1, publ. 9/18/2014.
Ivarsson teaches inositol derivatives covalently modified with up to three solubility functions such as polyethylene glycol moieties, for the treatment of conditions related to pathological calcium crystallization, such as cardiovascular calcifications, nephrocalcinosis, calcinosis cutis, chondrocalcinosis, and kidney stones (title & abstract; p. 1, lines 1-3 and 25-28). Ivarsson teaches additional conditions related to pathological calcium crystallization to be treated include vascular calcification, coronary artery disease, vascular stiffening, valvular calcification, nephrocalcinosis, calcinosis cutis, kidney stones, and chondrocalcinosis, as well as calcium pyrophosphate dihydrate crystal deposition disease, and progression of chronic kidney disease (p. 2, lines 12-36; p. 19, lines 9-16). Ivarsson teaches embodiments wherein the inositol derivatives have the following structural formulas (p. 13, line 16-end of page):
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. Ivarsson further teaches administering an inositol derivative for treatment by a variety of potential delivery routes (p. 17, lines 13-18). Ivarsson further teaches the modified inositol derivatives exhibit increased potency compared to inositol hexakisphosphate (IP6) for reducing calcification, and allows for more flexible dosing schedules compared to IP6 (p. 13, lines 1-15; p. 17, lines 4-6; Fig. 2).
Ivarsson doesn’t explicitly teach or suggest administering the inositol derivative for an interval of one week, which Applicants have defined as administration of the compound on days 1 and 8, but not on intervening days (specification, p. 2, lines 28-30).
Perello Bestard teaches compounds having C-O-P bonds, including inositol phosphates, for the treatment of conditions related to kidney failure and to inhibit the formation of calcium containing crystals (abstract; para [0002], [0024], [0069]). Perello Bestard teaches an embodiment wherein the compound having C-O-P bonds is IP6 (para [0046]). Perello Bestard further teaches kidney failure related diseases to be treated with the compound include calcium or calcium metabolism disorders, renal lithiasis, cardiovascular calcification, calcific tendinitis, calcinosis cutis, among others (para [0085-0088]). Perello Bestard teaches the compounds can be administered weekly, monthly, bimonthly, or any other frequency known to a person skilled in the art (para [0111]).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have arrived at the claimed method of treating a disease associated with the formation of calcium salt crystals comprising administering an inositol polyphosphate oligo(ethylene glycol) compound of formulas Ia, Ib, or Ic, wherein the compound is administered to the treated subject at an interval of one week in consideration of the combined teachings of Ivarsson and Perello Bestard. Ivarsson teaches administering inositol derivatives meeting formulas Ia, Ib and Ic for the treatment of conditions related to pathological calcium crystallization, such as vascular calcification, coronary artery disease, vascular stiffening, valvular calcification, nephrocalcinosis, calcinosis cutis, kidney stones, and chondrocalcinosis, as well as calcium pyrophosphate dihydrate crystal deposition disease, and progression of chronic kidney disease, and that these compounds have advantages compared to IP6, such as better potency allowing for more flexible dosing schedules. Perello Bestard teaches IP6, when administered for treating similar conditions associated with pathological calcification, can be administered weekly, monthly, bimonthly, or according to other schedules. Therefore, one of ordinary skill in the art would have found it prima facie obvious to have arrived at an administration interval of about one week by routine experimentation, as Ivarsson teaches the increased potency of the inositol derivatives allows for more flexible dosing schedules compared to IP6, e.g., less frequent dosing, in the absence of unexpected results.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ivarsson et. al., WO 2017098047 A1, publ. 6/15/2017, in view of Perello Bestard, US 20140271915 A1, publ. 9/18/2014 as applied to claims 1-5 above, and further in view of Khan et. al., Nat. Rev. Dis. Primers, vol. 2, pp. 1-50, publ. Nov. 2017.
Ivarsson teaches as discussed previously, but doesn’t explicitly teach treating a disease associated with the formation of calcium oxalate salt or precipitate.
Khan teaches kidney stones as mineral deposits in the renal calyces and pelvis that contain crystalline and organic components, with calcium oxalate being the main component of most stones which form on a foundation of calcium phosphate (abstract).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have arrived at the claimed method of treatment of a disease associated with the formation of a calcium oxalate salt or precipitate, such as kidney stones, in consideration of the combined teachings of Ivarsson, Perello Bestard, and Khan. Ivarsson teaches inositol derivatives covalently modified with up to three solubility functions such as polyethylene glycol moieties, including derivatives of formulas Ia, Ib, and Ic of the instant claims for the treatment of conditions related to pathological calcium crystallization, including kidney stones. Perello Bestard teaches IP6 can be administered weekly, monthly, bimonthly, or any other frequency known to a person skilled in the art, while Khan teaches most kidney stones contain calcium oxalate formed on a foundation of calcium phosphate. Since Ivarsson teaches the inositol derivatives for treating kidney stones, and Khan teaches most kidney stones to be composed of calcium oxalate, one of ordinary skill in the art would have arrived at the method of the instant claims, and have treated the condition associated with calcium oxalate precipitate formation, kidney stones, by administering to a subject in need thereof a compound of formula Ia, Ib, or Ic for an interval of one week, and have had a reasonable expectation of success.
Claim Rejections-Nonstatutory 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 1-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6-8, and 13-15 of copending Application No. 18253601 (reference application) in view of Perello Bestard, US 20140271915 A1. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to methods of treating a disease associated with the formation of, and/or tissue exposure to calcium salt crystals comprising administering inositol polyphosphate oligo alkyl ether compounds that overlap structurally. For example, both sets of claims recite the inositol polyphosphate oligo alkyl ether compounds as selected from formulas Ia, Ib, and Ic (see copending claim 8 & instant claim 1). The only difference is that the copending claims don’t recite administering for an interval of one week. However, this modification would have been prima facie obvious in view of Perello Bestard. Perello Bestard teaches compounds having C-O-P bonds, including inositol phosphates, for the treatment of conditions related to kidney failure (abstract para [0002], [0024], [0069]). Perello Bestard teaches an embodiment wherein the compound having C-O-P bonds is IP6 (para [0046]). Perello Bestard further teaches kidney failure related diseases to be treated with the compound include calcium or calcium metabolism disorders, renal lithiasis, cardiovascular calcification, calcific tendinitis, calcinosis cutis, among others (para [0085-0088]). Perello Bestard teaches the compounds can be administered weekly, monthly, bimonthly, or any other frequency known to a person skilled in the art (para [0111]).
Therefore, one of ordinary skill in the art would have found it prima facie obvious to have arrived at an administration interval of about one week, based on the administration period of Perello Bestard, and have had a reasonable expectation of success in the absence of unexpected results.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-7, and 9-12 of U.S. Patent No. 11707470 B2 in view of Perello Bestard, US 20140271915 A1. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to methods of treating a disease associated with the formation of, and/or tissue exposure to calcium salt crystals comprising administering inositol polyphosphate oligo alkyl ether compounds that overlap structurally. For example, both sets of claims recite the inositol polyphosphate oligo alkyl ether compounds as selected from formulas Ia, Ib, and Ic (see patented claim 7 & instant claim 1). The only difference is that the patented claims don’t recite administering for an interval of one week. However, this modification would have been prima facie obvious in view of Perello Bestard. Perello Bestard teaches compounds having C-O-P bonds, including inositol phosphates, for the treatment of conditions related to kidney failure (abstract para [0002], [0024], [0069]). Perello Bestard teaches an embodiment wherein the compound having C-O-P bonds is IP6 (para [0046]). Perello Bestard further teaches kidney failure related diseases to be treated with the compound include calcium or calcium metabolism disorders, renal lithiasis, cardiovascular calcification, calcific tendinitis, calcinosis cutis, among others (para [0085-0088]). Perello Bestard teaches the compounds can be administered weekly, monthly, bimonthly, or any other frequency known to a person skilled in the art (para [0111]).
Therefore, one of ordinary skill in the art would have found it prima facie obvious to have arrived at an administration interval of about one week, based on the administration period of Perello Bestard, and have had a reasonable expectation of success in the absence of unexpected results. As such, the instant and patented claims are obvious variants of each other and are not patentably distinct.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 13 of U.S. Patent No. 10624909 B2 in view of Perello Bestard, US 20140271915 A1. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to methods of treating a disease associated with the formation of, and/or tissue exposure to calcium salt crystals comprising administering inositol polyphosphate oligo alkyl ether compounds that overlap structurally. For example, both sets of claims recite the inositol polyphosphate oligo alkyl ether compounds as selected from formulas Ia, Ib, and Ic (see patented claim 13 & instant claim 1). The only difference is that the patented claims don’t recite administering for an interval of one week. However, this modification would have been prima facie obvious in view of Perello Bestard. Perello Bestard teaches compounds having C-O-P bonds, including inositol phosphates, for the treatment of conditions related to kidney failure (abstract para [0002], [0024], [0069]). Perello Bestard teaches an embodiment wherein the compound having C-O-P bonds is IP6 (para [0046]). Perello Bestard further teaches kidney failure related diseases to be treated with the compound include calcium or calcium metabolism disorders, renal lithiasis, cardiovascular calcification, calcific tendinitis, calcinosis cutis, among others (para [0085-0088]). Perello Bestard teaches the compounds can be administered weekly, monthly, bimonthly, or any other frequency known to a person skilled in the art (para [0111]).
Therefore, one of ordinary skill in the art would have found it prima facie obvious to have arrived at an administration interval of about one week, based on the administration period of Perello Bestard, and have had a reasonable expectation of success in the absence of unexpected results. As such, the instant and patented claims are obvious variants of each other and are not patentably distinct.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 14 of U.S. Patent No. 11028112 B2 in view of Perello Bestard, US 20140271915 A1. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to methods of treating a disease associated with the formation of, and/or tissue exposure to calcium salt crystals, cardiovascular calcification comprising administering inositol polyphosphate oligo alkyl ether compounds that overlap structurally. For example, both sets of claims recite the inositol polyphosphate oligo alkyl ether compounds as selected from formulas Ia, Ib, and Ic (see patented claim 14 & instant claim 1). The only difference is that the patented claims don’t recite administering for an interval of one week. However, this modification would have been prima facie obvious in view of Perello Bestard. Perello Bestard teaches compounds having C-O-P bonds, including inositol phosphates, for the treatment of conditions related to kidney failure (abstract para [0002], [0024], [0069]). Perello Bestard teaches an embodiment wherein the compound having C-O-P bonds is IP6 (para [0046]). Perello Bestard further teaches kidney failure related diseases to be treated with the compound include calcium or calcium metabolism disorders, renal lithiasis, cardiovascular calcification, calcific tendinitis, calcinosis cutis, among others (para [0085-0088]). Perello Bestard teaches the compounds can be administered weekly, monthly, bimonthly, or any other frequency known to a person skilled in the art (para [0111]).
Therefore, one of ordinary skill in the art would have found it prima facie obvious to have arrived at an administration interval of about one week, based on the administration period of Perello Bestard, and have had a reasonable expectation of success in the absence of unexpected results. As such, the instant and patented claims are obvious variants of each other and are not patentably distinct.
Information Disclosure Statements
The IDS filed on 7/24/23 and 4/25/25 have been considered.
Correspondence
Claims 1-6 were examined and are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627