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 .
Status of the Claims
Claims 1-19 were originally filed December 8, 2023.
Claims 1-19 are currently pending.
Claims 1, 2, 4, 5, 9, and 12 are currently under consideration.
Election/Restrictions
Applicant’s election of primate (e.g. human), prolonging survival of a recipient of an allogenic transplant, cyclo-His-Pro (CHP) only, pretransplant administration followed by posttransplant administration, 0.5-18 hours prior to anesthesia, kidney, and about 40 mg/kg as the species in the reply filed on July 10, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Please note: primate (subgenus) and human (species) are not in the present claims. Therefore, the art rejections of record do not require primate or human.
Claims 3, 6-8, 10, 11, 13-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 10, 2026.
Priority
The present application claims the benefit of 63/386,531 filed December 8, 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 2, 2024 is being considered by the examiner.
Specification
The abstract of the disclosure is objected to because the grammar and language of the abstract requires correction. Please carefully review the abstract. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1, 2, 4, and 5 are objected to because of the following informalities: “cyclo-his-pro (CHP)” should read “cyclo-His-Pro (CHP)”. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: “mount” should read “amount”. Appropriate correction is 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 applicant regards as his invention.
Claims 1, 2, 4, 5, 9, and 12 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. One of skill in the art would not be able to determine the scope of the present claims. For example, a nexus between the preamble (i.e. recipient of an allogenic transplant, an allogenic transplant in a recipient) and the body of the claim is missing (i.e. single administration step in the recipient). There is no mention of the allogenic transplant in the body of the claim. Therefore, it is unclear what the correlation is with the administration step and the allogenic transplant.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to cyclo-His-Pro in a “recipient” without significantly more. The claim recites “administering” cyclo-His-Pro to a “recipient”. This judicial exception is not integrated into a practical application because cyclo-His-Pro is found naturally in animals (i.e. “recipients”). The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims are drawn only to “administering” cyclo-His-Pro to a “recipient”. See Prasad, 1995, Bioactive Cyclic Dipeptides, Peptides, 16(1): 151-164.
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.
Claims 1, 2, 4, 5, 9, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Moon et al., 2020, Cyclo(His-Pro) Prevents Against Renal Injury Through Activating Nrf2-Mediated Pathway, Am J Transplant, 20(3): 719; Ma et al. U.S. Patent Application Publication 2020/0329698 published October 22, 2020; and Jung et al. WO 2020/197359 published October 1, 2020 (utilizing the English language equivalent U.S. Patent Application Publication 2022/0202897 published June 30, 2022 for the citations).
For present claims 1, 2, 4, 5, 9, and 12, Moon et al. teach methods of administering cyclo(His-Pro) to various mouse models for allogenic transplant (e.g. ischemia-reperfusion-injury mouse model, 5/6 nephrectomy rat model) (please refer to the entire abstract).
For present claims 1, 2, 4, 5, 9, and 12, Ma et al. teach methods of administering beneficial compounds to a living donor, donor organ (e.g. 16 or 24 hours prior to transplantation), recipient prior to transplantation, and/or after transplantation to improve organ health (i.e. promote cell survival after ischemia-reperfusion) wherein the organs include kidney (please refer to the entire specification particularly paragraphs 1-7, 10, 15, 17, 20, 103, 108, 111-116, 138).
For present claims 1, 2, 4, 5, 9, and 12, Jung et al. teach methods of administering cyclo (his-pro) (CHP) to tissues or organs including kidney, liver, lung, heart, genital, or pancreas at 0.001 to 100 mg/kg (please refer to the entire specification particularly the abstract; paragraphs 1-17, 32-66, 79-85, 91, 105, 106).
All the claimed elements (specific timing of administration for treating a transplant recipient and dosage of cyclo-His-Pro) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (providing a treatment at a specific time and a specific dosage to improve a transplant tissue or organ) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (specific time; one dosage) for another (another time, a specific dosage) would have yielded predictable results (improvement of tissue or organ health) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (altering timing and dosage of a compound/medication) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1, 2, 4, 5, 9, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Zaloga et al. U.S. Patent 5,576,287 issued November 19, 1996; Ma et al. U.S. Patent Application Publication 2020/0329698 published October 22, 2020; and Jung et al. WO 2020/197359 published October 1, 2020 (utilizing the English language equivalent U.S. Patent Application Publication 2022/0202897 published June 30, 2022 for the citations).
For present claims 1, 2, 4, 5, 9, and 12, Zaloga et al. teach methods of administering cyclo-histidine-proline/cyclo-his-pro as a preventative step after renal transplant (please refer to the entire specification particularly columns 4-6).
For present claims 1, 2, 4, 5, 9, and 12, Ma et al. teach methods of administering beneficial compounds to a living donor, donor organ (e.g. 16 or 24 hours prior to transplantation), recipient prior to transplantation, and/or after transplantation to improve organ health (i.e. promote cell survival after ischemia-reperfusion) wherein the organs include kidney (please refer to the entire specification particularly paragraphs 1-7, 10, 15, 17, 20, 103, 108, 111-116, 138).
For present claims 1, 2, 4, 5, 9, and 12, Jung et al. teach methods of administering cyclo (his-pro) (CHP) to tissues or organs including kidney, liver, lung, heart, genital, or pancreas at 0.001 to 100 mg/kg (please refer to the entire specification particularly the abstract; paragraphs 1-17, 32-66, 79-85, 91, 105, 106).
All the claimed elements (specific timing of administration for treating a transplant recipient and dosage of cyclo-His-Pro) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (providing a treatment at a specific time and a specific dosage to improve a transplant tissue or organ) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (specific time; one dosage) for another (another time, a specific dosage) would have yielded predictable results (improvement of tissue or organ health) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (altering timing and dosage of a compound/medication) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
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, 2, 4, 5, 9, and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,890,317 in view of Zaloga et al. U.S. Patent 5,576,287 issued November 19, 1996; Ma et al. U.S. Patent Application Publication 2020/0329698 published October 22, 2020; and Jung et al. WO 2020/197359 published October 1, 2020 (utilizing the English language equivalent U.S. Patent Application Publication 2022/0202897 published June 30, 2022 for the citations).
U.S. Patent 11,890,317 claim methods of treating a subject suffering from a kidney disease comprising administering cyclo-histidine-proline (CHP).
Zaloga et al. teach methods of administering cyclo-histidine-proline/cyclo-his-pro as a preventative step after renal transplant (please refer to the entire specification particularly columns 4-6).
Ma et al. teach methods of administering beneficial compounds to a living donor, donor organ (e.g. 16 or 24 hours prior to transplantation), recipient prior to transplantation, and/or after transplantation to improve organ health (i.e. promote cell survival after ischemia-reperfusion) wherein the organs include kidney (please refer to the entire specification particularly paragraphs 1-7, 10, 15, 17, 20, 103, 108, 111-116, 138).
Jung et al. teach methods of administering cyclo (his-pro) (CHP) to tissues or organs including kidney, liver, lung, heart, genital, or pancreas at 0.001 to 100 mg/kg (please refer to the entire specification particularly the abstract; paragraphs 1-17, 32-66, 79-85, 91, 105, 106).
All the claimed elements (kidney disease leading to kidney transplant, specific timing of administration for treating a transplant recipient and dosage of cyclo-His-Pro) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (providing a treatment at a specific time and a specific dosage to improve a transplant tissue or organ which is needed due to kidney disease) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (specific time; one dosage; genus of kidney disease) for another (species of kidney transplant, another time, a specific dosage) would have yielded predictable results (improvement of tissue or organ health) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (altering timing and dosage of a compound/medication; treating kidney transplant with CHP) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1, 2, 4, 5, 9, and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,433,114 in view of Zaloga et al. U.S. Patent 5,576,287 issued November 19, 1996; Ma et al. U.S. Patent Application Publication 2020/0329698 published October 22, 2020; and Jung et al. WO 2020/197359 published October 1, 2020 (utilizing the English language equivalent U.S. Patent Application Publication 2022/0202897 published June 30, 2022 for the citations).
U.S. Patent 11,433,114 claim methods of treating a subject suffering from a liver disease comprising administering cyclo-histidine-proline (CHP).
Zaloga et al. teach methods of administering cyclo-histidine-proline/cyclo-his-pro as a preventative step after renal transplant (please refer to the entire specification particularly columns 4-6).
Ma et al. teach methods of administering beneficial compounds to a living donor, donor organ (e.g. 16 or 24 hours prior to transplantation), recipient prior to transplantation, and/or after transplantation to improve organ health (i.e. promote cell survival after ischemia-reperfusion) wherein the organs include kidney (please refer to the entire specification particularly paragraphs 1-7, 10, 15, 17, 20, 103, 108, 111-116, 138).
Jung et al. teach methods of administering cyclo (his-pro) (CHP) to tissues or organs including kidney, liver, lung, heart, genital, or pancreas at 0.001 to 100 mg/kg (please refer to the entire specification particularly the abstract; paragraphs 1-17, 32-66, 79-85, 91, 105, 106).
All the claimed elements (liver disease leading to liver transplant, specific timing of administration for treating a transplant recipient and dosage of cyclo-His-Pro) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (providing a treatment at a specific time and a specific dosage to improve a transplant tissue or organ which is needed due to liver disease) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (specific time; one dosage; genus of liver disease) for another (species of liver transplant, another time, a specific dosage) would have yielded predictable results (improvement of tissue or organ health) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (altering timing and dosage of a compound/medication; treating liver transplant with CHP) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1, 2, 4, 5, 9, and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,918,693 in view of Zaloga et al. U.S. Patent 5,576,287 issued November 19, 1996; Ma et al. U.S. Patent Application Publication 2020/0329698 published October 22, 2020; and Jung et al. WO 2020/197359 published October 1, 2020 (utilizing the English language equivalent U.S. Patent Application Publication 2022/0202897 published June 30, 2022 for the citations).
U.S. Patent 10,918,693 claim methods of treating a subject suffering from a kidney disease comprising administering cyclo-histidine-proline (CHP).
Zaloga et al. teach methods of administering cyclo-histidine-proline/cyclo-his-pro as a preventative step after renal transplant (please refer to the entire specification particularly columns 4-6).
Ma et al. teach methods of administering beneficial compounds to a living donor, donor organ (e.g. 16 or 24 hours prior to transplantation), recipient prior to transplantation, and/or after transplantation to improve organ health (i.e. promote cell survival after ischemia-reperfusion) wherein the organs include kidney (please refer to the entire specification particularly paragraphs 1-7, 10, 15, 17, 20, 103, 108, 111-116, 138).
Jung et al. teach methods of administering cyclo (his-pro) (CHP) to tissues or organs including kidney, liver, lung, heart, genital, or pancreas at 0.001 to 100 mg/kg (please refer to the entire specification particularly the abstract; paragraphs 1-17, 32-66, 79-85, 91, 105, 106).
All the claimed elements (kidney disease leading to kidney transplant, specific timing of administration for treating a transplant recipient and dosage of cyclo-His-Pro) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (providing a treatment at a specific time and a specific dosage to improve a transplant tissue or organ which is needed due to kidney disease) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (specific time; one dosage; genus of kidney disease) for another (species of kidney transplant, another time, a specific dosage) would have yielded predictable results (improvement of tissue or organ health) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (altering timing and dosage of a compound/medication; treating kidney transplant with CHP) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1, 2, 4, 5, 9, and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10,683,300 in view of Zaloga et al. U.S. Patent 5,576,287 issued November 19, 1996; Ma et al. U.S. Patent Application Publication 2020/0329698 published October 22, 2020; and Jung et al. WO 2020/197359 published October 1, 2020 (utilizing the English language equivalent U.S. Patent Application Publication 2022/0202897 published June 30, 2022 for the citations).
U.S. Patent 10,683,300 claim cyclo-histidine-proline (CHP).
Zaloga et al. teach methods of administering cyclo-histidine-proline/cyclo-his-pro as a preventative step after renal transplant (please refer to the entire specification particularly columns 4-6).
Ma et al. teach methods of administering beneficial compounds to a living donor, donor organ (e.g. 16 or 24 hours prior to transplantation), recipient prior to transplantation, and/or after transplantation to improve organ health (i.e. promote cell survival after ischemia-reperfusion) wherein the organs include kidney (please refer to the entire specification particularly paragraphs 1-7, 10, 15, 17, 20, 103, 108, 111-116, 138).
Jung et al. teach methods of administering cyclo (his-pro) (CHP) to tissues or organs including kidney, liver, lung, heart, genital, or pancreas at 0.001 to 100 mg/kg (please refer to the entire specification particularly the abstract; paragraphs 1-17, 32-66, 79-85, 91, 105, 106).
All the claimed elements (treating transplant and/or recipient with cyclo-His-Pro, specific timing of administration for treating a transplant recipient and dosage of cyclo-His-Pro) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (providing a treatment at a specific time and a specific dosage to improve a transplant tissue or organ) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (specific time; one dosage; method of treating a transplant and/or recipient) for another (another time, a specific dosage) would have yielded predictable results (improvement of tissue or organ health) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (altering timing and dosage of a compound/medication; treating transplant with CHP) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1, 2, 4, 5, 9, and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,820,834 in view of Zaloga et al. U.S. Patent 5,576,287 issued November 19, 1996; Ma et al. U.S. Patent Application Publication 2020/0329698 published October 22, 2020; and Jung et al. WO 2020/197359 published October 1, 2020 (utilizing the English language equivalent U.S. Patent Application Publication 2022/0202897 published June 30, 2022 for the citations).
U.S. Patent 11,820,834 claim methods of treating a subject suffering from a kidney disease comprising administering cyclo-histidine-proline (CHP).
Zaloga et al. teach methods of administering cyclo-histidine-proline/cyclo-his-pro as a preventative step after renal transplant (please refer to the entire specification particularly columns 4-6).
Ma et al. teach methods of administering beneficial compounds to a living donor, donor organ (e.g. 16 or 24 hours prior to transplantation), recipient prior to transplantation, and/or after transplantation to improve organ health (i.e. promote cell survival after ischemia-reperfusion) wherein the organs include kidney (please refer to the entire specification particularly paragraphs 1-7, 10, 15, 17, 20, 103, 108, 111-116, 138).
Jung et al. teach methods of administering cyclo (his-pro) (CHP) to tissues or organs including kidney, liver, lung, heart, genital, or pancreas at 0.001 to 100 mg/kg (please refer to the entire specification particularly the abstract; paragraphs 1-17, 32-66, 79-85, 91, 105, 106).
All the claimed elements (kidney disease leading to kidney transplant, specific timing of administration for treating a transplant recipient and dosage of cyclo-His-Pro) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (providing a treatment at a specific time and a specific dosage to improve a transplant tissue or organ which is needed due to kidney disease) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (specific time; one dosage; genus of kidney disease) for another (species of kidney transplant, another time, a specific dosage) would have yielded predictable results (improvement of tissue or organ health) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (altering timing and dosage of a compound/medication; treating kidney transplant with CHP) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1, 2, 4, 5, 9, and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,534,496 in view of Zaloga et al. U.S. Patent 5,576,287 issued November 19, 1996; Ma et al. U.S. Patent Application Publication 2020/0329698 published October 22, 2020; and Jung et al. WO 2020/197359 published October 1, 2020 (utilizing the English language equivalent U.S. Patent Application Publication 2022/0202897 published June 30, 2022 for the citations).
U.S. Patent 12,534,496 claim methods of treating a subject suffering from a kidney disease comprising administering cyclo-histidine-proline (CHP).
Zaloga et al. teach methods of administering cyclo-histidine-proline/cyclo-his-pro as a preventative step after renal transplant (please refer to the entire specification particularly columns 4-6).
Ma et al. teach methods of administering beneficial compounds to a living donor, donor organ (e.g. 16 or 24 hours prior to transplantation), recipient prior to transplantation, and/or after transplantation to improve organ health (i.e. promote cell survival after ischemia-reperfusion) wherein the organs include kidney (please refer to the entire specification particularly paragraphs 1-7, 10, 15, 17, 20, 103, 108, 111-116, 138).
Jung et al. teach methods of administering cyclo (his-pro) (CHP) to tissues or organs including kidney, liver, lung, heart, genital, or pancreas at 0.001 to 100 mg/kg (please refer to the entire specification particularly the abstract; paragraphs 1-17, 32-66, 79-85, 91, 105, 106).
All the claimed elements (kidney disease leading to kidney transplant, specific timing of administration for treating a transplant recipient and dosage of cyclo-His-Pro) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (providing a treatment at a specific time and a specific dosage to improve a transplant tissue or organ which is needed due to kidney disease) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (specific time; one dosage; genus of kidney disease) for another (species of kidney transplant, another time, a specific dosage) would have yielded predictable results (improvement of tissue or organ health) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (altering timing and dosage of a compound/medication; treating kidney transplant with CHP) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
TRH derivative or analogue including cyclo-His-Pro administered after transplantation – see WO 2006/096829
TRH derivative or analogue including cyclo-histidyl-proline administered after transplantation – see U.S. Patent 5,686,420
Anti-inflammatory properties of cyclo(His-Pro) – see Minelli et al., 2012, Cyclo(His-Pro) exerts anti-inflammatory effects by modulating NF-kB and Nrf2 signaling, The International Journal of Biochemistry & Cell Biology, 44: 525-535.
Cytoprotection of cyclo(His-Pro) – see Minelli et al., 2009, Cyclo(His-Pro) promotes cytoprotection by activating Nrf2-mediated up-regulation of antioxidant defense, J Cell Mol Med, 13(6): 1149-1161.
Future Communications
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/AMBER D STEELE/Primary Examiner, Art Unit 1658
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