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 Claims
The claim listing filed 05 January 2024 is pending. Claims 1-15 are being examined on the merits in this office action.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 05 January 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statement is being considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See page 9. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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)(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 1-7 and 12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Franz (US 2009/0297470 A1, cited in the IDS filed 5 January 2024).
Please note, the pin citations are derived from the pre-grant publication of US 2009/0297470 A1.
Regarding claim 1, Franz teaches a method of using parathyroid hormone-related peptide (PTHrP), preferably PTHrP (1-34), another name for abaloparatide, to repair tissues suffering from ischemia, specifically ischemic myocardial events, before performing reperfusion (i.e., a surgical or interventional procedure) ([0002] “Accordingly, the uses and methods of the present invention are preferably suitable for the … treatment of ischemia. Moreover, the present invention relates to a composition comprising … parathyroid hormone-related peptide (PTHrP), preferably PTHrP (1-34) …”; [0131] “The term “surgical or interventional procedure” as used herein relates to a surgical and/or interventional procedure which is suitable to improve organ function, to improve blood flow in defect organ tissue and/or to induce revascularization as thrombolysis (either systemic or local via catheter delivery), balloon angioplasty, stenting, ...”; [0139] “In a preferred embodiment of the invention the pharmaceutical composition of the present invention is to be administered before a surgical or interventional procedure.”). Franz also teaches the use of PTHrP (1-34) in treating ischemia, a cardiomyocyte reperfusion injury, when administered before, during or after a surgical or interventional measure ([0143] “Moreover, as described above, the pharmaceutical composition of the present invention, after it has been administered before, during or after a surgical or interventional measure is further administered for the period of time as described above so as to preferably prevent and/or treat ischemia.”).
Regarding claim 2, Franz teaches the method being able to treat myocardial infarction ([0145] “It is particularly preferred that the myocardial ischemia which is treated with the pharmaceutical composition of the present invention is caused by … myocardial infarction …”).
Regarding claim 3, Franz teaches the pharmaceutical composition being administered before reperfusion, said reperfusion being surgical procedures comprising balloon angioplasty and stenting ([0131] “The term “surgical or interventional procedure” as used herein relates to a surgical and/or interventional procedure which is suitable to improve organ function, to improve blood flow in defect organ tissue and/or to induce revascularization as thrombolysis (either systemic or local via catheter delivery), balloon angioplasty, stenting, ...”; [0139] “In a preferred embodiment of the invention the pharmaceutical composition of the present invention is to be administered before a surgical or interventional procedure.”).
Regarding claim 4, Franz teaches the pharmaceutical composition being administered subcutaneously ([0118] “In a particularly preferred embodiment the pharmaceutical composition is administered subcutaneously.”).
Regarding claim 5, Franz teaches the composition being administered between 1 to 5 days before performing reperfusion ([0139] “In a preferred embodiment of the invention the pharmaceutical composition of the present invention is to be administered before a surgical or interventional procedure. … the present invention is to be administered before one day, preferably two days, more preferably three days and even more preferably four or five days of said surgical or interventional measure, for example, to prevent ischemic disease as described herein.”).
Regarding claim 6, Franz teaches the composition being administered once daily for 1 day before performing reperfusion ([0137] “The dosages are preferably given once, twice, trice, four times or five times a day for the period of 1, 2, 3, 4, 5, 6, 7… ”; [0139] “In a preferred embodiment of the invention the pharmaceutical composition of the present invention is to be administered before a surgical or interventional procedure. … the present invention is to be administered before one day, … of said surgical or interventional measure, for example, to prevent ischemic disease as described herein.”).
Regarding claim 7, Franz teaches that the composition is capable of being administered concurrently with performing reperfusion ([0140] “In another further preferred embodiment of the invention the pharmaceutical composition of the present invention is to be administered during a surgical or interventional procedure.”).
Regarding claim 12, Franz teaches that the composition can be administered to a subject at risk of suffering from ischemia and defines ischemia to include myocardial infarction ([0126-127] “Thus, the pharmaceutical composition of the present invention is preferably suitable for the prevention and/or treatment of ischemia. … The term “prevention” or “preventing” when used herein means to obtain a protective effect on a tissue which is already suffering from ischemia so as to prevent further damage and/or a protective effect on a tissue which is at a risk of suffering from ischemia.”; [0144] “Preferably, the ischemia treated with the pharmaceutical composition of the present invention … As described supra, ischemia may occur in any tissue and/or organ suffering from a lack of oxygen and/or metabolites for a prolonged time which results in organic defects. … Said organ defects are caused by … myocardial infarction …” ).
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 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Franz (US 2009/0297470 A1, cited in the IDS filed 5 January 2024), as applied to claim 1 above, and further in view of Cosman et al., hereafter “Cosman”, (“Cardiovascular Safety of Abaloparatide in Postmenopausal Women With Osteoporosis: Analysis From the ACTIVE Phase 3 Trial.” J Clin Endocrinol Metab. 2020 Nov 1;105(11):3384–95. doi: 10.1210/clinem/dgaa450. PMID: 32658264; PMCID: PMC7500469.)
Regarding claim 8, Franz teaches a composition comprising abaloparatide being able to be subcutaneously administered ([0118] “In a particularly preferred embodiment the pharmaceutical composition is administered subcutaneously.”).
Franz does not teach the amount of abaloparatide being administered being 80µg.
Cosman teaches abaloparatide increasing the heart rate with no significant increase in cardiovascular adverse events, including but not limited, myocardial infarction (pg. 3385, “Abaloparatide was associated with transient increases in HR and small decreases in BP in postmenopausal women with osteoporosis, with no increase in risk of serious cardiac AEs, MACE, or HF.”; pg. 3386, “MACEs included nonfatal myocardial infarction, … ”).
Cosman also teaches that the participants of this study being subcutaneously administered 80µg of abaloparatide daily (pg. 3385, “Women were randomized to daily subcutaneous abaloparatide 80 µg, …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Franz’s teachings with Cosman’s teachings because both Franz and Cosman teach treatment of myocardial infarction.
One of ordinary skill in the art before the effective filing date of the claimed invention would have a reasonable expectation of success because the abaloparatide and PTHrp (1-34) are the same.
Regarding claim 9, Franz teaches a composition comprising abaloparatide being able to be subcutaneously administered ([0118] “In a particularly preferred embodiment the pharmaceutical composition is administered subcutaneously.”).
Cosman teaches abaloparatide increasing the heart rate with no significant increase in cardiovascular adverse events, including but not limited, myocardial infarction (pg. 3385, “Abaloparatide was associated with transient increases in HR and small decreases in BP in postmenopausal women with osteoporosis, with no increase in risk of serious cardiac AEs, MACE, or HF.”; pg. 3386, “MACEs included nonfatal myocardial infarction, … ”).
Cosman also teaches that the participants of this study being subcutaneously administered 80µg of abaloparatide daily (pg. 3385, “Women were randomized to daily subcutaneous abaloparatide 80 µg, …”).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Franz (US 2009/0297470 A1, cited in the IDS filed 5 January 2024), as applied to claim 1, and further in view of Hattersley et al., hereafter “Hattersley” (US 10,568,937 B2).
Regarding claim 10, Franz teaches a composition comprising abaloparatide being able to be transdermally administered ([0117] “The administration of the candidate agents of the present invention can be done in a variety of ways, including, but not limited to, … transdermally, …”).
Franz does not teach abaloparatide being administered being via a transdermal microneedle patch in an amount ranging from about 100µg to about 300µg.
Hattersley teaches preparation formulations for transdermal delivery of abaloparatide (col. 1, lines 66-67, “Provided herein in certain embodiments are preparation formulations for use in transdermal delivery of abaloparatide …”).
Hattersley also shows an example where a transdermal microneedle patch is prepared with 100µg of abaloparatide (col. 29, lines 50-58, “Pharmacokinetics of Abaloparatide Delivered Via Transdermal Patch Prepared Using Preparation Formulations with PBS Buffer in Human -The pharmacokinetic profile of transdermal administration of abaloparatide and the abaloparatide-SC treatment was assessed in healthy postmenopausal women from 50 to 80 years of age, inclusive. Subjects received a single application of a transdermal patch (100 μg abaloparatide) …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Franz’s teachings with Hattersley’s teachings because both Franz and Hattersley teach administering abaloparatide transdermally in a therapeutically acceptable amount. One of ordinary skill in the art would have been reasonably motivated to administer the abaloparatide for the treatment to repair tissues suffering from ischemia, as taught by Franz, to the method of administering abaloparatide transdermally, as taught by Hattersley because the abaloparatide and PTHrp (1-34) are the same, and the teachings of Hattersley provide a known method of administering a known peptide. Hence the combination of references would have been readily apparent and deemed to be a mere (A) Combining prior art elements according to known methods to yield predictable results (see MPEP 2143(I)).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Franz (US 2009/0297470 A1, cited in the IDS filed 5 January 2024), as applied to claim 1 above, and further in view of Maloney et al., hereafter “Maloney” (“Phase I clinical trial using escalating single-dose infusion of chimeric anti-CD20 monoclonal antibody (IDEC-C2B8) in patients with recurrent B-cell lymphoma.” Blood. 1994 Oct 15;84(8):2457-66. PMID: 7522629.).
Regarding claim 11, Franz teaches a composition comprising abaloparatide being able to be intravenously administered ([0117] “The administration of the candidate agents of the present invention can be done in a variety of ways, including, but not limited to, … intravenously, …”). Franz also teaches that PTH(1-34) is administered intravenously at a rate of 1U/kg/min ([0162] “… it was shown that PTH(1-34) administration intravenously (1 U/kg/min) starting 30 minutes after coronary occlusion …”).
Franz does not teach abaloparatide being administered at a dose sufficient to provide a maximum exposure of about 240 pmol/kg·min.
Maloney teaches that in drug development, Phase I clinical trials are an essential step that establishes dosage and/or schedule for new drugs, in addition to this phase being used to determine infusional related toxicity (or maximum infusion rate) (pg. 2458, “No toxicity was observed in these studies. We describe here the first phase 1 clinical trial of single-dose infusion with the chimeric anti-CD20 antibody (IDEC-C2B8) in patients with relapsed B-cell NHL. … This was a phase I clinical trial of single-dose IDEC-C2B8 chimeric anti-CD20 MoAb administered to patients with relapsed B-cell NHL. … Three patients were treated at each dose level with a single intravenous infusion of 10, 50, 100, 250, or 500 mg/m2 of MoAb. Patients were evaluated for infusional related toxicity and effect …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Franz’s teachings with Maloney’s teachings because Franz teaches administering abaloparatide intravenously in a therapeutically acceptable amount. One of ordinary skill in the art would have been reasonably motivated to administer the abaloparatide for the treatment to repair tissues suffering from ischemia, as taught by Franz, and figure out the maximum exposure rate of intravenously administered abaloparatide due to Maloney teaching that evaluating infusional related toxicity in intravenously administered drugs is a known step in Phase I clinical trials. Hence the combination of references would have been readily apparent and deemed to be a mere (A) Combining prior art elements according to known methods to yield predictable results (see MPEP 2143(I)).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Franz (US 2009/0297470 A1, cited in the IDS filed 5 January 2024) and as applied to claim 1 above, and further in view of Hattersley et al., hereafter “Hattersley 2016” (“Binding Selectivity of Abaloparatide for PTH-Type-1-Receptor Conformations and Effects on Downstream Signaling.” Endocrinology. 2016 Jan;157(1):141-9. doi: 10.1210/en.2015-1726. Epub 2015 Nov 12. PMID: 26562265; PMCID: PMC4701881.).
Regarding claim 13, Franz teaches a composition comprising abaloparatide being able to be subcutaneously administered ([0118] “In a particularly preferred embodiment the pharmaceutical composition is administered subcutaneously.”).
Franz does not teach that the expression level of phosphorylated Akt, phosphorylated ERK or both is enhanced relative to the absence of abaloparatide.
Hattersley 2016 teaches that abaloparatide (ABL) induces a rapid and sustained increase in phosphorylated ERK (“The capacity of ABL and control ligands to activate ERK-1/2 signaling was assessed in GP-2.3 cells. Each ligand, at 5 minutes after being added to the cells (15) induced an increase in ERK-1/2 phosphorylation, …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Franz’s teachings with Hattersley 2016’s teachings because Franz teaches administering abaloparatide subcutaneously in a therapeutically acceptable amount. One of ordinary skill in the art would have been reasonably motivated to believe that the abaloparatide used in the repair of tissues suffering from ischemia, as taught by Franz, results in an increase in phosphorylated ERK as taught by Hattersley 2016, due to both references teaching abaloparatide.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Franz (US 2009/0297470 A1, cited in the IDS filed 5 January 2024) and Hassanein et al., hereafter “Hassanein”, (US 6953655 B1).
Regarding claim 14, Franz teaches a method of using parathyroid hormone-related peptide (PTHrP), preferably PTHrP (1-34), another name for abaloparatide, to repair tissues suffering from ischemia, specifically ischemic myocardial events, before performing reperfusion (i.e., a surgical or interventional procedure) ([0002] “Accordingly, the uses and methods of the present invention are preferably suitable for the … treatment of ischemia. Moreover, the present invention relates to a composition comprising … parathyroid hormone-related peptide (PTHrP), preferably PTHrP (1-34) …”; [0131] “The term “surgical or interventional procedure” as used herein relates to a surgical and/or interventional procedure which is suitable to improve organ function, to improve blood flow in defect organ tissue and/or to induce revascularization as thrombolysis (either systemic or local via catheter delivery), balloon angioplasty, stenting, ...”; [0139] “In a preferred embodiment of the invention the pharmaceutical composition of the present invention is to be administered before a surgical or interventional procedure.”). Franz teaches the use of PTHrP (1-34) in treating ischemia, a cardiomyocyte reperfusion injury, when administered before, during or after a surgical or interventional measure ([0143] “Moreover, as described above, the pharmaceutical composition of the present invention, after it has been administered before, during or after a surgical or interventional measure is further administered for the period of time as described above so as to preferably prevent and/or treat ischemia.”). Additionally, Franz teaches that the term ischemia as used in the instant invention relates to a condition wherein a tissue/organ is suffering from lack of oxygen supply, for example to the heart and that medical interventions can stop blood flow ([0129] “The term “ischemia” as used herein relates to a condition that may occur in any tissue and/or organ that is suffering a lack of oxygen supply and/or supply with metabolites which occurs when there is an imbalance between oxygen supply and demand, due to inadequate perfusion, e.g., … that leads to insufficient oxygen to tissues such as, for example, the heart … However, also medical interventions such as the interruption of the blood flow, e.g., during bypass surgery may lead to ischemia.”).
Franz does not teach that the cardiomyocyte reperfusion injury is associated with a cardiac transplant.
Hassanein teaches that current donor organ preservation protocols do not completely protect the heart from myocardial damage resulting from ischemia and reperfusion injuries, these injuries are thought to be the leading cause of late organ failure (col. 1-2, lines. 66-67 and 1-15, “Generally, current donor organ preservation protocols do not attempt to recreate an in vivo-like physiologic state for harvested organs. … These protocols utilize a variety of crystalloid-based cardioplegic solutions that do not completely protect the donor heart from myocardial damage resulting from ischemia and reperfusion injuries. In addition to myocardial damage, ischemia, reperfusion and/or increased potassium concentrations may also cause coronary vascular endothelial and smooth muscle injury leading to coronary vasomotor dysfunction, which is believed to be the leading cause of late organ failure.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Franz’s teachings of the administration of a composition comprising PTHrP (1-34) by combining it with the teachings of Hassanien that shows donor hearts are very susceptible to ischemia and that the methods being used don’t completely protect the donor heart. It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use the composition of Franz to treat cardiomyocyte reperfusion injury associated with cardiac transplants due to the art of Hassanien teaching that there is a known issue of myocardial damage in donor organs. One of ordinary skill in the art would have been reasonably motivated to believe that the abaloparatide used in the repair of tissues suffering from ischemia, as taught by Franz, would be applicable to the problem of donor heart ischemia as described in Hassanein.
Regarding claim 15, Franz teaches the use of PTHrP (1-34) in treating ischemia when administered before a surgical or interventional measure ([0143] “Moreover, as described above, the pharmaceutical composition of the present invention, after it has been administered before, during or after a surgical or interventional measure is further administered for the period of time as described above so as to preferably prevent and/or treat ischemia.”).
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 and 8-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, 21, and 22 of copending Application No. 19/391,741 (reference application), in view of Franz (US 2009/0297470 A1, cited in the IDS filed 5 January 2024), Tankó et al., hereafter “Tankó” (“Relationship Between Osteoporosis and Cardiovascular Disease in Postmenopausal Women”, Journal of Bone and Mineral Research, Volume 20, Issue 11, 1 November 2005, Pages 1912–1920, https://doi.org/10.1359/JBMR.050711) and Hattersley et al., hereafter “Hattersley” (US 10,568,937 B2).
Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to different methods of using the same peptide.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding instant claim 1, ‘741 teaches a method of treating a subject having a spinal fracture, the method comprising administering a therapeutically effective amount of abaloparatide to a subject having a spinal fracture (See claims 1 and 13).
‘741 does not teach the abaloparatide being administered in a method for treating cardiomyocyte reperfusion injury before, during or after performing reperfusion.
Tankó teaches that there is an increase in risk for cardiovascular events associated with prior vertebral fracture (pg. 1918 “The 3‐fold increase in risk for cardiovascular events associated with at least one prior vertebral fracture (independent of localization) …”; pg. 1914 “Information on cardiovascular events was collected by asking participants at each visit if they had a myocardial infarction…”).
Franz teaches a method of using parathyroid hormone-related peptide (PTHrP), preferably PTHrP (1-34), another name for abaloparatide, to repair tissues suffering from ischemia, specifically ischemic myocardial events, before performing reperfusion (i.e., a surgical or interventional procedure) ([0002] “Accordingly, the uses and methods of the present invention are preferably suitable for the … treatment of ischemia. Moreover, the present invention relates to a composition comprising … parathyroid hormone-related peptide (PTHrP), preferably PTHrP (1-34) …”; [0131] “The term “surgical or interventional procedure” as used herein relates to a surgical and/or interventional procedure which is suitable to improve organ function, to improve blood flow in defect organ tissue and/or to induce revascularization as thrombolysis (either systemic or local via catheter delivery), balloon angioplasty, stenting, ...”; [0139] “In a preferred embodiment of the invention the pharmaceutical composition of the present invention is to be administered before a surgical or interventional procedure.”). Franz also teaches the use of PTHrP (1-34) in treating ischemia, a cardiomyocyte reperfusion injury, when administered before, during or after a surgical or interventional measure ([0143] “Moreover, as described above, the pharmaceutical composition of the present invention, after it has been administered before, during or after a surgical or interventional measure is further administered for the period of time as described above so as to preferably prevent and/or treat ischemia.”).
It would have been obvious to one of ordinary skill in the art to use the method of treatment as described in ‘741 because the claims teach a method comprising administering abaloparatideto a subject having a spinal fracture, and Tankó teaches that spinal fractures and cardiovascular events, including myocardial infarction, are correlated, which was show to be used to treat tissues suffering from myocardial ischemia. One of ordinary skill in the art would be motivated to find a composition to treat myocardial infarction due to the teaching of Tankó showing that spinal fractures and cardiovascular events, including myocardial infarction, are correlated. The claimed invention is drawn to the use of abaloparatide. One of ordinary skill in the art before the effective filing date of the claimed invention would be motivated with reasonable expectation of success to use the method comprising administering abaloparatide of ‘741 to treat cardiomyocyte reperfusion injury as described in Franz due to both ‘741 and Franz teaching abaloparatide, and Franz teaching that abaloparatide can be used to treat cardiomyocyte reperfusion injury, and Tankó teaching a relationship between spinal fractures and myocardial infarction.
Regarding instant claim 8, ‘741 teaches a method of treating a subject having a spinal fracture being administered, subcutaneously, between 20 µg and 100 µg of abaloparatide (See claims 21 and 22).
Regarding instant claim 9, ‘741 teaches a method of treating a subject having a spinal fracture being administered, subcutaneously, between 80 µg of abaloparatide (See claim 22).
Regarding instant claim 10, ‘741 teaches a method of treating a subject having a spinal fracture being administered, transdermally, between 100 µg and 400 µg of abaloparatide (See claims 21 and 22).
‘741 does not teach the abaloparatide being administered using a transdermal microneedle patch.
Hattersley teaches preparation formulations for transdermal delivery of abaloparatide (col. 1, lines 66-67, “Provided herein in certain embodiments are preparation formulations for use in transdermal delivery of abaloparatide …”).
Hattersley also shows an example where a transdermal microneedle patch is prepared with 100µg of abaloparatide (col. 29, lines 50-58, “Pharmacokinetics of Abaloparatide Delivered Via Transdermal Patch Prepared Using Preparation Formulations with PBS Buffer in Human -The pharmacokinetic profile of transdermal administration of abaloparatide and the abaloparatide-SC treatment was assessed in healthy postmenopausal women from 50 to 80 years of age, inclusive. Subjects received a single application of a transdermal patch (100 μg abaloparatide) …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify ‘741’s teachings with Hattersley’s teachings because both ‘741 and Hattersley teach administering abaloparatide transdermally in a therapeutically acceptable amount. One of ordinary skill in the art before the effective filing date of the claimed invention would be motivated with reasonable expectation of success to use the method comprising administering abaloparatide of ‘741 to treat cardiomyocyte reperfusion injury using a transdermal microneedle patch as described in Franz and Hattersley due to both ‘741 and Franz teaching abaloparatide, and Franz teaching that abaloparatide can be administered transdermally.
One of ordinary skill in the art before the effective filing date of the claimed invention would have a reasonable expectation of success because both references teach methods of using abaloparatide and the teachings of Hattersley provide a known method of administering a known peptide.
Claim 1, 8 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 10568937, in view of Franz (US 2009/0297470 A1, cited in the IDS filed 5 January 2024), Gerber et al., hereafter “Gerber”, (“Association between myocardial infarction and fractures: an emerging phenomenon.” Circulation. 2011 Jul 19;124(3):297-303. doi: 10.1161/CIRCULATIONAHA.110.007195. Epub 2011 Jun 27. PMID: 21709062; PMCID: PMC3155422.) and Hattersley et al., hereafter “Hattersley” (US 10,568,937 B2). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to different methods of using the same peptide.
Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to different methods of using the same peptide.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding instant claim 1, ‘937 teaches a method of accelerating, or facilitating fracture healing, or treating fractures comprising the administration of a patch comprising a plurality of microprojections covered at least in part by a formulation comprising abaloparatide and one or more excipients selected from the group consisting of Zn2+ salts, Mg2+ salts, and Ca2+ salts. (See claim 1).
‘937 does not teach the abaloparatide being administered in a method for treating cardiomyocyte reperfusion injury before, during or after performing reperfusion.
Gerber teaches that there is a large risk of osteoporotic fracture after suffering from myocardial infarction (MI) (pg. 7, “In this geographically defined population, we found a large excess risk of osteoporotic fracture after MI, which increased markedly over the past 3 decades. The trend applied to all segments of the population and all fracture sites.”).
Franz teaches a method of using parathyroid hormone-related peptide (PTHrP), preferably PTHrP (1-34), another name for abaloparatide, to repair tissues suffering from ischemia, specifically ischemic myocardial events, before performing reperfusion (i.e., a surgical or interventional procedure) ([0002] “Accordingly, the uses and methods of the present invention are preferably suitable for the … treatment of ischemia. Moreover, the present invention relates to a composition comprising … parathyroid hormone-related peptide (PTHrP), preferably PTHrP (1-34) …”; [0131] “The term “surgical or interventional procedure” as used herein relates to a surgical and/or interventional procedure which is suitable to improve organ function, to improve blood flow in defect organ tissue and/or to induce revascularization as thrombolysis (either systemic or local via catheter delivery), balloon angioplasty, stenting, ...”; [0139] “In a preferred embodiment of the invention the pharmaceutical composition of the present invention is to be administered before a surgical or interventional procedure.”). Franz also teaches the use of PTHrP (1-34) in treating ischemia, a cardiomyocyte reperfusion injury, when administered before, during or after a surgical or interventional measure ([0143] “Moreover, as described above, the pharmaceutical composition of the present invention, after it has been administered before, during or after a surgical or interventional measure is further administered for the period of time as described above so as to preferably prevent and/or treat ischemia.”).
It would have been obvious to one of ordinary skill in the art to use the method of treatment as described in ‘937 because the claims teach a method comprising administering abaloparatide to a patient in need of fracture treatment, while Gerber teaches a connection between osteoporotic fracture and myocardial ischemia. One of ordinary skill in the art would be motivated to find a composition to treat myocardial infarction due to the teaching of Gerber showing that populations have an increased risk of fracture after myocardial infarction. The claimed invention is drawn to the use of abaloparatide. One of ordinary skill in the art before the effective filing date of the claimed invention would be motivated with reasonable expectation of success to use the method comprising administering abaloparatide to a subject with a fracture, as described in ‘937, to treat cardiomyocyte reperfusion injury as described in Franz due to both ‘937 and Franz teaching abaloparatide, and Gerber teaching a relationship between fracture and myocardial infarction.
Regarding instant claim 8, ‘937 teaches a method of accelerating, or facilitating fracture healing, or treating fractures being administered via a patch that comprises abaloparatide in an amount between 200-450 μg. (See claim 7)
‘937 does not teach the abaloparatide being administered using a subcutaneously.
Franz teaches the pharmaceutical composition being administered subcutaneously ([0118] “In a particularly preferred embodiment the pharmaceutical composition is administered subcutaneously.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify ‘937’s teachings with Franz’s teachings because both ‘937 and Franz teach administering abaloparatide transdermally, while Franz also says abaloparatide can be administered subcutaneously. One of ordinary skill in the art before the effective filing date of the claimed invention would be motivated with reasonable expectation of success to use the method comprising administering abaloparatide of ‘937 to treat cardiomyocyte reperfusion injury using a subcutaneous method as described in Franz due to both ‘937 and Franz teaching abaloparatide, and Franz teaching that abaloparatide can be administered subcutaneously.
Regarding instant claim 10, ‘937 teaches a method of accelerating, or facilitating fracture healing, or treating fractures being administered via a patch that comprises abaloparatide in an amount between 200-450 μg. (See claim 7) The amount of 200-300 μg, as necessitated by the instant application, is encompassed in the range described in ‘937.
Claim 1 and 8-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12496330, in view of Franz (US 2009/0297470 A1, cited in the IDS filed 5 January 2024), Kaye et al., hereafter “Kaye”, (“Risk Factors for Adverse Cardiac Events After Lumbar Spine Fusion.” Int J Spine Surg. 2018 Oct 15;12(5):638-643. doi: 10.14444/5079. PMID: 30364741; PMCID: PMC6198627.) and Hattersley et al., hereafter “Hattersley” (US 10,568,937 B2). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to different methods of using the same peptide.
Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to different methods of using the same peptide.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding instant claim 1, ‘330 teaches a method of treating a subject having a spinal fusion surgery, the method comprising administering a therapeutically effective amount of abaloparatide to the subject after having the spinal fusion surgery, wherein the administration is daily subcutaneous administration of 80 μg abaloparatide; wherein the treatment enhances spinal fusion, bone formation, or both, without elevating bone resorption; and wherein the enhanced spinal fusion or bone formation is determined by a CT scan. (See claim 1).
‘330 does not teach the abaloparatide being administered in a method for treating cardiomyocyte reperfusion injury before, during or after performing reperfusion.
Kaye teaches that cardiac events, including myocardial infarction) after lumbar spinal fusion carry a high mortality rate (pg. 639 “The 30-day postoperative data were analyzed to assess for the incidence of adverse cardiac events including cardiac arrest or myocardial infarction. ”; pg. 642, “Cardiac events after lumbar fusion are rare but have devastating complications. … the risk of sustaining a cardiac event after lumbar spine fusion was 4.76/1000 cases … The risk of mortality among that cohort was an alarmingly high 24.6% …”)
Franz teaches a method of using parathyroid hormone-related peptide (PTHrP), preferably PTHrP (1-34), another name for abaloparatide, to repair tissues suffering from ischemia, specifically ischemic myocardial events, before performing reperfusion (i.e., a surgical or interventional procedure) ([0002] “Accordingly, the uses and methods of the present invention are preferably suitable for the … treatment of ischemia. Moreover, the present invention relates to a composition comprising … parathyroid hormone-related peptide (PTHrP), preferably PTHrP (1-34) …”; [0131] “The term “surgical or interventional procedure” as used herein relates to a surgical and/or interventional procedure which is suitable to improve organ function, to improve blood flow in defect organ tissue and/or to induce revascularization as thrombolysis (either systemic or local via catheter delivery), balloon angioplasty, stenting, ...”; [0139] “In a preferred embodiment of the invention the pharmaceutical composition of the present invention is to be administered before a surgical or interventional procedure.”). Franz also teaches the use of PTHrP (1-34) in treating ischemia, a cardiomyocyte reperfusion injury, when administered before, during or after a surgical or interventional measure ([0143] “Moreover, as described above, the pharmaceutical composition of the present invention, after it has been administered before, during or after a surgical or interventional measure is further administered for the period of time as described above so as to preferably prevent and/or treat ischemia.”).
It would have been obvious to one of ordinary skill in the art to use the method of treatment as described in ‘330 because the claims teach a method comprising administering abaloparatide, which was show to be used to treat tissues suffering from myocardial ischemia while Kaye teaches that that cardiac events after lumbar spinal fusion carry a high mortality rate. One of ordinary skill in the art would be motivated to find a composition to treat myocardial infarction due to the teaching of Kaye showing that that cardiac events (including myocardial infarction) after lumbar spinal fusion carry a high mortality rate The claimed invention is drawn to the use of abaloparatide. One of ordinary skill in the art before the effective filing date of the claimed invention would be motivated with reasonable expectation of success to use the method comprising administering abaloparatide of ‘330 to treat cardiomyocyte reperfusion injury as described in Franz due to both ‘330 and Franz teaching abaloparatide, and Franz teaching that abaloparatide can be used to treat cardiomyocyte reperfusion injury.
Regarding instant claim 8, ‘330 teaches a method of treating a subject having a spinal fusion surgery, the method comprising the administration is daily subcutaneous administration of 80 μg abaloparatide. (See claim 1)
Regarding instant claim 9, ‘330 teaches a method of treating a subject having a spinal fusion surgery, the method comprising the administration is daily subcutaneous administration of 80 μg abaloparatide. (See claim 1)
Regarding instant claim 10, ‘330 teaches a method of treating a subject having a spinal fusion surgery being administered via subcutaneous injection. (See claim 1)
‘330 does not teach the abaloparatide being administered using a transdermal microneedle patch in an amount from about 100 µg to about 300 µg.
Franz teaches a composition comprising abaloparatide being able to be transdermally administered ([0117] “The administration of the candidate agents of the present invention can be done in a variety of ways, including, but not limited to, … transdermally, …”).
Hattersley teaches preparation formulations for transdermal delivery of abaloparatide (col. 1, lines 66-67, “Provided herein in certain embodiments are preparation formulations for use in transdermal delivery of abaloparatide …”).
Hattersley also shows an example where a transdermal microneedle patch is prepared with 100µg of abaloparatide (col. 29, lines 50-58, “Pharmacokinetics of Abaloparatide Delivered Via Transdermal Patch Prepared Using Preparation Formulations with PBS Buffer in Human -The pharmacokinetic profile of transdermal administration of abaloparatide and the abaloparatide-SC treatment was assessed in healthy postmenopausal women from 50 to 80 years of age, inclusive. Subjects received a single application of a transdermal patch (100 μg abaloparatide) …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify ‘330’s teachings with Hattersley’s teachings because both ‘330 and Hattersley teach a method of administering abaloparatide to treat a patient population. One of ordinary skill in the art before the effective filing date of the claimed invention would be motivated with reasonable expectation of success to use the method comprising administering abaloparatide of ‘330 to treat cardiomyocyte reperfusion injury using a transdermal microneedle patch as described in Franz and Hattersley due to both ‘330 and Franz teaching abaloparatide, and Franz teaching that abaloparatide can be administered transdermally.
One of ordinary skill in the art before the effective filing date of the claimed invention would have a reasonable expectation of success because both references teach methods of using abaloparatide and the teachings of Hattersley provide a known method of administering a known peptide.
Claims 1 and 8-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 4, 7 and 10-12 of U.S. Patent No. 11782041, in view of Franz (US 2009/0297470 A1, cited in the IDS filed 5 January 2024) and Hattersley et al., hereafter “Hattersley” (US 10,568,937 B2). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the same peptide but the instant application is a method of using.
Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to different methods of using the same peptide.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding instant claim 1, ‘041 teaches a formulated abaloparatide drug product and a method of treating a subject thereof comprising administering to the subject in need thereof the formulated abaloparatide drug product. (See claims 1, 7 and 10-12).
‘041 does not teach the abaloparatide being administered in a method for treating cardiomyocyte reperfusion injury before, during or after performing reperfusion.
Franz teaches a method of using parathyroid hormone-related peptide (PTHrP), preferably PTHrP (1-34), another name for abaloparatide, to repair tissues suffering from ischemia, specifically ischemic myocardial events, before performing reperfusion (i.e., a surgical or interventional procedure) ([0002] “Accordingly, the uses and methods of the present invention are preferably suitable for the … treatment of ischemia. Moreover, the present invention relates to a composition comprising … parathyroid hormone-related peptide (PTHrP), preferably PTHrP (1-34) …”; [0131] “The term “surgical or interventional procedure” as used herein relates to a surgical and/or interventional procedure which is suitable to improve organ function, to improve blood flow in defect organ tissue and/or to induce revascularization as thrombolysis (either systemic or local via catheter delivery), balloon angioplasty, stenting, ...”; [0139] “In a preferred embodiment of the invention the pharmaceutical composition of the present invention is to be administered before a surgical or interventional procedure.”). Franz also teaches the use of PTHrP (1-34) in treating ischemia, a cardiomyocyte reperfusion injury, when administered before, during or after a surgical or interventional measure ([0143] “Moreover, as described above, the pharmaceutical composition of the present invention, after it has been administered before, during or after a surgical or interventional measure is further administered for the period of time as described above so as to preferably prevent and/or treat ischemia.”).
It would have been obvious to one of ordinary skill in the art to use the method of treatment as described in ‘041 because the claims teach a formulated abaloparatide drug product, which was show to be used to treat tissues suffering from myocardial ischemia. The claimed invention is drawn to the use of abaloparatide. One of ordinary skill in the art before the effective filing date of the claimed invention would be motivated with reasonable expectation of success to use the method comprising administering abaloparatide of ‘041 to treat cardiomyocyte reperfusion injury as described in Franz due to both ‘041 and Franz teaching abaloparatide, and Franz teaching that abaloparatide can be used to treat cardiomyocyte reperfusion injury.
Regarding instant claim 8, ‘041 teaches a formulated abaloparatide drug product being administered subcutaneously in an amount of 80 μg abaloparatide. (See claims 4 and 10)
Regarding instant claim 9, ‘041 teaches a formulated abaloparatide drug product being administered subcutaneously in an amount of 80 μg abaloparatide. (See claims 4 and 10)
Regarding instant claim 10, ‘041 teaches a formulated abaloparatide drug product being administered subcutaneously in an amount of 80 μg abaloparatide. (See claims 4 and 10)
‘041 does not teach the abaloparatide being administered using a transdermal microneedle patch in an amount from about 100 µg to about 300 µg.
Franz teaches a composition comprising abaloparatide being able to be transdermally administered ([0117] “The administration of the candidate agents of the present invention can be done in a variety of ways, including, but not limited to, … transdermally, …”).
Hattersley teaches preparation formulations for transdermal delivery of abaloparatide (col. 1, lines 66-67, “Provided herein in certain embodiments are preparation formulations for use in transdermal delivery of abaloparatide …”).
Hattersley also shows an example where a transdermal microneedle patch is prepared with 100µg of abaloparatide (col. 29, lines 50-58, “Pharmacokinetics of Abaloparatide Delivered Via Transdermal Patch Prepared Using Preparation Formulations with PBS Buffer in Human -The pharmacokinetic profile of transdermal administration of abaloparatide and the abaloparatide-SC treatment was assessed in healthy postmenopausal women from 50 to 80 years of age, inclusive. Subjects received a single application of a transdermal patch (100 μg abaloparatide) …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify ‘041’s teachings with Hattersley’s teachings because both ‘041 and Hattersley teach a method of administering abaloparatide to treat a patient population. One of ordinary skill in the art before the effective filing date of the claimed invention would be motivated with reasonable expectation of success to use the method comprising administering abaloparatide of ‘041 to treat cardiomyocyte reperfusion injury using a transdermal microneedle patch as described in Franz and Hattersley due to both ‘041 and Franz teaching abaloparatide, and Franz teaching that abaloparatide can be administered transdermally.
One of ordinary skill in the art before the effective filing date of the claimed invention would have a reasonable expectation of success because both references teach methods of using abaloparatide and the teachings of Hattersley provide a known method of administering a known peptide.
Claims 1 and 8-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 12-13 of U.S. Patent No. 10980862, in view of Franz (US 2009/0297470 A1, cited in the IDS filed 5 January 2024) and Tankó et al., hereafter “Tankó” (“Relationship Between Osteoporosis and Cardiovascular Disease in Postmenopausal Women”, Journal of Bone and Mineral Research, Volume 20, Issue 11, 1 November 2005, Pages 1912–1920, https://doi.org/10.1359/JBMR.050711). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the same peptide but the instant application is a method of using.
Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to different methods of using the same peptide.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding instant claim 1, ‘862 teaches a method of treating osteoporosis in a human subject comprising administering a therapeutically effective amount of abaloparatide subcutaneously. (See claims 1 and 12-13).
‘862 does not teach the abaloparatide being administered in a method for treating cardiomyocyte reperfusion injury before, during or after performing reperfusion.
Tankó teaches that women with osteoporosis are at an increased risk for cardiovascular events, including myocardial infarction (pg. 1912, “Postmenopausal women with osteoporosis are at an increased risk for cardiovascular events… ”; pg. 1914 “Information on cardiovascular events was collected by asking participants at each visit if they had a myocardial infarction…”).
Franz teaches a method of using parathyroid hormone-related peptide (PTHrP), preferably PTHrP (1-34), another name for abaloparatide, to repair tissues suffering from ischemia, specifically ischemic myocardial events, before performing reperfusion (i.e., a surgical or interventional procedure) ([0002] “Accordingly, the uses and methods of the present invention are preferably suitable for the … treatment of ischemia. Moreover, the present invention relates to a composition comprising … parathyroid hormone-related peptide (PTHrP), preferably PTHrP (1-34) …”; [0131] “The term “surgical or interventional procedure” as used herein relates to a surgical and/or interventional procedure which is suitable to improve organ function, to improve blood flow in defect organ tissue and/or to induce revascularization as thrombolysis (either systemic or local via catheter delivery), balloon angioplasty, stenting, ...”; [0139] “In a preferred embodiment of the invention the pharmaceutical composition of the present invention is to be administered before a surgical or interventional procedure.”). Franz also teaches the use of PTHrP (1-34) in treating ischemia, a cardiomyocyte reperfusion injury, when administered before, during or after a surgical or interventional measure ([0143] “Moreover, as described above, the pharmaceutical composition of the present invention, after it has been administered before, during or after a surgical or interventional measure is further administered for the period of time as described above so as to preferably prevent and/or treat ischemia.”).
It would have been obvious to one of ordinary skill in the art to use the method of treatment as described in ‘862 because the claims teach a method of treating an subject with osteoporosis and Tankó teaches that osteoperosis and cardiovascular events, including myocardial infarction, are correlated. One of ordinary skill in the art would be motivated to find a composition to treat myocardial infarction due to the teaching of Tankó showing that spinal fractures and cardiovascular events, including myocardial infarction, are correlated. The claimed invention is drawn to the use of abaloparatide. One of ordinary skill in the art before the effective filing date of the claimed invention would be motivated with reasonable expectation of success to use the method comprising administering abaloparatide of ‘862 to treat cardiomyocyte reperfusion injury as described in Franz due to both ‘862 and Franz teaching abaloparatide, and Franz teaching that abaloparatide can be used to treat cardiomyocyte reperfusion injury and Tankó teaching a relationship between osteoporosis and myocardial infarction.
Regarding instant claim 8, ‘862 teaches a method of treating osteoporosis in a human subject comprising administering a therapeutically effective amount of abaloparatide subcutaneously in a dosage amounting to 80 μg. (See claims 1 and 12-13).
Regarding instant claim 9, ‘086 teaches a method of treating osteoporosis in a human subject comprising administering a therapeutically effective amount of abaloparatide subcutaneously in a dosage amounting to 80 μg. (See claims 1 and 12-13).
Regarding instant claim 10, ‘086 teaches a method of treating osteoporosis in a human subject comprising administering a therapeutically effective amount of abaloparatide with a transdermal patch comprising a plurality of microprojections coated at least in part by a formulation comprising about 300 μg abaloparatide and an excipient comprising one or more Zn2+ salts. (See claim 1)
Claims 1 and 8-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11-14 and 18-20 of copending Application No. 18/346,426 (reference application), in view of Franz (US 2009/0297470 A1, cited in the IDS filed 5 January 2024), Chapman et al., hereafter “Chapman” (“Long-Term Outcomes in Patients With Type 2 Myocardial Infarction and Myocardial Injury”. November 17, 2017. https://doi.org/10.1161/CIRCULATIONAHA.117.031806) and Hattersley et al., hereafter “Hattersley” (US 10,568,937 B2).
Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to different methods of using the same peptide.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to different methods of using the same peptide.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding instant claim 1, ‘426 teaches a method of accelerating long bone fracture healing in a subject in need thereof, the method comprising subcutaneously administering a therapeutically effective amount of abaloparatide. (See claims 1, 11-12 and 18-20).
‘426 does not teach the abaloparatide being administered in a method for treating cardiomyocyte reperfusion injury before, during or after performing reperfusion.
Chapman teaches that patients with myocardial infarction typically have long bone fracture (pg. 1238, “The most common diagnoses in patients with type 2 myocardial infarction or myocardial injury were … or long bone fracture …”).
Franz teaches a method of using parathyroid hormone-related peptide (PTHrP), preferably PTHrP (1-34), another name for abaloparatide, to repair tissues suffering from ischemia, specifically ischemic myocardial events, before performing reperfusion (i.e., a surgical or interventional procedure) ([0002] “Accordingly, the uses and methods of the present invention are preferably suitable for the … treatment of ischemia. Moreover, the present invention relates to a composition comprising … parathyroid hormone-related peptide (PTHrP), preferably PTHrP (1-34) …”; [0131] “The term “surgical or interventional procedure” as used herein relates to a surgical and/or interventional procedure which is suitable to improve organ function, to improve blood flow in defect organ tissue and/or to induce revascularization as thrombolysis (either systemic or local via catheter delivery), balloon angioplasty, stenting, ...”; [0139] “In a preferred embodiment of the invention the pharmaceutical composition of the present invention is to be administered before a surgical or interventional procedure.”). Franz also teaches the use of PTHrP (1-34) in treating ischemia, a cardiomyocyte reperfusion injury, when administered before, during or after a surgical or interventional measure ([0143] “Moreover, as described above, the pharmaceutical composition of the present invention, after it has been administered before, during or after a surgical or interventional measure is further administered for the period of time as described above so as to preferably prevent and/or treat ischemia.”).
It would have been obvious to one of ordinary skill in the art to use the method of treatment as described in ‘426 because the claims teach a formulated abaloparatide drug product, due to Chapman teaching that patients with myocardial infarction typically have long bone fracture which was show to be used to treat tissues suffering from myocardial ischemia. The claimed invention is drawn to the use of abaloparatide. One of ordinary skill in the art before the effective filing date of the claimed invention would be motivated with reasonable expectation of success to use the method comprising administering abaloparatide of ‘426 to treat cardiomyocyte reperfusion injury as described in Franz due to both ‘086 and Franz teaching abaloparatide, and Franz teaching that abaloparatide can be used to treat cardiomyocyte reperfusion injury, and Chapman teaching that patients with myocardial infarction typically have long bone fracture which was show to be used to treat tissues suffering from myocardial ischemia.
Regarding instant claim 8, ‘426 teaches a method of accelerating long bone fracture healing in a subject in need thereof, the method comprising subcutaneously administering a therapeutically effective amount of abaloparatide in an amount of 20-100 µg and 80 µg. (See claims 11-12 and 19)
Regarding instant claim 9, ‘426 teaches a method of accelerating long bone fracture healing in a subject in need thereof, the method comprising subcutaneously administering a therapeutically effective amount of abaloparatide in an amount of 20-100 µg and 80 µg. (See claims 11-12 and 19)
Regarding instant claim 10, ‘426 teaches a method of accelerating long bone fracture healing in a subject in need thereof, the method comprising daily transdermal administration of from about 100 to about 400 pg of abaloparatide. (See claims 13-14 and 20)
‘426 does not teach the transdermal administration being done via a transdermal microneedle patch.
Hattersley teaches preparation formulations for transdermal delivery of abaloparatide (col. 1, lines 66-67, “Provided herein in certain embodiments are preparation formulations for use in transdermal delivery of abaloparatide …”).
Hattersley also shows an example where a transdermal microneedle patch is prepared with 100µg of abaloparatide (col. 29, lines 50-58, “Pharmacokinetics of Abaloparatide Delivered Via Transdermal Patch Prepared Using Preparation Formulations with PBS Buffer in Human -The pharmacokinetic profile of transdermal administration of abaloparatide and the abaloparatide-SC treatment was assessed in healthy postmenopausal women from 50 to 80 years of age, inclusive. Subjects received a single application of a transdermal patch (100 μg abaloparatide) …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify ‘426’s teachings with Hattersley’s teachings because both ‘426 and Hattersley teach a method of administering abaloparatide to treat a patient population. One of ordinary skill in the art before the effective filing date of the claimed invention would be motivated with reasonable expectation of success to use the method comprising administering abaloparatide of ‘426 to treat cardiomyocyte reperfusion injury using a transdermal microneedle patch as described in Franz and Hattersley due to both ‘426 and Franz teaching abaloparatide, and Franz teaching that abaloparatide can be administered transdermally.
One of ordinary skill in the art before the effective filing date of the claimed invention would have a reasonable expectation of success because both references teach methods of using abaloparatide and the teachings of Hattersley provide a known method of administering a known peptide.
Status of Claims
Claims 1-8 and 12 are rejected under 35 U.S.C. 102(a)(2). Claim 8-11 and 13-15 are rejected under 35 U.S.C. 103. Claims 1 and 8-10 are rejected on the ground of nonstatutory double patenting.
No claims are allowed.
Conclusion
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/Daliyah M. Brown/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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