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 .
Sequence Compliance
Claims 1, 7, 9 and 18 refer to sequences that have corresponding sequence identifiers that must be recited in the claims. ST.26 requires that amino acid sequences, as used in §§ 1.832 through 1.835, encompass:
(1) An unbranched sequence or linear region of a branched sequence containing 4 or more specifically defined amino acids, wherein the amino acids form a single peptide backbone.
(c) Where the description or claims of a patent application discuss a sequence that is set forth in the "Sequence Listing XML" in accordance with paragraph (a) of this section, reference must be made to the sequence by use of the sequence identifier, preceded by "SEQ ID NO:" or the like in the text of the description or claims, even if the sequence is also embedded in the text of the description or claims of the patent application.
Appropriate correction is required.
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.
Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Due Larsen et al. (US2019/0365865) in view of Soula et al. (US10,646,551), as evidenced by U.S. Pharmacopeia (FDA, Mannitol Label 2019).
Due Larsen teaches compounds having dual agonist activity at the GLP-1 (glucagon-like-peptide 1) and GLP-2 (glucagon-like peptide 2) receptors, and a pharmaceutical composition containing the compound or a pharmaceutically acceptable salt or solvate thereof in admixture with a pharmaceutically acceptable carrier, an excipient or a vehicle (abstract). This reference teaches that these dual agonists are of the following formula:
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(Claim 1). This reference further teaches a specific embodiment, in which the dual agonist is
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(Claim 3). This reference further teaches that and the pH of the solution was adjusted to pH 6, 7, 7.5 or 9 using either HCl or NaOH and that the final peptide concentration was 0.2 mg/ml, for the similar test peptide Hy-H[Aib]EGTFSSELATILD[K([17-carboxy-heptadecanoyl]- isoGlu)]KAARDFIAWLIEHKITD-OH [0673, 0691]. This reference further teaches a variety of buffers that provide an optimal pH of 7, with a stability rating of A [tables 3 and 4, 0690-0694]. This reference also teaches that the pharmaceutical composition may be formulated as a liquid suitable for administration by injection or infusion [0206].
The difference between the prior art and the instant claims is that the prior art does not teach a phenol and/or m-cresol preservative with Tris buffer.
Soula teaches insulin compositions that are suitable for injection, having a pH of 7.4±0.4, a preservative of either m-cresol and/or phenol and tris buffer (Claims 1, 6). Specifically, this reference teaches the commercial insulin preparation of glulisine, which comprises m-cresol, NaCl and Tris buffer with the peptide (Col. 55, lines 24-50). This reference further teaches that mannitol and NaCl are used as tonicity agents (Col. 26, lines 63-67).
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to have taken the formulation of Due Larsen and used the m-cresol and/or phenol and tris combination taught by Soula for similar peptides. One would be motivated to do so because this preservative and buffer combination is known in the art as a commercial formulation for insulin peptides, which have similar properties to the GLP-1 peptide of Due Larsen, and both references teach the same pH and the same routes of administration. As such, there is a reasonable expectation of success that the combination of m-cresol and/or phenol will be a stable and effective formulation for delivering the GLP1/GLP-2 dual agonist of Due Larsen.
This meets the limitations of claims 1 and 7-9 because Due Larsen teaches the same peptide formulas of these claims, and Soula renders it obvious to add the phenol and/or cresol with Tris to the dual agonists. Claim 2 is met because Due Larsen and Soula both teach injections which are parenteral, and need to match the osmotic pressure of the blood stream. Furthermore, Soula teaches various tonicity agents, including mannitol and NaCl. Claims 3 and 4 are met because Soula teaches m-cresol and phenol. Claim 6 is met because both references teach a pH of about 7, and Due Larsen teaches that the compounds were stable at pH 7, with a rating of A for stability in a variety of different buffers, rendering them functionally equivalent and obvious to substitute. Claims 12 and 13 are met because Soula teaches adding mannitol as a tonicity agent. As to claim 19, D-mannitol is commonly referred to as mannitol, even though D and L mannitol differ in chirality; however, in the context of pharmaceutical formulations, it is widely known that mannitol generally refers to D-mannitol and they are used interchangeably in clinical, specifically intravenous applications, as evidenced by the FDA label, which states that “Mannitol, USP is chemically designated D-mannitol” (US Pharmacopia, Mannitol, 2019). As such, the interchangeability of the terminology and its use renders claim 19 obvious. Claim 15 is met because Soula teaches NaCl as a tonicity agent. Claim 18 is met because Due Larsen teaches salts formed with hydrochloride acid, which would yield a chloride salt [0591].
As to the concentrations of claims 5, 10, 11, 14, 16, 17 and 20, these would be obvious to optimized through routine experimentation. MPEP 2144.05 states: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").[AltContent: rect]
As such, these concentrations would be obvious to optimize in the formulation, absent evidence of the concentration being critical. Here, there is no such evidence of the criticality of the claimed ranges of any of these concentrations, based on the data of the specification.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 12,576,025 in view of Soula et al.
Claim 1 of ‘025 teaches An isotonic parenteral pharmaceutical composition, comprising: a. at least about 1 mg/mL of one or more GLP-1/GLP-2 dual agonist, wherein the one or more GLP-1/GLP-2 dual agonist is Hy-H[Aib]EGSFTSELATILD[K([17-carboxy-heptadecanoyl]-isoGlu)QAARDFIAWLIQHKITD-OH (CPD10H) (SEQ ID NO: 1) or any pharmaceutically acceptable salt thereof with about 5 mM to about 50 mM of phosphate buffer component, about 190 mM to about 240 mM of mannitol, wherein said composition further comprises a solvent, and wherein said composition has a pH of about pH 6.0 to about pH 8.2.
The difference between ‘025 and the instant claims is that ‘025 does not teach adding phenol and/or m-cresol and Tris to the composition.
Soula teaches insulin compositions that are suitable for injection, have a pH of 7.4±0.4, a preservative of either m-cresol and/or phenol and tris buffer (Claims 1, 6). Specifically, this reference teaches the commercial insulin preparation of glulisine, which comprises m-cresol, NaCl and Tris buffer with the peptide (Col. 55, lines 24-50). This reference further teaches tonicity agents NaCl and mannitol (Col. 26, lines 63-67).
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to have taken the formulation of ‘025 and used the m-cresol and/or phenol with tris combination taught by Soula. One would be motivated to do so because it is commercial formulation for insulin peptides, which have similar properties to the GLP-1 peptide of ‘025. As such, there is a reasonable expectation of success that this combination of m-cresol and/or phenol with be a stable and effective formulation for delivering the GLP1/GLP-2 dual agonist of ‘025.
This meets the limitations of claims 1 and 7-9 because ‘025 teaches the same dual agonist peptides formulas, and Soula renders it obvious to add the phenol and/or cresol preservative with Tris to the compositions of the claims. Claim 2 is met because claim 8 of ‘025 teaches an isotonic parenteral formulation. Furthermore, Soula teaches various tonicity agents, including mannitol and NaCl. Claims 3 and 4 are met because Soula teaches m-cresol and phenol. Claim 6 is met because claim 1 of ‘025 teaches a pH of about 6.0-8.2. Claims 12, 13 and 19 are met because claims 7 and 22 teach D-mannitol. Claims 15 and 18 are met because claims 8 and 9 of ‘025 teach chloride salts. Claims 9 and 10 of ‘025 teach s concentrations of the dual agonist and mannitol within the same ranges, meeting claims 10, 11 and 14.
As to the concentrations of claims 5, 16, 17 and 20, claims these would be obvious to optimized through routine experimentation, as discussed above in MPEP 2144.05.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,905,745 in view of Soula et al. and evidenced by US Pharmacopeia.
Claim 1 of ‘857 teaches the formula:
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and claim 3 teaches
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. Claims 4 and 5 teach their pharmaceutical salts.
The difference between the prior art and the instant claims is that the prior art does not teach a phenol and/ m-cresol preservative with Tris buffer.
Soula teaches insulin compositions that are suitable for injection, have a pH of pH of 7.4±0.4, a preservative of either m-cresol and/or phenol and tris buffer (Claims 1, 6). Specifically, this reference teaches the commercial insulin preparation of glulisine, which comprises m-cresol, NaCl and Tris buffer with the peptide (Col. 55, lines 24-50). This reference further teaches tonicity agents NaCl and mannitol (Col. 26, lines 63-67).
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to have taken the formulation of ‘745 and used the m-cresol and/or phenol with tris combination taught by Soula. One would be motivated to do so because it is commercial formulation for insulin peptides, which have similar properties to the GLP-1 peptide of ‘745. As such, there is a reasonable expectation of success that this combination of m-cresol and/or phenol with be a stable and effective formulation for delivering the GLP1/GLP-2 dual agonist of ‘745.
This meets the limitations of claims 1 and 7-9 because ‘745 teaches the same exact peptide formulas and Soula renders it obvious to add the phenol and/or cresol with Tris to the peptides of the claims. Claim 2 is met because Soula teaches injections which are parenteral, and need to match the osmotic pressure of the blood stream. Furthermore, Soula teaches various tonicity agents, including mannitol and NaCl.
Claims 3 and 4 are met because Soula teaches m-cresol and phenol. Claim 6 is met because both reference teach a pH of about 7, and Soula teaches peptide formulations having a pH of 7.4±0.4 with a preservative of either m-cresol and/or phenol and tris buffer. Claims 12, 13 and 19 are met because Soula teaches adding mannitol as a tonicity agent, which refers to D-mannitol, as they are used interchangeably in clinical applications. Claim 15 is met because Soula teaches adding NaCl. Claim 18 is met because Soula teaches various embodiments of chloride salt (e.g., compound 10, Col. 37).
As to the concentrations of claims 5, 10, 11, 14, 16, 17 and 20, these would be obvious to optimized through routine experimentation as discussed above in MPEP 2144.05.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-45 of U.S. Patent No. 11,395,847 in view of Soula et al. and evidenced by US Pharmacopeia.
Claim 42 of ‘847 teaches Hy-H[Aib]EGTFSSELATILD[K([17-carboxy-hepta- decanoyl]-isoGlu)]QAARDFIAWLIQHKITD-OH, and claim 9 teaches a pharmaceutical salt composition of said peptide.
The difference between ‘847 are the instant claims that that ‘847 does not teach adding phenol and/or m-cresol with Tris buffer to the composition.
Soula teaches insulin compositions that are suitable for injection, have a pH of pH of 7.4±0.4, a preservative of either m-cresol and/or phenol and tris buffer (Claims 1, 6). Specifically, this reference teaches the commercial insulin preparation of glulisine, which comprises m-cresol, NaCl and Tris buffer with the peptide (Col. 55, lines 24-50). This reference further teaches tonicity agents NaCl and mannitol (Col. 26, lines 63-67).
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to have taken the formulation of ‘847 and used the m-cresol and/or phenol with tris combination taught by Soula. One would be motivated to do so because it is commercial formulation for insulin peptides, which have similar properties to the GLP-1 peptide of ‘847. As such, there is a reasonable expectation of success that this combination of m-cresol and/or phenol with be a stable and effective formulation for delivering the GLP1/GLP-2 dual agonist of ‘847.
This meets the limitations of claims 1 and 7-9 because ‘847 teaches the same exact peptide formulas and Soula renders it obvious to add the phenol and/or cresol with Tris to the peptides of the claims. Claim 2 is met because Soula teaches injections which are parenteral, and need to match the osmotic pressure of the blood stream. Furthermore, Soula teaches various tonicity agents, including mannitol and NaCl.
Claims 3 and 4 are met because Soula teaches m-cresol and phenol. Claim 6 is met because both reference teach a pH of about 7, and Soula teaches peptide formulation having a pH of 7.4±0.4 with a preservative of either m-cresol and/or phenol and tris buffer. Claims 12, 13 and 19 are met because Soula teaches adding mannitol as a tonicity agent, which refers to D-mannitol, as they are used interchangeably in clinical applications. Claim 15 is met because Soula teaches adding NaCl. Claim 18 is met because Soula teaches various embodiments of chloride salts (e.g., compound 10, Col. 37).
As to the concentrations of claims 5, 10, 11, 14, 16, 17 and 20, these would be obvious to optimized through routine experimentation, as discussed above in MPEP 2144.05.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/039,992 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 teaches the same exact peptide formulation of instant claims 1, but with a phosphate buffer, rather that Tris buffer.
The difference between ‘992 and the instant claims is that ‘992 does not teach a Tris buffer.
The teachings of Soula have been described supra.
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to have taken the formulation of ‘992 and used the m-cresol and/or phenol of ‘992 with the tris combination taught by Soula. One would be motivated to do so because it is commercial formulation for insulin peptides, which have similar properties to the GLP-1 peptide of ‘992. As such, there is a reasonable expectation of success that this combination of m-cresol and/or phenol with be a stable and effective formulation for delivering the GLP1/GLP-2 dual agonist of ‘992.
This meets the limitations of claims 1 and 7-9 because ‘992 teaches the same formulations of peptides with phenol and/or m-cresol, and Soula renders it obvious to add or substitute Tris buffer. The remaining depend claims 2-20 are identical to the instant claims, expect that claim 6 is drawn to a phosphate instead of Tris buffer. As such, claims 2-20 are rendered obvious by ‘992 and Soula.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 18/688,026 (reference application) in view of Soula and evidenced by US Pharmacopeia. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 teaches:
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The difference between the claims of ‘026 and the instant claims is that ‘026 does not teach phenol and/or cresol with Tris in the composition.
The teachings of Soula have been described supra.
This meets the limitations of claims 1 and 7-9 because ‘026 teaches the same exact peptide formulas and Soula renders it obvious to add the phenol and/or cresol with Tris to the peptides of the claims. Claim 2 is met because Soula teaches injections which are parenteral, and need to match the osmotic pressure of the blood stream. Furthermore, Soula teaches various tonicity agents, including mannitol and NaCl.
Claims 3 and 4 are met because Soula teaches m-cresol and phenol. Claim 6 is met because both reference teach a pH of about 7, and Soula teaches peptide formulation having a pH of 7.4±0.4 with a preservative of either m-cresol and/or phenol and tris buffer. Claims 12, 13 and 19 are met because Soula teaches adding mannitol as a tonicity agent, which refers to D-mannitol, as they are used interchangeably in clinical applications. Claim 15 is met because Soula teaches adding NaCl. Claim 18 is met because Soula teaches various embodiments of chloride salts (e.g., compound 10, Col. 37).
As to the concentrations of claims 5, 10, 11, 14, 16, 17 and 20, these would be obvious to optimized through routine experimentation, as discussed above in MPEP 2144.05.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18/275,195 (reference application) in view of Soula and evidenced by US Pharmacopeia. Although the claims at issue are not identical, they are not patentably distinct from each other because Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 teaches a general formula correspond to the dual agonist of claim 1, and claim 15 teaches:
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The difference between the claims of ‘195 and the instant claims is that ‘195 does not teach phenol and/or cresol with Tris in the composition.
The teachings of Soula have been described supra.
This meets the limitations of claims 1 and 7-9 because ‘195 teaches the same exact peptide formulas and Soula renders it obvious to add the phenol and/or cresol with Tris to the peptides of the claims. Claim 2 is met because Soula teaches injections which are parenteral, and need to match the osmotic pressure of the blood stream. Furthermore, Soula teaches various tonicity agents, including mannitol and NaCl.
Claims 3 and 4 are met because Soula teaches m-cresol and phenol. Claim 6 is met because both reference teach a pH of about 7, and Soula teaches peptide formulation having a pH of 7.4±0.4 with a preservative of either m-cresol and/or phenol and tris buffer. Claims 12, 13 and 19 are met because Soula teaches adding mannitol as a tonicity agent, which refers to D-mannitol, as they are used interchangeably in clinical applications. Claim 15 is met because Soula teaches adding NaCl. Claim 18 is met because Soula teaches various embodiments of chloride salts (e.g., compound 10, Col. 37).
As to the concentrations of claims 5, 10, 11, 14, 16, 17 and 20, these would be obvious to optimized through routine experimentation, as discussed above in MPEP 2144.05.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 18/037,795 (reference application) in view of Soula and evidenced by US Pharmacopeia. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 9, 10, 11 and 19 teaches the same peptides of the instant claims.
The difference between the claims of ‘795 and the instant claims is that ‘795 does not teach phenol and/or m-cresol with Tris in the composition.
The teachings of Soula have been described supra.
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to have taken the formulation of ‘795 and used the m-cresol and/or phenol with tris combination taught by Soula. One would be motivated to do so because it is commercial formulation for insulin peptides, which have similar properties to the GLP-1 peptide of ‘795. As such, there is a reasonable expectation of success that this combination of m-cresol and/or phenol with be a stable and effective formulation for delivering the GLP1/GLP-2 dual agonist of ‘795.
This meets the limitations of claims 1 and 7-9 because ‘795 teaches the same exact peptide formulas and Soula renders it obvious to add the phenol and/or cresol with Tris to the peptides of the claims. Claim 2 is met because Soula teaches injections which are parenteral, and need to match the osmotic pressure of the blood stream. Furthermore, Soula teaches various tonicity agents, including mannitol and NaCl.
Claims 3 and 4 are met because Soula teaches m-cresol and phenol. Claim 6 is met because both reference teach a pH of about 7, and Soula teaches peptide formulation having a pH of 7.4±0.4 with a preservative of either m-cresol and/or phenol and tris buffer. Claims 12, 13 and 19 are met because Soula teaches adding mannitol as a tonicity agent, which refers to D-mannitol, as they are used interchangeably in clinical applications. Claim 15 is met because Soula teaches adding NaCl. Claim 18 is met because Soula teaches various embodiments of chloride salts (e.g., compound 10, Col. 37).
As to the concentrations of claims 5, 10, 11, 14, 16, 17 and 20, these would be obvious to optimized through routine experimentation, as discussed above in MPEP 2144.05.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 7-9, 11-13, 15, 20, 22, 30-32, 37-42 of copending Application No. 19/236,746 (reference application) in view of Soula and evidenced by US Pharmacopeia. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 teaches the same peptides of the instant claims.
The difference between the claims of ‘746 and the instant claims is that ‘746 does not teach phenol and/or cresol with Tris in the composition.
The teachings of Soula have been described supra.
This meets the limitations of claims 1 and 7-9 because ‘746 teaches the same exact peptide formulas and Soula renders it obvious to add the phenol and/or cresol with Tris to the peptides of the claims. Claim 2 is met because Soula teaches injections which are parenteral, and need to match the osmotic pressure of the blood stream. Furthermore, Soula teaches various tonicity agents, including mannitol and NaCl.
Claims 3 and 4 are met because Soula teaches m-cresol and phenol. Claim 6 is met because both reference teach a pH of about 7, and Soula teaches peptide formulation having a pH of 7.4±0.4 with a preservative of either m-cresol and/or phenol and tris buffer. Claims 12, 13 and 19 are met because Soula teaches adding mannitol as a tonicity agent, which refers to D-mannitol, as they are used interchangeably in clinical applications. Claim 15 is met because Soula teaches adding NaCl. Claim 18 is met because Soula teaches various embodiments of chloride salts (e.g., compound 10, Col. 37).
As to the concentrations of claims 5, 10, 11, 14, 16, 17 and 20, these would be obvious to optimized through routine experimentation, as discussed above in MPEP 2144.05.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/JEANETTE M LIEB/Primary Examiner, Art Unit 1654
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