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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 6, 2026 has been entered.
Status of the Claims
Claims 1-38 were originally filed December 17, 2022.
The amendment received May 15, 2023 amended claims 1, 12, 14, 22, 23, 27, 29, 31, and 34-36; cancelled claims 4-6, 9-11, 13, 15, 16, 19-21, 26, 28, 30, 32, 33, 37, and 38; and added new claim 39.
The amendment received November 19, 2024 amended claim 1.
The amendment received December 5, 2025 changed the status identifiers only.
The amendment received May 4, 2026 amended claims 1, 3, 12, 14, 17, 18, 22-25, 27, 29, 31, 34, and 39 and canceled claims 7, 8, 35, and 36. Please note: claims 14, 23-25, 27, and 29 have improper status identifiers (i.e. “(Currently amended)” instead of “(Currently amended, Withdrawn)”).
The amendment received September 6, 2026 amended claims 22 and 23.
Claims 1-3, 12, 14, 17, 18, 22-25, 27, 29, 31, 34, and 39 are currently pending.
Claims 1, 3, 12, 17, 18, 22, 31, 34, and 39 are currently under consideration.
Election/Restrictions
Applicants elected, without traverse, a patient diagnosed with glioblastoma, primary glioblastoma, ST101 (SEQ ID NO: 2), IV infusion for a total of 30-360 minutes, administered weekly for at last three weeks, an antihistamine administered within about 48 hours of SEQ ID NO: 2/ST101 in the reply filed on December 5, 2025. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Please note: species requirements are not “optional”. Therefore, the “optional” election was not considered.
Claims 2, 14, 23-25, 27, and 29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim.
Priority
The present application is a 371 (National Stage) of PCT/US2021/038264 filed June 21, 2021 which claims the benefit of 63/172,560 filed April 8, 2021; 63/041,991 filed June 21, 2020; 63/041,990 filed June 21, 2020; 63/041,989 filed June 21, 2020; 63/041,988 filed June 21, 2020; and 63/041,986 filed June 21, 2020.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Withdrawn Rejections
The rejection of claim 22 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention (lack of antecedent basis) is withdrawn in view of the amendment received September 6, 2026.
The rejection of claims 1, 3, 12, 17, 18, 22, 31, 34, and 39 under 35 U.S.C. 103 as being obvious over Kappel et al. U.S. Patent Application Publication 2019/0201483 published July 4, 2019 (effective filing date of January 3, 2018); Greene et al. U.S. Patent Application Publication 2016/0046686 published February 18, 2016; and Le Joncur et al., May 8, 2019 (online), Vulnerability of invasive glioblastoma cells to lysosomal membrane destabilization, EMBO Molecular Medicine, 11: e9034 (21 pages) is withdrawn in view of the 37 CFR 1.130(a) declaration filed September 6, 2026 regarding Kappel et al. U.S. Patent Application Publication 2019/0201483.
Sequence Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising a sequence of SEQ ID NO: 1” requires only a 2mer of SEQ ID NO: 1, “comprising the sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with any N-/C-terminal additions or any 5’/3’ additions, “consisting of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 and the same length as SEQ ID NO: 1, and “selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3. Any claim requiring a specific percent identity, necessarily requires at least the recited percent identity.
Therefore, present independent claims 1 and 22 and all dependent claims require 100% identity to present SEQ ID NO: 2.
Maintained Rejections
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, 3, 12, 17, 18, 22, 31, 34, and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,525,100 in view of Greene et al. U.S. Patent Application Publication 2016/0046686 published February 18, 2016 and Le Joncur et al., May 8, 2019 (online), Vulnerability of invasive glioblastoma cells to lysosomal membrane destabilization, EMBO Molecular Medicine, 11: e9034 (21 pages).
U.S. Patent No. 10,525,100 claims methods of treating neoplastic cells with SEQ ID NO: 65 (present SEQ ID NO: 1; residues 1-22 of present SEQ ID NO: 2)
Greene et al. teach methods of treating glioblastoma in humans via administering ATF5 domains including leucine zippers (i.e. variants of ST101) and D amino acids fused to penetratin CPP RQIKIWFQNRRMKWKK wherein isoleucine is a conservative amino acid substitution for leucine (residues 23-38 of present SEQ ID NO: 2) and saline wherein the amount can be determined by the skilled artisan to be effective to treat glioblastoma and administered intravenously (please refer to the entire specification particularly the abstract; paragraphs 3-5, 6-10, 35-52, 59-62, 64, 65, 70-72, 76, 79, 83, 84). Greene et al. also teach coadministration with therapeutically effective agents including other anti-cancer agents (please refer to the entire specification particularly paragraph 85).
Le Joncour et al. teach methods of treating glioblastomas with antihistamines (please refer to the entire reference particularly the abstract; Introduction; Clemastine evokes glioma cell death; Discussion).
Generally, differences in concentration, temperature, or timing will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration, temperature, or timing 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." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) and 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."). See also 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.").
The claims would have been obvious because a particular known technique (intravenous administration to a human with glioblastoma, dosage, timing of administration, coadministration of anticancer therapeutics) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co v. Teleflex Inc., 82 USPQ2d1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over U.S. Patent No. 10,525,100 in view of Greene et al. and Le Joncur et al. for claims 1, 3, 12, 17, 18, 22, 31, 34, and 39 were considered but are not persuasive for the following reasons.
Applicants contend that U.S. Patent No. 10,525,100 does not teach the exact method of the present claims. Applicants contend that one of skill in the art would not optimize concentrations, timing, and similar parameters based on the cited references.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 10,525,100 in view of Greene et al. and Le Joncur et al. renders obvious the method of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
U.S. Patent 10,525,100 claims a method of promoting cytotoxicity in a neoplastic cell, the method comprising contacting the neoplastic cell with the ATF5 peptide according to claim 1 (i.e. VAEAREELERLEARLGQARGEL – SEQ ID NO: 65 residues 1-22 of present SEQ ID NO: 2).
U.S. Patent 10,525,100 claims a method of inhibiting proliferation of a promoting neoplastic cell, the method comprising contacting the neoplastic cell with the ATF5 peptide according to claim 1 (i.e. VAEAREELERLEARLGQARGEL – SEQ ID NO: 65 residues 1-22 of present SEQ ID NO: 2).
The claims of U.S. Patent 10,525,100 are not limited to an in vitro method. Thus, the methods claimed in U.S. Patent 10,525,100 also encompass in vivo methods.
Greene et al. and Le Joncur et al. provide the additional components of the presently claimed method (see above).
Greene et al. teach that an amount that is effective to treat the tumor and/or neoplastic cell in a subject to whom the pharmaceutical composition is administered. That amount may be readily determined by the skilled artisan. See paragraph 84.
Greene et al. teach 1 mg/kg (see paragraphs 98, 111).
Claims 1, 3, 12, 17, 18, 22, 31, 34, and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 9-16 of copending Application No. 18/985,452 in view of Greene et al. U.S. Patent Application Publication 2016/0046686 published February 18, 2016 and Le Joncur et al., May 8, 2019 (online), Vulnerability of invasive glioblastoma cells to lysosomal membrane destabilization, EMBO Molecular Medicine, 11: e9034 (21 pages).
Copending Application No. 18/985,452 claims methods of treating neoplastic cells with retroinverso and variants of SEQ ID NO: 53 which result in present SEQ ID NO: 1 (i.e. residues 1-22 of present SEQ ID NO: 2) and CPP of residues 23-38 of present SEQ ID NO: 2/ST101.
Greene et al. teach methods of treating glioblastoma in humans via administering ATF5 domains including leucine zippers (i.e. variants of ST101) and D amino acids fused to penetratin CPP RQIKIWFQNRRMKWKK wherein isoleucine is a conservative amino acid substitution for leucine (residues 23-38 of present SEQ ID NO: 2) and saline wherein the amount can be determined by the skilled artisan to be effective to treat glioblastoma and administered intravenously (please refer to the entire specification particularly the abstract; paragraphs 3-5, 6-10, 35-52, 59-62, 64, 65, 70-72, 76, 79, 83, 84). Greene et al. also teach coadministration with therapeutically effective agents including other anti-cancer agents (please refer to the entire specification particularly paragraph 85).
Le Joncour et al. teach methods of treating glioblastomas with antihistamines (please refer to the entire reference particularly the abstract; Introduction; Clemastine evokes glioma cell death; Discussion).
Generally, differences in concentration, temperature, or timing will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration, temperature, or timing 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." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) and 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."). See also 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.").
The claims would have been obvious because a particular known technique (intravenous administration to a human with glioblastoma, dosage, timing of administration, coadministration of anticancer therapeutics) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co v. Teleflex Inc., 82 USPQ2d1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over copending Application No. 18/985,452 in view of Greene et al. and Le Joncur et al. for claims 1, 3, 12, 17, 18, 22, 31, 34, and 39 were considered but are not persuasive for the following reasons.
Applicants contend that copending Application No. 18/985,452 only claims L-amino acids.
Applicants’ arguments are not convincing since the claimed invention of copending Application No. 18/985,452 in view of Greene et al. and Le Joncur et al. renders obvious the method of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
Greene et al. teach methods of treating glioblastoma in humans via administering ATF5 domains including leucine zippers (i.e. variants of ST101) and D amino acids fused to penetratin CPP RQIKIWFQNRRMKWKK wherein isoleucine is a conservative amino acid substitution for leucine (residues 23-38 of present SEQ ID NO: 2) and saline wherein the amount can be determined by the skilled artisan to be effective to treat glioblastoma and administered intravenously (please refer to the entire specification particularly the abstract; paragraphs 3-5, 6-10, 35-52, 59-62, 64, 65, 70-72, 76, 79, 83, 84). Greene et al. also teach coadministration with therapeutically effective agents including other anti-cancer agents (please refer to the entire specification particularly paragraph 85).
Furthermore, it is common knowledge in the prior art that utilization of D amino acids can provide stability to therapeutic peptides (references will be provided upon request).
Copending Application No. 18/985,452 claims a method of promoting cytotoxicity in a neoplastic cell, the method comprising contacting the neoplastic cell with the ATF5 peptide according to claim 1 (i.e. VAEAREELERLEARLGQARGEL – SEQ ID NO: 61 residues 1-22 of present SEQ ID NO: 2).
Copending Application No. 18/985,452 claims a method of inhibiting proliferation of a neoplastic cell, the method comprising contacting the neoplastic cell with the ATF5 peptide according to claim 1 (i.e. VAEAREELERLEARLGQARGEL – SEQ ID NO: 61 residues 1-22 of present SEQ ID NO: 2).
The claims of copending Application No. 18/985,452 are not limited to an in vitro method. Thus, the methods claimed in copending Application No. 18/985,452 also encompass in vivo methods.
Greene et al. and Le Joncur et al. provide the additional components of the presently claimed method (see above).
Greene et al. teach that an amount that is effective to treat the tumor and/or neoplastic cell in a subject to whom the pharmaceutical composition is administered. That amount may be readily determined by the skilled artisan. See paragraph 84.
Greene et al. teach 1 mg/kg (see paragraphs 98, 111).
Claims 1, 3, 12, 17, 18, 22, 31, 34, and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 5, 13, 15, 17, 22-28, and 33 of copending Application No. 19/118,719 in view of Greene et al. U.S. Patent Application Publication 2016/0046686 published February 18, 2016 and Le Joncur et al., May 8, 2019 (online), Vulnerability of invasive glioblastoma cells to lysosomal membrane destabilization, EMBO Molecular Medicine, 11: e9034 (21 pages).
Copending Application No. 19/118,719 claims a method of inhibiting growth of a solid tumor in a subject via administering with SEQ ID NO: 2 (100% identity and the same length as present SEQ ID NO: 2) at 500 mg wherein the solid tumor is a melanoma, carcinoma, sarcoma, LA/MBC, GBM, or CRPC and administration is intravenously.
Greene et al. teach methods of treating glioblastoma in humans via administering ATF5 domains including leucine zippers (i.e. variants of ST101) and D amino acids fused to penetratin CPP RQIKIWFQNRRMKWKK wherein isoleucine is a conservative amino acid substitution for leucine (residues 23-38 of present SEQ ID NO: 2) and saline wherein the amount can be determined by the skilled artisan to be effective to treat glioblastoma and administered intravenously (please refer to the entire specification particularly the abstract; paragraphs 3-5, 6-10, 35-52, 59-62, 64, 65, 70-72, 76, 79, 83, 84). Greene et al. also teach coadministration with therapeutically effective agents including other anti-cancer agents (please refer to the entire specification particularly paragraph 85).
Le Joncour et al. teach methods of treating glioblastomas with antihistamines (please refer to the entire reference particularly the abstract; Introduction; Clemastine evokes glioma cell death; Discussion).
Generally, differences in concentration, temperature, or timing will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration, temperature, or timing 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." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) and 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."). See also 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.").
The claims would have been obvious because a particular known technique (intravenous administration to a human, dosage, timing of administration, coadministration of anticancer therapeutics) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co v. Teleflex Inc., 82 USPQ2d1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over copending Application No. 19/118,719 in view of Greene et al. and Le Joncur et al. for claims 1, 3, 12, 17, 18, 22, 31, 34, and 39 were considered but are not persuasive for the following reasons.
Applicants contend that since copending Application No. 19/118,719 claims a combination therapy, that the provisional double patenting rejection should be withdrawn.
Applicants’ arguments are not convincing since the claimed invention of copending Application No. 19/118,719 in view of Greene et al. and Le Joncur et al. renders obvious the method of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
The present claims have open comprising language and are not limited to administration of SEQ ID NO: 2 alone. Furthermore, present claim 17 refers to administering one or more secondary agents
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
WO 2019/136125
U.S. Patent Application Publication 2018/0237499
U.S. Patent 10,316,077
U.S. Patent 11,878,047
U.S. Patent 12,208,131
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/AMBER D STEELE/Primary Examiner, Art Unit 1658
