DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-38 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.
Claims 1-3, 7, 8, 12, 14, 17, 18, 22-25, 27, 29, 31, 34-36, and 39 are currently pending.
Claims 1, 3, 7, 8, 12, 17, 18, 22, 31, 34-36, and 39 are currently under consideration.
Election/Restrictions
Applicant’s election of 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 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Please note: 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Claims 2, 14, 23-25, 27, and 29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 5, 2025.
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.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on February 15, 2023 and May 28, 2024 (2) are being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: the first line of the specification should be updated to include PCT/US2021/038264 filed June 21, 2021.
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 8 is objected to because of the following informalities: the arbitrary name of “ST101” should be replaced with “SEQ ID NO: 2” (see paragraph 2 of the originally filed specification). Appropriate correction is required.
Claim 12 is objected to because of the following informalities: all method steps should be recited as active, positive steps (i.e. administered should read administering). Appropriate correction is required.
Claim 17 is objected to because of the following informalities: all method steps should be recited as active, positive steps (i.e. administered should read administering). Appropriate correction is required.
Claim 18 is objected to because of the following informalities: all method steps should be recited as active, positive steps (i.e. administered should read administering). Appropriate correction is required.
Claim 22 is objected to because of the following informalities: the arbitrary name of “ST101” should be replaced with “SEQ ID NO: 2” (see paragraph 2 of the originally filed specification). Appropriate correction is required.
Claim 22 is objected to because of the following informalities: acronyms should be defined with the first recitation in the claim. Appropriate correction is required.
Claim 31 is objected to because of the following informalities: all method steps should be recited as active, positive steps (i.e. administered should read administering). Appropriate correction is required.
Claim 34 is objected to because of the following informalities: all method steps should be recited as active, positive steps (i.e. administered should read administering). Appropriate correction is required.
Claim 35 is objected to because of the following informalities: the arbitrary name of “ST101” should be replaced with “SEQ ID NO: 2” (see paragraph 2 of the originally filed specification). Appropriate correction is required.
Claim 36 is objected to because of the following informalities: the arbitrary name of “ST101” should be replaced with “SEQ ID NO: 2” (see paragraph 2 of the originally filed specification). Appropriate correction is required.
Claim 39 is objected to because of the following informalities: all method steps should be recited as active, positive steps (i.e. administered should read administering). Appropriate correction is required.
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 claim 1 and all dependent claim require 100% identity to present SEQ ID NO: 1. It is unclear what is required by present independent claim 22 and all dependent claims due to the utilization of the arbitrary name ST101.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the patient" in line 2. There is insufficient antecedent basis for this limitation in the claim. Utilization of “the human patient” is suggested.
Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation "the patient" in line 1. There is insufficient antecedent basis for this limitation in the claim. Utilization of “the human patient” is suggested.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. One of skill in the art would not be able to determine the scope of the present claim. For example, SEQ ID NO: 1 is not a cell-penetrating peptide (CPP). Therefore, it is unclear if the CPP is broadening the scope of SEQ ID NO: 1 or not. Utilization of “further comprising” is suggested.
Claim 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. One of skill in the art would not be able to determine the scope of the present claim. For example, it is unclear what ST101 requires (e.g. full-length SEQ ID NO: 2, 100% identity to SEQ ID NO: 2, etc.) and what the scope of “is” requires (e.g. open, closed, etc.).
Claim 18 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 18 recites the limitation "the subject" in line 2. There is insufficient antecedent basis for this limitation in the claim. Utilization of “the human patient” is suggested.
Claim 22 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 22 recites the limitation "the patient" in lines 2 and 4. There is insufficient antecedent basis for this limitation in the claim. Utilization of “the human patient” is suggested.
Claim 22 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. One of skill in the art would not be able to determine the scope of the present claim. For example, it is unclear what ST101 requires (e.g. full-length SEQ ID NO: 2, 100% identity to SEQ ID NO: 2, etc.).
Claim 35 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. One of skill in the art would not be able to determine the scope of the present claim. For example, the specification at paragraph 87 reads that the clearance is due to ST101/SEQ ID NO: 2. Therefore, it is unclear if any additional reagents are necessary to reach the clearance levels or not.
Claim 36 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. One of skill in the art would not be able to determine the scope of the present claim. For example, the specification at paragraph 87 reads that the half-life is due to ST101/SEQ ID NO: 2. Therefore, it is unclear if any additional reagents are necessary to reach the half-life or not.
Claim 39 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 39 recites the limitation "the subject" in line 2. There is insufficient antecedent basis for this limitation in the claim. Utilization of “the human patient” is suggested.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 7 depends on independent claim 1. Claim 1 requires SEQ ID NO: 1 which is not a CPP. Therefore, it is unclear if the CPP further limits SEQ ID NO: 1 or not (e.g. a CPP is added to SEQ ID NO: 1 or not). Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 35 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 35 is dependent on independent claim 22. Independent claim 22 requires ST101/SEQ ID NO: 2. Dependent claim 35 is simply reciting a function of ST101/SEQ ID NO: 2 (i.e. clearance levels; see paragraph 87 of the originally filed specification). Therefore, dependent claim 35 fails to further limit the reagents utilized in the method and/or the method steps. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 36 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 36 is dependent on independent claim 22. Independent claim 22 requires ST101/SEQ ID NO: 2. Dependent claim 36 is simply reciting a function of ST101/SEQ ID NO: 2 (i.e. half-life; see paragraph 87 of the originally filed specification). Therefore, dependent claim 36 fails to further limit the reagents utilized in the method and/or the method steps. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Please note: due to the myriad of claim objections and 35 USC 112 rejections, applicants are respectfully requested to carefully review the claims for any additional issues.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 7, 8, 12, 17, 18, 22, 31, 34-36, and 39 are rejected 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).
The applied reference (U.S. Patent Application Publication 2019/0201483) has a common common assignee (Sapience Therapeutic, Inc.) and common inventors (Barry Kappel, Gene Merutka, and Jimmy Rotolo) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
For present claims 1, 3, 7, 8, 12, 17, 18, 22, 31, 34-36, and 39, Kappel et al. teach methods of treating human patients with glioblastoma via administering a D amino acid retro inverso ATF5 bZIP domain/leucine zipper domain (VAEAREELERLEARLGQARGEL; SEQ ID NO: 65; residues 1-22 of present SEQ ID NO: 2/ST101) alone or in combination as a fusion protein with a CPP including modified penetratin (RQLKLWFQNRRMKWKK; SEQ ID NO: 26 wherein leucine is a conservative amino acid substitution from isoleucine of unmodified penetratin SEQ ID NO: 25; residues 23-38 of present SEQ ID NO: 2/ST101) and saline wherein the dosage was 20 mg/kg, 25 mg/kg, or 50 mg/kg and was administered twice a day, three times per week for three weeks, or twice daily for three weeks (please refer to the entire specification particularly the abstract; paragraphs 3-5, 8, 10-13, 17, 56-87, 110-115; Tables 1-3). Kappel et al. teach SEQ ID NO: 14 which is the same length and has 100% identity with present SEQ ID NO: 2/ST101.
However, Kappel et al. do not teach intravenous administration.
For present claims 1, 3, 7, 8, 12, 17, 18, 22, 31, 34-36, and 39, Greene et al. teach methods of treating glioblastoma in humans via administering ATF5 domains including leucine zippers 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).
However, Kappel et al. do not teach antihistamines.
For present claims 17, 18, and 39, 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, 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).
Claims 22, 31, 34-36, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Greene et al. U.S. Patent Application Publication 2016/0046686 published February 18, 2016; Su et al., 2018, Effect of Retro-Inverso Isomer of Bradykinin on Size-Dependent Penetration of Blood-Brain Tumor Barrier, Small, 14: 1702331 (9 pages); 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).
For present claims 22, 31, 34-36, and 39, 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).
However, Greene et al. do not teach retroinverso peptides.
For present claims 22, 31, 34-36, and 39, Su et al. teach that retroinverso peptides can be utilized for treatment of glioblastoma (please refer to the entire reference particularly the abstract; sections 2.2, 2.3).
However, Greene et al. do not teach antihistamines.
For present claims 22, 31, 34-36, and 39, 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 (making retroinverso peptides to increase stability, 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).
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, 7, 8, 12, 17, 18, 22, 31, 34-36, 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)
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).
Claims 1, 3, 7, 8, 12, 17, 18, 22, 31, 34-36, and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 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 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.
Claims 1, 3, 7, 8, 12, 17, 18, 22, 31, 34-36, and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 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 methods of treating glioblastoma with SEQ ID NO: 1 (present SEQ ID NO: 1) or ST101 with similar administration dosages and timing as presently claimed.
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.
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
Ran et al., 2017, D-Retroenantiomer of Quorum-Sensing Peptide-Modified Polymeric Micelles for Brain Tumor-Targeted Drug Delivery, ACS Appl Mater Interfaces, 9: 25672-25682.
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