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 1-138 were originally filed June 1, 2022.
The amendment received July 7, 2022 canceled claims 1-138 and added new claims 139-159.
The amendment received March 21, 2026 amended claims 139, 142, 143, 145-147, 153-155, 157, and 158; cancelled claims 149-152; and added new claims 160-162.
Claims 139-148 and 153-162 are currently pending.
Claims 139-145, 148, and 153-157 are currently under consideration.
Please note: withdrawn claim 161 should be dependent on claim 139.
Election/Restrictions
Applicants elected, without traverse, Group I (claims 139-158) in the reply filed on July 29, 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: applicants stated that the election was made with traverse, but no traversal was provided.
Claims 159 and 160 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim.
Applicants elected, without traverse, SEQ ID NO: 10, docetaxel, and 2 (at about 1% (w/w)), acetyl, succinic acid linker, dextrose at about 5% (w/v), formic acid at about 0.04% (v/v), polysorbate 80 at about 10% (w/v), pH of 4.1-4.5, and formate salt as the species in the reply filed on July 29, 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)).
Claims 146, 147, 158, 161, and 162 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Potential Rejoinder
Applicant elected claims directed to a product. If a product claim is subsequently found allowable, withdrawn process claims that depend from or otherwise include all the limitations of the allowable product claim will be rejoined in accordance with the provisions of MPEP § 821.04. Process claims that depend from or otherwise include all the limitations of the patentable product will be entered as a matter of right if the amendment is presented prior to final rejection or allowance, whichever is earlier. Amendments submitted after final rejection are governed by 37 CFR 1.116; amendments submitted after allowance are governed by 37 CFR 1.312.
In the event of rejoinder, the requirement for restriction between the product claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all the criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103, and 112. Until an elected product claim is found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowed product claim will not be rejoined. See “Guidance on Treatment of Product and Process Claims in light of In re Ochiai, In re Brouwer and 35 U.S.C. § 103(b),” 1184 O.G. 86 (March 26, 1996). Additionally, in order to retain the right to rejoinder in accordance with the above policy, applicant is advised that the process claims should be amended during prosecution either to maintain dependency on the product claims or to otherwise include the limitations of the product claims. Failure to do so may result in a loss of the right to a rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Priority
The present application is a 371 (National Stage) of PCT/CA2020/051686 filed December 7, 2020 which claims the benefit of 62/945,111 filed December 6, 2019.
Withdrawn Objection
The objection to claim 143 regarding the recitation of “Formula (XXXIX)” and “(XXXIX)” is unnecessary as the formula name does not provide any additional information is withdrawn in view of the amendment received March 21, 2026.
New Objections
Claim Objections
Claim 143 is objected to because of the following informalities: “is represented by” should read “comprising”, “consisting of”, etc. Appropriate correction is required.
Claim 153 is objected to because of the following informalities: the claim is dependent on a cancelled claim (i.e. claim 151). 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.
Withdrawn Rejections
The rejection of claim 142 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of the amendment received March 21, 2026.
The rejection of claim 158 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of the amendment received March 21, 2026. Please note: the claim is now withdrawn as being drawn to a nonelected species. See the amendment received March 21, 2026.
The rejection of claims 139-146, 148-150, 154, 155, 157, and 158 under 35 U.S.C. 103 as being unpatentable over Beliveau et al. WO 2017/088058 published June 1, 2017 and Kaur et al., 2017, Developments of Polysorbate (Tween) based microemulsions: Preclinical drug delivery, toxicity and antimicrobial applications, international Journal of Pharmaceutics, 529: 134-160 is withdrawn in view of the amendment received March 21, 2026.
The provisional rejection of claims 139-146 and 148-157 on the ground of nonstatutory double patenting as being unpatentable over claims 51, 52, 69-71, 73-79, and 82 of copending Application No. 17/270,787 in view of Beliveau et al. WO 2017/088058 published June 1, 2017 and Mcauley et al. WO 2018/141910 published August 9, 2018 is withdrawn in view of the ABN of the application.
Maintained and/or Modified* Rejections
*wherein the modification is due to amendment
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 139-145, 148, and 153-157 are rejected under 35 U.S.C. 103 as being unpatentable over Beliveau et al. WO 2017/088058 published June 1, 2017; Kaur et al., 2017, Developments of Polysorbate (Tween) based microemulsions: Preclinical drug delivery, toxicity and antimicrobial applications, international Journal of Pharmaceutics, 529: 134-160; and Mcauley et al. WO 2018/141910 published August 9, 2018.
For present claims 139-146, 148, and 153-157, Beliveau et al. teach a conjugate of A-(B)n wherein A is SEQ ID NO: 10 (i.e. same length and 100% identity to present SEQ ID NO: 10) conjugated to B which are cancer therapeutics including docetaxel wherein conjugation can be via lysines or via a linker including succinic acid, and n can be 1-4 wherein A can be protected via an N-terminal acetyl (i.e. see SEQ ID NO: 15 which has the same length and 100% identity with present SEQ ID NO: 15) and pharmaceutically acceptable acid addition salts including fumaric (i.e. formate) and buffers including formic acid (please refer to the entire specification particularly the abstract; paragraphs 2, 10-16, 19, 20, 34-39, 41, 42, 44, 48-58, 61, 62, 68, 73, 74, 78-83, 86-117, 127-130, 136-141, 143, 145, 146, 148, 151, 154-175, 193, 194, 196, 197, 220-236, 242, 247, 248, 252, 256, 260, 266-272, 280-287, 289, 290, 295, 297-300, 360, 369, 378, 381, 384-410, 416-426, 429-433; SEQ ID NOs: 8 and 14; Tables 3, 4, 5; Examples; claims). Please note: the “]” in several of the paragraph numbers is showing as a “1”. The present citations are referring to the sequential numbering of the paragraphs. Beliveau et al. also teach 2 mM or 18 mg/kg of conjugate (see Figures 11A, 11B, 15C, 25A, 25C, 26A, 26B) and 2 mM, 5 mM, 10 mM, 6 mg/kg doxorubicin (see Figures 15 A, 15B, 15C, 25A, 25C). Beliveau et al. also teach SEQ ID NOs: 6 and 7 with 85.2% identity to present SEQ ID NO: 10 and SEQ ID NOs: 1 and 5 with 65.4% identity to present SEQ ID NO: 10.
However, Beliveau et al. does not teach polysorbate, dextrose, or a pH of about 3.5 to about 4.5.
For present claims 139-145, 148, and 153-157, Kaur et al. teach utilizing polysorbate 80 in polypeptide therapeutics at a weight % of 4, 8, or 12, at 75 or 80 mg, or 15, 20, or 25 (%v/v) (please refer to the entire reference particularly the abstract; Introduction, Section 2; Tables 1, 4, 7, 12, 15, 18).
For present claims 139-145, 148, and 153-157, Mcauley et al. teach low pH pharmaceutical compositions comprising polypeptide conjugates including linkers at 5% weight or 0.1-8 mg/ml wherein the compositions comprise buffers, dextrose or sucrose at 2-12% (w/v), polysorbate 80 at 0.001-0.5% w/v, and formic acid at 0.1% (v/v) at a pH of 3.5-6 (please refer to the entire specification particularly the abstract; paragraphs 10, 19, 24, 25, 30-32, 35, 37, 46, 47, 67, 95, 113, 225, 237, 265, 266, 278, 280, 324, 325, 332, 333, 340, 343; Examples).
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." 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 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 (i.e. utilizing saccharides in pharmaceutical formulations, utilizing surfactants including polysorbate 80 in polypeptide therapeutic formulations; making polypeptide conjugates with a low pH) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 103 as being unpatentable over Beliveau et al.; Kaur et al.; and Mcauley et al. for claims 139-145, 148, and 153-157 were considered but are not persuasive for the following reasons.
Applicants contend that the specific % w/v for polysorbate 80 and dextrose are not taught. Applicants argue unexpected results based on formulations 2 and 8.
Applicants’ arguments are not convincing since the teachings of Beliveau et al.; Kaur et al.; and Mcauley et al. render the composition of the instant claims prima facie obvious.
Kaur et al. teach utilizing polysorbate 80 in polypeptide therapeutics at a weight % of 4, 8, or 12, at 75 or 80 mg, or 15, 20, or 25 (%v/v) (please refer to the entire reference particularly the abstract; Introduction, Section 2; Tables 1, 4, 7, 12, 15, 18).
Mcauley et al. teach low pH pharmaceutical compositions comprising polypeptide conjugates including linkers at 5% weight or 0.1-8 mg/ml wherein the compositions comprise buffers, dextrose or sucrose at 2-12% (w/v), polysorbate 80 at 0.001-0.5% w/v, and formic acid at 0.1% (v/v) at a pH of 3.5-6 (please refer to the entire specification particularly the abstract; paragraphs 10, 19, 24, 25, 30-32, 35, 37, 46, 47, 67, 95, 113, 225, 237, 265, 266, 278, 280, 324, 325, 332, 333, 340, 343; Examples).
Unexpected results must be commensurate in scope with the present claims. See MPEP § 716.02(d).
Formulation 2 contains 5% Tween™ 80, 80% D5W, formate, 3.2 mg TH1902, 2.5 mg docetaxel, and water; pH 2.95.
Formulation 8 contains 5% Tween™ 80 (100% w/v), 80% D5W, acetate, 3.04 mg TH1902, 2.5 mg docetaxel, and water; pH 2.95.
It is presumed that TH1902 is SEQ ID NO: 10 (100% identity and the same length). This is not clear from the present specification.
Furthermore, the specific % w/v for polysorbate and dextrose are taught in the prior art.
"The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." See In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) and In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005).
A single example where Tween™ was not beneficial does not negate the plethora of other examples where Tween™ is beneficial.
Mcauley et al. is utilized to teach dextrose.
Kaur et al. is utilized to teach higher % w/v of polysorbate 80.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
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 139-145, 148, and 153-157 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 78-97 of copending Application No. 18/278,821 in view of Beliveau et al. WO 2017/088058 published June 1, 2017; Kaur et al., 2017, Developments of Polysorbate (Tween) based microemulsions: Preclinical drug delivery, toxicity and antimicrobial applications, international Journal of Pharmaceutics, 529: 134-160; and Mcauley et al. WO 2018/141910 published August 9, 2018.
Copending Application No. 18/278,821 claims A-(B)n wherein A is SEQ ID NO: 10, B is an antitumor agent including doxorubicin, and n is 0-5, and protecting groups of acetyl.
Beliveau et al. teach a conjugate of A-(B)n wherein A is SEQ ID NO: 10 (i.e. same length and 100% identity to present SEQ ID NO: 10) conjugated to B which are cancer therapeutics including docetaxel, doxorubicin, cabazitaxel, auristatin, or amanitin wherein conjugation can be via lysines or via a linker including succinic acid, and n can be 1-4 wherein A can be protected via an N-terminal acetyl (i.e. see SEQ ID NO: 15 which has the same length and 100% identity with present SEQ ID NO: 15) and pharmaceutically acceptable acid addition salts including fumaric (i.e. formate) and buffers including formic acid (please refer to the entire specification particularly the abstract; paragraphs 2, 10-16, 19, 20, 34-39, 41, 42, 44, 48-58, 61, 62, 68, 73, 74, 78-83, 86-117, 127-130, 136-141, 143, 145, 146, 148, 151, 154-175, 193, 194, 196, 197, 220-236, 242, 247, 248, 252, 256, 260, 266-272, 280-287, 289, 290, 295, 297-300, 360, 369, 378, 381, 384-410, 416-426, 429-433; SEQ ID NOs: 8 and 14; Tables 3, 4, 5; Examples; claims). Please note: the “]” in several of the paragraph numbers is showing as a “1”. The present citations are referring to the sequential numbering of the paragraphs. Beliveau et al. also teach 2 mM or 18 mg/kg of conjugate (see Figures 11A, 11B, 15C, 25A, 25C, 26A, 26B) and 2 mM, 5 mM, 10 mM, 6 mg/kg doxorubicin (see Figures 15 A, 15B, 15C, 25A, 25C). Beliveau et al. also teach SEQ ID NOs: 6 and 7 with 85.2% identity to present SEQ ID NO: 10 and SEQ ID NOs: 1 and 5 with 65.4% identity to present SEQ ID NO: 10.
Kaur et al. teach utilizing polysorbate 80 in polypeptide therapeutics at a weight % of 4, 8, or 12, at 75 or 80 mg, or 15, 20, or 25 (%v/v) (please refer to the entire reference particularly the abstract; Introduction, Section 2; Tables 1, 4, 7, 12, 15, 18).
Mcauley et al. teach low pH pharmaceutical compositions comprising polypeptide conjugates including linkers at 5% weight or 0.1-8 mg/ml wherein the compositions comprise buffers, dextrose or sucrose at 2-12% (w/v), polysorbate 80 at 0.001-0.5% w/v, and formic acid at 0.1% (v/v) at a pH of 3.5-6 (please refer to the entire specification particularly the abstract; paragraphs 10, 19, 24, 25, 30-32, 35, 37, 46, 47, 67, 95, 113, 225, 237, 265, 266, 278, 280, 324, 325, 332, 333, 340, 343; Examples).
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." 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 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 (i.e. utilizing saccharides in pharmaceutical formulations, utilizing surfactants including polysorbate 80 in polypeptide therapeutic formulations; making polypeptide conjugates with a low pH) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (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. 18/278,821 in view of Beliveau et al.; Kaur et al.; and Mcauley et al. for claims 139-145, 148, and 153-157 were considered but are not persuasive for the following reasons.
Applicants point to the traversal of the 35 USC 103 rejection above.
Applicants’ arguments are not convincing since the claimed invention of copending Application No. 18/278,821 in view of Beliveau et al.; Kaur et al.; and Mcauley et al. renders obvious the composition 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). Please refer to the response to the traversal of the 35 USC 103 rejection above.
Claims 139-145, 148, and 153-157 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,269,902 in view of Beliveau et al. WO 2017/088058 published June 1, 2017; Kaur et al., 2017, Developments of Polysorbate (Tween) based microemulsions: Preclinical drug delivery, toxicity and antimicrobial applications, international Journal of Pharmaceutics, 529: 134-160; and Mcauley et al. WO 2018/141910 published August 9, 2018.
U.S. Patent No. 12,269,902 claims conjugates of A-(B)n wherein A is SEQ ID NO: 10 or SEQ ID NO: 15, B is a therapeutic agent including docetaxel, and n is 0-5, linkers, and acetyl at the N-terminus.
Beliveau et al. teach a conjugate of A-(B)n wherein A is SEQ ID NO: 10 (i.e. same length and 100% identity to present SEQ ID NO: 10) conjugated to B which are cancer therapeutics including docetaxel, doxorubicin, cabazitaxel, auristatin, or amanitin wherein conjugation can be via lysines or via a linker including succinic acid, and n can be 1-4 wherein A can be protected via an N-terminal acetyl (i.e. see SEQ ID NO: 15 which has the same length and 100% identity with present SEQ ID NO: 15) and pharmaceutically acceptable acid addition salts including fumaric (i.e. formate) and buffers including formic acid (please refer to the entire specification particularly the abstract; paragraphs 2, 10-16, 19, 20, 34-39, 41, 42, 44, 48-58, 61, 62, 68, 73, 74, 78-83, 86-117, 127-130, 136-141, 143, 145, 146, 148, 151, 154-175, 193, 194, 196, 197, 220-236, 242, 247, 248, 252, 256, 260, 266-272, 280-287, 289, 290, 295, 297-300, 360, 369, 378, 381, 384-410, 416-426, 429-433; SEQ ID NOs: 8 and 14; Tables 3, 4, 5; Examples; claims). Please note: the “]” in several of the paragraph numbers is showing as a “1”. The present citations are referring to the sequential numbering of the paragraphs. Beliveau et al. also teach 2 mM or 18 mg/kg of conjugate (see Figures 11A, 11B, 15C, 25A, 25C, 26A, 26B) and 2 mM, 5 mM, 10 mM, 6 mg/kg doxorubicin (see Figures 15 A, 15B, 15C, 25A, 25C). Beliveau et al. also teach SEQ ID NOs: 6 and 7 with 85.2% identity to present SEQ ID NO: 10 and SEQ ID NOs: 1 and 5 with 65.4% identity to present SEQ ID NO: 10.
Kaur et al. teach utilizing polysorbate 80 in polypeptide therapeutics at a weight % of 4, 8, or 12, at 75 or 80 mg, or 15, 20, or 25 (%v/v) (please refer to the entire reference particularly the abstract; Introduction, Section 2; Tables 1, 4, 7, 12, 15, 18).
Mcauley et al. teach low pH pharmaceutical compositions comprising polypeptide conjugates including linkers at 5% weight or 0.1-8 mg/ml wherein the compositions comprise buffers, dextrose or sucrose at 2-12% (w/v), polysorbate 80 at 0.001-0.5% w/v, and formic acid at 0.1% (v/v) at a pH of 3.5-6 (please refer to the entire specification particularly the abstract; paragraphs 10, 19, 24, 25, 30-32, 35, 37, 46, 47, 67, 95, 113, 225, 237, 265, 266, 278, 280, 324, 325, 332, 333, 340, 343; Examples).
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." 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 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 (i.e. utilizing saccharides in pharmaceutical formulations, utilizing surfactants including polysorbate 80 in polypeptide therapeutic formulations; making polypeptide conjugates with a low pH) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (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. 12,269,902 in view of Beliveau et al.; Kaur et al.; and Mcauley et al. for claims 139-145, 148, and 153-157 were considered but are not persuasive for the following reasons.
Applicants point to the traversal of the 35 USC 103 rejection above.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 12,269,902 in view of Beliveau et al.; Kaur et al.; and Mcauley et al. renders obvious the composition 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). Please refer to the response to the traversal of the 35 USC 103 rejection above.
Claims 139-145, 148, and 153-157 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,780,882 in view of Beliveau et al. WO 2017/088058 published June 1, 2017; Kaur et al., 2017, Developments of Polysorbate (Tween) based microemulsions: Preclinical drug delivery, toxicity and antimicrobial applications, international Journal of Pharmaceutics, 529: 134-160; and Mcauley et al. WO 2018/141910 published August 9, 2018.
U.S. Patent No. 11,780,882 claims conjugates comprising SEQ ID NO: 10 or SEQ ID NO: 15, an anticancer agent, linkers, and acetyl at the N-terminus.
Beliveau et al. teach a conjugate of A-(B)n wherein A is SEQ ID NO: 10 (i.e. same length and 100% identity to present SEQ ID NO: 10) conjugated to B which are cancer therapeutics including docetaxel, doxorubicin, cabazitaxel, auristatin, or amanitin wherein conjugation can be via lysines or via a linker including succinic acid, and n can be 1-4 wherein A can be protected via an N-terminal acetyl (i.e. see SEQ ID NO: 15 which has the same length and 100% identity with present SEQ ID NO: 15) and pharmaceutically acceptable acid addition salts including fumaric (i.e. formate) and buffers including formic acid (please refer to the entire specification particularly the abstract; paragraphs 2, 10-16, 19, 20, 34-39, 41, 42, 44, 48-58, 61, 62, 68, 73, 74, 78-83, 86-117, 127-130, 136-141, 143, 145, 146, 148, 151, 154-175, 193, 194, 196, 197, 220-236, 242, 247, 248, 252, 256, 260, 266-272, 280-287, 289, 290, 295, 297-300, 360, 369, 378, 381, 384-410, 416-426, 429-433; SEQ ID NOs: 8 and 14; Tables 3, 4, 5; Examples; claims). Please note: the “]” in several of the paragraph numbers is showing as a “1”. The present citations are referring to the sequential numbering of the paragraphs. Beliveau et al. also teach 2 mM or 18 mg/kg of conjugate (see Figures 11A, 11B, 15C, 25A, 25C, 26A, 26B) and 2 mM, 5 mM, 10 mM, 6 mg/kg doxorubicin (see Figures 15 A, 15B, 15C, 25A, 25C). Beliveau et al. also teach SEQ ID NOs: 6 and 7 with 85.2% identity to present SEQ ID NO: 10 and SEQ ID NOs: 1 and 5 with 65.4% identity to present SEQ ID NO: 10.
Kaur et al. teach utilizing polysorbate 80 in polypeptide therapeutics at a weight % of 4, 8, or 12, at 75 or 80 mg, or 15, 20, or 25 (%v/v) (please refer to the entire reference particularly the abstract; Introduction, Section 2; Tables 1, 4, 7, 12, 15, 18).
Mcauley et al. teach low pH pharmaceutical compositions comprising polypeptide conjugates including linkers at 5% weight or 0.1-8 mg/ml wherein the compositions comprise buffers, dextrose or sucrose at 2-12% (w/v), polysorbate 80 at 0.001-0.5% w/v, and formic acid at 0.1% (v/v) at a pH of 3.5-6 (please refer to the entire specification particularly the abstract; paragraphs 10, 19, 24, 25, 30-32, 35, 37, 46, 47, 67, 95, 113, 225, 237, 265, 266, 278, 280, 324, 325, 332, 333, 340, 343; Examples).
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." 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 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 the substitution of one known element (i.e. genus of anticancer agents) for another (i.e. species of docetaxel, doxorubicin, cabazitaxel, auristatin, or amanitin) would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. utilizing saccharides in pharmaceutical formulations, utilizing surfactants including polysorbate 80 in polypeptide therapeutic formulations; making polypeptide conjugates with a low pH) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (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. 11,780,882 in view of Beliveau et al.; Kaur et al.; and Mcauley et al. for claims 139-145, 148, and 153-157 were considered but are not persuasive for the following reasons.
Applicants point to the traversal of the 35 USC 103 rejection above.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 11,780,882 in view of Beliveau et al.; Kaur et al.; and Mcauley et al. renders obvious the composition 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). Please refer to the response to the traversal of the 35 USC 103 rejection above.
Claims 139-145, 148, and 153-157 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11,034,727 in view of Beliveau et al. WO 2017/088058 published June 1, 2017; Kaur et al., 2017, Developments of Polysorbate (Tween) based microemulsions: Preclinical drug delivery, toxicity and antimicrobial applications, international Journal of Pharmaceutics, 529: 134-160; and Mcauley et al. WO 2018/141910 published August 9, 2018.
U.S. Patent No. 11,034,727 claims conjugates of A-(B)n wherein A is SEQ ID NO: 10 or SEQ ID NO: 15, B is a therapeutic agent including docetaxel, and n is 1-4, linkers, and acetyl at the N-terminus.
Beliveau et al. teach a conjugate of A-(B)n wherein A is SEQ ID NO: 10 (i.e. same length and 100% identity to present SEQ ID NO: 10) conjugated to B which are cancer therapeutics including docetaxel, doxorubicin, cabazitaxel, auristatin, or amanitin wherein conjugation can be via lysines or via a linker including succinic acid, and n can be 1-4 wherein A can be protected via an N-terminal acetyl (i.e. see SEQ ID NO: 15 which has the same length and 100% identity with present SEQ ID NO: 15) and pharmaceutically acceptable acid addition salts including fumaric (i.e. formate) and buffers including formic acid (please refer to the entire specification particularly the abstract; paragraphs 2, 10-16, 19, 20, 34-39, 41, 42, 44, 48-58, 61, 62, 68, 73, 74, 78-83, 86-117, 127-130, 136-141, 143, 145, 146, 148, 151, 154-175, 193, 194, 196, 197, 220-236, 242, 247, 248, 252, 256, 260, 266-272, 280-287, 289, 290, 295, 297-300, 360, 369, 378, 381, 384-410, 416-426, 429-433; SEQ ID NOs: 8 and 14; Tables 3, 4, 5; Examples; claims). Please note: the “]” in several of the paragraph numbers is showing as a “1”. The present citations are referring to the sequential numbering of the paragraphs. Beliveau et al. also teach 2 mM or 18 mg/kg of conjugate (see Figures 11A, 11B, 15C, 25A, 25C, 26A, 26B) and 2 mM, 5 mM, 10 mM, 6 mg/kg doxorubicin (see Figures 15 A, 15B, 15C, 25A, 25C). Beliveau et al. also teach SEQ ID NOs: 6 and 7 with 85.2% identity to present SEQ ID NO: 10 and SEQ ID NOs: 1 and 5 with 65.4% identity to present SEQ ID NO: 10.
Kaur et al. teach utilizing polysorbate 80 in polypeptide therapeutics at a weight % of 4, 8, or 12, at 75 or 80 mg, or 15, 20, or 25 (%v/v) (please refer to the entire reference particularly the abstract; Introduction, Section 2; Tables 1, 4, 7, 12, 15, 18).
Mcauley et al. teach low pH pharmaceutical compositions comprising polypeptide conjugates including linkers at 5% weight or 0.1-8 mg/ml wherein the compositions comprise buffers, dextrose or sucrose at 2-12% (w/v), polysorbate 80 at 0.001-0.5% w/v, and formic acid at 0.1% (v/v) at a pH of 3.5-6 (please refer to the entire specification particularly the abstract; paragraphs 10, 19, 24, 25, 30-32, 35, 37, 46, 47, 67, 95, 113, 225, 237, 265, 266, 278, 280, 324, 325, 332, 333, 340, 343; Examples).
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." 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 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 (i.e. utilizing saccharides in pharmaceutical formulations, utilizing surfactants including polysorbate 80 in polypeptide therapeutic formulations; making polypeptide conjugates with a low pH) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (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. 11,034,727 in view of Beliveau et al.; Kaur et al.; and Mcauley et al. for claims 139-145, 148, and 153-157 were considered but are not persuasive for the following reasons.
Applicants point to the traversal of the 35 USC 103 rejection above.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 11,034,727 in view of Beliveau et al.; Kaur et al.; and Mcauley et al. renders obvious the composition 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). Please refer to the response to the traversal of the 35 USC 103 rejection above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication 2010/0215683
SEQ ID NOs: 1, 2, 37, and 38 have 65.4% identity with present SEQ ID NO: 10.
WO 2006/069200
At least SEQ ID NO: 16026 has 65.4% identity with present SEQ DI NO: 10.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/AMBER D STEELE/Primary Examiner, Art Unit 1658
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