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 .
Election/Restrictions and Claim Status
Applicants’ amendments and arguments filed 8/25/26 are acknowledged. Any objection or rejection from the 2/25/26 office action that is not addressed below is withdrawn based on the amendments and/or arguments.
Previously, Group 1 and the species as set forth on pages 8-9 in the reply filed on 12/19/25 were elected.
Claims 20-21, 23 and 25-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/19/25.
Claims to the elected species are rejected as set forth below. Any relevant art that was uncovered during the search for the elected species is cited herein in order to advance prosecution. Although claim 13 for example does not necessarily read on the elected species it is included in the instant examination.
Claims 2-9, 11-12, 15, 18, 22 and 24 have been canceled.
Claims 1, 10, 13-14, 16-17, 19 and 28 are being examined.
Priority
The priority information is found in the filing receipt dated 8/19/24.
Claim Rejections - 35 USC § 103
Claims were previously rejected based on the references cited below. Since the claims have been amended the rejections are updated to correspond to the instant claims.
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.
Claim(s) 1, 10, 13-14, 16-17, 19 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Katzmarek et al. (WO 2020/086965 as cited with IDS 10/7/24; ‘Katzmarek’).
Katzmarek teach improvements in selection of polymers for formulations (abstract). Katzmarek teach formulas of a generic structure (section 0003). Katzmarek teach that figure 1a shows the monomers and components used for synthesis and figure 1b shows the formulations (section 0008 and figure 1). Katzmarek teach the synthesis of A1 polymer which comprises bisphenol A glycerolate diacrylate, 4-(2-amino methyl) morpholine and dodecyl amine (C12 per section 0211 on page 73) (page 72 section 0207 and Table 2 on page 80). Katzmarek teach that nanoparticles were formed with mRNA and PEG-lipid (section 0214 page 76). Katzmarek teach specific amounts of the PEG-lipid (section 0193 page 68 and Table 6 page 84). Katzmarek teach lyophilization and spray drying (section 0161 page 59). Katzmarek recognize the use of kits (section 0213 page 75). Katzmarek teach seeking optimized nanoparticles and teach evaluation of synthesis parameters including the end capping group (section 0191 page 67) and teach that the end cap has a significant effect on efficacy (section 0193 page 68). In claim 8, Katzmarek teach various end capping groups (page 97).
Katzmarek does not teach an example with end capping group that is instant E63.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Katzmarek based on the specific teachings and suggestions of Katzmarek. Since Katzmarek teach seeking optimized nanoparticles and teach evaluation of synthesis parameters including the end capping group (section 0191 page 67) and teach that the end cap has a significant effect on efficacy (section 0193 page 68) one would have been motivated to make polymers based on the A1 polymer with the end capping groups of claim 8 including the 8th group of claim 8. Katzmarek teach the synthesis of A1 polymer which comprises bisphenol A glycerolate diacrylate, 4-(2-amino methyl) morpholine and dodecyl amine (C12 per section 0211 on page 73) (page 72 section 0207 and Table 2 on page 80). Katzmarek teach that nanoparticles were formed with mRNA and PEG-lipid (section 0214 page 76). Further, since Katzmarek teach that nanoparticles were formed with mRNA and PEG-lipid (section 0214 page 76) and suggest specific amounts of the PEG-lipid (section 0193 page 68 and Table 6 page 84) one would have been motivated to make such compositions. Since Katzmarek teach lyophilization and spray drying (section 0161 page 59) and recognize the use of kits (section 0213 page 75) one would have been motivated to prepare the compositions in the form of a kit for ease of use. One would have had a reasonable expectation of success based on the specific teachings and suggestions of Katzmarek. For example, Katzmarek teach methods of synthesis (example 1 beginning on page 72).
In relation to the R group of claim 1, Katzmarek teach bisphenol A glycerolate diacrylate (figure 1a and page 72 section 0207) which is instant B7.
In relation to the R’ group of claim 1, Katzmarek teach dodecyl amine (C12 per section 0211 on page 73) (page 72 section 0207 and Table 2 on page 80) which is instant Sc12.
In relation to the R’’ group of claim 1, Katzmarek teach 4-(2-amino methyl) morpholine (figure 1a and page 72 section 0207 and Table 2 on page 80) which is instant S90.
In relation to the R’’’ group of claim 1, Katzmarek suggest various end capping groups including the 8th group of claim 8 which is instant E63.
In relation to the mRNA of claim 1, Katzmarek teach that nanoparticles were formed with mRNA (section 0214 page 76).
In relation to claim 10, Katzmarek recognize various amounts of the components (Table 2 page 80).
In relation to claim 13, Katzmarek teach that nanoparticles were formed with PEG-lipid (section 0214 page 76).
In relation to claim 14, Katzmarek teach specific amounts of the PEG-lipid (section 0193 page 68 and Table 6 page 84).
In relation to claim 16, Katzmarek teach that nanoparticles were formed with PEG-lipid (section 0214 page 76). Katzmarek teach lyophilization and spray drying (section 0161 page 59).
In relation to claim 17, Katzmarek teach that nanoparticles were formed (section 0214 page 76). Katzmarek teach lyophilization and spray drying (section 0161 page 59).
In relation to claim 19, Katzmarek teach nanoparticle synthesis (section 0214 page 76) which is interpreted as meeting the claim limitation. Katzmarek teach lyophilization and spray drying (section 0161 page 59).
In relation to claim 28, Katzmarek teach lyophilization and spray drying (section 0161 page 59) and recognize the use of kits (section 0213 page 75) so one would have been motivated to prepare the compositions in the form of a kit for ease of use.
Claim(s) 1, 10, 13-14, 16-17, 19 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaczmarek et al. (NPL2 as cited with IDS 10/7/24; ‘Kaczmarek2016’) in view of Prokopovich et al. (US 2017/0209468; ‘Prokopovich’).
Kaczmarek2016 states that more detailed experimental procedures can be found in the Supporting Information (page 138111 last paragraph before Acknowledgements). A copy of the Supporting Information (Kaczmarek et al. ‘Polymer-lipid nanoparticles for systemic delivery of mRNA to the lungs’ Angew Chem Int Ed V55 2016, 21 pages; ‘SupportingKaczmarek2016’) was previously provided for completeness of the record.
Kaczmarek2016 teach formulations for intravenous administration for example for delivery of mRNA to the lungs (abstract). Kaczmarek2016 teach compounds including DD90-C12-122 which are combined with mRNA to form nanoparticles (figure 1 and first paragraph of experimental section on page 13811). Kaczmarek2016 teach formulations with PEG-lipid (figure 1) specifically 7 mol % PEG-lipid (page 13808 2nd column, first complete paragraph). Kaczmarek2016 suggest varying the formulation components to access even more potent formulations (page 13810-13811 connecting paragraph).
Kaczmarek2016 does not teach an example with end capping group that is instant E63.
Prokopovich teach poly beta-amino esters as transport delivery vehicles (abstract) with applications for intravenous administration (section 0103). Prokopovich teach that an investigation of the end-capping amine role in drug delivery showed that diethylenetriamine was more effective than ethylenediamine (structures shown in Table 3) which can be attributed to the longer chain helping the stability and the extra nitrogen resulting in a higher charge of the polymer conjugate (section 0179). Prokopovich recognize drying under vacuum and lyophilization (sections 0152, 0159, 0162 0237) and the use of kits (sections 0192 and 0195).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Kaczmarek2016 based on the specific teachings and suggestions of Kaczmarek2016. Since Kaczmarek2016 suggest varying the formulation components to access even more potent formulations (page 13810-13811 connecting paragraph) one would have been motivated to do such. Since Prokopovich teach that an investigation of the end-capping amine role in drug delivery showed that diethylenetriamine was more effective than ethylenediamine (structures shown in Table 3) (section 0179) one would have been motivated to use the diethylenetriamine group in the constructs of Kaczmarek2016. Since Kaczmarek2016 teach formulations with PEG-lipid (figure 1) specifically 7 mol % PEG-lipid (page 13808 2nd column, first complete paragraph) one would have been motivated to make such formulations. Since Prokopovich recognize drying under vacuum and lyophilization (sections 0152, 0159, 0162 0237) and the use of kits (sections 0192 and 0195) one would have been motivated to prepare the compositions in the form of a kit for ease of use. One would have had a reasonable expectation of success based on the specific teachings and suggestions of Kaczmarek2016. For example, Kaczmarek2016 teach methods of synthesis (paragraph connecting columns 1-2 on page 13811). In addition, Prokopovich provide specific teachings related to cartilage. Cartilage is present in lungs which is expressly recited by Kaczmarek2016 (abstract).
In relation to the R group of claim 1, Kaczmarek2016 teach compounds including DD90 (figure 1) which is instant B7.
In relation to the R’ group of claim 1, Kaczmarek2016 teach dodecyl amine (C12 per figure 1) which is instant Sc12.
In relation to the R’’ group of claim 1, Kaczmarek2016 teach 4-(2-amino methyl) morpholine (figure 1 compound 90) which is instant S90.
In relation to the R’’’ group of claim 1, Kaczmarek2016 teach end capping group 118 (figure 1). Further, Prokopovich teach that the end-capping amine role in drug delivery showed that diethylenetriamine was more effective than ethylenediamine (structures shown in Table 3) which can be attributed to the longer chain helping the stability and the extra nitrogen resulting in a higher charge of the polymer conjugate (section 0179) where diethylenetriamine is instant E63.
In relation to the mRNA of claim 1, Kaczmarek2016 teach compounds including DD90-C12-122 which are combined with mRNA (figure 1 and first paragraph of experimental section on page 13811).
In relation to claim 10, Kaczmarek2016 teach specific ratios (page 13811 paragraph connecting columns 1-2).
In relation to claims 13-14, Kaczmarek2016 teach formulations with PEG-lipid (figure 1) specifically 7 mol % PEG-lipid (page 13808 2nd column, first complete paragraph).
In relation to claim 16, Kaczmarek2016 teach formulations with PEG-lipid (figure 1) specifically 7 mol % PEG-lipid (page 13808 2nd column, first complete paragraph).
In relation to claim 17, Kaczmarek2016 teach compounds including DD90-C12-122 which are combined with mRNA to form nanoparticles (figure 1 and first paragraph of experimental section on page 13811).
In relation to claim 19, Kaczmarek2016 teach compounds including DD90-C12-122 which are combined with mRNA to form nanoparticles (figure 1 and first paragraph of experimental section on page 13811).
In relation to claim 28, Prokopovich recognize drying under vacuum and lyophilization (sections 0152, 0159, 0162 0237) and the use of kits (sections 0192 and 0195) so one would have been motivated to prepare the compositions in the form of a kit for ease of use.
Response to Arguments - 103
Applicant's arguments filed 8/25/26 have been fully considered but they are not persuasive with respect to the rejections set forth above.
Although applicants argue that Katzmarek does not teach an example with the E63 group, MPEP 2123 recognizes that references are relevant for all that they contain. In relation to the R’’’ group of claim 1, Katzmarek suggest various end capping groups including the 8th group of claim 8 which is instant E63 (which is the same as instant E63 based on how it fits into the general formula; formula I of Katzmarek (claim 1) does not include an amine before the terminal D while instant formula I includes an amine before the terminal R’’’).
Although applicants argue that Kaczmarek does not suggest end-capping plays an important role in endosomal disruption, it is noted that the instant claims are not drawn to endosomal disruption. MPEP 2144 recognizes that the rationale to modify a reference can be different from applicant’s rationale.
Although applicants argue that Kaczmarek 2016 does not teach an example with the E63 group, MPEP 2123 recognizes that references are relevant for all that they contain.
Although applicants argue that Kaczmarek 2016 does not suggest end-capping plays an important role in endosomal disruption, it is noted that the instant claims are not drawn to endosomal disruption. MPEP 2144 recognizes that the rationale to modify a reference can be different from applicant’s rationale.
Although applicants argue that there is no motivation to combine with Prokopovich with an expectation of success, Kaczmarek2016 suggest varying the formulation components to access even more potent formulations (page 13810-13811 connecting paragraph) one would have been motivated to do such. Since Prokopovich teach that an investigation of the end-capping amine role in drug delivery showed that diethylenetriamine was more effective than ethylenediamine (structures shown in Table 3) (section 0179). One would have had a reasonable expectation of success based on the specific teachings and suggestions of Kaczmarek2016. For example, Kaczmarek2016 teach methods of synthesis (paragraph connecting columns 1-2 on page 13811). In addition, Prokopovich provide specific teachings related to cartilage. Cartilage is present in lungs which is expressly recited by Kaczmarek2016 (abstract).
Double Patenting
Claims were previously rejected under double patenting. Since the claims have been amended, the rejections are updated to correspond to the instant claims.
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, 10, 13-14, 16-17, 19 and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 7, 10, 14-15, 18, 20, 22-23, 27-28, 32, 37-38, 40, 42-44, 51-52, 54, 56-57 and 59 of copending Application No. 18/859,372 (reference application; ‘372’). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
372 recites nanoparticles that contain nucleic acids (claim 1a) specifically mRNA (claim 20) and a cationic polymer (claim 1a) specifically a PBAE (claim 27). 372 recites a formula of the PBAE (claim 28) and recites a specific compound that contains B7, S90, Sc12 and E63 (claims 37 and 43). In claim 43, 372 recite a specific formula and mRNA and a PEGylated lipid (claim 43). 372 recites various components including a buffer (claim 1b) and a PEG-lipid (claim 1c) in a specific amount (claim 15).
372 does not recite the specifics of claim 28.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 372 based on the specific teachings and suggestions of 372. Since 372 recite a specific formula and mRNA and a PEGylated lipid (claim 43) one would have been motivated to make such composition. Since 372 teach specific components and teach as nanoparticles (claim 1) one would have been motivated to make such nanoparticles and one would have been motivated to provide such components in an appropriate form for the preparation. One would have had a reasonable expectation of success based on the specific teachings and suggestions of 372.
In relation to the formula of claims 1 and 10, 372 recites a specific compound that contains B7, S90, Sc12 and E63 and refers to 50% (claims 37 and 43).
In relation to the mRNA of claim 1, 372 recite mRNA (claim 43).
In relation to the PEGylated lipid of claims 13-14, 372 recite a specific formula and mRNA and a PEGylated lipid (claim 43). 372 recites various components including a PEG-lipid (claim 1c) in a specific amount (claim 15).
In relation to claims 17 and 19, 372 teach specific components and teach as nanoparticles (claim 1) so one would have been motivated to make such nanoparticles in an appropriate amount.
In relation to claim 28, 372 teach specific components and teach as nanoparticles (claim 1) so one would have been motivated to provide such components in an appropriate form for the preparation.
Claims 1, 10, 13-14, 16-17, 19 and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6, 10-11, 15-18, 20-25, 27-32, 37-41, 47-50 and 57-60 of copending Application No. 18/684,083 (reference application; ‘083’). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
083 recites nanoparticles that contain nucleic acids (claim 1) specifically mRNA (claim 25). 083 recites a compound (claim 1) and recites specific groups in claim 11 and in claim 15 recites B7-S90,Sc12-E63 50%/50%. 083 recites specific amounts (claim 16). 083 recites the inclusion of a PEG-lipid at a particular amount (claim 20). 083 recites lyophilized forms (claim 30) and kits (claim 60).
083 does not recite a specific example with a specific compound and PEG-lipid.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 083 based on the specific teachings and suggestions of 083. Since 083 recite a specific formula (claim 15) and mRNA (claim 25) and a PEGylated lipid (claim 20) one would have been motivated to make such composition. One would have had a reasonable expectation of success based on the specific teachings and suggestions of 083.
In relation to the formula of claims 1 and 10, 083 recites specific groups in claim 11 and in claim 15 recites B7-S90,Sc12-E63 50%/50%.
In relation to the mRNA of claim 1, 083 recite mRNA (claim 25).
In relation to the PEGylated lipid of claims 13-14, 083 recites the inclusion of a PEG-lipid at a particular amount (claim 20)
In relation to claims 16-17 and 19, 083 recites nanoparticles (claim 1) and specific amounts (claim 16).
In relation to claim 28, 083 recites kits (claim 60).
Response to Arguments – Double Patenting
Applicant's arguments filed 8/25/26 have been fully considered but they are not persuasive with respect to the rejections set forth above.
Although applicants argue about situations in which a provisional double patenting rejection is the only rejection remaining, such fact pattern does not currently exist (see 103 rejections above).
Conclusion
Applicant's amendment necessitated any 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658
Prosecution Insights