DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Amendment after Non-final office action filed on 7/22/2026 is acknowledged.
3. Claim filed on 7/22/2026 is acknowledged.
4. Claims 2, 4, 6-10, 12, 14-17, 19, 20, 22-25, 28, 30-33, 37, 39, 40, 42-45, 47-53, 55-59 and 63-65 have been cancelled.
5. Claims 1, 3, 5, 11, 13, 18, 21, 26, 27, 29, 34-36, 38, 41, 46, 54, 60-62 and 66-68 are pending in this application.
6. Claims 41, 46 and 54 remain withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. Claim 38 remains withdrawn from consideration as being drawn to non-elected species.
7. Applicant elected without traverse Group 1 (claims 1-3, 5, 11-13, 18, 21, 26, 27, 29-31, 34-36, 38 and 60-65) and elected a composition comprising complexes of (i) firefly luciferase (Fluc) mRNA, (ii) DMG-PEG 2000, and (iii) compound 30 with the structure
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as species of composition in the reply filed on 3/7/2025.
Restriction requirement was deemed proper and made FINAL in the previous office actions. Group 1 is drawn to a composition comprising: one or more polyanionic compounds; one or more polyethylene glycol (PEG) compounds; and one or more cationic compounds, wherein the one or more cationic compounds have a structure of formula (la) or a salt thereof; and wherein the one or more cationic compounds, the one or more PEG compounds and the one or more polyanionic compounds have a combined mass percentage of at least 90% w/w of the composition. A search was conducted on the elected species; and this appears to be free of prior art. A search was extended to the genus in claim 1; and prior art was found. Claim 38 remains withdrawn from consideration as being drawn to non-elected species. Claims 1, 3, 5, 11, 13, 18, 21, 26, 27, 29, 34-36, 60-62 and 66-68 are examined on the merits in this office action.
Claim Interpretations
8. The interpretation of instant claims 66-68 remains as what set forth in the previous office actions. And such interpretation applies to all the rejections set forth below.
Withdrawn Objections and Rejections
9. Objection to claims 1, 18, 61 and 65 is hereby withdrawn in view of Applicant’s amendment to the claim.
10. Rejection to claims 65 and 66 under 35 U.S.C. 112(d) or 35 U.S.C. 112 (pre-AIA ), 4th paragraph is hereby withdrawn in view of Applicant’s amendment to the claim.
11. Rejections to claims 1, 5, 11, 13, 18, 21, 26, 27, 29, 34-36, 66 and 67 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims of co-pending Application No. 17/998574 and co-pending Application No. 18/681132; and in view of the combined teachings of Burkoth et al (US 2006/0019912 A1, filed with IDS) and Dong et al (WO 2016/187531 A1, filed with IDS) with routine optimization are hereby withdrawn in view of the change of Applicant in instant application.
Maintained/Revised Rejections
Claim Rejections - 35 U.S.C. § 103
12. 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 of this title, 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.
13. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
14. Claims 1, 5, 11, 13, 18, 21, 26, 27, 29, 34-36, 66 and 67 remain rejected under 35 U.S.C. 103 as being unpatentable over Burkoth et al (US 2006/0019912 A1, filed with IDS) and in view of Dong et al (WO 2016/187531 A1, filed with IDS).
The instant claims 1, 5, 11, 13, 18, 21, 26, 27, 29, 34-36, 66 and 67 are drawn to a composition comprising: one or more polyanionic compounds; one or more polyethylene glycol (PEG) compounds; and one or more cationic compounds, wherein the one or more cationic compounds have a structure of formula (la) or a salt thereof; and wherein the one or more cationic compounds, the one or more PEG compounds and the one or more polyanionic compounds have a combined mass percentage of at least 90% w/w of the composition.
Burkoth et al, throughout the patent, teach a composition for delivery of a variety of polynucleotides; wherein the composition is in the form of lipid-conjugated polyamide compound-based delivery vehicles; wherein the variety of polynucleotides can be plasmid DNA, RNA, antisense oligonucleotides and siRNA; and wherein the composition comprises complexes comprising the polynucleotides and one or more cationic compounds with the structure
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, for example, Abstract; Figure 1; page 1, paragraphs [0002] and [0007]; page 2, paragraph [0027]; page 3, paragraph [0035]; page 4, paragraph [0059]; and page 5, paragraph [0069]. It meets the limitations of the one or more polyanionic compounds and the one or more cationic compounds have a structure of formula (la) recited in instant claim 1; and the limitations of instant claims 5, 11, 13, 18, 21, 26, 34, 66 and 67. Burkoth et al further teach such lipid-conjugated polyamide compounds typically form concentration-dependent, ordered two- or three-dimensional structures in solution, including micelles and liposomes, for example, page 9, paragraph [0123].
The difference between the reference and instant claims 1, 5, 11, 13, 18, 21, 26, 27, 29, 34-36, 66 and 67 is that the reference does not explicilty teach the limitations “one or more polyethylene glycol (PEG) compounds” and “wherein the one or more cationic compounds, the one or more PEG compounds and the one or more polyanionic compounds have a combined mass percentage of at least 90% w/w of the composition” recited in instant claim 1; and the limitations of instant claims 27, 29, 35 and 36.
However, Dong et al, throughout the patent, teach lipid-like nanoparticle for delivery of therapeutic, diagnostic, or prophylactic agents, such as polynucleotide; and a composition for delivery of such agent, wherein the composition comprises a compound of Formula I, a polyethylene glycol-lipid, and such agent; wherein the compound of Formula I can be one of TT2 to TT8, the polyethylene glycol-lipid can be DMG-PEG2000, and the agent can be a polynucleotide, such as siRNA, mRNA encoding a protein and/or peptide, or plasmid DNA, for example, Abstract; page 5, line 1 to page 6, line 3; page 19, lines 29-30; and Figures 1-3. Dong et al further teach the advantage of having PEG-lipid in the composition, in that PEG-lipid forms a hydrophilic outer layer and stabilize the particles, for example, page 48, lines 15-16. Dong et al also teach optimizing the ratio of DMG-PEG2000 to obtain lipid-like nanoparticle with both improved stability and higher delivery efficiency, for example, page 80, lines 28-30.
Therefore, it would have been obvious to one of ordinary skilled in the art to combine the teachings of Burkoth et al and Dong et al to develop a composition for delivery of a variety of polynucleotides; wherein the composition is in the form of lipid-conjugated polyamide compound-based delivery vehicles; wherein the variety of polynucleotides can be plasmid DNA, RNA such as mRNA encoding a protein and/or peptide, antisense oligonucleotides and siRNA; and wherein the composition comprises polynucleotides, polyethylene glycol-lipid such as DMG-PEG2000, and one or more cationic compounds with the structure
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.
Furthermore, one of ordinary skilled in the art would have been motivated to optimize the amount and/or ratio of the cationic compounds, the polyethylene glycol-lipid, and the polynucleotide in the composition for better/efficient delivery of the polynucleotide, including the cationic compounds, the polyethylene glycol-lipid and the polynucleotide have a combined mass percentage of at least 90% w/w of the composition recited in instant claim 1; the cationic compounds and the polyethylene glycol-lipid are present at a mass ratio of the cationic compounds-to-polyethylene glycol-lipid between 90:10 and 99:1 recited in instant claim 27; and the mass ratio of the cationic compounds to the polynucleotide is between 0.5:1 and 20:1 recited in instant claim 35, because Dong et al teach optimizing the ratio of DMG-PEG2000 to obtain lipid-like nanoparticle with both improved stability and higher delivery efficiency. And, the MPEP states the following: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) (see MPEP § 2144.05 II A).
One of ordinary skilled in the art would have been motivated to combine the teachings of Burkoth et al and Dong et al with routine optimization to develop a composition for delivery of a variety of polynucleotides; wherein the composition is in the form of lipid-conjugated polyamide compound-based delivery vehicles; wherein the variety of polynucleotides can be plasmid DNA, RNA such as mRNA encoding a protein and/or peptide, antisense oligonucleotides and siRNA; and wherein the composition comprises complexes comprising polynucleotides, polyethylene glycol-lipid such as DMG-PEG2000, and one or more cationic compounds with the structure
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; wherein the cationic compounds, the polyethylene glycol-lipid and the polynucleotide have a combined mass percentage of at least 90% w/w of the composition; the cationic compounds and the polyethylene glycol-lipid are present at a mass ratio of the cationic compounds-to-polyethylene glycol-lipid between 90:10 and 99:1; and the mass ratio of the cationic compounds to the polynucleotide is between 0.5:1 and 20:1, because similar to Burkoth et al, Dong et al, throughout the patent, teach lipid-like nanoparticle for delivery of therapeutic, diagnostic, or prophylactic agents, such as polynucleotide; and a composition for delivery of such agent, wherein the composition comprises a compound of Formula I, a polyethylene glycol-lipid, and such agent; wherein the compound of Formula I can be one of TT2 to TT8, the polyethylene glycol-lipid can be DMG-PEG2000, and the agent can be a polynucleotide, such as siRNA, mRNA encoding a protein and/or peptide, or plasmid DNA. Dong et al further teach the advantage of having PEG-lipid in the composition, in that PEG-lipid forms a hydrophilic outer layer and stabilize the particles. Furthermore, one of ordinary skilled in the art would have been motivated to optimize the amount and/or ratio of the cationic compounds, the polyethylene glycol-lipid, and the polynucleotide in the composition for better/efficient delivery of the polynucleotide, including the cationic compounds, the polyethylene glycol-lipid and the polynucleotide have a combined mass percentage of at least 90% w/w of the composition recited in instant claim 1; the cationic compounds and the polyethylene glycol-lipid are present at a mass ratio of the cationic compounds-to- polyethylene glycol-lipid between 90:10 and 99:1 recited in instant claim 27; and the mass ratio of the cationic compounds to the polynucleotide is between 0.5:1 and 20:1 recited in instant claim 35, because Dong et al explicitly teach optimizing the ratio of DMG-PEG2000 to obtain lipid-like nanoparticle with both improved stability and higher delivery efficiency. And, the MPEP states the following: 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 (see MPEP § 2144.05 II A).
A person of ordinary skilled in the art would have reasonable expectation of success in combining the teachings of Burkoth et al and Dong et al with routine optimization to develop a composition for delivery of a variety of polynucleotides; wherein the composition is in the form of lipid-conjugated polyamide compound-based delivery vehicles; wherein the variety of polynucleotides can be plasmid DNA, RNA such as mRNA encoding a protein and/or peptide, antisense oligonucleotides and siRNA; and wherein the composition comprises complexes comprising polynucleotides, polyethylene glycol-lipid such as DMG-PEG2000, and one or more cationic compounds with the structure
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; wherein the cationic compounds, the polyethylene glycol-lipid and the polynucleotide have a combined mass percentage of at least 90% w/w of the composition; the cationic compounds and the polyethylene glycol-lipid are present at a mass ratio of the cationic compounds-to- polyethylene glycol-lipid between 90:10 and 99:1; and the mass ratio of the cationic compounds to the polynucleotide is between 0.5:1 and 20:1.
Response to Applicant's Arguments
15. Applicant argues that “The Office relies on Dong for PEG-lipid stabilization and reasons that the amounts and ratios would have been optimized.”; “Nor does Dong provide a reasonable expectation that importing PEG-lipid into Burkoth would yield the claimed high-active-fraction composition.”; and “The present rejection identifies that both references concern nucleic-acid delivery particles and that Dong uses PEG-lipid for stabilization, but it does not adequately explain why a skilled artisan would have modified Burkoth's delivery vehicles using Dong's formulation-specific PEG-lipid teaching, or why there would have been a reasonable expectation of obtaining the claimed high-active-fraction composition in view of Dong's disclosed delivery-efficiency/stability tradeoff.”
16. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant's arguments about instant rejection, the Examiner agrees that none of the cited references individually teaches or suggests the composition recited in instant claims 1, 5, 11, 13, 18, 21, 26, 27, 29, 34-36, 66 and 67; and none of the cited references anticipates the composition recited in instant claims 1, 5, 11, 13, 18, 21, 26, 27, 29, 34-36, 66 and 67. However, the Examiner would like to point out that instant claims 1, 5, 11, 13, 18, 21, 26, 27, 29, 34-36, 66 and 67 are rejected under 35 U.S.C. 103 (obviousness type), and the rejection is based on the combined teachings of Burkoth et al and Dong et al with routine optimization, it is not necessary for each of the cited references to teach all the limitations of instant claims. Furthermore, the Examiner would like to point out that the MPEP states "One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references…" (see MPEP § 2145 IV).
In response to Applicant's arguments about instant rejection:
First, the Examiner would like to point out that the instant claimed composition is one comprising the recited components. And as stated in MPEP: “The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps.” (see MPEP § 2111.03). Therefore, the instant claimed composition does not exclude additional components, such as the components in the lipid-like nanoparticle taught in Dong et al.
Second, with regards to the routine optimization in the rejection set forth in Section 14 above, the Examiner would like to point out that the routine optimization in the rejection set forth in Section 14 above is not entirely relied on the cited Dong et al reference. In the instant case, Dong et al is cited to teach optimizing the ratio of DMG-PEG2000 to obtain lipid-like nanoparticle with both improved stability and higher delivery efficiency.
Third, as stated in the previous office action, the Examiner understands that the cationic compounds in the composition for delivering a polynucleotide, such as siRNA, mRNA encoding a protein or peptide, or plasmid DNA in Dong et al is not the same as either the cationic compounds in Burkoth et al or the compounds of instant formula (la) recited in instant claims. However, in the instant case, both Burkoth et al and Dong et al teach delivering agent such as polynucleotide with lipid-like or lipid-based particles. And Dong et al explicitly teach the advantage of having PEG-lipid in the composition, in that PEG-lipid forms a hydrophilic outer layer and stabilize the particles. Furthermore, there is also no evidence that the advantage of having PEG-lipid in the composition taught in Dong et al is limited to the lipid-like particles in Dong et al only; and such advantage would not apply to other lipid-like or lipid-based particles, including the lipid-based particles in Burkoth et al, such as micelles and liposomes. Therefore, in the instant case, in view of the combined teachings of Burkoth et al and Dong et al as a whole as set forth in Section 14 above, one of ordinary skilled in the art would understand and reasonably expect that the advantage of having PEG-lipid in the composition taught in Dong et al would apply to lipid-like or lipid-based particles in general. Thus, in the instant case, in view of the combined teachings of Burkoth et al and Dong et al with routine optimization as set forth in Section 14 above, one of ordinary skilled in the art would have been motivated to develop the composition recited in instant claims 1, 5, 11, 13, 18, 21, 26, 27, 29, 34-36, 66 and 67. Furthermore, the Examiner would like to point out that in the instant case, the motivation to combine the cited prior art references is explicitly taught in Dong et al. And there is no such requirement that Burkoth et al need to provide motivation to combined the cited prior art references (see MPEP § 2143.01). With regards to Applicant’s arguments about the effect of PEGylation discussed in Dong et al, the Examiner would like to point out that in this case, Dong et al explicitly teach optimizing the ratio of DMG-PEG2000 to obtain lipid-like nanoparticle with both improved stability and higher delivery efficiency. It is unclear to the Examiner that in view of the teachings of Dong et al as a whole, why and/or how one of ordinary skilled in the art would treat such teachings as no reasonable expectation of success. Further clarification is required.
Taken all these together, in view of the combined teachings of Burkoth et al and Dong et al with routine optimization as set forth in Section 14 above, a person of ordinary skilled in the art would have reasonable expectation of success to develop the composition recited in instant claims 1, 5, 11, 13, 18, 21, 26, 27, 29, 34-36, 66 and 67. In addition, with regards to the expectation of success, the MPEP states: “Absolute predictability is not a necessary prerequisite to a case of obviousness. Rather, a degree of predictability that one of ordinary skill would have found to be reasonable is sufficient. The Federal Circuit concluded that “[g]ood science and useful contributions do not necessarily result in patentability.” Id. at 1364, 83 USPQ2d at 1304.” (see MPEP § 2145).
Therefore, the rejection is deemed proper and is hereby maintained.
Obviousness Double Patenting
17. 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
18. (Revised due to Applicant’s amendment to the claim) Claims 1, 3, 5, 11, 13, 18, 26, 27, 29, 34-36, 60-62 and 66-68 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-26 of US patent 11446394 B2.
19. Instant claims 1, 3, 5, 11, 13, 18, 26, 27, 29, 34-36, 60-62 and 66-68 are drawn to a composition comprising: one or more polyanionic compounds; one or more polyethylene glycol (PEG) compounds; and one or more cationic compounds, wherein the one or more cationic compounds have a structure of formula (la) or a salt thereof; and wherein the one or more cationic compounds, the one or more PEG compounds and the one or more polyanionic compounds have a combined mass percentage of at least 90% w/w of the composition.
20. Claims 1-26 of US patent 11446394 B2 are drawn to a composition, comprising complexes of: one or more polyanionic compounds; and lipid components, wherein the lipid components comprise: (i) optionally one or more structural lipids; (ii) one or more phospholipids; (iii) one or more shielding lipids; and (iv) one or more tertiary amino lipidated and/or PEGylated cationic peptide compounds of formula (I) or salts thereof; and a method of delivering a polyanionic compound to a cell comprising contacting the cell with the composition of claim 1.
In the instant case, in view of the combined teachings of claims 1-26 of US patent 11446394 B2, it would have been obvious to one of ordinary skilled in the art to develop a composition comprising complexes of: one or more polyanionic compounds, such as mRNA encoding a polypeptide; one or more PEG compounds such as DMG-PEG2000; and one or more cationic compounds such as those recited in claim 24 of US patent 11446394 B2.
Furthermore, one of ordinary skilled in the art would have been motivated to optimize the amount and/or ratio of the cationic compounds, the PEG compounds, and the polyanionic compounds such as mRNA in the composition for better/efficient delivery of the polyanionic compounds such as mRNA, including the one or more cationic compounds, the one or more PEG compounds and the one or more polyanionic compounds have a combined mass percentage of at least 90% w/w of the composition recited in instant claim 1; the cationic compounds and the PEG compounds are present at a mass ratio of the cationic compounds-to-PEG compounds between 90:10 and 99:1 recited in instant claim 27; and the mass ratio of the cationic compounds to the nucleic acid is between 0.5:1 and 20:1 recited in instant claim 35. And, the MPEP states the following: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) (see MPEP § 2144.05 II A).
21. (Revised due to Applicant’s amendment to the claim) For the same/similar reasoning/rational as the rejection set forth in Sections 18-20 above, instant claims 1, 3, 5, 11, 13, 18, 21, 26, 27, 60-62 and 66-68 remain provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 11, 13, 36, 38, 57, 60, 64, 66, 72, 74, 77, 81, 84, 87, 93, 131, 137 and 139 of co-pending Application No. 18/020246 with routine optimization.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
22. Claims 1, 5, 11, 13, 18, 21, 26, 27, 29, 34-36, 66 and 67 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-16 of US patent 11879126 B2 in view of Burkoth et al (US 2006/0019912 A1, filed with IDS) and Dong et al (WO 2016/187531 A1, filed with IDS).
23. Instant claims 1, 5, 11, 13, 18, 21, 26, 27, 29, 34-36, 66 and 67 are drawn to a composition comprising: one or more polyanionic compounds; one or more polyethylene glycol (PEG) compounds; and one or more cationic compounds, wherein the one or more cationic compounds have a structure of formula (la) or a salt thereof; and wherein the one or more cationic compounds, the one or more PEG compounds and the one or more polyanionic compounds have a combined mass percentage of at least 90% w/w of the composition.
24. Claims 1-16 of US patent 11879126 B2 are drawn to a therapeutic mRNA composition; and a therapeutic mRNA composition comprising a single mRNA scaffold encapsulated in a delivery vehicle, wherein the delivery vehicle is selected from the group consisting of wherein the delivery vehicle is selected from the group consisting of lipid nanoparticles, polymer-based nanoparticles, cationic lipids, ionizable lipids, amino-lipidated peptoids, amphipathic molecules/nanoparticles, and tertiary amino lipidated cationic peptoids.
25. The difference between claims 1-16 of US patent 11879126 B2 and instant claims 1, 5, 11, 13, 18, 21, 26, 27, 29, 34-36, 66 and 67 is that claims 1-16 of US patent 11879126 B2 does not explicilty teach the delivery vehicle comprises one or more polyethylene glycol (PEG) compounds and one or more cationic compounds recited in instant claims 1, 5, 11, 13, 18, 21, 26, 27, 29, 34-36, 66 and 67.
However, in view of the combined teachings of Burkoth et al and Dong et al with routine optimization as set forth in Section 14 above, it would have been obvious to one of ordinary skilled in the art to modify the therapeutic mRNA composition recited in claims 1-16 of US patent 11879126 B2 and develop the composition recited in instant claims 1, 5, 11, 13, 18, 21, 26, 27, 29, 34-36, 66 and 67.
26. For the same/similar reasoning/rational as the rejection set forth in Sections 22-25 above, instant claims 1, 5, 11, 13, 18, 21, 26, 27, 29, 34-36, 66 and 67 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-5 and 8-19 of US patent 12011478 B2; and claims 1-7 of US patent 12121577 B1; and in view of the combined teachings of Burkoth et al (US 2006/0019912 A1, filed with IDS) and Dong et al (WO 2016/187531 A1, filed with IDS) with routine optimization as set forth in Section 14 above.
27. For the same/similar reasoning/rational as the rejection set forth in Sections 22-25 above, instant claims 1, 5, 11, 13, 18, 21, 26, 27, 29, 34-36, 66 and 67 remain provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 8-13 and 16-21 of co-pending Application No. 18/759011; claims 56, 60 and 63 of co-pending Application No. 18/867199; claims 1-18 and 29 of co-pending Application No. 18/995050; and claims 62-66 and 69-75 of co-pending Application No. 19/167922; and in view of the combined teachings of Burkoth et al (US 2006/0019912 A1, filed with IDS) and Dong et al (WO 2016/187531 A1, filed with IDS) with routine optimization as set forth in Section 14 above.
These are all provisional obviousness-type double patenting rejections because the conflicting claims have not in fact been patented.
Response to Applicant's Arguments
28. For the ODP rejection over claims of U.S. Patent No. 11446394, Applicant argues that claims of U.S. Patent No. 11446394 comprise extra components and do not teach the amounts, percentages and/or ratios recited in instant claims; and that claims of U.S. Patent No. 11446394 do not teach or suggest optimizing the amounts, percentages and/or ratios recited in instant claims. The same/similar arguments are presented for the ODP rejection over claims of co-pending Application No. 18/020246.
For all the ODP rejections with further in view of Burkoth et al (US 2006/0019912 A1, filed with IDS) and Dong et al (WO 2016/187531 A1, filed with IDS), Applicant presents the same and/or similar arguments as what in Section 15 above.
29. Applicant's arguments have been fully considered but have not been found persuasive.
With regards to Applicant’s arguments about the ODP rejection over claims of U.S. Patent No. 11446394 and co-pending Application No. 18/020246, first, the Examiner would like to point out that the instant claimed composition is one comprising the recited components. And as stated in MPEP: “The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps.” (see MPEP § 2111.03). Therefore, the instant claimed composition does not exclude extra components, such as the components recited in claims of U.S. Patent No. 11446394 and co-pending Application No. 18/020246. Second, as stated in Section 20 above, in the instant case, one of ordinary skilled in the art would have been motivated to optimize the amount and/or ratio of the cationic compounds, the PEG compounds, and the polyanionic compounds such as mRNA in the composition for better/efficient delivery of the polyanionic compounds such as mRNA, including the one or more cationic compounds, the one or more PEG compounds and the one or more polyanionic compounds have a combined mass percentage of at least 90% w/w of the composition recited in instant claim 1; the cationic compounds and the PEG compounds are present at a mass ratio of the cationic compounds-to-PEG compounds between 90:10 and 99:1 recited in instant claim 27; and the mass ratio of the cationic compounds to the nucleic acid is between 0.5:1 and 20:1 recited in instant claim 35. The MPEP states the following: 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 (see MPEP § 2144.05 II A). And in the instant case, other than statements/arguments, Applicant fails to provide any data and/or evidence to indicate the amount and/or ratio of the cationic compounds, the PEG compounds, and the polyanionic compounds such as mRNA in the composition recited in instant claims are critical. Applicant also fails to provide any reasoning and/or evidence to indicate the amount and/or ratio of the cationic compounds, the PEG compounds, and the polyanionic compounds such as mRNA in the composition recited in instant claims cannot be achieved via routine optimization.
With regards to Applicant’s arguments about all the ODP rejections with further in view of Burkoth et al (US 2006/0019912 A1, filed with IDS) and Dong et al (WO 2016/187531 A1, filed with IDS), Applicant’s arguments have been addressed in Section 16 above.
Taken all these together, these double patenting rejections are deemed proper. And until a proper terminal disclaimer is filed and approved by the Office, these double patenting rejections are hereby maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
No claim is allowed.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658
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