A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/21/2026 has been entered.
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 Final office action filed on 1/21/2026 is acknowledged.
3. Claim filed on 1/21/2026 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, 63 and 64 have been cancelled.
5. Claims 1, 3, 5, 11, 13, 18, 21, 26, 27, 29, 34-36, 38, 41, 46, 54, 60-62 and 65-68 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 Claims 41, 46 and 54 remain withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. Claim 38 remains withdrawn from consideration as being drawn to non-elected species.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 Claim 38 remains withdrawn from consideration as being drawn to non-elected species.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 65-68 are examined on the merits in this office action.
Non-compliant Amendment
8. The claim filed on 1/21/2026 is a non-compliant amendment. In the claim filed on 1/21/2026, Applicant deletes the period at the end of claim 65. However, Applicant fails to indicate such change made in claim 65 and also fails to update the status identifier for claim 65 (see MPEP § 714).
Claim Interpretations
9. As stated in the previous office action, with regards to the limitations recited in instant claims 66-68, in the instant case, claims 66-68 depend on claim 1, and include all the limitations recited in instant claim 1. Therefore, the Examiner is interpreting the composition recited in instant claims 66-68 include all the limitations recited in instant claim 1 with further limitation of the R4 group in the formula (la) recited in instant claim 1. And since either o or q recited in instant formula (la) can be 0, the one or more cationic compounds in the composition recited in instant claims 66-68 are not required to have the recited R4 group when both o and q are 0; and the limitations regarding R4 group recited in instant claims 66-68 only applies to the cationic compounds have a structure of formula (la) or a salt thereof with R4 group presented. Such interpretation applies to all the rejections set forth below.
Withdrawn Objections and Rejections
10. Objection to claims 21, 27, 29, 35, 36 and 60 is hereby withdrawn in view of Applicant’s amendment to the claim.
11. Rejection to claims 62 and 67 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.
12. Rejection to claims 1, 3, 5, 11, 13, 18, 26, 27, 34-36, 60-62 and 65-68 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 52-59, 61 and 64-70 of co-pending Application No. 17/279508 with routine optimization is hereby withdrawn in view of the abandonment of Application No. 17/279508.
Maintained/Revised Objections
13. (Revised due to Applicant’s amendment to the claim) Claim 1 remains objected to for the following minor informality: Applicant is suggested to amend claim 1 as “…each R4 is…a C1-C4-alkyl substituted by cycloalkyl, heterocyclylalkyl, alkylaryl, arylalkyl, alkylheteroaryl, heteroarylalkyl, alkoxy, alkoxyalkyl, or hydroxyalkyl, and wherein…one or more substituents selected from -OH, halo, or alkoxy…”.
14. (Revised due to Applicant’s amendment to the claim) Claim 18 remains objected to for the following minor informality: Applicant is suggested to amend claim 18 as “…or hydroxyalkyl; and wherein each cycloalkyl…one or more substituents selected from -OH, halo, or alkoxy”.
15. (Revised due to Applicant’s amendment to the claim) Claim 61 remains objected to for the following minor informality: Applicant is suggested to amend claim 61 as “…each R4 is…one or more substituents selected from -OH, halo, or alkoxy…”.
Response to Applicant's Arguments
16. Applicant fails to address all the minor issues in these claims. Therefore, these objections are deemed proper and are hereby maintained.
Maintained/Revised Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (d)
17. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
18. Claims 65 and 66 remain rejected under 35 U.S.C. 112(d) or 35 U.S.C. 112 (pre-AIA ), 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
19. Claim 65 depends on claim 1; and claim 65 recites “The composition of claim 1, wherein the one or more cationic compounds of formula (Ia) comprise one or more of compounds 1-36, 41, 42, 44, 49-52, 57-60, 65-68, 73-88, 91-100, 102, 103, and 111-118…”. However, some of the compounds 1-36, 41, 42, 44, 49-52, 57-60, 65-68, 73-88, 91-100, 102, 103, and 111-118 recited in instant claim 65 do not meet the limitations of the cationic compounds of formula (Ia) recited in instant claim 1. As an example, compound 67 with the structure
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does not meet the limitations of the cationic compounds of formula (Ia) recited in instant claim 1. Therefore, the scope of the cationic compounds of formula (Ia) recited in claim 65 is broader than that of the cationic compounds of formula (Ia) recited in instant claim 1. Claim 65 does not further limit the scope of the cationic compounds of formula (Ia) recited in instant claim 1; therefore, claim 65 is improper dependent forms for failing to further limit the subject matter of claim 1.
Furthermore, in order to overcome this rejection, Applicant is required to remove all the compounds that do not meet the limitations of the cationic compounds of formula (Ia) recited in instant claim 1.
20. Claim 66 depends on claim 1; and claim 66 recites various limitations of R4 group. In the instant case, the R4 group recited in instant claim 66 is broader than the R4 group in the compound having a structure of formula (la) or a salt thereof recited in instant claim 1. Therefore, the scope of the compound having a structure of formula (la) or a salt thereof recited in claim 66 is broader than that of the compound having a structure of formula (la) or a salt thereof recited in instant claim 1. Claim 66 does not further limit the scope of the compound having a structure of formula (la) or a salt thereof recited in instant claim 1; therefore, claim 66 is improper dependent forms for failing to further limit the subject matter of claim 1.
Response to Applicant's Arguments
21. Applicant argues that “The Office's rejection has not been fully explained and it is unclear to Applicant as to how or why the Office construes that Compound 67, for example, does not fall within the scope of claim 1…Compound 67 falls within the scope of formula (Ia) of amended claim 1.”; and “Applicant respectfully disagrees with the rejection of claim 66 and submits that the recited R4 groups fall within the subject matter of the compound of amended claim 1.”
22. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant's arguments about the rejection to instant claim 65, in the instant case, first, the Examiner would like to point out that it is the Examiner’s position that Applicant is fully capable of determining and/or understanding why the compound 67 with the structure
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does not meet the limitations of the cationic compounds of formula (Ia) recited in instant claim 1. It is unclear to the Examiner what kind of additional explanation is needed by Applicant. Further clarification is required. Second, the Examiner would like to point out that the schematic illustration of compound 67 presented by Applicant is incorrect. In the instant case, the Examiner would like to point out that the part with the structure
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in instant compound 67 meets the limitations of the part with the structure
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in instant formula (Ia). However, the part with the structure
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in instant compound 67 does not meets the limitation of the part with the structure
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in instant formula (Ia). Furthermore, as stated in Section 19 above, in order to overcome this rejection, Applicant is required to remove all the compounds that do not meet the limitations of the cationic compounds of formula (Ia) recited in instant claim 1. And as stated above, it is the Examiner’s position that Applicant is fully capable of determining and/or understanding any other compound that does not meet the limitations of the cationic compounds of instant formula (Ia) recited in instant claim 1.
In response to Applicant's arguments about the rejection to instant claim 66, R4 being C1-C5 straight chain alkyl recited in instant claim 66 does not meet the limitations of the R4 group in the cationic compounds of instant formula (Ia) recited in instant claim 1, in that the R4 group in the cationic compounds of instant formula (Ia) recited in instant claim 1 is C8-C24 alkyl and others.
Taken all these together, these rejections are deemed proper and are hereby maintained.
Claim Rejections - 35 U.S.C. § 103
23. 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.
24. 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.
25. (Revised) 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
26. Applicant argues that “there was no motivation to modify Burkoth and, further, there was no reasonable expectation of success for combining with Dong“ by arguing about each of the cited Burkoth et al and Dong et al references individually in that: “Burkoth does not provide any motivation, implicitly or explicitly, to modify its delivery system to arrive at the present claims with any reasonable expectation of success.”; and “Dong is directed to a distinct set of compounds that are different to both the cationic compounds of the present application and the lipid-conjugated compounds of Burkoth…Dong itself highlights that that there is a requirement for fine-tuning of the components in the presence of particular compounds: "PEGylation of TT3 LLNs improved particle stability and reduced particle size but hindered delivery efficiency." Dong at page 80. Thus, based on the teachings of Dong, there is no reasonable expectation of success in combining the compositions of the different lipid-conjugated polyamide compounds of Burkoth with the PEG compounds of the Dong publication. Moreover, Burkoth does not provide any apparent reason to modify in the first instance.”
27. 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, 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. Therefore, in view of the combined teachings of Burkoth et al and Dong et al as a whole as set forth in Section 25 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 25 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 on page 80 of 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 25 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).
Taken all these together, the rejection is deemed proper and is hereby maintained.
Obviousness Double Patenting
28. 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.
29. Claims 1, 3, 5, 11, 13, 18, 26, 27, 29, 34-36, 60-62 and 65-68 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-26 of US patent 11446394 B2.
30. Instant claims 1, 3, 5, 11, 13, 18, 26, 27, 29, 34-36, 60-62 and 65-68 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.
31. 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).
32. For the same/similar reasoning/rational as the rejection set forth in Sections 29-31 above, instant claims 1, 3, 5, 11, 13, 18, 21, 26, 27, 60-62 and 65-68 remain provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 5, 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.
33. 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).
34. 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.
35. 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.
36. 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 25 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.
37. For the same/similar reasoning/rational as the rejection set forth in Sections 33-36 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 25 above.
38. For the same/similar reasoning/rational as the rejection set forth in Sections 33-36 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 12, 13, 15-26 and 30-37 of co-pending Application No. 17/998574; claims 1, 2, 4, 6-14 and 16-24 of co-pending Application No. 18/681132; and claims 1-18 and 29 of co-pending Application No. 18/995050; 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 25 above.
These are all provisional obviousness-type double patenting rejections because the conflicting claims have not in fact been patented.
Please note: co-pending Application Nos. 17/998574 and 18/681132 share the same Applicant (UTCRACKER THERAPEUTICS, INC.) with instant application.
Response to Applicant's Arguments
39. For the ODP rejection over claims of U.S. Patent No. 11446394, Applicant argues that “U.S. Patent No. 11,446,394 is directed to compositions comprising complexes of a polyanionic compound, a phospholipid, a shielding lipid, and a cationic peptide. The cationic compounds claimed in U.S. Patent No. 11,446,394 are not the same as those claimed in the present application. See e.g., compound of formula (I) of U.S. Patent No. 11,446,394 that does not include any R4 moieties.”
For the ODP rejection over claims of U.S. Application No. 18/020,246, Applicant argues that “U.S. Application No. 18/020,246 is directed to systems for delivery comprising a cationic compound, an anionic or zwitterionic component, a non-cationic component and a shielding component, not a composition comprising, for example one or more polyethylene glycol (PEG) compounds, wherein the components of the composition including the PEG compounds have a combined mass percentage of at least 90% w/w of the composition.”
For the ODP rejection over claims of U.S. Patent No. 11879126, Applicant argues that “U.S. Patent No. 11,879,126 is directed to a therapeutic mRNA composition comprising specified mRNA scaffolds encapsulated in a delivery vehicle.”
For the ODP rejections over claims of US patent 12011478 B2 and claims of US patent 12121577 B1, Applicant argues that claims of these patent are directed to mRNA. Similar arguments are also presented for the ODP rejections over claims of U.S. Application No. 17/998,574 and claims of co-pending Application No. 18/681,132.
40. 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 US patent 11446394 B2, the Examiner would like to point out that both 0 and q in instant formula (Ia) can be 0. Therefore, the compound of instant formula (Ia) does not require to have a R4 group. Furthermore, as stated in Section 31 above, in the instant case, in view of the combined teachings of claims 1-26 of US patent 11446394 B2 with routine optimization, it would have been obvious to one of ordinary skilled in the art to develop a composition recited in instant claims 1, 3, 5, 11, 13, 18, 26, 27, 29, 34-36, 60-62 and 65-68.
With regards to Applicant’s arguments about the ODP rejection over claims of U.S. Application No. 18/020,246, first, it is unclear to the Examiner how and/or why the term “system” recited in claims of co-pending Application No. 18/020246 can’t be a composition. Further clarification is required. Second, similar to the ODP rejection over claims of US patent 11446394 B2, in the instant case, in view of the combined teachings of claims 1, 5, 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, it would have been obvious to one of ordinary skilled in the art to develop a composition recited in instant claims 1, 3, 5, 11, 13, 18, 26, 27, 29, 34-36, 60-62 and 65-68.
With regards to Applicant’s arguments about the ODP rejections over claims of U.S. Patent No. 11879126, claims of US patent 12011478 B2, claims of U.S. Patent No. 12/121,577, claims of U.S. Application No. 17/998,574 and claims of U.S. Application No. 18/681,132, the Examiner would like to point out these ODP rejections are based on further in view of the combined teachings of Burkoth et al and Dong et al with routine optimization as set forth in Section 25 above. 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 25 above, it would have been obvious to one of ordinary skilled in the art to develop the composition recited in instant claims 1, 5, 11, 13, 18, 21, 26, 27, 29, 34-36, 66 and 67 for delivering the RNA molecule recited in claims of U.S. Patent No. 11879126, claims of US patent 12011478 B2, claims of U.S. Patent No. 12/121,577, claims of U.S. Application No. 17/998,574 and claims of U.S. Application No. 18/681,132.
Furthermore, Applicant fails to present any arguments about the ODP rejection over claims of co-pending Application No. 18/995050.
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.
New Objections
41. Claim 65 is objected to for the following minor informality: Claim 65 needs to end with a period. Applicant is required to correct this error.
New Rejections
Obviousness Double Patenting
42. 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.
43. For the same/similar reasoning/rational as the rejection set forth in Sections 33-36 above, instant claims 1, 5, 11, 13, 18, 21, 26, 27, 29, 34-36, 66 and 67 are 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. 18/759394; claims 56, 60 and 63 of co-pending Application No. 18/867199; 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 25 above.
These are all provisional obviousness-type double patenting rejections because the conflicting claims have not in fact been patented.
Conclusion
No claim is allowed.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658
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