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 .
Amendments
In the reply filed 3/16/2026, Applicant has amended Claims 1 and 25, canceled claims 9, 11, 12, 14, 20-24, 72 and 73, and added new claims, Claims 74-76.
Claim 28 is pending but withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claims 1, 5, 15, 17-19, 25-27, 29, 45, 48, 51, 59, 65, 67-69 and 74-76 are under consideration.
Rejoinder
In light of Applicant’s amendments, the species election restriction requirement for the second block polymer of formula II, as set forth in the Office action mailed on 11/21/2024, has been reconsidered. The homopolymer hydroxyethyl methacrylate (HEMA) is rejoined. Claim 27 is no longer withdrawn from consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/16/2026 was filed after the mailing date of the non-final Office action on 12/16/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Maintained Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5, 17-19, 25-26, 29, 45, 48, 51, 59, 65, 67, 69 and 74-76 stand rejected under 35 U.S.C. 103 as obvious over Duong et al. (US2022/0175812, filed 12/03/2021, published 6/09/2022, see IDS filed 11/08/2024) in view of Mueller et al., (WO2012/156058, filed 5/11/2012, see IDS filed 11/08/2024).
In regard to claims 1, 25 and 76, Duong teaches diblock copolymer nanoparticles comprising at least one cationic monomer for the electrostatic interaction of a DNA payload (Abstract, [0126-0131, 0194-0196, 0458-0464, 0471], see Example 3). Specifically, in regard to the claimed block monomer of Formula I, Duong suggests the cationic monomer of N-(2-aminoethyl methacrylamide) (AEMA) [0461], and in regard to the claimed homopolymer or copolymer of Formula II, Duong suggests the hydrophobic block monomer of butyl methacrylate (BMA) ([0134-0137, 0461], see Example 3).
With respect to claims 1, 25 and 76, as far as choosing the cationic block monomer and hydrophobic block monomer in general, Duong teaches that these two types of block monomers should be chosen so as to form a cationic corona-hydrophobic core diblock copolymer nanoparticle structure (see Fig. 9). In regard to choosing BMA as the hydrophobic core, Duong teaches this hydrophobic monomer throughout the patent document, and is used in the preferred embodiments. In regard to choosing AEMA form the genus of cationic monomers disclosed by Duong, the related prior art of Mueller teaches nanoparticles comprising a first and second block polymer for the delivery of nucleic acids to cells. Specifically, Mueller teaches the block polymers comprising aminoethylmethacrylamide (see Formula II of Mueller, wherein E1 is NH, and R2 is H on pgs. 8, 10, 26 & 81). Importantly, Mueller teaches because monomers like AEMA comprise both the secondary amine of the amide and the primary terminal amine, this allows varying protonation states in the physiological milieu of the cell. These additional unprotonated amines with different pKa values confer a buffering effect of a wider range of pH, which give the polymer an opportunity to escape from the endosome (the so-called “proton sponge effect”) (p. 4, 1st para.). Thus, it would have been obvious to choose AEMA as the cationic block monomer.
In regard to the mol% of the cationic block monomer as per claim 1, Duong teaches that molecular weight and number of units can be varied [0469], and provides preferred embodiments wherein the first cationic block monomer is at least 15 mol% or 20 mol% (Example 3, [0522-0528]. Furthermore, in regard to claims 1 and 29, the percentage and size of the cationic block monomer would have been obvious to optimize since Duong teaches that it is the cationic monomers that complex with the anionic nucleic acid payload [0454, 0456-0457, 0508], and it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
[AltContent: textbox ([img-media_image1.png])]In regard to claims 5, 17-19, and 26, as stated supra, Duong suggests the second block is the homopolymer of BMA, wherein Y is -O, and R1 is an unsubstituted butyl. Specifically, in regard to at least 2 adjacent BMA monomers, as stated supra Doung teaches a diblock of the following formula, wherein the second block is “n” units, and as stated supra, teaches that the degree of polymerization is at least two units [0469].
In regard to claim 29, as shown supra, the first block comprises “m” numbering units of AEMA, and as stated supra, Duong makes obvious wherein the first block is at least 20 mol% of the block copolymer.
In regard to claims 45, 48, 51, and 59, as stated supra, Duong teaches the block copolymer is complexed with DNA to form a nanoparticle, and Duong further teaches a polymer nanoparticle comprising the block copolymer with diameters between about 50-400 nm (Example 3, see also Fig. 6), and generally teaches that the diameter is a function of the molecular weight ratio of the cationic block polymer and the hydrophobic core block polymer (Fig. 9). In regard to claim 51, Duong teaches the target goal for PDI is less than 0.3 with a working example of 0.085 as measured by DSL [0511-0512], which the Examiner has considered to be “about” 0.15. Note the specification has not explicitly defined the range encompassed by “about”, the Examiner has applied the broadest reasonable interpretation of “about” as being with an order of magnitude. Notably, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
In regard to claims 65 and 74-75, Duong teaches the DNA is 8.5 kbp or more ([0211, 0473]), which the Examiner has considered to be “about” 15 kbp. Note the specification has not explicitly defined the range encompassed by “about”, the Examiner has applied the broadest reasonable interpretation of “about” as being with an order of magnitude.
In regard to claim 67, although Duong does not measure encapsulation efficiency of a nucleic acid, as stated supra, they do teach that when the polymer is transferred to a physiological pH, the core blocks self-assemble, encapsulating the payload in the hydrophobic core [0458], and teaches that the nucleic acid payload complexes to the block copolymer through electrostatic interaction [0194-0196], thereby suggesting at least a 75% encapsulation efficiency could have been achieved. Furthermore, one of ordinary skill would have been motivated to optimize the encapsulation of the DNA to at least 75% so as to protect the payload and prevent degradation of the nucleic acid by various enzymes once inside the cell as taught by Duong [0005, 0446].
In regard to claim 69, Duong demonstrates that the cell viability of cultured cells after transfection is at least 70% ([0550]). Furthermore, the survival of transfected cells, is an intended use of the claimed composition, and a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 3/16/2026 are acknowledged.
First Applicant argues that there was no motivation to choose AEMA from the genus of cationic monomers taught by Duong nor Mueller. Specifically, Applicant argues that Duong does not provide a preferred embodiment of a polymer of AEMA, but instead uses DMAEMA. Furthermore, Applicant argues that the rationale from Mueller to have cationic monomers to achieve a proton sponge effect is directed to PEI, not AEMA. Applicant argues that Mueller does not teach AEMA, and Muller teaches the advantaged of DMAEMA compared to PEI. Thus, the cited prior art suggests using DMAEMA and not AEMA, and the Examiner does not identify any problems with DMAEMA to justify using AEMA.
Second, Applicant argues that the claimed combination of AEMA based co-polymers achieved unexpected results. Specifically, Applicant argues that Figures 2 and 3 of the specification demonstrate that AEMA as block 1 is able to encapsulate large nucleic acids with near 100% efficiency compared to DMAEMA or DPAEMA, and transfect Schwann cells with large 20 kbp plasmid with a significantly higher efficiency than with DMAEMA or DPAEMA based polymers.
Applicant's arguments have been fully considered but they are not found persuasive.
Although Duong does not provide a preferred embodiment of a diblock copolymer comprising AEMA and BMA, Duong does teach that polymer nanoparticles comprise a cationic corona-hydrophobic core structure, Duong explicitly teaches both of these cationic and hydrophobic monomers, and Duong teaches approximate concentrations of monomers to make a polymer nanoparticle. The MPEP 2123 (I) states that patents are relevant as prior art for all they contain, and that a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill [AltContent: textbox ([img-media_image2.png])]the art, including nonpreferred embodiments. In regard to the teachings of Mueller, in contrast to Applicant’s allegation, Mueller does provide a reasonable disclosure of aminoethylmethacrylamide (see Formula II of Mueller see adjacent, wherein E1 is NH, n is 2, E2 is absent, and R2 is H), and Mueller teaches because monomers like AEMA comprise both the secondary amine of the amide and the primary terminal amine, this allows varying protonation states in the physiological milieu of the cell, which naturally would lead to the so-called “proton sponge effect”. This would have been recognized by one of ordinary skill to be an inherent property of a monomer such as AEMA comprising two amine groups. Applicant is reminded that preferred embodiments are not the only teaching of a reference. “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989).
In regard to Applicant’s arguments directed to their unexpected results with AEMA, Applicant is reminded that unexpected results must be commensurate in scope with claimed invention. As a first matter, none of the independent claims require a nucleic acid, much less a large nucleic acid, to be included in the co-polymer composition. In regard to claims that actually include a nucleic acid, the encapsulation efficiency results from Figure 2 are derived from experimental data conducted with AEMA as the first monomer and BMA as the second monomer (see Example 1, Table 2, p.39 of Applicant’s disclosure). Furthermore, Applicant transfection efficiency of Schwann cells from Figure 3 are derived from experimental data conducted with AEMA as the first monomer and 10:1 mixtures of BMA with HEMA as the second monomers (see Example 2, Table 5, pgs.50-51 of Applicant’s disclosure). However, Applicant’s claims are broader than BMA as the second monomer or mixtures of BMA with HEMA as the second monomer, but also included HEMA alone and the (methyl)acrylamide forms thereof. See, Grasselli, 713 F.2d at 743, 218 USPQ at 778 (evidence of superior properties for sodium containing composition insufficient to establish the non-obviousness of broad claims for a catalyst with “an alkali metal” where it was well known in the catalyst art that different alkali metals were not interchangeable and applicant had shown unexpected results only for sodium containing materials); In re Greenfield, 571 F.2d 1185, 1189, 197 USPQ 227, 230 (CCPA 1978) (evidence of superior properties in one species insufficient to establish the nonobviousness of a subgenus containing hundreds of compounds); In re Lindner, 457 F.2d 506, 508, 173 USPQ 356, 358 (CCPA 1972) (one test not sufficient where there was no adequate basis for concluding the other claimed compounds would behave the same way).
Claim 68 stands rejected under 35 U.S.C. 103 as obvious over Duong et al. (US2022/0175812, filed 12/03/2021, published 6/09/2022, see IDS filed 11/08/2024) in view of Mueller et al., (WO2012/156058, filed 5/11/2012, see IDS filed 11/08/2024), as evidenced by Lackington et al. (Acta Bio, 2018, 75:115-128, prior art of record).
As state above, Duong teaches a diblock copolymer nanoparticle complexed with a plasmid DNA, and demonstrates the intended use of transfecting cells.
However, Duong is silent to the transfection efficiency of Schwann cells.
Nevertheless, Duong demonstrates that the transfection efficiency of HEK cells as measured by GFP expression with plasmid DNA and diblock polymersomes is about half the signal of lipofectamine ([0552], Fig. 4).
Importantly, Lackington (2018) evidences that the transfection efficiency of the Schwann cell line (i.e., S42 cells) with plasmid DNA is almost 60% with lipofectamine (Fig. 2). Thus, the ability of polymersomes to transfect a Schwann cell line with plasmid DNA with at least a 1% transfection efficiency appears to be a natural feature of the diblock polymersomes of Duong.
Furthermore, the transfection of cells, including Schwann cells is an intended use of the claimed composition, and a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 3/16/2026 are acknowledged and have been addressed above.
Withdrawn 35 USC § 103
The prior rejection of Claim 15 under 35 U.S.C. 103 as obvious over Duong et al. (US2022/0175812, filed 12/03/2021, published 6/09/2022, see IDS filed 11/08/2024) in view of Mueller et al., (WO2012/156058, filed 5/11/2012, see IDS filed 11/08/2024), as applied to claim 1, in further in view of Sugiyama et al. (Chem Letters, 1997, 26(3):219-220) is withdrawn in light of Applicant’s amendment of Claim 1 to limit the monomer unit of formula II to an R group of a unsubstituted butyl or 2-ethanol, which are limitations neither Duong, Mueller, nor Sugiyama teach nor suggest. Specifically, Duong requires a hydrophobic core, and suggests the more hydrophobic monomer N-(2-hydroxypropyl) methacrylamide (HPMA), while the claimed methacrylamide (i.e., hydroxyethyl methacrylamide) is more of a hydrophilic monomer, and therefore Duong teaches away from hydroxyethyl methacrylamide.
New Claim Rejections - 35 USC § 103
as necessitated by amendment
Claims 1, 5, 15, 17-19, 25, 27, 29, 45, 48, 51, 59, 65, 67, 69 and 74-76 are rejected under 35 U.S.C. 103 as obvious over Reinkeke et al. (US2023/0203220, filed 5/28/2021, published 6/29/2023) in view of Mandl et al. (US2022/0339294, filed 9/09/2020, published 10/27/2022).
In regard to claims 1, 25, and 76, Reinkeke teaches polyplex nanoparticles comprising a co-polymer comprising a backbone having a first (meth)acryl monomer with a cationic alkylamino (R1) functional group, and a second (meth)acryl monomer with a neutral hydrophilic hydroxyl (R2) functional group (Abstract), [0017, 0022, 0078], Fig. 2, see Claim 1 of Reineke). Specifically in regard to the first monomer Reinkeke teaches of aminoethyl methacrylamide (AEMA) with the ethylamino R1 functional group ([0078], see Fig. 2).
In regard to the mol% of the cationic block monomer as per claim 1, Reineke teaches that molecular weight and number of units can be varied (see Fig. 2b “n” to “m” ratio), and teaches the cationic block monomer is 25-75% ([0091], Example 1, Table 2)
Furthermore, in regard to claims 1 and 29, the percentage and size of the cationic block monomer would have been obvious to optimize since Reineke teaches that it is the cationic monomers that complex with the anionic nucleic acid payload to achieve the optimum N/P ratio [0115, 0133], and it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Furthermore, in regard to claim 76, the limitation directed to the delivery of large nucleic acids, is an intended use of the claimed composition, and a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Reinkeke teaches the polymeric gene delivery vehicles have the ability to encapsulate large payloads such as pDNA of at least 5 kpb [0005, 0062, 0126], the prior art structure is capable of performing the intended use, and it meets the claim.
However, in regard to claims 1, 25, and 76, although Reinkeke suggests the hydrophilic R2 functional group is a hydroxyethyl (see Fig. 2B top), Reinkeke does not claim nor put forth a clear working example of a co-polymer comprising aminoethyl methacrylamide and a second (methyl)acryl monomer comprising a hydrophilic hydroxyethyl R2 functional group as the second monomer.
Nevertheless, Mandl et al. (2000) teaches nanoparticles comprising a first polymer and a second hydrophilic polymer such as hydroxyethyl methacrylamide or hydroxyethyl methacrylate for use in nanoparticles that deliver nucleic acids to cells ([0052-0053], see also Claim 13 of Mandl).
Accordingly, it would have been obvious to prepare the co-polymer comprising a backbone having a first (meth)acryl monomer with a cationic alkylamino (R1) functional group such as AEMA, and a second (meth)acryl monomer with a neutral hydrophilic hydroxyethyl (R2) functional group as taught by Reineke, and to choose hydroxyethyl methacrylamide or hydroxyethyl methacrylate as the second (meth)acryl monomer as taught by Mandl with a reasonable expectation of success. One of ordinary skill would have been motivated to do so as taught by Mandl because nanoparticles comprising these polymers would be biocompatible and biodegradable for use with gene therapy ([0012-0013], see also Claims 1 and 17-21 of Mandl).
In regard to claims 5, 15, 17-19 and 27, as stated supra, Reinkeke suggests the hydrophilic R2 functional group is a hydroxyethyl, and Mandl et al. (2000) teaches that hydroxyethyl methacrylamide (where Y=NH) and hydroxyethyl methacrylate (where Y=O) were well-known hydrophilic polymers for use in nanoparticles that deliver nucleic acids to cells. In regard to the number of second monomer units as per claims 17-19, as stated supra, Reineke teaches that number of units can be varied (see Fig. 2b “m”, as well as Table 2).
In regard to claims 45, 48, 51, and 59, as stated supra, Reineke teaches the block copolymer is complexed with pDNA or RNP to form a nanoparticle, and Reineke further teaches a polymer nanoparticle comprising the block copolymer with diameters between about 50-300 nm (Example 3, see also Fig. 6 & 11), and generally teaches that the diameter is a function of N/P ratio. In regard to claim 51, Reineke provides working examples where the standard deviation appears to less than 1/2 of the mean diameter such as in Fig. 11, again depending on the N/P ratio, which results in a PDI of less than 0.25 as measured by DLS when the standard deviation is ½ of the mean diameter ([0069, 0180, 0207]), which the Examiner has considered to be “about” 0.15-0.3. Note the specification has not explicitly defined the range encompassed by “about”, the Examiner has applied the broadest reasonable interpretation of “about” as being with an order of magnitude. Notably, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
In regard to claims 65 and 74-75, as stated supra, Reinkeke teaches the polymeric gene delivery vehicles have the ability to encapsulate large payloads such as pDNA of at least 5 kpb [0005, 0062, 0126], which the Examiner has considered to be “about” 15 kbp. Note the specification has not explicitly defined the range encompassed by “about”, the Examiner has applied the broadest reasonable interpretation of “about” as being with an order of magnitude.
In regard to claim 67, although Reinkeke does not measure encapsulation efficiency of a nucleic acid, she does indicate that the polymers have the ability to encapsulate large payloads [0005], and demonstrates that the transfection efficiency as measured by GFP expression as high at 100% (see Fig. 9B), and in HEK293 cells as measured by NHEJ editing efficiency of 58% [0219], thereby suggesting at least a 75% encapsulation efficiency could have been achieved. Furthermore, one of ordinary skill would have been motivated to optimize the encapsulation of the DNA to at least 75% so as to protect the payload as taught by Reinkeke [0114, 0132].
In regard to claim 69, Reinkeke teaches that the copolymers have good cell internalization with low cytotoxicity [0005, 0016, 0063, 0186], and demonstrate that most copolymers exhibit cell viability of at least 70% (i.e., 0.7 normalized cell viability) (Fig. 8C). Furthermore, the survival of transfected cells, is an intended use of the claimed composition, and a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 3/16/2026 are acknowledged and have been addressed above.
Claim 68 is rejected under 35 U.S.C. 103 as obvious over Reinkeke et al. (US2023/0203220, filed 5/28/2021, published 6/29/2023) in view of Mandl et al. (US2022/0339294, filed 9/09/2020, published 10/27/2022), as evidenced by Lackington et al. (Acta Bio, 2018, 75:115-128, prior art of record).
As state above, Reinkeke teaches a diblock copolymer nanoparticle complexed with a ribonucleoprotein complex, and demonstrates the intended use of transfecting cells.
However, Reinkeke is silent to the transfection efficiency of Schwann cells.
Nevertheless, Reinkeke demonstrates that the transfection efficiency of HEK293 cells as measured by NHEJ editing efficiency of 58%, which is twice as high as those observed with lipofectamine ([0219]).
Importantly, Lackington (2018) evidences that the transfection efficiency of the Schwann cell line (i.e., S42 cells) with pDNA is almost 60% with lipofectamine (Fig. 2). Since Reinkeke teaches the design rules for RNPs and pDNA delivery are substantially congruent [0221], the ability of polymer nanoparticles to transfect a Schwann cell line with ribonucleoproteins with at least a 1% transfection efficiency appears to be a likely feature of the diblock polymer nanoparticles of Reinkeke.
Furthermore, the transfection of cells, including Schwann cells, is an intended use of the claimed composition, and a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 3/16/2026 are acknowledged and have been addressed above.
Maintained Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type 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); 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 conflicting 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.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1, 5, 17-19, 25-27, 29 and 76 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-4, 6-18 of copending Application No. 19/225,707. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the diblock copolymer comprising AEMA and BMA or HEMA of cited application anticipates the diblock copolymer of instant application. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the cited application claims are much more specific. Thus the invention of said claims of the cited application are in effect “species” of the “generic” invention of the instant claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Since the instant application claims are anticipated by cited application claims, said claims are not patentably distinct.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 3/16/2026 are acknowledged and ask that instant non-statutory double patenting rejections be held in abeyance.
Claims 45, 48, 51, 59, and 67-69 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-4, 6-18 of copending Application No. 19/225,707. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the diblock copolymer comprising AEMA and BMA of cited application makes obvious the diblock copolymer of instant application. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the cited application claims recite a range of diameters and PDI that overlap with instant claims. Notably, in the case where the claimed ranges "overlap or lie inside ranges disclosed" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Furthermore, in regard to the intended uses and functional characteristics of the instantly claimed composition, these would be naturally occurring features of the diblock copolymers where they overlap in scope with cited application.
Since the instant application claims are obvious over cited application claims, said claims are not patentably distinct.
Claims 65 and 74-75 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-4, 6-18 of copending Application No. 19/225,707, in view of Duong et al. (US2022/0175812, filed 12/03/2021, published 6/09/2022, see IDS filed 11/08/2024). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the diblock copolymer comprising AEMA and copolymer BMA in a nanoparticle with a nucleic acid of cited application makes obvious the diblock copolymer of instant application. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that although the cited application claims recited up to 3 different nucleic acids, they are silent to their combined length of about 15 kbp.
Nevertheless, the Examiner has interpreted “about” as an order of magnitude and driving the expression of multiple microRNAs from a plasmid of about 1.5 kbp was well known in the art. For example, Duong teaches diblock copolymer nanoparticles complexed with nucleic acids that are 8.5 kbp or more ([0211, 0473]),
Accordingly, it would have been obvious to one of ordinary skill at the time of filing of the invention to have claimed a nucleic acid of at least 1.5 kbp with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to do so because a single vector would ensure equal packaging of the microRNA.
Since the instant application claims are obvious over cited application claims in view of Duong, said claims are not patentably distinct.
Withdrawn Double Patenting
The prior provisional rejection of Claim 15 on the grounds of nonstatutory double patenting as being unpatentable over claims 1-4, 6-18 of copending Application No. 19/225,707, in view of Sugiyama et al. (Chem Letters, 1997, 26(3):219-220) is withdrawn in light of Applicant’s amendment to exclude HPMA as one of the second monomers.
New Double Patenting
Claims 15 is provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-4, 6-18 of copending Application No. 19/225,707, in view of Mandl et al. (US2022/0339294, filed 9/09/2020, published 10/27/2022). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the diblock copolymer comprising AEMA and copolmer BMA of cited application makes obvious the diblock copolymer of instant application. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the cited application claims do not recited a copolymer of hydroxyethyl methacrylamide.
Mandl et al. (2000) teaches that hydroxyethyl methacrylamide was a well-known hydrophilic polymer for use in nanoparticles that deliver nucleic acids to cells ([0052-0053], see also Claim 13 of Mandl).
Accordingly, it would have been obvious to one of ordinary skill at the time of filing of the invention to have claimed a diblock copolymer wherein the second block is a copolymer of hydroxyethyl methacrylamide as taught by Mandl with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to do so because Mandl because nanoparticles comprising these polymers would be biocompatible and biodegradable for use with gene therapy ([0012-0013], see also Claims 1 and 17-21 of Mandl).
Since the instant application claims are obvious over cited application claims in view of Mandl, said claims are not patentably distinct.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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 date of this final action.
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm.
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/ARTHUR S LEONARD/Examiner, Art Unit 1631
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