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 8/27/2025, Applicant has amended Claims 1-20.
Claims 8-14 and 16-20 are pending but withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.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 1-7 and 15 are under consideration.
Election/Restrictions
Applicant’s election of the following invention in the reply filed on 4/24/2025 has been acknowledged.
Group I, claims 1-7, drawn to a composition comprising a PBAE polymer.
Group III, claim 15, drawn to the composition comprising a PBAE polymer and a loaded mRNA has been rejoined.
Applicant’s election of the following species has been acknowledged.
Formula II,
the linker is a bisacrylate-containing compound comprising 1,4-butanediol bisacrylate,
R1 is a hydrophilic amine compound comprising N,N-dimethylethylenediamine,
R2 is a hydrophobic amine compound comprising n-octadecylamine,
R3 is a linear or branched chain of a diamino-compound comprising 1,4-butanediamine,
R4 is a halogenated hydrocarbon comprising iodomethane.
Formula I has been rejoined.
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Withdrawn 35 USC § 112(a)
The prior rejection of Claims 1-7 and 15 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in light of Applicant’s amendments of instant claims to remove the phrase “tissue-specific”.
Withdrawn 35 USC § 112(b)
The prior rejection of Claims 3-7 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in light of Applicant’s amendments of instant claims to provide the proper antecedent basis.
New Claim Rejections - 35 USC § 112(a)
NEW MATTER
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 3-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regard to Claim 3, the new limitation directed to the bisacrylate-containing compound “is” 1,4-butanediol bisacrylate, in instant claim appears to represent new matter. In regard to Claim 4, the new limitation directed to the hydrophilic amine compound “is” N,N-dimethylethylenediamine or 2-amino-1,3-propanediol, in instant claim appears to represent new matter. In regard to Claim 5, the new limitation directed to the hydrophobic amine compound “is” n-octadecylamine, in instant claim appears to represent new matter. In regard to Claim 6, the new limitation directed to linear chain diamino compound “is” 1,4-butanediamine, in instant claim appears to represent new matter. In regard to Claim 7, the new limitation directed to the halogenated hydrocarbon “is” iodomethane, in instant claim appears to represent new matter.
MPEP 2163.06 notes “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112(a), pre-AIA first paragraph - written description requirement. In re Rasmussen , 650 F.2d 1212, 211 USPQ 323 (CCPA 1981).” No basis for these limitations was identified in Applicant’s remarks filed 8/27/2025, a review of the specification by the Examiner did NOT find any specific basis for the recited limitations. By contrast, the Examiner only found support for the claimed compounds as precursor molecules in the syntheses of the claimed genus of PBAE polymers (see Examples 1-3 of Applicant’s specification). As noted by the MPEP, new matter includes not only the addition of wholly unsupported subject matter, but may also include the introduction of claim changes which involve narrowing the claims by introducing elements or limitations which are not supported by the as-filed disclosure is a violation of the written description requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996). In Ex parte Ohshiro, 14 USPQ2d 1750 (Bd. Pat. App. & Inter. 1989), the Board affirmed the rejection under 35 U.S.C. 112, first paragraph, of claims to an internal combustion engine which recited "at least one of said piston and said cylinder (head) having a recessed channel." The Board held that the application which disclosed a cylinder head with a recessed channel and a piston without a recessed channel did not specifically disclose the "species" of a channeled piston (see MPEP 2163.05 (II) Narrowing or Subgeneric Claim).
New Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-7 are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regard to Claims 3-7, where Applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999).
[AltContent: textbox ([img-media_image2.png])]In regard to Claim 3, the phrase directed to the bisacrylate-containing compound “is” 1,4-butanediol bisacrylate, is used by the claim to mean “is from”, while the accepted meaning is “is equivalent to”. In other words, in light of Applicant’s specification, it is clear that the linker comprising the bisacrylate-containing compound is NOT 1,4-butanediol bisacrylate, which is the unpolymerized form and still retains the alkene bonds (see chemical structure adjacent). Specifically, Applicant’s working examples use 1,4-butanediol diacrylate as a precursor for the syntheses of PBAE polymers. The phrase is indefinite because the specification does not clearly redefine the phrase.
[AltContent: textbox ( [img-media_image3.png] [img-media_image2.png])]In regard to Claim 4, the phrase directed to the hydrophilic amine compound “is” N,N-dimethylethylenediamine or 2-amino-1,3-propanediol, is used by the claim to mean “is from”, while the accepted meaning is “is equivalent to”. In other words, in light of Applicant’s specification, it is clear that the R1 group comprising the hydrophilic amine compound is NOT N,N-dimethylethylenediamine or 2-amino-1,3-propanediol (see chemical structure adjacent), which are the unpolymerized forms and still retain unsubstituted amines. Specifically, Applicant’s working examples use ,N-dimethylethylenediamine or 2-amino-1,3-propanediol as precursors for the syntheses of PBAE polymers The phrase is indefinite because the specification does not clearly redefine the phrase.
[AltContent: textbox ([img-media_image4.png])]In regard to Claim 5, the phrase directed to the hydrophobic amine compound “is” n-octadecylamine, is used by the claim to mean “is from”, while the accepted meaning is “is equivalent to”. In other words, in light of Applicant’s specification, it is clear that the R2 group comprising the hydrophobic amine compound is NOT n-octadecylamine, which is the unpolymerized form and still retains unsubstituted methyl (see chemical structure adjacent). Specifically, Applicant’s working examples use n-octadecylamine (or its unsaturated form oleyamine) as precursors for the syntheses of PBAE polymers. The phrase is indefinite because the specification does not clearly redefine the phrase.
[AltContent: textbox ([img-media_image5.png])]In regard to Claim 6, the phrase directed to linear chain diamino compound “is” 1,4-butanediamine is used by the claim to mean “is from”, while the accepted meaning is “is equivalent to”. In other words, in light of Applicant’s specification, it is clear that the R3 group comprising the diamino compound is NOT 1,4-butanediamine, which is the unpolymerized form and still retains unsubstituted amine (see chemical structure adjacent). Specifically, Applicant’s working examples use 1,4-butanediamine as a precursor for the syntheses of PBAE polymers. The phrase is indefinite because the specification does not clearly redefine the phrase.
[AltContent: textbox ([img-media_image6.png])]In regard to Claim 7, the phrase directed to the halogenated hydrocarbon “is” iodomethane, is used by the claim to mean “is from”, while the accepted meaning is “is equivalent to”. In other words, in light of Applicant’s specification, it is clear that the R4 group comprising the halogenated hydrocarbon is NOT iodomethane, which is the unpolymerized form and still retains unsubstituted methyl (see chemical structure adjacent). Specifically, Applicant’s working examples use iodomethane as a precursor for the syntheses of PBAE polymers. The phrase is indefinite because the specification does not clearly redefine the phrase.
Furthermore, in regard to Claim 6, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949). In the present instance, Claim 6 recites the broad recitation of a “linear chain or branched chain diamino-compound”, and the claim also recites linear chained 1,4-butanediamine which is the narrower statement of the limitation.
New Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1-3, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Green et al. (WO2024/098053, filed 11/06/2023, with priority to US 63/382,410 filed 11/04/2022, prior art of record)
In regard to Claim 1, Green (WO2024) et al. teach a cationic PBAE based polymer comprising both hydrophilic and hydrophobic side chains for the delivery of mRNA based nucleic acids to cells (see formula below):
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Specifically, Green (WO2024) teaches that this cationic PBAE polymer comprises the generic PBAE backbone found in instant Formula I comprising hydrophilic amine side chain monomers of compounds comprising a R group (i.e., R1 of Formula I), lipophilic amine side chain monomers of compounds comprising an aminoalkyl (i.e., R2 of Formula I), an ester based diacrylate-containing linker R (i.e., linker), and diamino-compound end capping groups R' (i.e., R3) (Fig. 2A, see also Claims 1-4 of Green’s priority document). Although Green (WO2024) does not proved the exact subunit numbers (i.e., m to n ratio), they do disclose examples where a 50%/50% ratio of hydrophilic/hydrophobic monomer are used (p. 23, lines 11-12 of Green’s priority document). Thus, Green (WO2024) makes obvious a 1:1 ratio of m:n.
Green (WO2024) goes on to teach the advantages of nanoparticles for the delivery of nucleic acids comprising the ester linkages based on bisacrylate containing compounds that allow for quick hydrolytic degradation and low toxicity, while the secondary and tertiary amines can electrostatically complex with negatively charged nucleic acids, and the hydrophobic alky side chain enables tight nanoparticle complexation (p. 11, Detailed Description, 3rd para. of Green’s priority document).
In regard to the preamble of Claim 1, as stated supra, Green (WO2024) teaches the PBAE nanoparticle comprises a mRNA molecule (see Claim 11 of priority document).
In regard to Claims 1 and 2, Green (WO2024) teaches the “PBAE polymer has a molecular weight of from 5 to 10 kDa” (p. 14, 3rd para. of Green’s priority document). 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). It is routine procedure to optimize component amounts to arrive at an optimal product that is superior for its intended use, since it has been held 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. See M.P.E.P. §2144.05.
[AltContent: textbox ([img-media_image8.png])]In regard to Claims 1 and 3, Green (WO2024) teaches the linker R is from the bisacrylate-containing compound of 1,4-butanediol bisacrylate (Fig. 2B, structure “B3”, see also from Claim 2 of Green’s priority document).
[AltContent: textbox ([img-media_image9.png])]In regard to Claim 1, Green (WO2024) teaches the hydrophilic amine side chain (alias R1 of Formula I) is an alcohol amine derived from diethanolamine (Fig. 2B, see also Claim 4, structure S9 of Green’s priority document).
[AltContent: textbox ([img-media_image10.png])]In regard to Claims 1 and 5, as stated supra, Green (WO2024) teaches a genus of hydrophobic alkyl side chain (alias R2 of Formula I) (see excerpt from Fig. 2A). Although Green (WO2024) teaches Sc18 alkyl amines with an unsaturated bond such as oleyamine, they disclose many alkyl amine monomers with fully saturated bonds and therefore make obvious the Sc18 alkyl amines with fully saturated bonds such as octadecylamine.
[AltContent: textbox ([img-media_image11.png])]In regard to Claim 1, Green (WO2024) teach the end capping R1 group (alias R’) attached to the terminal nitrogen is derived from a branched butanediamine (see structure from Claim 4 of Green’s priority document).
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 9/27/2025 are acknowledged and have been address above.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Green et al. (WO2024/098053, filed 11/06/2023, with priority to US 63/382,410 filed 11/04/2022, prior art of record), in view of Pfeifer (US2017/0348402, filed 7/30/2015)
As stated supra, Green (WO2024) et al. suggest a cationic PBAE based polymer comprising both hydrophilic and hydrophobic side chains according to Formula I for the delivery of mRNA based nucleic acids to cells.
In regard to Claim 4, although Green (WO2024) teaches the hydrophilic amine side chain (alias R1 of Formula I) is an alcohol amine, they are silent to the alcohol amine of 2-amino-1,3-propanediol.
[AltContent: textbox ([img-media_image12.png])]Pfieffer (US2017) teaches a PBAE carrier for the delivery of nucleic acids to a cell, wherein the side chain is the alcohol amines derived from 2-amino-1,3-propanediol ([0100, 0322], Example 1, see excerpt from Fig. 14A, adjacent).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to prepare the PBAE carrier as taught by Green (WO2024) comprising a hydrophilic alcohol amine side chain and substitute the amino-propanediol side chain derived from 2-amino-1,3-propanediol as taught by Pfieffer with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as taught by Pfieffer because 2-amino-1,3-propanediol (i.e., serinol) is not only cationic for attracting negatively charged nucleic acids, but is nontoxic and biodegradable [0016].
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 9/27/2025 are acknowledged and have been addressed above.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Green et al. (WO2024/098053, filed 11/06/2023, with priority to US 63/382,410 filed 11/04/2022, prior art of record), in view of Palmiero et al (WO2019/090045, filed 11/02/2018)
As stated supra, Green (WO2024) et al. suggest a cationic PBAE based polymer comprising both hydrophilic and hydrophobic side chains according to Formula I for the delivery of mRNA based nucleic acids to cells.
In regard to Claim 4, although Green (WO2024) teaches the hydrophilic amine side chain (alias R1 of Formula I) is a secondary amine (e.g., see side chain structure “S10”), they are silent to the secondary amine of N,N-dimethylethylenediamine.
[AltContent: textbox ([img-media_image13.png])]Palmiero et al. (WO2019) teaches a PBAE carrier for the delivery of nucleic acids to a cell, wherein the side chains are conjugated to the secondary amine derived from dimethylethylenediamine ([0141, 0243], Fig. 7 compound “3”, see excerpt adjacent).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to prepare the PBAE carrier as suggested by Green (WO2024) comprising side chains comprising secondary amines and substitute the secondary amine of N,N-dimethylethylenediamine as taught by Pamiero with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so because including both secondary amines and tertiary amines allows the polymer to be reversible protonated over a range of physiological pHs, thereby tuning the electrostatic complex with negatively charged nucleic acids (see again p. 11, 3rd para. of Green’s priority document).
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 9/27/2025 are acknowledged and have been addressed above.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Green et al. (WO2024/098053, filed 11/06/2023, with priority to US 63/382,410 filed 11/04/2022, prior art of record), in view of Palmiero et al (WO2019/090045, filed 11/02/2018)
As stated supra, Green (WO2024) et al. suggest a cationic PBAE based polymer comprising both hydrophilic and hydrophobic side chains according to Formula I for the delivery of mRNA based nucleic acids to cells.
In regard to Claim 6, although Green (WO2024) teach the end capping R1 group (alias R’) attached to the terminal nitrogen is derived from a branched butanediamine, they are silent to the end capping group comprising a linear 1,4-butanediamine.
[AltContent: textbox ([img-media_image14.png][img-media_image13.png])]Palmiero et al. (WO2019) teaches a PBAE carrier for the delivery of nucleic acids to a cell, wherein the side chains R3/R4 conjugated to the end amine (i.e, X is NH) are 1,4-butanediamine ([0130-0133m 0160], see excerpt adjacent).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to prepare the PBAE carrier as suggested by Green (WO2024) comprising end caps comprising a branched butanediamine and substitute the linear butandediamne as taught by Pamiero with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so because Green (WO2024) does reduce to practice a PBAE polymer comprising the end cap of a linear propanediamine (i.e., structure E1), which was found to be effective for transfection of mRNA in vivo (p. 34, Example 3 of Green’s priority document).
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 9/27/2025 are acknowledged and have been addressed above.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Green et al. (WO2024/098053, filed 11/06/2023, with priority to US 63/382,410 filed 11/04/2022, prior art of record), in view of Liu et a. (Mol Pharm, 2016, 15;4558-4567) and Green et al. (WO2020/077159, filed 10/10/2019, published 4/16/2020)
As stated supra, Green (WO2024) et al. suggest a cationic PBAE based polymer comprising both hydrophilic and hydrophobic side chains according to Formula I for the delivery of mRNA based nucleic acids to cells.
In regard to Claim 7, although Green (WO2024) et al. suggest the hydrophobic and hydrophobic side chains are conjugated to tertiary amines in the backbone (alias R1 and R2 of Formula I), they are silent to N-methyl substituted quaternary amines in the backbone (i.e., Formula II).
Liu et al. (2018) teaches a PBAE carrier for the delivery of siRNA to a cell, wherein the side chains are conjugated to a N-methyl quaternary amine in the backbone (p. 4559, Scheme 2B).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to prepare the PBAE carrier as suggested by Green (WO2024) in view of Green (WO2020) comprising side chains on tertiary amines and substitute N-methyl quaternary amines as taught by Liu with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so at taught by Liu because the positively charged quaternary amine increased RNA binding efficiency based on self-assembly electrostatic interactions (Abstract).
Furthermore, in regard to claims 1 and 7 as per the halogenation of the N-methyl quaternary amine, while Green (WO2024) only generically discloses inclusion of halogens (p. 14, 2nd para. of priority document), Green (WO2024) cite their prior disclosure of Green (WO2020), which was incorporated by reference in its entirety (p. 13, line 21-24 of Green’s priority document).
Green (WO2020) explicitly teaches PBAE polymer comprising halogenated hydrocarbon chains (see Fig. 51 above), and further defines the term “halogen” as referring to an iodo group and the term haloalkyl is meant to include a halo-C1-alkyl (p. 100, lines 15-19).
Accordingly it would have been predictably obvious to choose the halogenated N-methyl group of iodomethane with a reasonable expectation of success, and one of ordinary skill would have immediately envisioned this option form the limited number of species of halogens. Furthermore, since Green (WO2024) incorporates Green (WO2020) by reference, it would have been obvious to one of ordinary skill in the art to have incorporate elements from the prior disclosure to modify the PBAE polymers.
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 9/27/2025 are acknowledged and have been addressed above.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Green et al. (WO2024/098053, filed 11/06/2023, with priority to US 63/382,410 filed 11/04/2022, prior art of record), in view of Green et al. (WO2020/077159, filed 10/10/2019, published 4/16/2020)
As stated supra, Green (WO2024) et al. suggest a cationic PBAE based polymer comprising both hydrophilic and hydrophobic side chains according to Formula I for the delivery of mRNA based nucleic acids to cells.
In regard to claim 15, as stated supra, Green (WO2024) teaches the PBAE nanoparticle comprises a mRNA molecule (see also Claim 11 of priority document). Specifically, Green (WO2024) teaches the mRNA encodes GFP to serve as a reporter to evaluate transfection efficiency (p. 32, last para., p. 33, Example 2 of Green’s priority document). Although Green (WO2024) does not explicitly state that the GFP mRNA encodes eGFP, Green (WO2024) cite their prior disclosure of Green (WO2020), which was incorporated by reference in its entirety (p. 13, line 21-24 of Green’s priority document).
Green (WO2020) makes obvious the use of eGFP (see Fig. 1, Fig. 53) because of its enhanced fluorescent intensity.
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to prepare the PBAE carrier comprising GFP mRNA as suggested by Green (WO2024) and choose eGFP as taught by Green (WO2020) with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so because of its enhanced fluorescent intensity. Furthermore, since Green (WO2024) incorporates Green (WO2020) by reference, it would have been obvious to one of ordinary skill in the art to have incorporate elements from the prior disclosure to modify the PBAE polymers.
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 9/27/2025 are acknowledged and have been addressed above.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Doug Schultz can be reached on 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARTHUR S LEONARD/Examiner, Art Unit 1631
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