DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 2/23/2026 has been entered.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 102
Claim(s) 1-2, 33-34, 36, 48-50 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vader, Pharm Res (2012) 29:352-361.
Vader teaches a polymer formed by the reaction of cystaminebisacrylamide, aminobutanol, and PEG-NH2 (Fig. 1):
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146
740
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(Fig. 1). Vader teaches the Mw is 47.8 kg/mol (Table 1) which falls in the claimed range of at least 20 kg/mol.
The polymer of Vader meets claims the claimed formula (I) when R1 and R2 is H, L1-L4 are ethylene, L5 is a butylene group and R3 is an OH group.
Vader does not use a PMMA standard but instead uses a PEG standard. However, one of ordinary skill in the art would recognize that a Mw of 47.8 kg/mol would fall in the claimed range of greater than 20 kg/mol regardless of the standard used because any potential variation due to the standard would be less than 20% of the Mw. Additionally, a Mw of 47.8 would also have at least 13 repeat units. Vader teaches the polymers have a polydispersity of 1.4 (Table 1) indicating variation in the polymer size (n).
Claim Rejections - 35 USC § 103
Claim(s) 1-2, 33, 35, 48-50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Engbersen (US 2013/0157926).
Engbersen teaches boronated polymers which are formed by first forming a polymer of the structure
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104
254
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where R10 is H2N-CR8a2)w- (¶ 86-88) and where R1 includes H, R2 includes C1-C20 alkylene interrupted by -S-S- groups, and A includes N, and p is 1-100 (¶ 14-16, 28). Engbersen teaches examples such as
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184
668
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Which contains monomeric units meeting claimed formula (I) when R3 is NH2 (¶ 196). This is formed by the reaction of
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140
318
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(¶ 167) which has a monomeric unit weight of about 348. Engbersen does not explicitly recite the Mw of the polymer in the examples. However, Engberson teaches the Mw of the boronated polymer is preferably 1,000-200,000 (¶ 61) which overlaps the claimed range. Alternatively, when p is 1-100, the corresponding ‘n’ is 1-100, giving a molecular weight of about 348-34,800 (given a monomeric unit weight of about 348). This range overlaps the claimed range. Engberson teaches the Mw and Mn are not identical (¶ 60-61) indicating that a plurality of polymers with different molecular weights (and repeat units) are present.
Regarding the limitation ‘calibrated using poly(methyl methacrylate) standards’, a Mw of 1,000-200,000 and 348-34,800 overlaps the claimed range of at least 20 kg mol-1, regardless of the standard used and because any potential systemic overestimation is not mathematically significant enough to more than halve the Mw taught by Engberson.
Engberson teaches Mw which overlap claimed ranges. It is well settled that where prior art describes the components of a claimed compound or compositions in concentrations within or overlapping the claimed concentrations a prima facie case of obviousness is established. See MPEP 2144.05; In re Harris, 409, F3.d 1339, 1343, 74 USPQ2d 1951, 1953 (Fed. Cir 2005); In re Peterson, 315 F.3d 1325, 1329, 65 USPQ 3d 1379, 1382 (Fed. Cir 1997); In re Woodruff, 919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936-37 (CCPA 1990); In re Malagari, 499 F.2d 1297, 1303, 182 USPQ 549, 553 (CCPA 1974). In light of the cited patent case law, it would have been obvious to one of ordinary skill in the art to use a range within the claimed range because a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art and Engberson suggests the Mw. A person of ordinary skill would be motivated to use the claimed amount, based on the teachings of Engberson. See MPEP 2123.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saetrom (US 2017/0044540) in view of Engbersen (US 2013/0157926).
Saetrom teaches a composition of saRNA with a therapeutic composition (abstract) where the composition includes saRNA and an acceptable carrier (¶ 123) including polyamidoamines which may have a cystamine core (¶ 134-135).
Saetrom does not explicitly recite the claimed polymer of formula (I).
However, Engbersen teaches boronated polymers which are formed by first forming a polymer of the structure
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104
254
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where R10 is H2N-CR8a2)w- (¶ 86-88) and where R1 includes H, R2 includes C1-C20 alkylene interrupted by -S-S- groups, and A includes N, and p is 1-100 (¶ 14-16, 28). Engbersen teaches examples such as
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184
668
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Which contains monomeric units meeting claimed formula (I) when R3 is NH2 (¶ 196). This is formed by the reaction of
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140
318
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(¶ 167) which has a monomeric unit weight of about 348. Engbersen does not explicitly recite the Mw of the polymer in the examples. However, Engberson teaches the Mw of the boronated polymer is preferably 1,000-200,000 (¶ 61) which overlaps the claimed range. Alternatively, when p is 1-100, the corresponding ‘n’ is 1-100, giving a molecular weight of about 348-34,800 (given a monomeric unit weight of about 348). This range overlaps the claimed range.
Regarding the limitation ‘calibrated using poly(methyl methacrylate) standards’, a Mw of 1,000-200,000 and 348-34,800 overlaps the claimed range of at least 20 kg mol-1, regardless of the standard used and because any potential systemic overestimation is not mathematically significant enough to more than halve the Mw taught by Engberson.
Engberson teaches Mw which overlap claimed ranges. It is well settled that where prior art describes the components of a claimed compound or compositions in concentrations within or overlapping the claimed concentrations a prima facie case of obviousness is established. See MPEP 2144.05; In re Harris, 409, F3.d 1339, 1343, 74 USPQ2d 1951, 1953 (Fed. Cir 2005); In re Peterson, 315 F.3d 1325, 1329, 65 USPQ 3d 1379, 1382 (Fed. Cir 1997); In re Woodruff, 919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936-37 (CCPA 1990); In re Malagari, 499 F.2d 1297, 1303, 182 USPQ 549, 553 (CCPA 1974). In light of the cited patent case law, it would have been obvious to one of ordinary skill in the art to use a range within the claimed range because a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art and Engberson suggests the Mw. A person of ordinary skill would be motivated to use the claimed amount, based on the teachings of Engberson. See MPEP 2123.
It would have been obvious to use the polymers of Engberson because they have higher transfection efficiency (¶ 59, 117).
Response to Arguments
Applicant's arguments filed 2/23/2026 have been fully considered but they are not persuasive.
Applicant argues that although the polymers of Engbersen share the general amide-amide backbone motif as the claimed pABOLs, their molecular weight, structural design, and intended function differ.
Regarding molecular weight, Applicant directs attention to Table 1 which has molecular weights of 3,400-4,900. This is not persuasive.
Engberson teaches the Mw of the boronated polymer is preferably 1,000-200,000 (¶ 61) which overlaps the claimed range. Alternatively, when p is 1-100, the corresponding ‘n’ is 1-100, giving a molecular weight of about 348-34,800 (given a monomeric unit weight of about 348). This range overlaps the claimed range.
The amounts in Table 1 are preferred embodiments. A preferred embodiment is not controlling, rather, all disclosures “including unpreferred embodiments” must be considered. See MPEP 2123 and In re Lamberti 192 USPQ 278, 280 (CCPA 1976) citing In re Mills 176 USPQ 196 (CCPA 1972). Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. See MPEP 2123 and In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).
Applicant argues that the high molecular weight PABOLs unexpectedly offer significantly improved saRNA encapsulation, cytoplasmic delivery, and immunogenic expression, while Engbersen does not teach extending the PAA chain length would generate such effects.
This is not persuasive.
Evidence of unexpected results must comply with MPEP 716.02, including MPEP 716.02(d), the evidence must be commensurate in scope with the claims. In this case, the claims encompass an extremely large genus, containing innumerable species due to the numerous variables of claimed formula (I). For example, R3 can be an OH group or a -SO2O-C12alkynyl group. The evidence in the instant specification appears to provide a single example in different molecular weights (see Table 1 on pg. 40 of the instant specification). There is no evidence that the full scope of claimed formula (I), having differing L1, R1, L2, L3, R2, L4, L5, and R3 groups would share the alleged unexpected results.
Regarding Applicant’s position that Engbersen does not teach extending the PAA chain length would generate the alleged improved effects, it is noted that this is not required. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by application. See MPEP 2144(IV).
Applicant argues that Saetrom concentrates on short RNA species such as siRNA and miRNA which are two orders of magnitude smaller than saRNA. This is not persuasive as Saetrom explicitly directs attention to saRNA (abstract).
Applicant argues that there is no motivation or reasonable expectation of success to develop high molecular weight pABOL compositions optimized for saRNA. This is not persuasive because Saetrom teaches a composition of saRNA with a therapeutic composition (abstract) where the composition includes saRNA and an acceptable carrier (¶ 123) including polyamidoamines which may have a cystamine core (¶ 134-135) and Engberson teaches the Mw of the boronated polymer is preferably 1,000-200,000 (¶ 61) and that they have higher transfection efficiency (¶ 59, 117). The polymers in Engberson are being combined by the methods taught in Saetrom with no change in the respective functions. Thus, there is nothing present in the combination to suggest anything other than predictable results. Applicant’s position relies on the differences in saRNA from siRNA and miRNA. However, as noted above, Saestrom is directed to saRNA.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT C BOYLE whose telephone number is (571)270-7347. The examiner can normally be reached Monday-Thursday, 10am-4pm.
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/ROBERT C BOYLE/Primary Examiner, Art Unit 1764