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 .
Priority
The instant application was filed 21 December 2023. The Applicant claims priority to provisional application 63/440,210 filed 20 January 2023. Therefore, the effective filing date of the instant application is 20 January 2023.
Examiner’s Note
The Applicant's amendments and arguments filed 24 June 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections
not reiterated from previous office actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 24 June 2026, it is noted that claims 10 and 15 have been amended, claims 18 and 19 have been canceled, and no new claims have been added. Support for the amendments can be found on at least pg. 35 of the specification. No new matter has been added.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 10-17 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heyes (US 20110313017 A1).
Regarding claim 10, the instant claim recites Formula I (R-POZ-L-Lipid), where R may comprise an initiating group, POZ comprises poly(ethyloxazoline), L comprises a degradable linking group, and the Lipid comprises a non-charged lipid comprising at least one hydrophobic moiety, an ionizable or cationic lipid, a helper lipid, and a sterol lipid. Heyes teaches a method of delivering therapeutic agents to tissues (abs; entire teaching; para. 125) of a mammal (para. 27), wherein the composition comprises a lipid particle (para. 23). The therapeutic nucleic acid agent may be encapsulated (para. 51), where the lipid particles may have a diameter of 30-150 nm (para. 53), which is interpreted as a “lipid nanoparticle.” The composition may further include neutral lipids (para. 25), cholesterol and phospholipids (para. 25), cationic lipids (paras. 23, 24), and PEG lipids (para. 55). Heyes teaches a structure showing the general structure for POZ-DAA, R3 is Hydrogen, R4 is an ethyl group, and n is 5 to 240 (paras. 318, 319).
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Furthermore, Heyes teaches Formula II (para. 310), where L (linking group) may be disulfides (para. 312). POZa and POZb may be [N(COR3)CH2CH2]x and [N(COR3)CH2CH2]y, respectively, where R3 (initiating group) may be an ethyl group (unsubstituted alkyl group) (para. 315). Heyes teaches that Formula II (below) includes a covalently linked POZ-lipid conjugate (para. 16), where lipid broadly includes phospholipids (para. 50).
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In regards to Applicant’s amendment of claim 10 (i.e. “a non-charged dialkylamine lipid”), Heyes teaches that hydrophobic lipids may be included in the composition as part of the lipid conjugates (para. 55). The hydrophobic lipids have nonpolar groups, such as N-N-dialkylamino (para. 73), where nonpolar groups are interpreted as “non-charged.”
Regarding claim 11, the composition may be administered intramuscularly (para. 27).
Regarding claim 12, the composition may be administered in single or divided doses (para. 365). Subsequent doses of the formulation may be administered after days or weeks.
Regarding claim 13, subsequent doses of the formulation may be administered after days or weeks, such as 4 weeks (para. 126), which is interpreted as addressing “at least 30 days.”
Regarding claim 14, the nucleic acid-lipid particle may be delivered to a liver cell (para. 122).
Regarding claim 15, Heyes teaches Formula II (para. 310), where L (linking group) may be disulfides (para. 312). POZa and POZb may be [N(COR3)CH2CH2]x and [N(COR3)CH2CH2]y, respectively, where R3 (initiating group) may be an ethyl group (unsubstituted alkyl group) (para. 315).
In regards to Applicant’s amendment of claim 15 (i.e. “n is 1 to 1000”), x of the above formula is an integer from 1 to 1000 (para. 311).
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Regarding claim 16, R1 of Formula II may be Hydrogen (para. 311).
Regarding claim 17, Heyes teaches Formula II (para. 310), where L may be disulfides (para. 312).
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Regarding claim 20, the formulation is used to deliver nucleic acids, such as mRNA (para. 47).
Heyes does not specifically teach an exact combination of Formula I (R-POZ-L-Lipid), where R may comprise an initiating group, POZ comprises poly(ethyloxazoline), L comprises a degradable linking group, and the Lipid comprises a non-charged lipid comprising at least one hydrophobic moiety, an ionizable or cationic lipid, a helper lipid, and a sterol lipid, as recited in claim 10.
In regards to selecting the combination of the components recited in claim 10, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Heyes teaches methods of delivering therapeutic nucleic acids comprising Formula II (para. 310), where L may be disulfides (para. 312). POZa and POZb may be [N(COR3)CH2CH2]x and [N(COR3)CH2CH2]y, respectively, where R3 may be an ethyl group (para. 315). The claimed invention is directed towards a method of delivering a payload to target tissue comprising Formula I (R-POZ-L-Lipid), where R may comprise an initiating group, POZ comprises poly(ethyloxazoline), L comprises a degradable linking group, and the Lipid comprises a non-charged lipid comprising at least one hydrophobic moiety, an ionizable or cationic lipid, a helper lipid, and a sterol lipid. Since Heyes teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
Response to Arguments
Applicant's arguments filed 24 June 2026 have been fully considered but they are not persuasive.
The Applicant argues that Heyes teaches DAA lipids and does not teach dialkylamine lipids, as recited in the amendment (Remarks, pgs. 7-8).
Applicant’s argument is not found persuasive. In regards to Applicant’s amendment of claim 10 (i.e. “a non-charged dialkylamine lipid”), Heyes provides several examples of suitable lipid conjugates, where POZ-DAA is one example (para. 55). Furthermore, Heyes teaches that hydrophobic lipids may be included in the composition as part of the lipid conjugates (para. 55). The hydrophobic lipids have nonpolar groups, sch as N-N-dialkylamino (para. 73), where nonpolar groups are interpreted as “non-charged.”
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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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