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.
Election/Restrictions
Claims 1-9, 21-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 25 February 2026 .
Applicant's election with traverse of Group II (claims 10-20) in the reply filed on 25 February 2026 is acknowledged. The traversal is on the ground(s) that there is no serious search burden and Group I and Group II are not independent or distinct. This is not found persuasive because the scope of Group I and Group II method claims are different and distinct enough to require numerous search queries and different classification searches.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112
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 10 and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 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.
Claim 10 recites different types of lipids. It is not clear if the claim requires “a non-charged lipid comprising at least one hydrophobic moiety, an ionizable or cationic lipid, a helper lipid, and a sterol lipid,” or if they are alternatives.
Claim 15 recites POZ formula [N(COR2)CH2CH2]n. The “n” variable is not defined. Therefore, the metes and bounds of the limitation cannot be determined.
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) 10-20 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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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).
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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).
Regarding claim 18, the composition may further include neutral lipids (para. 25), cholesterol and phospholipids (para. 25), cationic lipids (paras. 23, 24), and PEG lipids (para. 55).
Regarding claim 19, the composition may be a POZ-DAG conjugate (para. 323). The compound has diacylglycerol groups, where R1 and R2 may be myristoyl or dimyristoyl groups (para. 323).
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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.
Conclusion
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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