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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-20, 23-24, and 49-50, drawn to a lipid nanoparticle composition, in the reply filed on May 27, 2026 is acknowledged.
The traversal is on the ground(s) that Groups I, II, and IV represents a single inventive concept and that there would be no search burden to the examine Groups I, II, and IV together, as a search for the product would necessarily uncover methods of using them.
First, this is not found persuasive because composition and method claims are unique to one another. A product and a process of using the product can be shown to be distinct inventions if either or both of the following can be shown: (A) the process of using as claimed can be practiced with another materially different product; or (B) the product as claimed can be used in a materially different process [MPEP 806.05(h)]. In this instance, the product [if the therapeutic substance is a nucleic acid] as claimed can be used for vaccination, enzyme replacement therapies, and the treatment of genetic disorders.
Second, this is not found persuasive because each group requires a different field of search as they have different classification and require the use of different search queries. In addition, a search for the limitations of claim 1 would not encompass the search required to examine the method steps delineated in invention II or IV. The method steps of Groups II and IV require additional consideration under 35 U.S.C. 112(a) regarding enablement and written description issues that do not necessarily apply to the product as claimed in invention I.
The requirement is still deemed proper and is therefore made FINAL.
Claims 25, 48, 51, 56, and 61-64 are withdrawn from further consideration pursuant to 37 CFR l.142(b), as being drawn to nonelected groups, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on May 27, 2026.
Summary
Claims 1-20, 23-24, and 49-50 are pending in this office action. Claims 25, 48, 51, 56, and 61-64 are withdrawn. Applicant is encouraged to amend the withdrawn claims to be within the same scope as the pending claims to expedite rejoinder upon allowance. All pending claims are under examination in this application.
Priority
The current application filed on June 20, 2023 is a 371 of PCT/US2021/064639 filed December 21, 2021, which in turn claims domestic priority to provisional patent application 63/129,343 filed on December 22, 2020.
Information Disclosure Statement
Receipt of the Information Disclosure Statements filed July 19, 2024, March 27, 2026, April 16, 2026, and May 29, 2026 are acknowledged. A signed copy of the four documents are attached to this office action.
Claim Objections
Claims 8 and 15-16 are objected to because of the following informalities:
Claim 8: Please insert an “a” prior to “zwitterionic phosphatidyl serine moiety.”
Claims 15 and 16: Please use lowercase for the text “claim.”
Claim 15: On page 4 of the claim set, after the phosphate, please remove the period and replace it with a comma (…n = 1, X = H…) to be consistent with the sulfonamide clause later in the claim.
Appropriate correction is required.
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.
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 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 non-obviousness.
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 1-20, 23-24, and 49-50 are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (US8,617,592B2) in view of Yonezawa et al. (Advanced Drug Delivery Reviews, Published August 2020), and Manoharan et al. (WO2010/054401A1).
[The Examiner is going to introduce each reference and then combine them in the rejection of the instant claims.]
1. Jiang et al.
Jiang et al. is considered to be the prior art closest to the present application and teaches self-assembled particles from zwitterionic polymers and related methods (see title). In addition, Jiang et al. disclose zwitterionic block copolymers and zwitterionic conjugates that advantageously self-assemble into particles, particles assembled from the zwitterionic block copolymers and zwitterionic conjugates, pharmaceutical compositions that include the self-assembled particles, and methods for delivering
therapeutic and diagnostic agents using the particles (see abstract).
2. Yonezawa et al.
Yonezawa et al. teach recent advances in siRNA delivery mediated by lipid-based nanoparticles (see title). Also, Yonezawa et al. disclose small interfering RNA (siRNA) has been expected to be a unique pharmaceutic for the treatment of broad spectrum intractable diseases. However, its unfavorable properties such as easy degradation in the blood and negative-charge density are still a formidable barrier for clinical use. For disruption of this barrier, siRNA delivery technology has been significantly advanced in the past two decades. The approval of Patisiran (ONPATTRO™) for the treatment of transthyretin-mediated amyloidosis, the first approved siRNA drug, is a most important milestone. Since lipid-based nanoparticles (LNPs) are used in Patisiran, LNP-based siRNA delivery is now of significant interest for the development of the next siRNA formulation. In this review, we describe the design of LNPs for the improvement of siRNA properties, bioavailability, and pharmacokinetics. Recently, a number of siRNA encapsulated LNPs were reported for the treatment of intractable diseases such as cancer, viral infection, inflammatory neurological disorder, and genetic diseases. We believe that these contributions address and will promote
the development of an effective LNP-based siRNA delivery system and siRNA formulation (see abstract).
3. Manoharan et al.
Manoharan et al. teach novel lipids and compositions for the delivery of therapeutics (see title). In addition, Manoharan et al. disclose that the present invention provides lipids that are advantageously used in lipid particles for the in vivo delivery of therapeutic agents to cells. In particular, the invention formula (I) provides lipids having the following structure XXXIII wherein: R1 and R2 are each independently for each occurrence optionally substituted C10-C30 alkyl, optionally substituted C10-C30 alkenyl, optionally substituted C10-C30 alkynyl, optionally substituted C10-C30 acyl, or -linker-ligand; R3 is H, optionally substituted C1-C10 alkyl, optionally substituted C2-C10 alkenyl, optionally substituted C2-C10 alkynyl, alkyl hetrocycle, alkylphosphate, alkylphosphorothioate, alkylphosphorodithioate, alkylphosphonates, alkylamines, hydroxyalkyls, w-aminoalkyls, w-(substituted)aminoalkyls, w-phosphoalkyls, w-thiophosphoalkyls, optionally substituted polyethylene glycol (PEG, mw 100-40K), optionally substituted mPEG (mw 120-40K), heteroaryl, heterocycle, or linker-ligand; and E is C(O)O or OC(O) (see abstract).
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Combination of Jiang et al. and Yonezawa et al.
Regarding instant claim 1, Jiang et al. and Yonezawa et al. teach a lipid nanoparticle composition. The necessary citations within Jiang et al. and Yonezawa et al. that correspond to instant claim 1 are compiled within Table I.
Table I
Instant Claim 1
Jiang et al. and Yonezawa et al. Citations
A lipid nanoparticle composition comprising:
Jiang et al. disclose a lipid nanoparticle (LNP) composition (see Col. 3, In 6-10; Col 4. In 22; and Col. 4, In 37-39 within Jiang et al.) composition comprising:
(i) at least one zwitterionic polymer-containing lipid in which a lipid moiety is covalently attached to a zwitterionic polymer;
(i) at least one zwitterionic polymer-containing lipid in which a lipid moiety is covalently attached to a zwitterionic polymer (see Col. 3, In 6-10,
Col. 6, In 6-10; Col. 10, In 5-10; and Col. 10, In 54-63 within Jiang et al.);
(ii) at least one non-cationic lipid selected from charged and uncharged lipids, wherein the non- cationic lipid is not attached to a polymer;
(ii) at least one non-cationic lipid selected from charged and uncharged lipids, wherein the non-cationic lipid is not attached to a polymer (see Col. 4, In 6-9, "DOPG" within Jiang et al.);
(iii) at least one cationic or ionizable lipid containing a secondary, tertiary, or quaternary amino group and
Jiang et al. does not disclose (iii) at least ne cationic or ionizable lipid containing an amine. However, Yonezawa et al. disclose a lipid nanoparticle composition (see abstract within Yonezawa et al.) comprising (iii) at least one cationic or ionizable lipid containing a quaternary amino group (see pg. 68, Col. 1, para 4.; Figure 7, "DOTAP" within Yonezawa et al.) and
(iv) at least one therapeutic substance.
(iv) at least one therapeutic substance (see pg. 68, Col. 1, para 4; Figure 7, "siRNA" within Yonezawa et al.).
Furthermore, Jiang et al. also disclose (iv) at least one therapeutic substance (see Col. 4, In 34-36 within Jiang et al.).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify to combine the teachings of Jiang et al. and Yonezawa et al. to design a zwitterionic polymer-lipid nanoparticle for delivery of a therapeutic agent, because Jiang et al. and Yonezawa et al. teach compositions of lipid nanoparticles that can be used for the in vivo delivery of therapeutic agents. The motivation for doing so would be to develop a lipid nanoparticle composition that would replace the problematic components in conventional LNPs and provide improved functioning biopharmaceutical products.
[Jiang et al. and Yonezawa et al. disclose all the elements of instant claim 1 within the remaining instant claims of this 35 U.S.C. 103 section.]
Regarding instant claim 2, Jiang et al. and Yonezawa et al. teach wherein said lipid moiety in component (i) is a diacylglyceride.
Jiang et al. disclose wherein said lipid moiety in component (i) is a diacylglyceride (see Col. 6, In 1-10; and Col. 10, In 22-23 "phosphatidylglycerol" within Jiang et al.).
Regarding instant claim 3, Jiang et al. and Yonezawa et al. teach wherein component (i) excludes a polyalkylene oxide segment.
Jiang et al. disclose wherein component (i) excludes a polyalkylene oxide (see Col. 10, In 6-23 within Jiang et al.).
Regarding instant claims 4-6, Jiang et al. and Yonezawa et al. teach wherein the zwitterionic polymer in component (i) is selected from the group consisting of a poly(carboxybetaine) (PCB), a poly(sulfobetaine), a poly(phosphobetaine), poly(phosphatidylcholine), glutamic acid-lysine (EK)-containing polypeptide, a poly(trimethylamine N-oxide) polymer and a poly(zwitterionic phosphatidyl serine).
Jiang et al. disclose wherein the zwitterionic polymer in component (i) is poly(carboxybetaine) (see Col. 10, In 6-10 within Jiang et al.).
Regarding instant claim 7, Jiang et al. and Yonezawa et al. teach wherein the non-cationic lipid in component (ii) contains a zwitterionic moiety.
Yonezawa et al. disclose wherein the non-cationic lipid in component (ii) contains a zwitterionic moiety (see pg. 65, Col. 2, para 2, "DSPC" within Yonezawa et al.).
Regarding instant claim 8, Jiang et al. and Yonezawa et al. teach wherein the zwitterionic moiety is selected from the group consisting of a phosphobetaine, phosphatidylcholine, carboxybetaine, sulfobetaine, trimethylamine N-oxide, glutamic acid-lysine (EK)-containing peptide, or zwitterionic phosphatidyl serine moiety.
Yonezawa et al. disclose wherein the zwitterionic moiety is phosphatidylcholine (see pg. 65, Col 2, para 2, "DSPC" within Yonezawa et al.).
Regarding instant claim 9, Jiang et al. and Yonezawa et al. teach wherein the non-cationic lipid is selected from the group consisting of a dioleoylphosphatidylglycerol (DOPG), dipalmitoylphosphatidylglycerol (DPPG), dioleoylphosphatidylethanolamine (DOPE), palmitoyloleoyl-phosphatidylethanolamine (POPE), dipalmitoylphosphatidylethanolamine (DPPE), dimyristoylphosphoethanolamine (DMPE), distearoylphosphatidylethanolamine (DSPE), 16-0-monomethyl-phospho ethanolamine, 16-0-dimethyl-phosphoethanolamine, 18-1-trans-phosphoethanolamine, 1- stearoyl-2-oleoyl phosphatidyethanolamine (SOPE), and 1,2-dioleoyl-sn glycero-3- phophoethanolamine (transDOPE).
Jiang et al. disclose wherein the non-cationic lipid is selected from Dioleoyl-phosphatidylglycerol (DOPG) (see Col. 4, In 8-9 within Jiang et al.).
Regarding instant claims 10-12, Jiang et al. and Yonezawa et al. teach wherein component (ii) excludes a polyalkylene oxide segment.
Jiang et al. disclose wherein the component (ii) excludes a polyalkylene oxide segment and the non-cationic lipid of component (ii) is a phospholipid selected from a phosphatidyl ethanolamine lipid (see Col 10, In 14-22 within Jiang et al.). Jiang does not disclose the phospholipid as a phosphatidyl serine lipid.
It would have been obvious to one of ordinary skill in the art to combine the teachings of Jiang et al. and Yonezawa et al. with routine experimentation to select phosphatidylserine as the non-cationic lipid, because Jiang et al. teach the use of phosphatidylethanolamine in the design of the lipid nanoparticles, and one of ordinary skill could consider using phosphatidylserine in its place, since both phosphatidyl serine and phosphatidyl ethanolamine are both aminophospholipids whose metabolism is interrelated, in that phosphatidylserine can be converted into phosphatidylethanolamine.
Regarding instant claim 13, Jiang et al. and Yonezawa et al. teach wherein the cationic or ionizable lipid in component (iii) possesses a secondary, tertiary, or quaternary amino group.
Yonezawa et al. disclose wherein the cationic or ionizable lipid in component (iii) possesses a quaternary amino group (see pg. 68, Col. 1, para 4; Figure 7, "DOTAP" within Yonezawa et al.).
Regarding instant claim 14, Jiang et al. and Yonezawa et al. teach wherein the cationic or ionizable lipid in component (iii) possesses a secondary, tertiary, or quaternary group along with a functional group which is negatively charged under physiological conditions.
Jiang et al. disclose wherein the cationic lipid in component (iii) possesses a quaternary group along with a functional group which is negatively charged under physiological conditions (see Col. 7, In 14-35 within Jiang et al.).
Regarding instant claim 15, Jiang et al. and Yonezawa et al. teach wherein the cationic or ionizable lipid meets the instant claim 15 limitations.
Jiang et al. disclose the cationic lipid wherein R-1 and R2 are each alkyl, wherein the alkyl group can be is saturated and branched or unbranched and can be further substituted (see Col. 8, In 55-59; and Col. 7, In 25-40, "R6 and R8 are each alkyl" within Jiang et al.), L is a covalent linker group between N and A, wherein the covalent linker group comprises CH2-COOCH2- (see Col. 7, In 45-46; and Col. 8, In 43-50), A-(X)n is a functional group that is negatively charged under certain pH conditions and can comprise (i) A(X)n as a carboxylic acid group, where A is COOH and n is O (see Col. 7, In 25-44, "A is carbon" within Jiang et al.).
Combination of Jiang et al., Yonezawa et al., and Manoharan et al.
Regarding instant claim 16, Jiang et al., Yonezawa et al., and Manoharan et al. teach the appropriate lipid taught within instant claim 16.
Jiang et al. disclose wherein the functional group is A(X)n which is a carboxylic acid group, where A is COOH and n is 1 (see Col. 7, In 25-44; and Col. 8, In 51-54, "A is carbon and L4 is CH2" within Jiang et al.). Jiang et al. does not disclose the functional group as any of the structures of instant claim 16. Manoharan et al. disclose a lipid nanoparticle formulation comprising cationic lipids (see abstract within Manoharan et al.) with functional groups selected from the first structure of instant claim 16 (see pg. 19, left column, 6th structure within Manoharan et al.). Manoharan et al. does not disclose the functional group further comprising COOH.
It would have been obvious to one of ordinary skill in the art combine the teachings of Jiang et al., Yonezawa et al., and Manoharan et al. with routine experimentation to design a lipid nanoparticle composition comprising a cationic lipid because each of Jiang et al., Yonezawa et al., and Manoharan et al. disclose lipid nanoparticIe formuIations comprising cationic Iipids, wherein the cationic lipid can comprise ionizable comonomers such that one end of the lipid can be cationic and the other end is anionic, with a COOH, and therefore one of ordinary skill, would consider modifying the functional lipid taught by Manoharan et al. with an anionic group or COOH to form an ion pair copolymer, that will improve the overall stability of the nanoparticle.
Regarding instant claims 19-20 and 23, Jiang et al., Yonezawa et al., and Manoharan et al. teach wherein the therapeutic substance in component (iv) is a nucleic acid molecule.
Jiang et al. disclose wherein the therapeutic substance in component (iv) is a nucleic acid molecule that is an RNA, which is selected from mRNA and siRNA (see Col. 12, In 29-46 within Jiang et al.). Jiang does not disclose the RNA as viral RNA. However, Manoharan et al. disclose that the nucleic acid that is present in a lipid-nucleic acid particle according to this invention includes any form of nucleic acid that is known. The nucleic acids used herein can be single-stranded DNA or RNA, or double-stranded DNA or RNA, or DNA-RNA hybrids. Examples of double-stranded DNA include structural genes, genes including control and termination regions, and self-replicating systems such as viral or plasmid DNA. Examples of double-stranded RNA include siRNA and other RNA interference reagents. Single-stranded nucleic acids include, e.g., antisense oligonucleotides, ribozymes, microRNA, and triplex- forming oligonucleotides (see pg. 35, para 4 within Manoharan et al.).
Combination of Jiang et al. and Yonezawa et al.
Regarding instant claim 17, Jiang et al. and Yonezawa et al. teach wherein the cationic or ionizable lipid in component (iii) excludes a polyalkylene oxide segment.
Yonezawa et al. disclose wherein the cationic or ionizable lipid component in (iii) excludes polyalkylene oxide (see pg. 68, Col. 1, para 4; and Figure 7, "DOTAP" within Yonezawa et al.).
Regarding instant claim 18, Jiang et al. and Yonezawa et al. teach wherein the lipid nanoparticle composition further comprises: (v) cholesterol or derivative thereof.
Yonezawa et al. disclose wherein the lipid nanoparticle composition further comprises (v) cholesterol (see pg. 66, Figure 2; Col. 1, para 1; and pg. 69, Col. 1, para 1 within Yonezawa et al.).
Regarding instant claim 24, Jiang et al. and Yonezawa et al. teach wherein the therapeutic substance is a spike protein of a virus.
Jiang et al. disclose wherein the therapeutic substance is a protein (see Col. 12, In 64-67; and Col. 15, In 7-17 within Jiang et al.). Jiang et al. does not disclose the protein as a spike protein of a virus. However, Yonezawa et al. disclose it was recently revealed that SARS-CoV-2 utilizes angiotensin converting enzyme II (ACE2) as a receptor for intracellular entry (see pg. 72, left column, para 3 within Yonezawa et al.) The spike protein of SARS-CoV-2 binds to ACE2 making it an attractive drug target (see PTO-892 NPL V-W).
It would have been obvious to one ordinary skill in the art to combine the teachings of Jiang et al. and Yonezawa et al. with routine experimentation to include a spike protein of a virus within the lipid nanoparticle compositions, since Jiang et al. teach that proteins can be delivered via the lipid nanoparticle composition, and Yonezawa et al. teach that the spike protein of SARS-CoV-2 binds to ACE2.
Regarding instant claim 49, Jiang et al. and Yonezawa et al. teach a lipid composition comprising the lipid moiety of instant claim 15.
Jiang et al. and Yonezawa et al. disclose the lipid moiety of instant claim 15, and Jiang further discloses a lipid composition comprising said lipid moiety (see Col. 3, In 6-9; and Col. 15, In 44-48 within Jiang et al.).
Regarding instant claim 50, Jiang et al. and Yonezawa et al. teach a lipid composition comprising the lipid moiety of instant claim 16.
Jiang et al. and Yonezawa et al. disclose the lipid moiety of instant claim 16, and Jiang further discloses a lipid composition comprising said lipid moiety (see Col. 3, In 6-9; and Col. 15, In 44-48 within Jiang et al.).
Analogous Art
The Jiang et al., Yonezawa et al., and Manoharan et al. references are directed to the same field of endeavor as the instant claims, that is, a zwitterionic polymer containing LNP, as disclosed within instant claim 1.
Obviousness Analysis
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the zwitterionic polymer containing LNP disclosed by Jiang et al., using the teachings of Yonezawa et al. and Manoharan et al. in order to arrive at the subject matter of the instant claims.
The Jiang et al., Yonezawa et al., and Manoharan et al. references all have considerable overlap in the LNP arts. In this instance, Jiang et al. supplies the template for the zwitterionic polymer containing LNP, Yonezawa et al. supplies a cationic or ionizable lipid containing an amine, while Manoharan et al. supplies the support for a claim specific lipid and nucleic acids. All references are directed to LNPs and therefore constitute analogous art under MPEP §2141.01(a). A POSITA would have reasonably consulted the three references when seeking to develop a LNP containing a zwitterionic polymer.
Given these teachings, a POSITA would have been motivated to combine the template for LNPs containing zwitterionic polymers as disclosed by Jiang et al., the cationic or ionizable lipid containing an amine supplied by Yonezawa et al., and the support for a claim specific lipid and nucleic acids disclosed by Manoharan et al.
The modification constitutes a simple substitution of one known element for another to obtain a predictable result [MPEP §2143(I)(B)].
The combination represents the use of a known technique to improve a similar composition in the same way [MPEP §2143(I)(C)].
The art provides a finite number of identified, predictable solutions, and the POSITA would have pursued the claimed configuration with a reasonable expectation of success [MPEP §2143(I)(E); KSR].
The combination of the LNPs containing a zwitterionic polymer taught by Jiang et al. along with the use of the necessary claim limitations taught by Yonezawa et al. and Manoharan et al. would allow a research and development scientist (POSITA) to develop the invention taught in the instant application.
Furthermore, the additional claim limitations taught by Yonezawa et al. and Manoharan et al. would have been viewed by a POSITA as routine design optimizations or known modifications for LNPs containing zwitterionic polymers. The motivation for doing so would be to develop a lipid nanoparticle composition that would replace the problematic components in conventional LNPs and provide improved functioning biopharmaceutical products. Implementing these features in Jiang et al.’s LNPs containing zwitterionic polymers would not require more than ordinary skill or routine experimentation.
Accordingly, the combination of Jiang et al., Yonezawa et al., and Manoharan et al. provides all the elements of the claimed invention. The resulting LNPs containing zwitterionic polymers, constitute no more than the predictable outcome of combining familiar prior art components, and therefore the claimed subject matter would have been obvious to a POSITA prior to the effective filing date of the invention.
Conclusion
No claims are allowed.
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/JOHN W LIPPERT III/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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