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 without traverse of claims 1-9, as well as the species DMPC, an HDL apolipoprotein mimetic, and SEQ ID NO: 4 in the reply filed on 11/13/2025 is acknowledged.
Priority
The instant application filed on 04/18/2023 is a 371 of PCT/US2021/055736 filed on 10/20/2021 which claims priority to U.S. Provisional Application Number 63/093,839 filed on 10/20/2020. U.S. PRO 63/093,839 finds support for the instantly claimed invention; therefore, the effective filing date of the instant application is 10/20/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/10/2024 and 09/25/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawing Objections
The drawings are objected to because higher quality figures are requested for Figures 2 and 5. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-9 are objected to because of the following informalities: “…Claim…” should be lowercase and instead read “claim”. This is an objection, not a rejection, because this appears to be a typographical error. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b), Indefiniteness
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.
Claims 1-9 are rejected under 35 U.S.C. 112(b) 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 1 recites “(e.g., complexed, conjugated, encapsulated, absorbed, adsorbed, admixed)”; however, the abbreviation “e.g.,” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention (see, e.g., MPEP 2173.05(d)). Moreover, it is unclear if the limitations that are recited in parentheses are part of the claimed invention, or a preferred embodiment. For the purposes of applying prior art the Examiner has interpreted the limitations in parentheses to be preferred embodiments and not part of the claimed invention.
Claim 1 recites “HDL”; however, abbreviations must be spelled out upon first use.
Claim 3 recites “(e.g., a human subject)”; however, the abbreviation “e.g.,” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention (see, e.g., MPEP 2173.05(d)). Moreover, it is unclear if the limitations that are recited in parentheses are part of the claimed invention, or a preferred embodiment. For the purposes of applying prior art the Examiner has interpreted the limitations in parentheses to be preferred embodiments and not part of the claimed invention.
Claim 3 recites “12-LOX”; however, abbreviations must be spelled out upon first use.
Claim 6 recites “….a combination of one…”; however, it is unclear how one lipid component can be in a combination. For the purposes of applying prior art, the Examiner has interpreted this claim to mean that the lipid component can comprise any one of the lipids recited in the Markush group, or a combination of the lipids recited within the Markush group.
Claim 9 recites “…wherein the ApoA-I mimetic is described by any of SEQ ID NOs: 1-336 and….”; however, it is unclear if the ApoA-I mimetic is two different peptides selected from SEQ ID NOs: 1-336 and SEQ ID NOs: 337-370, or if the ApoA-I mimetic is one peptide that is selected from SEQ ID NOs: 1-370. For the purposes of applying prior art, the Examiner has interpreted the ApoA-I mimetic to be one peptide selected from SEQ ID NOs: 1-370.
Claim 9 recites the limitation "the ApoA-I"; however, there is insufficient antecedent basis for this limitation in the claim. No ApoA-I was previously recited. Moreover, if ApoA-I is an abbreviation, it must be spelled out upon first use. The Examiner has interpreted ApoA-I to be apolipoprotein A-I.
Claims 2 and 4-5, and 7-8 are included in this rejection for depending rejected independent claim 1 and failing to rectify the noted deficiencies.
Claim Rejections - 35 USC § 103, Obviousness
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 nonobviousness.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Moon (WO 2017/223085; Date of Publication: December 28, 2017 – cited in the IDS filed on 05/10/2024) in view of Maloney (U.S. Patent No. 10,752,581; Date of Publication: August 25, 2020 – cited in the IDS filed on 05/10/2024).
Moon’s general disclosure relates to “nanoparticles associated with (e.g., complexed, conjugated, encapsulated, absorbed, adsorbed, admixed) biomacromolecule agents configured for treating, preventing or ameliorating various types of disorders” (see, e.g., Moon, abstract). Moreover, Moon discloses that the nanoparticle is synthetically produced and comprises a mixture of at least one phospholipid and at least one HDL apolipoprotein or apolipoprotein mimetic (see, e.g., Moon, pg. 4, lines 3-4). Additionally, Moon discloses that the nanoparticles can be used as a therapeutic for treating and/or preventing cardiovascular related disorders (see, e.g., Moon, pg. 113, lines 27-29).
Regarding claim 1 pertaining to the composition, Moon teaches a synthetic HDL (sHDL) nanoparticle (see, e.g., Moon, abstract), that comprises a mixture of a phospholipid, such as 1-2-dimyristoyl-sn-glycero-3-phosphatidylcholine (DMPC) (see, e.g., Moon, Examples 5-7) and HDL apolipoprotein or apolipoprotein mimetic (see, e.g., Moon, pg. 4, lines 3-4).
Regarding claim 2 pertaining to sustained release, Moon teaches that the sHDL nanoparticle mixture comprising a phospholipid and apolipoprotein exhibited sustained release of their cargo (i.e., antigen/CpG adjuvant (Ag/CpG)) within endosomes/lysosomes over 24 hours (see, e.g., Moon, Figure 20).
Regarding claims 4 and 8 pertaining to the HDL apolipoprotein, Moon teaches that the HDL apolipoprotein can be an HDL apolipoprotein mimetic (see, e.g., Moon, abstract).
Regarding claim 5 pertaining to the molar ratio, Moon teaches “the sHDL nanoparticles have a molar ratio of phospholipid/ HDL apolipoprotein from 2 to 250 (e.g., 10 to 200, 20 to 100, 20 to 50, 30 to 40)” (see, e.g., Moon, pg. 67, lines 10-11).
Regarding claim 6 pertaining to the lipid component, Moon teaches that the lipid component is 1-2-dimyristoyl-sn-glycero-3-phosphatidylcholine (DMPC) (see, e.g., Moon, Examples 5-7).
Regarding claim 7 pertaining to the charge of the lipid component, Moon teaches that the lipid component can be neutral (i.e., uncharged) (see, e.g., Moon, pg. 90, lines 24-25).
Regarding claim 9 pertaining to the ApoA-I mimetic, Moon teaches SEQ ID NO: 4, which encodes a “22A” ApoA-I mimetic (see, e.g., Moon, Examples 1-4), and which has 100% sequence identity to instant SEQ ID NO: 4 (see, e.g., Office Action Appendix).
However, Moon does not teach: N-2-benzothiazolyl-4-[[2-hydroxy-3-methoxyphenyl)methyl]amino]-benzenesulfonamide (ML355) (claim 1); or wherein the sHDL-ML355 is capable of inhibiting platelet aggregation, inhibiting thrombosis formation, inhibiting vessel occlusion, and/or inhibiting platelet associated 12-LOX activity (claim 3).
Maloney’s general disclosure relates to identification of compounds that are potent and selective inhibitors of 12-LOX (see, e.g., Maloney, “Summary of the Invention”, col. 4, lines 22-23). Moreover, Maloney discloses that compound ML355 is an inhibitor of 12-LOX (see, e.g., Maloney, Figures 4-5). Additionally, Maloney teaches that treatment of platelets with ML355 results in decreased platelet aggregation (see, e.g., Maloney, Figures 11A-B).
Regarding claims 1 and 3 pertaining to ML355, Maloney teaches ML355 for inhibiting 12-LOX activity (see, e.g., Maloney, Figures 4-5) and decreasing platelet aggregation (see, e.g., Maloney, Figure 11A-B).
Regarding claim 3 pertaining to the effects exhibited by sHDL-ML355, the ability of sHDL-M355 to inhibit platelet aggregation, inhibit thrombosis formation, inhibit vessel occlusion, and inhibit platelet associated 12-LOX activity is considered inherent to the composition. The combined prior art of Moon and Maloney teaches producing and administering the same sHDL-ML355 composition, which would be inherently lead to the same inhibitory effects since the inherent properties exhibited by the composition would be present within the administered composition (see, e.g., MPEP 2112.02).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce Moon’s sHDL nanoparticle comprising a lipid and an HDL apolipoprotein, wherein the sHDL nanoparticle also comprises ML355, as taught by Maloney. One would have been motivated to do so because Moon teaches that the sHDL, lipid, HDL apolipoprotein mixture produces a stable, ultrasmall nanoparticle capable of protecting and delivering cargo for biotherapeutics (see, e.g., Moon, pg. 1, lines 20-29). Additionally, Moon teaches that this nanoparticle platform is generally applicable for personalize therapeutics with a wide range of bioactive molecules (see, e.g., Moon, pg. 2, lines 24-25). Moreover, Maloney teaches that ML355 is an inhibitor of 12-LOX (see, e.g., Maloney, Figures 4-5), which has therapeutic implications for cancer, inflammatory diseases, neurodegenerative diseases, diabetes, cardiovascular disease, etc. (see, e.g., Maloney, “Background of the Invention”, cols. 1-3). Therefore, ML355 is a molecule that can be used to treat or prevent 12-LOX mediated diseases or disorders (see, e.g., Maloney, col. 5, lines 27-30 & Figures 4-5). Therefore, based on the teachings of Moon and Maloney, it would have been obvious to combine sHDL comprising a lipid component and an HDL apolipoprotein component, with ML355 in order to inhibit 12-LOX mediated disorders. Moreover, based on the teachings of Moon and Maloney, the sHDL nanoparticle mixture would be capable of protecting and delivering the ML355 cargo for 12-LOX mediated diseases. One would have expected success because Moon and Maloney teach the sHDL nanoparticle and ML355 moiety for treatment of various diseases and disorders.
Conclusion
Claims 1-9 are rejected.
No claims are allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE IANNUZO whose telephone number is (703)756-5559. The examiner can normally be reached Mon - Fri: 8:30-6:00 EST.
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/NATALIE IANNUZO/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653