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 .
DETAILED ACTION
Claims 2, 3, 6, and 7 are cancelled. Claims 1, 4, and 5-11 are pending. Claims 5-11 are withdrawn. Claims 1 and 4 are under examination.
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 final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/08/2026 has been entered.
Response to Arguments
Applicant's arguments filed 06/08/2026 have been fully considered but they are not persuasive. Applicant argues that Wagner and Stoffel fail to disclose all limitations of claim 1 as amended. However, Wagner teaches nanodisc embodiments and/or structures (para. [00140]). Wagner teaches that the term “conventional nanodisc” refers to a discoidal phospholipid bilayer encompassed by a membrane scaffold protein (MSP) e.g., two molecules of an amphipathic alpha-helical protein wrapped around the perimeter of the disc in an anti-parallel fashion (para. [00143]). Wagner teaches that the amphipathic alpha-helical protein of the nanodisc may comprise an ApoA-I polypeptide (para. [0012]), i.e., ApoA1, which comprises at least one repeat of the ApoA-I C-terminal lipid binding domain (para. [0058]). Stoffel teaches a chimeric polypeptide, i.e., a fusion protein, comprising two different apolipoproteins: apolipoprotein A1 and apolipoprotein M (Page 8, lines 4-9). It would be obvious to one of ordinary skill in the art that apolipoprotein M as taught by Stoffel may be fused to the apolipoprotein A1 in the nanodisc of Wagner, which contains the apolipoprotein A1 binding domain. Therefore, the combination of Wagner and Stoffel teach all limitations of independent claim 1 as amended.
Claim Rejections - 35 USC § 103
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.
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 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Wagner et al. (WO 2018/017442 A1), previously cited, in view of Stoffel (WO 2009/056330 A1), previously cited.
Regarding claim 1, Wagner teaches nanodisc embodiments and/or structures (para. [00140]). Wagner teaches that the term “conventional nanodisc” refers to a discoidal phospholipid bilayer encompassed by a membrane scaffold protein (MSP) e.g., two molecules of an amphipathic alpha-helical protein wrapped around the perimeter of the disc in an anti-parallel fashion (para. [00143]). Wagner teaches that the amphipathic alpha-helical protein may be apolipoprotein (para. [00143]), and teaches that the amphipathic alpha helix domain may comprise an ApoA-I polypeptide (para. [0012]), which comprises at least one repeat of the ApoA-I C-terminal lipid binding domain (para. [0058]).
Wagner does not teach that the amphipathic alpha-helical protein is a fusion protein of two different apolipoproteins. However, Stoffel teaches a chimeric polypeptide, i.e., a fusion protein, comprising two different apolipoproteins: apolipoprotein A1 and apolipoprotein M (Page 8, lines 4-9).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to fuse apolipoprotein M as taught by Stoffel to the apolipoprotein A1 protein in the nanodisc of Wagner, which contains the lipid binding domain. One of ordinary skill in the art would have been motivated to do so because Stoffel teaches that apoM modulates HDL function in a beneficial manner (p. 2, lines 26-27) and teaches that apolipoprotein A1 may be fused to apolipoprotein M (Page 8, lines 4-9). One of ordinary skill in the art would have had a reasonable expectation of success because Wagner and Stoffel are in the same field of endeavor of apolipoprotein therapeutics.
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Regarding claim 4, because of the term “an amino acid sequence”, any amino acid sequence that shares at least 3 contiguous amino acids with SEQ ID NO:1 is considered to read on the claim. Wagner teaches that the C-terminal lipid binding domain of ApoA-1 is shown in residues 68-267 of SEQ ID NO:5 (para. [0058]), while Stoffel teaches a fusion protein comprising apoM, wherein apoM has an amino acid sequence shown in SEQ ID NO:1 or 7 (p. 5, lines 20-37). A polypeptide comprising SEQ ID NO:1 of Stoffel fused to residues 68-267 of SEQ ID NO:5 of Wagner shares 89.2% sequence identity to instant SEQ ID NO:1 (see alignment below).
Allowable Subject Matter
There are no prior art references that teach a sequence with 100% sequence identity to instant SEQ ID NO:1. Therefore, to overcome the rejection presented in this Office action, Applicant may consider the following amendment, which has been drafted by the Examiner:
Claim 1. A fusion protein nanodisc, comprising:
a discoidal phospholipid bilayer; and,
a membrane scaffold protein comprising two molecules, wherein each comprises a polypeptide with the amino acid sequence of SEQ ID NO:1
wherein the two molecules are wrapped around a perimeter of the discoidal phospholipid bilayer in an anti-parallel fashion.
Cancel claims 4, 5 and 8-11.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL EMILY MARTIN whose telephone number is (703)756-1416. The examiner can normally be reached M-Th 8:30-16:00, F 8:30-10:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at (571) 272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/RACHEL EMILY MARTIN/Examiner, Art Unit 1657
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