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 .
Claims 1-16 are presented for examination.
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.
Claim I is 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 1 is indefinite as to the phrase “A nanodisc with improved substrate conversion ability of angiotensin enzyme 2”. It is not clear how the functional limitation further defines the structure or composition of the claimed invention. MPEP § 2173.05(g) ("the use of functional language in a claim may fail 'to provide a clear-cut indication of the scope of the subject matter embraced by the claim' and thus be indefinite"). This lack of clarity renders claim 1 and the claims depending thereon ( claims 3-7 and 10) indefinite.
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.
Claim(s) 1-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kweon et al. (US 20190255145) in view of Ghobadi et al. (US 20230181759) and further in view of Warner et al. (Angiotensin-converting enzyme-2: a molecular and cellular perspective) and Hong et al. (Ectodomain shedding of angiotensin converting enzyme 2 in human airway epithelia).
The claims are drawn to a nanodisc with improved substrate conversion ability of angiotensin converting enzyme 2 (ACE2) comprising:
a lipid bilayer derived from phospholipid, having a flat disc-shaped bilayer structure, and including a hydrophilic moiety disposed outside and a hydrophobic moiety disposed inside; a membrane scaffold protein (MSP) surrounding a side surface of the lipid bilayer where the hydrophobic moiety is exposed to the outside; and angiotensin converting enzyme 2 (ACE2) hydrophobically linked to the inside of the lipid bilayer.
The claims are also drawn to a nanodisc comprising: a lipid bilayer derived from phospholipid, having a flat disc-shaped bilayer structure, and including a hydrophilic moiety disposed outside and a hydrophobic moiety disposed inside; and a membrane scaffold protein (MSP) surrounding a side surface of the lipid bilayer where the hydrophobic moiety is exposed to the outside, wherein the membrane scaffold protein (MSP) is a membrane scaffold protein fused with angiotensin converting enzyme 2 (ACE2).
Regarding claim 1, Kweon teaches a lipid bilayer nanodisc and a membrane scaffold protein, and a composition for preventing or treating viral infections, which includes the nano-perforator, and more particularly, to a pharmaceutical composition for preventing or treating viral infections, which includes a nano-perforator in which a lipid bilayer is surrounded by a membrane scaffold protein, a method of preventing or treating viral infections. See Para [0001] and [0018]. Kweon teaches that the membrane scaffold protein surrounding the outer circumferential surface of the lipid bilayer may be an amphipathic protein including a hydrophobic region and a hydrophilic region. The nano-perforator may be formed such that the hydrophobic region (e.g., hydrophobic amino acid) of the membrane scaffold protein binds to a hydrophobic region (e.g., lipid) of the lipid bilayer nanodisc, and the hydrophilic region (e.g., hydrophilic amino acid) of the membrane scaffold protein is exposed to the outside. For example, the membrane scaffold protein may be an amphipathic protein having a helical structure. See Para [0025]. Kweon teaches that the receptor itself may be inserted into or bind to the lipid bilayer, or the receptor may be inserted into or bind to the lipid bilayer via a linker. See Para [0039]. Kweon does not teach the use of angiotensin converting enzyme 2, but teaches other agents such as sialic acid being linked to the lipid bilayer. See Para [0040]. Kweon also teaches a viral activity inhibitor or viral replication inhibitor including a lipid bilayer nanodisc and a membrane scaffold protein surrounding an outer circumferential surface of the nanodisc. See Para [0056].
Ghobadi teaches a method of reducing or treating a respiratory viral infection in a subject by administering to the subject an effective amount of a nanoparticle composition where the nanoparticle has at least one targeting moiety conjugated to the surface, where the targeting moiety is selected from a recombinant angiotensin converting enzyme-2 (ACE-2) polypeptide and an anti-ACE-2 antibody. In one aspect, the nanoparticle is a liposome and may also include an anti-viral agent. See Para [0005]. Ghobadi further teaches pharmaceutical compositions comprising at least one pharmaceutically acceptable excipient and a nanoparticle comprising at least one targeting moiety conjugated to the surface, wherein the targeting moiety is a recombinant angiotensin converting enzyme-2 (ACE-2) polypeptide. Ghobadi teaches that In addition, the nanoparticle compositions are useful to increase angiotensin converting enzyme-2 (ACE-2) levels in cells and tissues susceptible to infection by a respiratory virus. Increasing ACE-2 levels using a nanoparticle composition can prevent and/or resolve acute lung injury in subjects with infection. See Par [0013]. The use of phospholipid bilayer is taught in Para [0029]. It would have been obvious to a person skilled in the art to use angiotensin converting enzyme 2 as a targeting agent motivated by the teachings of Ghobadi, which teaches the use of angiotensin converting enzyme 2 as a targeting agent conjugated to the surface of nanoparticles.
Regarding claim 2, Ghobadi teaches pharmaceutical compositions comprising at least one pharmaceutically acceptable excipient and a nanoparticle comprising at least one targeting moiety conjugated to the surface, wherein the targeting moiety is a recombinant angiotensin converting enzyme-2 (ACE-2) polypeptide.
Regarding claim 3 and 4, Kweon teaches the use of the claimed lipid bilayer. See para [0022].
Regarding claim 5, Kweon teaches protein having a helix structure. See Para [0029].
Regarding claim 6, Kweon teaches scaffold protein being an apolipoprotein. See Para [0027].
Regarding claim 7, Ghobadi teaches pharmaceutical compositions comprising at least one pharmaceutically acceptable excipient and a nanoparticle comprising at least one targeting moiety conjugated to the surface, wherein the targeting moiety is a recombinant angiotensin converting enzyme-2 (ACE-2) polypeptide. Hong teaches that ACE2 is shed from human airway epithelia, a site of SARS-CoV infection. Hong teaches that the ACE2 cleavage site resides between amino acid 716 and the putative trans membrane domain starting at amino acid 741. See first column 1. Hong makes clear that angiotensin converting enzyme II the transmembrane domain starting from amino acid 741 is removed.
Regarding claim 8, the process by which the membrane scaffold protein is fused with angiotensin converting enzyme does not create a patentably distinct composition.
Regarding claims 9 and 10, Ghobadi teaches that In addition, the nanoparticle compositions are useful to increase angiotensin converting enzyme-2 (ACE-2) levels in cells and tissues susceptible to infection by a respiratory virus. Increasing ACE-2 levels using a nanoparticle composition as described herein can prevent and/or resolve acute lung injury in subjects with infection. See Para [0013]. The substrate conversion of angiotensin II to angiotensin 1-7 is taught by Warner, which teaches ACE2 efficiently hydrolyses the potent vasoconstrictor angiotensin II to angiotensin (1–7). See the abstract.
Regarding claims 11 and 12, Kweon teaches the use of the claimed lipid bilayer. See para [0022].
Regarding claim 13, Kweon teaches protein having a helix structure. See Para [0029].
Regarding claim 14, Kweon teaches scaffold protein being an apolipoprotein. See Para [0027].
Regarding claim 15, Ghobadi teaches pharmaceutical compositions comprising at least one pharmaceutically acceptable excipient and a nanoparticle comprising at least one targeting moiety conjugated to the surface, wherein the targeting moiety is a recombinant angiotensin converting enzyme-2 (ACE-2) polypeptide. Hong teaches that ACE2 is shed from human airway epithelia, a site of SARS-CoV infection. Hong teaches that the ACE2 cleavage site resides between amino acid 716 and the putative trans membrane domain starting at amino acid 741. See first column 1. Hong makes clear that angiotensin converting enzyme II the transmembrane domain starting from amino acid 741 is removed.
Regarding claim 16, Ghobadi teaches that In addition, the nanoparticle compositions according to the disclosure are useful to increase angiotensin converting enzyme-2 (ACE-2) levels in cells and tissues susceptible to infection by a respiratory virus. Increasing ACE-2 levels using a nanoparticle composition can prevent and/or resolve acute lung injury in subjects with infection. See Para [0013]. The substrate conversion of angiotensin II to angiotensin 1-7 is taught by Warner, which teaches ACE2 efficiently hydrolyses the potent vasoconstrictor angiotensin II to angiotensin (1–7). See the abstract.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617
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