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
This office action is in response to applicant’s communication filed on 8/18/25 and the interview with Charles Ho on 9/23/25. Claims 1-11 are pending.
Applicant’s election without traverse of the following compound is acknowledged herewith:
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Applicant’s elected species has been found allowable and is free of the prior art.
As a result, claims 1-11 are being examined in this Office Action.
Priority
The applicant claims benefit as follows:
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Objections
Claims 1-2 and 5-7 are objected to because of the following informalities:
Claim 1 is objected to because of applicant’s recitation of “wherein the nanopore structure is a single-molecule transmembrane nanopore structure with nanometer-sized channels”. The examiner recommends the applicant incorporate the transitional phrase “comprising” in claim 1, which could then read “wherein the nanopore structure is a single-molecule transmembrane nanopore structure comprising nanometer-sized channels”.
Claim 2 is objected to because of applicant’s recitation of “the synthetic macrocyclic compound into the phospholipid bilayer membrane to forming a stable transmembrane structure”. The examiner recommends instead “the synthetic macrocyclic compound into the phospholipid bilayer membrane thereby forming a transmembrane structure”, for clarity.
Claim 5 is objected to because the structure below is blurry and the functional groups are indiscernible:
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Claim 6 is objected to because of applicant’s recitation of “wherein the synthetic steps of the structure comprise”. The examiner instead recommends “obtained by a process comprising the steps of:”, for clarity.
Claim 6, step 9), is also objected to because of applicant’s recitation of “hydrophobicity of hydrocarbon chains of the phospholipid molecules”. The examiner instead recommends “hydrophobicity of the hydrocarbon chains on the phospholipid molecules”, for clarity.
Claim 7 is objected to because of applicant’s recitation of “the lipid solution is one selected from the group consisting of”. The examiner instead recommends “wherein the lipid solution is selected from the group consisting of”, for clarity.
Appropriate correction is required.
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.
Claims 2, 6 and 9-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 2 is indefinite because of the claim language “stable transmembrane structure”. Claim 6 is indefinite because of the claim language “very close to the support hole” and “stable nanopore channels”. The specification does not define the metes and bounds of “stable transmembrane structure”, “very close to the support hole” and “stable nanopore channels”, such that one would know what is included and what is excluded. Appropriate correction is required.
Claim 6 is indefinite because of the claim language “by a chemical method”, which does not include active steps. Claims 9-11 are also indefinite because they provide for the use of the “synthetic macrocycle molecular nanopore structure”.
Since these claims do not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Appropriate correction is required.
Claim Rejections –35 USC 101
The following is a quotation of 35 U.S.C. 101:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 9-11 are rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966). See MPEP 2173.05(q).
Claim Rejections – 35 USC 102
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 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 the appropriate paragraphs of the AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
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 1-4 and 6-8 are rejected under AIA 35 U.S.C. 102(a)(1) as being anticipated by Badi et al. (Advanced Materials, 2009, 21, 4054) (in applicant’s IDS filed 10/10/22, see also the supporting information and the graphical abstract), as evidenced by Kucerka et al. (Biochimica et Biophysica Acta, 2011, 1808, 2761).
The instant claims are drawn to:
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Badi et al. teaches a synthetic molecular pore structure formed from a single molecule, in an electrolyte solution. The synthesized cyclodextrin (CD) is derivatized with both hydrophobic heptyl side chains and poly(ethylene oxide) (PEO) side chains (see structure of the CD derivative below). Badi et al. exemplifies (1β), a CD derivative containing per-2,3-di-O-heptyl-β-CD, with an average of 12 ethylene oxide (EO) units per branch (see second entry (1β) in Table 2 on page 4056). This cyclodextrin derivative contains both heptyl side chains and (PEO) side chains linked by an ether bond. The hydrophobic heptyl side chains insert into the lipid bilayer membrane forming long-lived channels to give a synthetic molecular pore structure (see the graphical abstract below). (page 4054, first column, last paragraph to second column, first paragraph; page 4056, first column, last paragraph to second column, last paragraph and Table 2) (supporting information: page 3, second to the last paragraph, page 4, Scheme 1) (graphical abstract)
Thus, Badi et al. teaches channel forming cyclodextrin (CD) derivatives, in which poly(ethylene oxide) (PEO) chains are added to the CD scaffold of the molecule initiator: per-2,3-di-O-heptyl-β-CD. Badi et al. teaches in Table 2 estimated diameters (D) for the channels. Since the pore diameter for the 1β channel in Table 2 is 1.08 Å, this reads on applicant’s limitation for a cavity pore size of 1 Å to 50 Å in diameter as required in claim 1. (page 4055, second column, 4th and 5th paragraphs; page 4056, Table 2, second entry)
Badi et al. teaching for the CD derivative’s “structural arguments for thickness” states that “one channel is made by two facing CDs derivatives”, as also shown below in Badi et al.’s graphical abstract. (page 4056, first column, last paragraph)
In the supplementary information, Badi et al. teaches formation of their lipid bilayers at 20 degree C using Diphytanoylphosphatidylcholine (DPhyPC) (Avanti Polar Lipids) (supplementary information, page 3, “Bilayer experiments” section).
The evidentiary reference Kucerka et al. shows that the bilayer thickness (DB) for (DPhyPC) at 20 degree C is 36.3 Å. (page 2765, Table 2, last row)
Thus since Badi et al.’s “structural arguments for thickness” teaches one channel is made of two CDs derivatives, this would give the atomic level thickness for the CD derivatives to be about half the channel bilayer thickness. Since the bilayer thickness is 36.3 Å, half of that would be 18.15 Å. Thus the atomic level thickness for Badi et al.’s CD derivatives would be approximately 18.15 Å, which would read on applicant’s limitation for an atomic level thickness of 1 Å to 30 Å, as required in claim 1.
The structure shown below is of per-2,3-di-O-heptyl-β-CD, functionalized with (n = 7) PEO side chains (β cyclodextrin derivatized with both hydrophobic heptyl side chains and poly(ethylene oxide) side chains). (supporting information: page 4, Scheme 1, final product):
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Badi et al. shows below the half-channels formed from two modified CDs inserted into the lipid bilayer membrane. This Scheme 1 depicts the synthetic molecular channel structure in the lipid bilayer membrane. The graphical depiction below to the right shows how one full channel is approximately the same thickness as that of the lipid bilayer membrane, which is made of “two facing CDs derivatives”. (page 4056, Scheme 1):
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Badi et al.’s graphical abstract below depicts the synthetic molecular channel structure of per-2,3-di-O-heptyl-β-CD functionalized with (n = 7) PEO side chains (β cyclodextrin derivatized with both hydrophobic heptyl side chains and poly(ethylene oxide) side chains) in a membrane lipid bilayer. (page 4056, first column, last paragraph; graphical abstract)
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With regard to applicant's claims 6-8, the examiner interprets these as product-by-process claims. Thus, “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of productions. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior art was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) Also see MPEP 2113
Therefore these claims are fully met.
Conclusion
Claims 1-11 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer Cho Sawyer whose telephone number is (571) 270 1690. The examiner can normally be reached on Monday-Friday 9 AM - 6 PM PST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Renee Claytor can be reached on (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-274-1690.
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Jennifer Cho Sawyer
Patent Examiner
Art Unit: 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691