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 of Group I, claims 1-9 and 37, in the reply filed on June 2, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 13, 14, 16, 17, 29-32, 42, and 46 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Drawings
The drawings were received on June 2, 2022. These drawings are acceptable.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: A METHOD OF CONCENTRATING A TETHERING COMPLEX IN A REGION OF AN AMPHIPHILIC LAYER.
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 (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 the appropriate paragraphs of 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.
Claim(s) 1-9 and 37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clarke et al (US 2014/0262784 A1) (provided by applicant in IDS dated 10/13/2022), and as evidenced by Holden et al (US 2021/0008557 A1) with regard to claim 8.
Clarke discloses a method of concentrating a tethering complex in a region of an amphiphilic layer (See Para. 0112 for discussion of a membrane being an amphiphilic layer), said amphiphilic layer comprising a plurality of amphiphilic molecules and a detector (See Paras. 0097-0098 for discussion of the amphiphilic membrane preferably being a lipid bilayers used for in vitro investigation of membrane proteins by single-channel recording; can be used as biosensors to detect the presence of a range of substances; Para. 0112 discusses how the analyte is not coupled to the membrane via the detector; Paras. 0139-0143 describe embodiments of the detector), wherein the tethering complex comprises one or more hydrophilic components connected by a hydrophobic linker (See Para. 0112 for discussion of the analyte being coupled to the membrane via a hydrophobic anchor present in the membrane, wherein the hydrophobic anchor is preferably a lipid, fatty acid, sterol, carbon nanotube, polypeptide, protein or amino acid; Para. 0117 further describes how the analyte is preferable coupled to the membrane via linkers such as polynucleotides, polyethylene glycol, polysaccharides and polypeptides);
the method comprising contacting the tethering complex or one or more components thereof with said plurality of amphiphilic molecules (See Para. 0121 and Table 3 for discussion of coupling a polynucleotide analyte to an amphiphilic layer and attachment types); and
wherein the amphiphilic layer comprises a first region comprising the detector, and a second region, wherein the first region differs chemically and/or physically from the second region, and wherein the tethering complex preferentially localizes to the first region relative to the second region; thereby concentrating the tethering complex in the first region of the amphiphilic layer (See Paras. 0219-0221 for discussion of how the detector comprise a pore or a plurality of pores and other transmembrane and/or intramembrane proteins as well as other molecules in addition to the pore, wherein the analyte interacts with the pore; Paras. 0222-0224 discusses a sequencing protocol wherein the method comprises (a) coupling the target polynucleotide to a membrane; (b) allowing the target polynucleotide to interact with a detector present in the membrane, wherein the detector comprises a transmembrane pore and an exonuclease, such that the exonuclease digests an individual nucleotide from one end of the target polynucleotide; (c) allowing the nucleotide to interact with the pore; (d) measuring the current passing through the pore during the interaction and thereby determining the identity of the nucleotide; and (e) repeating steps (b) to (d) at the same end of the target polynucleotide and thereby determining the sequence of the target polynucleotide; the first region is being considered the area comprising the nanopore(s)/detector(s), and the second region is the area of the membranes not encompassing the nanopore(s)/detector(s)).
With respect to claim 2 Clarke discloses that the tethering complex comprises a first hydrophilic component connected to a second hydrophilic component by a hydrophobic linker (See Para. 0091 for discussion of triblockpolymers that have the general motif hydrophilic-hydrophobic-hydrophilic; See Paras. 0155 and Table 4).
With respect to claim 3 Clarke discloses that the first region is a multi-layered region of the amphiphilic layer (See Paras. 0096 and 0098 for discussion of how the amphiphilic layer may be a bilayer; also see Para. 0220).
With respect to claim 4 Clarke discloses wherein the first region and the second region both comprise the same type of amphiphilic molecules (See Paras. 0090-0111 for discussion of the amphiphilic layer and various ways that it can be formed and modified; Para. 0091 discusses how the membranes formed of triblock copolymers can be constructed to provide the correct chain lengths and properties required to form membranes and to interact with pores and other proteins; it should be noted that the first region is interpreted to encompass a portion of the membrane that contains the nanopore(s)/transmembrane pore(s) – See Paras. 0142-0149 for further discussion of the transmembrane pore; Para. 0107 discusses how the lipid composition can comprise one or more different lipids and can be chosen such that the bilayer has the required properties to be formed).
With respect to claim 5 Clarke discloses wherein the first region comprises a first composition of amphiphilic molecules and the second region comprises a second composition of amphiphilic molecules, and the first composition differs from the second composition (See Para. 0107 for discussion of how the lipid composition can comprise one or more different lipids and can be chosen such that the bilayer has the required properties to be formed).
With respect to claim 6 Clarke discloses wherein the first region and the second region of the amphiphilic layer respectively correspond to first and second areas of a substrate, wherein the first area of the substrate differs chemically and/or physically from the second area (See Paras. 0090-0111 and 0142-0149 for discussion of how nanopores/transmembrane pores are incorporated into regions of the amphiphilic membrane layer; it is being interpreted that the first regions that encompass the pores are physically different from the regions of the membrane that do not comprise pores).
With respect to claim 7 Clarke discloses wherein the first area corresponds to an aperture in a substrate (See Paras. 0090-0111 and 0142-0149 for discussion of the incorporation of nanopores/transmembrane pores in the amphiphilic membrane layer) and the second area corresponds to an optionally coated portion of the substrate. Applicant should note that the use of the term “optionally” is interpreted such that prior art that does not teach a coated portion would suffice to read upon the claimed recitation.
With respect to claim 8 Clarke discloses wherein the first region corresponds to the interfacial surface area between a first droplet and a second droplet pair, wherein the first and second droplets each have an amphiphilic coating; and the second region corresponds to the surface area of the portion of the first droplet which does not interface with a second droplet (See Para. 0099 for discussion of the formation of lipid bilayers; Para. 0108 discusses the lipid composition that forms a lipid biolayers, which typically comprise a head group, an interfacial moiety, and two hydrophobic tail groups which may be the same of different. Pg. 50 of applicant’s specification filed June 2, 2022 discusses a similar composition of lipid molecules as described by Clarke. It should further be noted that Holden et al (US 2021/0008557 A1) describes that a membrane formed by a bilayer of amphipathic molecules may be referred to as a droplet interface bilayer (DIB). Multiple membranes can be formed at the interface between multiple pairs of droplets, and DIBs may be used for the study of transmembrane pores inserted therein. Thus, it is interpreted that Clarke adequately discloses the recitation of claim 8).
With respect to claim 9 Clarke discloses that the first region and the second region are phase separated regions of the amphiphilic layer (See Para. 0106 for discussion of how the bilayer may be present in a number of lipid phases including, but not limited to the liquid disordered phase, liquid ordered phase, solid ordered phase, and planar bilayer crystals; Para. 0107 describes how the lipid composition can comprise one or more different lipids and can be chosen such that the bilayer has the required properties to be formed).
With respect to claim 37 Clarke discloses a method of characterizing a target analyte; the method comprising concentrating the analyte in the region of a detector using the method of claim 1 (See Para. 0137 for discussion of how several linkers can be utilized to bind the analyte simultaneously, thus increasing the concentration of analyte relative to that of the adapter), and taking one or more measurements as the analyte moves with respect to the detector, wherein the one or more measurements are indicative of one or more characteristics of the analyte, and thereby characterizing the analyte as it moves with respect to the detector (See abstract and Para. 0074 for discussion of how the method relates to determining the presence, absence, or characteristics of an analyte; Paras. 0075, 0078, 0094, and 0217 discusses how coupling the analyte to a membrane containing the detector allows the presence or characteristics of the analyte to be determined when the analyte is present at specific concentrations).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITTANY I FISHER whose telephone number is (469)295-9182. The examiner can normally be reached IFP.
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/BRITTANY I FISHER/Examiner, Art Unit 1796 November 1, 2025