Detailed Action
► The applicant's Preliminary Amendment filed 13 DEC 2022 has been entered. Following the entry of the Preliminary Amendment, Claim(s) 47-66 is/are pending.
► The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Priority
► This application is a DIV of 16/317,085 filed 11 JAN 2019, now US Pat 11,485,995,
which is a 371 of PCT/GB2017/052089 filed 14 JUL 2017 and which claims foreign priority to GB1612458.8 filed 14 JUL 2016.
Sequence Rules
► This application complies with the sequence rules and the sequence(s) have been entered by the Scientific and Technical Information Center.
35 U.S.C. 112(b)/ 112 (pre-AIA ), second paragraph
► 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 Rejection(s) under 35 U.S.C. 112(b)/ 112 (pre-AIA ), second paragraph
► Claim(s) 55 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in that it fails to point out what is included or excluded by the claim language.
Claim 55 is indefinite because it uses the phrase “such as ...”. The use of exemplary claim language makes these claims indefinite. See the MPEP at 2173.05(d).
It is well established that the description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences lead to confusion over the intended scope of a claim. Ex parte Hall, 83 USPQ 38 (Bd. App. 1949).
35 U.S.C. 102
► The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that may 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
35 U.S.C. 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.
► 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 Rejection(s) under 35 U.S.C. 102
► Claim(s) 47-48, 50-59, 61-63 and 65 is/are rejected under 35 U.S.C. 102(a)(2) or (a)(1) as being anticipated by Langecker et al. [EP 2695949 (2014) - hereinafter “Langecker”].
Claim 47 is drawn to a method for molecular sensing comprising :
providing a semi-fluid or lipid membrane having a first side and a second side;
providing a nucleic acid membrane-spanning nanopore located in the membrane, wherein the nucleic acid membrane-spanning nanopore defines a central channel that allows for fluid communication between the first side of the membrane and the second side of the membrane, wherein the minimum internal width of the central channel of the nanopore is from about 5 nm to about 20 nm; and iil) measuring a change in electrical properties of the nucleic acid membrane-spanning nanopore in the presence of an analyte, wherein detection of a change in electrical properties is indicative of the presence of the analyte.
Langecker teach a method comprising all of the limitations of Claim 47. For example, Langecker teach DNA origami-based nanopores present within lipid bilayer membranes useful for DNA sequencing wherein a change in electrical properties of the nucleic acid membrane-spanning nanopore in the presence of an analyte is measured, wherein detection of a change in electrical properties is indicative of the presence of the analyte , See especially the abstract and p. 2-19 most notably Langecker teach nucleic acid origami-based nanopores with a “diameter in the nm range, such as about 0.1 nm to about 1,000 nm, e.g. about 0.1 to about 100 nm”, see para 18, thereby meeting the limitation ogf Claim 27 which reads “wherein the minimum internal width of the central channel of the nanopore is from about 5 nm to about 20 nm.”
Claim 48 is drawn, in part, to an embodiment of the method of Claim 47, wherein the semi-fluid or lipid membrane is selected from the group consisting of: a membrane comprising a lipid bilayer; and a membrane comprising a semi- fluid membrane formed of polymers.
Langecker teach these limitation(s), see at least para 20. Fatty acids the constitutes of the membrane lipid bilayers disclosed in para 20 are considered polymers
As regards Claim 50-54 and 58 see at least section(s) 1.4 and 2.4-2.6 in Langecker.
As regards Claim 55-58 and 62 see especially paras 114-116.
As regards Claim 59 and 61-62 see especially paras 13, 23 and 57-64 and 83-104.
As regards Claim 61, Langecker teach preferred embodiments of forming their nanopore structure including the use of DNA strands, scaffold oligos , staple oligos and hydrophobically-modified oligos. see especially paras 13, 23 and 57-64 and 83-104 in Langecker.
As regards Claim 63, Langecker.teach the use of both helper and adaptor oligo(s)/strand(s).
As regards Claim 65, note that Langecker teach the use of sterol (e.g. cholesterol ) modified oligos strands, see especially paras 60-61.
Claim Rejection(s) under 35 U.S.C. 103
► Claim(s) 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Langecker as applied above against Claims 47-48 and further in view of Morton et al. [J. of Materials Chemistry B 3:5080-5086(2015) – hereinafter “Morton”].
Claim 49 is drawn to an embodiment of the method of Claim 48, wherein the polymer(s) forming the semi-fluid membrane comprise amphiphilic synthetic block copolymers, suitably selected from hydrophilic copolymer blocks and hydrophobic copolymer blocks.
Langecker teach a method comprising most of the limitation recited by Claim 48 for the reaon(s) outlined above but fail to teach thje use of amphiphilic synthetic block copolymers. However, it was well known to form nanopores in semi-fluid membrane(s) comprised amphiphilic synthetic block copolymers as evidenced by Morton, see at least the abstract. Accordingly, absent an unexpected result it would have been prima facie obvious to the PHOSITA at the time of the invention to substitute the the semi-fluid membrane of Morton for those disclosed by Langecker. Please note that substitution of one known second method/reagent with known properties for a first known method/reagent with known properties would have been prima facie obvious to the ordinary artisan at the time of the invention in the absence of an unexpected result. As regards the motivation to make the substitution recited above, the motivation to combine arises from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. Support for making this obviousness rejection comes from the M.P.E.P. at 2144.07 and 2144.09, as well as, the SCOTUS decision in KSR International. Co. v. Teleflex, Inc., et al., 550 U.S.398 (2007).
► Claim(s) 60, 61 and 64 is/are rejected under 35 U.S.C. 103 as being unpatentable over Langecker.
As regards the limitation of Claim 60, Langecker disclose several dimension/characteristics of their embodied nuclei acid based nanopores/nanosensors, see at least paras 40-47. That said, Langecker does not expressly teach “wherein the membrane spanning region has a wall thickness of more than one DNA duplex.” However. It is noted that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
As regards Claim(s) 61 and 64, Langecker teach preferred embodiments of forming their nanopore structure including the use of DNA strands, PNA strand modified DNA strands, scaffold oligos, staple oligos and hydrophobically-modified oligos, helper oligos and adaptor oligos. see especially paras 13, 23 and 57-64 and 83-104 in Langecker. That said, Langecker does not expressly teach that the adaptor oligos must comprise DNA. Regardless absent a showing of some criticality this limitation is considered to be a simple design choice (i.e. a preference of choice) well within the knowledge, skill, abilities and common sense of the PHOSITA at the time of the invention.
► Claim(s) 66 is/are rejected under 35 U.S.C. 103 as being unpatentable over Langecker as applied above against Claims 47 and further in view of Ju et al.[US 20150111759 – hereinafter “Ju”]
Claim 66 is drawn to an embodiment wherein the semi-fluid or lipid membrane is provided with a plurality of nucleic acid membrane-spanning nanopores .
Langecker teach a method comprising most of the limitation recited by Claim 66 for the reaon(s) outlined above against Claim 47 but fail to expressly teach semi-fluid or lipid membrane(s) provided with a plurality of nucleic acid membrane-spanning nanopores. However, nanopore arrays were known which arrays comprise semi-fluid or lipid membrane(s) provided with a plurality of membrane-spanning nanopores. see at least Figs. 5 and 37 and para 146. Accordingly, absent an unexpected result it would have been prima facie obvious to the PHOSITA at the time of the invention to modify the membranes/devices of Langecker such that a plurality of nanopores is provided. The PHOSITA would have been motivated to make the modification recited in order to gain the advantages of multiplex analysis.
Conclusion
C. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ethan Whisenant whose telephone number is (571) 272-0754. The examiner can normally be reached Monday-Friday from 8:30 am -5:30 pm EST or any time via voice mail. If repeated attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Anne Gussow, can be reached at (571) 272-6047.
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/ETHAN C WHISENANT/Primary Examiner, Art Unit 1683 ethan.whisenant@uspto.gov
EXAMINER SEARCH NOTES
11 DEC 2025 - ECW
Databases searched: All available via PE2E SEARCH
CAplus, Medline and BIOSIS via STNext; and Google Scholar (note the search terms used below)
Reviewed the parent(s), if any, and any search(es) performed therein : see the BIB data sheet
Reviewed, the search(es), if any, performed by prior examiners including any international examiners.
Planned Search
Search terms:
All Inventor(s) e.g. Howorka S?/au
DNA or RNA
Nanopore$
Sequenc$
Origami
Staple
Scaffold
Ion flow or current
Block copolymers
(Semi-fluid or lipid) (Membrane or bilayer)
► See the Examiner’s PE2E SEARCH notes/strategy in IFW