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 without traverse of Species C, a barrier comprising a nanopore, alpha-hemolysin in the reply filed on 12/17/25 is acknowledged.
Claims 6, 8, 10, 14-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/17/25.
Species C is crosslinked via the interface coupling agent, which is claim 7. The subject matter of Claim 7 has been indicated as allowable below. Thus, Claim 5 was examined (crosslinking at the hydrophilic block)
Priority
The claims have a priority date of the filing of the provisional application: 3/31/22
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/17/25, 11/9/23, 6/20/23 have been considered by the examiner.
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 3 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 3 recites the limitation "the first layer" and “the second layer”. There is insufficient antecedent basis for this limitation in the claim. Claim 3 should depend from claim 2.
Claim Rejections - 35 USC § 102
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) 1-5, 9, 11-13, 16-19, 34 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Wang (CN112831395A, English translation provided).
Wang discloses cell membranes for nanopore sequencing (title). Example 2 discloses synthesizing a triblock copolymer PMOXA-PDMS-PMOXA (hydrophilic-hydrophobic-hydrophilic) wherein the endgroups of the hydrophilic blocks comprise a methacrylate group (page 7 of the translation). This forms the bilayer seen in Figure 1. The membrane crosslinks at the hydrophilic blocks. These triblock copolymers meet the claimed amphiphilic molecules of claim 1 (e.g. they have hydrophilic and hydrophobic groups), the crosslinking of claim 1, and, the membrane of figure 1 implicitly has a fluid on either side of it and thus meets the barrier of claim 1. Elements above thusly meet all elements of claim 1. The bilayer of Fig 1 is a first and second layer (“bi” indicates 2 layers), meeting claim 2, both layers are crosslinked in Fig 1, meeting claim 3. The blocks are implicitly coupled to each other, e.g. both ends of the hydrophobic block is directly attached (coupled) to hydrophilic blocks, as required by claim 4. They are crosslinked via the unsaturation at the endgroups of the hydrophilic blocks, as required by claim 5. They are triblocks (as discussed above), meeting claim 9, having a hydrophilic-hydrophobic-hydrophilic structure, meeting claim 11. The crosslinking is via a polymerization reaction, e.g. reacting the end methacrylate groups polymerizes the endgroups together, as required by claim 12, the methacrylate reaction is an allyl moiety, as required by claim 13. A nanopore test device is used (example 2 and fig 2) meeting the aperture requirements of claim 18. Elements above meet claims 19 and 34.
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.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as obvious over Wang in view of Brown (WO 2021/111139, US 2023/0041418 is used as an Equivalent document for the citations below).
Wang includes elements as set forth above. Wang adds a nanopore former such as hemolysin (see under Example 2, page 7) but does not disclose the use of alpha-hemolysin.
Brown discloses methods of tethering complexes in amphiphilic layers (abstract). These layers are akin to Wang, e.g. they are assembled layers of amphiphilic molecules. Brown discloses the use of nanopores as a transmembrane pore [0281]. This is the same purpose as Wang, e.g. to insert a pore (opening) in the amphiphilic layer. Brown discloses alpha-hemolysin to be a known nanopore former [0289].
It would have been obvious before the effective filing date of the invention to include in Wang the use of alpha-hemolysin, as taught by Brown, since this is recognized in the art as suitable for the intended use there of, e.g. a known nanopore former. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), wherein the selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination.
Allowable Subject Matter
Claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: A barrier between first and second fluids comprising amphiphilic molecules wherein the amphiphilic molecules comprise at least one hydrophobic block coupled to at least one hydrophilic block at an interface and are crosslinked at the interface, is not suggested or disclosed.
Closest prior art includes Wang, as above, however Wang only suggests crosslinking at the hydrophilic or hydrophilic block, not at the interface where the blocks are coupled. Other close prior art includes US 2002/0037986 however these are also crosslinked via endgroups of the amphiphilic molecule.
Conclusion
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/ALICIA BLAND/ Primary Examiner, Art Unit 1759