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 I (Claims 1-5, 7, 8, 11, and 13) in the reply filed on March 31, 2026 is acknowledged.
Claim 14-21, 23, 36, and 45 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 March 31, 2026.
Priority
Applicant’s claim for the benefit of a prior-filed application (has PRO 63/325,737, filed on March 31, 2022) under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Claim Interpretation
Claim 1 recites the limitation “one or more hydrophilic blocks having an approximate length A and one or more [hydrophobic] blocks having an approximate length B.” The claim does not recite any numerical value or range for A or B. Under the broadest reasonable interpretation, A and B are labels identifying the respective lengths of the hydrophilic and hydrophobic blocks. Thus, the limitation is met by a block copolymer having hydrophilic and hydrophobic blocks with respective chain lengths.
Claim 1 recites the limitation “end groups coupled to ends of the hydrophilic blocks that form outer surfaces of the barrier, the end groups having a different hydrophilicity than the hydrophilic blocks.” Under the broadest reasonable interpretation, the limitation requires terminal end groups coupled to the outer hydrophilic blocks. The “different hydrophilicity” language does not recite a particular hydrophilicity value, measurement method, or required functional effect, and is interpreted as characterizing the relative surface property of the terminal end groups compared with the hydrophilic polymer blocks.
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(d):
(d) REFERENCE IN DEPENDENT FORMS. —Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 1-5, 7-8, 11, and 13 are 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 recites “one or more hydrophilic blocks having an approximate length A” and “one or more hydrophilic blocks having an approximate length B,” thereby identifying both the A-length blocks and the B-length blocks as hydrophilic blocks. Claim 1 later recites “the hydrophobic blocks being located within the barrier.” Accordingly, the claim is indefinite because the claim first identifies the B-length blocks as hydrophilic, but later requires hydrophobic blocks within the barrier, making the identity and scope of the recited block structure unclear. Claims 2–5, 7, 8, 11, and 13, which depend on Claim 1, are similarly rejected by virtue of dependency.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 8 recites the limitation “wherein the hydrophobic block is poly(isobutylene) (PIB).” Claim 5, from which Claim 8 depends, recites “wherein the hydrophobic block is polybutadiene (PBd).” The specification discloses PBd and PIB as alternative species for the hydrophobic block (¶[0008]–¶[0010], ¶[0143], ¶[0150], ¶[0185]). Accordingly, Claim 8 does not further limit the hydrophobic block of Claim 5, but instead attempts to redefine it with a different polymer.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102 / § 103
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.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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.
Claims 1-4, 7, 11, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CLARKE et al. (US20140262784A1, hereinafter as CLARKE).
Regarding Claims 1–4 and 7, CLARKE discloses a nanopore detection/sequencing system in which an analyte is coupled to a membrane containing the relevant detector, thereby positioning the analyte and detector in the same membrane system for detection (¶[0007]).
The amphiphilic layer of the membrane is formed from block copolymers, which include two or more monomer subunits polymerized into a single polymer chain. One subunit is hydrophobic and the other subunit or subunits are hydrophilic in aqueous media, allowing the polymer to form a biological-membrane-like structure. The polymer has different configurations, including diblock, triblock, or higher block-count copolymers (i.e., Claim 4 and Claim 7), with the triblock configuration having a hydrophilic-hydrophobic-hydrophilic arrangement. The hydrophobic polymer is made from siloxane or other non-hydrocarbon based monomers, and the triblock copolymer membrane provides increased mechanical and environmental stability compared with biological lipid membranes (¶[0090]–¶[0093]).
The membrane/pore system includes a pore present in or inserted into an artificial membrane, and the membrane forms a barrier to the flow of ions, nucleotides, and polynucleotides. The nanopore-sensing apparatus includes a chamber containing an aqueous solution, with the membrane formed in an aperture of the supporting structure separating the chamber into two sections (¶[0230]–¶[0234]).
In Example 5, the chip has 128 wells with platinum electrodes and a 30 µm aperture, and the monolayers are formed from a 50 mg/mL tri-block copolymer solution of TBCP 6-33-6, identified as OH-PMOXA-(PEG linker)-PDMS-(PEG linker)-PMOXA-OH, in oil (i.e., Claim 2 and Claim 3). The MspA nanopore is added to the chip in buffer and inserted in the tri-block copolymer membrane (¶[0332]–¶[0336]).
Regarding Claim 13, CLARKE discloses the barrier of Claim 1. The membrane/pore system includes a pore present in or inserted into the membrane, and the membrane forms a barrier to the flow of ions, nucleotides, and polynucleotides (¶[0230]–¶[0231]). In Example 5, the MspA nanopore is added to the chip in buffer and inserted in the tri-block copolymer membrane (¶[0332]–¶[0336]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over CLARKE as applied to claim 4 above, and further in view of GRZELAKOWSKI (US20170113193A1).
Regarding Claim 5, CLARKE discloses the barrier of Claim 1. However, CLARKE does not explicitly disclose “the hydrophobic block is polybutadiene (PBd).”
GRZELAKOWSKI discloses a filtration membrane including a porous support and a layer of vesicles covalently bonded to the support surface, where the vesicles include transmembrane proteins and are formed from an amphiphilic block copolymer (¶[0007]).
The amphiphilic block copolymer is a diblock copolymer AB having a hydrophilic block and a hydrophobic block, or a triblock copolymer ABA having hydrophilic end blocks and a hydrophobic inner block. The hydrophobic block includes polymers such as polydimethylsiloxane, polyisoprene, and polybutadiene (PBd) (¶[0085]–¶[0086]).
In Example 4, a diblock copolymer polybutadiene-PMOXA is prepared by using functionalized polybutadiene as a macro-initiator for polymerization of 2-methyl-2-oxazoline, thereby forming PBd-PMOXA, and the resulting PB₁₂-PMOXA₅-NH-(CH₂)₂-NH₂ polymer is used to prepare vesicles (¶[0613]–¶[0622]).
The PBd hydrophobic block provides a known alternative hydrophobic block material for amphiphilic copolymer membrane formation, with the additional ability to be crosslinked due to its unsaturation. In view of CLARKE’s amphiphilic block copolymer barrier having a hydrophobic siloxane/PDMS block, a person skilled in the art would have used PBd for the hydrophobic block as a known alternative material with predictable results.
Therefore, it would have been obvious to a person having ordinary skill in the art, prior to the effective filing date of the claimed invention, to use polybutadiene (PBd), as disclosed by GRZELAKOWSKI, for the hydrophobic block in the barrier disclosed by CLARKE.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over CLARKE as applied to claim 1 above, and further in view of MEIER et al. (US20020037986A1, hereinafter MEIER).
Regarding Claim 11, CLARKE discloses the barrier of Claim 1. However, CLARKE does not explicitly disclose “the block copolymer is a triblock copolymer having two hydrophobic blocks and one hydrophilic block.”
MEIER discloses membranes made from segmented amphiphilic A+B copolymers, where A is hydrophilic and B is hydrophobic, and the copolymers self-assemble when dispersed in water. The membranes are freestanding or supported on a substrate, and the copolymer may be configured as a triblock ABA copolymer or a BAB copolymer (¶[0006]). The amphiphilic segmented copolymer may be configured as an A-B diblock, a B-A-B triblock having one A segment and two B segments attached to its termini, or an A-B-A triblock having one B segment and two A segments attached to its termini (¶[0046]).
The BAB triblock configuration provides a known alternative amphiphilic segment arrangement having two hydrophobic blocks and one hydrophilic block, allowing the hydrophilic/hydrophobic balance of the copolymer barrier to be adjusted for planar membrane formation. In view of CLARKE’s amphiphilic block copolymer barrier, a person skilled in the art would have used the BAB triblock configuration disclosed by MEIER as an alternative triblock arrangement for the barrier to adjust the hydrophilic/hydrophobic segment architecture while maintaining self-assembled membrane formation with predictable results.
Therefore, it would have been obvious to a person having ordinary skill in the art, prior to the effective filing date of the claimed invention, to use the BAB triblock configuration, as disclosed by MEIER, for the block copolymer in the barrier disclosed by CLARKE.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAK L. CHIU whose telephone number is (703)756-1059. The examiner can normally be reached M-F: 9:00am - 6:00pm (CST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, PREM C. SINGH can be reached at (571)272-6381. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TAK L. CHIU/Examiner, Art Unit 1777
/KRISHNAN S MENON/Primary Examiner, Art Unit 1777
Prosecution Insights