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 .
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.
Claims 1, 10-11, 16, 18-21, 25, and 27-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang (CN112831395A). Wang is read from an English machine translation which has been placed in the application file.
With regards to claim 1, Wang discloses a membrane located within a patch clamp system for carrying nanopore proteins (i.e., a barrier, which is implied to be located between first and second fluids), wherein the membrane is formed around a plurality of holes located on an array chip of holes (i.e., the barrier is suspended by a barrier support defining an aperture, including one more layers suspended across the aperture) (Wang – translation: abstract; page 3, “It should be noted that…”; page 4, “According to an embodiment of the present invention, the self-assembly is performed…” and “According to a specific embodiment of the present invention, the cell-like membrane is obtained…”). The membrane is formed of a block copolymer having one hydrophobic block located between two hydrophilic blocks, the hydrophilic blocks forming outer surfaces of a bilayer structure and the hydrophobic block forming an interior of the bilayer structure, the block copolymer being, for example, 6PMOXA-33PDMS-6PMOXA polymer (i.e., poly(2-methy oxazoline)-b-poly(dimethyl siloxane)-b-poly(2-methyl oxazoline), which is a block copolymer having two hydrophilic blocks which may be considered to have an approximate length A and one or more hydrophobic blocks having an approximate length B, the hydrophilic blocks forming outer surfaces of the barrier and the hydrophobic blocks being located within the barrier, the hydrophobic blocks comprising PDMS) (Wang: page 3, “It should be noted that…”; page 4, “According to an embodiment… diblock… or triblock…”; page 5, “1. The unmodified…”). It is noted that the hydrophobic blocks are PDMS, and the poly(2-methyl oxazoline) is disclosed as terminated with a methacrylate group (i.e., has a carboxylic acid moiety, as a methacrylate is a reacted carboxylate) (see above discussion).
With regards to claim 10, the membrane of Wang includes a nanopore which provides transmission between adjacent fluids surrounding the membrane (i.e., further comprising a nanopore disposed therein and providing contact between the first fluid and the second fluid) (see above discussion).
With regards to claim 11, Wang discloses a membrane located within a patch clamp system for carrying nanopore proteins (i.e., a barrier, which is implied to be located between first and second fluids), wherein the membrane is formed around a plurality of holes located on an array chip of holes (i.e., the barrier is suspended by a barrier support defining an aperture, including one more layers suspended across the aperture) (Wang – translation: abstract; page 3, “It should be noted that…”; page 4, “According to an embodiment of the present invention, the self-assembly is performed…” and “According to a specific embodiment of the present invention, the cell-like membrane is obtained…”). The membrane is formed of a block copolymer having one hydrophobic block located between two hydrophilic blocks, the hydrophilic blocks forming outer surfaces of a bilayer structure and the hydrophobic block forming an interior of the bilayer structure, the block copolymer being, for example, 6PMOXA-33PDMS-6PMOXA polymer (i.e., poly(2-methy oxazoline)-b-poly(dimethyl siloxane)-b-poly(2-methyl oxazoline), which is a block copolymer having two hydrophilic blocks disposed opposite a hydrophobic block, the first and second hydrophilic blocks forming outer surfaces of the barrier and the hydrophobic blocks being located within the barrier) (Wang: page 3, “It should be noted that…”; page 4, “According to an embodiment… diblock… or triblock…”; page 5, “1. The unmodified…”). It is noted that the hydrophobic blocks are PDMS, and poly(2-methyl oxazoline) has a carboxylic acid moiety (see above discussion).
With regards to claim 16, alternatively, the hydrophilic block may comprise polymerized ethylene oxide (Wang: page 3, “The hydrophilic monomer…”).
With regards to claim 18, the first and second hydrophilic blocks may instead comprise polymerized N-Methlolacrylamide (i.e., an amide) (see above discussion).
With regards to claim 19, the first and second hydrophilic blocks may instead comprise a carboxylic acid (see above discussion).
With regards to claim 20, since the first and second hydrophilic blocks are connected to ends of the hydrophobic block, there must exist molecules responsible for these connections (i.e., first and second linkers coupling in the manner as claimed).
With regards to claim 21, Wang discloses a membrane located within a patch clamp system for carrying nanopore proteins (i.e., a barrier, which is implied to be located between first and second fluids), wherein the membrane is formed around a plurality of holes located on an array chip of holes (i.e., the barrier is suspended by a barrier support defining an aperture, including one more layers suspended across the aperture) (Wang – translation: abstract; page 3, “It should be noted that…”; page 4, “According to an embodiment of the present invention, the self-assembly is performed…” and “According to a specific embodiment of the present invention, the cell-like membrane is obtained…”). The layers of the membrane are formed of layers of block copolymer having one hydrophobic block and one hydrophilic block, the hydrophilic block forming outer surfaces of a bilayer structure and the hydrophobic block forming an interior of the bilayer structure (i.e., each molecule of the copolymer comprising a hydrophobic block coupled to a hydrophilic block, constituting first and second layers, the second layer forming first and second outer surfaces, the hydrophobic blocks of the first and second pluralities of molecules contacting one another within the barrier) (Wang: page 3, “It should be noted that…”; page 4, “According to an embodiment… diblock… or triblock…”; page 5, “1. The unmodified…”). It is noted that the hydrophobic blocks are PDMS, and poly(2-methyl oxazoline) has a carboxylic acid moiety (see above discussion).
With regards to claim 25, alternatively, the hydrophilic block may comprise polymerized ethylene oxide (Wang: page 3, “The hydrophilic monomer…”).
With regards to claim 27, since the hydrophilic block is connected to an end of the hydrophobic block, there must exist a molecule responsible for these connections (i.e., a linker).
With regards to claim 28, it is noted that, technically, any functional group may be a product of a click reaction, and therefore, the linker of claim 27 must necessarily meet the present claim.
With regards to claim 29, the first and second hydrophilic blocks comprise carboxylic acid groups (see above discussion).
With regards to claim 30, the membrane of Wang comprises a nanopore disposed within its barrier for fluid transport (i.e., fluidically coupling the first and second fluids) (see above discussion).
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.
Claims 4, 6-7, 12-15, 17, 22-24, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Wang as applied to claims 1, 11, and 21 above, and in further view of Kellis et al (WO2015/095163A2).
With regards to claim 4, Wang discloses a membrane as applied to claim 1 above (see above discussion). In particular, the block copolymer of Wang may be formed of two blocks (i.e., a diblock copolymer) (Wang: page 2, “Based on the discovery…”). However, Wang does not appear to teach the claimed thickness of approximately 2A + 2B.
Kellis teaches that, in the field of biomimetic membranes, the size of the formed membranes “can be controlled by… methods known to those skilled in the art,” and further, that the size of individual block copolymer segments and their ratio “can easily be controlled” (Kellis: para. [00281] and [00314]). According to Kellis, such sizes are controlled in order to ensure that the formed membranes are stabilized against fusion with other materials and enzymatic degradation (Kellis: para. [00281]). In light of the foregoing, a person of ordinary skill would have found it obvious to have optimized the thickness of the formed membrane relative to the number of segments A and B, as such adjustment is explicitly instructed by Kellis, under the guise of providing improved resistance to fusion and enzymatic degradation (see above discussion).
With regards to claim 6, a person of ordinary skill in the art would have found it obvious to have selected polyisobutylene for the hydrophobic block in the copolymer of Wang and Kellis in order to enable improved affinity to target molecules (Kellis: para. [00304] and [00321]).
With regards to claim 7, Kellis teaches that, in the field of biomimetic membranes, the size of the formed membranes “can be controlled by… methods known to those skilled in the art,” and further, that the size of individual block copolymer segments and their ratio “can easily be controlled” (Kellis: para. [00281] and [00314]). According to Kellis, such sizes are controlled in order to ensure that the formed membranes are stabilized against fusion with other materials and enzymatic degradation (Kellis: para. [00281]). In light of the foregoing, a person of ordinary skill would have found it obvious to have optimized the thickness of the formed membrane relative to the number of segments A and B, as such adjustment is explicitly instructed by Kellis, under the guise of providing improved resistance to fusion and enzymatic degradation (see above discussion).
With regards to claim 12, Kellis teaches that, in the field of biomimetic membranes, the size of the formed membranes “can be controlled by… methods known to those skilled in the art,” and further, that the size of individual block copolymer segments and their ratio “can easily be controlled” (Kellis: para. [00281] and [00314]). According to Kellis, such sizes are controlled in order to ensure that the formed membranes are stabilized against fusion with other materials and enzymatic degradation (Kellis: para. [00281]). In light of the foregoing, a person of ordinary skill would have found it obvious to have optimized the thickness of the formed membrane relative to the number of segments A and B, as such adjustment is explicitly instructed by Kellis, under the guise of providing improved resistance to fusion and enzymatic degradation (see above discussion).
With regards to claim 13, Kellis teaches that, in the field of biomimetic membranes, the size of individual block copolymer segments and their ratio “can easily be controlled” (Kellis: para. [00281] and [00314]). According to Kellis, such sizes are controlled in order to ensure that the formed membranes are stabilized against fusion with other materials and enzymatic degradation (Kellis: para. [00281]). In light of the foregoing, a person of ordinary skill would have found it obvious to have optimized the number of segments A and B, as such adjustment is explicitly instructed by Kellis, under the guise of providing improved resistance to fusion and enzymatic degradation (see above discussion).
With regards to claim 14, Kellis teaches that, in the field of biomimetic membranes, the size of individual block copolymer segments and their ratio “can easily be controlled” (Kellis: para. [00281] and [00314]). According to Kellis, such sizes are controlled in order to ensure that the formed membranes are stabilized against fusion with other materials and enzymatic degradation (Kellis: para. [00281]). In light of the foregoing, a person of ordinary skill would have found it obvious to have optimized the number of segments A and B, as such adjustment is explicitly instructed by Kellis, under the guise of providing improved resistance to fusion and enzymatic degradation (see above discussion).
With regards to claim 15, a person of ordinary skill in the art would have found it obvious to have selected polyisobutylene for the hydrophobic block in the copolymer of Wang and Kellis in order to enable improved affinity to target molecules (Kellis: para. [00304] and [00321]).
With regards to claim 17, the hydrophobic block includes PDMS having 33 subunits, which a hydrophobic block according to the present specification (see above discussion). A composition and its properties have been held to be inseparable, per MPEP 2112. Therefore, the hydrophobic block disclosed in Wang must necessarily have the claimed glass transition temperature.
With regards to claim 22, Kellis teaches that, in the field of biomimetic membranes, the size of the formed membranes “can be controlled by… methods known to those skilled in the art,” and further, that the size of individual block copolymer segments and their ratio “can easily be controlled” (Kellis: para. [00281] and [00314]). According to Kellis, such sizes are controlled in order to ensure that the formed membranes are stabilized against fusion with other materials and enzymatic degradation (Kellis: para. [00281]). In light of the foregoing, a person of ordinary skill would have found it obvious to have optimized the thickness of the formed membrane relative to the number of segments A and B, as such adjustment is explicitly instructed by Kellis, under the guise of providing improved resistance to fusion and enzymatic degradation (see above discussion).
With regards to claim 23, Kellis teaches that, in the field of biomimetic membranes, the size of individual block copolymer segments and their ratio “can easily be controlled” (Kellis: para. [00281] and [00314]). According to Kellis, such sizes are controlled in order to ensure that the formed membranes are stabilized against fusion with other materials and enzymatic degradation (Kellis: para. [00281]). In light of the foregoing, a person of ordinary skill would have found it obvious to have optimized the number of segments A and B, as such adjustment is explicitly instructed by Kellis, under the guise of providing improved resistance to fusion and enzymatic degradation (see above discussion).
With regards to claim 24, Kellis teaches that, in the field of biomimetic membranes, the size of individual block copolymer segments and their ratio “can easily be controlled” (Kellis: para. [00281] and [00314]). According to Kellis, such sizes are controlled in order to ensure that the formed membranes are stabilized against fusion with other materials and enzymatic degradation (Kellis: para. [00281]). In light of the foregoing, a person of ordinary skill would have found it obvious to have optimized the number of segments A and B, as such adjustment is explicitly instructed by Kellis, under the guise of providing improved resistance to fusion and enzymatic degradation (see above discussion).
With regards to claim 26, a person of ordinary skill in the art would have found it obvious to have selected polyisobutylene for the hydrophobic block in the copolymer of Wang and Kellis in order to enable improved affinity to target molecules (Kellis: para. [00304] and [00321]).
Response to Arguments
Applicant’s arguments with respect to the grounds of rejection under 35 U.S.C. 112(b) have been fully considered and are found persuasive. Applicant has provided a clear recitation of the claimed one or more hydrophilic blocks and one or more hydrophobic blocks. Therefore, the grounds of rejection under 35 U.S.C. 112(b) have been withdrawn.
Applicant's arguments filed April 16th, 2026, have been fully considered but they are not persuasive.
On pages 9-10, Applicant argues that Wang teaches poly(2-methyoxazoline) as first and second hydrophilic blocks, and therefore, Wang does not teach a first or second hydrophilic blocks comprising a carboxylic acid and/or a primary amine. This argument is not found persuasive as Wang discloses its hydrophilic blocks as further terminated with a methacrylate group, which as best understood in the context of the present specification, includes carboxylic acid as a moiety.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/E.W./
Examiner, Art Unit 1783
/MARIA V EWALD/Supervisory Patent Examiner, Art Unit 1783
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