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 .
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.
Status of Claims
Claims 1-7, 12, 14-19, 21, 37-41 and 43-58 are pending. Claims 5, 15, 19, 21, 37-41 and 43-58 are withdrawn. Claims 1-3, 6-7, 12, 14, 16-18 are under examination.
Withdrawn Rejections
In light of the canceled claim 8, the 35 U.S.C. 112(a) rejection is hereby withdrawn.
In light of the amendments, the 35 U.S.C. 112(b) rejection is hereby withdrawn.
In light of the amendments, the 35 U.S.C. 102(a)(1) rejection is hereby withdrawn,
In light of the amendments, the 35 U.S.C. 103 rejection is hereby withdrawn.
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.
Claims 1-3, 6-7, 12, 14 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over El-Aassar et al. (“Functionalized electrospun nanofibers from poly (AN-co-MMA) for enzyme immobilization”, Journal of Molecular Catalysis B: Enzymatic 85-86, pgs. 140-148, published 2013).
El-Aassar teaches β-Galactosidase from Aspergillus oryzae was immobilized on amino functionalized poly (AN-co-MMA) nanofibers using glutaradehyde (at abstract). El-Aassar further teaches the poly(AN-co-MMA) copolymer solutions were electrospun (at pg. 141, left col., para. 1 of section 2.2). El-Aassar teaches in Fig. 1 that poly-(AN-co-MMA) nanofibers contain a aldehyde for conjugation with PEI and glutaraldehyde and CN group which would read on the membrane support further comprises one or more inert functional groups immobilized directly on the surface of the membrane support (e.g. CN group), a linear spacer arm of determined length immobilized on the membrane support wherein the linear spacer each comprise a terminus (i.e., glutaraldehyde) and a ligand coupled to the terminus wherein the ligand comprises a peptide, a protein, or both (i.e., β-galactosidase enzyme conjugated to CHO). Note that the limitation of “membrane support further comprises one or more inert functional groups immobilized directly on the surface of the membrane support” includes nanofibers containing inert groups on the surface of the membrane support (such as OCH3 and CN groups), as it is directly on the surface of the membrane support. Meanwhile, the phrase “immobilized” does not provide distinct structural features in the claimed affinity membrane. Additionally, the phrase “inert functional group” is directed to the claimed ligand (i.e., peptide, protein or both), as functional groups are inert to a specific ligand and reactive to other distinct ligands.
Even though El-Aassar teaches inert functional groups and a linear spacer arm comprising a terminus, the reference does not teach a plurality of linear spacer arms.
However, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a plurality of glutaraldehyde spacers on the nanofibers because the nanofibers would have contained a plurality of OCH3 pendants through methyl methacrylate polymerization.
With respect to claim 2, El-Aassar teaches poly(An-coMMA) nanofibers (at abstract).
With respect to claim 3, El-Aassar teaches the poly(AN-co-MMA) copolymer solutions were electrospun (at pg. 141, left col., para. 1 of section 2.2).
With respect to claim 6, El-Aassar teaches the ligand is coupled to the terminus of the linear spacer arm via an amine-reactive functional group (i.e., CHO reacted with NH2).
With respect to claim 7, El-Aassar teaches poly(An-coMMA) nanofibers (at abstract).
With respect to claim 12, El-Aassar teaches glutaraldehyde which would read on a length of between 1 and 30 atoms.
With respect to claim 14, El-Aassar teaches B-galactosidase solution is 0.005/20 mg/mL (at pg. 142, left col., para. 1 of section 2.6). which would read on the ligand is present on the nanofiber membrane support at density of up to about 1000 mg of the ligand per gram of the nanofiber membrane support.
With respect to claims 17-18, El-Aassar teaches B-galactosidase (at abstract and Fig. 1), reads on the claimed structure of the Ligand (i.e., comprises a peptide, a protein, or both), which is capable of performing the intended use of can bind. The intended use must result in a structural difference between the claimed ligand and prior art’s ligand to patentably distinguish the claimed ligand.
Claims 1-3, 6-7, 12, 14 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Tseng et al. (“Clinical diagnosis of colorectal cancer using electrospun triple-blend fibrous mat-based capture assay of circulating tumor cells”, J. Mater. Chem. B, 2016, vol. 4, pgs. 6565-6580) in view of Ma et al. (“Electrospun polyethersulfone affinity membrane: Membrane preparation and performance evaluation”, Journal of Chromatography B, vol. 877, pgs. 3686-3694, published 2009, hereinafter Ma II).
With respect to claim 1, Tseng teaches a nylon-6, PSBMA, and PAA in the electrospun triple-blend fibrous mats were optimized to avoid degradation and to balance between the non-biofouling behavior and the antibody immobilizing efficiency (at abstract). Fig. 1 teaches electrospun nylon-6/PAA/PSBMA fibers with streptavidin with Leukocyte and CTCs. Fig. 1 also shows the membrane support further comprises one or more inert functional groups immobilized directly on the surface of the membrane support and a plurality of spacer arms of determined length immobilized on the membrane support wherein the spacer arms each comprise a terminus and a ligand coupled to the terminus wherein the ligand comprises a peptide, a protein, or both. Fig. 2 shows spacing between streptavidin immobilization and an inert functional group on the electrospun membrane support.
Tseng does not teach linear spacer arms (claim 1).
Ma II teaches non-woven polyethersulfone (PES) membranes were prepared by electrospinning (at abstract). Ma II further teaches spin columns packed with protein A/G immobilized PES membranes were demonstrated to be capable of binding IgG specifically (at abstract). Fig. 1 shows ligand immobilization on the membrane and NH2-DADPA-NH2 functional groups comprising a terminus amine group and MAA polymer with a carboxyl group, which both would read on the membrane support further comprises a plurality of linear spacer arms. Fig. 1 also shows that additional spacer such as NH2-DADPA-NH2 is used to conjugate bigger molecule such as Cibacron blue G3GA (CB) as compared to protein A/G.
Therefore, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the electrospun fibers as taught by Tseng with linear spacer arms as taught by Ma II because Tseng recognizes that spacing is performed on electrospun polymer for immunoassay detection (see Figs. 1-2) and Ma II teaches that linear spacers are recognized as linkers to facilitate the attachment certain molecule sizes and proteins. Thus, it would have been obvious to have incorporated linear spacers to attach streptavidin molecules because Ma II recognizes spacers as extensions are needed to attach certain proteins.
The person would have a reasonable expectation of success in using linear spacers with the electrospun fibers because it has been well understood by Tseng and Ma II to comprise the electrospun fibers with linear chemical compounds for protein attachments.
With respect to claims 2-3, Tseng teaches electrospun nanofibers (at pg. 6567, left col., para. 1).
With respect to claim 6, Tseng teaches in Fig. 2 amin-reactive functional group with streptavidin. As stated above, Tseng does not teach the linear spacer arms. Ma II teaches the linear spacer (see above). Thus, it would have been obvious to have incorporated linear spacers to attach streptavidin molecules because Ma II recognizes spacers as extensions are needed to attach certain proteins.
With respect to claim 7, Tseng teaches non-cellulose polymer (Fig. 1).
With respect to claim 12, as stated above, Tseng does not teach the linear spacer arms. Ma II teaches in Fig. 1 shows ligand immobilization on the membrane and NH2-DADPA-NH2 functional groups, which would read on the spacer arm has a length of between 1 and 30 atoms.
With respect to claim 14, Tseng teaches the streptavidin-modified fibrous mats were incubated in biotinylated anti-EpCAM antibody (5 µg mL-1) to form the substrate for the cell-capture experiment.
With respect to claims 17-18, Tseng teaches a streptavidin reads on the claimed structure of the Ligand (i.e., comprises a protein), which is capable of performing the intended use of can bind. The intended use must result in a structural difference between the claimed ligand and prior art’s ligand to patentably distinguish the claimed ligand.
Claims 1-3, 6-7, 12, 14 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Schneiderman et al. (“WO2017/189977A1, published 11/02/2017).
The rejection over Schneiderman is based on the elected species.
With respect to claims 1-3, Schneiderman teaches porous polymeric cellulose can be incorporated into membranes and/or hydrogels and the membranes comprising the porous polymeric cellulose are particularly suitable for functionalization media (at abstract). Schneiderman teaches the composite nanofiber can be prepared by electrospinning a cellulose-based polymer and a second non-cellulose-based polymer (at pg. 7, lines 20-30). Schneiderman teaches electrospun nanofibers (at pg. 8, lines 28-30). Schneiderman teaches for use in bioseparation, the hybrid compositions of the present invention are ideally biologically inert, meaning that they should resist non-specific binding of insoluble solids such as cells and cellular debris, as well as unwanted interactions with proteins, sugars, nucleic acids, viruses, and other soluble components present in many biological produced systems (at pg. 12, lines 1-5). Schneiderman teaches carboxyl groups from grafting onto the surface can act as the active coupling site by creating a covalent amide bond between the functionalized carboxyl group and an exposed amine group on a protein ligand such as protein A or G (at pg. 15, lines 11-20). Schneiderman teaches functionalization include the addition of ion-exchange groups such as a weak or strong acids, and bases, hydrophobic groups such as phenolic compounds, and affinity ligands such as antibodies (at pg. 11, lines 28-32, i.e., protein A binds to IgG). Schneiderman teaches the ion exchange capacity of a hybrid compositions can include diethylaminoethyl groups as a weak anion exchange ligand or carboxylic acid as a weak cation exchange ligand (at pg. 13, lines 21-24). Schneiderman teaches a crosslinking system comprises a crosslinking agent such as 1,4 butanediol diglycidyl ether (at pg. 3, lines 17-20 and pg. 10, lines 3-10).
Schneiderman does not explicitly exemplify the combination of inert functional groups and a plurality of linear spacer arms on the electrospun membrane.
However, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to have combined inert functional groups (ion exchange groups) with crosslinking agent such as 1,4 butanediol diglycidyl ether because Schneiderman teaches affinity ligands are attached to the membrane and resist non-specific binding on the membrane.
With respect to claim 6, Schneiderman teaches carboxyl groups from grafting onto the surface can act as the active coupling site by creating a covalent amide bond between the functionalized carboxyl group and an exposed amine group on a protein ligand such as protein A or G (at pg. 15, lines 11-20).
With respect to claim 7, Schneiderman teaches the composite nanofiber can be prepared by electrospinning a cellulose-based polymer and a second non-cellulose-based polymer (at pg. 7, lines 20-30). Schneiderman teaches electrospun nanofibers (at pg. 8, lines 28-30).
With respect to claim 12, Schneiderman teaches a crosslinking system comprises a crosslinking agent such as 1,4 butanediol diglycidyl ether (at pg. 3, lines 17-20 and pg. 10, lines 3-10).
With respect to claim 14, Schneiderman teaches the dynamic binding capacity is 60 mg/mL (at pg. 16, lines 10-14).
With respect to claims 16-18, Schneiderman teaches carboxyl groups from grafting onto the surface can act as the active coupling site by creating a covalent amide bond between the functionalized carboxyl group and an exposed amine group on a protein ligand such as protein A or G (at pg. 15, lines 11-20). Thus, Schneiderman’s Protain A is capable of performing the intended use of can bind. The intended use must result in a structural difference between the claimed ligand and prior art’s ligand to patentably distinguish the claimed ligand.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 6-7, 12, 14 and 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10919986 B2 (‘986) (of record) in view of Schneiderman (WO2017/189977A1, published 11/02/2017).
Patent ‘986 recites a hybrid cellulose membrane composition comprising: a first electrospun nanofiber, wherein the first electrospun nanofiber comprises cellulose; and a second electrospun nanofiber, wherein the second electrospun nanofiber comprises a non-cellulose based polymer; wherein the composition comprises pores and/or channels; wherein the cellulose is crosslinked by a crosslinking agent; wherein the crosslinking agent is an aldehyde, an organochloride, an ether, a multi-functional carboxylic acid, glycerol, a urea derivative, a glycidyl ether, or a mixture thereof; and wherein the composition comprises at least 30 wt. % of the cellulose. Claim 8 recites the crosslinking agent is citric acid, malic acid, maleic acid, itaconic acid-maleic acid, 1,2,3,4 butanetetracarboxylic acid (BTCA), glycerol, glyoxal, and mixtures thereof. Claim 10 recites the composition is a filtration, separation, and/or functionalization media. Claim 11 recites the composition is bound to a ligand. However, the Patent does not explicitly recite inert functional group and ligand comprises peptide, protein, or both.
Schneiderman has been discussed above. Thus, it would have been obvious to the person of ordinary skill in the art at the time of filing of the claimed invention to have incorporated the electrospun fibers as recited by the Patent with the peptide, protein or both as taught by Schneiderman because Schneiderman teaches carboxyl groups from grafting onto the surface can act as the active coupling site by creating a covalent amide bond between the functionalized carboxyl group and an exposed amine group on a protein ligand such as protein A or G and functional groups for ion-exchange can be attached to the electrospun membrane.
The person would have a reasonable expectation of success in conjugating a peptide, a protein or both onto the electrospun polymer because it has been well understood in the art to attach ligand to electrospun polymers.
Claims 1-3, 6-7, 12, 14 and 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 11560438 B2 (‘438) (of record) in view of Schneiderman (WO2017/189977A1, published 11/02/2017).
Patent No. ‘438 recites a membrane composition comprising: a first electrospun nanofiber, wherein the first electrospun nanofiber comprises cellulose; and a second electrospun nanofiber, wherein the second electrospun nanofiber comprises a non-cellulose based polymer; and a plurality of pores and/or channels; and wherein the composition is crosslinked and comprises at least 30 wt. % of the cellulose. Claim 5 recites the composition comprises a functionalization. Claim 7 recites the functionalization comprises a cation exchange group, an anion exchange group, or an affinity ligand. Claim 8 recites the anion exchange group comprises a diethylaminoethyl (DEAE) group. Claims 9-10 recite the crosslinking system comprises one or more of an aldehyde, an organochloride, an ether, a multi-functional carboxylic acid, a urea derivative, a glycidyl ether, citric acid, malic acid, maleic acid, itaconic acid-maleic acid, 1,2,3,4 butanetetracarboxylic acid (BTCA), glyoxal, glycerol, 1,4 butanediol diglycidyl ether, and a polyo. However, the Patent does not recite the ligand comprises a peptide, a protein or both.
Schneiderman has been discussed above. Thus, it would have been obvious to the person of ordinary skill in the art at the time of filing of the claimed invention to have incorporated the electrospun fibers as recited by the Patent with the peptide, protein or both as taught by Schneiderman because Schneiderman teaches carboxyl groups from grafting onto the surface can act as the active coupling site by creating a covalent amide bond between the functionalized carboxyl group and an exposed amine group on a protein ligand such as protein A or G.
The person would have a reasonable expectation of success in conjugating a peptide, a protein or both onto the electrospun polymer because it has been well understood in the art to attach ligand to electrospun polymers.
With respect to instant claim 12, Patent claim 31 recites a dyanamic binding capacity on a mass basis of at least about 120 mg/g of the membrane composition.
Claims 1-3, 6-7, 12, 14 and 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 12479931 B2 (‘931) (of record) in view of Schneiderman (WO2017/189977A1, published 11/02/2017).
Patent No. ‘931 recites a separation media for biological separations comprising: a fiber membrane comprising regenerated cellulose fibers wherein the regenerated cellulose is crosslinked by a multi-functional carboxylic acid; wherein the fiber membrane comprises a plurality of pores and/or channels; wherein the regenerated cellulose fibers comprise a surface functionalization comprising a cation exchange group, an anion exchange group, or a ligand; and wherein the fiber membrane comprises at least 30 wt. % of the cellulose. Claim 6 recites wherein the anion exchange group comprises a diethylaminoethyl (DEAE) group. Claim 8 recites the ligand is a protein or binds a protein. However, the Patent does not explicitly recite linear spacers as claimed.
Schneiderman has been discussed above. Thus, it would have been obvious to the person of ordinary skill in the art at the time of filing of the claimed invention to have incorporated the electrospun fibers as recited by the Patent with the a crosslinking agent such as butanediol diglycidyl ether as taught by Schneiderman because Schneiderman teaches carboxyl groups from grafting onto the surface can act as the active coupling site by creating a covalent amide bond between the functionalized carboxyl group and an exposed amine group on a protein ligand such as protein A or G.
The person would have a reasonable expectation of success in conjugating a crosslinking agent onto the electrospun polymer because it has been well understood in the art to attach ligand to electrospun polymers.
Response to Arguments
Applicant’s arguments filed 06/23/2026 and 07/23/2026 have been considered but are moot because Applicant’s amendments necessitated a new ground of rejection. Note that Ma II is a different prior reference than Ma, as previously rejected 01/28/2026.
With respect to the non-statutory double patenting rejections, the rejections are maintained for the reasons stated above. The rejections have been modified in view of Schneiderman. Therefore, the arguments are moot.
Conclusion
No claim is allowed.
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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/N.P.N/Examiner, Art Unit 1678
/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
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