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 1-20 are pending. Claims 13-17 are drawn to the nonelected inventions. Claims 1-12 and 18-20 are under examination.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-12 and 18-20) in the reply filed on 02/02/2026 is acknowledged. Applicant further traversed elected the species of (1) a core magnetic Fe3O4 particle coated by SiO2 wherein the particle size is 1 µm, (2) an aminated silane coupling agent of APTES, (3) an acrylic acid monomer molecule of the polymer, (4) a connection component of biotin-streptavidin affinity complex, and (5) a purification element of Protein A. Because the aminated silane coupling agent is not a required element in product Group I (as elected), the species of APTES is currently not required for the examination of the elected claims.
The traversals are on the ground(s) that Groups I-III have the same or corresponding special technical features and thus the different categories of invention will be considered to have unity of invention for a product, a process specially adapted for the manufacture of the said product, and a use of the said product. This is not found persuasive. As discussed in the obviousness rejection, the special technical feature of the claimed invention does not make a contribution over the prior art references (see below). Additionally, it appears that the process for manufacturing the product only contain a functional group for a single biotin or biotin analog, whereas the product itself requires a plurality of biotins or biotin analogs (claim 1) and biotin or biotin analog is not required to be attached to the polymer (claim 19). In other words, the process is not specially adapted for said product.
The requirement is still deemed proper and is therefore made FINAL.
Claims 13-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected groups, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement.
Claim Objections
Claims 3 and 19 are objected to because of the following informalities: The claims recite CBP, SUMO, GST, and MBP should be accompanied by the unabbreviated forms. Additionally, the claims recits “Streg tag” should be – Strep tag –, as it appears to be a typo. Appropriate correction is required.
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.
Claims 1-12 and 18-20 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.
With respect to claim 1, the claim recites the limitation of “the other ends of the polymer are free from the outer surface of the magnetic microsphere” is unclear to the metes and bounds of what the phrase “free from” in a structural limitation to describe the claimed microsphere. For example, in a polymerization for coating, the other ends of the polymer would be on top of its own polymer. Therefore, would that be considered free from the outer surface of the magnetic body? The person of ordinary skill in the art would not understand the structural orientation of a polymer on the surface of the microsphere with the language of “free from”. In other words, is the polymer coating or brush orientation?
Additionally, claim 1 recites a single branched-chain arranged on the polymer and further recites said branched-chain has a single end to connect to a plurality of biotins or biotin analogs are unclear to the structure of the branched-chain. The claim is unclear to how a single end of a branched-chain is capable of connecting to a plurality of biotins or biotin analogs. Claims 2-12 and 18-20 are rejected as being dependent from claim 1.
With respect to claims 3-10, 12 and 18-20, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). These claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 3 recites the broad recitation “an avidin-type tag, a polypeptide-type tag, a protein-type tag, an antibody-type tag, an antigen-type tag, or a combination thereof”, and the claim also recites “preferably, the avidin-type tag is avidin, a biotin-binding avidin analog, a biotin analog-binding avidin analog, or a combination thereof; more preferably, an end of the branched-chain of the polymer on the biomagnetic microsphere connects with biotin; the purification element is avidin, which forms a binding effect of an affinity complex with the biotin; more preferably, the avidin is a streptavidin, a modified streptavidin, a streptavidin analog, or a combination thereof; preferably, the polypeptide-type tag is selected from any one of following tags or a variant thereof: a CBP tag, a histidine tag, a C-Myc tag, a FLAG tag, a Spot tag, a C tag, an Avi tag, a Streg tag, a tag comprising a sequence of WRHPQFGG (SEQ ID NO: 7), a tag comprising a variant sequence of WRHPQFGG (SEQ ID NO: 7), a tag comprising a sequence of RKAAVSHW (SEQ ID NO: 8), a tag comprising a variant sequence of RKAAVSHW (SEQ ID NO: 8), or a combination thereof; preferably, the protein tag is selected from any one of following tags or a variant protein thereof: an affinity protein, a SUMO tag, a GST tag, an MBP tag and a combination thereof; more preferably, the affinity protein is selected from Protein A, Protein G, Protein L, modified Protein A, modified Protein G, modified Protein L and a combination thereof ” which is the narrower statement of the range/limitation.
Claim 4 recites the broad recitation “a connection component containing an affinity complex”, and the claim also recites “preferably, the biotin or the biotin analog has the avidin or the avidin analog connected through the affinity complex interaction, the purification element connects to the avidin or the avidin analog directly or indirectly; more preferably, the purification element connects to the biotin or the biotin analog at an end of the branched-chain of the polymer through an avidin-type tag-purification element covalent ligation complex, and through a connection component that is an affinity complex formed between the avidin-type tag and the biotin or the biotin analog; further preferably, the purification element forms a connection component of the affinity complex with the biotin or the biotin analog at the end of the branched-chain of the polymer by a avidin-purification element covalent ligation complex” which is the narrower statement of the range/limitation.
Claim 5 recites the broad recitation “a covalent bond, through supramolecular interaction, through a connection component, or through a combination thereof”, and the claim also recites “preferably, the covalent bond is a dynamic covalent bond; more preferably, the dynamic covalent bond comprises an imine bond, an acylhydrazone bond, a disulfide bond or a combination thereof; preferably, the supramolecular interaction is selected from: a coordination binding, an affinity complex interaction, an electrostatic adsorption, a hydrogen bonding, a n-n overlapping interaction, a hydrophobic interaction or a combination thereof; preferably, the affinity complex interaction is selected from: a biotin-avidin interaction, a biotin analog-avidin interaction, a biotin-avidin analog interaction, a biotin analog-avidin analog interaction” which is the narrower statement of the range/limitation.
Claim 6 recites the broad recitation “further comprising an avidin combined with the biotin or the biotin analog”, and the claim also recites “preferably, the avidin is any one of streptavidin, modified streptavidin, and streptavidin analogs or a combination thereof” which is the narrower statement of the range/limitation. Claim 7 is rejected as being dependent from claim 6.
Claim 8 recites the broad recitation “wherein a size of the magnetic microsphere body is selected from any one of following particle size scales or a range between any two particle size scales: 0.1m…. 1000pm” and the claim also recites “preferably, a diameter of the magnetic microsphere body is selected from 0.1-10 pm; preferably, a diameter of the magnetic microsphere body is selected from 0.2-6 pm; preferably, a diameter of the magnetic microsphere body is selected from 0.4-5 pm; preferably, a diameter of the magnetic microsphere body is selected from 0.5-3 pm; preferably, a diameter of the magnetic microsphere body is selected from 0.2-1 pm; preferably, a diameter of the magnetic microsphere body is selected from 0.5-1 pm; preferably, a diameter of the magnetic microsphere body is selected from 1 pm-1 mm; preferably, an average diameter of the magnetic microsphere body is 200 nm, 250 nm, 300 nm, 350 nm, 400 nm, 450 nm, 500 nm, 550 nm, 600 nm, 650 nm, 700 nm, 750 nm, 800 nm, 850 nm, 900 nm, 950 nm, 1000 nm, with a deviation of ±20%, more preferably ±10%” which is the narrower statement of the range/limitation.
Claim 9 recites the broad recitation “the polymer is a polyolefin backbone or an acrylic polymer backbone”, and the claim also recites “ preferably, the linear backbone of the polymer is a polyolefin backbone, and is provided by a backbone of an acrylic polymer; more preferably, a monomer unit of the acrylic polymer is one of acrylic acid, acrylate, acrylic ester, methacrylic acid, methacrylate, methacrylate easter, or a combination thereof” which is the narrower statement of the range/limitation.
Claim 10 recites the broad recitation “a covalent bond based on a functional group”, and the claim also recites “preferably, the covalent bond based on the functional group refers to a covalent bond having a functional group participating in a covalent coupling, wherein the functional group is a carboxyl group, a hydroxyl group, an amino group, a sulfhydryl group, a salt form of a carboxyl group, a salt form of an amino group, a formate group, or a combination thereof” which is the narrower statement of the range/limitation.
Claim 12 recites the broad recitation “the magnetic microsphere body is a magnetic material”, and the claim also recites “preferably, the magnetic material is one or a combination of iron oxides, iron compounds, iron alloys, cobalt compounds, cobalt alloys, nickel compounds, nickel alloys, manganese oxides, and manganese alloys; more preferably, the magnetic material is one of Fe304, y-Fe2O3, Iron Nitride, Mn304, FeCrMo, FeAlC, AlNiCo, FeCrCo, ReCo, ReFe, PtCo, MnAlC, CuNiFe, AlMnAg, MnBi, FeNiMo, FeSi, FeAl, FeSiAl, BaO-6Fe2O3, SrO-6Fe2O3, PbO-6Fe2O3, GdO or a combination thereof” which is the narrower statement of the range/limitation.
Claim 18 recites the broad recitation “an end of the branched-chain of the polymer on the biomagnetic microsphere has a plurality of biotins connected”, and the claim also recites “preferably, the end of the branched-chain of the polymer on the biomagnetic microsphere connects to a plurality of avidins through a binding action of an affinity complex” which is the narrower statement of the range/limitation.
Claim 19 recites the broad recitation “the purification element is selected from: an avidin-type tag, a polypeptide-type tag, a protein- type tag, an antibody-type tag, an antigen-type tag, or a combination thereof”, and the claim also recites “preferably, the avidin-type tag is avidin, a biotin-binding avidin analog, a biotin analog-binding avidin analog, or a combination thereof; more preferably, the avidin is a streptavidin, a modified streptavidin, a streptavidin analog, or a combination thereof; preferably, the polypeptide-type tag is selected from any one of following tags or a variant thereof: a CBP tag, a histidine tag, a C-Myc tag, a FLAG tag, a Spot tag, a C tag, an Avi tag, a Streg tag, a tag comprising a sequence of WRHPQFGG (SEQ ID NO: 7), a tag comprising a variant sequence of WRHPQFGG (SEQ ID NO: 7), a tag comprising a sequence of RKAAVSHW (SEQ ID NO: 8), a tag comprising a variant sequence of RKAAVSHW (SEQ ID NO: 8), or a combination thereof; preferably, the protein tag is selected from any one of following tags or a variant protein thereof: an affinity protein, a SUMO tag, a GST tag, an MBP tag and a combination thereof; more preferably, the affinity protein is selected from Protein A, Protein G, Protein L, modified Protein A, modified Protein G, modified Protein L and a combination thereof; more preferably, the outer surface of the magnetic microsphere body has at least one polymer with a linear backbone and a branched- chain arranged, an end of the linear backbone is fixed onto the outer surface of the magnetic microsphere body, a plurality of other ends of the polymer are free from the outer surface of the magnetic microsphere body, and an end of the branched-chain of the polymer on the biomagnetic microsphere has a plurality of affinity proteins connected; further preferably, a skeleton of the branched-chain between the affinity protein and the linear backbone of the polymer further has a binding action of the affinity complexes; more preferably, the affinity protein is selected from Protein A, Protein G, Protein L, modified Protein A, modified Protein G, modified Protein L and a combination thereof ” which is the narrower statement of the range/limitation.
Claim 20 recites the broad recitation “a connection component containing an affinity complex”, and the claim also recites “preferably, the biotin or the biotin analog has the avidin or the avidin analog connected through the affinity complex interaction, the purification element connects to the avidin or the avidin analog directly or indirectly; more preferably, the purification element connects to the biotin or the biotin analog at an end of the branched-chain of the polymer through an avidin-type tag-purification element covalent ligation complex, and through a connection component that is an affinity complex formed between the avidin-type tag and the biotin or the biotin analog; further preferably, the purification element forms a connection component of the affinity complex with the biotin or the biotin analog at the end of the branched-chain of the polymer by a avidin-purification element covalent ligation complex” which is the narrower statement of the range/limitation.
Additionally, claims 3 and 19 contain the trademark/trade names of FLAG, Spot tag, C-tag, Avitag, and Strep-tag. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade names are used to identify/describe specific tag structures and, accordingly, the identification/description is indefinite. Applicant should replace these recitations with a generic structure or sequence of the tags. Note that if a sequence is added, it must comply with the sequence rules in an application.
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 1-12 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (“Synthesis of Magnetic Spherical Polyelectrolyte Brushes”, Macromolecules, vol. 44, pgs. 632-639, published 01/12/2011) in view of Dong et al. (“Patterned Biofunctional Poly(acrylic acid) Brushes on Silicon Surfaces”, Biomacromolecules, vol. 8, pgs. 3082-3092, published 09/20/2007).
With respect to claim 1, Chen teaches a magnetic spherical polyelectrolyte brushes (MSPB) with embedded magnetite nanoparticles in core were successfully synthesized and characterized by dynamic light scattering (DLS) and the magnetic spherical poly(acrylic acid) PAA brushes were synthesized (at abstract). Scheme 1 producing MSPB through PAA polymer would read on a biomagnetic microsphere comprises a magnetic microsphere body, wherein an outer surface of the magnetic microsphere body has at least one polymer with a linear backbone and a branched-chain (i.e., PAA) arranged, an end of the linear backbone is fixed onto the outer surface of the magnetic microsphere body, a plurality of other ends of the polymer are free from the outer surface of the magnetic microsphere body. Scheme 1 also shows that PAA contains a plurality of carboxylic acids on the linear polymer. Chen teaches the nanosized MSPB open the way of many potential applications such as protein immobilization, and magnetic field-guided drug delivery and quick magnetic response and good redispersibility guarantee the easy recycling of MSPB for applications (see pg. 637, right col., 2nd to last para.).
Chen does not teach an end of the branched-chain of the polymer on the biomagnetic microsphere has a plurality of biotins or biotin analogs connected.
Dong teaches protein patterning was carried out using a simple procedure and a variety of biomolecules containing amino groups could be covalently tethered to the dense carboxyl groups of the brush and the polymer resulted in patterned poly(acrylic acid) PAA brushes and using biotin-tagged bovine serum albumin (BSA) as a model, a simple strategy was developed for immobilization of small biological molecules using BSA as linkages, while BSA can simultaneously blocked nonspecific interactions (see abstract and pg. 3090, Scheme 5). Scheme 5 shows a plurality of biotin-tagged to BSA.
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 attached the magnetic spherical particle as taught by Chen with the biotin-tagged bovine BSA as taught Dong because Chen teaches the potential application to immobilize proteins with the PAA brushes and Dong teaches the PAA brushes are modified to attach biotins for streptavidin connection through the branched-chain of PAA backbone and BSA can simultaneously blocked nonspecific interactions.
The person would have a reasonable expectation of success in incorporating the PAA brushes of Chen with biotins because it has been well recognized by Chen and Dong that PAA polymer brush produces carboxylic acid side chains for protein immobilization.
With respect to claim 2, the recitation of “wherein an end of the branched-chain of the polymer connects to a purification element” is intended use. Because claim 1 does not recite a purification element and claim 2 recites a “wherein clause”, the limitations directed to connecting a purification element is intended use. The intended use must result in a structural difference between the claimed biotin structure and prior art’s biotin to patentably distinguish the claimed structure. Because the prior art’s reads all the structural limitations of the claimed connection component comprises the biotins, the prior art’ structure is configured and capable of performing the intended use. However, the purification element is not a required element for the magnetic microsphere body of claims 1-2. Also, claims 3-5 and 20 are dependent from claim 2 and thus these limitations are further directed to the intended use languages.
With respect to claim 6, see discussion above, Chen does not teach biotin and avidin. Dong teaches protein patterning and a variety of biomolecules containing amino groups could be covalently tethered to the dense carboxyl groups of the brush and the polymer resulted in patterned poly(acrylic acid) PAA brushes and using biotin-tagged bovine serum albumin (BSA) as a model to attach streptavidin (see abstract and pg. 3090, Scheme 5). Scheme 5 shows a plurality of biotin-tagged to BSA. Therefore, it would have been obvious to the person to have attached the magnetic spherical particle with the biotin-tagged bovine BSA for streptavidin attachments because Chen teaches the potential application to immobilize proteins with the PAA brushes and Dong teaches the PAA brushes are modified to attach biotins for streptavidin connection through the branched-chain of PAA backbone.
With respect to claim 7, see discussion above, Chen does not teach an affinity protein. Dong teaches protein patterning and a variety of biomolecules containing amino groups could be covalently tethered to the dense carboxyl groups of the brush and the polymer resulted in patterned poly(acrylic acid) PAA brushes and using biotin-tagged bovine serum albumin (BSA) as a model to attach streptavidin (see abstract and pg. 3090, Scheme 5). Scheme 5 shows a plurality of biotin-tagged to BSA. Therefore, it would have been obvious to the person to have attached the magnetic spherical particle with the biotin-tagged bovine BSA (affinity protein) for streptavidin attachments because Chen teaches the potential application to immobilize proteins with the PAA brushes and Dong teaches the PAA brushes are modified to attach biotin-tagged BSA for streptavidin connection through the branched-chain of PAA backbone. Note that BSA would read on the structure of an affinity protein because BSA protein is connected to avidin via biotin.
With respect to claim 8, Chen teaches the magnetic spherical polyelectrolyte brushes (MSPB) consist of a polystyrene (PS) core around 100 nm diameter embedded with magnetite nanoparticles (see pg. 632, right col., para. 1). Fig. 2 shows the MSPB with the claimed ranges.
With respect to claim 9, Chen teaches poly(acrylic acid) brushes (see abstract), which would read on acrylic backbone.
With respect to claim 10, as discussed above, Dong teaches in Scheme 5 an indirect covalent bond with biotin via BSA or direct covalent bond via biotin-tagged BSA (biotin analog).
With respect to claim 11, Chen teaches in Scheme 1 MPL has functional group that is covalent bond to PAA brushes to from MSPB.
With respect to claim 12, Chen teaches iron oxide nanoparticles (see Scheme 1). However, the reference does not teach SiO2. Dong teaches SiO2 (see Scheme 5). Therefore, it would have been obvious to the person to have used the magnetic spherical particle with SiO2 of Dong because Dong teaches the ability to retain and immobilize protein onto PAA brushes through the covalent attachment SiO2.
With respect to claim 18, see discussion above in claim 1.
With respect to claim 19, see discussion above in claim 1. Note that the plurality of biotin-tagged on BSA for streptavidin (see Scheme 5) would read on an avidin-type tag.
With respect to claim 20, see claim 3 above.
Claims 1-12 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (“Synthesis of Magnetic Spherical Polyelectrolyte Brushes”, Macromolecules, vol. 44, pgs. 632-639, published 01/12/2011) in view of Dong et al. (“Patterned Biofunctional Poly(acrylic acid) Brushes on Silicon Surfaces”, Biomacromolecules, vol. 8, pgs. 3082-3092, published 09/20/2007), Xu et al. (“Preparation of Fe3O4,@SiO2@PAA multilayer core-shell structural composite microspheres and its dye adsorption performance”, Forestry Engineering, vol. 3, no. 3, pgs. 52-56, published May 2018, IDS submitted 05/01/2024, cite no. 3), Zarnt et al. (US2018/0172680A1, published 06/21/2018) and HOU et al. (“Preparation of Functionalized Fe3O4@SiO2 Magnetic Nanoparticles for Monoclonal Antibody Purification”, Chem. Res. Chin. Univ., published 2016, 32(6), 889―894).
For the species elections and with respect to claims 1-12 and 18-20, Chen and Dong have been discussed in the above rejection. However, the references do not explicitly teach a core magnetic Fe3O4 particle coated by SiO2 wherein the particle size of the magnetic microsphere is 1µm, and Protein A.
Xu teaches F3O4 magnetic microspheres were synthesized and the SiO2 shell was coated on the surface of Fe3O4 magnetic microspheres and SiO2 was modified by APTES and polyacrylic acid (PAA) layer was synthesized on the outside of the SiO2 shell (see abstract and Fig. 1) which forms Fe3O,@SiO2@PAA microspheres. Xu teaches the multi-layer core-shell composite microspheres have good magnetic responsiveness and show good adsorption properties (see pg. 55, left col.).
Zarnt teaches a microparticle with PEG 12 to 30 (liner polymer) and analyte specific binding agent (see abstract). Zarnt teaches that biotin-streptavidin binding pair (see para. [0030] and Figs. 1-2). Zarnt teaches the microparticles have a diameter range of 50 nanometers to 20 micrometers (see para. [0023]).
HOU teaches magnetic Fe3O4@SiO2 nanoparticles with superparamagnetic properties and approximately up to 203 of protein A could be uniformly immobilized onto the modified magnetic beads (see abstract and Scheme 1). HOU also teaches Fe3O4@SiO2 nanoparticles were modified by APTES (see Scheme 1). HOU teaches iron oxide MNPs are widely used in the separation and purification of antibodies (see pg. 889, left col., para. 1) and Protein A coated magnetic particles have become commercially available, which have been successfully employed in antibody purification (see pg. 890, left col.., bottom of para. 2).
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 used the modified magnetic spherical brush particles as taught by Chen and Dong containing biotins with SiO2 and Protein A as taught by Xu, and HOU because Xu teaches attaching PAA onto the magnetic particles is through SiO2 and HOU teaches that Fe3O4@SiO2 nanoparticles conjugate Protein A wherein Protein A coated on magnetic particle has been recognized to be successful in antibody purification. Additionally, it would have been obvious to have modified the magnetic spherical brush particles to 1µm and a single core because HOU teaches the core-shell is also superparamagnetic and Zarnt recognizes that microparticles containing linear polymer for biotin-streptavidin affinity have a diameter of 50nm to 10µm. Therefore, it would have been prima facie obvious to have the magnetic spherical brush particles to be 1µm, as the claimed particle size overlaps with the prior art’s range of producing microparticles for biotin-streptavidin affinity.
The person would have a reasonable expectation of success in using the modified magnetic spherical brush particles with SiO2 and Protein A on a single iron oxide core because it has been well recognized in the art to modify SiO2 for PAA polymer and Protein A.
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 1-12 and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-7 and 14-16 of copending Application No. 17/621,432 (‘432) in view of Dong et al. (“Patterned Biofunctional Poly(acrylic acid) Brushes on Silicon Surfaces”, Biomacromolecules, vol. 8, pgs. 3082-3092, published 09/20/2007).
The copending Application ‘432 of claim 1 recites biomagnetic microsphere, wherein an outer surface of a magnetic microsphere body of the biomagnetic microsphere has at least one liner polymer with a branched chain; one end of the linear polymer with the branched chain is covalently coupled to the outer surface of the magnetic microsphere body, while a plurality of other parts are free on the outer surface of the magnetic microsphere body; a backbone of the linear polymer is a polyolefin backbone, the branched chain of the linear polymer contains a functional group, and the functional group is able to bind to a target object. The copending Application does not recite biotins or biotin analogs (claims 1-6) and purification elements or avidins (claims 7-12 and 18-20).
Dong has been discussed in the above rejection. Therefore, it would have been obvious to the person of ordinary skill in the art at the time of filing date of the claimed invention to have used the recited biomagnetic microsphere as recited by the copending Application with biotins, biotin analogs, purification elements and avidins as taught by Dong because Dong teaches biotins are attached to linear polymer for target affinity. The person would have a reasonable expectation of success in using the recited biomagnetic microsphere with biotins for streptavidins because the copending Application recites the functional groups is able to bind to a target object through linear polymer.
With respect to instant claims 2-5 and 20, the recitation of “wherein an end of the branched-chain of the polymer connects to a purification element” is intended use. Because claim 1 does not recite a purification element and claim 2 recites a “wherein clause”, the limitations directed to connecting a purification element is intended use. The intended use must result in a structural difference between the claimed biotin structure and prior art’s biotin to patentably distinguish the claimed structure. Because the prior art’s reads all the structural limitations of the claimed connection component comprises biotins, the prior art’ structure is configured and capable of performing the intended use.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
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/N.P.N/Examiner, Art Unit 1678
/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
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