DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of claims 1-16 in the reply filed on 20 APRIL 2026 is acknowledged.
Claims 17, 25, 30, and 37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 20 APRIL 2026.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e)(1) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/231,489, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The provisional application 63/231,489 essentially is a research paper describing a cellulose acetate membrane coated with a zwitterionic polycarboxybetaine urethane (PCBU) layer used in a plasma separation device. Instant claim 1 is much more broad, adding both a zwitterionic polyurethane or pre-polymer thereof, which is an entire genus of compounds, and a membrane entirely composed of the zwitterionic polyurethane or pre-polymer thereof. As an optional limitation of claim 1, monomeric units derived from polyols are not mentioned.
The Biofilm Formation Test of instant claim 2 is not mentioned in the prior-filed application.
The value of 5 ng/cm2 of fibrinogen adsorption is instant claim 3 is not mentioned in the prior-filed application.
The flux of the membrane unaided by vacuum of instant claim 4 is not mentioned in the prior-filed application.
The rejection rate of non-plasma components by the membrane of instant claim 5 is not mentioned in the prior-filed application.
The size of the first chamber has support of up to 10 mL in the prior-filed application, but instant claim 8 contains ranges of up to 1 L.
The alternative materials besides PCBU of instant claim 9 are not mentioned in the prior-filed application.
The copolymers of instant claim 10 are not mentioned in the prior-filed application.
The only porous support membrane with support from instant claims 14 and 15 is the cellulose acetate porous support membrane.
The pore ranges from instant claim 16 do not have support as the membranes used in the prior-filed application had an average pore size of 0.4 microns, and there is no justification for altering the size to the ranges in the instant claim 16.
Accordingly, instant claims 1-16 are not entitled to the benefit of the prior-filed Application No. 63/231,489.
Claim Status
Rejected Claims: 1-16
Withdrawn Claims: 17, 25, 30, and 37
Cancelled Claims: 18-24, 26-29, 31-36, and 38-39
Claim Interpretation
Instant claim 13 recites the limitation “the surface morphology and pore size distribution is substantially similar to a surface morphology and a pore size distribution of the porous membrane support prior to the addition of the zwitterionic polyurethane”, emphasis added. Substantially similar is potentially unclear on its own, but the instant specification states that the pore size distribution of the membrane is “substantially similar” to the pore size distribution of the porous membrane support when the pore size distribution of the membrane is within 20% of the pore size distribution of the porous membrane support prior to application of the zwitterionic polyurethan or prepolymer thereof (Page 16). The Examiner will use the 20% benchmark as defined in the specification as “substantially similar” for the interpretation of instant claim 13.
Claim Objections
Claims 1 and 14 are objected to because of the following informalities:
In Claim 1, “the combined amount of monomeric unit” in line 13 of the claim should read “the combined amount of the monomeric unit”.
In Claim 14, “glassy polymer, of a combination thereof” in lines 2-3 of the claim should read “ glassy polymer, or a combination thereof”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-16 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 the limitation "the whole blood" in lines 5-6 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-16 are rejected because of their dependence upon claim 1.
Claim 15 recites the limitation "the porous membrane support" in lines 1-2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 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 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 1-9 and 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over Changchun Liu et al, “Membrane-based, sedimentation-assisted plasma separator for point-of-care applications”, Analytical Chemistry, vol. 85, no. 21, 5 NOVMEBER 2013 (2013-11-05), Pages 10463-10470, XP055894817, US, ISSN: 0003-2700, DOI: 10.1021/ac402459h (hereinafter Liu) in view of Li et al US Patent Application No. US 20100152708 A1 (hereinafter Li).
Regarding Claim 1, Liu teaches a membrane based sedimentation assisted plasma separator (i.e., a plasma separation device comprising; Abstract)
with a central chamber that holds whole blood (i.e., a blood inlet) and two plasma chambers that holds separated plasma (i.e., a plasma outlet; Figs. 1 and 2),
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wherein there is an opening at the top of the device to input blood (i.e., a blood inlet comprising an inlet tunnel configured for loading a whole blood sample) with a chamber for holding the blood sample (i.e., and a first chamber configured for collecting the whole blood sample; Fig. 2),
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wherein there is a collection trench in the plasma outlet that collects the plasma separated by the membrane (i.e., the plasma outlet comprising a second chamber for collecting plasma separated from the whole blood; Fig. 1),
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wherein the device has a membrane disposed between each side of the blood chamber and each of the plasma collection outlets (i.e., the device comprising a membrane disposed between the blood inlet and the plasma outlet configured for separating the plasma from the whole blood; Fig. 1),
wherein the membrane is an asymmetric polysulfone membrane (Page 3, Paragraph 3).
Liu does not teach wherein the membrane comprises a zwitterionic polyurethane or pre-polymer thereof, wherein the zwitterionic polyurethane or pre-polymer thereof comprises a monomeric unit comprising a zwitterion or precursor thereof.
However, Li teaches substrates coated with non-fouling materials (i.e., the membrane comprising; Abstract) such as a zwitterionic polyurethane (i.e., a zwitterionic polyurethane or pre-polymer thereof; Paragraphs 0217, Example 1) with examples of zwitterionic monomers including carboxy betaine monomer moieties (i.e., wherein the zwitterionic polyurethane or pre-polymer thereof comprises a monomeric unit comprising a zwitterion or precursor thereof; Paragraph 0076-0080) wherein polysulfone is a suitable substrate material (Paragraph 0062), wherein membranes for biomolecule and protein separation are listed as specific examples for use cases (Paragraph 0066), and wherein the purpose of the coating is to make the surface non-fouling and specifically highly resistant to protein fouling (Abstract) in blood contacting applications (Paragraph 0075).
Li is analogous to the claimed invention because it pertains to substrate coatings to make surfaces highly resistant to protein adsorption (Abstract). It would have been obvious to one of ordinary skill in the art at the time of filing the instant claimed invention to modify the membrane as taught by Liu with the zwitterionic polyurethan coating as taught by Li because the zwitterionic polyurethane coating would make the membrane surface highly resistant to protein fouling when contacting blood.
Regarding Claim 2, the limitation “wherein the membrane has a biofilm surface coverage of less than 50%, less than 40%, less than 30%, less than 20%, less than 10%, less than 5%, or less than 1% after exposure to P. aeruginosa for three weeks when tested in accordance with the Biofilm Formation Test” is directed toward an expected result from the practice or use of the claimed invention and is therefore not subject to patentability. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established (In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)). See MPEP §2112.01(I). Furthermore, unless attributed to a specific physical property of the membrane, it is assumed the generic zwitterionic polyurethane membrane of claim 1 is capable of performing this way in the Biofilm Formation Test.
Regarding Claim 3, the limitation “wherein the membrane comprises less than 5 ng/cm2 of fibrinogen adsorbed on the membrane surface, when tested in accordance with the Protein Adsorption Test” is directed toward an expected result from the practice or use of the claimed invention and is therefore not subject to patentability. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established (In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)). See MPEP §2112.01(I). Furthermore, unless attributed to a specific physical property of the membrane, it is assumed the generic zwitterionic polyurethane membrane of claim 1 is capable of performing this way in the Protein Adsorption Test.
Regarding Claim 4, the limitation “wherein the membrane has a flux of at least about 0.05 mL/min, at least about 0.075 mL/min, at least about 0.1 mL/min, at least about 0.25 mL/min, or at least about 0.40 mL/min without application of an external driving force” is directed toward an expected result from the practice or use of the claimed invention and is therefore not subject to patentability. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established (In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)). See MPEP §2112.01(I). Furthermore, unless attributed to a specific physical property of the membrane, it is assumed the generic zwitterionic polyurethane membrane of claim 1 is capable of the flux without a driving force.
Regarding Claim 5, the limitation “wherein less than about 2%, less than about 1%, or less than about 0.05% by volume of non-plasma components of the whole blood pass through the membrane” is directed toward an expected result from the practice or use of the claimed invention and is therefore not subject to patentability. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established (In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)). See MPEP §2112.01(I). Furthermore, unless attributed to a specific physical property of the membrane, it is assumed the generic zwitterionic polyurethane membrane of claim 1 is capable of preventing non-plasma components from passing through the membrane.
Regarding Claim 6, Liu further teaches wherein the device has a membrane disposed between each side of the blood chamber and each of the plasma collection outlets (i.e., wherein the membrane is disposed between the first and second chamber; Fig. 1)
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Regarding Claim 7, Liu further teaches that a pipette tip is inserted into the plasma exit port to form a seal and a negative pressure is applied with the pipette such that the plasma filters through the membrane, flows through the collection trenches, and then is collected by the pipette (i.e., further comprising a vacuuming plasma chamber operably associated with the plasma outlet; Page 4).
Regarding Claim 8, Liu further teaches that the plasma separator extracted blood from a sample size of 1.8 mL which was loaded into the plasma separation chamber (i.e., wherein the first chamber has a capacity for a volume of the whole blood sample in a range of about 0.001 to about 1000 mL, about 0.001 to about 750 mL, about 0.01 to about 500 mL, about 0.01 to about 250 mL, about 0.01 to about 100 mL, about 0.01 to about 75 mL, about 0.01 to about 50 mL, about 0.01 to about 25 mL, about 0.01 to about 20 mL, 0.05 to about 20 mL, about 0.1 to about 18 mL, about 0.25 to about 16 mL, about 0.5 to about 15 mL, about 0.75 to about 10 mL, or about 1 to about 5 mL; Page 4).
Regarding Claim 9, Li further teaches that poly carboxy betaines have exceptional resistance to biofouling and are well suited to blood contacting applications (Paragraph 0079) with example 1 teaching the grafting of carboxy betaine onto polyurethane to create anti-thrombotic rods (Paragraphs 0217-0219) with the use of monomers such as carboxy betaine methacrylate to create poly(carboxy betaine methacrylate) (i.e., wherein the zwitterionic polyurethane or prepolymer thereof comprises a polycarboxybetaine urethane, polycarboxybetaine methacrylate; Paragraph 0111).
Regarding Claim 11, Liu further teaches that the membrane is an asymmetric polysulfone membrane (i.e., wherein the membrane comprises a porous membrane support having at least one surface and at least one pore; Page 3, Paragraph 3).
Li further teaches that the non-fouling coating is attached to a substrate surface (Paragraph 0002), the coatings can be grafted onto substrates with porous structures (Paragraph 0013), and wherein polysulfone is a suitable substrate material (Paragraph 0062) and the coating is a zwitterionic polyurethane (i.e., and the porous membrane support includes a layer of the zwitterionic polyurethane or pre-polymer thereof on a surface of the porous membrane support; Paragraphs 0217, Example 1).
Regarding Claim 12, Li further teaches that the non-fouling coating is attached to a substrate surface (Paragraph 0002) and the coatings can be grafted onto substrates with porous structures (i.e., wherein the zwitterionic polyurethane or prepolymer thereof covers substantially all surfaces and pore walls of the porous membrane support; Paragraph 0013).
Regarding Claim 13, Li further teaches that the coating method does not significantly affect the mechanical or physical properties of the substrate material (Abstract) wherein the device dimensions are within 1% of the uncoated substrate (i.e., wherein the membrane has a surface morphology and a pore size distribution and the surface morphology and pore size distribution is substantially similar to a surface morphology and a pore size distribution of the porous membrane support prior to the addition of the zwitterionic polyurethane; Paragraph 0016).
Regarding Claim 14, Liu further teaches that the membrane is an asymmetric polysulfone membrane (i.e., wherein the porous support membrane comprises a thermoplastic polymer; Page 3, Paragraph 3).
Regarding Claim 15, Liu further teaches that the membrane is an asymmetric polysulfone membrane (i.e., wherein the porous support membrane comprises polysulfone; Page 3, Paragraph 3).
Regarding Claim 16, Liu further teaches that the asymmetric polysulfone membrane has a mean pore size of about 2 µm on its downstream surface (i.e., wherein the membrane has a pore size in a range of about 20 nm to about 5 µm, about 50 nm to about 4.5 µm, about 75 nm to about 4 µm, about 100 nm to about 3.5 µm, about 250 nm to about 3 µm, about 500 nm to about 2.5 µm, about 750 nm to about 2 µm; Page 5, Paragraph 2).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Li as applied to claim 1 above, and further in view of Huifeng et al “Winning the fight against biofilms: the first six-month study showing no biofilm formation on zwitterionic polyurethanes”, Chemical Science, vol. 11, no. 18, 1 JANUARY 2020 (2020-01-01) pages 4709-4721, XP055969311, United Kingdom, ISSN: 2014-6520, DOI: 10.1039/C9SC06155J (hereinafter Huifeng).
Regarding Claim 10, Liu in view of Li does not teach wherein the zwitterionic polyurethane comprises hydrolyzed poly((diethanolamine ethyl acetate)-co- poly(1,6-diisocyanatohexane)), hydrolyzed poly((diethanolamine ethyl acetate)-co-poly(tetrahydrofuran)-co-poly(1,6-diisocyanatohexane)), hydrolyzed poly((diethanoamino-N- hydroxyl ethyl acetate)-co-poly(1,6-diisocyanatohexane)), hydrolyzed poly((diethanoamino- N-hydroxyl ethyl acetate)-co-poly(tetrahydrofuran)-co-poly(1,6-diisocyanatohexane)), hydrolyzed poly((diethanolamine ethyl acetate)-co-poly(diethanoamino-N-hydroxyl ethyl acetate)-co-poly(1,6-diisocyanatohexane)), hydrolyzed poly((diethanolamine ethyl acetate)- co-poly(diethanoamino-N-hydroxyl ethyl acetate)-co-poly(tetrahydrofuran)-co-poly(1,6- diisocyanatohexane)), and a combination thereof.
However, Huifeng teaches a condensation process directly incorporating anti-fouling groups into polyurethane during polymer synthesis utilizing diethanolamine ethyl acetate (DEAEA) and hexamethylene diisocyanate (HDI) (i.e., wherein the zwitterionic polyurethane comprises hydrolyzed poly((diethanolamine ethyl acetate)-co- poly(1,6-diisocyanatohexane))) where DEAEA acts as a chain extender and anti-fouling precursor and HDI as a crosslinking agent for the purpose of tuning the mechanical properties, the swelling property, and the anti-fouling properties of the resulting polymer (Page 4710-4711, Results and Discussion, Synthesis of PCBGUs) and PCBGUs are beneficial for coatings (Page 4714, Col. 2, Paragraph 1).
Huifeng is analogous to the claimed invention because it pertains to zwitterionic polyurethanes and their anti-fouling properties (Abstract). It would have been obvious to one of ordinary skill in the art at the time of filing the instant claimed invention to modify the coating made obvious by Liu in view of Li with the synthesis method as taught by Huifeng because the synthesis method would incorporate elements that allow for the tuning of the coating’s mechanical properties, swelling property, and anti-fouling properties.
Conclusion
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/A.A.G./ Examiner, Art Unit 1777
/IN SUK C BULLOCK/ Supervisory Patent Examiner, Art Unit 1772
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