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 .
Claim Objections
Claim 1 objected to because of the following informalities: Line 5 “binding specifity” appears to be a typo of “binding specificity”; line 7 “moeity” appears to be a typo of “moiety” . Appropriate correction is required.
Claim 4 objected to because of the following informalities: Line 3 “secon” appears to be a typo of “second”. 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 11-13, 15-16 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.
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). In the present instance:
Claims 11 recite the broad recitation “concentration of from about 2% to 30%”, and the claim also recites “3%-10%” which is the narrower statement of the range/limitation.
Claim 12 recites the broad recitation “a ratio of the monomer to the crosslinker is 200:1 to 1:0”, and the claim also recites “preferably 50:1 to 10:1” which is the narrower statement of the range/limitation.
Claim 13 recites the broad recitation “a ratio of the photoinitiator to the mixture is about 0.01% to 10%”, and the claim also recites “preferably 0.1% to 1%” which is the narrower statement of the range/limitation.
The claim(s) 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.
Regarding claim 15-16, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-7, 14, 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamei et al (US 2019/0187140 A1) in view of Jenkins et al, "A polymer hydrogel modified lateral flow sensing platform", Sensors and Actuators B 262 (2018) 493–498.
Regarding claim 1, Kamei et al teach a system for detecting or identifying an analyte (Para 0168; FIG. 1B), comprising: a lateral flow test strip (Para. 0048: LFA; Figure 1B), a test zone situated on the lateral flow test strip (Figure 1B, "test zone" is sufficiently broad to read on the entire test device including the sample pad, hydrogel, control and test lines), comprising an affinity molecule immobilized thereon (Figure 1B, see item "indicator" and Para 0169,0246) wherein the affinity molecule is pre-selected to have a binding specificity with an analyte of interest (Figure 1B, "indicator" Para 0169: analytes will bind to the colorimetric indicator on the conjugate pad, and the resulting indicator-target complexes will be captured on the reaction pad as shown by a visible spot) and a hydrogel composition deposited on the test zone (Figure 1B, "hydrogel"), comprising an anchor moiety embedded therein (Figure 1B, "secondary antibody" para. 0275 probe-analyte complex applied to the hydrogel), wherein the anchor moiety is pre-selected to bind or react with the affinity molecule (Para 0275) thereby immobilizing the affinity molecule on the test zone (Figure 1B, see item "indicator"). Kamei et al is silent to the hydrogel composition comprises about 0.01% to 20%, or 0.01% to 10%, or about 0.1% to 5%, or about 0.5% to 5%, or about 0.5% to 2% by weight modified monomers, each modified monomer comprising the anchor moiety.
Jenkins et al teach the hydrogel PAA with percentages of 0.1%, 0.5%, 1%, 5%, and 10% causing a narrowing of the band of the results with 10%. It is desirable to provide desired monomer concentrations to form hydrogels that have conditions to provide the desired lateral flow in the device. In re Boesch (205 USPQ 215) teaches the optimization of a result effective variable is ordinarily within the skill of the art. A result effective variable is one that has well known and predictable results. The choice of a hydrogel composition comprises about 0.01% to 20%, or 0.01% to 10%, or about 0.1% to 5%, or about 0.5% to 5%, or about 0.5% to 2% by weight modified monomers, is a result effective variable that gives the well-known and expected results of providing a hydrogel capable of polymerizing and providing desirable properties for detection as taught by Jenkins et al. In the absence of a showing of unexpected results, the Office maintains the % by weight modified monomers of about 0.01% to 20%, or 0.01% to 10%, or about 0.1% to 5%, or about 0.5% to 5%, or about 0.5% to 2% would have been within the skill of the art as optimization of a results effective variable.
Regarding claim 2, Kamei et al teach the lateral flow test strip comprises a substrate, a sample pad, a probe conjugate pad, a detection pad, and an absorbent pad, and wherein the detection pad comprises the test zone and a control line (Para. 0054)
Regarding claim 3, Kamei et al teach on the lateral flow test strip, the sample pad is positioned at a first end, followed by the probe conjugate pad and the absorbent pad at a second end (Figure 1B).
Regarding claim 4, Kamei et al teach on the lateral flow test strip, the probe conjugate pad is positioned at a first end, followed by the sample pad and the absorbent pad at a second end. However, Regents discloses a sandwich configuration that comprises a conjugate pad followed by a reaction pad followed by a sink (Figure 2). It would have been obvious to one of skill in the art to identify wherein on the lateral flow test strip, the probe conjugate pad is positioned at a first end, followed by the sample pad and the absorbent pad at a second end to provide the test in a sandwich configuration by routine experimentation.
Regarding claim 5, Kamei et al teach the system of claim 1, wherein the test zone is shaped to be a line, a square, a circle, an oval, or any combination thereof. (Figure 1B, "sample pad" is a square)
Regarding claim 6, Kamei et al teach the analyte of interest is selected from a nucleic acid, an oligonucleotide, a protein, a peptide, an antibody, an antigen, a carbohydrate, an epitope, a metabolite, a biomarker, and any combination thereof. (Para. 0164: analyte including nucleic acid).
Regarding claim 7, Kamei et al teach the hydrogel composition comprises a polymeric material selected from a polyacrylamide, a poly(ethylene glycol), a polysaccharide, a polypeptide, a copolymer of two or more polymers, and any combination thereof. (Para. 0167: polyethylene glycol)
Regarding claim 14, Kamei et al teach the anchor moiety comprises a protein (Figure 1B, see item "secondary antibody", antibodies comprise proteins).
Regarding claim 17, Kamei et al teach modified monomer comprises an acrylamide derivative bearing an oligonucleotide, a peptide, or an oligosaccharide, or any combination thereof. (Para 0220: 2-hydroxyethyl methacrylate (HEMA) and acrylic acid (AA) on to XG via redox initiator system of ammonium persulfate (APS) and N, N, N, N-tetramethylethylenediamine (TMED), in the presence of N, N-methylenebisacrylamide (MBA) crosslinking agent, sodium bicarbonate foaming agent, a triblock copolymer of polyoxyethylene/polyoxypropylene/polyoxyethylene as a foam stabilizer", methylenebisacrylamide comprises a carbonyl carbon bound to an amine and therefor a peptide bond).
Regarding claim 18, Kamei et al teach a method for detecting or identifying an analyte, comprising: providing the system of claims 1 (see rejection supra); flowing a sample through the lateral flow test strip; and detecting the presence or absence or amount of the analyte of interest. (Fig. 1B).
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamei/Jenkins in view of Lim (US 20190227055).
Regarding claims 15-16, Kamei/Jenkins teach PEG based hydrogels such as PEG dimethacrylate (Para. 0215). Kamei/Jenkins is silent to the modified monomer comprises an acrylate derivative bearing a functional group, such as an acrylate amine, an acrylate oxyamine, an acrylate hydrazine, an acrylate boric acid, or any combination thereof; methacrylate amine, a methacrylate oxyamine, a methacrylate hydrazine, a methacrylate boric acid, or any combination thereof.
Lim teach PEG based hydrogels can include functional groups such as acrylate amines to co-polymerize proteins such as streptavidin (Para. 0037). It is desirable to provide functional groups that immobilize desirable proteins that can be used for detection in lateral flow assays (Para. 0063: Lim teaches the use in lateral flow assays). Simple substitution of one known element for another to obtain predictable results is held to be obvious. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the PEG dimethacrylate functional group of Kamei with the PEG acrylate amine (Claim 16: merely adding the amine group to the dimethacrylate of Kamei: reads on "methacrylate amine") of Lim to provide the above advantage of providing functional groups that immobilize desirable proteins that can be used for detection in lateral flow assays.
Claim(s) 8-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamei/Jenkins in view of Zhao et al (US 2019/0070826 A1).
Regarding claims 8-13, Kamei/Jenkins et al teach a modified monomer, monomer, crosslinker, and photoinitiator (Para. 0193: PEGDMA, Irgacure 2959). Kamei/Jenkins is silent to a photoinitiator is selected from benzophenone and its derivatives, benzoylphenyl-acrylamides, azo initiators, and any combination thereof; crosslinker is a derivative of a diacrylate, a bisacrylamide, an ethylene glycol diacrylate, or any combination thereof; monomer is selected from an acrylamide, an acrylic ester, a water-soluble derivative of acrylic acid, and any combination thereof; monomer is present in the mixture at a concentration of from about 2% to 30% by weight, preferably 3%-10%; a ratio of the photoinitiator to the mixture is about 0.01% to 10%, preferably 0.1% to 1%.
Zhao et al teach a photoinitiator is selected from benzophenone and its derivatives, benzoylphenyl-acrylamides, azo initiators, and any combination thereof (Para. 0079: benzophenone); crosslinker is a derivative of a diacrylate, a bisacrylamide, an ethylene glycol diacrylate, or any combination thereof (Para. 0076: polyethylene glycol diacrylate); a monomer selected from an acrylamide, an acrylic ester, a water-soluble derivative of acrylic acid, and any combination thereof (Para. 0076: acrylamide); monomer is present in the mixture at a concentration of from about 2% to 30% by weight, preferably 3%-10% (Para.0080: 20 wt . % PEGDA); a ratio of the photoinitiator to the mixture is about 0.01% to 10%, preferably 0.1% to 1% (Para. 0079: benzophenone 10%). It is desirable to provide hydrogels well known monomer and photoinitiator in proper amounts to provide hydrogels having high water content, permeability to chemical and biological molecules (Para. 0004).
Simple substitution of one known element for another to obtain predictable results is held to be obvious. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the monomers and photoinitiator and the amounts each of Zhao for the monomers and photoinitiator of Kamei to provide the above advantage of providing hydrogels well known monomer and photoinitiator in proper amounts to provide hydrogels having high water content, permeability to chemical and biological molecules.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS MICHAEL WHITE whose telephone number is (571)270-3747. The examiner can normally be reached M-F 8:30am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris R. Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Dennis White/Primary Examiner, Art Unit 1758
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