DETAILED ACTION
Status of the Claims
1. Claims 1-15 are being examined in this application
Election/Restrictions
2. Applicant’s election without traverse of claims 1-19 in the reply filed 7/31/2026 is acknowledged.
Attorney, Basil M. Angelo also elected species A1 (1-15) over the telephone call on 9/4/2026.
Claim Objections
3. Claim 7 is objected to because of the following informalities: Claim 7 recites “optionally wherein said second structure comprises any biocompatible polymer or wherein the biosensor”. The recitation of wherein the biosensor is incomplete sentence and claim 17 is also missing period at the end of the claim.
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.
4. Claim 1 is 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 distal end" and “the proximal end” in lines 6 and 9 respectively. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3-7, 9-11, is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin et al. (US 2023/0032773, Provisional filing date Dec 24,2019).
Claim 1. Lin et al. teach a biosensor (analyte sensing system; see Fig 6) comprising:
first and second substrates defining a cavity therebetween (15-1/15-2 and 15-3 layer define microchannel therebetween; see Fig 6);
a sensing structure having a functionalized active surface provided on the first substrate, within said cavity (electrode member 31 functionalized with bio-sensing probes provided on 15-3 substrate; see Fig 6 and [0060]);
a flow control structure provided on said second substrate and extending into said cavity (suspended section 18 provided on second substrate 15-1/15-2 and extend into microchannel; [0056] and Fig 6), wherein a gap between the distal end of the flow control structure and said sensing structure provides a fluid flow channel across said functionalized active surface (space between the suspended structure and electrode provides U shaped channel encompassing electrode; [0055][0056]); and
an inlet port adjacent the proximal end of the flow control structure, at one end of said fluid flow channel (sample inlet 11-2 proximal end of the suspended section at one end of the microchannel; see Fig 11-2), and an outlet port at the opposite end of the fluid flow channel (outlet at the other end of the channel; see Fig 6);
wherein the flow control structure is shaped and configured such that, in use, fluid dropped/injected at the inlet port flows into and through the fluid flow channel to the outlet port, thereby exerting a shear force on said active surface (suspended structure(s) provide different height in the microchannel, thus inherently providing shear force to sample flowing through the microchannel).
Claim 3. Lin et al. teach flow control structure comprises an outer surface adjacent the inlet port that is rounded and convex relative to the fluid flow path from said inlet port to said outlet port (suspended section 18 provided on second substrate 15-1/15-2 has outer surface adjacent to sample inlet 11-2 and has rounded and convex shape relative to microchannel; [0056] and Fig 5),
Examiner is construing the limitation of “optionally wherein the flow control structure may comprises a trapezoid or truncated dome having substantially parallel planar first and second bases, wherein the diameter of the first base is larger than that of the second base, 20 and wherein the first base is on the second substrate and the second base is located nearest the functionalized active surface, with said gap therebetween” to be an optional element in the biosensor claim and not a required element of the claimed sensor.
Claim 4. Lin et al. teach the second substrate is a solid dielectric substrate (second substrate 15-1/15-2 comprised of rigid plastic such polycarbonate (reads on dielectric substrate) [0042]).
Claim 5. Lin et al. teach the flow control structure comprises a polymer (layer 18 is made up of softer, elastic material such as silicone; [0054]).
Claim 6. Lin et al. teach a first structure on the first substrate, located at a first end of the functionalized active surface and extending into the cavity, wherein a gap between the distal end of the first structure and the second substrate defines said inlet port (see circled first structure on the substrate 15-3 below in Fig 6, the gap between the distal end of the structure and substrate 15-1/15-2 defines inlet port 11-2).
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Examiner is construing the limitation of “ optionally wherein said first structure comprises any biocompatible polymer” to be an optional element in the biosensor claim and not a required element of the claimed sensor.
Claim 7. Lin et al. teach a second structure on the first substrate, located downstream of the functionalized active surface, wherein a gap between a distal end of the second structure and the second substrate defines said outlet port (see marked structure in Fig 6 below reads on second structure on substrate 15-3 located downstream of electrode 31 and gap between the distal end of the structure and substrate 15-1/15-2 forms outlet).
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Examiner is construing the limitation of “optionally wherein said second structure comprises any biocompatible polymer or wherein the biosensor” to be an optional element in the biosensor claim and not a required element of the claimed sensor.
Claim 9. Lin et al. teach an electrode located between the sensing structure and the first substrate for applying an electrostatic potential to said sensing structure (electrode 31 located between probes and substrate 15-3 for applying voltage; see Fig 6 and [0033]).
Examiner is construing the limitation of “optionally wherein said electrode is located at one end of the sensing structure, and a conductive contact is located at the opposite end, and downstream, thereof, the conductive contact being provided between the first substrate and the sensing structure, and optionally further comprising means for applying an electrostatic potential to said electrode, said electrostatic potential being of a polarity that acts to attract analyte molecules of interest” to be an optional element in the biosensor claim and not a required element of the claimed sensor.
Claim 10. Lin et al. teach the sensing structure comprises a plurality of spaced apart channels, each channel defining a functionalized active surface (electrode 31 comprises three space apart channels comprising functionalized active surface of the electrode; see Fig 6).
Claim 11. Lin et al. teach further comprising a reference electrode on said sensing structure [0060].
Claim 13. Lin et al. teach means for applying mechanical agitation to said sensing structure [0095].
Examiner is construing the limitation of “means for applying mechanical agitation to said sensing structure optionally comprises ac-electrohydrodynamic or electromagnetic agitation means” to be an optional element in the biosensor claim and not a required element of the claimed sensor.
Claim 14. Lin et al. teach a quantification module arranged and configured to receive electrical signals from said sensing structure and determine a presence and/or concentration of analyte molecules of interest in a sample fluid flowing through said fluid flow channel, in use (readout device to detect electric signal to measure presence of target analyte [0033][0032]).
Examiner is construing the limitation of “optionally wherein said quantification module is configured to determine, from said chemi-resistive and GFET signals, a presence and/or concentration of analyte molecules bound to the functionalized active surface based on an average quantity derived therefrom, or optionally wherein said quantification module is configured to generate an average % change in the combined chemi-resistive and GFET signals represented as an analytic quantification of said analyte molecules of interest” to be an optional element in the biosensor claim and not a required element of the claimed sensor.
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. as applied to claim 1 and further in view of Johnson et al. (US2016/0003763).
Claim 2. Lin et al. teach sensing structure comprises a graphene layer functionalized by linker and probe molecules configured to bind with analyte molecules of interest (conductive coating of carbon, silver, gold or graphite forms the sensing electrode functionalized by linking layer and biosensing probes configured to bind to analyte of interest; [0072][0106]. Lin et al. do not explicitly teach the conductive coating comprises graphene. However, Johnson et al. teach biosensor comprised of electrode for modulating the binding interactions between a probe and analyte of interest, wherein the electrode is comprised of graphene, glassy carbon, gold or silver (abstract and [0266]). Therefore, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960) (see MPEP § 2144.07).
Claim(s) 12 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. as applied to claim 1 and further in view of Lau et al. (US2009/0142772).
Claims 12 and 15. Lin et al. do not teach said functionalized active surface comprises a layer or coating of NSA blocking substance thereon and the second substrate is a solid, optically transparent/translucent dielectric. However, Lau et al. teach apparatus comprising substrate having plurality of analyte binding areas specific to target analyte and transparent cover forming a flow channel with substrate ([0007] and claim 22 [0153][0155]), the PEG layer is disposed onto the substrate to form non-fouling surface resistant to non-specific adsorption of biomolecules [0136].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Lau et al. teaching to functionalized active surface of Lin et al. with PEG layer to form non-fouling surface resistant to non-specific adsorption of biomolecules and use transparent second substrate to visualize real time events and/or improve specificity.
Allowable Subject Matter
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Cited prior art, Lin et al. do not teach a second structure on the first substrate, located downstream of the functionalized active surface, wherein a gap between a distal end of the second structure and the second substrate defines said outlet port, and further comprising a third structure located on the first substrate, spaced apart from and downstream of the second structure and the outlet port, wherein a space between the second and third structures defines an outer reservoir.
Conclusion
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/GURPREET KAUR/
Primary Examiner
Art Unit 1759
Prosecution Insights