DETAILED ACTION
The Drawing amendment filed on 11/27/2025 has been entered, no claim amendments were filed.
Claims 14-17 are pending and currently under examination.
Response to the Arguments
Objections to the Drawings in the previously mailed non-final have been withdrawn in light of applicants Drawings amendments.
Applicant’s arguments regarding previous rejection(s) of claim(s) 1, 5, 19-22, 24-27, and 50 under 35 U.S.C. 103 have been fully considered and are not persuasive. The 35 U.S.C. 103 rejections documented in the previously mailed non-final have been maintained and revised in light of applicants arguments on Pg. 3-5.
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.
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.
Claims 14-17 remain/are rejected under 35 U.S.C. 103 as being unpatentable over Prober et al. (“Prober”; U.S. Patent No. US 7122384 B2, Pub. Oct. 17, 2006, Filed on Nov. 5, 2003).
Prober discloses “Microparticle-based analytical methods, systems and applications are provided. Specifically, the use of resonant light scattering as an analytical method for determining either or both a particle's identity and the presence and optionally, the concentration of one or more particular target analytes is described. Applications of these microparticle-based methods in biological and chemical assays are also disclosed.” (Abstract)
Regarding claim 14, Prober teaches a bio-sensor comprising “fixed arrays” (Col 29 ln 4). Prober teaches a bio-sensor comprising “a large variety of sample matrices … sample can be pre-treated prior to use depending on the details of the assay, techniques for which would be well known by those in the art” (Col 31 ln 39-54). Prober also teaches a biosensor comprising “a sample 113 is typically combined with a solution ... Various additional steps may be carried out, such as incubations, washings, the addition of miscellaneous reagents, etc.” (Col 30 ln 59-63; Figure 1). Prober also teaches a biosensor comprising an optical cell. (Figure 3) Prober teaches a biosensor comprising “ microparticles may be derivatized with known capture probes and placed in specific fixed locations that do not change during the experiment” (Col. 18, ln 19-22). ”“fixed arrays” read on an analyte fixing unit comprising a substrate. “addition of miscellaneous reagents” reads on fixing agents. The optical cell reads on an unit where an analyte would be fixed to similar to that of Fig. 1 and Fig. 9 of the instant application. Thus, Prober teaches a bio-sensor comprising: an analyte fixing unit configured to fix a target analyte.
Regarding claim 14, Prober teaches a bio-sensor comprising “biotinylated glass microparticles” (Col 52 ln 22; Figure 3 see below) and “a capture probe affixed to the outer surface of the particle” (Col 9 ln 33-34). Thus, Prober teaches a bio-sensor comprising an optical probe configured to selectively conjugate to the target analyte and to retro-reflect incident light thereto.
Regarding claim 14, Prober teaches a bio-sensor comprising “light sources” (Col 33 ln 11; Col 33 ln 8-20; Figure 3 see below-laser). Thus, Prober teaches a bio-sensor comprising a light source unit configured to irradiate light to the optical probe.
Regarding claim 14, Prober teaches a bio-sensor comprising “detection fibers” and “detecting the light with detectors or imaging devices” (Col 33 ln 6; Col 33 ln 28-29; Figure 3 see below-collection fibers and to detector). Thus, Prober teaches a bio-sensor comprising an optical receiving unit configured to receive the retro-reflected light from the optical probe.
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The teachings of Prober are documented above in the rejection of claim 14 under 35 U.S.C. 103. Claims 15-16 depend on claim 14. Claim 17 depends on claim 16 which depends on claim 14.
Regarding claim 15, Prober teaches a bio-sensor wherein “microparticle comprises a transparent glass core” (Col 35 ln 4-5). Thus, Prober teaches a bio-sensor wherein the optical probe comprises a transparent core particle.
Regarding claim 15, Prober teaches a bio-sensor wherein “optional number m of layers 101 ... 103 with outer radii r1 ... rm and indices of refraction n1 ... nm. The number of layers m may be zero, and if greater than zero, will typically be less than about 5. In this context, the term "layer" or "layers" may include regions containing sharp refractive index boundaries, or zones of variable refractive index without sharp boundaries. In either case, variability of refractive index and layer dimension may provide richness to the resonant light scattering spectrum, which can be used to advantage in particle identification” (Col 32 ln 18-27; Figure 2 see below). Prober teaches a bio-sensor wherein “one or more optically active layers” (Col 9 ln 65). Prober teaches a bio-sensor wherein “one or more layers to provide functionalities appropriate for the applications of interest. The thicknesses and refractive indices of layers, if present, may vary depending on the needs of the specific application and on the wavelengths of light used to make the required measurements” (Col 19 ln 22-26). Prober teaches a bio-sensor wherein the optical probe comprising “resonant scattering features travel in orbits just inside the outer surface of the particle, trapped by total internal reflection.” (Col. 85 ln 3-6). Thus, Prober teaches a bio-sensor wherein the optical probe comprises a total-reflection inducing layer covering a portion of a surface of the core particle, wherein the inducing layer is made of a material having a refractive index lower than a refractive index of the core particle with respect to a visible light wavelength range of 360 nm to 820 nm; and wherein the optical probe comprises a modifying layer on the total-reflection inducing layer.
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Regarding claim 15, Prober teaches a bio-sensor wherein “a capture probe affixed to the outer surface of the particle” (Col 9 ln 33-34). Prober teaches a bio-sensor wherein “such layers will have specific linker chemistry for attaching capture probes” (Col 17 ln 23-24). Thus, Prober teaches a bio-sensor wherein the optical probe comprises an analyte-sensing substance bound to the modifying layer, wherein the analyte- sensing substance is selectively conjugated to the target analyte.
Regarding claim 16, Prober teaches a bio-sensor wherein “fixed arrays” (Col 29 ln 4) “fixed arrays” read on an analyte fixing unit comprising a substrate. Prober teaches a bio-sensor wherein “a large variety of sample matrices … sample can be pre-treated prior to use depending on the details of the assay, techniques for which would be well known by those in the art” (Col ln 39-54). Prober also teaches “a sample 113 is typically combined with a solution ... Various additional steps may be carried out, such as incubations, washings, the addition of miscellaneous reagents, etc.” (Col 30 ln 59-63; Figure 1). “addition of miscellaneous reagents” reads on a fixing substance disposed on the substrate and configured to be selectively conjugated to the target analyte. Thus, Prober teaches a bio-sensor wherein the analyte fixing unit comprises a substrate; and an analyte fixing substance disposed on the substrate and configured to be selectively conjugated to the target analyte, wherein the light source unit irradiates the light in a direction inclined by about 5° to 60° with respect to a normal line to a surface of the substrate.
Regarding claim 17, Prober teaches Figure 7 involving a bio-sensor comprising an optical receiving unit-imaging devices (image capture board and video) comprising a light dividing unit-beamsplitter (025), image capture unit (027 and 017), and image analyzing unit- computer (010) and video monitor (017). (Figure 7 see below). Thus, Prober teaches a bio-sensor wherein the optical receiving unit comprises a light dividing unit configured to divide received light into first light incident into the optical probe and second light retro-reflected from the optical probe; an image forming unit configured to receive the second light from the light dividing unit and to form an image corresponding to the second light; and an image analyzing unit configured to analyze the image formed by the image forming unit, wherein the light dividing unit is oriented at an angle of about 0° to 60° with respect to the normal line of the surface of the substrate, which is orientated in a same or adjacent direction of the light irradiated by the light
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source.
It is noted that the courts have held that “while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function.” In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). In addition, “[A]pparatus claims cover what a device is, not what a device does.” Hewlett- Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). See MPEP § 2114.
It is also noted that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists, and that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Therefore, the invention as recited in claims 14-17 are prima facie obvious over the prior art Prober et al. One of ordinary skill in the art would have had a reasonable expectation of success given the lack of novelty. It would have been obvious to have a biosensor with an analyte fixing unit, an optical probe, a light source, and an optical receiving unit according to the limitations of the instant application claims 14-17 based on Prober et al. (U.S. Patent No. US 7122384 B2).
Response to Arguments
Applicant' s arguments filed 11/27/2025 (Pg. 3-5) with respect to claim 14-17 have been considered but are not persuasive. To clarify some instances argued in the response filed 11/27/2025 see responses to each argument made by Applicant below:
Applicants’ argument: “The cited potion in Prober does not teach use of the fixed arrays in his biosensor disclosed therein. The cited portion rather highlights the disadvantages of fixed arrays, suggesting that the biosensor of Prober does not utilize such a structure.
Prober acknowledges diffusion limitations and signal constraints inherent to the fixed-array systems. These disadvantages teach away from adopting such fixed arrays.” (Pg. 3)
Response: In response to applicants’ arguments stated above, the cited portion does teach the use of the fixed arrays as recited in the Non-final office action (Pg. 6) and revised rejection documented above, “Prober teaches a bio-sensor wherein the analyte is “fixed arrays” (Col 29 ln 4). Prober teaches a bio-sensor wherein “a large variety of sample matrices … sample can be pre-treated prior to use depending on the details of the assay, techniques for which would be well known by those in the art” (Col 31 ln 39-54). Prober also teaches “a sample 113 is typically combined with a solution ... Various additional steps may be carried out, such as incubations, washings, the addition of miscellaneous reagents, etc.” (Col 30 ln 59-63; Figure 1). Prober also teaches an optical cell. (Figure 3) “fixed arrays” read on an analyte fixing unit comprising a substrate. “addition of miscellaneous reagents” reads on fixing agents. The optical cell reads on an unit where an analyte would be fixed to similar to that of Fig. 1 and Fig. 9 of the instant application. Thus, Prober teaches a bio-sensor comprising: an analyte fixing unit configured to fix a target analyte.”. Furthermore, Prober teaches the use of the fixed arrays in multiple embodiments, such as “microparticles may be derivatized with known capture probes and placed in specific fixed locations that do not change during the experiment” (Col. 18, ln 19-22).
Also, while Prober does acknowledge limitations and signal constraints inherent to the fixed-array systems. Prober also suggests tips to still use the fixed-array systems. (Col 29 ln 3-7), Thus, Prober does not teach away from adopting such fixed arrays.
Applicants’ argument: “The present invention uses retro-reflected light from an optical probe conjugated to an analyte. However, Prober describes resonant light scattering detection based on the spectral analysis of scattered light; it does not teach retro-reflected optical detection from a discrete optical probe. Retro-reflection (light returned along the incident path) is fundamentally different from scattering (light diffused in multiple directions). Thus, Prober does not disclose a retro-reflective optical probe, an analyte fixing unit, or an optical receiving unit configured to collect retro-reflected light.” (Pg. 4)
Response: In response to applicant's argument that “the present invention uses retro-reflected light from an optical probe conjugated to an analyte”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Furthermore, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a retro-reflective optical probe) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicants’ argument: “Prober provides no teaching relating to the total reflection” (Pg. 4).
Response: In response to applicants’ arguments stated above, Prober teaches a bio-sensor wherein “optional number m of layers 101 ... 103 with outer radii r1 ... rm and indices of refraction n1 ... nm. The number of layers m may be zero, and if greater than zero, will typically be less than about 5. In this context, the term "layer" or "layers" may include regions containing sharp refractive index boundaries, or zones of variable refractive index without sharp boundaries. In either case, variability of refractive index and layer dimension may provide richness to the resonant light scattering spectrum, which can be used to advantage in particle identification” (Col 32 ln 18-27; Figure 2 see below). Prober teaches a bio-sensor wherein “one or more optically active layers” (Col 9 ln 65). Prober teaches a bio-sensor wherein “one or more layers to provide functionalities appropriate for the applications of interest. The thicknesses and refractive indices of layers, if present, may vary depending on the needs of the specific application and on the wavelengths of light used to make the required measurements” (Col 19 ln 22-26). Prober teaches a bio-sensor wherein the optical probe comprising “resonant scattering features travel in orbits just inside the outer surface of the particle, trapped by total internal reflection.” (Col. 85 ln 3-6). Thus, Prober teaches a bio-sensor wherein the optical probe comprises a total-reflection inducing layer covering a portion of a surface of the core particle, wherein the inducing layer is made of a material having a refractive index lower than a refractive index of the core particle with respect to a visible light wavelength range of 360 nm to 820 nm; and wherein the optical probe comprises a modifying layer on the total-reflection inducing layer.
Applicants’ argument: “the substrate of claim 16 is not taught by Prober either” (Pg. 4)
Response: In response to applicants’ argument that the substrate is not taught, Prober does teach/suggest a substrate as recited in the non-final office action on Pg. 9 and revised rejection above, Prober teaches a bio-sensor wherein “fixed arrays” (Col 29 ln 4) “fixed arrays” read on an analyte fixing unit comprising a substrate. Prober teaches a bio-sensor wherein “a large variety of sample matrices … sample can be pre-treated prior to use depending on the details of the assay, techniques for which would be well known by those in the art” (Col ln 39-54). Prober also teaches “a sample 113 is typically combined with a solution ... Various additional steps may be carried out, such as incubations, washings, the addition of miscellaneous reagents, etc.” (Col 30 ln 59-63; Figure 1). “addition of miscellaneous reagents” reads on a fixing substance disposed on the substrate and configured to be selectively conjugated to the target analyte. Thus, Prober teaches a bio-sensor wherein the analyte fixing unit comprises a substrate; and an analyte fixing substance disposed on the substrate and configured to be selectively conjugated to the target analyte, wherein the light source unit irradiates the light in a direction inclined by about 5° to 60° with respect to a normal line to a surface of the substrate.
Applicants’ argument: “the idea of inducing total internal reflection by irradiating light at an oblique angle, as recited in the claim, is entirely absent.” (Pg. 4)”
Response: In response to applicants’ argument stated above, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Furthermore, as stated above, Prober does teach the idea of inducing total internal reflection as stated in the response above to the argument about no teaching relating to the total reflection.
Conclusion of Response to Arguments
In view of the amendments, revised rejections and above responses to arguments are documented in this Final Office Action. No claims are in condition for allowance.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENDRA R VANN-OJUEKAIYE whose telephone number is (571)270-7529. The examiner can normally be reached M-F 9:00 AM- 5:00 PM.
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/KENDRA R VANN-OJUEKAIYE/Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682