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 .
Remarks
This office action fully acknowledges Applicant’s remarks and amendments filed on 03/23/2026.
Claims 13-15, 17-19, 21, 23-24, and 29-38 are pending.
Claims 1-12, 16, 20, 22, and 25-28 are canceled.
Claims 24 and 29-35 are withdrawn.
Claims 36-38 are newly added.
Allowable Subject Matter
Claims 36-38 are 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.
The following is a statement of reasons for the indication of allowable subject matter: None of the particular crown-ether-type luminescent chelators of the new Claims 36-38 appeared in Examiner’s search of the prior art. Similar structures were discovered, but none with the 3-oxo-6-hydroxyxanthene substituent of Claims 36-38.
Claim Interpretation
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitations are:
“a first moiety configured to interact with the target”, as in Claim 17.
“the first moiety...configured to chelate a target”, as in Claim 18.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
(1 & 2) “a ring structure”, as in para. [0009] of Applicant’s instant pre-grant publication US 2023/0152226 A1...and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 13-15, 19, 21, and 23, as best understood, are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 2019/0357825 A1), hereinafter “Chen”, in view of Kane et al. (US PAT 5,681,532 A), hereinafter “Kane”, and Bentsen et al. (US 2009/0124875 A1), hereinafter “Bentsen”.
Regarding Claim 13, Chen teaches an optical sensor for detecting a target present in a sample fluid (Fig. 1A-B), comprising:
a detection chamber configured to receive the sample fluid (Fig. 1B: “testing chamber” – See also para. [0064]: “The present invention is applicable to measurements in both the gas and liquid phases...”);
a polymeric optical sensor medium that ([0022]: “Preferably the optically-active substance is a luminophore, especially a fluorophore and/or the matrix material is or comprises a polymer.” – [0078]: “For example, FIG. 1A shows a PMMA based polymer (matrix material) sensing film (about 2 μm thickness), containing CNTs and an optically-active substrate (PtOEP).”)
is disposed within the detection chamber and has an inner surface configured to contact sample fluid present in the detection chamber ([0091]: “During the experiment, the fiber optic oxygen sensor was inserted into the testing chamber...” – As the testing chamber is filled with a fluid such as liquid or gas, the sensor further disposed therein thereby contacts said fluid occupying the same common space. – See also Fig. 8A specifically showing the sensor tip in the chamber.), and an outer surface disposed against an inner surface of a planar first wall of the detection chamber (As the testing chamber of Chen comprises a hollow interior for holding the sample, the walls of said testing chamber thereby comprise an outer surface (the exterior surface facing the surroundings of the device) disposed against an inner surface (the interior surface facing the sample).),
is at least semi-permeable to the target ([0028]: “...the presence of the CNTs will increase the free volume of the matrix, therefore the permeability (or diffusivity and the solubility) of the matrix is increased. This allows fluid analytes, e.g. gases such as oxygen, to diffuse in and out of the matrix material (i.e. increasing oxygen permeability), thus interacting with the optically-active substance.”),
comprises a luminescent reagent that is covalently bound to a polymer of the polymeric optical sensing medium ([0051]: “The optically-active substance is typically bonded to or blended with the polymer.”) and is configured to generate an optical signal indicative of a presence of the target within the optical sensor medium when the optical sensor medium is irradiated with excitation light from an excitation source ([0005-0006]: “A short pulse of excitation light from a LED is transmitted along a fiber optic light guide to excite a luminescent dye that is immobilized in the sensing matrix at the sensor tip. The resulting emission of luminescent light, quenched by the presence of oxygen molecules, travels back up the fiber and is detected by a detector. The lifetime and intensity of emitted fluorescence are inversely proportional to the concentration of gaseous or dissolved oxygen according to the Stern-Volmer relation.” – [0082]: “The presence of the analyte alters the emission in a way that enables the concentration of analyte to be determined.” – Further, regarding the recitation “when the optical sensor medium is irradiated”, this is drawn to a conditional process recitation that is not necessitated by the claim. Applicant may wish to amend the claim to recite “in response to” instead of “when”.), and
(v) comprises an optical isolating agent configured to absorb or scatter light at the excitation wavelength ([0009]: “The present inventors have made the surprising finding that the time response of optical sensors can be significantly improved by including carbon nano-tubes (CNTs) in the sensing matrix, without any loss of sensitivity.” – CNTs absorb light at 475 nm (the excitation wavelength), as is further evidenced through the discussion in para. [0029] discussing small-diameter CNTs which are known to have a band gap in the blue-green region of the visible spectrum (about 2.6 eV) and thereby absorb strongly at 475 nm.) whereby the optical sensing medium has a transmittance of about 20% or less at the excitation wavelength along an axis oriented normal to the outer surface of the optical sensor medium (Chen teaches a broad range of CNT concentration in the medium ([0053]), as well as varying thicknesses of the sensing matrix film ([0061]) so as to achieve maximized sensitivity of the sensor device. As such, one of ordinary skill in the art would find it obvious that Chen is optimized to a particular transmittance, such as including the claimed about 20%, so as to enable a maximal utilization of the incident light for the sensing, and to ensure the transmitted light to the sensor falls within a workable detection range of the sensor so as to avoid sensor saturation.)
as in Claim 13.
Further regarding Claim 13, Chen does not specifically teach the optical sensor discussed above further comprising (iv) an optical reference that is covalently bound to a polymer of the polymeric optical sensing medium and is configured to generate an optical signal generally independent of the presence of the target within the optical sensor medium when the optical sensor medium is irradiated with light from an excitation source, as in Claim 13
However, Kane teaches a respective optical sensor having a matrix/dye composition allowing for an optical signal emitted from dye molecules in response to irradiation with excitation light to be utilized for measuring oxygen concentration (col. 4, line 35: “...an oxygen-permeable membrane for use in such a sensor, which comprises a polymeric matrix of a cured perfluorinated urethane polymer, and, incorporated therein, an oxygen-sensitive indicator component and a reference dye component.”). Therein, the device of Kane utilizes an indicator dye sensitive to the target analyte, and a reference dye, both of which may be covalently bound to the matrix (col. 9, line 55: “The oxygen-sensitive indicator and the reference dye will generally be physically entrapped within the polymeric matrix, but it may also be covalently bound thereto.”), and wherein the ratio of the emission intensity of the indicator dye to the reference dye is indicative of the target analyte concentration, thereby correcting for external factors such as temperature (col. 4, line 30: “...the apparent quantity of oxygen present in the fluid is corrected for variation in external factors by determining the ratio of the oxygen indicator emission signal to the reference dye emission signal.”).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the optical sensor of Chen to further include (iv) an optical reference that is covalently bound to a polymer of the polymeric optical sensing layer and is configured to generate an optical signal generally independent of the presence of the target within the optical sensor medium when the optical sensor medium is irradiated with light from an excitation source, such as suggested by Kane, so as to correct for external factors/environmental variation, thereby improving accuracy.
Further regarding Claim 13, Chen does not specifically teach the optical sensor discussed above wherein the detection chamber comprises a generally planar first wall that is transparent at an excitation wavelength of 475 nm, as in Claim 13.
However, Bentsen teaches a respective optical sensor device wherein a detection chamber is formed by coating a recognition element 102 and a transducing element 104 (Fig. 1: together forming the sensing element 110 -- impregnated with chemicals to detect creatine and transduce the detected signal) are formed as a detection chamber by application of an overcoat layer 214 and backing layer 212 (planar first wall) forming substantially planar walls about the sensing element 110 (Fig. 2). Therein, the backing layer 212 (the planar first wall) is transparent at an excitation wavelength of 475 nm (Given that Fig. 2 shows the optical excitation assembly 206 adjacent the backing layer 212 for shining light through the backing layer 212 and into the sensing element 110 for sensing, and para. [0148] discloses that a wavelength of 475 nm is used for excitation of the sensing element 110.). Further, Chen discloses “Advantageously, at the excitation wavelengths used (e.g. a peak wavelength of around 400 nm to 500 nm)...”. These wavelengths correspond to most common fluorophores.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Chen wherein the detection chamber comprises a generally planar first wall that is transparent at an excitation wavelength of 475 nm, such as suggested by Bentsen, as a mere obvious alternative arrangement to the fiber-coupled optical excitation and emission of Chen achieving the identical function of exciting a sample and collecting the emitted fluorescent light, and wherein Chen and Bentsen commensurately disclose excitation wavelength in the 475 nm range.
Regarding Claim 14, the prior art meets the limitations of Claim 13 as discussed above. Further, Chen teaches the optical sensor discussed above wherein the optical sensor medium has a thickness in a dry state, of about 75 μm or less ([0061] – See further the 35 USC 112 section above regarding the excitation source as an inferentially claimed prospective workpiece not provided a particular orientation to establish the claimed optical axis.), as in Claim 14.
Regarding Claim 15, the prior art meets the limitations of Claim 13 as discussed above. Further, Chen teaches the optical sensor discussed above wherein the optical sensor medium has a thickness in the dry state, of at least about 20 μm ([0061] – See further the 35 USC 112 section above regarding the excitation source as an inferentially claimed prospective workpiece not provided a particular orientation to establish the claimed optical axis.), as in Claim 15.
Regarding Claim 19, the prior art meets the limitations of Claim 13 as discussed above. Further, Chen teaches the optical sensor discussed above wherein the optical isolating reagent comprises carbon black, carbon nanostructures, and/or a non-fluorescent dye ([0009]: “The present inventors have made the surprising finding that the time response of optical sensors can be significantly improved by including carbon nano-tubes (CNTs) in the sensing matrix, without any loss of sensitivity.” – Carbon nanotubes are carbon nanostructures.), as in Claim 19.
Regarding Claim 21, the prior art meets the limitations of Claim 13 as discussed above. Further, Chen teaches the optical sensor discussed above wherein the sample fluid comprises blood, plasma, or serum ([0015]: “the sample is blood”), as in Claim 21.
Examiner further notes that the “a sample fluid” of Claim 13 is recited by way of a capability of the optical sensor (“for detecting”) and is thereby not a positively claimed element. Thus, the requirements of Claim 21 regarding the sample fluid represent a mere intended workpiece of the device using the sample fluid. Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II).
Regarding Claim 23, the prior art meets the limitations of Claim 13 as discussed above. Further, Chen teaches the optical sensor discussed above wherein the target is selected from a group consisting of Ca++, K+, Na+ or H+, creatinine, lactate and glucose ([0025]: “analytes such as oxygen, glucose or hydrogen ions”), as in Claim 23.
Further, similarly as above regarding Claim 21, Examiner notes that the “a target” of Claim 13 is recited by way of a capability of the optical sensor (“for detecting”) and is thereby not a positively claimed element. Thus, the requirements of Claim 23 regarding the target represent a mere intended workpiece of the device using the target. Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Kane and Bentsen, as applied to Claims 13-15, 19, 21, and 23 above, and in further view of Gee et al. (US 2006/0024833 A1), hereinafter “Gee”.
Regarding Claim 17, the prior art meets the limitations of Claim 13 as discussed above. Further, Chen does not specifically teach the optical sensor discussed above wherein the luminescent reagent comprises a first moiety configured to interact with the target, a second moiety comprising a fluorescent moiety, and a linker by which the luminescent reagent is covalently bound to the polymer and wherein the linker is disposed between the first moiety and the second moiety or is disposed on the first moiety, as in Claim 17.
However, Gee teaches a respective optical sensor having a matrix/dye composition allowing for an optical signal emitted from dye molecules in response to irradiation with excitation light to be utilized for the determination of the concentration of target analytes in a solution ([0157]) wherein the dye is provided as a first moiety configured to interact with the target (“ion sensing moiety”), a second moiety comprising a fluorescent moiety (“reporter moiety”), and a linker (“spacer or linker between the sensing and reporter moieties”) – see para. [0088]. Therein, this arrangement provides a modular dye structure capable of optimization for the detection of particular or different targets through changing of the first/sensing moiety ([0015]), such as for ion sensing as in Gee. – See further para. [0078, 0093] regarding the first moiety being a ring structure as in the Claim Interpretation section above.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the optical sensor of Chen wherein the luminescent reagent comprises a first moiety configured to interact with the target, a second moiety comprising a fluorescent moiety, and a linker by which the luminescent reagent is covalently bound to the polymer and wherein the linker is disposed between the first moiety and the second moiety or is disposed on the first moiety, such as suggested by Gee, so as to provide a modular dye structure capable of optimization for the detection of particular or different targets through changing of the first/sensing moiety, thereby allowing the device to be used for detecting and quantifying a greater variety of target analytes.
Regarding Claim 18, the prior art meets the limitations of Claim 17 as discussed above. Further, as discussed above regarding Claim 17, one skilled in the art would find it obvious to modify the optical sensor of Chen with the dual linked moieties of Gee so as to provide for detection of a greater variety of target analytes. Therein, Chen teaches the first moiety as configured to chelate a target ([0013-0015]), thereby providing a structure for the detection of ions in solution. – See further para. [0078, 0093] regarding the first moiety being a ring structure as in the Claim Interpretation section above.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when modifying the optical sensor of Chen with the dual linked moieties of Gee, to provide the first moiety as a chelator, such as suggested by Gee, so as to provide a sufficient structure for the detection of ions in solution, as similarly contemplated by Chen ([0065]).
Response to Arguments
35 USC 112
Applicant’s remarks and amendments submitted 03/23/2026 sufficiently overcome the 35 USC 112(b) rejections of Claims 13-19, 21, and 23 as indefinite. As such, those rejections under 35 USC 112(b) are withdrawn.
35 USC 103
Applicant’s arguments are on the alleged grounds that Chen teaches a sensor configured for a decreased response time, whereas the claimed transmittance of about 20% or less at 475 nm would unfavorably increase the response time of Chen.
Applicant’s arguments are not persuasive because Chen discusses a range of wavelengths used including 475 nm, and the newly added prior art of Bentsen provides for a 475 nm transparent sensor sidewall, as 475 nm is a wavelength of excitation of many common fluorophores, as discussed above in the body of the action.
Further, reducing the transmittance would not necessarily reduce the response time in Chen as such a transmittance level is not specifically excluded by Chen, and is thereby expected to remain in a workable range of Chen as optimized by an operator. In optical sensors, transmittance is the amount of light that reaches the sensing element. If transmittance is high, more light passes through, which can cause the sensor to saturate or respond more slowly due to internal signal processing limits. Lowering transmittance reduces the signal intensity, which can help the sensor operate in a more linear, dynamic range, and avoid saturation effects. As the claims do not specify an intensity of the incident light, Chen may be used at a range of incident intensities as optimized to allow the detected signal to fall within an optimal detection range of Chen, thereby overcoming any drops in response time due to a more opaque/absorbative medium.
Thus, Examiner sets forth the rejection of Claims 13-15, 19, 21, and 23 over Chen in view of Kane and the newly cited prior of Bentsen, as necessitated by Applicant’s amendments specifying a wall of the sample chamber be transparent to 475 nm light.
Applicant further argues that the additional prior art of Shahriari and Gee fail to provide for the newly claimed transmittance of 20% or less at 475 nm. However, as discussed above, the 475 nm aspect is common among widely used fluorophores and is further specifically provided through Bentsen, and the 20% transmittance would be obvious to one of ordinary skill in the art to optimize such that the light reaching the sensor is within the detection range of the sensor.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
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