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 filed on March 2nd, 2026. Claims 1-6, 9, and 11-18 are pending. Claims 7, 9, 10, 19, and 20 are canceled.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 2nd, 2026 has been entered.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the multiplexor as in cls. 2&12 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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, 3-5, 8, 11, 13-15, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bailey et al. (US 2013/0261010), hereafter Bailey, in view of Najar (USPN 11,079,376).
With regard to claim 1 Bailey, discloses a non-invasive testing device comprising an input 1104 configured to receive a sample, at least a microfluidics channel 502 fluidically connected to the input (see pars.[0028,0073,0108,0269,0356], figs. 5, 11, for example), and wherein Bailey further discloses at least a first waveguide 202/208 (i.e. a first one in the array as seen in fig. 9) in fluidic communication with the input via the at least a microfluidics channel and configured to propagate a first EM wave and vary a first optical property (configured to/ varying refractive index as in cls. 5/15) as a function of the sample, at least a second optical waveguide 202/208 (i.e. a second one in the array in fig. 9) in fluidic communication with the input and configured to propagate a second EM wave and vary in a second optical property as a function of the sample (pars.[0005,0016,0056] refractive index and comprising a ring resonator 208 as in cls. 3/13; see also par.[0039] with respect to antibody-functionalized microring resonators). Further, as in cl. 1, Bailey discloses at least a sensor 925 (photodetector/EM sensor) in communication with the at least a first waveguide and the at least a second waveguide and configured to detect as recited therein as Bailey provides for multiplexed analysis of first and second constituents of the sample by utilizing different capture probes to each of the waveguides in the array (pars.[0028,0056,0074-0076,0100-0103,0108-0114,0162], figs. 1, 9, 11, 25, for example). Likewise to the above, Bailey discloses the application of the above-discussed functioning structural elements as in the recited method of claim 11. With regard to claims 4 and 14, the at least a first waveguide is configured to provide communication between the first EM wave and a portion of the sample by propagating an evanescent wave from a surface (par.[0016,0039], for example). With regard to claims 8 and 18, the device is configured to contain a first marker wherein the first marker is configured to selectively conjugate the first antigen and vary the first optical property (par.[0168]; Examiner notes that the marker itself has not been claimed and the recitation is drawn to the capability of the microfluidic device contain such, which is provided by Bailey, wherein at least the spatial confines of the device of Bailey afford the ability to contain a marker as claimed).
With regard to claim 1, Bailey does not specifically disclose wherein a first surface of the at least a first waveguide is coated with a capture antibody configured to selectively bind to a SARS-CoV-2 antigen and vary the first optical property.
With regard to claim 11, Bailey does not specifically disclose wherein a first surface of the at least a first waveguide is coated with a capture antibody configured to selectively bind to a SARS-CoV-2 antigen and vary the first optical property.
Najar discloses detecting COVID-19 infection using a silicon photonic biosensor device in which the transition metal dichalcogenide monolayer, which is embedded in the optical layer and defines a bottom wall of the open cell, is functionalized with a capture antibody for selectively binding to SARS-Cov-2 virus in a cavity of the device above a reference microring resonator and wherein the microring resonator is coupled thereto the metal dichalcogenide monolayer(resonators shown as itmes 22-28 within respective cavities/cells 14-20) optically coupled to the waveguide (i.e. items 56-62) (abstract; lines 4-17, col. 2, cl. 13, fig 1, for example).
It would have been obvious to one of ordinary skill in the art to modify Bailey to provide a first surface the at least a first waveguide is coated with a capture antibody configured to selectively bind to a SARS-CoV-2 antigen as in cls. 1/11 such as suggested by the analogous art of Najar to a photonic biosensor provided with functionalization by a capture antibody in adjacent communication with a microring resonator, in which Bailey is likewise drawn to providing antitbody(ies) to microring resonator(s) for assessing an immunoassay and the provision for SARS-CoV-2 affords a further application and functionality to the photonic biosensor of Bailey that is clinically relevant, and related to the immunoassay application discussed therein (pars.[0005,0039,0151]), and wherein provision to provide the functionalization to a first surface of the at least one first waveguide represents an obvious engineering design choice to provide the arrangement as in Bailey and one in which likewise affords the opto-fluidic communication for ascertaining a binding event thereat, and would have a reasonable expectation of success therein.
Claim(s) 2 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bailey in view of Najar, as applied above to claims 1, 3-5, 8, 11, 13-15, and 18, and in further view of Lear et al. (US 2015/0268162), hereafter Lear.
Bailey/Najar does not specifically disclose that the device further comprises a multiplexor in communication with the at least a first waveguide, the at least a second waveguide, and the sensor as recited in claims 2 and 12.
Lear discloses a multi-analyte optical sensor having an optical waveguide with a light source for providing light to the waveguide and a photodetector sensor for detecting light therethrough (abstract). Lear further discloses a multiplexor in communication with the waveguide and photodetector sensor for selectively coupling to various contacts that correlate to various detection zones that are differently sensitized to first, second, third, and fourth analytes so as to readout signal results for the desired, respective analyte(s) (pars.[0003,0030,0039], for example).
It would have been obvious to one of ordinary skill in the art to modify Bailey/Najar to further include a multiplexor as recited in claims 2 and 12 such as suggested by the analogous art of optical waveguide biosensing and wherein Lear is likewise concerned with multiplexing and analysis of multiple, different analytes (pars.[0006,0162]) in which such a multiplexor provides the realized benefit to these ends and affording the ability to selectively readout desired detection zones for their respective target analyte.
Claim(s) 6 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bailey in view of Najar, as applied above to claims 1, 3-5, 8, 11, 13-15, and 18, and in further view of Lear.
Bailey/Najar does not specifically disclose that the at least a first waveguide is configured to provide communication between the first EM wave and a portion of the sample by propagating surface plasmons upon a surface.
Lear discloses a multi-analyte optical sensor (abstract). Lear discloses that evanescent field optical waveguide sensor devices include those of Mach-Zender interferometers, ring resonators, as well as similar application with surface plasmon sensors which also provide a sensing mechanism with evanescent fields (par.[0006], for example).
It would have been obvious to one of ordinary skill in the art to modify Bailey/Najar to provide a first waveguide is configured to provide communication between the first EM wave and a portion of the sample by propagating surface plasmons upon a surface such as suggested by Lear in order to provide an obvious, alternative sensing infrastructure to Bailey which likewise discloses an optical waveguide sensor utilizing a sensing mechanism with evanescent fields and in which utilizing of such a first waveguide configured to propagate surface plasmons would have a reasonable expectation of success for the likewise desired purpose as in Bailey/Najar.
Claim(s) 1-5, 8, 11-15, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jakubowicz et al. (US 2024/0001358), hereafter Jakubowicz, in view of Glanville et al. (USPN 11,021,532), hereafter Glanville.
Jakubowicz discloses a diagnostic photonic biosensor apparatus, method, and system (abstract). With regard to claim 1, Jakubowicz discloses an input 106 configured to receive a sample, at least a first waveguide in fluidic communication with the input (within section ‘104’ to the photonic integrated circuit (PIC); figs. 1a,b, pars.[0006-0009], for example, in which the PIC includes at least one waveguide [multiple shown as in figs. 4a,b] and at least one detection element [i.e. ring resonator(s) as the sensor(s)] provided along the at least one waveguide and positioned to contact fluid within the fluid pathway at the section of the sample detection zone). Jakubowicz further discloses that the at least a first waveguide 210a is configured to propagate a first EM wave and vary in a first optical property as a function of the sample; Jakubowicz further discloses at least a second waveguide 210b (and comprising a ring resonator as in one of 212c, 212d of fig. 4A as in cls. 3/13; further note additional single and multi-channel embodiments as in fig. 9B) in fluidic communication with the input and configured to propagate a second EM wave and vary in a second optical property as a function of the sample (pars.[0007,0009,0010,0067], and in the at least one first waveguide varying refractive index as a function of the sample, and in the second at least one first waveguide varying refractive index as a function of the sample as in cls. 5/15, wherein the claimed recitations do not preclude such nominally designated “first” and “second” optical properties being the same. Jakubowicz further discloses at least a sensor (a detector as in fig. 5 VII, par.[0068] in which the light source and detector are in communication with the at least a first optical waveguide and the at least a first second optical waveguide). Jakubowicz further discloses functionalizing a surface of the detection elements (as in a first surface of the at least a first waveguide as claimed) to provide an antigen-functionalized ring(s) configured to selectively bind to a SARS-CoV-2 antibody and vary the first optical property, and in detecting first and second constituents of the sample from the EM waves propagated along the at least a first waveguide and at least a second waveguide (pars.[0095,0097,0098,0101,0106], fig. 13, for example). Examiner asserts that Jakubowicz likewise provides for the application of the system as in the method of clam 11 as seen through the disclosure cited above.
With regards to claims 2/12, Jakubowicz discloses the device further comprises a multiplexor in communication with the at least a first waveguide the at least a second waveguide, and the sensor, wherein the multiplexor is configured to multiplex the first EM wave and the second EM wave (pars.[0009,0066,0082], fig. 3B, 9B, for example, given by the connections established by way of an array of photonic integrated circuits and the fixture 902b).
With regards to claims 4/14, Examiner assert that an optical ring resonator waveguide biosensor, which is disclosed by Jakubowicz, inherently involves such evanescent field propagation capability with respect to a first waveguide providing communication from the EM wave and a portion of the sample as recited herein.
With regards to claims 8/18, the device of Jakubowicz is further configured to contain a first marker, wherein the first marker is configured to selectively conjugate the first antigen and vary the first optical property, wherein Examiner asserts that the device of Jakubowicz affords within its spatial confines that capability of containing a first marker, and further noting that the marker itself is not a positively claimed element and is drawn to a prospective workpiece not afforded patentable weight.
With regard to claim 1, Jakubowicz does not specifically disclose wherein a first surface of the at least a first waveguide is coated with a capture antibody configured to selectively bind to a SARS-CoV-2 antigen and vary the first optical property.
With regard to claim 11, Jakubowicz does not specifically disclose wherein a first surface of the at least a first waveguide is coated with a capture antibody configured to selectively bind to a SARS-CoV-2 antigen and vary the first optical property.
Glanville discloses a device and method for diagnosing a subject as being infected with a SARS-CoV-2 virus, wherein the subject’s sample is contacted with an SH antibody of antigen-binding fragment that selectively binds to SARS-CoV-2, and samples may be tested in any suitable assay form such as in ELISA, lateral flow assay, IHC, etc. wherein the sample is contacted with antibody that selectively binds to SARS-CoV-2 (lines 7-22, col. 4; lines34-48, col. 49, for example).
It would have been obvious to one of ordinary skill in the art to modify Jakubowicz to provide a first surface of the at least a first waveguide is coated with a capture antibody configured to specifically bind to SARS-CoV-2 antigen such as taught by Glanville in order to provide an obvious and complementary immunoassay scheme in which Jakubowicz discloses a capture antigen functionalized ring(s) configured to selectively bind to a SARS-CoV-2 antibody and vary the first optical property so as to afford an ability to assess a convalescent ‘COVID’ patient (or patient that has taken the vaccine) for their immune response and development of antibodies to SARS-CoV-2 and the reverse approach as in utilizing a capture antibody provides a complementary and further clinically-relevant format and assay scheme that yields a more complete assessment in that it affords a patient to be diagnosed as being infected with SARS-CoV-2 in the binding of SARS-CoV-2 antigens to the capture antibody, and wherein such implementation would have a reasonable expectation of success therein for a similar and complementary approach.
Claim(s) 2 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jakubowicz in view of Glanville as applied above to claims 1-5, 8, 11-15, and 18, and in further view of Lear et al. (US 2015/0268162), hereafter Lear.
Jakubowicz/Glanville has been discussed above.
If Jakubowicz is taken as not specifically disclosing that the device further comprises a multiplexor in communication with the at least a first waveguide, the at least a second waveguide, and the sensor as recited in claims 2 and 12 (cited above as in pars.[0009,0066,0082], fig. 3B, 9B, for example, given by the connections established by way of an array of photonic integrated circuits and the fixture 902b) , than such a modification would have been obvious to one of ordinary skill in the art.
Lear discloses a multi-analyte optical sensor having an optical waveguide with a light source for providing light to the waveguide and a photodetector sensor for detecting light therethrough (abstract). Lear further discloses a multiplexor in communication with the waveguide and photodetector sensor for selectively coupling to various contacts that correlate to various detection zones that are differently sensitized to first, second, third, and fourth analytes so as to readout signal results for the desired, respective analyte(s) (pars.[0003,0030,0039], for example).
It would have been obvious to one of ordinary skill in the art to modify Jakubowicz/Glanville to further include a multiplexor as recited in claims 2 and 12 such as suggested by the analogous art of optical waveguide biosensing and wherein Lear is likewise concerned with multiplexing and analysis of multiple, different analytes (pars.[0006,0162]) in which such a multiplexor provides the realized benefit to these ends and affording the ability to selectively readout desired detection zones for their respective target analyte.
Claim(s) 6 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jakubowicz in view of Glanville as applied above to claims 1-5, 8, 11-15, and 18, and in further view of Lear.
Jakubowicz/Glanville has been discussed above.
Jakubowicz/Glanville does not specifically disclose that the at least a first waveguide is configured to provide communication between the first EM wave and a portion of the sample by propagating surface plasmons upon a surface.
Lear discloses a multi-analyte optical sensor (abstract). Lear discloses that evanescent field optical waveguide sensor devices include those of Mach-Zender interferometers, ring resonators, as well as similar application with surface plasmon sensors which also provide a sensing mechanism with evanescent fields (par.[0006], for example).
It would have been obvious to one of ordinary skill in the art to modify Jakubowicz/Glanville to provide a first waveguide is configured to provide communication between the first EM wave and a portion of the sample by propagating surface plasmons upon a surface such as suggested by Lear in order to provide an obvious, alternative sensing infrastructure to Jakubowicz/Glanville which likewise discloses an optical waveguide sensor utilizing a sensing mechanism with evanescent fields and in which utilizing of such a first waveguide configured to propagate surface plasmons would have a reasonable expectation of success for the likewise desired purpose as in Jakubowicz/Glanville.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-8 and 11-18 have been considered but are moot because the new ground of rejection in view of the amendments provided to the claims.
As discussed above, herein claims 1, 3-5, 8, 11, 13-15, and 18 are rejected under 35 USC 103 as being unpatentable over Bailey in view of the newly-applied prior art of Najar, wherein Najar provides analogous subject matter to photonic biosensors and obvious modification to Bailey for the herein-claimed “wherein a first surface…is coated with…a capture antibody…to SARS-CoV-2…” as in claims 1 and 11.
The remaining dependent claims are rejected as discussed above in the body of the claims.
Further, as discussed above, claims 1-5, 8, 11-15, and 18 are rejected under 35 USC 103 as being unpatentable over newly-adpped Jakubowicz in view of newly-applied Glanville, along with redundant and remaining dependent claims rejected under 35 USC 103 in further view of Lear for the reasons discussed above in the body of the action.
As such, pending claims 1-6, 8, 11-16, and 18 are rejected under 35 USC 103 over the cited art above and in the body of the action.
Further, the Drawings are objected to for the reasons discussed above in the body of the action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEIL N TURK/Primary Examiner, Art Unit 1798
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