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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2-4 and 12-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 2 and 12 recite “the edge coupling further comprises a grating coupling”, which is new matter. At most, paragraph [0049] of the Applicant’s specification recites the couplings in the alternative (“a photodetector may receive the output signal using a vertical coupling, edge coupling, a grating coupler, or any couplers thereof”). However, there is no indication of an edge coupling further comprising a grating coupler.
Claims 3-4 and 13-14 are rejected by virtue of their dependence from claims 2 and 12, respectively.
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 1-10 and 12-14 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.
Claim 1 recites “the apparatus” in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the recitation will be interpreted to be “the device”. Claims 2-10 recite “The apparatus” in line the preambles, which will be interpreted to be “The device”.
Claims 2-10 are rejected by virtue of their dependence from claim 1.
Claim 2 recites “the edge coupling further comprises a grating coupling” in line 2. An optical edge coupling appears to be mutually exclusive from a grating coupling. See ¶ [0049] of the Applicant’s specification which recites the couplings in the alternative (“a photodetector may receive the output signal using a vertical coupling, edge coupling, a grating coupler, or any couplers thereof”). Additionally, one of ordinary skill in the art would not understand how an edge coupling comprises a grating coupling. For the purposes of examination, the recitation will be interpreted such that the edge coupling is replaced with a grating coupling. Claim 12 recites a similar limitation, so it is rejected on similar grounds.
Claim 3 recites “the housing” in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the recitation will be interpreted to be “a housing”. Claims 4, 13, and 14 recite the same limitation, so the claims are rejected on the same grounds.
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.
Claims 1-2, 6-7, 10-12, 16-17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0103884 A1 (Delamarche) (previously cited) in view of US 2015/0024507 A1 (Han) (Previously cited) and Edge Couplers in Silicon Photonic Integrated Circuits: A Review (Mu).
With regards to claims 1 and 11, Delamarche teaches a multipurpose fluid extraction device for diagnostics and a method of use (Fig. 3 and ¶ [0006] disclose a method for monitoring bone implant health using a diagnostic apparatus; ¶ [0007] describes the diagnostic patch apparatus; also see ¶ [0101]), the apparatus comprising: a fluid extraction system, wherein the fluid extraction system is configured to extract a fluid from a user (Fig. 3 and ¶ [0057] depict one or more microneedles 314; ¶ [0058] discloses extraction of sample fluid through the microneedles); a microfluidic assembly, wherein the microfluidic assembly is configured to provide a flow of the extracted fluid (Fig. 3 depicts a sample pump 318; Fig. 5 and ¶ [0058] depict a sample pump 318 in the form of a multiple pumping microchannels 500 to enhance capillary action to suction fluid through an input microchannel 502), wherein the microfluidic assembly comprises a microfluidic channel (Fig. 5 and ¶ [0058] depict an input microchannel 502); a sensor, wherein the sensor is configured to output a sensor signal to a reader device (Figs. 3 and 6 and ¶ [0066] depict at least one sensor 340, each sensor 340 having a corresponding electrical lead 341 for connection with the reader module; ¶ [0068] depict sensors 340 sensing one or more of various analytes; Figs. 3 and 8 and ¶ [0069] depict the reader module 306 having one or more sensor interfaces 368 to connect to the electrical leads 341 and to read the sensor outputs); a reader device, wherein the reader device is configured to detect one or more characteristics of the extracted fluid as a function of the sensor signal (¶ [0056] depicts the reader module 306 obtains measurements from the analysis module 304 (which includes the sensors 340) and facilitates processing of the measurements to assess a patient’s diagnostic status; ¶ [0076] discloses that based on the sensor readings, the reader module 306 determines possible presence of synovial cavity infection using microprocessor 376); an assay component fluidically connected to the microfluidic assembly, wherein the assay component is configured to test the extracted fluid (Figs. 3 and 6 and ¶ [0066] depict at least another sensor 340 in fluid communication with sample chamber 322 via fluid conduit 342; ¶ [0058] depict sample chamber 322 in fluid communication with sample pump 318; ¶ [0075] discloses that the sensor suite may include two or more electrodes for electrochemical detection of analytes, e.g., electrochemical immunoassay); and a fluid collecting reservoir fluidically connected to the microfluidic assembly, wherein the fluid collecting reservoir is configured to collect the extracted fluid from the microfluidic assembly (Fig. 3 and ¶ [0063] depict a sponge or overflow volume 332 in fluidic communication with the sample chamber 322; ¶ [0058] depict sample chamber 322 in fluid communication with sample pump 318).
Delamarche is silent regarding whether the sensor is a photonic sensor configured to output a sensor signal to a reader device.
In the same field of endeavor of monitoring blood samples (¶ [0003] of Han), Han teaches a photonic sensor for monitoring biomarkers (¶ [0044] depict an immunodiagnostic sensor/detector including at least one optical microring resonator) and configured to output a sensor signal to a reader device (¶¶ [0011], [0047] and Fig. 1B disclose the optical resonator and waveguide optically connected to at least one photodetector, a processor in electronic communication with the at least one photodetector, an a controller in communication with the processor), wherein the reader device is configured to detect one or more characteristics of the extracted fluid as a function of the sensor signal of the photonic sensor (¶ [0053] discloses the processor can convert analysis signals to at least one value representative of a measurement of the resonant wavelength shift which can be used to calculate a concentration of at least one biomarker in the sample). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted one of the sensors of Delamarche with the photonic sensor of Han. Because both elements are capable of detecting biomarkers in a blood sample (¶ [0008] of Han; ¶ [0068] of Delamarche), it would have been the simple substitution of one known equivalent element for another to obtain predictable results. Additionally, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the reader device of Delamarch to incorporate that it is configured to receive to detect one or more characteristics of the extracted fluid as a function of the sensor signal of the photonic sensor as taught by Han. The motivation would have been to provide the reader device with the ability to analyze the signals from the photonic sensor to arrive at concentration measurements.
Although Han teaches the photonic sensor is configured to be optically coupled to an optical input source and a reader device (¶ [0011] discloses the waveguide optically coupled to an optical input source and at least one photodetector), Han is silent regarding whether the photonic sensor is connected to the reader device using an optical edge coupling.
In a system relevant to the problem of providing optical connections to photonic sensors, Mu teaches a photonic sensor is connected to a device using an optical edge coupling (Page 2, first paragraph discloses using grating couplers or edge couplers to provide optical coupling to photonic waveguides). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate the photonic sensor is connected to the reader device using an optical edge coupling as taught by Mu. The motivation would have been to ensure that the optical energy is coupled efficiently.
With regards to claims 2 and 12, for the purposes of examination, the claim will be interpreted such that the edge coupling is replaced with a grating coupling.
The above combination is silent regarding whether edge coupling is replaced with a grating coupling.
In a system relevant to the problem of providing optical connections to photonic sensors, Mu teaches using either edge coupling or grating coupling for coupling light to photonic waveguides (Page 2, first paragraph discloses using grating couplers or edge couplers to provide optical coupling to photonic waveguides). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the edge coupling of the above combination with a grating coupling as taught by Mu. Because both elements are capable of transmitting and guiding lights to photonic waveguides, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
With regards to claims 6 and 16, the above combination teaches that the microfluidic assembly is further configured to provide the flow of the extracted fluid to the photonic sensor (see the above combination regarding Delamarche in view of Han; see ¶ [0066] of Delamarche which indicates that microchannel 348 connects the sample subchamber 346 to sensor 340).
The above combination is silent regarding whether the flow of the extracted fluid is over the photonic sensor.
In the same field of endeavor of monitoring blood samples (¶ [0003] of Han), Han teaches a flow of fluid over the photonic sensor (Fig. 1A and ¶ [0043] depict surfaces of optical resonators receive flowable medium over them). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microfluidic assembly of the above combination to incorporate that it is configured to provide the flow of the extracted fluid over the photonic sensor as taught by Han. The motivation would have been to provide an optimal configuration of fluid flow for analyzing the fluid using the photonic sensor.
With regards to claims 7 and 17, the above combination teaches or suggests that the photonic sensor comprises a microring resonator (¶ [0044] of Han depict an immunodiagnostic sensor/detector including at least one optical microring resonator).
With regards to claims 10 and 20, the above combination teaches or suggests the fluid collecting reservoir is further configured to passively pump the extracted fluid for the flow of the extracted fluid of the microfluidic assembly (¶ [0063] of Delamarche teaches a sponge or overflow volume 332 comprising a microchannel for allowing the fluid to continue to flow through the sample chamber 322).
Claims 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Delamarche in view of Han and Mu, as applied to respective claims 2 and 12 above, and further in view of US 2011/0172508 A1 (Chickering, III) (previously cited).
With regards to claims 3 and 13, the above combination is silent regarding whether the assay component is removably inserted into the housing through a first aperture of the housing.
In the same field of endeavor of sampling and diagnostic devices, Chickering, III teaches an assay component is removably inserted into a housing through a first aperture of the housing (¶ [0130] discloses a user may need to insert a test strip in a device (and optionally, withdraw and replace the test strip between uses), wherein the insertion necessarily requires insertion through an aperture or opening). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the patch of the above combination to incorporate an assay component is removably inserted into a housing through a first aperture of the housing as taught by Chickering, III. The motivation would have been to allow for the assay component to be replaced between uses (¶ [0130] of Chickering, III) and/or to allow the test strip to be removed from the device and determined externally (¶ [0130] of Chickering, III).
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Delamarche in view of Han and Mu, as applied to respective claims 2 and 12 above, and further in view of US 2021/0069714 A1 (Jebrail) (previously cited)
With regards to claims 4 and 14, the above combination is silent regarding whether the fluid collecting reservoir is removably inserted into the housing through a second aperture of the housing.
In the same field of endeavor of testing fluid samples, Jebrail teaches a fluid collecting reservoir is removably inserted into the housing through an aperture of the housing (¶ [0266] depicts a wick can be removable and replaceable from the device, such as through a port or opening). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate that the sponge 332 of Delamarche of the above combination is removably inserted into the housing through an aperture of the housing as taught by Jebrail. The motivation would have been to allow for the sponge to be replaced when it is saturated.
The Examiner notes that Delamarche teaches an opening 312 (a first aperture) in Fig. 3 The above combination in view of Jebrail results in a second aperture for removing sponge 332.
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Delamarche in view of Han and Mu, as applied to respective claims 1 and 11 above, and further in view of US 2009/0318834 A1 (Fujiwara) (previously cited).
With regards to claims 5 and 15, the above combination is silent regarding whether the fluid extraction system comprises an optical skin piercing component configured to pierce a skin of the user.
In a system relevant to the problem of collecting fluid samples, Fujiwara teaches a fluid extraction system comprises an optical skin piercing component configured to pierce a skin of the user (¶ [0115] depicts a blood test apparatus using a laser emitting apparatus that can perform puncturing). Fujiwara further teaches a channels for collecting the fluid from the user (Figs. 9-10 and ¶ [0127] depicts blood spreading inside storing part). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the needle and fluid collection scheme of Delamarche of the above combination with the optical skin piercing component and fluid collection scheme of Fujiwara. Because both elements are capable of piercing skin and collecting a fluid sample (¶¶ [0125], [0127] of Fujiwara; Fig. 3 and ¶¶ [0057], [0058] of Delamarche), it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
Claims 8-9 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Delamarche in view of Han and Mu, as applied to respective claims 1 and 11 above, and further in view of US 2021/0318300 A1 (Miller) (previously cited)
With regards to claims 8 and 18, the above combination is silent with regards to whether the assay component comprises a lateral flow assay.
In a system relevant to the problem of detecting analytes in a fluid sample, Miller teaches an assay component comprising a lateral flow assay (¶ [0114] teaches a lateral flow assay for testing a fluid sample). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the assay component of Delamarche to incorporate that it is a lateral flow assay. Because both elements are capable of detecting components in a sample (¶ [0114] of Miller; ¶ [0075] of Delamarche), it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
With regards to claims 9 and 19, the above combination is silent with regards to whether the photonic sensor is further configured to detect a change in the lateral flow assay of the assay component.
In a system relevant to the problem of detecting analytes in a fluid sample, Miller teaches a photonic sensor is further configured to detect a change in the lateral flow assay of the assay component (¶ [0114] discloses using ring resonators to detect the result of a lateral flow assay). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate that the photonic sensor is further configured to detect a change in the lateral flow assay of the assay component as taught by Miller. The motivation would have been to reduce sample volume, simplify operation, deliver a simple readout, or improve re-usability (see ¶ [0012] of Miller).
Response to Arguments
Objections to the Drawing
In view of the amendments to the drawing filed 05/20/2026, the drawing objections were withdrawn.
Objections to the Specification
In view of the amendments to the specification field 05/20/2026, the objections to the specification were withdrawn.
Rejections under 35 U.S.C. §112(b)
There are new grounds of rejections under 35 U.S.C. §112(b) necessitated by the claim amendments filed 05/20/2026.
Rejections under 35 U.S.C. §103
Applicant's amendment and arguments filed 05/20/2026 with respect to the 35 USC 103 rejections set forth in the Non-Final Rejection mailed 11/20/2026 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Mu. The previously applied 103 rejection has been modified to incorporate the teachings of Mu.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL C KIM whose telephone number is (571)272-8637. The examiner can normally be reached M-F 8:00 AM - 5:00 PM EST.
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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