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 January 12th, 2026. Claims 1-8 and 11-18 are pending. Claims 9, 10, 19, and 20 are canceled.
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 “at least a microfluidics channel fluidically connected…configured to perform passive flow using a wicking pad…first waveguide in fluidic communication with the input via the at least a [first] microfluidics channel” as in independent claims 1 and 11 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 § 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 1-8 and 11-18 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.
The amended recitations in both of independent claims 1 and 11 to “at least a microfluidics channel fluidically connected…configured to perform passive flow using a wicking pad…first waveguide in fluidic communication with the input via the at least a [first] microfluidics channel” is drawn to new matter in the claims.
These recitations are not supported by the disclosure.
Applicant’s remarks of January 12th, 2026 do not offer a particular place within the disclosure that provides this support and Examiner is unable to find support for these recitations upon reviewing the disclosure.
The most pertinent place within the disclosure is found in par.[0031] of the specification within the application as-filed (and concordantly in par.[0042] in Applicant’s pre-grant publication US 2023/0012903). However, no particular support is provided herein for the amended recitations. The discussion within this portion of the disclosure is drawn to general discussion of a disposable cartridge, and wherein open fluid channels in the cartridge precluded aggregated gold particles from causing clogging.
There is further discussion to “[t]he similarity of the assay configuration to lateral flow assays enables an inexpensive, simplified cartridge with completely passive flow driven by a wicking pad. This discussion is narrative in nature and fails to provide for the particular structure of the at least a first microfluidics channel fluidically connected to the input and configured to perform passive flow using a wicking pad and wherein the at least a first waveguide is in fluid communication with the input via the at least a [first] microfluidics channel as claimed.
The latter portion of par.[0031] prophetically offers support to such a cartridge with passive flow by way of Patent No. XX, filed XX, entitled “[]” that is incorporated herein, however the cited patent is wholly unidentified.
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 1-8 and 11-18 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.
The recitations in independent claims 1 and 11 to “the microfluidics channel” lacks proper antecedent basis in the claims.
Examiner asserts that it appears Applicant intends to recite “the at least first waveguide” or the like.
This is likewise seen in claim 1 with respect to “via the at least a microfluidics channel” wherein the descriptor first should be included.
Claims 11-18 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.
The metes and bounds of the active step(s) given to the recited methodology are indefinitely provided herein.
With respect to the amendment of “the microfluidics channel configured to perform passive flow using a wicking pad” it is unclear what further, active step(s), if any, are sought to be a part of the methodology.
The amendment provided that is within the paragraph to the step of “varying…” does not provide further steps to such process of “varying….in a first property as a function of the sample…” as the subsequent amendment is drawn to general discussion of the functional connection of the input to the first waveguide, nor does it provide an actively recited process step as it may relate to the initial “receiving” step.
To this end, the recitation “…the microfluidics channel configured to perform flow using a wicking pad” reads as a functionality of the microfluidics channel and is without positive provision to an added step within the confines of the method.
If Applicant intends an additional or further detail to the step of “receiving,” then the claim should be amended in clear fashion so as to set forth the added active step(s) therein that relate to this amendment.
The recitation itself is also indefinitely provided by way of the indefinite usage of the recitation using a wicking pad, wherein general discussion to the use of a wicking pad indefinitely sets forth the metes and bound of what active step(s) are afforded to provide such “using.”
This is likewise seen with respect to the initial recitation that the “…input is fluidically connected to the first waveguide using at least a microfluidics channel” wherein, in this instance, it appears that Applicant should simply remove the term “using” and provide that the input is fluidically connected to the first waveguide by/with/through at least a microfluidics channel (Examiner further notes that there is a redundant recitation to “at least at least”).
As recited herein, for purposes of prior art, the recitation is interpreted to provide the physical infrastructure of an input fluidically connected to at least a microfluidics channel” wherein it is not required that the prior art provide an active step of passive flow through a wicking pad therein.
Claim Rejections - 35 USC § 102
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 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, 3-5, 7, 8, 11, 13-15, 17, and 18 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Bailey et al. (US 2013/0261010), hereafter Bailey.
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, the microfluidics channel configured to perform passive flow using a wicking pad (Examiner notes that recitation itself is drawn to a functionality of the microfluidics channel and wherein the “using…” is both within the functionality itself and is drawn to a process not afforded patentable weight, nor does it provide a wicking pad as a positively claimed structural element of the testing device, and as Bailey discloses a commensurately structured and arranged ‘at least a first microfluidics channel’ as claimed, it is fully capable of [herein, ‘configured’] those functionalities recited therein) (see pars.[0028,0073,0108,0269,0356], figs. 5, 11, for example). 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 (refractive index and comprising a ring resonator 208 as in cls. 3/13). 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 such as in the recited method of claim 11 in as much as best understood herein, and noting that the present claims do not clearly or actively necessitate any particular active steps to any sought flow introduction/receiving in which a fluid is flown through a microfluidic channel(s) and through a wicking pad therein so as to be passively introduced to the input and fluidically connected first waveguide. 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], for example). With regard to claims 7 and 17, a first surface (as best understood herein) is coated with a capture antibody configured to selectively bind to a first antigen and vary the first optical property (par.[0167,0169]). With regard to claims 8 and 18, the microfluidic device (as best understood herein) 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, and wherein Bailey further discloses a capture probe as a first marker).
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) 2 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bailey in view of Lear et al. (US 2015/0268162), hereafter Lear.
Bailey has been discussed above.
Bailey 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 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 Lear.
Bailey has been discussed above.
Bailey 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 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.
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, claims 1-8 and 11-18 are rejected under 35 USC 112 a/1st as introducing new matter wherein the amendments provided herein are not supported by the disclosure for the reasons discussed therein.
Coincident therewith, the drawings are objected to for the reasons discussed above.
Further, claims 1-8 and 11-18 are rejected under 35 USC 112 b/2nd as being indefinitely defined for the reasons discussed therein.
With regards to claims 1, 3-5, 7, 8, 11, 13-15, 17, and 18 rejected under 35 USC 102a as being anticipated by Bailey, Applicant traverses the rejection.
Applicant asserts that Bailey does not teach or suggest the amendments as in cls. 1 and 11 to “at least a microfluidics channel fluidically connected…configured to perform passive flow using a wicking pad…first waveguide in fluidic communication with the input via the at least a [first] microfluidics channel.”
As discussed above, Examiner asserts that Bailey does not provide disclosure thereto as seen in pars.[0028,0073,0108,0269,0356], figs. 5, 11, for example.
Examiner further notes that with respect to claim 1 the recitation itself is drawn to a functionality of the microfluidics channel and wherein the “using…” is both within the functionality itself and is drawn to a process not afforded patentable weight, nor does it provide a wicking pad as a positively claimed structural element of the testing device, and as Bailey discloses a commensurately structured and arranged ‘at least a first microfluidics channel’ as claimed, it is fully capable of [herein, ‘configured’] those functionalities recited therein.
Similarly, as in independent claim 11, Examiner asserts that Bailey discloses the application of such as in the recited method of claim 11 in as much as best understood herein, and noting that the present claims do not clearly or actively necessitate any particular active steps to any sought flow introduction/receiving in which a fluid is flown through a microfluidic channel(s) and through a wicking pad therein so as to be passively introduced to the input and fluidically connected first waveguide.
With regard to remaining dependent 3-5, 7, 8, 13-15, 17, and 18 Applicant asserts that they are also patentably distinct as these claims rely upon the above-discussed amended recitations.
Examiner asserts that as there are no such deficiencies with respect to Bailey, the remaining claims 3-5, 7, 8, 13-15, 17, and 18 are also maintained rejected under 35 USC 103 over the cited art in the body of the action.
With regard to remaining dependent claims 2, 12, 6, 16, Applicant asserts that they are also patentably distinct as these claims rely upon the above-discussed amended recitations.
Examiner asserts that as there are no such deficiencies with respect to Bailey, the remaining claims 2, 12, 6, and 16 are also maintained rejected under 35 USC 103 over the cited art in the body of the action.
By this, claims 1-8 and 11-18 are maintained rejected for the reasons discussed above in the body of the action.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Moll et al. (US 2013/0203627) discloses a cartridge comprising waveguide arrangement along with a wick pad for drawing fluid therethrough that is relevant to Applicant’s field of endeavor.
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 NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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