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 .
DETAILED ACTION
Amendment
The amendment filed on 08/05/2026 has been entered into this application. Claim 30 has/have been added.
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 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) 1-9, 12-13 and 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lewis et al. (2015/0362421 A1, previously cited reference).
Regarding claim 1, Lewis discloses an analysis system (figs. 1-14) (see abstract) for a translucent bodily fluid, comprising:
a flow chamber is a microfluidic detection cell 20 for the translucent bodily fluid (allowing light to pass through) defining an imaging section therein [pars. 0065-70];
an illumination source is included in a source 16 arranged to provide illumination light to the imaging section window shaft 27 or detection region or a larger single detection area or more than one detection area [par. 0071] that is included in the microfluidic detection cell 20 of the flow chamber the microfluidic detection cell 20 [pars. 0065-70];
an optical sensor a two-dimensional array detector 24 arranged proximate to the flow chamber the microfluidic detection cell 20 and arranged to receive light after passing through the flow chamber the microfluidic detection cell 20, the optical sensor the two-dimensional array detector 24 providing detection signals [pars. 0065-70]; comprising detection signals or acquire data/image expressly and inherently comprising interference between a diffracted portion of an illumination wavefront and a non- scattered reference wavefront [pars. 0073-76, 0078 and 0082]; and
a processor a particle characterization subsystem 42 included in a particle characterization system 10 or processor [pars. 0089-90] arranged to communicate with the optical sensor the two-dimensional array detector 24 to receive the detection signals therefrom, wherein the illumination source that included in the source 16 provides at least partially coherent light that is included in a coherent scattering illumination source [pars. 0008-9, 0066] to the imaging section of the flow chamber such that the detection signals correspond to a two-dimensional image by the two-dimensional array detector 24, and wherein the processor the particle characterization subsystem 42 included in a particle characterization system 10 or processor is configured to extract information from the two-dimensional image by the two-dimensional array detector 24 for particles/samples when present within the translucent bodily fluid the allowing light to pass through fluid samples passing through the flow chamber the microfluidic detection cell 20 [pars. 0009-12].
As to claim 2, Lewis also discloses wherein the illumination source that is included in a source 16 comprises a substantially monochromatic light-emitting diode (LED) [par. 0087] and a pinhole aperture stop a window bolt 28 slid into the window shaft 27 [pars. 0068-69] or a single illumination window 94 (although multiple illumination windows and/or multiple illumination sources may also be used) [par. 0106] arranged between the LED (16) and the imaging section of the flow chamber window shaft 27 or detection region or a larger single detection area or more than one detection area [par. 0071] that is included in the microfluidic detection cell 20 [pars. 0067-70].
As to claim 3, Lewis also discloses wherein the illumination source 16 comprises light from a laser [par. 073] is a laser diode directed onto the imaging section of the flow chamber the microfluidic detection cell 20.
As to claim 4, Lewis also discloses wherein the illumination source comprises a plurality of different wavelengths a variety of different spectral characteristics [par. 0066], and each being directed onto the imaging section of the flow chamber the microfluidic detection cell 20.
As to claim 5, Lewis further discloses wherein the imaging section the window shaft 27 or detection region or a larger single detection area or more than one detection area [par. 0071] that is included in the microfluidic detection cell 20 or a window bolt 28 slid into the window shaft 27 [pars. 0068-69] or a single illumination window 94 as can be seen in the depicted drawing 9figs. 1- 2B, and 3) of the flow chamber the microfluidic detection cell 20 defines a substantially rectangular lumen therein that is arranged to have a flat surface oriented substantially orthogonal to illumination light from the illumination source (16), the substantially rectangular lumen being thinner in a thickness direction of light travel therethrough to the optical sensor the two-dimensional array detector 24 than a cross direction that is substantially orthogonal to the direction of light travel therethrough and substantially orthogonal to a direction of flow of the translucent bodily fluid microfluidic through the substantially rectangular lumen [pars. 0065-70].
As to claim 6, Lewis further discloses wherein the information extracted from the two-dimensional image from/by the two-dimensional array detector 24 comprises implicitly at least one of an output of the translucent bodily fluid microfluidic particles, a flow rate of the translucent bodily fluid, a translucence of the translucent bodily fluid [pars. 0005-6, 0029, 0037-39 and 0071].
As to claim 7, Lewis further discloses wherein the flow chamber the microfluidic detection cell 20 further comprises a first end configured to attach to and to be detached from a sipper tube 106 functionally equivalent to a catheter (i.e. rubber or plastic tube) and a second end configured to attach to and to be detached from a fluid collection device pressure source 104 or a multi-well plate 114 or carousel [par. 0108-110].
As to claim 8, Lewis further discloses wherein the flow chamber the microfluidic detection cell 20 is an interchangeable flow chamber that is sample selectable from a reversible pressure source 104 [par. 0110] that is capable of being interchanged while reusing the illumination source (16), optical sensor (24), and processor the particle characterization subsystem 42 included in a particle characterization system 10 or processor [pars. 0089-90].
As to claim 9, Lewis also discloses wherein the interchangeable flow chamber the sample selectable from the reversible pressure source 104 is aligned (i.e. arrangement of components so they function optimally together) with respect to the optical sensor the two-dimensional array detector 24 (see fig. 2A-2B) with the use of (i.e. one of alignment rails and magnets).
As to claims 12-13 and 26, Lewis further discloses a structure that is use in the analysis system that is implementing limitations such as, wherein the translucent (allowing light to pass through) bodily fluid is biological materials, microbiological and cells one of (i.e. urine, synovial fluid, cerebrospinal fluid, vitreous humor, pleural effusion, peritoneal lavage, peritoneal dialysate, pericardial fluid, serous fluid, and seminal fluid) (claim 12); and wherein the particles the biological particles comprise at least one of (i.e. bacteria, red blood cells, white blood cells, crystalline particles, urinary casts, bacteria, fungi, parasites, ascites, tumor cells, and birefringent crystals) [pars. 0003, 0005, 0007, 0034] (claim 13); and non-transient, computer a user computer or general-purpose computer platforms executable code which when executed by a computer causes the computer to perform the method of claim 13 [pars. 0005, 0090, 0101 and 0117] (claim 26).
Allowable Subject Matter
Claims 10-11 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.
As to claim 10, the prior art of record, taken alone or in combination, fails to disclose or render obvious wherein the processor is further configured to extract information from the two-dimensional image by performing an adaptive sparse reconstruction, the adaptive sparse reconstruction comprising: receiving the two-dimensional image; and applying an unsupervised learning model to obtain phase retrieval, point spread function (PSF) estimation, and holographic reconstruction, wherein the PSF is a generalized PSF that accounts for two-dimensional imaging through a system, in combination with the rest of the limitations of the claim. Claim 11 is/are allowable by virtue of their /its dependency.
Claim 30 is/are allowed.
As to claim 30, the prior art of record, taken alone or in combination, fails to disclose or render obvious wherein the processor is configured to extract information from the two-dimensional image for particles when present within the translucent bodily fluid passing through the flow chamber by performing an adaptive sparse reconstruction, the adaptive sparse reconstruction comprising: receiving the two-dimensional image; and applying an unsupervised learning model to obtain phase retrieval, point spread function (PSF) estimation, and holographic reconstruction, wherein the PSF is a generalized PSF that accounts for two-dimensional imaging through a system, in combination with the rest of the limitations of the claim.
Response to Arguments
Applicant’s arguments/remarks, (see pages 9-11), filed on 08/05/2026, with respect to the rejection(s) of claim(s) have been fully considered but are not persuasive.
Applicant’s arguments:
a) Applicant argues in parti that Consider claim 1. Claim 1, as amended, recites in part, "the optical sensor providing detection signals comprising interference between a diffracted portion of an illumination wavefront and a non-scattered reference wavefront." Lewis is silent regarding "interference between a diffracted portion of an illumination wavefront and a non-scattered reference wavefront," much less using detection signals with such interference such that "the detection signals correspond to a two- dimensional image," as recited in claim 1.
Therefore, because claim 1 recites at least one feature not disclosed or adequately suggested by the cited combination, claim 1 is patentable and in condition for allowance. The claims 2-9, 12- 13 and 26 depend from claim 1 while reciting additional features, and are likewise patentable.
Accordingly, the rejection of claims 1-9, 12-13 and 26 under 35 U.S.C. §102 should be withdrawn.
Examiner's response:
With respect to argument (a), it is respectfully pointed out to applicant that this argument is not persuasive because the feature "interference between a diffracted portion of an illumination wavefront and a non-scattered reference wavefront," as recited in independent claim 1, as claimed, is an intended result detected by optical sensor/detector(s) from the arrangement of illumination light that illuminated the imaging section of the flow chamber. It is respectfully pointed out to applicant that the newly amended claim limitation and this argument (a) is not persuasive because prior art Lewis shows the same claimed structure/arrangement that is providing the detection signals that comprising interference between a diffracted portion of an illumination wavefront and a non-scattered reference wavefront. Further, it is respectfully pointed out to applicant that this argument is not persuasive because Applicant(s) has/have not provided any factual evidence of sufficient structure to distinguish the instant claimed structure from the structure of the prior art Lewis.
In conclusion, Applicant has/have not provided any proof and/or any factual evidence that the claim as amended and recited in claim 1 is/are not anticipated. Rather, the arguments merely appear to be a recitation with respect to the manner in which a claimed apparatus/device (i.e. optical sensor/detector(s)) is intended to be employed which does not differentiate the claimed apparatus/device (i.e. optical sensor/detector(s)) from a prior art apparatus/device (i.e. optical sensor/detector(s)). It is respectfully pointed out to applicant that this/these argument(s) is/are not persuasive because, it has been held that a recitation with respect to the manner in which a claimed apparatus/device (i.e. optical sensor/detector(s)) is intended to be employed does not differentiate the claimed apparatus/device (i.e. optical sensor/detector(s)) from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ 2d 1647 (1987). As such, it is respectfully pointed out to applicant that this argument is not persuasive.
Finally, Applicant has argued the patentability of dependent claims, based solely upon the patentability of independent claim(s), and has presented no additional arguments exclusively pertaining to the claims, since the applicant has not argued the examiner’s position about the rejection(s) regarding the dependent claims, in the previous Official action. The applicant has acquiesced.
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 Isiaka Akanbi whose telephone number is (571) 272-8658. The examiner can normally be reached on 8:00 a.m. - 4:30 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tarifur R. Chowdhury can be reached on (571) 272-2287. The fax phone number for the organization where this application or proceeding is assigned is 703-872-9306.
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/ISIAKA O AKANBI/Primary Examiner, Art Unit 2877
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