DETAILED ACTION
In application filed on 10/25/2023, Claims 1-24 are pending. The claim set submitted on 5/08/2026 is considered because this is the most recent claim set with some preliminary amendments. Claims 1-19 and 23-24 are considered in the current office 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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on11/20/2023 and 5/08/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election of Claims 1-19 and 23-24 in the reply filed on 05/08/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 20-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/08/2026.
Group I, Claims 1-19 and 23-24 are considered on the merits below.
Drawings
The drawings are objected to because certain reference characters in figures, not limited to Figures 1-14 do have low resolution. Applicant should provide Figures with improved resolution.
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 § 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.
Claims 1-3, 10-11, 13-16 and 23 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Zhang et al. ("Worm-based microfluidic biosensor for real-time assessment of the metastatic status." Cancers 13.4 (2021): 873.’, submitted in IDS 11/20/2023).
Regarding Claim 1, Zhang teaches a biosensing system comprising a microfluidics-based biosensor (See Simple Summary…low-cost worm-based (WB) microfluidic biosensor), the biosensor (See Simple Summary…low-cost worm-based (WB) microfluidic biosensor) comprising:
a first layer (referred to as one of the two layers [Section 2.1.1, Device Fabrication; Page 2; See Page 5, Section 3.1]; Also See Page 3…barrier layer; Also See Fig. 2B…channels layer]) comprising at least a plurality of fluid inlets (referred to as interconnected channels with four sample inlets [Page 5; Results]) for loading one or more samples (See Page 5, Section 3.1…sample inlets) and a window (See Section 2.1.1…Microfluidic chips were fabricated using standard soft-lithography techniques in PDMS; Under BRI, Examiner submits that PDMS is optically transparent, thereby teaching “window”; See Fig. 1, ref. c for the circular dotted region , thereby teaching “window”); and
a second layer (referred to as microwell layer [Page 3; Section 2.1.3]) being disposed under (See Fig. 2B for “disposed under”) the first layer(referred to as one of the two layers [Section 2.1.1, Device Fabrication; Page 2; See Page 5, Section 3.1]; Also See Page 3…barrier layer; Also See Fig. 2B…channels layer] and comprising an organism loading region (See Fig. 1, ref. B6 for the C. elegans loading region; See Page 3…inlets for sample loading) and a plurality of bio-incubation chambers (referred to as microwells of the microwell layer [Section 2.1.3; Fig. 2B]) each having a plurality of obstructing mechanisms (See Fig. 2…agar coating on the loading chambers [Results; Page 5])) so that a type of organisms (referred to as worms [Abstract]) incubated therein is selectively attracted or repelled (See simple summary…We observed a higher distribution of worms associated with samples of higher metastatic potential (p < 0.005)) by one or more analytes (See Simple Summary…We found that the secreted metabolite glutamate was a chemorepellent, and lower glutamate levels were associated with samples derived from more metastatic cancer cell clusters) in order to move away from the bio-incubation chambers (referred to as microwells of the microwell layer [Section 2.1.3; Fig. 2B]) towards the one or more analytes (See Simple Summary… secreted metabolite glutamate). The limitation “or stay within the bio-incubation chambers” is viewed as optional and thus not required by the claim.
wherein a presence of the one or more analytes (‘glutamate’) in the one or more samples(‘(MDA-MB-231)’) indicates a metastatic status (See Page 8, Section 3.4…Cancer cell clusters with more metastatic potential (MDA-MB-231) of the samples (See Page 8, section 3.4…We demonstrated that the glutamate concentration of 0.02 mg/mL generated the most significant CI level (3.6 +/- 0.03), which was within the range of glutamate levels detected from cancer cell clusters with more metastatic potential (MDA-MB-231). Higher concentrations of glutamate (≥0.04 mg/mL) led to lower CI levels. Specifically, the lowest CI level was reported with the highest glutamate concentration tested (0.1 mg/mL; CI level: 1.1 ± 0.04). The limitation “or a subject from which the samples are obtained” is viewed as optional and thus not required by the claim.
In addition, Claim 1 recites a first layer, a second layer, bio-incubation chambers and then recites how these structures function. Claim 1 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding Claim 2, Zhang teaches wherein each of the plurality of fluid inlets (referred to as interconnected channels with four sample inlets [Page 5; Results]) is disposed adjacent (See Fig. 1A-B for disposed adjacent; under BRI, the microchip is made with an PDMS which is optically transparent) to an edge of the window (See Section 2.1.1…Microfluidic chips were fabricated using standard soft-lithography techniques in PDMS; Under BRI, Examiner submits that PDMS is optically transparent, thereby teaching “window”; See Fig. 1, ref. c for the circular dotted region which is “area for Celegans” , thereby teaching “window”; Also under BRI, the embodiment of the “window” has an edge).
Regarding Claim 3, Zhang teaches wherein the window (See Section 2.1.1…Microfluidic chips were fabricated using standard soft-lithography techniques in PDMS; Under BRI, Examiner submits that PDMS is optically transparent, thereby teaching “window”; See Fig. 1, ref. c for the circular dotted region , thereby teaching “window”) is disposed substantially (Under BRI, Examiner submits that the window can be disposed anywhere on the embodiment of the barrier layer since the chips are made of PDMS which is optically transparent) at a center of the first layer (referred to as one of the two layers [Section 2.1.1, Device Fabrication; Page 2; See Page 5, Section 3.1]; Also See Page 3…barrier layer; Also See Fig. 2B…channels layer]).
Regarding Claim 10, Zhang teaches that the type of organisms (See Fig. 1…Worms were placed into chambers; See Simple Summary…Caenorhabditis elegans) is a kind of nematodes (See Simple Summary…Caenorhabditis elegans are nematodes).
Regarding Claim 11, Zhang teaches that the type of nematodes (See Simple Summary…Caenorhabditis elegans are nematodes) is Caenorhabditis elegans (See Simple Summary…Caenorhabditis elegans are nematodes).
Regarding Claim 13, Zhang teaches that the one or more samples (See Page 2…C. elegans showed a chemotactic preference for specific volatile compounds in cells, urine, and tissue samples of cancer patients) comprise biological fluids, body fluids, metabolites, extracts from tissues or lesions, or media containing any of the above (See Page 2…C. elegans showed a chemotactic preference for specific volatile compounds in cells, urine, and tissue samples of cancer patients).
Regarding Claim 14, Zhang teaches that the one or more samples (See Page 2…C. elegans showed a chemotactic preference for specific volatile compounds in cells, urine, and tissue samples of cancer patients) are liquid biopsies comprising urine, saliva, mucus secretion, and extracts from tissues or lesions (See Page 2…C. elegans showed a chemotactic preference for specific volatile compounds in cells, urine, and tissue samples of cancer patients).
Regarding Claim 15, Zhang teaches that the subject is human or non-human animal (See Page 2…screen patient-derived cultures from a liquid biopsy or tumor biopsy for early detection of metastasis, thereby teaching human).
Regarding Claim 16, Zhang teaches that the one or more analytes (See Simple Summary… secreted metabolite glutamate) comprise urea, urine-derived metabolites and biological cells (it is known that Glutamate is a glutamate is a naturally occurring amino acid and a key metabolite that can be found and measured in urine).
Regarding Claim 23, Zhang teaches the biosensing system of claim 1 (See Claim 1 rejection).
Zhang further teaches a kit (See Simple Summary…high-throughput screening and low-cost worm-based (WB) microfluidic biosensor) for determining metastasis of a biological sample (See Simple Summary…with samples derived from more metastatic cancer cell clusters…) comprising the biosensing system of claim 1 (See Claim 1 rejection).
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 4, 8-9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. ("Worm-based microfluidic biosensor for real-time assessment of the metastatic status." Cancers 13.4 (2021): 873.’, submitted in IDS 11/20/2023) as applied to claim 1 above.
Regarding Claim 4, Zhang teaches that each of the plurality of bio-incubation chambers (referred to as microwells of the microwell layer [Section 2.1.3; Fig. 2B]) is arranged in fan-like shape (See Fig. 2B for the fan-like shape) from a center of the second layer (referred to as microwell layer [Page 3; Section 2.1.3]; Under BRI, the microwell layer (second layer) has a center) from a plan view of the biosensor (See Simple Summary…low-cost worm-based (WB) microfluidic biosensor).
Zhang does not explicitly teach the substantial diverging from a center of the second layer.
However, Zhang discloses the claimed invention except for the claimed “substantial diverging from a center of the second layer.”
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include that the plurality of bio-incubation chambers is arranged in fan-like shape diverging substantially from a center of the second layer, since it has been held that the configuration was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration claimed was significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding Claim 8, Zhang teaches that the organism loading region (See Fig. 1, ref. B6 for the C. elegans loading region; See Page 3…inlets for sample loading); and different bio-incubation chambers (referred to as microwells of the microwell layer [Section 2.1.3; Fig. 2B]).
Zhang does not explicitly teach arrangement of the organism loading region being disposed at an intersection of different bio-incubation chambers.
However, Zhang discloses the claimed invention except for the claimed arrangement of the organism loading region being disposed at an intersection of different bio-incubation chambers.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the arrangement of the organism loading region being disposed at an intersection of different bio-incubation chambers, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding Claim 9, Zhang teaches that each of the plurality of bio-incubation chambers (referred to as microwells of the microwell layer [Section 2.1.3; Fig. 2B]) has a cavity (See Fig. 2B for the cavity of the microwells) to accommodate the type of organisms (See Fig. 1…Worms were placed into chambers) and allow for a culture medium to incubate with the organisms (See Page 2…Compared with standards obtained from healthy cell cultures, C. elegans showed a chemotactic preference for specific volatile compounds in cells, urine, and tissue samples of cancer patients, thereby teaching “allow for a culture medium to incubate with the organisms”).
In addition, Claim 9 recites a plurality of bio-incubation chambers then recites how these structures function. Claim 9 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding Claim 12, Zhang teaches that the first layer (referred to as one of the two layers [Section 2.1.1, Device Fabrication; Page 2; See Page 5, Section 3.1]; Also See Page 3…barrier layer; Also See Fig. 2B…channels layer]) communicates with the second layer (referred to as microwell layer [Page 3; Section 2.1.3]) through one or more fluid channels (referred to as interconnected channels which is linked to the four sample inlets [Page 2, Section 2.1.1]; Also see Page 2, lines 2.1.1…fluidic inlets and outlets were punched into the layers before bonding), where each of the fluid channels (referred to as interconnected channels which is linked to the four sample inlets [Page 2, Section 2.1.1]) or each intersection of two or more of the fluid channels (this limitation “or…” is viewed as optional) has a larger width but a smaller height from a cross-sectional view than those of fluid channels (referred to as interconnected channels which is linked to the four sample inlets [Page 2, Section 2.1.1]; Also see Page 2, lines 2.1.1…fluidic inlets and outlets were punched into the layers before bonding) within the bio-incubation chambers (referred to as microwells of the microwell layer [Section 2.1.3; Fig. 2B]).
Zhang does not explicitly teach that “where each of the fluid channels or each intersection of two or more of the fluid channels has a larger width but a smaller height from a cross-sectional view than those of fluid channels within the bio-incubation chambers.
However, Zhang does teach that the biosensing system of Claim 1 is a microfluidic device where the only difference between the prior art and the claim is that “where each of the fluid channels or each intersection of two or more of the fluid channels has a larger width but a smaller height from a cross-sectional view than those of fluid channels within the bio-incubation chambers”.
The Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (See MPEP § 2144.05, Part II, Subpart B; In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design and fabricate a biosensing system “where each of the fluid channels or each intersection of two or more of the fluid channels has a larger width but a smaller height from a cross-sectional view than those of fluid channels within the bio-incubation chambers, for the benefit of evaluating patient status in real time, thereby facilitating early detection of metastases and routine management (Zhang, Simple Summary), allowing for biomarker discovery or the use of WB biosensors to monitor patient status in real-time, thereby facilitating the early detection of metastases (Zhang, Page 2, Introduction).
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. ("Worm-based microfluidic biosensor for real-time assessment of the metastatic status." Cancers 13.4 (2021): 873.’, submitted in IDS 11/20/2023) as applied to claim 1 above, and further in view of Shenderov et al. (US20210162415A1).
Regarding Claim 5, Zhang teaches that the obstructing mechanisms (See Fig. 2…agar coating on the loading chambers [Results; Page 5])) in each of the plurality of bio-incubation chambers (referred to as microwells of the microwell layer [Section 2.1.3; Fig. 2B]).
Zhang does not explicitly teach that the obstructing mechanisms in each of the plurality of bio-incubation chambers are a plurality of polygonal structures.
In the analogous art of a whole blood assay chip that enables separation of the cellular compartment from surrounding plasma, facilitating multiplexed measurement of otherwise difficult to detect soluble factors produced upon cellular stimulation,
Shenderov teaches that the obstructing mechanisms (referred to as the fluidic barrier that is used in the incubation chamber which includes a micro-pillar [Para 0016; Fig. 2, 4, ref. 8) in each of the plurality of bio-incubation chambers (See Para 0016… The fluidic barrier that is used in the incubation chamber; See Para 0028… three or four different incubation chambers) are a plurality of polygonal structures (See Fig. 4, ref. 8 for the polygonal structures of the micropillars).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the biosensing system of Zhang to include that the obstructing mechanisms in each of the plurality of bio-incubation chambers are a plurality of polygonal structures, as taught by Shenderov for the benefit of providing a fluidic barrier which provides a structure that blocks particles (e.g., such as microbeads and red blood cells) of a desired size while allowing for the diffusion of smaller molecules (Shenderov, Para 0059), allowing for the development of a novel diagnostic tool for reliable and timely diagnosis of allergies to substances such as antibiotics, drugs, and foods ((Shenderov, Para 0006).
Regarding Claim 6, The combination of Zhang and Shenderov does not explicitly teach that that the plurality of polygonal structures is a plurality of triangular prism-shaped structures.
However, one having ordinary skill in the art at the time the invention was made would recognize this limitation as nothing more than a change of shape of the micropillars of Shenderov, to effect the determination of the optimal shape and could seek the benefit of providing a fluidic barrier which provides a structure that blocks particles (e.g., such as microbeads and red blood cells) of a desired size while allowing for the diffusion of smaller molecules (Shenderov, Para 0059), allowing for the development of a novel diagnostic tool for reliable and timely diagnosis of allergies to substances such as antibiotics, drugs, and foods ((Shenderov, Para 0006).
Regarding Claim 7, the combination of Zhang and Shenderov does not teach that each of the plurality of polygonal structures is evenly spaced apart from the other to define a plurality of runways for the type of organisms to move away from the bio-incubation chambers towards the one or more analytes.
In the analogous art of a whole blood assay chip that enables separation of the cellular compartment from surrounding plasma, facilitating multiplexed measurement of otherwise difficult to detect soluble factors produced upon cellular stimulation, Shenderov teaches that each of the plurality of polygonal structures (See Fig. 4, ref. 8 for the polygonal structures of the micropillars) is evenly spaced apart (See Para 0059; Fig. 4, ref. 8…The distance between the “micro-pillars” ) from the other to define a plurality of runways (‘distance (spacing) between the “micro-pillars”’) for the type of organisms to move away (See Para 0059; Fig. 4, ref. 8…The distance between the “micro-pillars” will determine the size cut-off for particles that can diffuse between the channels) from the bio-incubation chambers (See Para 0016… The fluidic barrier that is used in the incubation chamber; See Para 0028… three or four different incubation chambers) towards the one or more analytes (referred to as blood cells [Para 0135, 0144]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the biosensing system of Zhang to include that each of the plurality of polygonal structures is evenly spaced apart from the other to define a plurality of runways for the type of organisms to move away from the bio-incubation chambers towards the one or more analytes, as taught by Shenderov for the benefit of determining the size cut-off for particles that can diffuse between the channels. Thus, the fluidic barrier provides fluidic resistance as well as a means of preventing the direct mixing of the sample and a target (Shenderov, Para 0059), allowing for the development of a novel diagnostic tool for reliable and timely diagnosis of allergies to substances such as antibiotics, drugs, and foods ((Shenderov, Para 0006).
In addition, Claim 7 recites a plurality of polygonal structures and a plurality of runways then recites how these structures function. Claim 7 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. ("Worm-based microfluidic biosensor for real-time assessment of the metastatic status." Cancers 13.4 (2021): 873.’, submitted in IDS 11/20/2023) as applied to claim 1 above, and further in view of Jarvius et al. (US20200363616A1)
Regarding Claim 17, Zhang teaches the biosensing system of claim 1 (See Claim 1 rejection).
Zhang does not teach a holder of the biosensor, a linear translation stage, and a lens disposed under the biosensor, wherein the holder is attached to the linear translation stage for securing the biosensor on the linear translation stage.
In the analogous art of a device for microscopy-based analysis of samples. In some examples the device is able to detect the presence, amount, and/or absence of microscopic objects in a sample, such as microscopic biological objects, Jarvius teaches that a holder of the biosensor (referred to as a sample holder comprising a plurality of sample chambers [Para 0178]), a linear translation stage (referred to as the support may be configured to move the sample holder a distance of between 30 mm and 130 mm, for example 40 mm and 100 mm, for example 50 mm to 70 mm, in each linear translation [Para 0127]), and a lens (referred to as objective lens [abstract; Fig. 1A, ref 25] ) disposed under (See Figs 1A-B) the biosensor (referred to as a sample holder comprising a plurality of sample chambers [Para 0178]), wherein the holder (referred to as a sample holder comprising a plurality of sample chambers [Para 0178]) is attached to the linear translation stage (referred to as the support may be configured to move the sample holder a distance of between 30 mm and 130 mm, for example 40 mm and 100 mm, for example 50 mm to 70 mm, in each linear translation [Para 0127]; See Para 0120… the support may be configured to translate the received sample holder linearly in a first direction (for example, from a radially outward position towards the centre of the sample holder), then to rotate the received sample holder in a second direction (e.g. in a clockwise or anticlockwise direction, about a vertical axis of the sample holder).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the biosensing system of Zhang to include a holder of the biosensor, a linear translation stage, and a lens disposed under the biosensor, wherein the holder is attached to the linear translation stage for securing the biosensor on the linear translation stage, as taught by Jarvius, for the benefit of detecting the presence, amount, and/or absence of microscopic objects in a sample, such as microscopic biological objects (Jarvius, Para 0001), allowing for the improvement on the capabilities of methods and devices in this field (Jarvius, Para 0002).
Regarding Claim 18, the biosensing system of Claim 17 is obvious over Zhang in view of Jarvius.
Zhang does not teach that the linear translation stage is a precision z-axis translation stage with fixed x- and y-axis positions.
In the analogous art of a device for microscopy-based analysis of samples. In some examples the device is able to detect the presence, amount, and/or absence of microscopic objects in a sample, such as microscopic biological objects, Jarvius teaches that the linear translation stage (referred to as the support may be configured to move the sample holder a distance of between 30 mm and 130 mm, for example 40 mm and 100 mm, for example 50 mm to 70 mm, in each linear translation [Para 0127]; See Para 0120… the support may be configured to translate the received sample holder linearly in a first direction (for example, from a radially outward position towards the centre of the sample holder), then to rotate the received sample holder in a second direction (e.g. in a clockwise or anticlockwise direction, about a vertical axis of the sample holder) is a precision z-axis translation stage with fixed x- and y-axis positions (See Para 0127…. the support may be configured to move the sample holder a distance of between 30 mm and 130 mm, for example 40 mm and 100 mm, for example 50 mm to 70 mm, in each linear translation; See Para 0120… the support may be configured to translate the received sample holder linearly in a first direction (for example, from a radially outward position towards the centre of the sample holder), then to rotate the received sample holder in a second direction (e.g. in a clockwise or anticlockwise direction, about a vertical axis of the sample holder).
Examiner further submits that the structure of the support of the combination of Zhang and Jarvius has a similar structure as that of the claimed invention and therefore anticipates the “precision z-axis translation stage with fixed x- and y-axis positions” of Claim 18.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the biosensing system of Zhang to include that the linear translation stage is a precision z-axis translation stage with fixed x- and y-axis positions as taught by Jarvius, for the benefit of detecting the presence, amount, and/or absence of microscopic objects in a sample, such as microscopic biological objects (Jarvius, Para 0001), allowing for the improvement on the capabilities of methods and devices in this field (Jarvius, Para 0002).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. ("Worm-based microfluidic biosensor for real-time assessment of the metastatic status." Cancers 13.4 (2021): 873.’, submitted in IDS 11/20/2023) and further in view of Jarvius et al. (US20200363616A1), as applied to claim 17 above, and further in view of Balagurusamy et al. (US20190072750A1)
Regarding Claim 19, the biosensing system of Claim 17 is obvious over Zhang in view of Jarvius.
Zhang does not teach that the lens is a droplet lens or microlens for magnifying an area of interest in images of the biosensor captured by a smartphone or mobile device integrated with an imaging module.
In the analogous art of A microscope lens system includes a body having a surface, a microlens, and an aperture positioned between the microlens and the surface, Balagurusamy teaches that the lens (referred to as microlens [Fig. 5, ref. 402]) is a droplet lens or microlens (referred to as microlens [Fig. 5, ref. 402]) for magnifying an area of interest in images of the biosensor (referred to as microlens adapter [Para 0032]) captured by a smartphone or mobile device (referred to as mobile device [Fig. 5, ref. 132]; See Para 0032…Mobile device 132 is further coupled to a microlens adapter 136 to facilitate capture of one or more images or videos sequences of an object through a microlens positioned within microlens adapter 136) integrated with an imaging module (referred to as example configuration [Fig. 5, ref. 500]; See Para 0055…Example configuration 500 further includes a light source 506 positioned below subject object 504 upon an object platform 508; Also See Fig. 5, ref. 502…camera lens).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the biosensing system of Zhang and Jarvius to include that the lens is a droplet lens or microlens for magnifying an area of interest in images of the biosensor captured by a smartphone or mobile device integrated with an imaging module, as taught by Balagurusamy for the benefit of providing an embodiment to be used for imaging microbeads and their motion with an example low-cost illumination setup that is portable and compact for field applications as compared to presently available microscopes that can produce similar results (Balagurusamy, Para 0054), allowing for the provision of a method, system, and computer program product for making a low cost microscope using existing camera-enabled mobile devices. More particularly, the present invention relates to a method, system, and computer program product for a microlens adapter for mobile devices (Balagurusamy, Para 0001).
In addition, Claim 19 a lens, biosensor, smartphone or mobile device and an imaging module then recites how these structures function. Claim 19 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. ("Worm-based microfluidic biosensor for real-time assessment of the metastatic status." Cancers 13.4 (2021): 873.’, submitted in IDS 11/20/2023) and further in view of Jarvius et al. (US20200363616A1), as applied to claim 23 above, and further in view of Earney et al. (US20160160276A1).
Regarding Claim 24, Zhang does not teach that the precision z-axis translation stage comprises a stage shaft, a rotor, a plurality of clamps and screws.
In the analogous art of an inspection apparatus including: (a) a translucent or transparent plate having a bottom surface, at least a portion of the bottom surface having an opaque material printed thereon in a pattern having at least one transparent or translucent portion; and (b) a chamber disposed below the bottom surface, whereby light emitted from the chamber or through the chamber can pass through the at least one transparent or translucent portion, Earney teaches that the precision z-axis translation stage (referred to as carriage [Para 0051]; See Para 0051… the microfluorometers can be affixed to a carriage… The microfluorometers may, however, be independently actuated in the z dimension to provide for independent focus control ) comprises a stage shaft (referred to as a first shaft [Para 0073]) , a rotor (referred to as rotor [Para 0074]), a plurality of clamps (See Para 0074…shaft clamp 205 and shaft clamp 206) and screws (See Para 0074…lead screw and lead nut).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Kit of Zhang to include t that the precision z-axis translation stage comprises a stage shaft, a rotor, a plurality of clamps and screws, as taught by Earney for the benefit of having the microfluorometer to be conveniently moved, for example in a scanning operation, to allow imaging of a substrate that is larger than the field of view of the micro fluorometer (Earney, Para 0051), allowing for the provision of tools which facilitate accurate calibration of alignment and validation of optical detection systems. Embodiments of the invention set forth herein satisfy this need and provide other advantages as well (Earney, Para 0003).
Conclusion
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/OYELEYE ALEXANDER ALABI/ Examiner, Art Unit 1797
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