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 .
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 spring (14), the first position, and the second position in claim 19 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 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.
Claim(s) 4-5, 6-8, and 18-19 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(s) 4-5, recites the device limitation “the hydrogel layer is adapted to electrophoretically filter”. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “electrophoretically filter” in claim(s) 4-5 is used by the claim to mean or achieve the action of “(filtering and separating a plurality of sample moieties, concentrating a plurality of oligonucleotides,” while the accepted meaning is “a porous hydrogel layer.” The term is indefinite because the specification does not clearly redefine the term. Furthermore, the technical features necessary for achieving this result. It is not clear how the hydrogel layer must be adapted to achieve these results. Claims 4-5 disclose electrophoretic separation / transport of analytes. It appears that two electrodes are essential for this, however claim 1 only discloses one electrode. It is therefore not clear how the electrophoretic separation / transport is to be achieved.
Claim(s) 6-8, recites the device limitation(s) as "the ... electrode is adapted to control a temperature" (claim 6), "the temperature results in lysis of the sample" (claim 7), and "the temperature enhances hybridization ... " (claim 8), which relate to a method of using the device. The features in apparatus claims 6-8 relate to a method of using the apparatus rather than clearly defining the apparatus in terms of its technical features. The intended limitations are therefore not clear from this claim.
Claim(s) 18-19, recites the device limitation(s) as "a dongle… in electrical communication with (the biosensor device)” (claim 18), suggesting that the electrical contact is permanent. While, claim 19 defines a mechanism for selectively forming an electrical contact between an electrode probe of a dongle and the biosensor device of claim 1. This inconsistency between the claims should be removed.
Claim 19, recites the device limitation(s) as "a spring… a first position… a second position…” to reflect contact between an electrode probe and a patterned biosensor layer. One with ordinary skills in the arts would anticipate controlling the communication between the electrode probe and a patterned biosensor layer (as various positions) by using a physical tool/structure such as, a spring or clamp or slot when using a dongle or similar device, or by manual adjustments that would render similar results as the instant device. The technical or structural relationship between the dongle and the biosensor device or vertical stack as a whole is unclear.
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.
Claim(s) 1-18, 21-24 and 26-29 are rejected under 35 U.S.C. 103 as being unpatentable over Mazzari et al. (US20120244547A1) and Pulitzer et al. (US20180364224A1).
Regarding Claim 1, Mazzari et al. teaches a biosensor device for detecting an analyte in a sample (See the Abstract, the combination of the sensing component 40 and the biosensor assembly 10, i.e. a biosensor device, and the Claim(s) 1-20, 28-29, and 34-37, in [0050]-[0056], [0062]-[0064], [0071]-[0073], [0075], [0078], [0082], [0093], [0128], in Fig. 1-4 and Fig. 12),
the biosensor device comprising:
a vertical stack (See the sensing component 40 in [0050]-[0051] in Fig. 1) comprising:
a patterned biosensor layer (See the combination of the capture molecule layer 46 and the first electrode 42, i.e. a biosensor layer, in [0051] in Fig. 1);
a hydrogel layer disposed above and in contact with the patterned biosensor layer (See how the electrolytic gel 48 is positioned to surround the capture molecule layer 46 and to contact the first electrode 42 in [0051] in Fig. 1);
a permeable metallic electrode disposed above the hydrogel layer (See how the second electrode 50 is an open screen electrode in [0051] in Fig. 1).
Yet, Mazzari et al. fails to explicitly teach a biosensor device for detecting an analyte in a sample, comprising: a vertical stack comprising: a sample collection layer disposed proximate and in contact with the permeable metallic electrode.
However, in the analogous art of two-sided flow-through immunoassays, Pulitzer et al. teaches a biosensor device for detecting an analyte in a sample (See the Abstract, the immunoassay test strip 100, the immunoassay device 1700, and the Claim(s) 1-20, in [0043-[0044], [0070], [0086]-[0090], [0097]-[0100], in Fig. 1-3, 8A-B, 15-16, 18, and 23A-B), comprising:
a vertical stack (See the immunoassay test strip 100, i.e. a vertical stack in [0043] in Fig. 1; Also, see the vertical immunoassay device 1700 in [0090] in Fig. 18) comprising:
a sample collection layer disposed proximate and in contact with the permeable metallic electrode (See how the sample pad 104, i.e. a sample collection layer, is disposed on one end of the strip 100, for collecting the biologic analyte 106, and how the sample pad 104 is disposed next to the conjugate pad 108 in [0043]-[0044] in Fig. 1; Also, see how the plurality of immunoassay test pads 1704, i.e. a sample collection layer, includes an immunoreactive membrane 1802 in [0090] in Fig. 18).
Thus, it would be obvious to one with ordinary skills in the arts to modify the vertical stack in the biosensor device of Mazzari et al. by incorporating a sample collection layer disposed proximate and in contact with the permeable metallic electrode (as taught by Pulitzer et al.) for the benefit of enabling more efficient collection and handling of a liquid sample a in biosensor device.
Regarding Claim(s) 2-5, The combination of Mazzari et al. and Pulitzer et al. teaches the device limitations of claim 1.
Mazzari et al. further teaches a biosensor device (See the Abstract, the combination of the sensing component 40 and the biosensor assembly 10, i.e. a biosensor device, and the Claim(s) 1-20, 28-29, and 34-37, in [0050]-[0056], [0062]-[0064], [0071]-[0073], [0075], [0078], [0082], [0093], [0128], in Fig. 1-4 and Fig. 12), wherein the patterned biosensor layer comprises at least one of a nanocarbon material, graphene with noble metal nanoislands formed thereon, a transition-metal dichalcongenide (TMD), a two-dimensional (2D) material, or a one-dimensional material (See the use of gold particles, thread-like material, self-assembled monolayers, carbon nanotubes in [0056], [0062], [0064], [0072]);
wherein the hydrogel layer comprises at least one of agarose or polyacrylamide (See how the electrolytic gel may include acrylamide, polyacrylamide, or other crosslinked polymers in [0086]);
wherein the hydrogel layer is adapted to electrophoretically filter and separate a plurality of sample moieties by size, and wherein the hydrogel layer is adapted to electrophoretically concentrate a plurality of oligonucleotides from the sample at a surface of the patterned biosensor layer (See in Claim(s) 1-20 in Fig. 1-5).
Regarding Claim(s) 6-9, The combination of Mazzari et al. and Pulitzer et al. teaches the device limitations of claim 1.
Mazzari et al. further teaches a biosensor device (See the Abstract, the combination of the sensing component 40 and the biosensor assembly 10, i.e. a biosensor device, and the Claim(s) 1-20, 28-29, and 34-37, in [0050]-[0056], [0062]-[0064], [0071]-[0073], [0075], [0078], [0082], [0093], [0128], in Fig. 1-4 and Fig. 12), wherein the permeable metallic electrode is adapted to control a temperature of the biosensor device (See how the second electrode 50 is suitable for temperature control in [0073]-[0075] in Fig. 1);
wherein the temperature results in lysis of the sample; wherein the temperature enhances hybridization of the analyte to a biomolecular ligand immobilized in contact with the patterned biosensor layer; wherein the permeable metallic electrode is configured to act as at least one of a cathode or an anode during electrophoresis through the hydrogel layer (See the combination of the capture molecule layer 46 and the first electrode 42, i.e. a biosensor layer, in [0051] and the biosensor assembly 10 in [0073]-[0075], [0093] in Fig. 4).
Note what is discussed in MPEP § 2114 I-II. "[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). The instant application recites the limitation “temperature control”, "lysis", and "enhanced hybridization", but fails to cover the structural components that execute the change/control of temperature or define how that the other apparatus components functionally or structurally relates to "lysis" and "enhanced hybridization".
Regarding Claim(s) 10-11, The combination of Mazzari et al. and Pulitzer et al. teaches the device limitations of claim 1.
Mazzari et al. further teaches a biosensor device (See the Abstract, the combination of the sensing component 40 and the biosensor assembly 10, i.e. a biosensor device, and the Claim(s) 1-20, 28-29, and 34-37, in [0050]-[0056], [0062]-[0064], [0071]-[0073], [0075], [0078], [0082], [0093], [0128], in Fig. 1-4 and Fig. 12), wherein the patterned biosensor layer is disposed above and in contact with a substrate (See how the combination of the capture molecule layer 46 and the first electrode 42, i.e. a biosensor layer, is above the substrate 44 in [0051] in Fig. 1);
wherein the substrate comprises at least one of glass, a polymeric film, a single crystal material, surface-enhanced Raman Spectroscopy(SERS) substrate, a localized surface plasma resonance (LSPR) substrate, a surface plasma resonance (SPR) substrate, fluorescence in situhybridization (FISH) labeled substrate, or an electrochemical sensing substrate (The substrate variations in [0070]).
Regarding Claim(s) 12-13, The combination of Mazzari et al. and Pulitzer et al. teaches the device limitations of claim 1.
Mazzari et al. further teaches a biosensor device (See the Abstract, the combination of the sensing component 40 and the biosensor assembly 10, i.e. a biosensor device, and the Claim(s) 1-20, 28-29, and 34-37, in [0050]-[0056], [0062]-[0064], [0071]-[0073], [0075], [0078], [0082], [0093], [0128], in Fig. 1-4 and Fig. 12), further comprising a biomolecular ligand immobilized over and in contact with the patterned biosensor layer (See the combination of the capture molecule layer 46 and the first electrode 42, i.e. a biosensor layer, in [0051]-[0054] in Fig. 1-3);
wherein the biomolecular ligand comprises at least one of a plurality of oligonucleotide probes, antibodies, antigens, or enzymes (See in [0063], [0072], [0078]).
Regarding Claim(s) 14-15, The combination of Mazzari et al. and Pulitzer et al. teaches the device limitations of claim 1.
Mazzari et al. fails to explicitly teach a biosensor device, wherein the sample collection layer comprises an absorbent filter medium.
However, in the analogous art of two-sided flow-through immunoassays, Pulitzer et al. teaches a biosensor device (See the Abstract, the immunoassay test strip 100, the immunoassay device 1700, and the Claim(s) 1-20, in [0043-[0044], [0070], [0086]-[0090], [0097]-[0100], in Fig. 1-3, 8A-B, 15-16, 18, and 23A-B), wherein the sample collection layer comprises an absorbent filter medium; wherein the sample collection layer comprises a matrix (See how the plurality of immunoassay test pads 1704, i.e. a sample collection layer, includes an absorbent pad 1804 for collection of excess biologic sample in [0090] in Fig. 18).
Thus, it would be obvious to one with ordinary skills in the arts to modify the biosensor device of Mazzari et al. by incorporating a sample collection layer comprising an absorbent filter medium and a matrix (as taught by Pulitzer et al.) for the benefit of collecting excess liquid sample in a biosensor device.
Regarding Claim(s) 16-17, The combination of Mazzari et al. and Pulitzer et al. teaches the device limitations of claim 1.
Mazzari et al. further teaches a biosensor device (See the Abstract, the combination of the sensing component 40 and the biosensor assembly 10, i.e. a biosensor device, and the Claim(s) 1-20, 28-29, and 34-37, in [0050]-[0056], [0062]-[0064], [0071]-[0073], [0075], [0078], [0082], [0093], [0128], in Fig. 1-4 and Fig. 12), wherein the sample collection layer is disposed above the permeable metallic electrode (See Fig. 1 in [0051]); further comprising an absorption layer disposed between the hydrogel layer and the permeable metallic electrode (See how the electrolytic gel 48 is positioned to surround the capture molecule layer 46 and to contact the first electrode 42 in [0051] in Fig. 1).
Yet, Mazzari et al. fails to explicitly teach a biosensor device for detecting an analyte in a sample, wherein the sample collection layer is disposed above the permeable metallic electrode; and further comprising an absorption layer disposed between the hydrogel layer and the permeable metallic electrode.
However, in the analogous art of two-sided flow-through immunoassays, Pulitzer et al. teaches a biosensor device for detecting an analyte in a sample (See the Abstract, the immunoassay test strip 100, the immunoassay device 1700, and the Claim(s) 1-20, in [0043-[0044], [0070], [0086]-[0090], [0097]-[0100], in Fig. 1-3, 8A-B, 15-16, 18, and 23A-B), wherein the sample collection layer is disposed above the permeable metallic electrode; and further comprising an absorption layer disposed between the hydrogel layer and the permeable metallic electrode (See how the sample pad 104, i.e. a sample collection layer, is disposed on one end of the strip 100, for collecting the biologic analyte 106, and how the sample pad 104 is disposed next to the conjugate pad 108 in [0043]-[0044] in Fig. 1; Also, see how the plurality of immunoassay test pads 1704, i.e. a sample collection layer, includes a immunoreactive membrane 1802 and the absorbent pad 1804 in [0090] in Fig. 18).
Thus, it would be obvious to one with ordinary skills in the arts to modify the biosensor device of Mazzari et al. by incorporating a sample collection layer is disposed above the permeable metallic electrode and an absorption layer disposed between the hydrogel layer and the permeable metallic electrode(as taught by Pulitzer et al.) for the benefit of enabling more efficient collection and handling of a liquid sample a in biosensor device.
Note what is discussed in MPEP § 2144 VI. concerning the rearrangement of parts of a claimed invention in comparison to the prior art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). The current claimed arrangement of the sample collection layer, the absorption layer, the hydrogel layer, and the permeable metallic electrode would render similar results as the biosensor devices in the prior art.Regarding
Claim 18, The combination of Mazzari et al. and Pulitzer et al. teaches the device limitations of claim 1.
Mazzari et al. further teaches a dongle in electrical communication with the biosensor device of claim 1 (See the Abstract, the combination of the sensing component 40 and the biosensor assembly 10, i.e. a biosensor device, and the Claim(s) 1-20, 28-29, and 34-37, in [0050]-[0056], [0062]-[0064], [0071]-[0073], [0075], [0078], [0082], [0093], [0128], in Fig. 1-4 and Fig. 12), the dongle (See the analysis device 12, i.e. a dongle, in Fig. 4 in [0093]; Also, see how the detachable module 300 that can interface to a handheld impedance measurement device 426 in [0128] in Fig. 12) comprising:
a housing (See in [0128] in Fig. 12);
a power supply disposed within the housing (See how the device may be powered by a battery in [0093] in Fig. 4); and
at least one electrode probe in electrical communication with the power supply and configured to make electrical contact to the patterned biosensor layer (See how an excitation voltage is applied to the electrodes in [0093] and the interfacing at 344 in [0128] in Fig. 4 and 12; Also, see how the analysis device 12, i.e. a dongle, must have an interface for communication with a computing device to be able to transfer data to an external memory device 16 such as a computer memory module).
Regarding Claim 21, Mazzari et al. teaches a method for fabricating a biosensor device (See the Abstract and the Claim(s) 21-27 in [0050]-[0056], [0062]-[0064], [0071]-[0073], [0075], [0078], [0082], [0093], [0128] in Fig. 1-4 and Fig. 12), the method comprising:
fabricating a vertical stack (See the sensing component 40 in [0050]-[0051] in Fig. 1) by:
providing a patterned biosensor layer (See the combination of the capture molecule layer 46 and the first electrode 42, i.e. a biosensor layer, in [0051] in Fig. 1);
forming a hydrogel layer over and in contact with the patterned biosensor layer (See how the electrolytic gel 48 is positioned to surround the capture molecule layer 46 and to contact the first electrode 42 in [0051] in Fig. 1);
forming a permeable metallic electrode over the hydrogel layer (See how the second electrode 50 is an open screen electrode in [0051] in Fig. 1).
Yet, Mazzari et al. fails to explicitly teach a method comprising: fabricating a vertical stack by: forming a sample collection layer proximate and in contact with the permeable metallic electrode.
However, in the analogous art of two-sided flow-through immunoassays, Pulitzer et al. teaches a method for fabricating a biosensor device (See the Abstract, the immunoassay test strip 100, the immunoassay device 1700, and the Claim(s) 1-20, in [0043-[0044], [0070], [0086]-[0090], [0097]-[0100], in Fig. 1-3, 8A-B, 15-16, 18, and 23A-B), the method comprising: fabricating a vertical stack (See the immunoassay test strip 100, i.e. a vertical stack in [0043] in Fig. 1; Also, see the vertical immunoassay device 1700 in [0090] in Fig. 18) by:
forming a sample collection layer proximate and in contact with the permeable metallic electrode (See how the sample pad 104, i.e. a sample collection layer, is disposed on one end of the strip 100, for collecting the biologic analyte 106, and how the sample pad 104 is disposed next to the conjugate pad 108 in [0043]-[0044] in Fig. 1; Also, see how the plurality of immunoassay test pads 1704, i.e. a sample collection layer, includes an immunoreactive membrane 1802 in [0090] in Fig. 18).
Thus, it would be obvious to one with ordinary skills in the arts to the modify method for fabricating a biosensor device of Mazzari et al. by incorporating a method step of forming a sample collection layer proximate and in contact with the permeable metallic electrode (as taught by Pulitzer et al.) for the benefit of enabling more efficient collection and handling of a liquid sample a in biosensor device.
Regarding Claim 22-24, The combination of Mazzari et al. and Pulitzer et al. teaches the method limitations of claim 21.
Mazzari et al. further teaches a method (See the Abstract and the Claim(s) 21-27 in [0050]-[0056], [0062]-[0064], [0071]-[0073], [0075], [0078], [0082], [0093], [0128] in Fig. 1-4 and Fig. 12), further comprising immobilizing a biomolecular ligand over and in contact with the patterned biosensor layer; further comprising immobilizing at least two different types of biomolecular ligands over and in contact with the patterned biosensor layer (See the capture molecules 46 in [0051], [0063], [0072], [0078], [0082] and in claim 24).
wherein immobilizing the at least two different types of biomolecular ligands comprises: a) applying at least two different types of capping agents to the patterned biosensor layer, b) selectively removing one of the capping agents, c) immobilizing a biomolecular ligand to the patterned biosensor layer, d) repeating steps b) and c) at least once with a different type of biomolecular ligand (See in Fig. 1-4).
Regarding Claim 26, Mazzari et al. teaches the method limitations of claim 25.
Mazzari et al. further teaches a method (See the Abstract and the Claim(s) 21-27 in [0050]-[0056], [0062]-[0064], [0071]-[0073], [0075], [0078], [0082], [0093], [0128] in Fig. 1-4 and Fig. 12), wherein the biosensor device (See the combination of the sensing component 40 and the biosensor assembly 10, i.e. a biosensor device, in [0051] in Fig. 1) comprises: a patterned biosensor layer (See the combination of the capture molecule layer 46 and the first electrode 42, i.e. a biosensor layer, in [0051] in Fig. 1), a hydrogel layer disposed above and in contact with the patterned biosensor layer (See how the electrolytic gel 48 is positioned to surround the capture molecule layer 46 and to contact the first electrode 42 in [0051] in Fig. 1), a permeable metallic electrode disposed above the hydrogel layer (See how the second electrode 50 is an open screen electrode in [0051] in Fig. 1).
Yet, Mazzari et al. fails to explicitly a method comprising: a biosensor device, comprising: a sample collection layer disposed proximate and in contact with the permeable metallic electrode.
However, in the analogous art of two-sided flow-through immunoassays, Pulitzer et al. teaches a method (See the Abstract, the immunoassay test strip 100, the immunoassay device 1700, and the Claim(s) 1-20, in [0043-[0044], [0070], [0086]-[0090], [0097]-[0100], in Fig. 1-3, 8A-B, 15-16, 18, and 23A-B), comprising: a biosensor device comprising:
a sample collection layer disposed proximate and in contact with the permeable metallic electrode (See how the sample pad 104, i.e. a sample collection layer, is disposed on one end of the strip 100, for collecting the biologic analyte 106, and how the sample pad 104 is disposed next to the conjugate pad 108 in [0043]-[0044] in Fig. 1; Also, see how the plurality of immunoassay test pads 1704, i.e. a sample collection layer, includes an immunoreactive membrane 1802 in [0090] in Fig. 18).
Thus, it would be obvious to one with ordinary skills in the arts to modify method and biosensor device of Mazzari et al. by incorporating a sample collection layer disposed proximate and in contact with the permeable metallic electrode (as taught by Pulitzer et al.) for the benefit of enabling more efficient collection and handling of a liquid sample a in biosensor device.
Regarding Claim(s) 27-28, Mazzari et al. teaches the method limitations of claim 25.
Mazzari et al. further teaches a method (See the Abstract and the Claim(s) 21-27 in [0050]-[0056], [0062]-[0064], [0071]-[0073], [0075], [0078], [0082], [0093], [0128] in Fig. 1-4 and Fig. 12), wherein the measuring device comprises a dongle (See the analysis device 12, i.e. a dongle, in Fig. 4 in [0093]; Also, see how the detachable module 300 that can interface to a handheld impedance measurement device 426 in [0128] in Fig. 12);
wherein activating the measuring device comprises at least one of applying an electrical signal to the biosensor device or illuminating the biosensor device (See in [0074]-[0075]).
Regarding Claim 29, Mazzari et al. teaches the method limitations of claim 25.
Mazzari et al. fails to explicitly a method, wherein the computing device comprises a smartphone.
However, in the analogous art of two-sided flow-through immunoassays, Pulitzer et al. teaches a method (See the Abstract, the immunoassay test strip 100, the immunoassay device 1700, and the Claim(s) 1-20, in [0043-[0044], [0070], [0086]-[0090], [0097]-[0100], in Fig. 1-3, 8A-B, 15-16, 18, and 23A-B), wherein the computing device comprises a smartphone (See the mobile device 802 in [0070]-[0073] in Fig. 8A-B).
Thus, it would be obvious to one with ordinary skills in the arts to modify method of Mazzari et al. by incorporating a computing device comprising a smartphone (as taught by Pulitzer et al.) for the benefit of transmitting data from a biosensor device.
Claim(s) 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mazzari et al. (US20120244547A1) and Pulitzer et al. (US20180364224A1), as applied to claim 18 above, and in further view of Bekki et al. (US20090294305A1).
Regarding Claim(s) 19-20, The combination of Mazzari et al. and Pulitzer et al. teaches the device limitations of claim 18.
The combination of Mazzari et al. and Pulitzer et al. fails to teach a dongle further comprising a spring configured to, in a first position, position the at least one electrode probe to contact the patterned biosensor layer, and, in a second position, to retract the at least one electrode probe; and where the dongle comprises an interface for electrical communication with a computing device.
However, in the analogous art of devices and methods for detecting cell analytes using photocurrents and electrodes, Bekki et al. teaches a device/dongle (See the Abstract, the measuring cell 21, the photocurrent detector 73, and the Claim(s) 48-74, in [0122]-[0141], [0156], [0173], [0196] in Fig. 5-7 and Fig 18A-20), further comprising a spring configured to, in a first position, position the at least one electrode probe to contact the patterned biosensor layer, and, in a second position, to retract the at least one electrode probe (See how the working-electrode contacts 33 are electrically connected with the electrode by using the probes bonded to the electron accepting layer 27 as electric contacts in [0129]-[0131] in Fig. 5-7; Also, see how the working electrode is electrically connected to a spring probe through which the working electrode was connected to a potentiostat (ALS Model 832A, PAS Kabushiki-Kaisha) in [0173], [0196] in Fig. 5-7);
where the dongle comprises an interface for electrical communication with a computing device (See how the detector 73, i.e. a dongle, is in communication with a computer 81, the electrode substrate 86, and the working electrode 79 in [0156] Fig. 18A-20).
Thus, it would be obvious to one with ordinary skills in the arts to modify the combined dongle of Mazzari et al. and Pulitzer et al. by incorporating a spring configured to, in a first position, position the at least one electrode probe to contact the patterned biosensor layer, and, in a second position, to retract the at least one electrode probe (as taught by Bekki et al.) for controlling the electrical communication between a biosensor later and an electrode probe within the device.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 25 is rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention. The instant method is disclosed in Mazzari et al. (US20120244547A1).
Regarding Claim 25, Mazzari et al. teaches a method for detecting an analyte in a sample (See the Abstract and the Claim(s) 21-27 in [0050]-[0056], [0062]-[0064], [0071]-[0073], [0075], [0078], [0082], [0093], [0128] in Fig. 1-4 and Fig. 12), the method comprising the steps of:
depositing the sample onto a top surface of a biosensor device (See Fig 1 in [0051]);
inserting the biosensor device into a measuring device (See how the sensing component may be a discrete separatable or insertable structure in [0093] in Fig. 4);
activating the measuring device to induce the biosensor device to generate a signal indicating at least one of a presence or a quantity of the analyte (See in [0093]); and
transmitting data describing the signal from the measuring dev ice to a computing device (See how the facilitating detection device (FOO) or handheld device measures impedance, the impedance is converted to digital form with the impedance converter, and then the digital form is mathematically converted to modulus and stored to be used in computing the key parameters for detection in [0093] in Fig. 4 and 12).
Conclusion
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/BRITNEY N. WASHINGTON/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797