DETAILED CORRESPONDENCE
Remarks
This Office Action fully acknowledges Applicant’s remarks filed on August 7th, 2025. Claims 21-34, 41, 42, 44-47, 51, 53, 55, 56, 58, and 59 are pending. Claims 1-20, 35-40, 43, 48-50, 52, 54, 57, 60, and 61 are canceled.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 7th, 2025.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
1) Detection assembly…configured to detect a signal… as in claims 29-32.
2) Sample collection unit for receiving a portion of the fluid…as in cl. 21.
3) Identifier detector that obtains identifier information from the information storage unit of the cartridge…as in cls. 21, 47.
4) Identifier configured to be detected by the identifier detector…as in cl. 58.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
1) The “detection assembly…configured to detect…” appears to be drawn to one more sensors selected from the group consisting of temperature, conductivity, potentiometric, and amperometric sensors, as well as those detectors described in pars. [0113,0114] (see Applicant’s pre-grant publication US 2013/0115685).
2) At least one chamber, such as seen in par. [0075] for example, and equivalents thereof.
3) A bar code scanner or LED, as seen in par.[0106,0109], and equivalents thereof.
4) A bar code, series of alphanumeric values, colors, raised bumps, as seen in par.[0106], and equivalents thereof.
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.
Claims 21-34, 41, 42, 44-47, 51, 53, 55, 56, 58, and 59 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 pre-AIA the applicant regards as the invention.
The metes and bounds of the structural constitution of the claimed system for its recited functionalities are indefinitely defined at present.
The structural arrangement of the recited assembly/reader assembly of independent claims 21, 47, and 58 (and thus dependents thereof) is indefinitely defined herein.
Independent claims 47 and 58 provide parts listings to the reader assembly and it is unclear how the processor, analyte detector, communication interface, and identifier detector are structurally/functionally related so as to form the operative reader assembly.
This is additionally seen with respect to the cartridge wherein its structural/functional relationship with the reader assembly is indefinitely provided so as to form the operative system as recited herein.
Additionally, as in cls. 21, 47, and 55 the recitation in each of the independent claims to “…wherein the computer server generates a notification to indicate…” is indefinitely provided for herein.
The recitation “the analyte amount” lacks proper antecedent basis in the claim, and wherein the claims do not set forth any step(s) of quantifying an analyte amount so as to allow basis for computer server-generated notification as claimed.
Further, for purposes of Examination, the recitation is taken as optional as it is predicated on a conditional process (“…when the analyte amount present…”) that is not positively necessitated.
Additionally, as in independent claims 47, the structural/functional relationship of the “reactant” within the cartridge is indefinitely defined. The recitation to “reactant for use with the sample received by…” is drawn to an intended usage recitation and does not suffice in clarifying the metes and bounds of its structural/functional relationship within the cartridge. For example, is the reactant in fluid communication with the “at least one channel?”
Further, in claims 21 and 58, the recitation “fluid is directed within the cartridge for contacting the reagent, after the cartridge is inserted into the assembly” (and similar language as in cl. 58) is indefinitely understood.
Initially, it is noted that such recitation is drawn to a narrative discussion of a process step that has no particular connection within the confines of the claimed system.
Further, the claimed system is without any element having the functionality or capability for directing fluid within the cartridge, let alone coincident with a particular event as in the insertion of the cartridge into the assembly.
This is similarly seen in claim 47 with respect to the selection of a protocol from the plurality, and the processor “thereby control how the sample is directed within the cartridge…” in which such is indefinitely provided for as the system itself is absent any structure(s) having the ability to direct sample within the cartridge let alone with respect to performing an assay.
Lastly, in independent claims 21, 47, and 58, the recited protocols and computer-selection thereof as claimed are indefinitely provided.
In claim 21, the protocol(s) are codified as comprising instructions executable by the processor for analyzing the fluid, and the computer server selects one of these protocols and “electronically transmits…to the communication interface…wherein the computer server generates a notification to indicate…when the analyte amount is statistically different…”
However, the claimed system is without any analytical element(s) that provide for the desired “analyzing” and coincidently-found “analyte amount” (noted above as lacking proper antecedent basis).
There is no correlation provided by the protocol(s) comprising instructions “for analyzing” and the affected operations of the system once a protocol has been selected by the computer server in order to carry out such an analysis and ascertain an analyte amount.
This is likewise seen in independent claim 47, as well as in independent claim 58 that provides a more generic recitation to protocols comprising “instructions” without any correlation to affected operations of the system that amount to allow for assessment of an analyte amount against a predetermined threshold and the generation of a notification therewith.
Claims 21, 47, and 58 (and dependents thereof), 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 pre-AIA the applicant regards as the invention.
The metes and bounds of the claimed system are indefinitely defined. Herein, it is unclear how the cartridge is related with respect to the reader (and as in the “fluidic device” and “reader assembly” as in cl. 58) so as to allow for the “…wherein the computer server selects a protocol…based on the identifier information received from the identifier detector and electronically transmits…” The claims do not provide a connection or functionality between the information storage unit of the cartridge which stores identifier information and functionality of the communication interface/computer server so as to provide for such “information received” and thus the protocol selection as claimed. Separately, but related, it is noted that the assembly/reader assembly are not positively coupled with one another in the system.
Herein, such identifier detector of the reader assembly obtains the identifier information from the information storage unit of the cartridge, but the claims do not provide functionality between the identifier detector (in the reader assembly) and the computer server for such transfer and reception of this identifier information at the computer server so as to provide for such protocol selection.
Does the communications interface have the further functionality of receiving this identifier information from the identifier detector and transmitting it to the computer server?
Clarification is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 21-26, 28-34, 41, 45-47, 51, 53, 55, 56, 58, and 59 are rejected under 35 U.S.C. 103(a) as being unpatentable over Reber et al. (USPN 5,961,451), hereafter Reber in view of Terbrueggen et al. (US 2004/0053290), hereafter Terbrueggen, and in view of Padmanabhan et al. (US 2003/0142291), hereafter Padmanabhan
With regards to claims 21-26, 28-35, 41, and 45-61, Reber et al. teaches a similar device configuration comprising a reader assembly/assembly given by interface 36 as a two-way communication interface (see, for example, in line 30, col. 4 – line 3, col. 5 and seen by the double-sided arrow between the interface 36 and the external device 40 in figure 1) figure 1 to receive assay protocols from an external device, and a detection assembly, and an associated insertable fluidic device/cartridge comprising biosensor 16 comprising a sample collection unit for receiving a sample, a reactant for use with the sample (e.g. an antigen for the immunoassay) (see, e.g., col. 2, lines 62-67; col. 3, lines 5-67; col. 5, lines 4 – 65; figure 2), wherein the detection assembly of cls. 29-32 comprises pairs of electrodes 72 as sensors for taking conductance (conductivity sensors as the at least one analyte detector; detection by optical means also envisioned, as in cls. 41&45) measurements of the biosensor (lines 19-32, col. 6, fig. 2). Additionally, Reber discloses a power button 34 as an actuator element for initiating the processing on the biosensor, wherein such initiation causes the electrodes to apply voltage so as to affect a fluid movement on the biosensor and thereby detect a resulting signal therefrom. Further, Reber discloses a processor 26 and a memory 30 coupled with the biosensor (biosensor 16 and memory 30 constitute an assay device, as claimed, in which the biochip contains at least one reactant and at least one structure for receiving a portion of bodily fluid) (see figures 1,2,&5-7, for example). The memory 30 can also serve to store a program that directs the processor 26 in operating the biosensor 16 (see, e.g., col. 4, lines 7 – 18; col. 6, lines 19 – 33). With regard to claim 33, the reader assembly is located at a point-of-care location as given by the location at which such device of Reber resides in its physical confines and is remote from the external device/computer server. The disclosed apparatus further comprises an interface 36 as a communication interface of cls. 21, 34, 47, and 58 for interfacing with an external device 40 (see figure 1). The external device 40 can comprise a wireless data network or a satellite network (external device as at least one computer server capable of transmitting the information concerning the signal to a patient and a medical practitioner simultaneously) (see col. 4, lines 42 - 55). Data can be communicated between the processor 26 and the external device 40 via a communication assembly comprising interface 36 and the processor provides for performing the reaction at a designated point-of-care location remote from a location of the external device (as the reaction takes place within the housing 42, remote from the external device as designated by the processor). The interface 36 can comprise a data port for a wireless telephone (see col. 4, lines 56 – 65; col. 7, lines 7– 52). The processor 26 can download a software program from the external device 40 to direct the operation of the disclosed apparatus including the biosensor. The processor 26 can communicate sensed data or stored data to the external device 40 (see col. 4, lines 31 – 41). The downloaded program directs the operation of the apparatus in performing subsequent tests (see col. 7, lines 60 – 67; col. 9, lines 25 – 35). Reber teaches that the programmability of the apparatus advantageously allows a plurality of different tests to be performed using a single apparatus (i.e. multiple protocols as in item (e); see col. 8, lines 13 – 20). Reber further teaches the incorporation and use of a wireless link (see, e.g., col. 4, lines 42 – 65; col. 7, lines 42 – 52). Reber teaches that the processor 26 transmits or downloads the require software program from the external device 40 required for performing the desired assay (see col. 4, lines 30 – 40; col. 8, lines 13 – 19). With regard to claim 53, the bodily fluid is not a positively claimed element of the system and the device of Reber is fully capable of being used with such a fluid in as much as required and recited herein.
Reber does not specifically disclose that the cartridge/fluidic device includes an information storage unit and an identifier detector, and wherein such information storage unit is a bar code, as in claims 21, 26, 47, and 58. Reber does not specifically disclose that the cartridge/fluidic device includes a lysing assembly as in claim 21. Further, while Reber discloses downloading protocols to the assembly to provide for further and future assays to be carried out, Reber does not specifically disclose that the processor of the reader assembly is programmed to utilize a signal arising from the obtaining of the identifier information from the cartridge wherein the computer server selects a protocol from the plurality thereof, as in claims 21, 47, and as in cls. 50 and 51. Reber also does not specifically disclose actuators controlled by the processor and configured to interact with the cartridge/fluidic device to direct fluid movement, and including a waste chamber, as in cls. 21,48, ,49, 52, 54-57, 57, 58, 60, and 61. Reber does not specifically disclose that the cartridge comprises fluidic channels (or at least one fluidic channel) in communication with the sample collection unit/sample chamber, as in claims 46/47. With regards to claims 55-57, and 59-61, while Reber discloses it is desired to be able to clean the biosensor, Reber does not disclose that the fluidic device comprises a waste chamber and an actuator configured to interact therewith.
Terbrueggen discloses devices and methods for biochip multiplexing (abstract). Terbrueggen disclose that the device comprises a barcode reader to read to read a corresponding barcode on the cartridge, and these barcodes are used to identify the sample, test being done, and assay protocols. Terbrueggen further discloses that the barcodes can be used to control the instrument (i.e. system comprising a reader assembly and cartridge) and the bar codes on the cartridge can be used to start and stop the assay. Terbrueggen further discloses that one or more modems, internet card, infrared ports, etc. may be included in the device to allow the transmission of data and other relevant information, such as the barcode information, assay conditions and protocols to a remote location (pars. [0428,0429,0446,0451,0457,0458], figures, for example).
Padmanabhan discloses a portable scattering and fluorescence cytometer (abstract). Padmanabhan discloses that a controller or processor receives signals from the appropriate valves (actuators) so that the desired fluid of the sample and supporting fluids are delivered within the fluidic circuit of cartridge 14 (such valves interact with the fluid driver, i.e. pump, and the fluidic circuit of the cartridge structure element that is for receiving at least a portion of the bodily fluid sample) (pars. [0012,0013,0062], figs. 2-4, for example). Padmanabhan further discloses that the fluidic device comprises a waste chamber and an actuator configured to cause fluid flow to the waste chamber and interact therewith (pars. [0012,0013,0062,0054], for example).
It would have been obvious to one of ordinary skill in the art to modify Reber to include an information storage unit comprising a bar code (further, an identifier for the assay device as a bar code as a more particular form of identifier) and a bar code reader as part of the reader assembly as well as the bar codes being utilized to control the instrument, wherein such bar codes provide the assay protocols to the on-board processor such as taught by Terbrueggen in order to provide for labeling the cartridges to provide relevant data to the user and/or computer processor as well as providing for allowing control of the system by way of the bar code information (including assay protocols) so as to allow for automated and efficient, particular processing of the cartridges placed in the device.
Wherein, it is further noted that Reber is not deficient in disclosing at least one external computer server, as in cls. 21 and 58, Terbrueggen further discloses that such assay protocols stored within the barcode can be communicated to at least one computer server (pars. [0457,0458]), wherein transmission thereto and subsequent control of the system coincident with the bar code information likewise constitutes the processor being programmed to utilize a signal arising from obtaining the identifier information from the cartridge, thus giving indication of the coupling of the cartridge to the reader to initiate retrieval of protocol(s) coincident therewith, in as much as recited in claims 21, 50 (flow as provided below with Padmanabhan), and 51. Further, as in claim 58, the recitation is provided as process recitation not afforded particular patentable weight and further noting that such recitation does not have any connection with the identifier/identifier detector among the fluidic device and reader assembly.
It would have been obvious to one of ordinary skill in the art to modify Reber to include one or more actuation elements controlled by the processor configured to interact with cartridge/fluidic device to direct fluid movement (as in cls. 21, 47, 52, 56, 60, and 61), and wherein the cartridge comprises fluidic channels in communication with the cartridge such as taught by Padmanabhan in order to provide to an active fluid control scheme in which the valves may be activated at particular times or coincident with pressure drops/desired flow rates such that the samples and supporting samples are properly provided to the cartridge.
Further, it is noted that the claims do not provide any particular structure(s) or functionality to such claimed lysing assembly and wherein Padmanabhan discloses a biosensor with antibody markers (in a likewise biosensor to that of Reber) and including a collection unit for receiving a fluid and including a lysing assembly such as red blood cell lysing assembly (pars. [0048-0050]) in order to preprocess the sample and provide it in a proper state before assaying and analysis thereof. To this end, modification by way of Padmanabhan would have been obvious to one of ordinary skill in the art to allow for processing of the sample to place it in proper condition for the particular biosensing assay at-hand.
Additionally, it would have been obvious to one of ordinary skill in the art to modify the fluidic device of Reber to comprise a waste chamber and actuator configured to interact there with as in cls. 52, 54-57, 59-61 such as taught by Padmanabhan as Reber discloses application with blood samples and it is desired to be able to clean the biosensor (lines 1-9, col. 7, for example), modification by Padmanabhan provides an integrate and on-board structural arrangement that allows for moving the biological fluids such as blood, which can spread disease, to a waste chamber so as to allow for proper disposal thereof away from the sensing chemistries (i.e. antibodies), avoiding unwanted interactions, and allowing for subsequent further usage at the sensing area.
Claim 27 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Reber in view of Terbrueggen and Padmanabhan as applied to claims 21-26, 28-34, 41, 45-47, 51, 53, 55, 56, 58, and 59 above, and further in view of Fish (US 2004/0132220).
Reber/ Terbrueggen/Padmanabhan does not specifically disclose that the information storage unit comprises a semiconductor memory device.
Fish discloses a diagnostic instrument for detecting analytes (abstract). Fish discloses a portable analyzer that has a microprocessor 82b and a memory device 82 embedded within the housing to control the operation of the instrument (par. [0113], figs. 16A.B, for example).
It would have been obvious to one of ordinary skill in the art to modify Reber/Terbrueggen to utilize a semiconductor memory device as the information storage unit such as taught by Fish in order to provide an obvious alternative form of information storage in which a semiconductor memory allows for enhanced storage of information thereon.
Claims 42 and 44 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Reber in view of Terbrueggen, Padmanabhan as applied to claims 21-26, 28-34, 41, 45-47, 51, 53, 55, 56, 58, and 59above, and further in view of Yguerabide et al. (US 2003/0112432), hereafter Yguerabide.
Reber/ Terbrueggen/ Padmanabhan does not specifically disclose optical detectors as a photodiode or CCD.
Yguerabide discloses an apparatus for reading signals generated from resonance scattered light particle labels (abstract). Yguerabide discloses an optical detection system that may utilize a CCD, photodiode, or PMT for particular analysis of signals from the sample under investigation (abstract; pars. [0019,0034,0063], for example).
It would have been obvious to one of ordinary skill in the art to modify Reber/Terbrueggen/Padmanabhan to utilize an optical detector comprising a photodiode or CCD such as taught by Yguerabide such that Reber discloses it is desirable to provide optical detection of the biosensor and optical detections systems involving a photodiode, PMT, or a CCD are well-known and conventional optical detectors which would suitably provide for accurate optical detection for the assays being carried out on the biosensor cartridge of Reber/ Terbrueggen/Padmanabhan.
Claims 21-26, 28-34, 41, 45-47, 51, 53, 55, 56, 58, and 59 are rejected under 35 U.S.C. 103(a) as being unpatentable over Reber et al. (USPN 5,961,451), hereafter Reber in view of Terbrueggen et al. (US 2004/0053290), hereafter Terbrueggen, and in view of Padmanabhan et al. (US 2003/0142291), hereafter Padmanabhan, Mault (US 2001/0044588).
With regards to claims 21-26, 28-35, 41, and 45-61, Reber et al. teaches a similar device configuration comprising a reader assembly/assembly given by interface 36 as a two-way communication interface (see, for example, in line 30, col. 4 – line 3, col. 5 and seen by the double-sided arrow between the interface 36 and the external device 40 in figure 1) figure 1 to receive assay protocols from an external device, and a detection assembly, and an associated insertable fluidic device/cartridge comprising biosensor 16 comprising a sample collection unit for receiving a sample, a reactant for use with the sample (e.g. an antigen for the immunoassay) (see, e.g., col. 2, lines 62-67; col. 3, lines 5-67; col. 5, lines 4 – 65; figure 2), wherein the detection assembly of cls. 29-32 comprises pairs of electrodes 72 as sensors for taking conductance (conductivity sensors as the at least one analyte detector; detection by optical means also envisioned, as in cls. 41&45) measurements of the biosensor (lines 19-32, col. 6, fig. 2). Additionally, Reber discloses a power button 34 as an actuator element for initiating the processing on the biosensor, wherein such initiation causes the electrodes to apply voltage so as to affect a fluid movement on the biosensor and thereby detect a resulting signal therefrom. Further, Reber discloses a processor 26 and a memory 30 coupled with the biosensor (biosensor 16 and memory 30 constitute an assay device, as claimed, in which the biochip contains at least one reactant and at least one structure for receiving a portion of bodily fluid) (see figures 1,2,&5-7, for example). The memory 30 can also serve to store a program that directs the processor 26 in operating the biosensor 16 (see, e.g., col. 4, lines 7 – 18; col. 6, lines 19 – 33). With regard to claim 33, the reader assembly is located at a point-of-care location as given by the location at which such device of Reber resides in its physical confines and is remote from the external device/computer server. The disclosed apparatus further comprises an interface 36 as a communication interface of cls. 21, 34, 47, and 58 for interfacing with an external device 40 (see figure 1). The external device 40 can comprise a wireless data network or a satellite network (external device as at least one computer server capable of transmitting the information concerning the signal to a patient and a medical practitioner simultaneously) (see col. 4, lines 42 - 55). Data can be communicated between the processor 26 and the external device 40 via a communication assembly comprising interface 36 and the processor provides for performing the reaction at a designated point-of-care location remote from a location of the external device (as the reaction takes place within the housing 42, remote from the external device as designated by the processor). The interface 36 can comprise a data port for a wireless telephone (see col. 4, lines 56 – 65; col. 7, lines 7– 52). The processor 26 can download a software program from the external device 40 to direct the operation of the disclosed apparatus including the biosensor. The processor 26 can communicate sensed data or stored data to the external device 40 (see col. 4, lines 31 – 41). The downloaded program directs the operation of the apparatus in performing subsequent tests (see col. 7, lines 60 – 67; col. 9, lines 25 – 35). Reber teaches that the programmability of the apparatus advantageously allows a plurality of different tests to be performed using a single apparatus (i.e. multiple protocols as in item (e); see col. 8, lines 13 – 20). Reber further teaches the incorporation and use of a wireless link (see, e.g., col. 4, lines 42 – 65; col. 7, lines 42 – 52). Reber teaches that the processor 26 transmits or downloads the require software program from the external device 40 required for performing the desired assay (see col. 4, lines 30 – 40; col. 8, lines 13 – 19). With regard to claim 53, the bodily fluid is not a positively claimed element of the system and the device of Reber is fully capable of being used with such a fluid in as much as required and recited herein.
Reber does not specifically disclose that the cartridge/fluidic device includes an information storage unit and an identifier detector, and wherein such information storage unit is a bar code, as in claims 21, 26, 47, and 58. Reber does not specifically disclose that the cartridge/fluidic device includes a lysing assembly as in claim 21. Further, while Reber discloses downloading protocols to the assembly to provide for further and future assays to be carried out, Reber does not specifically disclose that the processor of the reader assembly is programmed to utilize a signal arising from the obtaining of the identifier information from the cartridge wherein the computer server selects a protocol from the plurality thereof, as in claims 21, 47, and as in cls. 50 and 51. Reber also does not specifically disclose actuators controlled by the processor and configured to interact with the cartridge/fluidic device to direct fluid movement, and including a waste chamber, as in cls. 21,48, ,49, 52, 54-57, 57, 58, 60, and 61. Reber does not specifically disclose that the cartridge comprises fluidic channels (or at least one fluidic channel) in communication with the sample collection unit/sample chamber, as in claims 46/47. With regards to claims 55-57, and 59-61, while Reber discloses it is desired to be able to clean the biosensor, Reber does not disclose that the fluidic device comprises a waste chamber and an actuator configured to interact therewith.
Further, with regards to claims 21, 47, and 58, to the extent that “…the computer server generates a notification to indicate…” is necessitated by the claims, if Reber is not taken as disclosing this aspect than such a modification would have been obvious.
Terbrueggen discloses devices and methods for biochip multiplexing (abstract). Terbrueggen disclose that the device comprises a barcode reader to read to read a corresponding barcode on the cartridge, and these barcodes are used to identify the sample, test being done, and assay protocols. Terbrueggen further discloses that the barcodes can be used to control the instrument (i.e. system comprising a reader assembly and cartridge) and the bar codes on the cartridge can be used to start and stop the assay. Terbrueggen further discloses that one or more modems, internet card, infrared ports, etc. may be included in the device to allow the transmission of data and other relevant information, such as the barcode information, assay conditions and protocols to a remote location (pars. [0428,0429,0446,0451,0457,0458], figures, for example).
Padmanabhan discloses a portable scattering and fluorescence cytometer (abstract). Padmanabhan discloses that a controller or processor receives signals from the appropriate valves (actuators) so that the desired fluid of the sample and supporting fluids are delivered within the fluidic circuit of cartridge 14 (such valves interact with the fluid driver, i.e. pump, and the fluidic circuit of the cartridge structure element that is for receiving at least a portion of the bodily fluid sample) (pars. [0012,0013,0062], figs. 2-4, for example). Padmanabhan further discloses that the fluidic device comprises a waste chamber and an actuator configured to cause fluid flow to the waste chamber and interact therewith (pars. [0012,0013,0062,0054], for example).
Mault discloses a monitoring system for allowing a person to remotely monitor a physiological parameter of a subject, and including a server software program configured to analyze data and send an alert to the computing device if the data indicates a value outside of the acceptable range (see abstract, pars. [0053,0056,0064], claim 13, for example).
It would have been obvious to one of ordinary skill in the art to modify Reber to include an information storage unit comprising a bar code (further, an identifier for the assay device as a bar code as a more particular form of identifier) and a bar code reader as part of the reader assembly as well as the bar codes being utilized to control the instrument, wherein such bar codes provide the assay protocols to the on-board processor such as taught by Terbrueggen in order to provide for labeling the cartridges to provide relevant data to the user and/or computer processor as well as providing for allowing control of the system by way of the bar code information (including assay protocols) so as to allow for automated and efficient, particular processing of the cartridges placed in the device.
Wherein, it is further noted that Reber is not deficient in disclosing at least one external computer server, as in cls. 21 and 58, Terbrueggen further discloses that such assay protocols stored within the barcode can be communicated to at least one computer server (pars. [0457,0458]), wherein transmission thereto and subsequent control of the system coincident with the bar code information likewise constitutes the processor being programmed to utilize a signal arising from obtaining the identifier information from the cartridge, thus giving indication of the coupling of the cartridge to the reader to initiate retrieval of protocol(s) coincident therewith, in as much as recited in claims 21, 50 (flow as provided below with Padmanabhan), and 51. Further, as in claim 58, the recitation is provided as process recitation not afforded particular patentable weight and further noting that such recitation does not have any connection with the identifier/identifier detector among the fluidic device and reader assembly.
It would have been obvious to one of ordinary skill in the art to modify Reber to include one or more actuation elements controlled by the processor configured to interact with cartridge/fluidic device to direct fluid movement (as in cls. 21, 47, 52, 56, 60, and 61), and wherein the cartridge comprises fluidic channels in communication with the cartridge such as taught by Padmanabhan in order to provide to an active fluid control scheme in which the valves may be activated at particular times or coincident with pressure drops/desired flow rates such that the samples and supporting samples are properly provided to the cartridge.
Further, it is noted that the claims do not provide any particular structure(s) or functionality to such claimed lysing assembly and wherein Padmanabhan discloses a biosensor with antibody markers (in a likewise biosensor to that of Reber) and including a collection unit for receiving a fluid and including a lysing assembly such as red blood cell lysing assembly (pars. [0048-0050]) in order to preprocess the sample and provide it in a proper state before assaying and analysis thereof. To this end, modification by way of Padmanabhan would have been obvious to one of ordinary skill in the art to allow for processing of the sample to place it in proper condition for the particular biosensing assay at-hand.
Additionally, it would have been obvious to one of ordinary skill in the art to modify the fluidic device of Reber to comprise a waste chamber and actuator configured to interact there with as in cls. 52, 54-57, 59-61 such as taught by Padmanabhan as Reber discloses application with blood samples and it is desired to be able to clean the biosensor (lines 1-9, col. 7, for example), modification by Padmanabhan provides an integrate and on-board structural arrangement that allows for moving the biological fluids such as blood, which can spread disease, to a waste chamber so as to allow for proper disposal thereof away from the sensing chemistries (i.e. antibodies), avoiding unwanted interactions, and allowing for subsequent further usage at the sensing area.
Lastly, it would have been obvious to one of ordinary skill in the art to modify Reber to provide that the computer server generates a notification to indicate as recited in claims 21, 47, and 48 such as suggested by the analogous art of Mault so as to provide simple and fast communication to persons of interest such as in physicians, relatives, and caregivers in order to better serve and inform the user/patient that is under review.
Claim 27 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Reber in view of Terbrueggen , Padmanabhan, and Mault as applied to claims 21-26, 28-34, 41, 45-47, 51, 53, 55, 56, 58, and 59above, and further in view of Fish (US 2004/0132220).
Reber/ Terbrueggen/Padmanabhan/Mault does not specifically disclose that the information storage unit comprises a semiconductor memory device.
Fish discloses a diagnostic instrument for detecting analytes (abstract). Fish discloses a portable analyzer that has a microprocessor 82b and a memory device 82 embedded within the housing to control the operation of the instrument (par. [0113], figs. 16A.B, for example).
It would have been obvious to one of ordinary skill in the art to modify Reber/Terbrueggen/Mault to utilize a semiconductor memory device as the information storage unit such as taught by Fish in order to provide an obvious alternative form of information storage in which a semiconductor memory allows for enhanced storage of information thereon.
Claims 42 and 44 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Reber in view of Terbrueggen, Padmanabhan, and Mault as applied to claims 21-26, 28-34, 41, 45-47, 51, 53, 55, 56, 58, and 59above, and further in view of Yguerabide et al. (US 2003/0112432), hereafter Yguerabide.
Reber/ Terbrueggen/ Padmanabhan/Mault does not specifically disclose optical detectors as a photodiode or CCD.
Yguerabide discloses an apparatus for reading signals generated from resonance scattered light particle labels (abstract). Yguerabide discloses an optical detection system that may utilize a CCD, photodiode, or PMT for particular analysis of signals from the sample under investigation (abstract; pars. [0019,0034,0063], for example).
It would have been obvious to one of ordinary skill in the art to modify Reber/Terbrueggen/Padmanabhan/Mault to utilize an optical detector comprising a photodiode or CCD such as taught by Yguerabide such that Reber discloses it is desirable to provide optical detection of the biosensor and optical detections systems involving a photodiode, PMT, or a CCD are well-known and conventional optical detectors which would suitably provide for accurate optical detection for the assays being carried out on the biosensor cartridge of Reber/ Terbrueggen/Padmanabhan.
Response to Arguments
Applicant's arguments filed August 7th, 2025 have been fully considered but they are not persuasive.
With regards to claims 21-34, 41, 42, and 44-61 rejected under 35 USC 112 b/2nd paragraph, Applicant asserts that the claims are definite.
Applicant reiterates arguments as presented in the Reply of March 8th, 2024, and cites items (1)-(6).
Examiner reiterates those remarks provided in the Office Action mailed on February 7th, 2025, and herein directs Applicant to the body of the action that provides discussion to the presently-amended claims and their rejection under 35 USC 112 b/2nd paragraph and which provide for items (1)-(6) in as much as necessitated herein.
With regards to claims 21-26, 28-34, 41, and 45-61 rejected under 35 USC 103 as unpatentable over Reber in view of Terbruggen, Padmanabhan and in further view of Fish, Applicant reiterates those arguments made in the previous Replies.
Examiner reiterates the remarks to the arguments made in the previous Replies (as in past Office Actions mailed from April 2020 to the present) as the response herein is substantively the same as in Applicant’s prior Replies and Applicant is directed to such past, and Examiner maintains that the claims are properly rejected as discussed therein and above in the body of the action
Further, with regard to the recitation in claim 21 to “…wherein the computer server generates a notification to indicate…” the recitation is taken as optional as it is predicated on a conditional process (“…when the analyte amount present…”; and wherein “the analyte amount” is indefinitely recited as discussed above under 35 USC 112 b/2nd) that is not positively necessitated in the claim.
However, to this end, Examiner notes analogous prior art to that provided above is found with such a teaching to one of ordinary skill in the art should the claims be amended in a manner to necessitate this step and action.
See, for example, Mault (US 2001/0044588) to a monitoring system for allowing a person to remotely monitor a physiological parameter of a subject, and including a server software program configured to analyze data and send an alert to the computing device if the data indicates a value outside of the acceptable range (see abstract, pars. [0053,0056,0064], claim 13, for example).
Further, to this end, while not appearing to be actively necessitated by the claims, Examiner has added a second rejection of the claims under 35 USC 103 akin to that discussed above but with the addition of the prior art of Mault for the recitation of “the computer server generates a notification…” as in claims 21, 47, and 58, and is said to be an obvious modification for the reasons discussed above in the body of the action.
Thus, for the reasons discussed above, independent claims 21, 47, and 58 and dependents thereof are maintained rejected as well as as seen in the discussion in the body of the action.
Conclusion
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/NEIL N TURK/Primary Examiner, Art Unit 1798