DETAILED 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 .
Applicant’s arguments and amendments have been thoroughly reviewed and considered. Claims 3 and 8-10 have been canceled. Claims 1-2 and 4-7 are pending and are examined on the merits herein.
Response to Applicant’s Amendments
Drawing Objections
The drawings were objected to because they did not include a reference sign that was described in the specification. In light of Applicant’s amendments to the drawings submitted 6/9/2026, this objection has been withdrawn.
Claim Objections
Claims 6-7 were objected to for various informalities. In light of Applicant’s amendments to the claims submitted 6/9/2026, these objections have been withdrawn. However, see new grounds of objection below.
35 USC 112(b) Rejections
Claims 4-5 were rejected for various indefiniteness issues. In light of Applicant’s amendments to the claims submitted 6/9/2026, these rejections have been withdrawn, but see new grounds of rejection below related to Applicant’s claim amendments.
35 USC 103 Rejections
Claims 1-3 and 5 were rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (Sensors and Actuators B, 2015) in view of Zhu et al. (US 2018/0208655 A1).
Claim 4 was rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (Sensors and Actuators B, 2015), in view of Zhu et al. (US 2018/0208655 A1), and further in view of Ho et al. (US 2021/0389272 A1).
Claims 6-7 were rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (Sensors and Actuators B, 2015), in view of Zhu et al. (US 2018/0208655 A1), and further in view of Gau et al. (US 2005/0196855 A1).
In light of Applicant’s amendments to the claims submitted 6/9/2026, these rejections have been withdrawn for all currently pending claims, but see “Response to Applicant’s Arguments” and new grounds of rejection below. Claim 3 has been canceled, and so this rejection has been rendered moot.
Response to Applicant’s Arguments
Regarding the 35 USC 103 Rejections, Applicant argues that Cheng fails to teach the newly amended portion of the claim, and in particular how to use a GPNMB antibody. Applicant states that Cheng teaches a FET chip, which is not used in the instant invention, and that the instant invention has advantages over FETs (Remarks, page 7). Applicant also states that Zhu, the secondary reference, does teach anti-GPNMB antibodies, but must detect said antibodies with a spectrophotometer, as opposed to the instant invention, which can detect protein concentrations directly on the chip. Applicant also mentions that Cheng and Zhu belong to different fields of technique, and so there would allegedly be no reason for the ordinary artisan to combine the references (Remarks, page 8).
The fact that Cheng teaches a FET chip, when such a chip is not intended to be encompassed by Applicant’s invention, is irrelevant to the determination of whether or not Cheng teaches a product with the features recited in instant claim 1. This is particularly true as the biochip of claim 1 comprises the listed elements, and so can include additional features (see MPEP 2111.03). Additionally, the fact that Cheng and the instant invention may each have distinct advantages and disadvantages is not pertinent to an obviousness determination. This is because: 1) the rejection over claim 1 presented in the Non-Final Rejection was over Cheng in view of Zhu, and not Cheng alone, and 2) MPEP 2141.02 VI states, “‘[a] given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine.’" (quoting Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165, 77 USPQ2d 1865, 1870 (Fed Cir. 2006),” and MPEP 2144 IV states that rationale to arrive at a claimed invention need not be for the same reasons described by Applicant. Thus, even if Cheng in view of Zhu presents as a whole advantages and disadvantages that differ from those of the claimed invention, that does not obviate the obviousness of the combination of Cheng in view of Zhu, nor is obviousness obviated if the combination of Cheng in view of Zhu is made for a different reason than the motivation behind the instant invention.
Turning to the specific teachings of Cheng in view of Zhu, Cheng teaches a sensor that contains nearly all of the previously claimed features, including the use of antibodies for biomarker detection, and specifically for lung cancer biomarker detection, but did not teach antibodies specific for GPNMB (paras. 17-18 of the Non-Final Rejection). Zhu teaches that anti-GPNMB antibodies can be used to detect GPNMB in the context of lung cancer (para. 19 of the Non-Final Rejection). In combining the teachings of the references (para. 20 of the Non-Final Rejection), both a motivation (“Cheng teaches that additional markers could be added to their biosensor (e.g. page 330, column 1, para. 1 and page 333, “Conclusions”), which can increase diagnostic power (page 332, column 2, para. 2), and would thus be motivating to the ordinary artisan.”) and a reasonable expectation of success (“Zhu teaches many potential designs for anti-GPNMB antibodies (e.g. those in para. 8), providing evidence that the creation or procurement of such an antibody would be possible for the ordinary artisan. Additionally, as both Cheng and Zhu teach the use of serum samples in their methods, there would be a reasonable expectation of success in combining the teachings of the references.”) were provided. It is not suggested that the spectrophotometer methods of Zhu be used, but simply that the antibodies taught by the reference be used as additional antibodies in the method of Cheng.
In determining a reference can be used in an obviousness rejection, MPEP 2141.01(a) I provides the following guidance, “In order for a reference to be proper for use in an obviousness rejection under 35 U.S.C. 103, the reference must be analogous art to the claimed invention. In re Bigio, 381 F.3d 1320, 1325, 72 USPQ2d 1209, 1212 (Fed. Cir. 2004). A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). Note that "same field of endeavor" and "reasonably pertinent" are two separate tests for establishing analogous art; it is not necessary for a reference to fulfill both tests in order to qualify as analogous art. See Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212.” Note that this determination depends on whether the references are analogous to the claimed invention, and not to each other. In the instant case, Cheng teaches sensors for biomarker detection. Zhu teaches the use of antibodies for biomarker detection. As both are drawn to target detection, they are considered to be in the same field of endeavor as the claimed invention, which teaches the detection of GPNMB.
Thus, Applicant’s arguments against the use of Cheng and Zhu are not considered persuasive. The relevant portions of the rejections recited in the Non-Final Rejection mailed 3/11/2026 are reiterated below. In relating the previously cited references to the newly amended claims, Cheng in view of Zhu teaches the use of a GPNMB antibody that can bind to a GPNMB protein. Cheng also notes that the electrical signals associated with their sensor can be correlated with antigen concentrations, particularly in human serum (see Figures 2 and 4, for example). The sensor of Cheng also uses silicon as a substrate – see page 330, column 2, para. 1. These teachings are incorporated into rejections below, along with new rationale to address all of the newly added claim limitations. These amendments have thus required the new grounds of rejection below.
Claim Interpretation
The biochip of claim 1 is stated in the preamble to be for “tracking postoperative recurrence status of a patient with lung adenocarcinoma.” MPEP 2111.02 I and II state that in the case where the preamble limits the structure of the claim, said preamble must be considered limiting. However, if the preamble does not limit the structure of the claim, then the preamble is considered intended use. In the instant case, “tracking postoperative recurrence status of a patient with lung adenocarcinoma” does not limit the structure of the biochip (e.g. it does not impart an additional structural feature to the biochip), and instead merely describes an intended use of the biochip when said biochip measures expression amounts. This preamble is therefore not considered limiting for the purposes of applying prior art.
Additionally, Applicant does not specifically define the terms used in the instant claims for referring to portions of the biochip – i.e. the bare plate layer and sensing electrode of claim 1, the lower cover layer, middle interlayer, and upper cover layer of claim 6, and the relative electrode, reference electrode, micro-channel, and sample dripping area of claim 7. Because of this, prior art will be considered to read on these limitations in each claim if said prior art contains components that read on the broadest reasonable interpretation of each term. For example, as a “relative electrode” is not defined by the instant specification, this may simply refer to any electrode that serves any function. Specifically:
In claim 1, a “sensing electrode” is considered to require the claimed biological agent and the conduction of any electrical signal. The “base plate layer” does not require any additional features except the presence of the sensing electrode (which contains a silicon substrate with the GPNMB antibody).
In claim 7, “reference electrode” appears to be a term used in the prior art to refer to an electrode with a known potential, and so this interpretation will be used in evaluating the prior art.
In claim 1, it is stated that “the sensing electrode uses silicon as a substrate.” The term “substrate” is not specifically defined in the instant specification, and so the term is interpreted to mean a surface or layer in the sensing electrode. Later in the claim it is stated that “the antibody is fixed on the substrate,” with no specific definition for the term “fixed.” Thus, this term will be interpreted to refer to any means by which the antibody is directly or indirectly attached to the substrate.
Claim Objections
Claim 1 is objected to because of the following informalities: in line 6, it is recommended that the word “and” appear before “the antibody is fixed on the substrate” and that a semicolon appear after “to form a biosensor,” and that “when an antigen in a sample” read “and wherein when an antigen in a sample.” Appropriate correction is required.
Claim 5 is objected to because of the following informality: in lines 2-3, “detection of GPNMB gene” should read “detection of the GPNMB gene.” Appropriate correction is required.
Claim 7 is objected to because of the following informality: before the newly amended portion of the claim, the word “and” should be inserted. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2 and 4-7 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 1 is rejected due to the phrase “the biosensor transmits different electrical signals according to different contents of a GPNMB protein in the sample.” This is because the claim refers to the use of a single sample for this signal detection, which would have a single GPNMB protein concentration. It is thus unclear where the “different contents of a GPNMB protein” would be originating from, and thus the claim is indefinite.
Claims 2 and 4-7 are rejected due to their dependence on rejected claim 1.
Claim 2 is also rejected because the claim is drawn to using the biological agent to detect expression of GPNMB mRNA. As the biological agent is specified in claim 1 to be an antibody for detecting GPNMB protein, it is unclear how this biological agent would also be capable of directly detecting mRNA expression.
Claim 7 is also rejected because of the phrase “the relative electrode, the reference electrode, and the sensing electrode transmit different electrical signals according to different contents of the GPNMB protein in the sample.” Specifically, this claim depends on claim 1, which states that the biosensor, which is formed from the fixture of the antibody on the substrate of the sensing electrode, transmits different electrical signals according to different contents of the GPNMB protein in the sample. In claim 7, the relative and reference electrodes are added to the performance of this function, but these electrodes are not specified to contain any antibodies which would perform this function as described in claim 1. Additionally, the relative and reference electrodes are not stated to be part of the biosensor of claim 1 that performs this function. Furthermore, the sample is only noted to flow to the sensing electrode, and is not stated to be at all involved with the relative and reference electrodes. Thus, it is overall unclear how this phrase is resolved relative to the components and limitations already described in claim 1, and so claim is considered indefinite. The claim will be interpreted as though the detection of the electric signals related to GPNMB is still only resulting from the use of the sensing electrode, and that the relative and reference electrode, while producing detectable electrical signals, do not necessarily require those signals to be directly associated with GPNMB.
Claim 7 is additionally rejected for the phrase “transmits different electrical signals according to different contents of the GPNMB protein in the sample” for the same reasons described above in the rejection of claim 1. Namely, the claim refers to the use of a single sample, which would have a single GPNMB protein concentration. It is thus unclear where the “different contents of a GPNMB protein” would be originating from, and thus the claim is indefinite.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 states that “the biological agent measures an expression amount of mRNA or protein of the GPNMB gene.” In claim 1, from which this claim depends, the biological agent is specified to be an antibody that specifically binds to the GPNMG protein. In the embodiment of claim 2 concerning mRNA, the biological agent thus could not be an antibody for protein binding, and so this embodiment fails to include all the limitations of the claim upon which it depends. In the embodiment of claim 2 concerning protein, claim 1 already states this limitation, and so the claim fails to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (Sensors and Actuators B, 2015) in view of Zhu et al. (US 2018/0208655 A1).
Cheng teaches the use of field effect transistors (FETs) for sensitive, real-time, quantitative biosensing of tumor markers for lung cancer diagnosis (Abstract). Figure 1 shows the FET chip/biosensor, where antibodies were immobilized on the sensor to detect specific markers (see also page 330, column 1, para. 1). The sensor was made of SiO2 with APTES SAM and cross-linker glutaraldehyde on its surface, and antibodies were able to react directly with said surface for immobilization (page 330, column 2, para. 1, and note that Figure 1 states that use of Si for the FET surface). This use of silicon is in line with the claimed structure as interpreted in the “Claim Interpretation” section above. As the FET can detect electrical changes, it can act as a sensing electrode as claimed (pages 330-331, “Electrical measurements”). Cheng was able to detect the biomarkers of interest in human serum samples (Figure 4 and pages 331-332, “Quantitative detection of tumor markers in human serum using single-analyte FET biosensor”). Specifically, the electrical signals were able to be correlated with particular analyte concentrations (Figure 2 and page 331, column 2, para. 1 and Figure 4 and page 332, column 1, para. 2, and note that the second examples use human serum). Figures 5 and 6 show similar electrical signal/concentration analyses, and overall these data support the detection findings in both singleplex and multiplex contexts. Cheng concludes by stating that their sensor results in detection of target lung cancer biomarkers in human serum with as little as one drop of analyte solution, and can be used for differential diagnosis of lung cancer, particularly in multiplex formats with additional tumor markers (page 333, “Conclusions”).
However, Cheng does not teach the use of antibodies against GPNMB.
Zhu teaches the use of anti-GPNMB antibodies that can be used to detect GPNMB in tumor cells (Abstract). The antibodies of the invention can detect the expression of GPNMB in biological samples, and specifically samples from cancerous lung tissue (paras. 75 and 146). The biological sample used may be serum (paras. 30).
Prior to the effective filing date of the claimed invention, it would have been prima facie obvious for one of ordinary skill in the art to use the guidance provided by Zhu to add anti-GPNMB antibodies to the FET biosensor of Cheng. Cheng teaches that additional markers could be added to their biosensor (e.g. page 330, column 1, para. 1 and page 333, “Conclusions”), which can increase diagnostic power (page 332, column 2, para. 2), and would thus be motivating to the ordinary artisan. Particularly, Cheng teaches that their FET sensor can be used with additional biomarkers for lung cancer (e.g. GPNMB, as taught by Zhu) in multiplex format. Cheng also teaches that the electrical signals resulting from detection on their FET array are associated with target concentrations, and the reference is able to correlate particular concentrations with particular electrical signal values. As the array is for diagnosis, the ordinary artisan would realize that upon putting a patient sample onto the array and evaluating the signal results for the biomarkers shown in Cheng, a concentration for said biomarkers could be determined. The ordinary artisan would also be capable of repeating this methodology for the additional biomarkers to be added to the FET array, as said methodology would not be changing. This would result in the determination of particular GPNMB concentrations for a given sample. Zhu teaches many potential designs for anti-GPNMB antibodies (e.g. those in para. 8), providing evidence that the creation or procurement of such an antibody would be possible for the ordinary artisan. Additionally, as both Cheng and Zhu teach the use of serum samples in their methods, there would be a reasonable expectation of success in combining the teachings of the references.
Thus, claims 1-2 are prima facie obvious over Cheng in view of Zhu.
Regarding claim 5, the claimed limit of detection is not considered critical or to produce unexpected results. Page 3, para. 5 of the instant specification states the claimed limit of detection range is for “one embodiment of the present invention,” and page 13, para. 3 states, “In one embodiment, an LOD of the biochip of the present invention is not limited and can be adjusted appropriately according to a structure of the biochip, types and content of an antibody, etc.” MPEP 2144.05 I states, “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990),” and “…a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).” Thus, prior art will be considered to read on the claimed range of LODs if it teaches values within, overlapping, or close to the claimed range.
In Cheng, using their described antibodies (for CYFRA 21-1 and NSE), the limits of detection when analyzing human serum were 1 ng/ml and ~24 ng/ml, respectively (Figures 4 and 5, page 332, columns 1-2, joining para. and page 333, column 1, para. 2). In combining Cheng in view of Zhu, it would be prima facie obvious to optimize the anti-GPNMB antibodies on the FET biosensor to have a similar limit of detection to those presented in Cheng for their initial antibodies, so that all three biomarkers may be detected in a sample with enough discriminatory power to diagnose lung cancer in a patient. If the limit of detection for GPNMB was much higher than those presented for CYFRA 21-1 and NSE, then the addition of this biomarker would not be particularly useful, a fact which would motivate the ordinary artisan to optimize the limit of detection for GPNMB accordingly. As Cheng teaches multiple instances of determining if their antibodies can detect the desired biomarkers at particular levels, the ordinary artisan would be capable of performing similar analyses for an additional biomarker (GPNMB). As all three antibodies would also be used on the same FET sensor, similar methods for optimization would apply, further providing a reasonable expectation of success.
Thus, claim 5 is prima facie obvious over Cheng in view of Zhu.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (Sensors and Actuators B, 2015), in view of Zhu et al. (US 2018/0208655 A1), and further in view of Ho et al. (US 2021/0389272 A1).
Regarding claim 4, it is first noted that the concentration range described in the claim is not considered critical or to produce unexpected results. Page 3, para. 4 of the instant specification states that the claimed concentration range is for “one embodiment” of the present invention, and page 9, para. 3 states “The concentration of the antibody used in the biochip of the present invention is not limited and can be adjusted appropriately according to a structure of the biochip and a state of a patient with lung adenocarcinoma.” Page 23, para. 2 states that antibody concentrations were adjusted to obtain optimized detection results. MPEP 2144.05 II (A) states, “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.”
Cheng in view of Zhu teaches the biochips of claims 1-2 and 5, as described above. In Cheng, the antibody concentrations used for the provided antibodies was 50 µg/mL for a given volume (page 330, column 2, para. 1). In Zhu, concentrations of anti-GPNMB antibodies are shown. Figure 3 shows that concentrations of 0.05 µg/mL-0.9 µg/mL can be used for target detection with Western blotting (paras. 23 and 153). However, this does not provide concentrations of the antibody needed for target capture in a sensor.
Ho teaches biosensors to detect biomarkers (Abstract and paras. 3-4). They specifically utilize carbon nanotube field effect transistors (CNT-FET; para. 6). Paras. 87-88 and Table 1 detail determining the optimal coating concentration for an antibody on the CNT-FET in order to capture the most analyte (E. coli in this instance), where optimal concentrations were determined to be around 10 µg/mL.
Prior to the effective filing date of the claimed invention, it would have been prima facie obvious for one of ordinary skill in the art to use the guidance provided by Cheng, Zhu, and Ho to develop an optimal concentration of anti-GPNMB for use in the method of Cheng in view of Zhu. Ho teaches a method for obtaining an optimal antibody concentration that can successfully recognize a target on a FET, and so said method could be utilized with the anti-GPNMB in the FET of Cheng in view of Zhu. Zhu also provides antibody concentrations at which the anti-GPNMB is functional in a Western blotting scenario, which provides a general idea of the antibody concentrations that would be a good starting point for analysis, particularly in the 0.9 µg/mL range, which showed excellent results in Figure 3 of Zhu. Antibody concentration is therefore considered a result-effective variable, where it produces the recognized result of efficient and reliable target binding. Developing an optimal concentration would therefore be routine optimization, and thus, the ordinary artisan would be capable of arriving at the claimed concentration range (which includes the concentration values described by Zhu) for a particular given biosensor.
Thus, claim 4 is prima facie obvious over Cheng, in view of Zhu, and further in view of Ho.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (Sensors and Actuators B, 2015), in view of Zhu et al. (US 2018/0208655 A1), and further in view of Gau et al. (US 2005/0196855 A1).
Cheng in view of Zhu teaches the biochip of claims 1-2 and 5, as described above. And though Cheng teaches a sensing electrode as recited in claim 1, neither reference recites the structures described in instant claims 6 or 7.
Gau teaches a cartridge for the detection of biological agents in a sample (Abstract and paras. 5-7). The cartridge has a storage component (ref. character 12 in Figures 1A-B) and a transport component situated underneath it (ref. character 13 in Figures 1A-B; para. 44-46). The solutions in the storage component can be for use in an assay (para. 46). The transport component moves solutions from the storage component to sensors within the transport component (paras. 42 and 47). Disruption mechanisms (ref. character 16 in Figure 1A) in conjunction with lumens can be used to transport the solution into the transport component from the storage component (para. 47). Figure 3E shows an example of the storage and transport components being used together, where the disruption mechanism/lumen is piercing a portion of the storage component in which solution is stored (para. 60). Figure 4D shows a mechanism involving disrupters which also creates a channel between the storage components and the transport component (paras. 61-63). Figure 5A shows the entirety of a transport component. The transport component can have a cover (ref. character 62 in Figure 5A) that contains the disruption mechanisms (ref. character 16 in Figure 5A, paras. 70-72) that allow the solution to travel down to the sensors. Para. 50 specifically notes that channels bring the solutions from the storage component, through the disruption mechanism, and to the sensors. The base of the transport component (ref. character 60 in Figure 5A) contains sensors that include a working electrode, a reference electrode, and a counter electrode (para. 72, and ref. characters 72. 74, and 76 respectively in Figure 5A). Electrical leads (ref. character 78 in Figure 5A) provide electrical communication for the electrodes (para. 72). Finally, the transport component has a flexible layer (ref. character 64) underneath the base that contains ventilation (ref. character 87 in Figure 5A; para. 75).
In considering the teachings of Gau in light of the terminology used in instant claims 6-7, the storage component layer would be analogous to the upper cover layer, with the actual reservoirs of solution being the sample dripping area. The layer of the transport component with the disrupters and lumens/channels would be analogous to the middle interlayer, and the layer of the transport component containing the sensors would be analogous to the base plate layer containing three electrodes, where the working electrode is analogous to the claimed sensing electrode, the reference electrode remains the same in both Gau and the instant claims, and the counter electrode is analogous to the relative electrode. Finally, the flexible layer of the transport component would be analogous to the lower cover layer.
The assays that may be used with the cartridge of Gau are not specified, other than detecting biological agents in a sample (para. 5). Gau also teaches that their cartridge can be used for assays in the field, as it is small and efficient (para. 5). The reference also notes that multiple different solutions can be prepared and stored in particular conditions at the same time (paras. 42-43).
Prior to the effective filing date of the claimed invention, it would have been prima facie obvious for one of ordinary skill in the art to utilize the cartridge provided by Gau with the general assay of Cheng in view of Zhu. Specifically, Cheng in view of Zhu teach an assay involving an electrical biosensor containing antibodies for various lung cancer biomarkers (including GPNMB) that detect said biomarkers in a liquid human sample. Gau teaches a portable cartridge that can be used with assays, where the sensor on which the assay is conducted can be used to detect biological agents in a liquid sample. Therefore, the general assays encompassed by Cheng in view of Zhu and Gau overlap. Gau teaches the advantages of utilizing a single cartridge for their assays, including portability for field usage, the ability to perform multiple assays at once, and small and efficient equipment. Therefore, the ordinary artisan would be motivated to use the cartridge of Gau, fitted with the antibodies of Cheng in view of Zhu on the sensors, in order to detect the lung cancer biomarkers of Cheng in view of Zhu within a single cartridge. This would enable biomarker detection rapidly and in a clinical setting, providing quick results that could inform patient treatment plans and outcomes. There would be a reasonable expectation of success because the structure of the cartridge as taught by Gau, which has already been shown by the reference to be successful, would be unchanged, and the antibodies of Cheng in view of Zhu have been shown by the references to successfully detect their desired targets.
Thus, claims 6-7 are prima facie obvious over Cheng, in view of Zhu, and further in view of Gau.
Conclusion
No claims are currently allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRANCESCA F GIAMMONA whose telephone number is (571)270-0595. The examiner can normally be reached M-Th, 7-5pm.
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/F.F.G./Examiner, Art Unit 1681
/SAMUEL C WOOLWINE/Primary Examiner, Art Unit 1681
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