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 .
Claim Objections
Claim 17 is objected to because of the following informality: all occurrences of “Providing” should be changed to – providing – (that is, the letter “P” should be uncapitalized).
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 1-18 and 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over Yetisen et al., “Paper-based microfluidic point-of-care diagnostic devices,” Lab Chip, 2013,13, 2210-225 (hereafter “Yetisen”) in view of Perju et al., “Integrating high-performing electrochemical transducers in lateral flow assay,” Analytical and Bioanalytical Chemistry (2021) 413:5535–5549 (hereafter “Perju”) and Nayak et al.
US 2020/0150075 A1 (hereafter “Nayak”) or Claussen et al. US 2021/0332489 A1 (hereafter ‘Claussen”), and Du et al., “Tailoring the surface wettability of polyimide by UV laser direct texturing in different gas atmospheres,” Materials and Design 104 (2016) 134–140 (hereafter “Du”).
Addressing claim 1, Yetisen discloses an assay device for sensing of a sample fluid (see the title, Abstract, and Figures 3(A) and 3(B)) comprising:
an assay device (either the typical lateral flow assay device shown in Figure 3(A) or the typical flow-through assay device shown in Figure 3(B)) for sensing of a sample fluid (see the last paragraph on page 2212, bridging to page 2213) comprising:
at least one substrate (the “Reaction Matrix” in Figure 3(A) or the “Membrane Panel” in Figure 3(B)),
at least one channel (in Yetisen Figure 3(A) one of ordain skill in the art would understand that the “Sample Pad”, “Conjugate Pad”, “reaction Matrix”, and “Absorbent Pad” together form a channel. See Perju Figure 2 and the first paragraph of Principle of LFAs, which is on page 5537.),
wherein the substrate extends along a vertical direction (V) of the assay device and along a horizontal direction (H) of the assay device running perpendicularly to the vertical direction (V) (see annotated Figures 3(A) and 3(B) at end of tis claim rejection, and Applicant’s Figure 4a and 5a.1 ),
wherein the channel extends at least partially in the substrate and is configured to receive the sample fluid (this feature may be inferred form Yetisen Figures 3(A) and 3(B), especially in light of Perju Figure 2.), and
wherein the substrate, at least in the region of the channel, is porous (for this feature note (1) on page 5537 of Perju “The LFA requires low sample volumes to apply on a porous membrane, flowing further along the entire strip that consists
of different connected zones with specific functions (Fig. 2)…”, and (2) the following in the left column of Yetisen page 2217, “Pore size and pore size distribution are important parameters in selecting porous materials for the construction of microfluidic devices. The pore size (nominal or absolute) relates to the size of particles retained by the filter.135 Traditionally, membranes are characterised based on their nominal pore size.”).
However, neither assay device of Yetisen Figure 3(A) and Figure 3(B) is for electrochemical sensing. So, neither of these assay devices comprises at least one electrode, particularly “wherein at least part of the electrode is arranged in the channel and is configured to detect at least one electrical property being associated with the sample fluid, . . . .”
Perju discusses integrating high-performing electrochemical transducers into a lateral flow assay title. See the title and Abstract. This integrating involves arranging at least part of the electrode in the channel and is configured to detect at least one electrical property being associated with the sample fluid. See Perju Figure 3 and 4. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to configure the assay device of Yetisen
Figure 3(A) or Figure 3(B) for electrochemical sensing a sample fluid by arranging at least part of the electrode in the channel and is configured to detect at least one electrical property being associated with the sample fluid as taught by Perju because Perju discloses, “ Strategies using electrochemical detection offer attractive
features such as high sensitivity, selectivity, low instrumentation cost, and inherent miniaturization ability with improved analytical performance.” See Perju page 5536. Also, “In our opinion, the integration of electrochemical detection into a LFA is highly desirable, enabling quantitative detection with high sensitivity for precise diagnostics that should come into focus in the future.” See Perju page 5545. The electrodes adopted from Perju may be located in the assay device of Yetisen Figure 3(A) and Figure 3(B) as illustrated at the end of this claim rejection.
As for the claim 1 limitation “wherein at least the part of the electrode being arranged in the channel is porous, . . .”, Perju does not appear to disclose having any of the electrodes in the illustrated embodiments be porous. Nayak and Claussen each disclose forming porous graphene electrodes, which may be functionalized, onto a polymer substrate, such as a polyimide substrate. See in Nayak the title, Abstract, Figures 1A-E and 7, and paragraphs [0033]-[0036]; and in Claussen see the title, Abstract, Figures 1, 2, 5, 6, 8, 9, 11(B), 16, 21(A); and paragraphs [0003] and [0006]. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to have at least one of the electrodes in the assay decide of Yetisen as modified by Perju be porous in part as taught by Nayak or Claussen because as taught by Nayak, such electrodes have “. . . . high electrochemically active surface area, efficient charge transfer behavior and high repeatability of electrode material, . . . . Also, the laser based scaled-up fabrication technique provides the advantage in large scale commercialization for practical application.” See paragraphs [0054] and [0051]. Additionally, these electrodes are amenable to being functionalized in a wide variety of ways. See Nayak paragraphs [0041]-[0047]. Claussen discloses that such electrodes may be specifically functionalized and are especially useful for immunosensing. See Clausen paragraphs [0048]-[0052]. Also, “ The laser inducing and biofunctionalization are amenable to scalable manufacturing. This is primarily due to the lack of need for preconcentration and labeling steps makes the biosensor low-cost and well-suited for one-time, disposable biosensing.” See Clausen paragraph [0053]. Note that although in both Nayak and Clausen the polymer substate is primarily polyimide the Examiner does not believe that it is limited to this polymer. In any event, Du shows that surface wettability of polyimide may be tailored as desired using a UV laser. See in Du the title and Abstract.
As for the claim 1 limitation “wherein the substrate is configured to exert a capillary force onto the sample fluid in the channel such that the sample fluid is flowing through the part of the electrode being arranged in the channel …”, note the following in Yetisen, “The test process begins with introducing a sample to the proximal end of the strip where the sample pad is located. This step is often followed by addition of buffer solution to facilitate capillary flow. The sample pad then renders the sample compatible with the assay and releases the sample. The treated sample is wicked by capillary action to the conjugate pad which is previously impregnated with particulate conjugates. [italicizing by the Examiner]” See Yetisen page 213, left column. Also, note the following in Perju, “It is important to note that all pads must slightly overlap when assembled on the backing substrate, to ensure a proper fluidic contact between zones that allows the solution to be driven by the capillary forces smoothly till the end of the strip.” See Perju page 5537, right column.
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Addressing claim 2, as for the additional limitation “i) the electrode is configured to exert a capillary force onto the sample fluid in the channel such that the sample fluid is flowing through the part of the electrode being arranged in the channel, . . . .” it may be inferred from (1) the small pore sizes for the electrodes of Nayak and Claussen (see Nayak paragraph [0036] and Claussen paragraph [0253]) and (2) that the substrate for the assay device of Yetisen as modified by Perju, Nayak or Claussen, and Du is necessarily configured to exert a capillary force upon the sample (see the rejection of underlying claim 1 above).
As for the claim 2 limitation “ii) wherein the electrode (3) is configured to drive a capillary flow of the sample fluid…”, as a first matter the Examiner notes that it is optional as it is preceded by “or”. In any event, it may likewise be inferred from the prior art applied in claim1 as just discussed for claim 2 limitation (i).
Addressing claim 3, as for the limitation “i) the electrode is permeable to the sample fluid, . . . .”, it may be inferred from (1) the small pore sizes for the electrodes of Nayak and Claussen (see Nayak paragraph [0036] and Claussen paragraph [0253]) and (2) that the substrate for the assay device of Yetisen as modified by Perju, Nayak or Claussen, and Du is necessarily configured to exert a capillary force upon the sample (see the rejection of underlying claim 1 above).
As for the claim 3 limitation “ii) wherein the electrode is configured such that the sample fluid can flow through the electrode …”, as a first matter the Examiner notes that it is optional as it is preceded by “or”. In any event, it may likewise be inferred from the prior art applied in claim 1 as just discussed for claim 3 limitation (i).
Addressing claim 4, as for the limitation “wherein the substrate (2) is permeable to the sample fluid, . . . .” recall the following from the rejection of underlying claim 1,
As for the claim 1 limitation “wherein the substrate is configured to exert a capillary force onto the sample fluid in the channel such that the sample fluid is flowing through the part of the electrode being arranged in the channel …”, note the following in Yetisen, “The test process begins with introducing a sample to the proximal end of the strip where the sample pad is located. This step is often followed by addition of buffer solution to facilitate capillary flow. The sample pad then renders the sample compatible with the assay and releases the sample. The treated sample is wicked by capillary action to the conjugate pad which is previously impregnated with particulate conjugates. [italicizing by the Examiner]” See Yetisen page 213, left column. Also, note the following in Perju, “It is important to note that all pads must slightly overlap when assembled on the backing substrate, to ensure a proper fluidic contact between zones that allows the solution to be driven by the capillary forces smoothly till the end of the strip.” See Perju page 5537, right column.
As for the claim 4 limitation “ii) wherein the substrate (2) is configured such that the sample fluid can flow through the substrate (2)…”, as a first matter the Examiner notes that it is optional as it is preceded by “or”. In any event, it may likewise be inferred from the prior art applied in claim 1 as just discussed for claim 4 limitation (i).
Addressing claim 5, Yetisen as modified by Perju, Nayak or Claussen, and Du discloses having at least the electrode be patterned. See Nayak Figures 1A-E and paragraphs [0040] and [0041]; in Claussen see Figure 1 and paragraph [0096].
Addressing claim 6, as for the claim 6 limitation “i) the electrode is at least partially integrated into the substrate, . . . .”, note the following in Nayak, “In particular, embodiments of the present disclosure include large scale flexible electrochemical sensors that can be fabricated by adopting direct growth of graphitic carbon patterns on a substrate, such as a commercial polyimide surface, by use of a laser scribing approach, where the material modification can be referred to as laser scribed graphene (LSG).[italicizing by the Examiner]” See Nayak paragraph [0034]. Note in Claussen the following, “This work demonstrates the fabrication of a highly porous, high resolution, thin film (film thickness of ˜25 nm) laser-induced graphene on a polyimide sheet and its application to create in-field electrochemical immunosensor detection of foodborne pathogen, . . . .” See Clausen paragraph [0006].
As for the claim 6 limitation, “ii) the electrode is generated by pyrolysis of the substrate…”, as a first matter note that it is optional. Also, it is a product-by-process limitation. As such, the claim is not limited to the manipulation of the recited step (pyrolysis), only the structure implied by the step. See MPEP 2113. In any event, it is met by both Nayak and Claussen. In Nayak note the following, “ In an embodiment, the substrate can be a material that forms three dimensional laser scribed graphene upon exposure to a laser beam. The focused laser beam produces very high local temperatures (e.g., greater than about 2500° C.), which helps in carbonization and graphitization of the surface of the substrate.” See Nayak paragraph [0038]. In Claussen note the following, “Strong XPS signal was obtained from the carbon (C) C1s peak and the oxygen (O) O1s peak which resulted in a C/O ratio of 9.1, which indicates a high degree of carbonization of the PI after lasing.” See Claussen paragraph [0360].
Addressing claim 7, as for the claim 7 limitation “i) the substrate comprises or consists of at least one of a paper-based compound or a polymeric membrane material, . . . .” recall from the rejection of underlying claim 1 that in Nayak and Claussen the substrate for the electrodes is polyimide.
As for the claim 7 limitation “ ii) the electrode comprises or consists of at least one of a carbonaceous compound or a paper-templated metal…”, as a first matter this limitation is optional. In any event, the electrodes adopted from both Nayak and Claussen comprise a carbonaceous compound – graphene. See in Nayak the title and Abstract; and in Claussen see the title and Abstract.
Addressing claim 8, as for the claim 8 limitation “(i) at least the part of the electrode being arranged in the channel is hydrophilic, . . . .” note that Nayak discloses that surfactants may be adsorbed onto the electrode surface. See Nayak paragraphs [0046] and [0047].
Addressing claim 9, as for the claim 9 limitation “i) in the region of the channel, the substrate is hydrophilic, . . . .”, if not already so, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to be so because as sated in the rejection of underlying claim 1 above (underlining added),
Note that although in both Nayak and Clausen the polymer substate is primarily polyimide the Examiner does not believe that it is limited to this polymer. In any event, Du shows that surface wettability of polyimide may be tailored as desired using a UV laser. See in Du the title and Abstract.
As for the claim 1 limitation “wherein the substrate is configured to exert a capillary force onto the sample fluid in the channel such that the sample fluid is flowing through the part of the electrode being arranged in the channel …”, note the following in Yetisen, “The test process begins with introducing a sample to the proximal end of the strip where the sample pad is located. This step is often followed by addition of buffer solution to facilitate capillary flow. The sample pad then renders the sample compatible with the assay and releases the sample. The treated sample is wicked by capillary action to the conjugate pad which is previously impregnated with particulate conjugates. [italicizing by the Examiner]” See Yetisen page 213, left column. Also, note the following in Perju, “It is important to note that all pads must slightly overlap when assembled on the backing substrate, to ensure a proper fluidic contact between zones that allows the solution to be driven by the capillary forces smoothly till the end of the strip.” See Perju page 5537, right column.
Addressing claim 10, as for the claim 10 limitation “i) the coating is at least one of: at least partially arranged on and/or in at least one of the substrate, . . . .”, note the PDMS coating in Nayak Figure 1C (see also paragraph [0057]) and the dielectric coating 17 in Claussen Figure 2 (see also paragraph [0252]). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to provide a coating as taught by Nayak or Claussen in the assay device of Yetisen as modified by Perju, Nayak or Claussen, and Du because it can used to precisely define the measurement or active area of the electrode and will prevent unwanted chemical or electrochemical reactions along the electrode lead.
Although not needed to meet this claim as the following is an optional limitation, “iii) the coating is at least one of hydrophobic, has a melting temperature of 1500 or less, or comprises or consists of at least one of wax or, paraffin…”, to have the coating be wax instead of PDMS as in Nayak or the apparently unspecified dielectric material in Claussen is prima facie obvious as simple substitution of one known element for another to obtain predictable results (see MPEP 21439I)(B)) as Yetisen states, Impregnating paper strips with hydrophobic materials such as paraffin and wax to prevent cross contamination of reaction zones dates back to 1902.103 The first fabrication technique for the impregnation of paper with paraffin to create confined
spaces for qualitative spot testing appeared in 1937.104,105 [italicizing by the Examiner]” See Claussen page 2215.
Addressing claim 11, for the additional limitation of this claim consider annotated Yetisen Figure 3(B) at the end of the claim 1 rejection above, which is reproduced below.
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One of ordinary skill in the art would recognize horizontal capillary sample flow occurs in the lateral flow assay device configuration, but vertical capillary sample flow occurs in the flow-through assay device configuration.
Addressing claim 12, for the additional limitation of this claim consider annotated Yetisen Figure 3(A) at the end of the claim 1 rejection, which is reproduced below and recall the following form the rejection of claim 1 (underlining added),
Note that although in both Nayak and Clausen the polymer substate is primarily polyimide the Examiner does not believe that it is limited to this polymer. In any event, Du shows that surface wettability of polyimide may be tailored as desired using a UV laser. See in Du the title and Abstract.
As for the claim 1 limitation “wherein the substrate is configured to exert a capillary force onto the sample fluid in the channel such that the sample fluid is flowing through the part of the electrode being arranged in the channel …”, note the following in Yetisen, “The test process begins with introducing a sample to the proximal end of the strip where the sample pad is located. This step is often followed by addition of buffer solution to facilitate capillary flow. The sample pad then renders the sample compatible with the assay and releases the sample. The treated sample is wicked by capillary action to the conjugate pad which is previously impregnated with particulate conjugates. [italicizing by the Examiner]” See Yetisen page 213, left column. Also, note the following in Perju, “It is important to note that all pads must slightly overlap when assembled on the backing substrate, to ensure a proper fluidic contact between zones that allows the solution to be driven by the capillary forces smoothly till the end of the strip.” See Perju page 5537, right column.
Addressing claim 13, for the additional limitation of this claim note “Absorbent Pad” in Yetisen Figure 3(A) and the following on page 2212, “Lateral flow immunoassays can be subdivided into two major types: direct (i.e. double antibody sandwich assays) and competitive (i.e. inhibitive) formats. The assay format typically
consists of a number of segments that join together and are supported by a backing card. These segments include the sample pad, conjugate pad, reaction membrane and an absorbent pad (Fig. 3A). [italicizing by the Examiner]” Also note “Waste pad” in Perju Figure 2 and the following, “The last part of the LFS is called a waste pad which is overlapping with the NC membrane. This part is responsible for promoting the flow
and preventing the back flow of the sample solution. It is important to note that all pads must slightly overlap when assembled on the backing substrate, to ensure a proper fluidic contact between zones that allows the solution to be driven by
the capillary forces smoothly till the end of the strip. [italicizing by the Examiner]”
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Addressing claim 14, as for the claim 14 limitation “i) the capture zone is provided as a capture pad (8) being functionalized with the capture molecules, . . . .” see Perju Figures 2 and 3, noting therein “Conjugate pad”.
by both Nayak and Claussen. See in Nayak Figures 5-7; and in Claussen see Figures 2, 5, 6, and 8.
Addressing claim 15, for the additional limitations of this claim see Nayak Figure 1B, noting therein ‘WE” and “CE”, and paragraph [0057], noting especially, “The on-chip device structure includes a three-electrode platform (counter electrode (CE), working electrode (WE) and electrode (E or RE)) made up of 3D porous graphene sheets patterned over flexible PI sheet, as shown in FIGS. 1B and 2A and 2B.” Also, note the voltammograms in Figures 4D-F and in Figure 5. Additionally see Claussen paragraph [0371], noting especially, “Palmsens4 potentiostat was used for all electrochemical measurements. Square wave voltammetry was performed in a 5 mL volume of PBS pH 7.4. The potential was stepped from −0.6 to −1.5 V with a potential step of 5 mV, amplitude of 25 mV, and frequency of 25 Hz. A three-electrode setup was used: LIG working electrode, commercial Ag/AgCl reference electrode, and commercial platinum wire counter electrode.”
Addressing claim 16, as for the claim 16 limitation “i) the casing at least partially encases the substrate , the electrode and the channel, . . . .” see Yetisen Figures 3(A) and 3(B).
As for the claim 16 limitation “ ii) wherein the casing comprises at least one of: at least one sample inlet through which the sample fluid is insertable into the channel, . . . .”, as a first matter this limitation is optional. In any event, it is also disclosed by Yetsin Figures 3(A) and 3(B) noting therein ‘Sample Port”.
Addressing claim 17, Yetisen discloses an assay device for sensing of a sample fluid (see the title, Abstract, and Figures 3(A) and 3(B)) comprising:
an assay device (either the typical lateral flow assay device shown in Figure 3(A) or the typical flow-through assay device shown in Figure 3(B)) for sensing of a sample fluid (see the last paragraph on page 2212, bridging to page 2213) comprising:
at least one substrate (the “Reaction Matrix” in Figure 3(A) or the “Membrane Panel” in Figure 3(B)),
at least one channel (in Yetisen Figure 3(A) one of ordain skill in the art would understand that the “Sample Pad”, “Conjugate Pad”, “reaction Matrix”, and “Absorbent Pad” together form a channel. See Perju Figure 2 and the first paragraph of Principle of LFAs, which is on page 5537.),
wherein the substrate extends along a vertical direction (V) of the assay device and along a horizontal direction (H) of the assay device running perpendicularly to the vertical direction (V) (see annotated Figures 3(A) and 3(B) at end of this claim rejection, and Applicant’s Figure 4a and 5a.2 ),
wherein the channel extends at least partially in the substrate and is configured to receive the sample fluid (this feature may be inferred form Yetisen Figures 3(A) and 3(B), especially in light of Perju Figure 2.),
characterized in that the substrate at least in the region of the channel is porous (for this feature note (1) on page 5537 of Perju “The LFA requires low sample volumes to apply on a porous membrane, flowing further along the entire strip that consists of different connected zones with specific functions (Fig. 2)…”, and (2) the following in the left column of Yetisen page 2217, “Pore size and pore size distribution are important parameters in selecting porous materials for the construction of microfluidic devices. The pore size (nominal or absolute) relates to the size of particles retained by the filter.135 Traditionally, membranes are characterised based on their nominal pore size.”).
However, neither assay device of Yetisen Figure 3(A) and Figure 3(B) is for electrochemical sensing. So, neither of these assay devices comprises at least one electrode, particularly “wherein at least part of the electrode is arranged in the channel and is configured to detect at least one electrical property being associated with the sample fluid, . . . .”
Perju discusses integrating high-performing electrochemical transducers into a lateral flow assay title. See the title and Abstract. This integrating involves arranging at least part of the electrode in the channel and is configured to detect at least one electrical property being associated with the sample fluid. See Perju Figure 3 and 4. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to configure the assay device of Yetisen
Figure 3(A) or Figure 3(B) for electrochemical sensing a sample fluid by arranging at least part of the electrode in the channel and is configured to detect at least one electrical property being associated with the sample fluid as taught by Perju because Perju discloses, “ Strategies using electrochemical detection offer attractive
features such as high sensitivity, selectivity, low instrumentation cost, and inherent miniaturization ability with improved analytical performance.” See Perju page 5536. Also, “In our opinion, the integration of electrochemical detection into a LFA is highly desirable, enabling quantitative detection with high sensitivity for precise diagnostics that should come into focus in the future.” See Perju page 5545. The electrodes adopted from Perju may be located in the assay device of Yetisen Figure 3(A) and Figure 3(B) as illustrated at the end of this claim rejection.
As for the claim 17 limitation “wherein at least the part of the electrode being arranged in the channel is porous, . . .”, Perju does not appear to disclose having any of the electrodes in the illustrated embodiments be porous. Nayak and Claussen each disclose forming porous graphene electrodes, which may be functionalized, onto a polymer substrate, such as a polyimide substrate. See in Nayak the title, Abstract, Figures 1A-E and 7, and paragraphs [0033]-[0036]; and in Claussen see the title, Abstract, Figures 1, 2, 5, 6, 8, 9, 11(B), 16, 21(A); and paragraphs [0003] and [0006]. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to have at least one of the electrodes in the assay decide of Yetisen as modified by Perju be porous in part as taught by Nayak or Claussen because as taught by Nayak, such electrodes have “. . . . high electrochemically active surface area, efficient charge transfer behavior and high repeatability of electrode material, . . . . Also, the laser based scaled-up fabrication technique provides the advantage in large scale commercialization for practical application.” See paragraphs [0054] and [0051]. Additionally, these electrodes are amenable to being functionalized in a wide variety of ways. See Nayak paragraphs [0041]-[0047]. Claussen discloses that such electrodes may be specifically functionalized and are especially useful for immunosensing. See Clausen paragraphs [0048]-[0052]. Also, “ The laser inducing and biofunctionalization are amenable to scalable manufacturing. This is primarily due to the lack of need for preconcentration and labeling steps makes the biosensor low-cost and well-suited for one-time, disposable biosensing.” See Clausen paragraph [0053]. Note that although in both Nayak and Clausen the polymer substate is primarily polyimide the Examiner does not believe that it is limited to this polymer. In any event, Du shows that surface wettability of polyimide may be tailored as desired using a UV laser. See in Du the title and Abstract.
As for the claim 17 limitation “wherein the substrate is configured to exert a capillary force onto the sample fluid in the channel such that the sample fluid is flowing through the part of the electrode being arranged in the channel …”, note the following in Yetisen, “The test process begins with introducing a sample to the proximal end of the strip where the sample pad is located. This step is often followed by addition of buffer solution to facilitate capillary flow. The sample pad then renders the sample compatible with the assay and releases the sample. The treated sample is wicked by capillary action to the conjugate pad which is previously impregnated with particulate conjugates. [italicizing by the Examiner]” See Yetisen page 213, left column. Also, note the following in Perju, “It is important to note that all pads must slightly overlap when assembled on the backing substrate, to ensure a proper fluidic contact between zones that allows the solution to be driven by the capillary forces smoothly till the end of the strip.” See Perju page 5537, right column.
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So, Yetisen as modified by Perju, Nayak or Claussen, and Du implicitly discloses the claimed steps of providing at least one substrate, providing at least one electrode, providing at least one channel (5) as claimed.
Addressing claim 18, as for the claim 18 limitation, “i) the electrode is integrally formed in the substrate by pyrolysis of the substrate, . . . .”, it is met by both Nayak and Claussen. In Nayak note the following, “ In an embodiment, the substrate can be a material that forms three dimensional laser scribed graphene upon exposure to a laser beam. The focused laser beam produces very high local temperatures (e.g., greater than about 2500° C.), which helps in carbonization and graphitization of the surface of the substrate.” See Nayak paragraph [0038]. In Claussen note the following, “Strong XPS signal was obtained from the carbon (C) C1s peak and the oxygen (O) O1s peak which resulted in a C/O ratio of 9.1, which indicates a high degree of carbonization of the PI after lasing.” See Claussen paragraph [0360].
Addressing claim 20, for the additional limitation of this claim see again Nayak Figures 1A-E and paragraphs [0040] and [0041]; in Claussen see Figure 1 and paragraph [0096] from which one would infer that a patterning of the electrode and a patterning of the channel are at least one of independent from one another or generated separately from one another.
Addressing claim 21, as for the claim 21 limitation, “i) the electrode is entirely integrated into the substrate, . . . .” it may be inferred form Nayak Figures 1A-E and 7, and from Claussen Figures 1 and 5.
As for the claim 21 limitation, “ii) the electrode is generated by laser-pyrolysis or by flash pyrolysis or by using a pyrolysis furnace…”, as a first matter this limitation is optional. In any event, it is also disclosed by Nayak and Claussen. In Nayak note the following, “ In an embodiment, the substrate can be a material that forms three dimensional laser scribed graphene upon exposure to a laser beam. The focused laser beam produces very high local temperatures (e.g., greater than about 2500° C.), which helps in carbonization and graphitization of the surface of the substrate.” See Nayak paragraph [0038]. In Claussen note the following, “Strong XPS signal was obtained from the carbon (C) C1s peak and the oxygen (O) O1s peak which resulted in a C/O ratio of 9.1, which indicates a high degree of carbonization of the PI after lasing.” See Claussen paragraph [0360].
Addressing claim 22, as for the claim 22 limitation “i) the paper-based compound comprises cellulose fibers or the polymeric membrane material is nitrocellulose or polysulfone, . . . .”, in Yetisen as modified by Perju, Nayak or Claussen, and Du the polymeric membrane material is polyimide. However, to instead have it be nitrocellulose is prima facie obvious simple substitution of one known element for another to obtain predictable results (see MPEP 21439I)(B)) as Yetisen states, “Although nitrocellulose membranes have been used historically for filtration purposes,79 they have been adapted as a substrate for molecular detection in 1970s.80–8.”
As for the claim 22 limitation, “ii) the carbonaceous compound is a graphenic material…”, as a first matter this limitation is optional. In any event, it is also disclosed by Nayak and Claussen. See the title and Abstract; and see in Claussen the title and Abstract.
Addressing claim 23, as for the claim 23 limitation “i) at least one reference electrode being configured to establish a reference electrical potential, wherein the electrical potential being at least one of applicable or measurable at the working electrode is established with respect to the reference potential, . . . .” see Nayak Figure 1B, noting therein ‘WE”, “CE”, and ‘RE”, and paragraph [0057], noting especially, “The on-chip device structure includes a three-electrode platform (counter electrode (CE), working electrode (WE) and electrode (E or RE)) made up of 3D porous graphene sheets patterned over flexible PI sheet, as shown in FIGS. 1B and 2A and 2B.” Also, note the voltammograms in Figures 4D-F and in Figure 5. Additionally see Claussen paragraph [0371], noting especially, “Palmsens4 potentiostat was used for all electrochemical measurements. Square wave voltammetry was performed in a 5 mL volume of PBS pH 7.4. The potential was stepped from −0.6 to −1.5 V with a potential step of 5 mV, amplitude of 25 mV, and frequency of 25 Hz. A three-electrode setup was used: LIG working electrode, commercial Ag/AgCl reference electrode, and commercial platinum wire counter electrode.”
As for the claim 23 limitation, “ii) at least one evaluation device being configured to evaluate the electrical property being detected by the electrode…”, as a first matter this limitation is optional. In any event, it is implied by the following in Nayak paragraph [0064],“ The typical DPV response of the LSG electrode to the addition of different concentrations of DA, UA and AA in PBS solution is shown in FIGS. 4A-C.” Additionally see Claussen paragraph [0371], noting especially, “Palmsens4 potentiostat was used for all electrochemical measurements. Square wave voltammetry was performed in a 5 mL volume of PBS pH 7.4. The potential was stepped from −0.6 to −1.5 V with a potential step of 5 mV, amplitude of 25 mV, and frequency of 25 Hz. A three-electrode setup was used: LIG working electrode, commercial Ag/AgCl reference electrode, and commercial platinum wire counter electrode.”
As for the claim 24 limitation, “i) the electrode is integrally formed in the substrate by laser pyrolysis or by flash pyrolysis or by using a pyrolysis furnace, . . . .”,
in Nayak note the following, “ In an embodiment, the substrate can be a material that forms three dimensional laser scribed graphene upon exposure to a laser beam. The focused laser beam produces very high local temperatures (e.g., greater than about 2500° C.), which helps in carbonization and graphitization of the surface of the substrate.” See Nayak see Figures 1A-E and paragraph [0038]. In Claussen see Figures 1 and 5 and note the following in paragraph [0360], “Strong XPS signal was obtained from the carbon (C) C1s peak and the oxygen (O) O1s peak which resulted in a C/O ratio of 9.1, which indicates a high degree of carbonization of the PI after lasing.”
Other Relevant Prior Art
The International Search Report for international application no. PCT/EP203/068478 cites CN 109060923 A as an “X” document against claims 1-15 and 17, and as “Y” document against claim 9; cites WO 2015/138978 A1 as a “X” document against claims 1-13, 15-17, and 19; cites EP 3514542 A1 as a ‘X” document against claims 1, 4-17, and 19; cites WO 2013/036617 A1 as a “X” document against claims 1-15 and 17; and cites WO 2010/102279 A1 as a “X” document against claims 1-12 and 14-17. Several documents have been cited as purely “Y” documents against a number of claims. The corresponding Written Opinion relies upon these documents, labeled D1-D6, for rejecting the claims. However, none of these documents, alone or in combination, meet all of the limitations of independent claims 1 and 17 in U.S. application 18/996534.
For example, CN 109060923 A, based on an English language translation obtained by the U.S. Examiner, does not disclose “. . . ., and wherein at least the part of the electrode being arranged in the channel is porous, and wherein the substrate is configured to exert a capillary force onto the sample fluid in the channel such that the sample fluid is flowing through the part of the electrode being arranged in the channel.” See Figures 1 and 2 and note (1) that the electrodes (206) are arranged on a portion of the substrate that is hydrophobic (102). See the last paragraph on page 3, bridge to
page 4 There is also nothing to suggest that the any of the electrodes is necessarily porous: “The electrode material in the electrochemical system 206 is carbon paste, Ag/AgCl, graphene-doped carbon paste, carbon nanotubes, and Prussian blue.” See the second full paragraph on page 4.
In the Written Opinion the Figure 26 embodiment in WO2015138978A1 (D2 in the Written Opinion) is said to anticipate several claims. However, in Figure 26 the electrodes are located on a wax coated region of the substrate. Also, regarding the electrodes the document just states, “ Electrodes can be fabricated from any suitable conductive material, such as a metal (e.g.,gold, platinum, or titanium), metal alloy, metal oxide, conducting polymer (e.g., PEDOT or PANI), or conductive carbon. The electrodes can be, for example, screen printed electrodes formed using a conductive ink. In certain embodiments, the electrode can be a bulk electrode.” See the last paragraph on page 19.
In any event, the ‘X” and “Y” documents cited in the International Search Report and Written Opinion are at best redundant with the prior art applied in the rejections under 35 U..C 103 above.
Allowable Subject Matter
Claims 19 and 25 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
a) the combination of limitations in claim 19 has the following underlined feature
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In contrast, although Yetisen as modified by Perju, Nayak or Claussen, and Du disclose or more coatings (see, for example, the rejection of claim 10 under 35 U.S.C 103 above), they do not have a recess nor is such a recess an obvious modification; and
b) claim 25 depends from allowable claim 19.
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/ALEXANDER S NOGUEROLA/ Primary Examiner, Art Unit 1795
1 The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)("[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning."); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) ("Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings."). "The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ " Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
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See MPEP 804 II.B.2(a).
2 The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)("[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning."); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) ("Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings."). "The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ " Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
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See MPEP 804 II.B.2(a).
Prosecution Insights