DETAILED ACTION
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.
Claims 1, 4-10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Wickert (US 6174699) in view of Javey (US 20230157587) and Derda (US 9624523).
With respect to claim 1, Wickert discloses a testing device for testing the susceptibility of a biological probe to one or more bioactive substances. The device includes a plurality of substrates that include a first substrate (Figure 2:12) that is liquid-impermeable. A second substrate (Figure 2:14) is arranged above the first substrate and is made of a material that is liquid-permeable and liquid impregnable. A third substrate (Figure 2:18) is arranged above the second substrate and is liquid-impermeable, such that the first and third substrates are configured for encapsulating the second substrate. This is described in column 3, line 51 to column 5, line 6. Wickert further indicates that at least a portion of the second substrate is exposable to an environment of the testing device to receive the biological probe. Although the substrates of Wickert are held together using adhesive materials, Wickert does not state that an adhesive material is used to adhere the testing device to the body of a patient, such that the patient’s body warmth and/or humidity is usable for incubating the biological probe.
Javey discloses a wearable testing device comprising a first substrate (Figure 4: “Flexible PET”) and a second substrate (Figure 4:“Sensing membranes”). The testing device is adhered to a human or animal body (Figure 4:“Skin”) using an adhesive material (Figure 4:“Skin adhesive”). See, for example, paragraphs [0078] and [0145]-[0158].
Derda discloses a testing device for testing the susceptibility of a biological probe to one or more bioactive substances. The testing device comprises at least a first substrate (Figure 1:30) that is liquid impermeable and a second substrate (Figure 1:40) arranged above the first substrate that is liquid-permeable and liquid impregnable. Derda indicates in column 12, lines 39-48 that the testing device is intended to be worn close to a patient’s body so that the body warmth and/or humidity is usable for incubating the biological probe.
Before the effective filing date of the claimed invention, it would have been obvious to provide the Wickert testing device with an additional adhesive material portion in order to allow for attachment to a human or animal body. Javey teaches that this would allow for direct and continuous measurement of microorganisms on the person or clothes of a subject. Javey teaches that wearable biosensors provide immediate testing results and do not require automation or manual manipulation of fluids and sensing equipment. Derda further indicates that attachment to a patient would further facilitate incubation of the microorganisms in the testing device through the use of the patient’s own body heat, which is simple and efficient.
With respect to claim 2, Wickert, Javey and Derda disclose the combination as described above. Wickert indicates that the second substrate 14 is made of a liquid-permeable porous material (“Absorbent discs 14 are attached to the substrate 12 for holding and retaining liquid sample. Accordingly, the discs 14 may be constructed from a variety of absorbent materials, including cellulosics, polyolefins, polyesters, and polyamides, with cellulosics being preferred. Suitable cellulosics include paper, wood pulp and rayon and may include chemically modified cellulosics, such as cellulose esters”).
With respect to claim 4, Wickert, Javey and Derda disclose the combination as described above. Wickert states that that the substates arranged above the second substrate 14 are at least partially transparent to allow optical access to the second substrate (“the coversheet 18 is flexible, transparent to the extent one may conduct detection through the coversheet 18…”).
With respect to claims 5-7, Wickert, Javey and Derda disclose the combination as described above. Wickert shows that the substrates are arranged in a stacked layer, such that the substrates are attached to each other using a mutually overlapping attachment portion (Figure 1:32). The second substrate is arrangeable in a probe collection arrangement where overlapping substrates are disposed in an open configuration. See Fig. 1 (“the user places the inoculation vehicle 20 into contact with the discs 14 such that sample transfers from the vehicle 20 to the discs 14. Preferably, the vehicle 20 is of such a size as to cover the area of the substrate 12 having the discs 14”). The testing device may then be transferred to a protected incubation arrangement where the substrates completely overlap each other and are disposed in a closed configuration. See Fig. 2 and column 5, lines 52-62.
With respect to claim 8, Wickert, Javey and Derda disclose the combination as described above. Wickert further teaches that a substance pad (Figure 2:24) suitable for receiving bioactive substances is arranged on substrates 18 and faces the second substrate 14.
With respect to claim 9, Wickert, Javey and Derda disclose the combination as described above. Wickert indicates that a fourth substrate (Figure 2:26) is arranged between the second substrate 14 and the third substrate 18. The fourth substrate is a backing manufactured from the same material as substrate 12, and therefore is understood to be liquid-impregnable.
With respect to claims 10 and 13, Wickert, Javey and Derda disclose the combination as described above. The second and fourth substrates of Wickert are divided as fluidly independent substrate regions 14a, 14b (i.e., at least first and second partial substrates) along a longitudinal direction of the testing device. These independent partial substrate regions 14a, 14b are liquid-permeable and may be exposed to an environment of the testing device for receiving the biological probe.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Wickert (US 6174699) in view of Javey (US 20230157587) and Derda (US 9624523) as applied to claim 1, and further in view of Kitajima (US 4452887).
Wickert, Javey and Derda disclose the combination described above, however do not appear to teach a fifth substrate configured as a light and/or radiation shielding substrate.
Kitajima discloses a testing device comprising a plurality of stacked substrates. A light and/or radiation shielding substrate (Figure 1:3) is provided over a reagent substrate (Figure 1:2).
Before the effective filing date of the claimed invention, it would have been obvious to include a light and radiation shielding substrate arranged above the plurality of substrates in the Wickert testing device. Kitajima teaches that light shielding materials and layers are typically included in strip/patch testing devices using known fabrication techniques (“the non-porous light-shielding layer is a layer formed by dispersing a fine powder such as titanium dioxide, aluminum, barium sulfate, etc., in a water-permeable hydrophilic polymer binder and the thickness thereof is usually from 1 µm to 100 µm, preferably from 2 µm to 20 µm”). Kitajima further states that light and radiation shielding substrates provide the beneficial effect of blocking harmful wavelengths and reducing signal noise (“The non-porous light-shielding (or radiation-blocking) layers refers to a layer that permits effective passage of electromagnetic radiation used to effectively detect an analytical change produced in the analysis material”).
Claims 12 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Wickert (US 6174699) in view of Javey (US 20230157587) and Derda (US 9624523) as applied to claim 1, and further in view of Ching (US 20120288897).
Wickert, Javey and Derda disclose the combination described above. As discussed above, the second and fourth substrates of Wickert are divided as fluidly independent probe receiving portions 14a, 14b that are spatially separated from each other. Wickert, however, does not teach one or more substance reservoirs (e.g., disinfectant reservoirs) that are releasably sealed by a sealing element.
Ching discloses a testing device comprising a plurality of substrates that define a plurality of testing locations. A plurality of reagent reservoirs (Figure 18:6163a-d) are configured as blisters that each hold a fluid necessary for testing and detection. For example, the reagent reservoirs may include a washing/disinfectant solution. Ching indicates in paragraphs [0170]-[0173] that the reagent reservoirs are releasably sealed using a temporary liquid-impermeable element (Figure 18:6170) that may be broken to release a reagent fluid into an adjacent testing location.
Before the effective filing date of the claimed invention, it would have been obvious to modify the Wickert testing device to include one or more substance reservoirs that are configured to receive a bioactive and/or disinfectant substance. Ching shows how reagent fluids are controllably dispensed from a substance reservoir to a testing location in a controlled manner by using a frangible sealing element. Ching shows how each substance reservoir is independently addressable and how different reagents are transferred to a desired testing location at different times to produce a predetermined result.
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over Wickert (US 6174699) in view of Javey (US 20230157587) and Derda (US 9624523) as applied to claim 1, and further in view of Roscoe (US 9096883).
Wickert, Javey and Derda disclose the combination set forth above, however do not expressly state that the liquid-permeable material is paper having a pore size of 0.3 microns or less.
Roscoe discloses a testing device for testing the susceptibility of a biological probe to one or more bioactive substances. The device includes a plurality of substrates that include a first substrate (Figure 1:12) that is liquid-impermeable. A second substrate (Figure 2:121, 126) is arranged above the first substrate and is made of a material that is liquid-permeable and liquid impregnable. A third substrate (Figure 1:22) is arranged above the second substrate and is liquid-impermeable, such that the first and third substrates are configured for encapsulating the second substrate. This is described in column 3, line 61 to column 5, line 57. Column 5, lines 11-46 and column 6, line 53 to column 7, line 17 state that the second substrate may comprise paper having a pore size of 0.3 microns or less.
Before the effective filing date of the claimed invention, it would have been obvious to configure the Wickert liquid-permeable material as a paper having a pore size of 0.3 microns or less. Roscoe states that it is necessary to select a microorganism, yeast, mold and/or virus having a particular size, and that pores suitable for effectuating such a separation must be utilized (“Accordingly, the selection of a membrane filter with a suitable pore size may depend upon the target microorganism. For example, a membrane filter with a pore size of 1.0 µm or less, 0.8 µm or less, 0.6 µm or less, 0.4 µm or less, 0.2 µm or less, 0.1 µm or less, 0.05 µm or less, 0.03 µm or less, 0.02 µm or less, or 0.01 µm or less may be suitable to capture and detect target bacteria…”). Roscoe shows how such a liquid-permeable paper filter may be readily incorporated into a multi-layer microbial susceptibility testing device in predictable manner.
Response to Arguments
Applicant's arguments filed 04 August 2026 with respect to the rejection of claim 1 under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant argues that Jarvey is directed to a different kind of assay that offers continuous analysis of sweet using features (e.g., microfluidic channel, filler, electrodes) not found in Wickert. In response, it is noted that the premise of the proposed combination of Wickert with Jarvey is not to fundamentally redesign Wickert so that it is capable of monitoring sweat, but rather simply to include an adhesive layer on a surface of the first substrate. Wickert is already interested in testing biological samples, such as human body fluids, and therefore those of ordinary skill would have considered direct attachment of the Wickert device to the patient. It is prima facie obvious to apply a known technique (here, an adhesive layer) to a known device ready for improvement to yield predictable results. See MPEP 2143. Derda is further evidence that a microorganism incubation testing device (such as that of Wickert) would be improved when that point-of-care device is immediately incubated through attachment to the patient’s body. Derda teaches that this removes the need for a separate transportation step and additional incubator equipment.
Allowable Subject Matter
Claims 29, 34, 35, 49, 50, 52 and 53 are allowed.
The prior art does not disclose the claimed testing kits. Applicant’s arguments regarding Wickert (which is believed to be the closest prior art) are persuasive. Wickert does not teach the required multi-substrate configuration, and it would not have been obvious to provide Wickert with additional liquid-permeable and liquid-impregnable substrates for carrying bioactive substances and bacterial marking substances. The dry powder layers 14, 24 of Bjork, for example, are not liquid-permeable and liquid-impregnable, and it would not have been feasible to add them to Wickert’s structure because the Wickert pad 24 and backing 26 are detachable and removed prior to testing. Applicant’s arguments filed 04 August 2026 are persuasive.
The Takemoto (US 5494823) reference teaches a liquid-permeable and liquid-impregnable substrate disposed between liquid-impermeable substrates. Takemoto, however, does not teach additional liquid-permeable and liquid-impregnable layers that carry one or more bioactive substances and a bacterial marking substance.
The Miller (WO 2012012172) reference discloses a multilayer filter assembly used for microbial detection. Miller, like Bjork, uses dry coating layers for providing a bacterial marking substance, and does not teach the required configuration of additional liquid-permeable and liquid-impregnable substrates.
The Chandrapati (US 2020048679) and Nelson (US 5681712) references do not teach the required multi-substrate configuration, and, especially, liquid-permeable and liquid-impregnable substrates comprising bioactive substances and bacterial marking substances.
For purposes of clarity, it is noted that page 4 of the specification and paragraph [0016] of the printed publication clearly define the claimed term “liquid-impregnable” to refer to the ability of a substrate to retain within that substrate a liquid absorbed into the substrate. Absorbent and/or blotting papers are provided as examples. Accordingly, the term “impregnable” means essentially “impregnate-able”, as opposed to the common usage of the term “impregnable” which means essentially the opposite (e.g., an impregnable fortress, barrier, or object that prevents entry).
Conclusion
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 NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN A BOWERS/Primary Examiner, Art Unit 1799
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