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 11 is objected to because of the following informalities: Line 5 of claim 11 recites “condensing moisture from the test environment to expose the reagent to the moisture.” , and it appears that the period at the end of this sentence should be deleted and replaced with a semi-colon. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3 and 7-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Melker et al (US PGPub 2010/0216175), cited on the IDS.
Regarding Claim 1, Melker et al teaches a device for detecting a contaminant (such as glucose) in an environment (referred to as portable device 100, illustrated in Figures 5A-G)(see [0062], [0068], [0134] and [0136]), comprising:
a reagent (referred to as an enzyme) selected to react to the contaminant (i.e. the glucose) and configured to provide an alert upon reaction with the contaminant (see [0069] and [0152]); and an absorbent media (referred to as a hydrogel pad, such as hydrogel 140) including the reagent and a carrier containing water (see [0069]-[0070], [0081] and [0143]), the carrier capable of a temperature below the dew point of the environment, the absorbent media configured to absorb condensation from the environment (i.e. an EBC, exhaled breath condensate) (see[0048] and [0068]-[0072]) ; wherein the device may be provided below the dew point of the environment to produce the alert (such as through a graphical display) in the presence of contaminant (such that the device is capable of being at room temperature, freezing,or below freezing compared to the environment especially since condensate is formed and collected) (see [0036], [0048], [0141]).
Regarding Claim 2, Melker et al teaches that the carrier (i.e. the hydrogel pad) is frozen (i.e. freeze-dried) (see [0069]-[0070]).
Regarding Claim 3, Melker et al teaches that absorbent media is selected from air laid, water-absorbing polymer, plant pulp, and hemp fiber (specifically that the absorbent media is a hydrogel) (See [0069], [0073], [0081] and [0143])).
Regarding Claim 7, Melker et al teaches that the device further comprises a sensor (referred to as sensor 110) configured to detect the reagent reaction with the contaminant (wherein contaminant glucose reacts with enzyme contained in absorbent hydrophilic hydrogel) (see [0069] and [0171]), the sensor configured for wireless transmission of detected presence of contaminant (see [0176]).
Regarding Claim 8, Melker et al teaches that the device further comprises a tray (referred to as a breathing tube part 105, formed in a collapsed state), upon which the absorbent media (i.e. hydrogel 140 of sensor 110) is positioned (see Figures 5C and 5f AND [0138]).
Regarding Claim 9, Melker et al teaches a device for detecting a contaminant (such as glucose) (referred to as portable device 100, illustrated in Figures 5A-G)(see [0062], [0068], [0134] and [0136]), comprising:
a container (referred to as breathing tube 105) capable of at least partial enclosure to create a test target environment (wherein sensor 110 is disposed within the breathing tube 105, and sensor 110 contains an enzyme in a hydrogel)(see Figures 5A, 5C, 5F, [0134], [0138] and [0152]);
an absorbent media (referred to as a hydrogel, such as hydrogel 140) positioned to functionally communicate with the test target environment (wherein the hydrogel contains enzymes, which cause a reaction) (See [0047], [0069]-[0070], [0138] and [0152]); and a reagent (specifically an enzyme) selected to react to the contaminant (i.e. glucose), positioned on the absorbent media (the hydrogel of sensor 110)(see [0068]-[0070],[0138],[0152];Figs.2A-D,Figs.5C,5F); wherein a test target with a contaminant (i.e. glucose) may be placed in the container (the breathing tube 105), and the absorbent media (the hydrogel) may functionally communicate with the test target environment (the environment containing the target analyte), and the reagent (i.e. glucose) may react with the contaminant (see [0077], [0110], [0128] and [0156]).
Regarding Claim 10, Melker et al teaches that the reagent (i.e. the enzyme) is capable of being provided with a reagent temperature less than the test target (since the EBC and reagent enzyme are cooled (such as by a cooling means, such as a Peltier device) along with the hydrogel and exhaled breath to condense the water with the hydrogel that is present either before and/or after the water from the condensate is collection during operation) (see [0048], [0069]-[0072] and Figure 5E).
Regarding Claim 11, Melker et al teaches a method for detecting a contaminant (such as glucose) (see abstract), comprising:
creating an at least partially enclosure test environment (within a breathing tube 105 of device 100, containing a hydrogel) (see Figure 5A, [0134] and [0138]);
positioning a reagent (i.e. an enzyme) for exposure with the test environment, the reagent (the enzyme) selected for its ability for a reaction (through binding) to the contaminant (the glucose) (see [0069], [0138] and [0152]]) ;
condensing moisture (such as through exhaled breath EB or exhaled breath condensate EBC) (see [0068]) from the test environment (the environment of the breathing tube 105) (see [0069) to expose the reagent (the enzyme) to the moisture (see [0072]);
detecting the reaction to the contaminant (the glucose) (through sensor 110) (see [0075] and [0138]) ; and providing a first alert (such as through a graphical display) after detecting the reaction (see [0037], [0075] and [0141]).
Regarding Claim 12, Melker et al teaches that the reagent (i.e. the enzyme) is provided in a frozen carrier (i.e. a hydrogel pad which is freeze-dried) (see [0068]-[0070]) that contains water (wherein the hydrogel contains water) (see [0070] and [0081]).
Regarding Claim 13, Melker et al teaches that the reagent (i.e. the enzyme, see [0069[) is provided on an absorbent media (i.e. the hydrogel pad) and condensing moisture comprises condensing moisture on the absorbent media (see [0070]-[0074]).
Regarding Claim 14, Melker et al teaches that absorbent media is selected from air laid, water-absorbing polymer, plant pulp, and hemp fiber (specifically that the absorbent media is a hydrogel) (See [0069], [0073], [0081] and [0143])).
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.
Claim(s) 4-6 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Melker et al as applied to claims 1 and 13 above, and further in view of Rastegar et al (US PGPub 2014/0130729), cited on the IDS.
Regarding Claim 4, Melker et al does not disclose that an adhesive is provided on a first surface of the absorbent media, wherein the device is adhered to an inside surface of a food container.
However, in the analogous art of sensors used to indicate if a packaged material has been previously heated to above certain temperature level Rastegar et al teaches a defrost indicator, generally referred to by reference numeral 300. In the defrost indicator 300 if FIGS. 3a-3c, an indicia 104, such as a bar code is printed or otherwise disposed on a material 302, at least a portion of which is capable of expanding once it absorbs liquid 304, such as water. The liquid 304 is frozen and then attached to the material 302, as shown in FIG. 3b. Materials 302 that expand upon absorbing liquids are well known in the art, such as compressed sponge sheeting. Referring now to FIG. 3d, a variation of the defrost indicator 300 is shown in which the frozen liquid 304 is encased in an enclosure 306 and sealed to the material 302. An adhesive can be applied to surface 306a for adhering the enclosure 306 to a package. Alternatively, the enclosure can be fabricated integrally with a portion of the package 308 (see [0073]). It would have been obvious to one of ordinary skill in the art to modify the device of Melker et al by incorporating an adhesive on a first surface of the absorbent media (as taught by Rastegar et al) for the benefit of enabling one to secure the device to an inside surface of a food container (also disclosed by Rastegar et al) in order to indicate a change (such as a defrost level or moisture level change) in the inside of an enclosed (secured) environment like a conventional food container.
Regarding Claims 5-6, the combination of Melker et al and Rastegar et al teaches that the alert comprises a visible indicator (such as a color or light display or pattern) located at a second surface of the absorbent media (see [0159], [0162]-[0163] and [0194] of Melker et al). Furthermore, Rastegar et al discloses the use of a pattern of, letters or bar symbols as a visual/visible indicator (see [0071] and Figures 1d and 1G).
Regarding Claim 15, Melker et al teaches the method of claim 13.
However, Melker et al does not disclose detecting a non-reaction of the reagent to the contaminant, and providing an alternate alert of the non-reaction to the contaminant.
However, in the analogous art of sensors used to indicate if a packaged material has been previously heated to above certain temperature level Rastegar et al teaches a defrost indicator, generally referred to by reference numeral 300. In the defrost indicator 300 if FIGS. 3a-3c, an indicia 104, such as a bar code is printed or otherwise disposed on a material 302, at least a portion of which is capable of expanding once it absorbs liquid 304, such as water (see [0073]). Furthermore, Rastegar et al teaches detecting a non-reaction of the reagent (like water/liquid absorbing material freezable liquid) to the contaminant (see [0077] and providing an alternate alert of the non-reaction to the contaminant (such as indicating if an environment is defrosted or not defrosted, with indicia 602 displaying WAS NOT DEFROSTED, where the letters/writing indicate “not” before “defrosted), shown in Figures 6A-C) in order to indicate that the environment being monitored or tested did not have a particular condition present (see [0077]). It would have been obvious to one of ordinary skill in the art to modify the method of Melker et al by detecting a non-reaction of the reagent to the contaminant, and providing an alternate alert of the non-reaction (as taught by Rastegar et al) for the benefit of enabling the user to easily indicate (i.e. through lettering/words) that the environment being monitored or tested did not have a particular condition present, which in Melker’s case, would be the presence or absence of the glucose analyte below a certain threshold.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Gilboa-Geffen et al (US PGPub 20190079063) discloses systems, devices, signaling polynucleotides (SPNs), detection agents and methods for detecting the presence and/or absence of one or more allergens (which are contaminants) in a sample particularly a food sample. The detection system includes a separate sampler, at least one disposable detection vessel for receiving and processing a test sample and a detection device for measuring a fluorescent signal. SPNs derived from aptamer that bind allergens are provided as detection agents. SPNs have a single open structure, and are labeled with a fluorophore. Changes in fluorescence polarization of SPNs upon the binding of allergens are measured to calculate the allergen content in a sample (see abstract).
Williams et al (US PGPub 2018/0066300) discloses a portable, self-contained system for rapidly (i.e., within one to five minutes or more) detecting infectious agents, particularly pathogens in biological samples, particularly samples derived from beef, pork, or other meat, poultry, fish, or vegetable matter, although other biological materials, such as healthcare instruments and hospital surfaces, may be analyzed using the present invention. This system provides very high sensitivity (e.g., to a single cell of a particular infectious agent) without the need to culture infectious agents, such as bacteria, obtained from samples prior to testing. In an exemplary embodiment, the specific infectious agent is Escherichia coli, although other infectious agents (such as Salmonella, Listeria, and Campylobacter), toxins, and various contaminants may be detected with the present invention. Escherichia coli O157 H7, O26, O45, O103, O111, O121, and O145, in either separate assays or multiplexed assays, may all be detected using this invention (see [0044]).
Letourneau et al (US PGPub 20170242045) discloses a method of detecting an analyte in a liquid described herein comprises the steps of providing an apparatus comprising sample pad, a conjugate pad, and a detection layer, wherein the conjugate pad comprises at least one marker, such as an anti-analyte antibody-particle conjugate, and wherein the detection layer comprises an analyte-conjugate protein and a chromatographic membrane capable of receiving the liquid and allowing for migration of the liquid; exposing at least the sample pad to the liquid; and determining whether an interaction between the analyte-conjugate protein and the liquid occurs to detect the presence of the analyte. In some embodiments, the detection layer further comprises an anti-species antibody. In some embodiments, buffers or buffer solutions may be customized for deposition into or onto the sample pad, conjugate pad, or detection layer. Thus, in some embodiments, the sample pad, conjugate pad, or detection layer (which constitute the absorbent media) comprises residual buffer components. For example, a buffer solution may be deposited onto a detection layer and then dried to form test and/or control lines or areas. In some embodiments, the chromatographic membrane of the detection layer may comprise activated carbon, silica gel, ionic exchange resins, polyelectrolyte polymers, hydrogels, and/or size exclusion chromatography matrices. In some embodiments, the chromatographic membrane may comprise cellulose, nitrocellulose, glass fiber, similar materials or a combination of these materials (see [0019]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER WECKER whose telephone number is (571)270-1109. The examiner can normally be reached 9:30AM - 6 PM EST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at 571-272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNIFER WECKER/ Primary Examiner, Art Unit 1797