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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/9/23 and 1/8/24 is being considered by the examiner.
Claim Status
Claims 1-20 are pending and are examined.
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.
Claims 1-6, 8-15, 18, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Samproni (WO 2020/118021).
Regarding Claim 1, Samproni teaches a testing device, comprising:
a fluid collection device adapted to collect a fluid; and an assembly including a filter coupled to a test matrix, the test matrix including one or more lateral flow strips adapted to optically indicate a level of one or more analytes in the fluid, where the fluid collection device is configured to supply the fluid to the one or more lateral flow strips via the filter ([0059] In the example shown in FIG. 1 , the fluid treatment module 106 is provided with a lower portion 108, an upper portion 1 10, a second fluid reservoir 1 1 1 , a testing device, such as a lateral flow strip 1 12, a fluid channel 1 14, a first fluid port 1 16, a second fluid port 1 18, an optical zone 120, and a bar code 122. Although one testing device, such as the lateral flow strip 1 12 is shown in FIG. 1, it should be understood that the fluid treatment module 106 can be provided with multiple testing devices within a volume encompassed by the lower portion 108 and/or the upper portion 1 10. In this embodiment, each of the testing devices may be configured to conduct a predetermined test for a different analyte / condition.).
Regarding Claim 2, Samproni teaches the testing device of claim 1, further comprising a cap that is removably coupleable to the assembly via the fluid collection device ([0065] When the fluid sample has been analyzed using the lateral flow testing device 100, the cap may be removed and the fluid sample may be allowed to pass through the first fluid port 1 16 to be used for further testing.).
Regarding Claim 3, Samproni teaches the testing device of claim 2, wherein the fluid collection device is integrated with the cap, wherein the assembly further comprises a sealing interface at a collection end of the assembly, the sealing interface adapted to interface with the fluid collection device, wherein the sealing interface is coupled to the filter, and wherein at least a portion of the filter is exposed to atmosphere when the cap is not coupled to the assembly ([0061] The lower portion 108 and the upper portion 1 10 of the fluid treatment module 106 can be tubular devices that are sealably connected to form a housing that encompasses the second fluid reservoir 1 11).
Regarding Claim 4, Samproni teaches the testing device of claim 3, wherein when the cap is coupled to the assembly, the at least the portion of the filter is fluidly coupled to an interior of the fluid collection device ([0065] When the fluid sample has been analyzed using the lateral flow testing device 100, the cap may be removed and the fluid sample may be allowed to pass through the first fluid port 1 16 to be used for further testing.).
Regarding Claim 5, Samproni teaches the testing device of claim 4, wherein the sealing interface has a shape that is complimentary to a shape of the fluid collection device ([0061] The lower portion 108 and the upper portion 1 10 of the fluid treatment module 106 can be tubular devices that are sealably connected to form a housing that encompasses the second fluid reservoir 1 11. The lower portion 108 has the first fluid port 1 16 formed in an upper wall of the lower portion 108. The lower portion 108 and the upper portion 1 10 can be constructed of fluid impermeable materials, such as plastic using any suitable manufacturing process, such as 3D printing or injection molding. When the fluid treatment module 106 is connected to the fluid housing 102, a fluid sample may be transferred from the first fluid reservoir 104 to the second fluid reservoir 1 11).
Regarding Claim 6, Samproni teaches the testing device of claim 2, wherein the fluid collection device is integrated with the assembly ([0069] Figure 2 illustrates a lateral flow testing device 140 including a fluid collection device 141 having a fluid housing 142, a fluid treatment module 144 encompassed by the fluid housing 142, a first fluid reservoir 146, and a second fluid reservoir 148.).
Regarding Claim 8, Samproni teaches the testing device of claim 1, wherein the assembly further comprises a fluid channel fluidly coupled between the filter and the test matrix ([0061] Once in the second fluid reservoir 1 11, a portion of the fluid sample may be directed through the second fluid port 1 18 into the fluid channel 1 14 containing the lateral flow strip 1 12.).
Regarding Claim 9, Samproni teaches the testing device of claim 8, wherein the fluid channel is configured to divide the fluid equally between each lateral flow strip ([0061] Once in the second fluid reservoir 1 11, a portion of the fluid sample may be directed through the second fluid port 1 18 into the fluid channel 1 14 containing the lateral flow strip 1 12.).
Regarding Claim 10, Samproni teaches the testing device of claim 1, wherein the one or more lateral flow strips each comprise a plurality of sections arranged along a horizontal axis in an overlapping manner and in fluid communication ([0061] Once in the fluid channel 1 14, the fluid sample passes through the lateral flow strip 1 12 or other type of membrane or filter paper to enter an analysis portion 123 of the lateral flow strip 1 12 or membrane or filter paper. The examiner notes the term “Section” is broad.).
Regarding Claim 11, Samproni teaches the testing device of claim 10, wherein each section the plurality of sections overlaps an adjacent section by an amount in a range of 0.1% to 100% of a total surface of the section (the sections would be capable of overlapping an adjacent section by an amount in a range of 0.1% to 100% of a total surface of the section).
Regarding Claim 12, Samproni teaches the testing device of claim 1, further comprising a computing device configured to analyze an image of a test line and a control line of the one or more lateral flow strips, wherein the analyzing includes normalizing the test line and the control line to a standard blank background image, segmenting selected areas via an automated algorithm, identifying a local background comprising a round shaped outside of the segmented areas, subtracting a mean pixel intensity of the local background from an average pixel intensity of each segmented area, and normalizing to a sum of all the background subtracted area signals (the limitation beginning with configured to is directed to intended use of the device. A computing device would be capable of analyzing.)
Regarding Claim 13, Samproni teaches the testing device of claim 12, wherein an average pixel intensity of one or more areas of the test line is compared to an average pixel intensity of one or more areas of the control line to identify a disease condition (the average pixel intensity is directed to intended use of the device).
Regarding Claim 14, Samproni teaches the testing device of claim 1, wherein the fluid collection device is adapted to collect saliva ([0050] The term “sample” as used herein refers to any fluid that can be removed from a source of fluid, and that may be subject to multiple tests. In one embodiment, the term sample refers to a bodily fluid from a mammal, such as blood, saliva or urine.), and wherein the one or more lateral flow strips are adapted to optically indicate a level of one or more of E-cadherin, transforming growth factor-alpha (TGF-a), epidermal growth factor (EGF), interleukin-6 (IL-6), matrix metalloproteinase-2 (MMP-2), matrix metalloproteinase-7 (MMP-7), and pepsin in the saliva (the lateral test strips are capable of having antibodies attached to detected one of these proteins in the sample).
Regarding Claim 15, Samproni teaches the testing device of claim 1, wherein the testing device includes a data storing system which is configured to communicate with a reader and/or a computing device (The construction of the reader will depend upon the type of data generated by the means for testing.).
Regarding Claim 18, Samproni teaches the testing device of claim 1, further comprising an onboard light source to facilitate optical indication of a level of one or more analytes in the fluid, the onboard light source comprising UV light, IR light, ALI light, and/or visible light ([0061] The analysis portion 123 of the lateral flow strip 1 12 may be placed adjacent to the optical zone 120. The optical zone 120 is a portion of the lower portion 108 that is transparent to light of a predetermined spectrum so that the analysis portion 123 can be read through the optical zone 120. In some embodiments, the predetermined spectrum is visible light. [0091] In some embodiments, the reader 458 may also include a light source, such as a light emitting diode providing light through the housing 452).
Regarding Claim 19, Samproni teaches the testing device of claim 18, wherein the onboard light source is configured to emit light at an angle of about 300 to about 600 relative to the test matrix (the examiner notes that this limitation “configured to” is directed to a capability of the light source and the light source would be capable of emitting light at an angle.).
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Samproni (WO 2020/118021).
Regarding Claim 7, Samproni teaches the testing device of claim 1.
Samproni is silent to the fluid collection device is funnel-shaped.
Regarding the shape of the fluid collection device, see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.). See MPEP 2144.04 IVB.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the fluid collection device as taught by Samproni, to be funnel shaped, to allow for a liquid sample to fill the container slowly and separate particulate at the wider top.
Claims 16, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Samproni (WO 2020/118021), in view of Biornstad (US Pub 2016/0313340).
Regarding Claims 16 and 17, Samproni teaches the testing device of claim 1.
Samproni is silent to the filter has a pore size of about 0.01 µm to 2000 nm,
wherein the fluid collection device includes a pad to collect the fluid, wherein the pad comprises an indicator to indicate when sufficient fluid has been collected for analysis, wherein the one or more lateral flow strips include a combination of nanoparticles coupled to antibodies or antigens, wherein the combination of nanoparticles coupled to antibodies or antigens facilitates visualization of analytes in the fluid at analyte concentrations of about 0.01 picogram of analyte per 1 milliliter fluid.
Biornstad teaches in the related art of a lateral flow assay. [0011] Gold nanoparticles (AuNPs) conjugated with another anti-hsCRP antibody were encapsulated in the conjugation pad. [0041] FIG. 2 is a photography showing the results from one experiment using one particle size (124 nm) and varying the membrane pore size from 0.1 μm to 12 μm. The limitation beginning with “facilitates” is directed to intended use of the combination of nanoparticles coupled to antibodies or antigens.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added an indicator to the pad including a combination of nanoparticles coupled to antibodies or antigens, as taught by Biornstad, to the device of Samproni, to allow for specific detection of analytes in a biological specimen.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE BRAZIN whose telephone number is (571)270-1457. The examiner can normally be reached M-F 8-6.
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/JB/
/JILL A WARDEN/Supervisory Patent Examiner, Art Unit 1798