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 1/31/23 and 9/26/25 is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of claims 1, 3, 5, 7, 9-11, 13, and 22-26 are in the reply filed on 2/18/26 is acknowledged.
Claims 36-38, 40, 43-46 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (directed to a test assay device), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/18/26.
Claim Status
Claims 1, 3, 5, 7, 9-11, 13, and 22-26 are pending and are examined. Claims 36-38, 40, 43-46 are withdrawn and are not examined.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 is indefinite since claim 7 depends on cancelled claim 6. The claim will be interpreted as dependent on claim 1.
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 36, 37, and 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fleming (US Pub 2015/0010992).
Regarding Claim 36, Fleming teaches a device for determining the presence or absence of one or more health conditions, comprising: a signal output device comprising a housing containing at least a first and second strip, wherein an end portion of the first strip is capable of being placed into fluid communication with a first target sample solution of a first well of an testing container, and an end portion of the second strip is capable of being placed into fluid communication with a second target sample solution of a second well of the testing container, the signal output device configured to provide an indication of a status of the one or more health conditions for the first target sample solution and the second target sample solution ([0057] FIGS. 6 and 7 illustrate schematic representations of the operation of reader system 10. As shown in FIG. 6, excitation member 24 (e.g., a Xenon flashlamp) emits light 31 at a detection zone 32. In the illustrated embodiment, detection zone 32 comprises a portion of a lateral flow strip 33 that comprises one or more reporters (e.g., fluorescent beads 35) that emit fluorescent light 34 when illuminated by excitation member 24. Emitted fluorescent light 34 is directed towards imaging system 26, which can comprise at least one lens 36 and a CMOS sensor 38. Lens 36 can comprise multiple lenses configured to direct and focus light on the sensor 38. [0058] As shown in FIG. 6, imaging system 26 can have a field of view 37 that is capable of detecting the entire detection zone 32. As discussed in more detail below in other embodiments, field of view 37 can be sufficiently large to detect multiple detection zones. These multiple detection zones can include portions of multiple lateral flow strips 33 (or other analytical test members) and/or other viewable elements that contain information about the analytical tests being performed by the reader system.).
Regarding Claim 37, Fleming teaches the device of claim 36, wherein the housing of the signal output device completely or partially surrounds the first and second strips ([0052] FIGS. 1-4 illustrate an optical reader system 10 comprising an imaging system for determining the presence and/or amount of analytes in a fluid sample. Optical reader system 10 comprises a housing 12 that contains an imaging system 26. To illustrate the internal structure and components of reader system 10, housing 12).
Regarding Claim 38, Fleming teaches the device of claim 36, wherein the housing is sized to couple over an upper portion of the target container, above the base, to allow the first and second strips to be lowered into the first and second well ([0052] FIGS. 1-4 illustrate an optical reader system 10 comprising an imaging system for determining the presence and/or amount of analytes in a fluid sample. Optical reader system 10 comprises a housing 12 that contains an imaging system 26. To illustrate the internal structure and components of reader system 10, housing 12).
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, 3, 5, 7, 9-11, 13, and 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over Imrich (US Patent 5,415,994), in view of Fleming (US Pub 2015/0010992).
Regarding Claim 1, Imrich teaches a system (devices, methods and kits for detecting analytes in biological samples. More particularly, the present invention provides means by which analytes requiring extraction from biological samples prior to detection may be extracted and detected in a single step. See background of invention) comprising:
an extraction container for receiving a biological sample collected by a sample collection tool, the extraction container capable of containing a first buffer for extracting a target material associated with one or more health conditions from the sample to form a sample mixture comprising the target material and the first buffer (Fig. 2A and 2B extracting chamber, Col. 9, line 10);
a testing container comprising:
a holder (container 42 holding the extraction solution, Col. 9, line 42),
a first and second well configured to receive the sample mixture wherein the first and second well each comprise one or more additional buffers, that, when mixed with the sample mixture, form a first target sample solution in the first well, and a second target sample solution in the second well, the one or more additional buffers associated with the one or more health conditions (Figs. 1A and 1B for wells with buffers, no reference signs are shown in Figs. 1A and 1B for each feature in the prior art; The examiner notes that the limitation “when” is a conditional limitation and therefore directed to intended use of the system and that the “mixture” and “buffers” are not positively recited and are directed to intended use of the device.) and
a base of the holder (bowl 12, Col. 9 line 11)
Imrich is silent to a signal output device comprising a housing containing at least a first and second strip secured within the housing, wherein an end portion of the first strip is positioned within the signal output device for being placed into fluid communication with the first target sample solution of the first well, and an end portion of the second strip is positioned within the signal output device for being placed into fluid communication with the second target sample solution of the second well, the signal output device configured to provide an indication of a status of the one or more health conditions for the first target sample solution and the second target sample solution.
Fleming teaches in the related art of lateral flow devices. [0057] FIGS. 6 and 7 illustrate schematic representations of the operation of reader system 10. As shown in FIG. 6, excitation member 24 (e.g., a Xenon flashlamp) emits light 31 at a detection zone 32. In the illustrated embodiment, detection zone 32 comprises a portion of a lateral flow strip 33 that comprises one or more reporters (e.g., fluorescent beads 35) that emit fluorescent light 34 when illuminated by excitation member 24. Emitted fluorescent light 34 is directed towards imaging system 26, which can comprise at least one lens 36 and a CMOS sensor 38. Lens 36 can comprise multiple lenses configured to direct and focus light on the sensor 38. [0058] As shown in FIG. 6, imaging system 26 can have a field of view 37 that is capable of detecting the entire detection zone 32. As discussed in more detail below in other embodiments, field of view 37 can be sufficiently large to detect multiple detection zones. These multiple detection zones can include portions of multiple lateral flow strips 33 (or other analytical test members) and/or other viewable elements that contain information about the analytical tests being performed by the reader system.
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 a signal output device comprising a housing containing at least a first and second strip secured within the housing, wherein an end portion of the first strip is positioned within the signal output device for being placed into fluid communication with the first target sample solution of the first well, and an end portion of the second strip is positioned within the signal output device for being placed into fluid communication with the second target sample solution of the second well, as taught by Fleming, to the system of Imrich, for determining the presence and/or amount of analytes in a fluid sample, as taught by Fleming, in the Abstract.
Regarding Claim 3, modified Imrich teaches the system of claim 1, wherein the housing of the signal output device completely or partially surrounds the first and second strips (there are two plastic components in the device. The top piece contains the sample processing features, the bottom piece is used for strip placement. The top and bottom components are constructed so that a press fit secures the assembly. Col. 7, lines 37-41).
Regarding Claim 5, modified Imrich teaches the system of claim 1.
Modified Imrich is silent to the housing of the signal output device is sized to fit over an upper portion of the target container, above the base, to allow the first and second strips to be lowered into the first and second well, configured to sit on top of the testing container, and comprises at least one wedge or peg configured to prevent movement or displacement of each of the at least first and second strips within the housing.
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 sized the housing of the signal output device to fit over an upper portion of the target container, above the base, in the system as taught by modified Imrich, for a more compact system.
Regarding Claim 7, modified Imrich teaches the system of claim 6, further comprising one or more pressure points at one or more locations within the housing configured to prevent movement or displacement of the first and second strips and configured to provide vertical fluid flow or horizontal fluid flow of the first and second target sample solution (there are two plastic components in the device. The top piece contains the sample processing features, the bottom piece is used for strip placement. The top and bottom components are constructed so that a press fit secures the assembly. Col. 7, lines 37-41).
Regarding Claim 9, modified Imrich teaches the system of claim 1, wherein the housing further comprises at least a first and second window for viewing the first and second strips and reading the indication of the status of the one or more health conditions ([0079] The completed card was cut into 4.3 mm strips. Strips were inserted into custom plastic cassettes with a hole/well located in the sample application area and a window in the test reading area.).
Regarding Claim 10, modified Imrich teaches the system of claim 1, wherein each strip comprises: an absorbent pad, a conjugate release pad, a wicking pad, a test line, and a control line ([0071] Referring to FIG. 8, a test strip 50 can comprise a sample pad 52, a conjugate pad 54, a nitrocellulose membrane 56, and an absorbent pad 58. The membrane-based immunoassay strip can have a test line and a reference/control line provided on the membrane (e.g., by spraying) at specific positions.).
Regarding Claim 11, modified Imrich teaches the system of claim 1, wherein each strip of the one or more strips comprises: a loading zone capable of receiving the target sample solution; a reaction zone coupled to the loading zone and comprising a first reaction substance conjugated to a first label, wherein the first reaction substance is capable of preferentially coupling to a first target of the target material within the target sample solution, a testing zone coupled to the reaction zone and comprising a first testing substance retained at a first region of the testing zone, wherein the first testing substance is capable of preferentially coupling to the first target of the target material within the target sample solution; and a control zone comprising a control substance retained at the control zone, wherein the control substance is not capable of preferentially coupling to the target material within the target sample solution ([0071] Referring to FIG. 8, a test strip 50 can comprise a sample pad 52, a conjugate pad 54, a nitrocellulose membrane 56, and an absorbent pad 58. The membrane-based immunoassay strip can have a test line and a reference/control line provided on the membrane (e.g., by spraying) at specific positions. The test line reagent can comprise an anti-beta TSH antibody and reference/control line can comprise immobilized streptavidin. After treating conjugate pad 54 with a buffer, a reference conjugate of Europium labeled BSA-Biotin can be provided on conjugate pad 54 (e.g., by spraying). A backing 60 can be applied to the membrane 56 and the entire test strip 50 can be inserted into a structural support, such as a cassette.).
Regarding Claim 13, modified Imrich teaches the system of claim 1, wherein a health condition of the one or more health conditions is a health condition associated with at least one of a Streptococcus pyogenes infection, Chlamydia trachomatis infection, a Neisseria gonorrhoeae infection, a Trichomonas vaginalis infection, a Treponema pallidum infection, a Gardnerella vaginitis infection, human immunodeficiency virus, human papillomavirus infection, Hepatitis B, herpes simplex virus, a fertility status, or a pregnancy status (the health condition is capable of being any health condition. The claim is not limited to a specific health condition as it is not positively recited in the system).
Regarding Claim 22, modified Imrich teaches the system of claim 1, wherein the sample is one of a vaginal fluid, a vaginal tissue, a vaginal washing, a vaginal swab, a vaginal discharge, a cervical swab, a cervical tissue urethral swab, a urethral discharge, a rectal swab, a rectal material, a rectal washing, urine, blood, serum, plasma, saliva, tears, a skin swab, semen, seminal fluid, sputum, bronchial fluid, bronchial washing, peritoneal fluid, peritoneal washing, pleural fluid, pleural washing, cerebrospinal fluid, eye fluid, eye tissue, lung fluid, lung tissue, liver fluid, liver tissue, heart fluid, heart tissue, brain fluid, brain tissue, kidney fluid, kidney tissue, spleen fluid, spleen tissue, muscle fluid, muscle tissue, nasal fluid, nasal swab, throat fluid, or throat swab (the sample is capable of being any sample. The claim is not limited to a specific sample as it is not positively recited in the system).
Regarding Claim 23, modified Imrich teaches the system of claim 1, wherein the signal output device is capable of being signal processed using at least one of an optical sensor, optical reader, or a smartphone (the signal output device would be capable of being signal processed using at least one of an optical sensor, optical reader, or a smartphone).
Regarding Claim 24, modified Imrich teaches the system of claim 1.
Modified Imrich is silent to the at least first and second wells are separately housed within the testing container, and wherein the at least first and second wells are not fluidically connected.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have separated the first and second wells, in the system of modified Imrich, for detecting different analytes that are housed in different wells.
Regarding Claim 25, modified Imrich teaches the system of claim 1, wherein the housing further comprises at least a first chamber configured to hold the first strip, and a second chamber configured to hold the second strip, and wherein the first and second chambers are not fluidically connected (there are two plastic components in the device. The top piece contains the sample processing features, the bottom piece is used for strip placement. The top and bottom components are constructed so that a press fit secures the assembly. Col. 7, lines 37-41).
Regarding Claim 26, Imrich teaches a sample kit comprising:
an extraction container (Fig. 2A and 2B extracting chamber, Col. 9, line 10);
for receiving a sample collection tool for mixing of the sample with a buffer within the extraction container to form a sample mixture and for performing a first step in an extraction process to extract from the sample, where present, the following: (a) a first target material from one or more agents associated with a first health condition, and (b) a second target material from one or more agents associated with a second health condition (the limitation “for receiving…” is directed to intended use);
a testing container for receiving, from the extraction container, the sample mixture comprising the buffer mixed with the sample (bowl 12, Col. 9 line 11)
the testing container having at least the following: a first well containing one or more first reagents specific to the first health condition, the first well for receiving a portion of the sample mixture to combine with the one or more first reagents as a first target sample solution, and a second well containing one or more second reagents specific to the second health condition, the second well for receiving a portion of the sample mixture to combine with the one or more second reagents as a second target sample solution (Figs. 1A and 1B for wells with buffers, no reference signs are shown in Figs. 1A and 1B for each feature in the prior art; The examiner notes that the limitation “when” is a conditional limitation and therefore directed to intended use of the system and that the “mixture” and “buffers” are not positively recited and are directed to intended use of the device.).); and
Imrich is silent to a signal output device having a housing containing at least a first test strip and a second test strip, wherein, upon coupling of the housing to the testing container, the first test strip fluidically contacts the first target sample solution and the second test strip contacts the second target sample solution, the first test strip including one or more zones with substances for interaction with the first target material to indicate whether the first health condition is present, and the second test strip including one or more zones with substances for interaction with the second target material to indicate whether the second health condition is present.
Fleming teaches in the related art of lateral flow devices. [0057] FIGS. 6 and 7 illustrate schematic representations of the operation of reader system 10. As shown in FIG. 6, excitation member 24 (e.g., a Xenon flashlamp) emits light 31 at a detection zone 32. In the illustrated embodiment, detection zone 32 comprises a portion of a lateral flow strip 33 that comprises one or more reporters (e.g., fluorescent beads 35) that emit fluorescent light 34 when illuminated by excitation member 24. Emitted fluorescent light 34 is directed towards imaging system 26, which can comprise at least one lens 36 and a CMOS sensor 38. Lens 36 can comprise multiple lenses configured to direct and focus light on the sensor 38. [0058] As shown in FIG. 6, imaging system 26 can have a field of view 37 that is capable of detecting the entire detection zone 32. As discussed in more detail below in other embodiments, field of view 37 can be sufficiently large to detect multiple detection zones. These multiple detection zones can include portions of multiple lateral flow strips 33 (or other analytical test members) and/or other viewable elements that contain information about the analytical tests being performed by the reader system.
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 a signal output device comprising a housing containing at least a first and second strip secured within the housing, wherein an end portion of the first strip is positioned within the signal output device for being placed into fluid communication with the first target sample solution of the first well, and an end portion of the second strip is positioned within the signal output device for being placed into fluid communication with the second target sample solution of the second well, as taught by Fleming, to the system of Imrich, for determining the presence and/or amount of analytes in a fluid sample, as taught by Fleming, in the Abstract.
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 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JB/
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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