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 .
Response to Arguments
Applicant's arguments filed January 14, 2026 have been fully considered but they are not persuasive. Applicant has amended independent claim 1 to recite at least one lens positioned between the test strip with the excitation light directing region positioned so that emission signals from the test strip pass through the light directing region. Independent claim 1 has also been amended to recite the at least one lens positioned so that excitation light from the light source passes through the light transmission region to the test strip. Applicant has argued that reference to Petruno et al., (US 2007/0231922) do not teach the limitations of amended claim 1. The Examiner agrees that the embodiment of Petruno et al., cited in the previous Office Action does not teach the amended limitations of claim 1. However, in a separate embodiment not previously cited by the Examiner, reference to Petruno et al., does teach limitations that read on the amended limitations of claim 1. The Examiner points to paragraphs 0086, 0087, and figure 11 of Petruno et al., which teach two lenses positioned between a light source and a test strip wherein excitation light from the light source (figure 11 #212) passes through light transmission regions of the two lenses (figure 11 #’s 214, 216) to the test strip (figure 11 #’s 80, 82), and emissions from the test strip passes through the lenses to two detectors (figure 11 #’s 202, 204). Given these teachings, the Examiner contends that the combination of Rutter et al., in view of Petruno et al., as detailed below meets the claim limitations, thus the claims are not in condition for allowance.
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.
Claim(s) 1, 3, 6-8, 10-18, and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rutter et al., (US 2010/0267049) in view of Petruno et al., (US 2007/0231922).
Regarding claims 1, 3, and 6, Rutter et al., teach a lateral flow test strip reader (paragraphs 0244,0247) comprising a lateral flow test strip receptacle (paragraph 0023), a light source (paragraph 0020), an optical detector (paragraph 0026), and at least one lens having a light transmission region (paragraph 0151). Rutter et al., do not teach at least one lens between the detector and the test strip wherein the at least one lens comprises an excitation direction region and an excitation light transmission region.
Petruno et al., teach a diagnostic test system comprising an illumination system having a light source (paragraph 0086, figure 11 #206), two light detectors (paragraph 0086, figure 11 #'s 202, 204), and two lenses (paragraph 0087, figure 11 #’s 214, 216) wherein light (figure 11 #212) from the light source transmits through the lenses to the control and test regions of a test strip, and emissions from the control and test regions of a test strip transmits through the lenses to the detectors (paragraph 0087, figure 11). The Examiner is reading this combination as combining prior art elements according to known methods to yield predictable results which would have been obvious to one of ordinary skill in the art (MPEP 2141 III A). Reference to Petruno et al., clearly teach an arrangement wherein light is transmitted through two lenses to a strip, and emissions from the test strip are transmitted through the lenses to two detectors, thus one of ordinary skill in the art would have found it obvious to utilize the teachings of Petruno et al., when detecting emissions from a test strip. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Rutter et al., wherein at least one lens comprises a light transmission region and an excitation light directing region as combining prior art elements according to known methods to yield predictable results requires only routine skill in the art.
Regarding claim 7, the Examiner notes that the claimed emission signals are not structural elements of the lateral flow test strip reader, thus claim 7 is directed to the intended use of the claim reader. However, reference to Rutter et al., teach detection of one or more analytes in a sample (Abstract).
Regarding claim 8, Rutter et al., teach the light source being a laser (paragraph 0019).
Regarding claim 10, Rutter et al., teach a light source identical to that of the instant claims (paragraph 0020), thus one would expect the light source of Rutter et al., to exhibit properties identical to that of the instant claims. The Examiner notes that the test region, elongated test line, and elongated control line are elements of the test strip and not the lateral flow test strip reader. As detailed above, the Examiner contends that the test strip itself is not a structural element of the reader, and therefore does not impart structure to the reader.
Regarding claim 11, Rutter et al., teach the lateral flow test strip reader comprising a heater (paragraphs 0227,0231).
Regarding claim 12, Rutter et al., teach a temperature sensor (paragraphs 0227,0231) and a master module (temperature controller) that controls temperature (paragraph 0245).
Regarding claim 13, Rutter et al., do not teach the light source positioned off-axis based on the emission signals received by the light detector.
Petruno et al., teach a diagnostic test system wherein the light source is positioned off-axis bases on the emission signals received by the light detectors (figure 11). The Examiner is reading this combination as combining prior art elements according to known methods to yield predictable results which would have been obvious to one of ordinary skill in the art (MPEP 2141 III A). Reference to Petruno et al., clearly teach an arrangement wherein the light source is positioned off-axis based on the emission signals received by the detectors, thus one of ordinary skill in the art would have found it obvious to utilize the teachings of Petruno et al., when positioning the light source and detectors. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Rutter et al., wherein the light source is positioned off-axis based on the emission signals received by the light detectors as combining prior art elements according to known methods to yield predictable results requires only routine skill in the art.
Regarding claim 14, Rutter et al., teach the reader comprising an actuator that positions the test strip (paragraph 0233). The Examiner notes that reference to Rutter et al., teach a light source identical to that of the instant claims, thus the prior art light source would be capable of performing the functions of the claim. Additionally, the Examiner notes that the test and control regions of the lateral flow test strip are not structural elements of the claimed reader, and therefore do not impart structural elements into the claim.
Regarding claim 15, Rutter et al., teach the detection module comprising a filter (paragraphs 0026,0147,0151, 0153).
Regarding claim 16, the Examiner notes that the claim is directed to elements of the lateral flow test strip. As detailed above, the lateral flow test strip is not a structural element of the claimed lateral flow test reader, and therefore is not given patentable weight with respect to the lateral flow test reader as the lateral flow test strip is a separate component from the test reader.
Regarding claim 17, Rutter et al., teach a processor (signal analyzer) that analyzes the test strip (paragraph 0020).
Regarding claim 18, Rutter et al., teach a transmitter (paragraphs 0012, 0031,0211, 0213,0262).
Regarding claim 36, Rutter et al., teach a laser diode (paragraph 0155).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rutter et al., (US 2010/0267049) in view of Petruno et al., (US 2007/0231922) as applied to claim 1 above, and further in view of Cohen et al., (US 2005/0243321).
Regarding claim 5, Rutter et al., in view of Petruno et al., do not teach a Fresnel lens.
Cohen et al., teach an optical detection system (Abstract) wherein a Fresnel lens is utilized to focus light on a test sample (paragraph 0075). Cohen et al., teach that itis advantageous to utilize a Fresnel lens as a means of focusing light toward a test sample and/or detector (paragraph 0075).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Rutter et al., in view of Petruno et al., wherein a Fresnel lens is provided in order to utilize a lens capable of focusing light toward a test sample and/or detector as taught by Cohen et al.
Allowable Subject Matter
Claim 2 is 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: the prior art of record does not teach or suggest a lateral flow test strip reader comprising at least one lens wherein the excitation light transmission region of the at least one lens comprises an aperture in the lens configured to allow passage of the excitation light. Reference to Petruno et al., is cited for teaching two lenses having an excitation light transmission region; however, Petruno et al., does not teach or suggest the excitation light transmission region comprising an aperture in the lens.
Conclusion
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/DWAN A GERIDO/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797