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 Amendment
This is an office action in response to applicant's arguments and remarks filed on 12/31/2025. Claims 1, 3-11, and 15-18 are pending in the application.
Status of Objections and Rejections
All rejections from the previous office action are maintained.
Response to Arguments
On Pages 6-7 of the Remarks filed 12/31/2025, the Applicant states that the linear guide of claim 1 of the present invention is clearly different from the supports 50 of Klein in terms of name, structure, and intended purpose.
In response to this argument, the Examiner respectfully disagrees. Klein (US 4730921) teaches a support 50 that is analogous to the linear guide as it is used to support the moving carriage 22 which contains the sample to be analyzed, and is located under the assay platform, see Fig. 3. The recitation of the limitation of the linear guide being used to “support the test paper carrier to slide stably and smoothly and to ensure accurate positioning of the test strip carrier,” as required by the amended claim, is an intended use of the linear guide, and a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The structure is capable of supporting a test strip carrier and moving it along a guide rail and therefore meets the intended use of the claim.
In response to applicant's argument on Pages 7-8 that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the linear guide being a particular structure consisting of the guide rail, slider, circulating steel balls, and dustproof components) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. Further, it does not appear that the linear guide has support for these elements in the specification as the linear guide is stated to be “adapted for facilitating the moving platform to move,” see [0020] in the specification. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-8, and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ko (US 2019/0162652 A1), in further view of Yamauchi (US 2010/0087010 A1), Egan et al. (US 2013/0230844 A1, “Egan”), and Klein et al. (US 4730921, “Klein”).
Regarding claim 1, Ko teaches a screening test paper reading system (screening test paper reading system, see Abstract), comprising:
a reading unit having a reading device (reading unit 26, see Fig. 2 and [0019]);
a screening test paper having a reaction zone arranged thereon, wherein the reaction zone reacts chemically with a number of specific specimens and changes its the color of screening lines in the reaction zone accordingly (screening test paper 21 with reaction zones 211 that react with a sample to generate a color change in the reaction zone, see Fig. 2 and [0019]);
an optical analyzing unit, which is connected to the reading unit, adapted for analyzing spectrum signals of a screened line image received from a reaction zone on a screening test paper (reading unit 26 (reading unit), analyzes spectrum from reaction zone 211 on screening test paper 21, see [0019]- [0021]);
a test paper carrier having a bearing groove arranged thereon, adapted for accommodating the screening test paper and fixing the screening test paper on the test paper carrier (test paper carrier 22 has bearing groove 221 for holding and fixing test paper 21, see Fig. 2 and [0019]), and a linking member also arranged on the test paper carrier (gearing part 223 (linking member) arranged on carrier 22, see Fig. 3 and [0019]);
a driving device (driving device 25, see Fig. 2-3 and [0022]) wherein the driving device is connected with the linking member (driving device 25 is connected to gearing part 223 (linking member), see Fig. 3 and [0019]);
at least one casing device, which is a photo interrupter (detection device 24 (casing device) is an optical detector (photo interrupter), see Fig. 2 and [0019]), and a position sensor (detection device 24 also acts as position sensor, see [0019]), which is adapted for sensing a relative position of the moving and carrier platform unit, wherein the position sensor reads position to compute and locate relative positions of the casing device and the test paper carrier, so as to move the test paper carrier to a reading position required by the reading and light illumination unit (detection device 24 detects position of test paper carrier 22, see [0019]).
when a screening paper is placed onto the bearing groove of the test paper carrier, the driving device is activated and moves the moving platform through a linking member, and when the test paper carrier moves to a reading position in the reading and light illumination unit, and the reading device reads spectrum signals of a reflected image from the screened line illuminated in the reaction zone, and then transmits the spectrum signals of the reflected image subsequently to the optical analyzing unit for computing and analyzing (when test paper 21 is placed in bearing groove 221, driving device 25 is activated and moves via gearing part 223 (linking member) to reading position for spectrum analysis by reading unit 26 (reading unit and optical analyzing unit), see [0021]- [0022]).
However, Ko does not teach that the screening test paper system comprises an illumination unit and a light illumination device, a moving and carrier platform unit, which has a moving platform and a carrier base, wherein the carrier base is adapted for carrying the reading and light illumination unit, the test paper carrier, the moving platform and the driving device; and a circuit board unit, which is electrically connected between the reading and light illumination unit, the optical analyzing unit, and the moving and carrier platform unit, adapted for processing circuit signals received from the aforementioned units, wherein the test paper carrier for screening papers is connected and placed onto the moving platform.
In the analogous art of test strip analysis devices, Yamauchi teaches a reading and light illumination unit having a reading device and a light illumination device (optical head 2 with photo detecting element 22 (reading device) and light emitting element 21 (light illumination device), see Fig. 1 and [0057])
a moving and carrier platform unit, which has a moving platform (measurement apparatus 1a (unit) with setting plate 11 (moving platform), see Fig. 1 and [0057]),
a carrier base, wherein the carrier base is adapted for carrying the reading and light illumination unit, the test paper carrier, the moving platform and the driving device (drive mechanism 12 (carrier base) supports optical head 2 (reading and light illumination unit), test element casing 43 (test paper carrier), setting plate 11 (moving platform), and pinion 17 (driving device), see Fig. 1 and [0069]- [0070])
and a circuit board unit, which is electrically connected between the reading and light illumination unit, the optical analyzing unit, and the moving and carrier platform unit, adapted for processing circuit signals received from the aforementioned units (controller 13 (circuit board unit) analyzes the optical signals from optical head 2 (reading and light illumination unit), and is connected to the drive mechanism 12 (the moving and carrier platform unit) for positioning, see [0070]- [0074]), wherein the test paper carrier for screening papers is connected and placed onto the moving platform (the casing 43 (test paper carrier) is placed onto the setting plate 11 (moving platform), see Fig. 1 and [0072]), wherein the moving and carrier platform unit further comprises a position sensor, which is adapted for sensing a relative position of the moving and carrier platform unit (optical head 3 (position sensor) senses when setting plate 11 has moved to a certain position, see Fig. 9-12 and [0075]), the light illumination device radiates light to the screening paper (when the sample is applied to the test strip, the LED 21 is switched on, see [0073]).
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the modified the screening test paper apparatus of Ko to include the measurement apparatus (moving and carrier platform unit including moving platform, carrier base, and illumination means) controlled by a controller (circuit board unit) of Yamauchi for the benefit of detecting reflected light while illuminating a light on multiple positions on an immunochromatographic test strip (see [0013] in Yamauchi). Including the supporting electronics and the measurement apparatus of Yamauchi would have also enclosed the open components of the screening test paper apparatus of Ko and facilitated the illumination and movement of a test strip to obtain analysis results. The modification of the reading system of Ko to include the illumination and moving unit of Yamauchi would have had a reasonable expectation of successfully facilitating thorough analysis of test strips passing through a motorized unit.
Additionally, Ko modified by Yamauchi does not teach or suggest that the screening test paper apparatus reacts to IqM or IgG.
However, in the analogous art of apparatuses for reading test strips, Egan et al. teaches a system where the test strip comprises a test line that comprises IgG, see [0083]. It would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the previously modified apparatus of Ko to include the IgG test (screening) line to provide a monoclonal or polyclonal antibody binding partner for a target analyte within a sample, see [0083] in Egan et al.
Antibodies like IgG are a very common binding partner for immunoassays used to detect target antigens located within a biological sample; therefore, the modification of previously modified Ko to include the IgG screening line of Egan et al. would have had the reasonable expectation of successfully facilitating the detection of a target analyte by exposing the sample to the IgG antibody located on the test strip.
Further, Ko modified by Yamauchi and Egan does not teach that the device comprises a linear guide arranged under the test paper carrier to support the test paper carrier to slide stably and smoothly.
However, in the analogous art of devices for monitoring individual reaction areas, Klein et al. teaches a device for monitoring a color change at reaction area where the housing device comprises supports 50 that support the test device carriage 22 and receptacle 24, see Fig. 3 and Col. 4, Lines 65-68) (analogous to moving and carrier platform of previous prior art). The modification of a motorized platform to include sliding supports was known in the art as evidenced by Klein et al. for the benefit of smoothly sliding a test carriage from an insertion to a detection position, see Col. 4, Lines 35-68 in Klein.
Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the invention of Ko to further include the sliding support to further link the motor and linking member as exemplified by Klein et al. for the benefit of smoothly sliding a test carriage from an insertion to a detection position, see Col. 4, Lines 35-68 in Klein. Additionally, the modification of the device of Ko to include the support of Klein would have resulted in the predictable result of connecting the test carriage to a motorized platform to ensure that the carriage does not shift during optical analysis.
Regarding claim 3, Ko modified by Yamauchi and Egan teaches the screening test paper reading system, as recited in claim 1, wherein the driving device (motor) is a stepper motor (the motor can be a stepper motor to fix the moving distance of the test carrier, see [0022] in Ko).
Regarding claim 4, Ko modified by Yamauchi teaches the screening test paper reading system, as recited in claim 1, wherein the linking member is a gear rack (gearing part, or rack 223, to move the test paper to a corresponding position, see Fig. 3 and [0020] in Ko).
Regarding claim 5 Ko modified by Yamauchi and Egan teaches the screening test paper reading system, as recited in claim 1, wherein the screening test paper is for specific specimens selected from the group consisting of saliva, urine, blood, excrement, water, food, toxic and hazardous substance, microorganism, and combinations thereof (the screening test paper is applied to specific samples comprising saliva, urine, blood, excrement, water, food, toxic and hazardous substance or microorganisms, see [0011] in Ko).
Regarding claim 6, Ko modified by Yamauchi and Egan teaches the screening test paper reading system, as recited in claim 1, but does not teach wherein the screening test paper is an immunochromatography test paper.
However, the analogous prior art of Yamauchi teaches a test strip that is for Covid-19 IgM/IgG Rapid Test Kit, an immunochromatography test paper, a biological fast-track screening test paper or an immunity antibody fast-track screening test paper (casing 43 contains immunochromatographic test strip 41, see [0058] in Yamauchi).
It would have been obvious to one having an ordinary skill in the art at the time of the invention to modify Ko in view of Yamauchi to further employ an immunochromatographic test strip for testing antigen-antibody reactions as taught by Yamauchi which is well known in the art (Yamauchi, para 9, 58). The modification of the test strip of Ko for testing antigen-antibody reactions.
Regarding claim 7, Ko modified by Yamauchi and Egan teaches the screening test paper reading system, as recited in claim 1, wherein the further teaches that the light illumination device is selected from the group consisting of white LEDs, UV LEDs, NIR LEDs, laser diodes, halogen lamps, tungsten lamps, and combinations thereof (light emitting element is an LED, see [0063] in Yamauchi).
Regarding claim 8, Ko modified by Yamauchi and Egan teaches the screening test paper reading system, as recited in claim 1, wherein the optical analyzing unit is an optical wavelength spectrometer or a spectrum analyzer (reading unit 26 (the optical analyzing unit) is an optical wavelength spectrometer, see [0013] in Ko).
Regarding claim 15, Ko modified by Yamauchi and Egan teaches the screening test paper reading system, as recited in claim 1, but does not teach that the system further comprises a holding seat.
However, the analogous prior art of Yamauchi teaches a holding seat which is adapted for carrying the reading and light illumination unit and the optical analyzing unit (resin member 25 for holding optical head 2 (the reading and light illumination unit and optical analyzing unit), see Fig. 3 and [0062] in Yamauchi).
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the system of Ko to include the holding seat of Yamauchi for the benefit of providing support to the reading unit (optical head) in relation to the test strip that is be analyzed (see [0064] in Yamauchi). The modification of the system to include the holding system of Yamauchi would have had a reasonable expectation of successfully facilitating the analysis of a test strip using an optical measurer.
Regarding claim 16, Ko modified by Yamauchi and Egan teaches the screening test paper reading system, as recited in claim 15, wherein the holding seat further comprises a supportive rod which is adapted for connecting the holding seat and a carrier base (resin member 25 (holding seat) connects to PC substrate 26 and drive mechanism 12 (carrier base) via metal rods 27 (supportive rod), see Fig. 3 and [0063]).
Regarding claim 17, Ko modified by Yamauchi and Egan teaches the screening test paper reading system, as recited in claim 3, but does not teach where the driving device further comprises a motor holding seat which is adapted for carrying the stepper motor and affixing the stepper motor onto the carrier base
Yamauchi teaches where the driving device further comprises a motor holding seat which is adapted for carrying the stepper motor and affixing the stepper motor onto the carrier base (worm gear 18 (holding seat) carries pinion 17 (motor) and affixes motor onto drive mechanism 12, see Fig. 1 and [0069] in Yamauchi).
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the system of Ko to include the holding seat of Yamauchi for the benefit of providing support to the setting plate (moving platform) in relation to the reading unit that is used for analysis (see [0057] in Yamauchi). The modification of the system to include the holding system of Yamauchi would have had a reasonable expectation of successfully facilitating the analysis of a test strip using a moving platform with support.
Regarding claim 18, Ko modified by Yamauchi and Egan teaches the screening test paper reading system of claim 1, comprising a linear guide (arm of Egan) but does not explicitly teach that the system comprises a holding seat for the linear guide.
However, the analogous art of Egan teaches a receptacle 40 (holding seat) that holds the positioning arm 42 (linear guide).
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the previously modified reading device of Ko to include the receptacle (holding seat) that holds the positioning arm of Egan for the benefit of providing an empty slot for accommodating the positioning arm (linear guide) when the apparatus is not engaged with the testing device (test strip carrier). Providing an accommodation, or holding seat, for the positioning arm, or linear guide, would have had the reasonable expectation of providing a full apparatus that is able to accommodate all elements of the moving and carrier platform unit neatly, including the linear guide.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ko (US 2019/0162652 A1), in further view of Yamauchi (US 2010/0087010 A1), Egan et al. (US 2013/0230844 A1, “Egan”), and Klein et al. (US 4730921, “Klein”), as applied to claim 1 above, and further in view of Neagle et al. (US 2005/0051723).
Regarding claim 9, modified Ko teaches the screening test paper reading system, as recited in claim 1, with reading device (reading unit of Ko). However, Ko modified by Yamauchi does not teach that the reading device comprises an image enlarger.
In the analogous art of systems for the automated assay of a biological sample, Neagle teaches an image enlarger which enlarges spectrum signals of a reflected image reflected by a radiated light towards to-be-screened lines on the reaction zone (the enlarger is referred to as the receiver optics 292 that include an objective 162 for providing magnification of the sample 272, see Fig. 9 and [0102]).
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the reading device of Ko modified by Yamauchi and Egan to have added the image enlarger of Neagle for the benefit of allowing a user to control the light parameters provided to the sample to improve image resolution (see [0043]- [0046] in Neagle). Further, the claim would have been obvious because claimed elements (specifically the image enlarger of Neagle) are known in the prior art, and one skilled in the art would know to combine the elements (the image enlarger of Neagle) in the device of the previous combination, with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A and 2143.02).
Regarding claim 10, modified Ko does not explicitly teach that the image enlarger is a magnifying lens and a refractive lens. However, Neagle teaches that the image enlarger is made of a magnifying lens and a refractive lens (the magnifying lens is referred to as the objective lens 162 that provides magnification and a tube lens 296 for the pass through of the optical signal 274, see Fig. 9 and [0100]- [0102]).
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the screening test paper reading system described by the combination of Ko, Yamauchi, and Egan to have utilized the magnifying and refractive lens of Neagle as an image enlarger for the benefit of allowing a user to control the light parameters provided to the sample to improve image resolution (see [0102] in Neagle). Further, the claim would have been obvious because claimed elements are known in the prior art, and one skilled in the art would have combined the elements (specifically the magnifying lens and refractive lens of Neagle) in the device of the previous combination with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A and 2143.02).
Regarding claim 11, modified Ko and Neagle et al. teaches the screening test paper reading system, as recited in claim 10. Additionally, Neagle teaches that the magnification of the image enlarger ranges between 1.5 and 10 times (the overall receiver optic’s 292 is 6x, which falls within the instant application’s range, see [0102] in Neagle).
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/A.N.M./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758