DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/16/2025 has been entered.
Response to Amendment
This is an office action in response to applicant's arguments and remarks filed on 12/16/2025. Claims 2-25 are pending in the application, with claims 20-25 being withdrawn.
Status of Objections and Rejections
All rejections from the previous office action are maintained.
Response to Arguments
Applicant's arguments filed 12/16/2025 have been fully considered but they are not persuasive.
On Page 6 of Applicant’s Remarks, the Applicants submits that Claims 2-16 are patentable over the claims of U.S. Patent No. 10,295,472 at least in view of the amendments to Claim 2 set forth herein.
In light of this argument, the Examiner respectfully disagrees as claim 17 of the reference application teaches control electronics configured to determine the position of the assay test strip within the body during the user-caused moving of the assay test strip relative to the body of the reader, the control electronics configured to determine the presence or absence of analytes to which the assay test strip was exposed based on the first signal and the second signal detected while the assay test strip is moving relative to the at least one detector, wherein the first and signals detected while the assay test strip is moving contain information indicating the presence or absence of the analytes (the process of using the controller includes detecting a presence of at least one analyte reaction region based on at least one characteristic of the at least one analyte reaction region during the operator-caused moving of the assay test strip relative to the body of the assay test strip reader).
On Page 8 of the Remarks, the Applicant asserts that the detection of alignment features or position markers of Fouquet et al. (US 2007/0188736, cited on the IDS, “Fouquet”) would not provide any information indicating the presence or absence of an analyte, as is required by the newly amended claim limitations. For at least these reasons, Fouquet does not anticipate nor render obvious amended independent Claim 2.
In response to this argument, the Examiner respectfully disagrees. Fouquet teaches the at least one detector configured to detect a first signal based on a first point on the assay test strip and to detect a second signal based on a different second point on the assay test strip (detectors 62 and 64 detect a plurality of signals from different portions of the test strip, see Fig. 4-5 and [0053], where the different portions include the measurement region and the baseline region), where the control electronics (data analyzer 46, see Figs. 4-5 and [0048]) are configured to determine the presence or absence of analytes to which the assay test strip was exposed based on the first signal (measurement region signal 74, see [0055]) and the second signal (baseline region signal 76, see [0055]) detected while the assay test strip is moving relative to the at least one detector, wherein the first and second signals detected while the assay test strip is moving contain information indicating the presence or absence of the analytes (data analyzer 46 converts detected signals from detectors 62 and 64 to create a value, or profile, that indicates whether the test strip has detected an analyte, see Fig. 4-5 and [0056]- [0058]. The signals are based on the measurement region and baseline region’s position relative to the detection system 60, where the test strip continues to move after a first stop to move to the next test region 16, see Figs. 4-5 and [0055] – [0058]).
Additionally, the position markers of the invention of Fouquet mark the bounds of the measured regions and therefore provide information indicating the presence or absence of an analyte as the controller is using the alignment features to determine where a color change should occur, see [0079] – [0083].
On Page 9 of the Remarks, the Applicant states that although [0050] of Fouquet does disclose a power supply, the mere disclosure of insertion of a test strip into a device that contains a power supply does not in any way teach or suggest that the insertion of the test strip would cause the reader to power up.
In response to applicant's argument on Page 9 that the prior art of Fouquet does not teach that “the insertion of the assay test strip into the body causes the assay test strip reader to power up,” 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. Because the prior art of Fouquet contains a power source that activates responsive to the correct insertion of the test strip, see [0050], [0062], and [0070].
Claim Objections
Claim 2 is objected to because of the following informalities:
Page 3, Lines 2-3 of the instant claims should read as “wherein the first and second signals detected while the assay test strip is moving contain information indicating the presence or absence of the analytes”. Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,295,472. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 2 of the instant application, claim 1 of the reference application also teaches an assay test strip reader comprising: a body sized to receive an assay test strip comprising a test portion and an optically detectable encoder portion;
at least one detector positioned within and fixedly attached to the body, the at least one detector configured to detect a first signal based on a first point on the assay test strip and to detect a second signal based on a different second point on the assay test strip, the at least one detector further configured to detect the first signal and the second signal during an inserting of the assay test strip by a user sliding the assay test strip in a first direction with respect to the body, or a removing of the assay test strip by a user sliding the assay test strip in a different second direction with respect to the body, such sliding resulting in movement of the assay test strip with respect to the body and the at least one detector;
an optical position sensing mechanism configured to detect an amount of displacement of the assay test strip within the body during the user-caused moving of the assay test strip relative to the body of the reader based on optical detection of the encoder portion, the optical position sensing mechanism being thereby configured to detect at least one position of the assay test strip with respect to the reader and to generate at least one output signal indicative of a relative position of the assay test strip and the body (i.e. the control electronics are configured to determine a position along the length of the assay strip that was in the field of view of the detector at a time of detection of the analyte optical signal and to determine a distance between the known positions of the optically detectable markings of the encoder portion);
a signal converter electronically connected to the at least one detector, the signal converter configured to receive the first signal and the second signal detected by the at least one detector, wherein the detection of the first signal and the second signal takes place during the user-caused moving of the assay test strip relative to the body of the assay test strip reader (the control electronics are configured to receive the analyte optical signals and the encoder optical signals from the at least one detector); and
Claim 17 of the reference application teaches control electronics configured to determine the position of the assay test strip within the body during the user-caused moving of the assay test strip relative to the body of the reader, the control electronics configured to determine the presence or absence of analytes to which the assay test strip was exposed based on the first signal and the second signal detected while the assay test strip is moving relative to the at least one detector, wherein the first and signals detected while the assay test strip is moving contain information indicating the presence or absence of the analytes (the process of using the controller includes detecting a presence of at least one analyte reaction region based on at least one characteristic of the at least one analyte reaction region during the operator-caused moving of the assay test strip relative to the body of the assay test strip reader).
Regarding claim 3 of the instant application, claim 2 of the reference application teaches at least one detector comprises an optical detector.
Regarding claim 4 of the instant application, claim 9 of the reference application also teaches that the optical detector comprises at least one optical element selected from the group consisting of aperture elements, lenses, mirrors, and diffractive elements.
Regarding claim 5 of the instant application, claim 3 of the reference application also teaches at least one audio/visual indicator affixed to the body, wherein the control electronics are further configured to cause the at least one audio/visual indicator configured to output an audio/visual representation of the result.
Regarding claim 6 of the instant application, claim 4 of the reference application teaches that the result indicates a qualitative result of an analyte test.
Regarding claim 7 of the instant application, claims 5 and 6 of the reference application teach that the at least one detector includes at least one PIN-diode detector or at least one CMOS imager.
Regarding claim 8 of the instant application, claim 1 of the reference application teaches that the control electronics are configured to use the encoder portion to linearize the motion of the assay test strip within the assay test strip reader. (the control electronics use the determined distance and the data pairs to generate a linearized representation of a spacing of the magnitudes of the analyte optical signals along the length of the test strip).
Regarding claim 9 of the instant application, claim 8 of the reference application teaches that the at least one detector includes a plurality of detectors fixedly connected to the body of the assay test strip reader in a linear arrangement perpendicular to a direction of motion of the assay test strip, and wherein the profile includes a two-dimensional profile of the assay test strip.
Regarding claim 10 of the instant application, claim 10 of the reference application also teaches that the assay test strip reader comprises at least one display device, and wherein the control electronics are further configured to cause output of an indication of the result on the display device
Regarding claim 11 of the instant application, claims 11 and 12 of the reference application also teaches that the assay test strip is associated with a biological test, and wherein the result is indicative of a quantitative result of the biological test.
Regarding claim 12 of the instant application, claims 11 and 13 of the reference application also teaches that the assay test strip is associated with a biological test, and wherein the result is indicative of a qualitative result of the biological test.
Regarding claim 13 of the instant application, claim 1 and 14 of the reference application also teaches that a linearized representation is stored to create a results profile of the assay test strip.
Regarding claim 14 of the instant application, claim 14 of the reference application also teaches that the control electronics enable a connection to a separate processor-based device such that the linearized representation of the assay test strip can be stored on a memory device of the separate processor-based device.
Regarding claim 15 of the instant application, claim 15 of the reference application also teaches that the assay test strip is exposed to at least one biological fluid prior to insertion of the assay test strip in the body.
Regarding claim 16 of the instant application, claim 16 of the reference application also teaches that the insertion of the assay test strip into the body causes the assay test strip reader to power up.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 2-19 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Fouquet et al. (US 2007/0188736, cited on the IDS, “Fouquet”).
Regarding claim 2, Fouquet teaches an assay test strip reader (diagnostic test system 40, see Fig. 3 and [0041]) comprising:
a body (housing 42, see Fig. 3 and [0041]) sized to receive an assay test strip (test strip 50, see Fig. 3 and 8 and [0041]) comprising a test portion (measurement regions 16 and 18, see Fig. 8 and [0075]) and an optically detectable encoder portion (housing 42 receives test strip 50 wherein the test strip 50 has measurement regions 16 and 18 and optically encoded position markers 112- 118, see Fig. 8 and [0075]);
at least one detector positioned within and fixedly attached to the body (reader 44 within housing 42, see Fig. 3 and [0043], where the reader 44 comprises detectors 62 and 64, see Fig. 4-5 and [0053]), the at least one detector configured to detect a first signal based on a first point on the assay test strip and to detect a second signal based on a different second point on the assay test strip (detectors 62 and 64 detect a plurality of signals from different portions of the test strip, see Fig. 4-5 and [0053], where the different portions include the measurement region and the baseline region), the at least one detector further configured to detect the first signal and the second signal during an inserting of the assay test strip by a user sliding the assay test strip in a first direction with respect to the body, or a removing of the assay test strip by a user sliding the assay test strip in a different second direction with respect to the body, such sliding resulting in movement of the assay test strip with respect to the body and the at least one detector (detectors 62 and 64 detect a plurality of signals from multiple positions of the test strip 50 following the manual movement of the test strip into and out of the housing 42, see Figs. 7A-C, [0070], [0072], and [0074]);
an optical position sensing mechanism (reader 44, see Fig. 3 and [0078]) configured to detect an amount of displacement of the assay test strip within the body during the user-caused moving of the assay test strip relative to the body of the reader based on optical detection of the encoder portion (position markers 112-118), the optical position sensing mechanism being thereby configured to detect at least one position of the assay test strip with respect to the reader and to generate at least one output signal indicative of a relative position of the assay test strip and the body (reader 44 in tandem with data analyzer 46 detects movement of test strip using position markers 112-118 and outputs response based on position of test strip within housing 42, see [0078]- [0079]);
a signal converter electronically connected to the at least one detector (data analyzer 46 includes signal converter connected to detectors 62 and 64, see Fig. 3-5 and [0048]), the signal converter configured to receive the first signal and the second signal detected by the at least one detector (analyzer 46 receives signals from detectors 62 and 64 of reader 44, see Fig. 3-5, [0048], [0056], and [0074]) wherein the detection of the first signal and the second signal takes place during the user-caused moving of the assay test strip relative to the body of the assay test strip reader; and
Detection occurs during movement of the test strip, see Fig. 4-5 and [0053], and therefore the detection of the first signal and the second signal takes place during the user-caused moving of the assay test strip relative to the body of the assay test strip reader
control electronics configured to determine the position of the assay test strip within the body during the user-caused moving of the assay test strip relative to the body of the reader (data analyzer 46 is used to determine position of test strip 50 within housing 42 following handheld actuation, see [0078]), where the control electronics (data analyzer 46, see Figs. 4-5 and [0048]) are configured to determine the presence or absence of analytes to which the assay test strip was exposed based on the first signal (measurement region signal 74, see [0055]) and the second signal (baseline region signal 76, see [0055]) detected while the assay test strip is moving relative to the at least one detector, wherein the first and second signals detected while the assay test strip is moving contain information indicating the presence or absence of the analytes (data analyzer 46 converts detected signals from detectors 62 and 64 to create a value, or profile, that indicates whether the test strip has detected an analyte, see Fig. 4-5 and [0056]- [0058]. The signals are based on the measurement region and baseline region’s position relative to the detection system 60, where the test strip continues to move after a first stop to move to the next test region 16, see Figs. 4-5 and [0055] – [0058]).
Regarding claim 3, Fouquet teaches the system of Claim 2, wherein the at least one detector comprises an optical detector (detectors 62 and 64 are optical detectors, see [0053]).
Regarding claim 4, Fouquet teaches the system of Claim 3, wherein the optical detector comprises at least one optical element selected from the group consisting of aperture elements, lenses, mirrors, and diffractive elements (the detectors 62 and 64 include optical elements 70 and 72, see [0053], where the elements are refractive lenses, diffractive lenses, and optical filters, see [0053]).
Regarding claim 5, Fouquet teaches the system of Claim 2, further comprising at least one audio/visual indicator affixed to the body (results indicator 52 attached to housing 42, see Fig. 3 and [0051]), wherein the control electronics (data analyzer) are further configured to cause the at least one audio/visual indicator configured to output an audio/visual representation of a result indicating the presence or absence of the analytes to which the assay test strip was exposed (the data analyzer 46 converts the signal to be output visually by the indicator 52, see Fig. 3, [0041], and [0048]- [0049], where the test strip is used to produce results regarding presence of a target biological analyte, see [0001]).
Regarding claim 6, Fouquet teaches the system of Claim 2, wherein the result indicates a qualitative result of an analyte test (test strip is used to produce results regarding presence of a target analyte, see [0001], which is a qualitative result, see [0002] of the Instant Application).
Regarding claim 7, Fouquet teaches the system of Claim 2, wherein the at least one detector includes at least one PIN-diode detector or at least one CMOS imager (the detectors 62 and 64 are CMOS image sensors, see [0053]).
Regarding claim 8, Fouquet teaches the system of Claim 2, wherein the control electronics (data analyzer) are configured to use the encoder portion (position markers 112-118) to linearize the motion of the assay test strip within the assay test strip reader (data analyzer is used to locate position markers 112-118 to drive motor to move test strip through housing 42, see Fig. 7-8, [0072], [0074], and [0078]).
Regarding claim 9, Fouquet teaches the system of Claim 2, wherein the at least one detector includes a plurality of detectors fixedly connected to the body of the assay test strip reader in a linear arrangement perpendicular to a direction of motion of the assay test strip (detectors 62 and 64 are arranged linearly and point perpendicularly to the test strip, see Fig. 4), and wherein the profile includes a two-dimensional profile of the assay test strip (the detectors are two-dimensional optical detectors and therefore generate a two-dimensional profile of the test strip, see [0053]).
Regarding claim 10, Fouquet teaches the system of Claim 2, wherein the assay test strip reader comprises at least one display device (results indicator 52 attached to housing 42, see Fig. 3 and [0051]), and wherein the control electronics are further configured to cause output of an indication of the result on the display device (the data analyzer 46 converts the signal to be output visually by the indicator 52, see Fig. 3, [0041], and [0048]- [0049]).
Regarding claim 11, Fouquet teaches the system of Claim 2, wherein the assay test strip is associated with a biological test, and wherein the result is indicative of a quantitative result of the biological test (test strip is used to produce results regarding the signal strength and concentration of a target analyte, see [0058], which is a quantitative result, see [0017] of the Instant Application).
Regarding claim 12, Fouquet teaches the system of Claim 2, wherein the assay test strip is associated with a biological test, and wherein the result is indicative of a qualitative result of the biological test (test strip is used to produce results regarding presence of a target biological analyte, see [0001], which is a qualitative result, see [0002] of the Instant Application).
Regarding claim 13, Fouquet teaches the system of Claim 2, wherein the profile of the assay test strip is a linearized representation of spacing of detected regions of the test portion of the assay test strip (data analyzer 46 converts detected signals from detectors 62 and 64 to create a value, or profile, that indicates whether the test strip has detected an analyte at measurement portions 16 and 18, see Fig. 4-5 and [0056]- [0058]).
Regarding claim 14, Fouquet teaches the system of Claim 13, wherein the control electronics enable a connection to a separate processor-based device such that the linearized representation of the assay test strip can be stored on a memory device of the separate processor-based device (data analyzer 46 connects a microprocessor to the system, see [0048]).
Regarding claim 15, Fouquet teaches the system of Claim 2, wherein the assay test strip is exposed to at least one biological fluid prior to insertion of the assay test strip in the body (the test strip is exposed to a sample containing a target biological analyte, and is therefore exposed to a biological fluid, see [0001]).
Regarding claim 16, Fouquet teaches the system of Claim 2, wherein the insertion of the assay test strip into the body causes the assay test strip reader to power up (the test strip is inserted into the housing 42 that contains a power supply 54, see Fig. 3 and [0050]).
“the insertion of the assay test strip into the body causes the assay test strip reader to power up,” is a recitation of a function of the claimed invention. A functional limitation 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 function, then it meets the claim. Because the prior art of Fouquet contains a power source that activates responsive to the correct insertion of the test strip, see [0050], [0062], and [0070], it meets the limitation of the insertion of the test strip causing the test strip reader to power-up.
Regarding claim 17, Fouquet teaches the system of Claim 2, wherein the optical position sensing mechanism includes a photodiode (reader 44 includes semiconductor photodiode, see [0047] and [0053]).
Regarding claim 18, Fouquet teaches the system of Claim 2, wherein the optically detectable encoder portion (position markers 112-118) comprises a plurality of marks printed on the assay test strip (position marker 112-118 are printed on the test strip, see Fig. 8 and [0075]).
Regarding claim 19, Fouquet teaches the system of Claim 18, wherein the plurality of marks are spaced along at least a portion of the assay test strip at a regular spacing interval (the position markers are located evenly, or regularly, around the test strip measurement areas 16 and 18, see Fig. 8).
Conclusion
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/A.N.M./Examiner, Art Unit 1758
/SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758