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 .
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.
Claim 1 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of US 12055479. Although the claims at issue are not identical, they are not patentably distinct from each other because of claim 1 of the instant application is anticipated by claim 1 of US 12055479.
Claim 2 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of US 12055479. Although the claims at issue are not identical, they are not patentably distinct from each other because of claim 2 of the instant application is anticipated by claim 2 of US 12055479.
Claim 3 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of US 12055479. Although the claims at issue are not identical, they are not patentably distinct from each other because of claim 3 of the instant application is anticipated by claim 18 of US 12055479.
Claim 4 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of US 12055479. Although the claims at issue are not identical, they are not patentably distinct from each other because of claim 4 of the instant application is anticipated by claim 3 of US 12055479.
Claim 5 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of US 12055479. Although the claims at issue are not identical, they are not patentably distinct from each other because of claim 5 of the instant application is anticipated by claim 4 of US 12055479.
Claim 6 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of US 12055479. Although the claims at issue are not identical, they are not patentably distinct from each other because of claim 6 of the instant application is anticipated by claim 5 of US 12055479.
Claim 7 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of US 12055479. Although the claims at issue are not identical, they are not patentably distinct from each other because of claim 7 of the instant application is anticipated by claim 6 of US 12055479.
Claim 8 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of US 12055479. Although the claims at issue are not identical, they are not patentably distinct from each other because of claim 8 of the instant application is anticipated by claim 6 of US 12055479.
Claim 9 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of US 12055479. Although the claims at issue are not identical, they are not patentably distinct from each other because of claim 9 of the instant application is anticipated by claim 6 of US 12055479.
Claim 10 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of US 12055479. Although the claims at issue are not identical, they are not patentably distinct from each other because of claim 10 of the instant application is anticipated by claim 7 of US 12055479.
Claim 11 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of US 12055479. Although the claims at issue are not identical, they are not patentably distinct from each other because of claim 11 of the instant application is anticipated by claim 6 of US 12055479.
Claim 13 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of US 12055479. Although the claims at issue are not identical, they are not patentably distinct from each other because of claim 13 of the instant application is anticipated by claim 8 of US 12055479.
Claim 14 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of US 12055479. Although the claims at issue are not identical, they are not patentably distinct from each other because of claim 14 of the instant application is anticipated by claim 9 of US 12055479.
Claim 15 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of US 12055479. Although the claims at issue are not identical, they are not patentably distinct from each other because of claim 15 of the instant application is anticipated by claim 10 of US 12055479.
Claim 16 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of US 12055479. Although the claims at issue are not identical, they are not patentably distinct from each other because of claim 16 of the instant application is anticipated by claim 13 of US 12055479.
Claim 17 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of US 12055479. Although the claims at issue are not identical, they are not patentably distinct from each other because of claim 17 of the instant application is anticipated by claim 11 of US 12055479.
Claim 18 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of US 12055479. Although the claims at issue are not identical, they are not patentably distinct from each other because of claim 18 of the instant application is anticipated by claim 12 of US 12055479.
Claim19 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of US 12055479. Although the claims at issue are not identical, they are not patentably distinct from each other because of claim 19 of the instant application is anticipated by claim 17 of US 12055479.
Claim 20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18, 19 of US 12055479. Although the claims at issue are not identical, they are not patentably distinct from each other because of claim 20 of the instant application is anticipated by claims 18, 19 of US 12055479.
Claim 12 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of US 12055479 in view of US 20030214655 A1 (hereinafter Weiss).
Regarding claim 12, the modified apparatus of Toshio does not teach further comprising at least one interface connector incorporated in the case and configured to connect to at least one external device.
Weiss, from the same field of endeavor as Toshio, teaches further comprising at least one interface connector incorporated in the case and configured to connect to at least one external device (Weiss: paragraph [0043] lines 14-16).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Weiss to the modified device of Toshio to have further comprising at least one interface connector incorporated in the case and configured to connect to at least one external device in order to display the detected information in the screen of the computer (Weiss: paragraph [0043] lines 24-27).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1, 4, 8, 10, 11, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toshio, Y. et al., JP H11142338 A (hereinafter Toshio) in view of Liu, H. et al., WO 2010120917 A2 (hereinafter Liu), and in view of Wang, J. et al., US9097665B2 (hereinafter Wang).
Regarding claim 1, Toshio teaches a reflectometer, comprising: a case (Toshio: fig. 3 the case is element 11); a first reading head comprising first scanning optics configured to illuminate a first control zone of a test strip and receive first light from the first zone (Toshio: fig. 3 the first reading head are elements 31, 34, first zone is 1b, p. 9 para 2); “a second reading head comprising second scanning optics configured to illuminate a test zone of the test strip and receive second light from the test zone” (Toshio: fig. 3 the second reading head are elements 24, 21, test zone is 1a, p. 7 para 4); “a third reading head comprising third scanning optics configured to illuminate a second control zone of the test strip and receive third light from the second zone” (Toshio: fig. 3 the third reading head are elements 131, 134, second zone is 1a, p. 7 para 4); and “a microprocessor in operable communication with the first reading head, the second reading head, and the third reading head” (Toshio: fig. 3 element 140), “wherein the microprocessor is configured to: receive and analyze a first analog signal, a second analog signal, and a third analog signal corresponding to the first light, the second light, and the third light, respectively” (Toshio: fig. 3 element 140); and “an overall level of the analyte in the test solution based on the first level, the second level, and the third level” (Toshio: p. 12 para 3-4) “wherein the first reading head comprises a first support disposed in the case” (Toshio: this is shown in fig. 3, housing 11 supports all the elements inside), “a first light source disposed on the support, and a first light receiver disposed on the support” (Toshio: this is shown in fig. 3, housing 11 supports all the elements inside), “wherein the second reading head comprises a second support disposed in the case, a second light source disposed on the support, and a second light receiver disposed on the support” (Toshio: this is shown in fig. 3, housing 11 supports all the elements inside), “wherein the third reading head comprises a third support, a third light source disposed on the support, and a third light receiver disposed on the support” (Toshio: this is shown in fig. 3, housing 11 supports all the elements inside).
Toshio fails to teach determine a first level of an analyte in the first control zone based on the first light, a second level of the analyte in the test zone based on the second light, a third level of the analyte in the second control zone based on the third light and wherein the reflectometer is configured such that the first light source, the second light source, and the third light source all provide light at a same wavelength as each other.
Liu, from the same field of endeavor as Toshio, teaches “determine a first level of an analyte in the first control zone based on the first light, a second level of the analyte in the test zone based on the second light, a third level of the analyte in the second control zone based on the third light” (Liu: p. 4 para [0021] lines 3-10 teaches three reaction zones, para [0036] lines 2-6 teaches three regions with different concentration where two of these regions corresponds to the first and second zones and the other is the test zone, para [00076] teaches the three light signals).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Liu to Toshio (replacing the test strip of Liu to Toshio) to have “determine a first level of an analyte in the first control zone based on the first light, a second level of the analyte in the test zone based on the second light, a third level of the analyte in the second control zone based on the third light” in order to improve the accuracy of the signal detected (Liu: para [0033] last sentence).
Toshio, when modified by Liu, does not teach wherein the reflectometer is configured such that the first light source, the second light source, and the third light source all provide light at a same wavelength as each other.
Wang, from the same field of endeavor as Toshio, teaches “wherein the reflectometer is configured such that the first light source, the second light source, and the third light source” (Wang: col 2 lines 63-67) all provide light at a same wavelength as each other (Wang: col 3 lines 27-28, this also indicates the third light source emits the same wavelength).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Wang to Toshio, when modified by Liu, to have wherein the reflectometer is configured such that the first light source, the second light source, and the third light source all provide light at a same wavelength as each other in order to have a high accuracy and less interference when reading (Wang: Abstract last sentence).
Regarding claim 4, the modified apparatus of Toshio teaches “the reflectometer according to claim 1, wherein the first light source is a light emitting diode (LED), wherein the second light source is an LED, wherein the third light source is an LED” (Toshio: the light sources in fig. 3b of elements 21, 31, and 131 are all LEDs),”wherein the first light receiver is a phototransistor, wherein the second light receiver is a phototransistor, and wherein the third light receiver is a phototransistor” (Toshio: p. 15 para 6 lines 2-4, this also means the other two sets are phototransistors).
Regarding claim 8, Toshio, when modified by Liu, teaches “the reflectometer according to claim 1, wherein the case comprises a baffle board mounted within the case and configured to ensure that a distance from the first reading head to the test strip, a distance from the second reading head to the test strip, and a distance from the third reading head to the test strip is consistent across different test strips” (Toshio: the baffle board corresponds to element 12 in fig. 3a), at least one stopper slot configured to receive at least one stop of a cassette comprising the test strip (Toshio: at least one stopper slot corresponds to element 12a in fig. 3a, p. 8 para 7); and “a plurality of viewing slots configured to align with the first control zone, the test zone, the second control zone, the first reading head, the second reading head, and the third reading head” (Toshio: a plurality of viewing slots corresponds to elements 1a, 1b, 1c in fig. 3a).
Toshio, when modified by Liu, does not teach wherein the baffle board comprises: a plurality of legs respectively mounted to a plurality of posts within the case.
Wang, from the same field of endeavor as Toshio, teaches “wherein the baffle board comprises: a plurality of legs respectively mounted to a plurality of posts within the case” (Wang: the baffle board is where the test strip 2 is placed and is supported by several posts as shown in fig. 1 in element 52).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Wang to Toshio, when modified by Liu, to have “wherein the baffle board comprises: a plurality of legs respectively mounted to a plurality of posts within the case” in order to have a stable test strip inside the case.
Regarding claim 10, the modified apparatus of Toshio teaches the reflectometer according to claim 1, the test solution being a biological test solution (Toshio: p. 1 para [0001] lines 10-11).
Regarding claim 11, Toshio, when modified by Wang, teaches the reflectometer according to claim 1, wherein the case comprises a display screen in operable communication with the microprocessor (p. 15 para 5 lines 2-5).
Toshio, when modified by Wang, does not teach configured to display the overall level of the analyte.
Liu, from the same field of endeavor as Toshio, teaches “configured to display the overall level of the analyte” (Liu: p. 12-13 para [0079]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Liu to Toshio, when modified by Wang, to have “configured to display the overall level of the analyte” in order to improve the accuracy of the signal detected (Liu: para [0033] last sentence).
Regarding claim 15, Toshio, when modified by Wang, does not teach wherein the first level of the analyte in the first control zone and the third level of the analyte in the second control zone are utilized to establish an upper standard and a lower standard, respectively, to which the second level of the analyte in the test zone is compared.
Liu, from the same field of endeavor as Toshio, teaches “wherein the first level of the analyte in the first control zone and the third level of the analyte in the second control zone are utilized to establish an upper standard and a lower standard, respectively, to which the second level of the analyte in the test zone is compared” (Liu: p. 4 para [0021] lines 3-10 teaches three reaction zones, para [0036] lines 2-6 teaches three regions with different concentration where two of these regions corresponds to the first and second zones and the other is the test zone, para [00076] teaches the three light signals; the regions with the highest and lower concentrations represent the upper standard and a lower standard).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Liu to Toshio to have “does not teach wherein the first level of the analyte in the first control zone and the third level of the analyte in the second control zone are utilized to establish an upper standard and a lower standard, respectively, to which the second level of the analyte in the test zone is compared” in order to improve the accuracy of the signal detected (Liu: para [0033] last sentence).
Claim(s) 2, 3, 5, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toshio, Liu, and Wang as applied to claim(s) 1 above, and further in view of Weiss, J. et al. U. S. Patent No. US 20030214655 A1 (hereinafter Weiss).
Regarding claim 2, the modified apparatus of Toshio does not teach wherein the first light source and the first light receiver are disposed on the first support such that a first angle between a path of light emitted from the first light source and a path of light received by the first light receiver is in a range of 35o to 55o, wherein the second light source and the second light receiver are disposed on the second support such that a second angle between a path of light emitted from the second light source and a path of light received by the second light receiver is in a range of 35o to 55o, and wherein the third light source and the third light receiver are disposed on the third support such that a third angle between a path of light emitted from the third light source and a path of light received by the third light receiver is in a range of 35o to 55o.
Weiss, from the same field of endeavor as Toshio, teaches wherein the first light source and the first light receiver are disposed on the first support such that a first angle between a path of light emitted from the first light source and a path of light received by the first light receiver is in a range of 35o to 55o (Weiss: paragraph [0038] lines 24-25 in Weiss. 450 is within the range of Weiss.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Weiss to the modified apparatus of Toshio to have wherein the first light source and the first light receiver are disposed on the first support such that a first angle between a path of light emitted from the first light source and a path of light received by the first light receiver is in a range of 35o to 55o in order to minimize detection of specular reflection (Weiss: paragraph [0038] lines 23-24).
Toshio, when modified by Liu, Wang, and Weiss, wherein the second light source and the second light receiver are disposed on the second support such that a second angle between a path of light emitted from the second light source and a path of light received by the second light receiver is in a range of 35o to 55o, and wherein the third light source and the third light receiver are disposed on the third support such that a third angle between a path of light emitted from the third light source and a path of light received by the third light receiver is in a range of 35o to 55o.
Since Weiss generally teaches having the light source and receiver disposed at a first angle between 35o to 55o in order to minimize detection of specular reflection (Weiss: paragraph [0038] lines 23-24). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to also have the “wherein the second light source and the second light receiver are disposed on the second support such that a second angle between a path of light emitted from the second light source and a path of light received by the second light receiver is in a range of 35o to 55o, and wherein the third light source and the third light receiver are disposed on the third support such that a third angle between a path of light emitted from the third light source and a path of light received by the third light receiver is in a range of 35o to 55o” in order to minimize detection of specular reflection (Weiss: paragraph [0038] lines 23-24 in).
Regarding claim 3, the modified apparatus of Toshio does not teach wherein the first angle is about 45o, wherein the second angle is about 45o, and wherein the third angle is about 45o.
Weiss, from the same field of endeavor as Toshio, teaches wherein the first angle is about 45o (Weiss: paragraph [0038] lines 24-25 in Weiss. 45o is within the range of Weiss.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Weiss to the the modified apparatus of Toshio to have wherein the first angle is about 45o in order to minimize detection of specular reflection (Weiss: paragraph [0038] lines 23-24 in).
Toshio, when modified by Liu, Wang, and Weiss, does not teach wherein the second angle is about 45o, and wherein the third angle is about 45o.
Since Weiss generally teaches having the light source and receiver disposed at a first angle between 45o in order to minimize detection of specular reflection (Weiss: paragraph [0038] lines 23-24). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to also have the “wherein the second angle is about 45o, and wherein the third angle is about 45o” in order to minimize detection of specular reflection (Weiss: paragraph [0038] lines 23-24 in).
Regarding claim 5, the modified apparatus of Toshio does not teach wherein the first reading head further comprises at least one first light-focusing device disposed on the first support, wherein the second reading head further comprises at least one second light-focusing device disposed on the second support, wherein the third reading head further comprises at least one third light-focusing device disposed on the third support, wherein the at least one first light-focusing device comprises at least one of a light piper and a collimator, wherein the at least one second light-focusing device comprises at least one of a light piper and a collimator, and wherein the at least one third light-focusing device comprises at least one of a light piper and a collimator.
Weiss, from the same field of endeavor as Toshio, teaches wherein the first reading head further comprises at least one first light-focusing device (Weiss: element 56 in Fig. 5 and paragraph [0038] line28) disposed on the first support and wherein the at least one first light-focusing device comprises at least one of a light piper and a collimator (Weiss: element 56 in Fig. 5 and paragraph [0038] line 28).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Weiss to the modified device of Toshio to have wherein the first reading head further comprises at least one first light-focusing device disposed on the first support and wherein the at least one first light-focusing device comprises at least one of a light piper and a collimator in order to direct light to opening where the test strip is located (Weiss: paragraph [0038] lines 28-29).
Toshio, when modified by Liu, Wang, and Weiss, is silent with respect to wherein the second reading head further comprises at least one second light-focusing device disposed on the second support and wherein the at least one second light-focusing device comprises at least one of a light piper and a collimator; and wherein the third reading head further comprises at least one third light-focusing device disposed on the third support and wherein the at least one third light-focusing device comprises at least one of a light piper and a collimator.
Again, since the second and third support structures are identical to the first support structure, by virtue of the MPEP 2144.04 VI.B, In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to duplicate the limitations above to the modified device of Toshio to have the second and third support structures be identical to the first support structure that is it comprise at least one of a light piper or a collimator in order to direct light to opening where the test strip is located.
Regarding claim 12, the modified apparatus of Toshio does not teach further comprising at least one interface connector incorporated in the case and configured to connect to at least one external device.
Weiss, from the same field of endeavor as Toshio, teaches further comprising at least one interface connector incorporated in the case and configured to connect to at least one external device (Weiss: paragraph [0043] lines 14-16).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Weiss to the modified device of Toshio to have further comprising at least one interface connector incorporated in the case and configured to connect to at least one external device in order to display the detected information in the screen of the computer (Weiss: paragraph [0043] lines 24-27).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toshio, Liu, and Wang as applied to claim(s) 1 above, in view of Weiss, J. et al. U. S. Patent No. US 20030214655 A1 (hereinafter Weiss), and further in view Lee, D.-S. et al. U. S. Patent No. US 20100157300 A1 (hereinafter Lee).
Regarding claim 6, the modified apparatus of Toshio does not teach wherein the microprocessor converts the first analog signal, the second analog signal, and the third analog signal to a first digital signal, a second digital signal, and a third digital signal, respectively, and compares the first digital signal, the second digital signal, and the third digital signal to at least one look-up table to determine the first level of the analyte, the second level of the analyte, and the third level of the analyte based on the first digital signal, the second digital signal, and the third digital signal, respectively.
Weiss, from the same field of endeavor as Toshio, teaches “wherein the microprocessor converts the first analog signal to a first digital signal” (Weiss: para [0044] lines 9-14) and “compares the first digital signal to at least one look-up table to determine the first level of the analyte based on the first digital signal” (Weiss: paragraph [0093] column 2 lines 2-7).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Weiss to the modified device of Toshio to have “wherein the microprocessor converts the first analog signal to a first digital signal” and “compares the first digital signal to at least one look-up table to determine the first level of the analyte based on the first digital signal” in order to generate information concerning the detected analyte concentration level (Weiss: para [0044] lines 9-14).
Toshio, when modified by Liu, Wang, and Weiss does not “wherein the microprocessor converts the second analog signal, and the third analog signal to a second digital signal, and a third digital signal, respectively” and “compares the second digital signal, and the third digital signal to at least one look-up table to determine the second level of the analyte, and the third level of the analyte based on the second digital signal, and the third digital signal, respectively”.
Lee, from the same field of endeavor as Toshio, teaches “wherein the microprocessor converts the second analog signal, and the third analog signal to a second digital signal, and a third digital signal, respectively” (Lee: para [0042]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Lee to Toshio, when modified by Liu, Wang, and Weiss to have “wherein the microprocessor converts the second analog signal, and the third analog signal to a second digital signal, and a third digital signal, respectively” in order to obtain accurate optical detection result (Lee: para [0009]).
Toshio, when modified by Liu, Wang, Weiss, and Lee, does not explicitly teaches “compares the second digital signal, and the third digital signal to at least one look-up table to determine the second level of the analyte, and the third level of the analyte based on the second digital signal, and the third digital signal, respectively”.
Since Weiss generally teaches having “wherein the microprocessor converts the first analog signal to a first digital signal” (Weiss: para [0044] lines 9-14) and “compares the first digital signal to at least one look-up table to determine the first level of the analyte based on the first digital signal”. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to also have the “compares the second digital signal, and the third digital signal to at least one look-up table to determine the second level of the analyte, and the third level of the analyte based on the second digital signal, and the third digital signal, respectively” in order to generate information concerning the detected analyte concentration level (Weiss: para [0044] lines 9-14).
Claim(s) 7, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toshio, Liu, and Wang as applied to claim(s) 1 above, and further in view of Stanley, J. et al. WO 2019183052 A1 (hereinafter Stanley).
Regarding claim 7, the modified apparatus of Toshio teaches the reflectometer according to claim 1, wherein the case comprises a slot at a first end thereof, the slot being configured to receive the test strip (Toshio: fig. 3 element 12).
The modified apparatus of Toshio does not teach a cassette comprising the test strip.
Stanley, from the same field of endeavor as Toshio, teaches a cassette comprising the test strip (Stanley: p. 12 para [0062]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Stanley to the modified device of Toshio to have a cassette comprising the test strip in order to compare the reference data of the sample concentration to the actual data of the analyzer (Stanley: para [0021] lines 4-8).
Regarding claim 17, the modified apparatus of Toshio teaches a kit for measuring an overall level of an analyte in a test solution, the kit comprising: a test strip (Toshio: fig. 3b element 1); the reflectometer according to claim 1 (Toshio: fig. 3a element 100).
The modified apparatus of Toshio does not teach a cassette configured to receive the test strip.
Stanley, from the same field of endeavor as Toshio, teaches a cassette configured to receive the test strip (Stanley: p. 12 para [0062]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Stanley to the modified device of Toshio to have a cassette configured to receive the test strip in order to compare the reference data of the sample concentration to the actual data of the analyzer (Stanley: para [0021] lines 4-8).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toshio, Liu, and Wang as applied to claim(s) 1 above, and further in view of Lee, D.-S. et al. U. S. Patent No. US 20100157300 A1 (hereinafter Lee).
Regarding claim 9, the modified apparatus of Toshio does not teach further comprising a spring clip disposed in the case, wherein the spring clip is configured to hold in place a cassette comprising the test strip.
Lee, from the same field of endeavor as Toshio, teaches further comprising a spring clip disposed in the case, wherein the spring clip is configured to hold in place a cassette comprising the test strip (Lee: para [0054] lines 3-13).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Lee to the modified device of Toshio to have further comprising a spring clip disposed in the case, wherein the spring clip is configured to hold in place a cassette comprising the test strip in order to hold the test strip in place inside the case (Lee: para [0054] lines 3-13).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toshio, Liu, and Wang as applied to claim(s) 1 above, and further in view of Allen, M. et al., US5837546A (hereinafter Allen).
Regarding claim 13, the modified apparatus of Toshio does not teach further comprising a temperature sensor in operable communication with the microprocessor and configured to measure a temperature within the case and generate an output signal indicative of a temperature of at least one of the first reading head, the second reading head, and the third reading head, wherein the microprocessor is configured to utilize the output signal to compensate for temperature interference when determining the overall analyte level.
Allen, from the same field of endeavor as Toshio, teaches further comprising a temperature sensor (Allen: fig. 2 element 34 col 8 lines 38-43) in operable communication with the microprocessor (Allen: fig. 2 element 34 col 8 lines 38-43) and configured to measure a temperature within the case (Allen: fig. 2 element 34 col 8 lines 38-43) and “generate an output signal indicative of a temperature of at least one of the first reading head, the second reading head, and the third reading head, wherein the microprocessor is configured to utilize the output signal to compensate for temperature interference when determining the overall analyte level” (Allen: fig. 2 element 34 col 8 lines 38-43).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Allen to the modified device of Toshio to have further comprising a temperature sensor in operable communication with the microprocessor and configured to measure a temperature within the case and generate an output signal indicative of a temperature of at least one of the first reading head, the second reading head, and the third reading head, wherein the microprocessor is configured to utilize the output signal to compensate for temperature interference when determining the overall analyte level in order to provide ambient temperature information for calibration adjustment at temperature extremes (Allen: fig. 2 element 34 col 8 lines 38-43).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toshio, Liu, and Wang as applied to claim(s) 1 above, and further in view of Phelan, A. et al., US7315378B2 (hereinafter Phelan).
Regarding claim 14, the modified apparatus of Toshio does not teach further comprising a background light receiver in operable communication with the microprocessor and configured to receive reflected light from an area of the test strip and generate a reflected light analog signal, wherein the microprocessor is configured to utilize the reflected light analog signal to compensate for background light when determining the overall analyte level.
Phelan, from the same field of endeavor as Toshio, teaches further comprising a background light receiver (Phelan: the background light is reflected by the reference zone as cited in column 5 lines 4-8, fig. 3 and column 6 lines 47-48) in operable communication with the microprocessor (Phelan: fig. 2 element 18 and column 6 lines 48-55) and configured to receive reflected light from an area of the test strip (Phelan: fig. 3 and column 6 lines 47-48) and generate a reflected light analog signal (Phelan: Fig. 2 element 16 and column 6 lines 44-45) wherein the microprocessor is configured to utilize the reflected light analog signal to compensate for background light when determining the overall analyte level (Phelan: this limitation is explained in column 6 lines 65-67 and column 7 lines 1-9).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Phelan to the modified device of Toshio to have further comprising a background light receiver in operable communication with the microprocessor and configured to receive reflected light from an area of the test strip and generate a reflected light analog signal, wherein the microprocessor is configured to utilize the reflected light analog signal to compensate for background light when determining the overall analyte level in order to calibrate the assay result reading device (Phelan: column 5 lines 6-7).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toshio, Liu, and Wang as applied to claim(s) 1 above, and further in view of Fuchs, C. et al., US10697954B2 (hereinafter Fuchs).
Regarding claim 16, the modified apparatus of Toshio does not teach wherein the reflectometer is configured such that the first light source, the second light source, and the third light source all provide light simultaneously with each other.
Fuchs, from the same field of endeavor as Toshio, teaches wherein the reflectometer is configured such that the first light source, the second light source, and the third light source all provide light simultaneously with each other (Fuchs: fig. 9 col 14 lines 35-40).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Fuchs to the modified device of Toshio to have wherein the reflectometer is configured such that the first light source, the second light source, and the third light source all provide light simultaneously with each other in order to simultaneously analyze three or more chemico-physical parameters of the sample (Abstract lines 1-4).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toshio, Liu, Wang, and Stanley as applied to claim(s) 17 above, in view of Lu, P. et al. U. S. Patent No. US 20090155921 A1 (hereinafter Lu), and further in view of Shareef, N. et al. JP 2005508490 A (hereinafter Shareef).
Regarding claim 18, Toshio, when modified by Liu, Wang and Stanley, teaches “a plurality of viewing slots on an upper surface thereof configured to align with the first control zone, the test zone, the second control zone, the first reading head, the second reading head, and the third reading head” (Toshio: this is shown in fig. 3).
Toshio, when modified by Liu, Wang and Stanley, does not teach wherein the cassette comprises: a well on an upper surface thereof, the well comprising an opening configured to expose the test strip and to accept the test solution so it can reach the test strip; at least one stop on the upper surface thereof configured to inhibit the cassette from being inserted past a certain, predetermined point within the reflectometer; a plurality of holes on the upper surface thereof configured to allow air to escape from within the cassette; and wherein the cassette is disposable.
Lu, from the same field of endeavor as Toshio, teaches a well (Lu: element 8 in Fig. 1 and paragraph [0035] lines 1-2) on an upper surface thereof, the well comprising an opening configured to expose the test strip (Lu: fig. 1 element 8 comprises the well which an opening configured to expose the test strip) and to accept the test solution so it can reach the test strip (Lu: this is shown in Fig. 1 elements 7 and 8 and paragraph [0035] lines 1-2 in; the well is where the test solution is accepted so it can reach the test strip);“at least one stop on the upper surface thereof configured to inhibit the cassette from being inserted past a certain, predetermined point within the reflectometer” (Lu: the spot corresponds to the part of element 7 that interacts with element 10 as shown in fig. 2 to keep element 7 in place, para [0038]);
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Lu to Toshio, when modified by Liu, Wang and Stanley, to have wherein the cassette comprises: a well on an upper surface thereof, the well comprising an opening configured to expose the test strip and to accept the test solution so it can reach the test strip; at least one stop on the upper surface thereof configured to inhibit the cassette from being inserted past a certain, predetermined point within the reflectometer in order to hold the test strip in a stable position (Lu: paragraph [0012] lines 3-4 in).
Toshio, when modified by Liu, Wang, Stanley and Lu, does not teach a plurality of holes on the upper surface thereof configured to allow air to escape from within the cassette; and wherein the cassette is disposable.
Shareef, from the same field of endeavor as Lee, teaches a plurality of holes thereof configured to allow air to escape from within the cassette (Shareef: para [0032] last sentence); and wherein the cassette is disposable (Shareef: para [0026] lines 1-2).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to apply the teaching of Shareef to Toshio, when modified by Liu, Wang, Stanley and Lu, to have a plurality of holes thereof configured to allow air to escape from within the cassette; and wherein the cassette is disposable in order to maintain the temperature of the cassette at a desirable level (Shareef: paragraph [0032] lines 5-7) and reduce the risk of contamination (Shareef: paragraph [0026] lines 1-2).
Toshio, when modified by Liu, Wang, Stanley, Lu, and Shareef, does not teach a plurality of holes on the upper surface.
The limitation “a plurality of holes on the upper surface” is simply rearrangement of parts. See MPEP 2144.04 VI-C, In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to move the “plurality of holes on the upper surface” to Toshio, when modified by Liu, Wang, Stanley, Lu, and Shareef in order to prevent the interaction of the air with the test sample.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toshio, Liu, Wang, Weiss, Stanley, Lee, Allen, and Phelan. The entire limitation of claim 19 is the combination of claims 1, 2, 4-15.
Regarding claim 19, a reflectometer, comprising:
The limitation below is equivalent to claim 1. Thus, rejected the same arts as claim 1:
“a case; a first reading head comprising first scanning optics configured to illuminate a first control zone of a test strip and receive first light from the first control zone; a second reading head comprising second scanning optics configured to illuminate a text zone of the test strip and receive second light from the test zone; a third reading head comprising third scanning optics configured to illuminate a second control zone of the test strip and receive third light from the second control zone; and a microprocessor in operable communication with the first reading head, the second reading head, and the third reading head, wherein the microprocessor is configured to: receive and analyze a first analog signal, a second analog signal, and a third analog signal corresponding to the first light, the second light, and the third light, respectively; and determine a first level of an analyte in the first control zone based on the first light, a second level of the analyte in the test zone based on the second light, a third level of the analyte in the second control zone based on the third light, and an overall level of the analyte in the test solution based on the first level, the second level, and the third level, wherein the first reading head comprises a first support disposed in the case, a first light source disposed on the support, and a first light receiver disposed on the support, wherein the second reading head comprises a second support disposed in the case, a second light source disposed on the support, and a second light receiver disposed on the support, wherein the third reading head comprises a third support, a third light source disposed on the support, and a third light receiver disposed on the support, wherein the reflectometer is configured such that the first light source, the second light source, and the third light source all provide light at a same wavelength as each other”.
The limitation below is equivalent to claim 2. Thus, rejected the same arts as claim 2:
“wherein the first light source and the first light receiver are disposed on the first support such that a first angle between a path of light emitted from the first light source and a path of light received by the first light receiver is in a range of 35o to 55o, wherein the second light source and the second light receiver are disposed on the second support such that a second angle between a path of light emitted from the second light source and a path of light received by the second light receiver is in a range of 35o to 55o, wherein the third light source and the third light receiver are disposed on the third support such that a third angle between a path of light emitted from the third light source and a path of light received by the third light receiver is in a range of 35o to 55o”
The limitation below is equivalent to claim 4. Thus, rejected the same arts as claim 4:
“wherein the first light source is a light emitting diode (LED), wherein the second light source is an LED, wherein the third light source is an LED, wherein the first light receiver is a phototransistor, wherein the second light receiver is a phototransistor, wherein the third light receiver is a phototransistor”.
The limitation below is equivalent to claim 5. Thus, rejected the same arts as claim 5:
“wherein the first reading head further comprises at least one first light-focusing device disposed on the first support, wherein the second reading head further comprises at least one second light-focusing device disposed on the second support, wherein the third reading head further comprises at least one third light-focusing device disposed on the third support, wherein the at least one first light-focusing device comprises at least one of a light piper and a collimator, wherein the at least one second light-focusing device comprises at least one of a light piper and a collimator, wherein the at least one third light-focusing device comprises at least one of a light piper and a collimator”.
The limitation below is equivalent to claim 6. Thus, rejected the same arts as claim 6:
“wherein the microprocessor converts the first analog signal, the second analog signal, and the third analog signal to a first digital signal, a second digital signal, and a third digital signal, respectively, and compares the first digital signal, the second digital signal, and the third digital signal to at least one look-up table to determine the first level of the analyte, the second level of the analyte, and the third level of the analyte based on the first digital signal, the second digital signal, and the third digital signal, respectively”.
The limitation below is equivalent to claim 7. Thus, rejected the same arts as claim 7:
“wherein the case comprises a slot at a first end thereof, the slot being configured to receive a cassette comprising the test strip”.
The limitation below is equivalent to claim 8. Thus, rejected the same arts as claim 8:
“wherein the case comprises a baffle board mounted within the case and configured to ensure that a distance from the first reading head to the test strip, a distance from the second reading head to the test strip, and a distance from the third reading head to the test strip is consistent across different test strips, wherein the baffle board comprises: a plurality of legs respectively mounted to a plurality of posts within the case; at least one stopper slot configured to receive at least one stop of a cassette comprising the test strip; and a plurality of viewing slots configured to align with the first control zone, the test zone, the second control zone, the first reading head, the second reading head, and the third reading head”.
The limitation below is equivalent to claim 9. Thus, rejected the same arts as claim 9:
“wherein the reflectometer further comprises a spring clip disposed in the case, wherein the spring clip is configured to hold in place a cassette comprising the test strip”.
The limitation below is equivalent to claim 10. Thus, rejected the same arts as claim 10:
“wherein the test solution is a biological test solution”
The limitation below is equivalent to claim 11. Thus, rejected the same arts as claim 11:
“wherein the case comprises a display screen in operable communication with the microprocessor and configured to display the overall level of the analyte”
The limitation below is equivalent to claim 12. Thus, rejected the same arts as claim 12:
“wherein the reflectometer further comprises at least one interface connector incorporated in the case and configured to connect to at least one external device”
The limitation below is equivalent to claim 13. Thus, rejected the same arts as claim 13:
“wherein reflectometer further comprises a temperature sensor in operable communication with the microprocessor and configured to measure a temperature within the case and generate an output signal indicative of a temperature of at least one of the first reading head, the second reading head, and the third reading head,
wherein the microprocessor is configured to utilize the output signal to compensate for temperature interference when determining the overall analyte level”
The limitation below is equivalent to claim 14. Thus, rejected the same arts as claim 14:
“wherein the reflectometer further comprises a background light receiver in operable communication with the microprocessor and configured to receive reflected light from an area of the test strip and generate a reflected light analog signal,
wherein the microprocessor is configured to utilize the reflected light analog signal to compensate for background light when determining the overall analyte level”
The limitation below is equivalent to claim 15. Thus, rejected the same arts as claim 15:
“wherein the first level of the analyte in the first control zone and the third level of the analyte in the second control zone are utilized to establish an upper standard and a lower standard, respectively, to which the second level of the analyte in the test zone is compared”.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toshio, Liu, Wang, Weiss, Stanley, Lee, Allen, Phelan, and further in view of Fuchs. The entire limitation of claim 20 is the combination of claims 3 ,16.
Regarding claim 20,
The limitation below is equivalent to claim 3. Thus, rejected the same arts as claim 3:
“wherein the first angle is about 45o, wherein the second angle is about 45o, wherein the third angle is about 45o”
The limitation below is equivalent to claim 16. Thus, rejected the same arts as claim 16:
“wherein the reflectometer is configured such that the first light source, the second light source, and the third light source all provide light simultaneously with each other”.
Conclusion
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/ROBERTO FABIAN JR/Examiner, Art Unit 2877
/Kara E. Geisel/Supervisory Patent Examiner, Art Unit 2877