DETAILED ACTION
National Stage Application
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 .
Claim Interpretation
The specification (e.g., see “… reference light mainly includes light for focusing, light for tracking, and light for exciting fluorescent substances …” in paragraph 34) serves as a glossary (MPEP § 2111.01) for the claim term “reference light”.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of pre-AIA 35 U.S.C. 112, second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 10 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: “one or more lenses” to at least one of the recited structure.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were effectively filed absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned at the time a later invention was effectively filed in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 of this title, 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) 1-3, 8, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tiao et al. (US 2018/0149594) in view of Hirata et al. (US 2005/0270641).
In regard to claim 1, Tiao et al. disclose a test system, comprising:
(a) a carrier disc configured to carry a target sample (e.g., see “… Deoxyribonucleic acid (DNA) located on the sample S … glass holder 160 is a circular cartridge, and the circular cartridge is adapted to rotate, so that the chip C and the sample S move along a path perpendicular to the transmission path of the focusing light L_F …” in
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and paragraphs 24 and 31);
(b) a light source module configured for emitting reference light of at least two different wavelengths (e.g., see “… at least one scanning light source 120 includes a first scanning light source 120A and a second scanning light source 120B … wavelength of the first scanning light L_S1 is different from a wavelength of the second scanning light … for example … laser light having a 635 nanometers wavelength and configured to stimulate the red fluorescent dye Cy5 … laser light having a 520 nanometers wavelength and configured to stimulate the green fluorescent dye Cy3 …” in Fig. 1 and paragraph 22);
(c) a light guiding module located on an emitting path of the reference light, being configured for guiding the reference light to the target sample, and being configured for receiving and guiding detection light of at least two different wavelengths, the detection light being generated by the target sample in response to the reference light being projected on the target sample (e.g., see “… first optical guiding structure 114 is configured to guide the first scanning light L_S1 and the second scanning light L_S2 to the sample S to generate a first secondary light L_Se1 and a second secondary light …” in Fig. 1 and paragraph 22); and
(d) a detection module configured for receiving the detection light and obtaining biochemical information of the target sample according to the detection light (e.g., see “… In general, fluorescent dyes in different colors like Cy3 (green) and Cy5 (red) will be used to mark the biological samples and the standard control samples. When using excitation light sources in different wavelengths to excite fluorescent dyes, the corresponding fluorescences will be produced. By detecting the positions of the fluorescences, the sequences and the structures of DNA can be learned … light receiving device 130 includes … an avalanche photo diode (APD) … dichroic device DM4 is configured to separate the first secondary light L_Se1 from the second secondary light, so that the first secondary light L_Se1 and the second secondary light can be received by the light receiving device respectively …” in Fig. 1 and paragraphs 3 and 26),
wherein the light guiding module comprises an objective lens, the objective lens is configured to guide the reference light to the carrier disc and guide the detection light to the detection module, the detection light includes a first detection light and a second detection light, wavelength ranges of the first detection light and the second detection light are 550 nm to 740 nm (e.g., see “… fluorescent dyes in different colors like Cy3 (green) and Cy5 (red) … objective lens OL …” in Fig. 1 and paragraphs 3 and 23).
The system of Tiao et al. lacks an explicit description of details of the “… objective lens OL …” such as first, second, and third lens units arranged in sequence along the test system’s optical path, wherein each of the first and second lens units comprises a convex lens and a concave lens bonded to each other, wherein a numerical aperture of the objective lens is 0.6, and wherein a wave aberration of the objective lens is <0.07λ (e.g., 0.07λ=0.07x550 nm=38.5 nm). However, “… objective lens …” details are known to one of ordinary skill in the art (e.g., see “… With this configuration, an optical system with a high signal-to-noise ratio can be obtained … objective optical system unit 4 includes …. a negative compound lens, composed of a biconvex lens L16 and a biconcave lens L17 … a positive compound lens composed of a biconvex lens L18 and a negative meniscus lens L19 … a biconvex lens L23 … Numerical aperture at specimen side of NAob 0.69 … Optical Performance: Wavefront aberration, RMS value (unit: wavelength) … 546.07 0.019 …” in paragraphs 32 and 94 and tables 1 and 2 of Hirata et al.). It should be noted that “when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable results”. KSR International Co. v. Teleflex Inc., 550 U.S. 398 at 416, 82 USPQ2d 1385 (2007) at 1395 (citing United States v. Adams, 383 U.S. 39, 40 [148 USPQ 479] (1966)). See MPEP § 2143. In this case, one of ordinary skill in the art could have substituted a known conventional objective lens (e.g., comprising details such as “a negative compound lens, composed of a biconvex lens L16 and a biconcave lens L17”, “a positive compound lens composed of a biconvex lens L18 and a negative meniscus lens L19”, and “a biconvex lens L23”, in order to achieve “NAob 0.69” with “0.019” “Wavefront aberration, RMS value (unit: wavelength)” for “high signal-to-noise ratio”) for the objective lens of Tiao et al. and the results of the substitution would have been predictable. Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide a known conventional objective lens (e.g., comprising details such as a first lens unit, a second lens unit, and a third lens unit arranged in sequence along an optical path of the test system, each of the first lens unit and the second lens unit comprises a convex lens and a concave lens bonded to each other, a numerical aperture of the objective lens is 0.6, and a wave aberration of the objective lens is less than 0.07λ) as the objective lens of Tiao et al.
In regard to claim 2 which is dependent on claim 1, Tiao et al. also disclose that the light source module comprises a first laser source and a second laser source, the first laser source is configured to emit a first reference light of the reference light, and the second laser source is configured to emit a second reference light of the reference light (e.g., see “… at least one scanning light source 120 includes a first scanning light source 120A and a second scanning light source 120B … wavelength of the first scanning light L_S1 is different from a wavelength of the second scanning light … for example … laser light having a 635 nanometers wavelength and configured to stimulate the red fluorescent dye Cy5 … laser light having a 520 nanometers wavelength and configured to stimulate the green fluorescent dye Cy3 …” in Fig. 1 and paragraph 22), the detection module comprises a first detector configured for receiving the first detection light of the detection light and a second detector configured for receiving the second detection light of the detection light, the first detector and the second detector are located in different optical paths, the detection module is configured to obtain the biochemical information of the target sample according to the first detection light and the second detection light (e.g., see “… In general, fluorescent dyes in different colors like Cy3 (green) and Cy5 (red) will be used to mark the biological samples and the standard control samples. When using excitation light sources in different wavelengths to excite fluorescent dyes, the corresponding fluorescences will be produced. By detecting the positions of the fluorescences, the sequences and the structures of DNA can be learned … light receiving device 130 includes … an avalanche photo diode (APD) … dichroic device DM4 is configured to separate the first secondary light L_Se1 from the second secondary light, so that the first secondary light L_Se1 and the second secondary light can be received by the light receiving device respectively …” in Fig. 1 and paragraphs 3 and 26).
In regard to claim 3 which is dependent on claim 2, Tiao et al. also disclose that the first detector and the second detector are photodiodes (e.g., see “… In general, fluorescent dyes in different colors like Cy3 (green) and Cy5 (red) will be used to mark the biological samples and the standard control samples. When using excitation light sources in different wavelengths to excite fluorescent dyes, the corresponding fluorescences will be produced. By detecting the positions of the fluorescences, the sequences and the structures of DNA can be learned … light receiving device 130 includes … an avalanche photo diode (APD) … dichroic device DM4 is configured to separate the first secondary light L_Se1 from the second secondary light, so that the first secondary light L_Se1 and the second secondary light can be received by the light receiving device respectively …” in Fig. 1 and paragraphs 3 and 26).
In regard to claim 8 which is dependent on claim 1, Tiao et al. also disclose that the test system is configured to obtain biological information comprising base sequence information of nucleic acid as the target sample (e.g., see “… In general, fluorescent dyes in different colors like Cy3 (green) and Cy5 (red) will be used to mark the biological samples and the standard control samples. When using excitation light sources in different wavelengths to excite fluorescent dyes, the corresponding fluorescences will be produced. By detecting the positions of the fluorescences, the sequences and the structures of DNA can be learned … light receiving device 130 includes … an avalanche photo diode (APD) … dichroic device DM4 is configured to separate the first secondary light L_Se1 from the second secondary light, so that the first secondary light L_Se1 and the second secondary light can be received by the light receiving device respectively …” in Fig. 1 and paragraphs 3 and 26).
In regard to claim 9 which is dependent on claim 1, Tiao et al. also disclose that the test system is configured to obtain biological information of the target sample that carries a fluorescent substance, the light source module is further configure to emit laser light as the reference light, and the detection module is further configured to receive fluorescent light as the detection light (e.g., see “… In general, fluorescent dyes in different colors like Cy3 (green) and Cy5 (red) will be used to mark the biological samples and the standard control samples. When using excitation light sources in different wavelengths to excite fluorescent dyes, the corresponding fluorescences will be produced. By detecting the positions of the fluorescences, the sequences and the structures of DNA can be learned at least one scanning light source 120 includes a first scanning light source 120A and a second scanning light source 120B … wavelength of the first scanning light L_S1 is different from a wavelength of the second scanning light … for example … laser light having a 635 nanometers wavelength and configured to stimulate the red fluorescent dye Cy5 … laser light having a 520 nanometers wavelength and configured to stimulate the green fluorescent dye Cy3 … … light receiving device 130 includes … an avalanche photo diode (APD) … dichroic device DM4 is configured to separate the first secondary light L_Se1 from the second secondary light, so that the first secondary light L_Se1 and the second secondary light can be received by the light receiving device respectively …” in Fig. 1 and paragraphs 3, 22, and 26).
Claim(s) 4-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tiao et al. in view of Hirata et al. as applied to claim(s) 2 above, and further in view of Nagatomi (US 2015/0276598).
In regard to claim 4 which is dependent on claim 2, Tiao et al. also disclose a focusing and tracking module, wherein the focusing and tracking module is configured to receive a focusing light which are emitted by the target sample and combined into the detection light, and to obtain a focus signal and a tracking signal generated by the focusing light which are emitted by the target sample and combined into the detection light, and the focus signal and the tracking signal are configured to adjust positions where the first reference light and the second reference light are incident on the carrier disc (e.g., see “… photodetector of the control unit 116 is configured to receive the focusing light L_F returned from the surface C1 of the chip C, and the control unit 116 is, for example, configured to send a servo signal to a voice coil motor VCM of the first optical guiding structure 114 to keep the focusing light L_F and the at least one scanning light L_S focusing on the same surface C1 of the chip C …” in Fig. 1 and paragraph 21). The system of Tiao et al. lacks an explicit description of details of the “… focusing light …” such as being the first reference light. However, “… focusing light …” details are known to one of ordinary skill in the art (e.g., see “… correctly and efficiently apply a light beam to a specimen across the entire region from the inner radial portion to the outer radial portion of the specimen holding carrier and a fluorescence detector using the same … part of the incident excitation light beam is reflected on the reflective film 14, and the most part is transmitted through the reflective film 14. The excitation light beam reflected on the reflective film 14 is used for control that the focal point of the excitation light beam is caused to follow the track as described later. Moreover, the excitation light beam transmitted through the reflective film 14 reaches the well 13, and is applied to the specimen accommodated in the well 13. Thus, fluorescence is emitted from the specimen …” in paragraphs 16 and 56 of Nagatomi). It should be noted that “when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable results”. KSR International Co. v. Teleflex Inc., 550 U.S. 398 at 416, 82 USPQ2d 1385 (2007) at 1395 (citing United States v. Adams, 383 U.S. 39, 40 [148 USPQ 479] (1966)). See MPEP § 2143. In this case, one of ordinary skill in the art could have substituted a known conventional focusing light (e.g., comprising details such as “part of the incident excitation light beam is reflected” and “excitation light beam transmitted through the reflective film 14 reaches the well 13, and is applied to the specimen accommodated in the well 13. Thus, fluorescence is emitted from the specimen”, in order to “control that the focal point of the excitation light beam is caused to follow the track” so as to “correctly and efficiently apply a light beam to a specimen across the entire region from the inner radial portion to the outer radial portion of the specimen holding carrier and a fluorescence detector using the same”) for the focusing light of Tiao et al. and the results of the substitution would have been predictable. Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide a known conventional focusing light (e.g., comprising details such as being the first reference light) as the focusing light of Tiao et al.
In regard to claim 5 which is dependent on claim 4, Tiao et al. also disclose that the light guiding module comprises a first light splitting element, the first light splitting element is configured for guiding the reference light emitted by the light source module to the carrier disc, and for guiding the detection light to the detection module (e.g., see “… dichroic devices … DM2 …” in Fig. 1 and paragraph 27).
In regard to claim 6 which is dependent on claim 5, Tiao et al. also disclose that the light guiding module further comprises a second light splitting element, the second light splitting element is configured to guide the first detection light and the second detection light to the detection module, and to guide the focusing light in the detection light to the focusing and tracking module (e.g., see “… dichroic devices DM1 …” in Fig. 1 and paragraph 27).
In regard to claim 7 which is dependent on claim 6, Tiao et al. also disclose that the light guiding module further comprises a third light splitting element, the third light splitting element is configured to guide the first detection light to the first detector, and to guide the second detection light to the second detector (e.g., see “… light receiving device 130 includes … an avalanche photo diode (APD) … dichroic device DM4 is configured to separate the first secondary light L_Se1 from the second secondary light, so that the first secondary light L_Se1 and the second secondary light can be received by the light receiving device respectively …” in Fig. 1 and paragraph 26).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tiao et al. in view of Hirata et al. as applied to claim(s) 1 above, and further in view of Hwang et al. (Simulation of an oil immersion objective lens: A simplified ray-optics model considering Abbe’s sine condition, Optics Express Vol. 16, no. 26 (December 2008), pp. 21170-21183).
In regard to claim 10 which is dependent on claim 1 in so far as understood, Tiao et al. also disclose one or more lenses (e.g., see “… objective lens OL … focusing lens FL …” in Fig. 1 and paragraph 23). The system of Tiao et al. lacks an explicit description of details of the “… lens …” such as being made of glass. However, “… lens …” details are known to one of ordinary skill in the art (e.g., see “… Modern objective lenses made up of many glass lens elements and have attained a high quality and an excellence in performance based on the great extent of correction employed for primary optical aberrations. The manufacturers provide specification of the objective lens based on the parameters, such as numerical aperture (NA), magnification (M), working distance (WD), degree of aberration correction and certain other important characteristics, that are normally imprinted on the barrel of the objective lens …” in the first section 1 paragraph of Hwang et al.). It should be noted that “when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable results”. KSR International Co. v. Teleflex Inc., 550 U.S. 398 at 416, 82 USPQ2d 1385 (2007) at 1395 (citing United States v. Adams, 383 U.S. 39, 40 [148 USPQ 479] (1966)). See MPEP § 2143. In this case, one of ordinary skill in the art could have substituted a known conventional lens (e.g., comprising details such as “objective lenses made up of many glass lens elements”, in order to use an objective from one of the “manufacturers”) for the unspecified lens of Tiao et al. and the results of the substitution would have been predictable. Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide a known conventional lens (e.g., comprising details such as at least one of the lenses is made of glass) as the unspecified lens of Tiao et al.
Response to Arguments
Applicant’s arguments with respect to the amended claims have been fully considered but are moot in view of the new ground(s) of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Shun Lee whose telephone number is (571)272-2439. The examiner can normally be reached Monday-Friday.
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/SL/
Examiner, Art Unit 2884
/DAVID J MAKIYA/Supervisory Patent Examiner, Art Unit 2884